bsi_april 2016_raj gunashekar

1An MM Activ Publication | www.biospectrumindia.com | April 2016 | BioSpectrum

Volume 14 Issue 4 April 2016 www.biospectrumindia.com

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India’s

trillion-dollar

opportunities

in ICT, IoT

LATESTBIOSUPPLIERTECHNOLOGIES



BIOTALKPadma ShriAwardee,Prof. DipankarChatterji

BIOTALKPadma ShriAwardee,Prof. VeenaTandon

BIOTALKPadma BhushanAwardee,Dr Alla VenkataRama Rao

ARTICLES BYTHE INDUSTRY CAPTAINS

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4 BioSpectrum | April 2016 | www.biospectrumindia.com | An MM Activ Publication

Volume 14 Issue 4 April 2016 www.biospectrumindia.com

An Publication

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India’s

trillion-dollar

opportunities

in ICT, IoT




BIOTALKPadma ShriAwardee,Prof. DipankarChatterji

BIOTALKPadma ShriAwardee,Prof. VeenaTandon

BIOTALKPadma BhushanAwardee,Dr Alla VenkataRama Rao

ARTICLES BYTHE INDUSTRY CAPTAINS

COVERDESIGN BY: SHIHAB K A

BioContents

REGULARS

7 BIOEDIT

8 BIOMAIL

10 BIONEWS

62 BIOSUPPLIERS

65 BIOPEOPLE

COVERSTORY 20

BIOANALYSIS

BIOTALK

INTRODUCING THE ‘PFIZERKLINE EMPIRE’57

QE PRIZE WINNER DR LANGER SHARES HIS SUCCESS

Dr Robert Langer Winner of Queen Elizabeth Prize of Engineering 2015, & David H Koch Institute Professor, MIT, USA

16

464851

Latest BioSupplier Technologies

2016 Padma Shri Awardee Prof. Dipankar Chatterji

2016 Padma Shri Awardee, Prof. Veena Tandon

2016 Padma Bhushan Awardee, Dr Alla Venkata Rama Rao

‘We have performed extraordinarily well’

‘I did not want to follow the convention’

Scientific Research and Entrepreneurship does not go hand-in-hand

BIOSPECTRUM IS

PUBLISHING A SELECTION

OF OPEN INVITATION

ARTICLES BY THE

INDUSTRY CAPTAINS,

HIGHLIGHTING THE

LATEST BIOSUPPLIER

TECHNOLOGIES/

PRODUCTS THAT

ARE ENABLING THE

BIOSCIENCES INDUSTRY

ON THE COURSE OF DRUG

DISCOVERY.


BioContents

BIOIT

INDIA’S TRILLION-DOLLAR OPPORTUNITIES IN ICT, IOT

68

BIOCLUSTER

SCIENTISTS WELCOME NATIONAL BIOTECHNOLOGY DEVELOPMENT STRATEGY

54

Satyen Mohapatra

Madavan Vasudevan, Hitesh Goswami and Rohit Nandan Shukla., cofounders

Dr Sudha Rao, Founder & Director, Dhiti Omics

‘BELIEVE AND TAKE THE LEAP OF FAITH’

DEGREES FROM BEST SCHOOLS IS NO GUARANTEE FOR ENTREPRENEURIAL SUCCESS

72

80

BIOPRENEUR

BIOEVENT

ENVISIONING NANO HORIZONS

BIOPHARMA & HEALTHCARE SUMMIT ON JUNE 2 IN US

60

66

BANGALORE INDIA NANO 2016


Fourteen years ago, in March 2002, In-dia unleashed the power of technol-ogy to Indian farm-ers by allowing first

commercial cultivation of geneti-cally-modified (GM) crops.

But 14 years later, March 2016, the Indian government has sought to roll back the same

gains made by technology by unleashing arbi-trary state power in twin actions that seek to undermine the fledgling biotech industry.

And the twin government actions targeting the industry came within 48 hours of each other. On March 10, the government notified a sharp 74 percent reduction in trait fee (technology fee) charged by Bt cotton developer Monsanto on all the Bt cotton seeds sold by it from Rs 163 per pack to Rs 43. Also, the price of 450 gm packet of Bt cotton seed was fixed at Rs 800.The prevailining market prices of more than 200 varieties of cotton hybrids that carried the Bt gene ranged from Rs 830 to 1,200.

Monsanto has got a stay order on this action from Karnataka High Court. The world’s leading seed company has threatened to even pull out of the country over this issue jeopardizing the bil-lions of dollars invested in the R&D center and extension networks over the past three decades.

Such an action is throwback to the 1970 when two leading MNCs, IBM and Coca-Cola were thrown out of the country amidst nationalistic fervor. These two companies have come back so strongly that they are employers of thou-sands of people in the country and among the most trusted brands now.

Prime Minister Narendra Modi’s ministers spouting similar sentiments and Monsanto’s technology will be replaced by indigenous Bt cotton seeds are sheer bravado, not rooted in realism. The few GM technologies developed in

Indian laboratories have been starved of funds for more than 15 years even to carry out man-datory field trials to seek regulatory approval for commercial cultivation.

Monsanto needs the Indian market, the world’s second largest cotton grower, as much as the country needs this technology at the moment. The sensible thing to do is fast track develop-ment of indigenous technologies and let them compete in the global marketplace. Resorting to arbitrary state power in the world’s fast growing economy is certainly not a sign of strength.

The second government action happened on March 12, 2016 when the Chandrakant Kokate (VC, KLE University, Belgaum) report on fixed dose combination (FDC) drugs was pulled out of the freezer and used to instantly ban 344 drug combinations that have become the main-stay for Indian patients for decades. The Ko-kate report, prepared by the expert committee, was with the government since January 2015.

Why March 12, 2016 was chosen to shock the nation is a question which has no convincing answer. The Kokate committee has done a good job on this contentious issue in less than two years. There are many differing views on these combinations. The right thing to do would have been to put the report in public domain, initiate wide ranging discussions and prepare the ground for subsequent action. Such a step would have helped the society better.

A nation seeking global investments should refrain from arbitrary actions that undermine business confidence. India’s open society that assimilates the best from around the world for millennia deserves better. BS

Narayanan Suresh Group Editor

[email protected]

Price control, arbitrary bans threaten to unravel the biotech industry

BioEdit

*********


Vol 14; Issue 3; March 2016

Startlingstart-upsThe cover story on biotech start-ups wastimely.We do hear aboutstartups in commerce and IT on a daily basis.It was good to see biotech is not behind andthesefirms are coming up with novel ideas.It will definitely give the much needed push to the sector andcontribute to ‘DBT’s $100 bn by 2020’ project besides solving health woos of the country.

-Payal Mukherjee, Bangalore

Cloud computingThis has reference to the story on cloud computing in the last issue of BioSpectrum.IT has disrupted all sectors and life sciences is not far behind.This certainly is an era of cloud computing and the life science firms should move ahead and adopt cloud-based systems.The cover story on the start-ups made forinteresting and inspiring read.

- Priyansh Sen, Ahmedabad

Bravo BioSpectrumI would like to applaud BioSpectrum for doing a com-mendable job of highlightingstartupsinbiotech.Iwas amazed to see the number of startups in the biotech field.It certainly dispels the myth that funding is a hindrance in this field because of longer gestation period.DBT and BI-RAC are doing a good job by supporting biotech startups.

-Aditya Mahajan, Hyderabad

Highlight scientific researchMy heartiest congratulations to the entire BioSpectrum team to come up with such a wonderful and inspiring anni-versary issue. Just a request, it would be great if BioSpec-trum also take an initiative to publish about the research in the country, more frequently. It would help in highlight-ing scientific research in the country and re-energize the scientists as the research news seldom makes headlines.

Ankit Mehra, Noida

BIOSPECTRUM

RECREATING THE SILICON

VALLEY IN IN

DIA

MARCH 2016

Volume 14 Issue 3 March 2016 www.biospectrumindia.com

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India at the moment is at this cusp.

RECREATING THE

SILICON VALLEYIN INDIA

What’s

trending in

Indian Biotech

13TH ANNIVERSARY SPECIAL

Vol 14; Issue 4; April 2016

Publisher: Jagdish Patankar

EditorialChief Editor: Narayanan SureshEditor: Srinivas Rao ChandanExecutive Editor: Srinivas RasoorSenior Correspondent: Raj Gunashekar

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BioNews

Novartis launches the first IL-17A inhibitor to receive approval in IndiaNovartis Healthcareannounced the launch of Scapho (secukinumab)150 mg, for the treatment of moderate-to-severe plaque psoriasis in adult patients. Scapho is an injectable medicine and the first interleukin-17A (IL-17A) inhibitor to be approved in India.This approval marks a sig-nificant milestone in the treatment of psoriasis, providing a new and im-portant first-line biologic treatment option for patients who are candi-dates for systemic therapy.

Secukinumab was developed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic ther-apy with a recommended dose of 300 mg.Secukinumab has demonstrated a statistically significant improve-ment in clearing psoriatic lesions as early as 3 weeks.

“This is ground breaking news as clear skin can now be a reality for pa-tients struggling to cope with psoria-sis,” said DrAnchala Parthasaradhi, Director, Anchala Skin Institute, Hy-derabad. “Most psoriasis patients are not content with current therapy op-tions including the earlier biologics and there is a significant unmet need.Secukinumab seems to be a promis-ing treatment for psoriasis and can provide patients a better chance of achieving clear or almost clear skin.”

BioNews

Sun appoints Dhoni as Revital Hbrand ambassador

Sun Pharma’s Global Consumer Healthcare business announced-MSDhoni as the new brand am-bassador of Revital H. MSDhoni emerged as a popular choice based on aconsumer research conducted by the company.MS Dhoni is a cricketer known for pushing lim-its and achieving more and a per-

fect combination of physical fitness,strategic thinking and decision mak-ing and fits well in the active lifestyle value proposition of Revital H brand.

The brand has a strong hold on North, Central and East part of India and seeks to strengthen its market presence in West and South India.

Twenty-five years following its launch in the Indian market, Revital H, India’s leading health supplement gets a new makeover. Sun Pharma’s Global Consumer Healthcare is repositioning its iconic brand for active lifestyle and being ‘fit and active’. This repositioning follows a compre-hensive research undertaken by the company to understand changing consumer needs. The Vitamin and Dietary Health Supplement market in India is estimated to be Rs 8,828 crore and growing at 12 percent with top 10 brands (of which Revital H is a part) in the category contributing almost 48 percent of the market revenue.

Glenmark receives tentative approval for new genericGlenmark Pharmaceuticals USA (Glenmark) has been granted tentative approval by the United States Food and Drug Administration (US FDA) for its Lacosamide Oral Solution, 10 mg/mL, the generic version of Vimpat Oral Solution, 10 mg/mL of UCB.

Glenmark will market this product upon receiving final approval of its Lacosamide Oral Solution, 10 mg/mL ANDA. The patent listed in the Or-ange Book for Vimpat Oral Solution, 10 mg/mL is scheduled to expire on March 17,2022.

According to IMS Health sales data for the 12-month period ending Janu-ary 2016, the Vimpat market achieved annual sales of approximately $55.4 million.


BioNews

Torrent Pharma’s Dahej plant receives EIR from FDAPrior to this approval, the plant has also received approval from EU Germany.It was set up to cater mainly to the regulated in-ternational markets such as US, Brazil, Germany etc.

With the approval, this plant is now the 3rdplant of Torrent Pharma to receive US FDA ap-proval, out of its 5 manufactur-ing units.The company’s other US FDA approved plant include the plant at Indrad, Gujarat and Pithampur (Indore), MP.

The plant is spread across 70 acres with a built up area of around 97,000 sq. mtr.Phase I has an installed capacity of about 7,500 million tablets/cap-sules and 25 MT API per annum.

As per the company, construc-tion of phase II will commence soon and once commissioned the total capacity will increase to about 14,000 million tablets/capsules and 80 MT API per year.

Aurobindo Pharma gets FDA okay for sodium tablets Aurobindo Pharma is pleased to announce that the com-pany has received final approval from the US Food and Drug Administration (USFDA) to manufacture and mar-ket Naproxen Sodium Tablets USP, 220 mg (OTC).This product is expected to be launched in Q1 FY16-17.

The approved ANDA is bioequivalent and therapeutically

equivalent to the reference listed drug product (RLD) Aleve Tablets, of Bayer Healthcare.

Naproxen sodium tablets is used in the treatment and pre-vention of osteoporosis in postmenopausal women.The ap-proved product has an estimated market size of $96 million for the 12 months ending January 2016 according to IMS.

Pfizer launches Gelusil sachetPfizer’s GEP (Global Established Products) division in India announced the launch of its largest selling antacid Gelusil liquid in a ready-to-drink, on-the-go sachet for-mat.The sachet aims to reach out to consumers who are constantly on the go and have to rely on mul-tiple elements of cure to settle the acidity attacks.Being rolled out in metros, smaller towns and rural areas simultaneously, the Gelusil sachet is available across pharmacy stores and is priced at Rs 8per sachet.

Commenting on this launch, Mr Partha Ghosh, senior di-rector (Global Established Products) said, “Acidity can be a recurring condi-tion which can strike anyone, anytime, anywhere. It can cause heartburn and serious discomfort which can im-

pact normal work. Research reveals that many who suffer from acidity do not take it seriously and either ignore it or resort to traditional methods to deal with acidity attacks.While traditional methods may provide

symptomaticrelief,it does not ad-dress the real issue.

Gelusil’s balanced formula not only provides instant relief by neutralizing the acid secreted but also provides long lasting relief by protecting the stom-ach lining from damage due to excessive acid.”

This newly launched easy-to-carry sachet has a unique proposition of a ready-to-consume solution for acidity that does not require water or a glass.Itstamperproof packaging makes it convenient to carry and consume it just anytime/anywhere.


BioNews

Cipla invests extra $3 mn in Chase Pharmaceuticals“Cipla (EU),UK (‘Cipla UK’),a wholly owned subsidiary of the company, has pursuant to the approval of the board of Cipla UK, made an additional investment of $3 mil-lion in Chase Pharmaceuticals Corporation US (‘Chase’) towards full settlement of its obligation under the agreed arrangement for investment in Chase,”Cipla said in a fil-ing to BSE

“Consequently, Cipla UK’s total investment in Chase would aggregate to approximately $5.12 million for a 16.7 percent stake on a fully diluted basis,” it added.

The company in May 2014 had invested $1.5 million to acquire 14.6 percent stake in Chase Pharmaceuticals.

APAC market to offer huge opportunities in Cell AnalysisCell analysis plays a major role in gene identification, protein identification, transcription analysis and epig-enomics at cellular level.

It proves to be an ultra-sensitive device to elucidate spe-cific molecular processes and pathways and reveal the na-ture of cell heterogenecity.

Hospitals, academic institutions, government bodies, as well as pharmaceutical and biotechnology firms are in-creasing their focus on application of cell analysis as a modern emerging tool in research, drug discovery and diagnosis.

The cell analysis techniques global market is segmented into molecular approaches, image-based approaches and others.

The molecular approaches include the PCR, NGS and Microfluidics, cell isolation & separation techniques per-formed at cells genomic level, whereas the image-based approaches include microscopes, FISH, FRAP, tracking, high content screening (HCS), cytometrytechniques etc.

Biocon inks agreement with Lab PiSA for rh-insulin in USABiocon announced that its wholly owned subsidiary Bio-con SA has entered into an agreement with Laboratorios PiSA S.A. de C.V (PiSA) of Mexico forco-development and commercializationof generic recombinant human in-sulin (rh-insulin) for the US market.

This collaboration is a part of Biocon’s strategy to address the large demand for generic rh-insulin in the US,which accounts for over 40% of the global sales of $5 billion.

This is an extension of the company’s long standing relationship of over 10 years with its trusted partner, PiSA,who has a dominant position in insulins in Mexico.Biocon’s insulin glargine was the first to be approved in Mexico in 2015, as per the new bio-comparable approvals pathway. Both companies are committed to providing af-fordable access to insulins to patients.

This is a cost and profit sharing agreement with Biocon responsible for clinical development, regulatory approv-als, and commercialization of the product in the US.

This partnership will leverage Biocon’s manufacturing facilities for the drug substance and PiSA’s drug product facilities in Mexico. Furthermore, this arrangement will take advantage of Pisa’s proximity to the US market and Mexico’s NAFTA membership,which will ensure an effi-cient and optimal supply chain to address the needs of the US healthcare system for an affordable, high quality rh-insulin.

Biocon’s global clinical development experience with Insulin Glargine for the US will be a useful precedent in developing rh-insulin for the US market.Through this collaboration,we will introduce rh-insulin under the Bio-con brand to address the$2 billion market opportunity in the US.

Biocon Chairperson & MD Kiran Mazumdar-Shaw said: “Our partnership with PiSA demonstrates our commit-ment to provide access to affordable insulins to patients in the US. This collaboration will enable us to manufac-ture the rh-insulin drug product at PiSA’s facilities.”

91-22-41515151 / 41515111

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Nilsan Nishotech Systems Pvt Ltd

Plot No. -199E,MIDCThane Belapur Road,

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BioNews

India becomes second EMBO Associate Member StateThe Government of India through the Department of Biotechnology (DBT), Ministry of Science and Technology, EMBO and its inter-governmental funding body, the European Mo-lecular Biology Conference (EMBO), have signed a cooperation agreement to strengthen scientific interaction and collaborative research between India and Europe.After the signing of an agreement with Singapore in July 2015,India will now become the sec-ond country to acquire the status of EMBC Associate Member State.

The goal of the agreement is to boost Indo-European exchange and to pro-vide a platform for interaction with top-level scientists on both sides.As an EMBC Associate Member State, researchers workinginIndia are now eligible to participate in all EMBO programmesand activities.In-dian scientists can apply to EMBO’s programmes,such as long-term fel-lowships for postdoctoral research-ers, short-term fellowships, courses and workshops, as well as the EMBO Young Investigator Programme.At the same time, Europe will benefit from networking with the top-level scientists in India’s research com-munity. Deeper cooperation between nations will stimulate vision, ideas, and provide a framework for a long-term partnership.

“Through EMBO, we will not only have the excellent joint programmes that benefit India and Europe, but we hope to be a magnet that attracts bright young people to science from in- and outside India,” said Professor K VijayRaghavan, secretary of DBT, for the Government of India.

Strides acquire 3 brands from Moberg Pharma for $10 mnStrides Shasunannounced that its wholly-owned subsidiary Strides Pharma-has entered into an agreement with Moberg Pharma, Sweden, and its affili-ates to acquire Jointflex, Fergon and Vanquish brands for a total consider-ation of $10 million plus inventory value at closing.

The transaction adds $6.1 million of revenueand delivers above company EBITDA margins.Recent acquisitions has enabled Strides Shasun build an emerging OTC franchise both in its regulated and emerging markets.

The announced acquisition strengthens Strides Shasun’s strategy to build a global OTC franchise.The OTC portfolio now includes market leading Chem-ists Own umbrella brand in Australia and Nuprin in the US, acquired by erst-while Shasun from Scolr Pharma, US.

Nuprin has the global rights to the first Ibuprofen 12-hour Extended-Release (ER) tablets, as well as the associated Controlled Delivery Technology (CDT).The company has also filed ANDA’s that will further enhance the OTC port-folio in the US.

Once-a-week drug for Type 2 diabetes launchedEli Lilly and Company announced the launch of its recently approved dia-betes treatment Trulicity (dulaglutide) in India.Trulicity is the first once-weekly,injectable medication designed to improve blood sugar control in adults with type 2 diabetes.

Trulicity is part of a class of drugs known as a glucagon - like peptide (GLP-1) receptor agonists. It is not insulin and mimics the effects of GLP-1, a natural hormone that helps keep blood sugar levels normal, by helping the body re-lease its own insulin after food intake.

Trulicity (dulaglutide) comes in an easy to use, single-dose pen that does not require mixing or measuring and can be administered at any time of the day, independent of meals.

“Diabetes is a big burden on the healthcare system in India. Millions of Indians live with diabetes and have diverse needs”,said Edgard Olaizola, Managing Director, Lilly India.

He added, “Trulicity is an important addi-tion to our diabetes portfolio in India and this launch is an important milestone in our jour-ney to help a large number of patients and their caregivers.


BioNews

TR-Pharm, Dr Reddy’s announce collaborationDr Reddy’s Laboratories and TR-Pharm announced a strategic col-laboration agreement involving 3 biosimilar products. A total of three products will be registered and sub-sequently commercialized as a part of this agreement by TR-Pharm in Turkey. TR-Pharm will also manu-facture the drug substance and drug product upon completion of its facil-ity investment.

Mr Mehmet Göker, general manager of TR-Pharm, said, “Biosimilars are a key component of our investment strategy in Turkey to establish bio-technological API production for national use and regional exports.This agreement will not only enable more affordable medication but also support our research and develop-ment initiatives by building expertise within the country. We are pleased to have already started laying out the groundwork for manufacturing with Dr Reddy’s for high quality biosimi-lar products.”

Mr M V Ramana, executive vice-president and head branded markets (India and Emerging countries), said, “Turkey is a key emerging market and we are pleased to partner with TR-Pharm to ensure that patients in the region get access to our portfolio of high quality biosimilar products. Dr Reddy’s Laboratories is and re-mains committed to providing access to affordable and innovative drugs to populations around the world, and this partnership will make this hap-pen in Turkey.”

The partnership will also enable Dr Reddy’s to widen the global footprint of its biosimilar business.

3D-printed ‘Sneezeometer’ to help asthma patientsIndia has an estimated 15-20 million asthmatics with up to 15% of 5-11 year olds suffering the disease.

Research undertaken at the University of Surrey, UK, has led to the devel-opment of the world’s first ‘sneezeometer’, an airflow sensor or ‘spirom-eter’ that is sensitive enough to measure the speed of a sneeze.

For use in helping to diagnose a variety of respiratory conditions, the sneezeometer is twice as fast, and more sensitive than any other available device.

Spirometers measure lung capacity and are used widely to diagnose a vari-ety of chronic and acute respiratory conditions including asthma, Obstruc-tive Sleep Apnoea and Hypopnoea.

However, current devices are expensive, cumbersome and lack the sensi-tivity required in difficult diagnostic situations, such as neonatal care. An ultra-sensitive spirometer, Surrey’s sneezeometer measures the flow rate of air through a patient’s lungs.

MSF challenge to Pfizer’s patent on pneumonia vaccine

Médecins Sans Frontières/Doc-tors Without Borders (MSF) has filed a ‘patent opposition’ in In-dia to prevent US pharmaceuti-cal company Pfizer from getting a patent on the pneumococcal con-jugate vaccine (PCV13), so more affordable versions can become available to developing countries

and humanitarian organizations.

This is the first time a vaccine (biosimilar) patent has been challenged in India by a medical organization,with the goal of millions more children being protected against deadly pneumonia.

Pneumonia is the leading cause of childhood death,killing almost one mil-lion children each year.

Currently, pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) are the only two manufacturers of the vaccine, which could prevent a large number of these deaths.

Pfizer has priced PCV13 (marketed as Prevenar) out of reach of many de-veloping countries and humanitarian organizations.


BioTalk

QE Prize winner

Dr Langer shares his

successDr Robert Langer

Winner of Queen Elizabeth Prize of Engineering 2015, & David H Koch Institute Professor, Massa-

chusetts Institute of Technology (MIT), USA

D r Robert Samuel Langer was awarded the 2015 Queen Elizabeth Prize (QE-Prize) for Engineering in February 2015 at the Royal Academy of Engineering, London, UK. He is a world-renowned American scientist, engineer, inventor

and entrepreneur, and David H Koch Institute Professor at the Massachusetts Institute of Technology (MIT), USA.

The Queen Elizabeth Prize for Engineering is considered as the highest international accolade for engineering, and recognizes ground-breaking global innovation to inspire next-gen engineers.

The award is a global £1 million prize celebrating pio-neering innovations that has had a profound benefit to

humanity globally.

Dr Langer lab’s work is at the interface of biotechnology and material science. His lab’s major focus is in studying and development of polymers to deliver drugs, particu-larly genetically-engineered proteins, DNA and RNAi, continuously at controlled rates for prolonged periods of time.

Dr Langer exclusively spoke to BioSpectrum, where he shared his passion, origins, memories of his childhood laboratory, entrepreneurial tips and his award-winning work on controlled-release drug systems. Excerpts:

Q Firstly, a hearty congratulations Dr Langer. Tell us about your award-winning

BioTalk

Dr. Andreas Castan will discuss the upstream seed train and will show how a process intensification strategy can be used to compress timelines and decrease the cost for this unit operation.

Vaccine Manufacturing with Single-Use Technology: An Evaluation of Process EconomyDr. Mats Lundgren will share his insights on how to improve process economy and enhance end-product quality through the implementation of single-use technologies and novel microcarrier formats.

Unlocking the Potential for Efficiency in Downstream BioprocessesMadhu Raghunathan will walk you through several innovative strategies for achieving increased efficiency in buffer handling, chromatography unit operations, and downstream processing in general.

Single-Use Technology and Sustainability: Quantifying the Environmental ImpactBill Flanagan will talk about sustainability and how this relates to single-use technologies in biomanufacturing operations. He will present new data on the implications of a single-use strategy from a sustainability perspective.

The difference between a good and a great decision

can have extensive implications for the

future of a company.

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work to our Indian readers, and the impact of your controlled-release drug systems.

A Thank you. I think engineering is such a wonderful way to contribute to society. The two things that give me the greatest satisfaction are discovering

principles or making inventions that enable people to have happier and healthier lives, and seeing the people who train in our lab succeed to become future leaders in engineering themselves.

There are times when drugs administered to patients could react after being in the system for more than the required period of time or they might be ineffective by disappearing quickly. To tackle this, controlled drug re-lease helps maintain and sustain the drug release at an effective level for the suitable period of time. The polymer which was invented through my study helps in controlled dissemination of the drug molecules. My work which won the QEPrize is on engineered polymers which control the delivery of large molecular weight drugs for the treatment of diseases such as cancer and mental illness. It is already being used in various countries, including India.

I am thrilled to be the recipient of the Queen Elizabeth Prize 2015. The prize celebrates ground-breaking innova-tions in engineering and in addition strives to celebrate stories of engineering successes, raising the international public profile of engineering and inspiring new genera-tions of engineers to take up the challenges of the future.

QWhat sparked you to become a scientist?

A Some of it started as a child having chemistry, mi-croscope and erector sets. My dad also played a lot of math games with me. All this contributed to my

liking science and math.

Q Shed some light about the lab in your home’s basement in Albany.

A It was a small basement and I had a Gilbert chemis-try set. I put all the chemicals down there and I loved doing experiments where I would make

things like rubber and make solutions change colors via chemical reactions.

Q You have a background in Chemical Engineering. What made you to shift towards Biomedical Engineering?

AI always wanted to learn biology. My PhD thesis was on the enzymatic regeneration of ATP. I did my postdoc in a surgery lab at Boston’s children’s hos-

pital. I was the only engineer in the hospital. It really gave

For young people, I’d say dream big dreams, dreams that can change the world and make it a better place

me all kinds of ideas as to how chemical engineering could be applied to medicine.

Q You have been researching since the 70s. How difficult or hard has it been for you to

achieve what you have achieved today?

AVery difficult. My first nine research grants were turned down largely because my research went against conventional wisdom. No chemical engi-

neering department would hire me as a professor. And I ended up joining a nutrition department. The year after I joined, the department head who hired me left. So the as-sociate department heads decided to give me advice. They told me to start looking for another job. Time helped me overcome some of these issues as we proved that conven-tional wisdom was incorrect. And I just never gave up.

Q You have over 1,000 patents to your credit. How will you define innovation?

A A new idea or invention, and its implementation into real life

QYou are also an entrepreneur too. What do

you have to say to all the scientists who want to be an entrepreneur? A: I think it’s an attractive career path but not the only career path. Personally I love it because it enables myself and my students to take our ideas into the real world and help people. But science leads to many good career paths.

Q What are the common mistakes committed by scientists while they pursue their

entrepreneurial dreams?

AStarting a company too early. Not having good in-tellectual property (IPs).

Q What do you advice students who hesitate to become a scientist or pursue a research-

oriented career?

A I think that’s okay. Everyone should get lots of ad-vice. But they should follow their passion. I think people should do things that make them happy.

And they shouldn’t do things just to make money. BS

Raj Gunashekar


Latest BioSupplier Technologies

CoverStory

The invention of the microscope is one of the most important scientific development. Since, then the development in the laboratory instruments and technologies have grown leaps and bounds. The Human Genome Project to sequence the human took 13 long years. Today, it is possible to sequence DNA in a couple of hours.

As the research and development in the biosciences grows, so is the demand for more sophisticated technologies, instruments that are affordable, precise and timely.

In the ensuing pages, BioSpectrum is publishing a selection of open invitation articles by the industry captains, highlighting the latest BioSupplier technologies/products that are enabling the biosciences industry on the course of drug discovery.



CoverStory

Are you ready for laboratory transformation?Mr Amit ManjureHead-Clinical Marketing, Laboratory Diagnostics, Siemens Healthcare, India

The influence of diagnostic tests on clinical

decisions is very high. The global in vitro diagnostics market is estimated to reach $75.1 billion by 2020 Rising populations

in emerging econ-omies will lead to increased demand for medical de-vices, diagnostic

equipment and pharmaceuticals in the near future.At the same time,this demand will leverage technological advances.In vitro diagnostics (IVD) is one such in-dustry that is witnessing prolifera-tion of technology in terms of new assays, workflow excellence, turn-around time, etc.

IVD plays an integral role in health-care and disease management.The influence of diagnostic tests on clinical decisions is very high – almost 75% of clinical decisions are based on a diagnostic test.The global in vitro diagnostics market is estimated to reach $75.1 billion by 2020, growing at a CAGR of 5.8%.

The Indian IVD industry, still in the inception stage is valued at more than $500 million and is expected to surpass $1.5 billion by 2018.

Growth Drivers for IVDWith a population of more than 1 billion, India is world’s second largest country and therefore a sig-nificantmarket to the healthcare providers.The demographic change has led to growth in tier 2 and tier 3cities creating disposable income ultimately leading to a change in lifestyle patterns and an increase in the lifestyle diseases like cardiovas-cular diseases, lung disease, cancer, obesity, diabetes, etc. One in four Indians is at a risk of non-commu-nicable lifestyle disease.

Accurate and quick diagnosis of diseases has thus become a crucial factor in providing quality patient care.

Turn-around time (TAT)The diagnostics labs operate in a dynamic environment.In addition to the accurate diagnosis, reduced turnaround time (TAT), consistent delivery and affordability have be-come the need of the hour. Turn-


CoverStory

around time is the most noteworthy manifestation of laboratory service and a crucial barometer of laboratory performance.As a result, laboratories of all sizes are adapting total automa-tion across pre-analytical, analytical and post-analytical processes inte-grated with information technology (IT) since information systems are a key differentiator among major healthcare providers.

The innovations and discoveries in the IVD market are transforming the healthcare arena.The IVD market in-cludes a variety of advanced and cut-ting edge technologies to project the disease state, choose the right treat-ment and monitor thepatientsresponse to the treatment.Anarray of assay ca-ters to wide spectrum of diseases.

Automation, a unified solution de-veloped expressly for the changing workload and expanding needs of today’s clinical laboratory, isplaying a key role in the entire diagnostics set up.It provides unlimited potential for lab optimization by combining peak performance, adaptability, and intel-ligent technology.However,the chal-lenges of implementing lab automa-tion can be formidable.It is a complex

undertaking to meet business objec-tives and clinical requirements while managing logistics,timelines, people and technology to achieve workflow excellence. And the operations must continue uninterrupted during this transition!

The work in any laboratory is typi-cally broken in three phases.

1. The pre-analyticalphase:this com-prises of patient sample identifica-tion, test request registration and billing, sample collection, labeling by barcode, separation followed by transport and sample processing.

2. The analytical phase:this com-prises of properly calibrating the instruments,the quality control process and analysis of samples.

3. The post-analytical phase:This includes all the processes that follow the testing of the samples.Namely, the validation of test re-sults, transcription of results into the records, printing and dispatch of the results.Also, the data so generated needs to be stored.The samples also need to be stored

for specified period of time for repeats or add-ons.

With this background, it is critical for laboratories to optimize the follow-ing flow across these three phases.

The sample flow has to do with the collection of the samples, to sorting, transportation until their disposal and/or they are sent out.

The data (information) flow goes from order entry to receiving or accessing, quality control, etc. all the way to validation, reporting and billing.

The material flowincludes inven-tory tracking; invoicing and pay-ment etc.

Removal of non value-added steps such as reducing sample touch points,manual bench sorting aliquot-ing & transportation, sample rerun, results review is a key to achieving workflow excellence.

Automation – the way ahead!Statistics indicate that there has been an approximately 25 percent

H DX APTIO IOM BACK H DX APTIO WTUBES


CoverStory

increase in laboratory tests due to screening and follow up for lipid pro-file, blood glucose levels, glycosylated haemoglobin, speciality tests for thy-roid hormone levels, vitamin levels, infectious serology and basic cancer markers.

The diagnostics and pathological lab test market has the potential to grow at a CAGR of 18.9 percent.

With automation,labs of all sizes can transform their operations to harness change and drive maximum perfor-mance and efficiency.Laboratories can also customize their automation solutionsbyidentifying the sustainable workflows.Labs can consolidate mul-tidiscipline testing into a single, fully automated solution or improve spatial efficiency,tube utilization, or resource allocation. Siemens has helped diag-

nostic laboratories leverage the ben-efits of automation and information technology since 1998—making work-flow more efficient and flexible while improving turnaround times, reduc-ing errors, and cutting costs.

Laboratory automation allows for a broader diagnostic scope and in-creased accuracy.Ultimately, labora-tories will be able to perform more tests in-house and reduce their de-pendency on outsourcing services in addition to the decrease in number of duplicative laboratory process and increase in throughput.

This will also allow staff to be better utilized beyond bench testing and routine operation including but not limited to patient interaction,finance, marketing services and strategic planning002E. BS

Statistics indicate that there has been an approximately 25 percent increase in laboratory tests due to screening and follow up

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IKA® India Private Limited814/475 · Survey No.129/1 · Mysore Road · KengeriBangalore - 560060 · Karnataka · IndiaTel. +91 80 26253 900 · Fax +91 80 26253 901Hotline: [email protected] · www.ika.com

IKA® Temperature Control SystemsSafety, Power and Intelligence

Compact Immersion Circulator (ICC)

The ICC is a compact immersion circulator for demanding and universal applications, based on an exceptionally well thought-out ergonomic concept and design.

Industries:Industries:

Biotechnology, Food Technology, Chemical and Biotechnology, Food Technology, Chemical and Pharmaceutical Industry, Clinical and Pathology Pharmaceutical Industry, Clinical and Pathology Laboratories.

Applications:Applications:

Sample Incubation, Food Stability Testing, Sample Incubation, Food Stability Testing, Temperature Probe, Calibration, Material Temperature Probe, Calibration, Material Testing, Heating of double walled Reactors, Testing, Heating of double walled Reactors, Compensation of exothermal and endothermal Compensation of exothermal and endothermal Reactions.

Immersion Circulator (IC)

IC immersion circulators can be used to temper fl uids to temperatures of up to 250°C. Thanks to the fl exible bath bridge, the immer-sion circulator can be mounted on different sized baths.

Heated Bath Circulator (HBC)

HBC heated bath circulators heat up rapidly thanks to their high-quality insulation. The drain valve on the front allows the user to fully drain the bath safely.

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CoverStory

CRISPR-Cas9 genome editing – simple genome editing starts hereNamritha RavinderSenior R&D Manager, Synthetic biology, Thermo FisherScientific

The new GeneArt CRISPR Search & Design

tool allows scientists to search a database of >600,000 pre-designed CRISPR gRNAs in human and mouse genes Introducing the only com-

plete genome editing so-lution designed to expe-dite your research. Our easy-to-use,optimized an-dvalidated solutions span

theentire cell engineering work-flow, making genome editing ac-cessible to anyone at any level.We are continuing to expand our suite of genome editing products to span the entire cell engineering work-flow, from cell culture reagents, delivery reagents and sample prep-aration to genome modification, detection and analysis of known genetic variants. We offer our state-of-the-art online CRISPR search and design tool along with CRISPR-Cas9 in four formats: an all-in-one expression vector, Cas9 mRNA, Cas9 protein, and CRISPR libraries services paired with the

optimal cell culture reagents, de-livery method, and analysis tools based on required application and cell type (Figure1).

Optimal CRISPR design at the touch of afingerThe new GeneArt CRISPR Search & Design tool allows scientists to search a database of >600,000 pre-designed CRISPR gRNAs in human and mouse genes or analyze their sequence of interest for de novo gRNA designs using Thermo Fish-er’s proprietary algorithms. The tool is designed to analyze genes of interest, identify gRNA sequences adjacent to protospacer adjacent motif (PAM) sites, and rank order resulting gRNAs based on potential off-target effects.Up to 25 gRNA sequences per gene are provided with recommendations based on potential off-target effects for each CRISPR sequence.

Invitrogen GeneArt Platinum Cas9 Nuclease is wild type Cas9 in pro-tein form for genome editing with CRISPR-Cas9 technology. Cas9 protein and guide RNA (gRNA)


CoverStory

Namritha Ravinder is a senior R&D manager at Thermo Fisher Scientific in Carlsbad, California. She leads product development activities within the Synthetic Biology and Sample Prep team, with primary focus on building products, screening tools and workflowsforgenomeeditingandcellengineeringapplications.Priortohercurrentrole, she was a technical lead for a wide variety of synthetic biology custom service offerings including cDNA library generation; high-throughput gene expression and miRNA profiling for biomarker discovery; lentivirus production; and next-generation sequencing libraries. She did her postdoctoral research at Children’s hospital in Los Angeles in HIV virology and doctoral research in plant molecular biology and biotechnology at University of Alabama inHuntsville.

BRIEF PROFILENAMRITHA RAVINDER

form a very stable ribonucleo pro-tein (RNP) complex that provides the next level of cleavage efficien-cy over CRISPR-Cas9 vector and mRNA-based systems when paired with Invitrogen Lipofectamine CRIS-PRMAX Cas9 Transfection Reagent.The Cas9 RNP complex can act im-mediately after it enters the cell, since transcription and translation are not required (Figure 2). More-over, the complex is rapidly cleared from the cell, minimizing the chance for off-target cleavage events when compared to vector-based systems.

GeneArt Platinum Cas9 Nuclease is the recombinant Streptococcus pyogenes Cas9 (wt) protein purified from E.coli that can be used for ge-nome editing with CRISPR technol-ogy. Features and benefits include:

Two availableconcentrations

1µg/µL(B25640)foruseinstandardeditingscenarios,includingcelllinessuchas HEK293 orHCT116

3 µg/µL (B25641) for optimiza-tion of editing conditions in more difficultscenarios such as in primary or embryonic cell lines, or when screening multiple gRNA sequences at atime

Streamlinedcell engineering by eliminating transcription and

translation in thecell

Elimination of time-consuming cloningsteps

Minimization off-target cleav-age due to rapid clearance of the protein complex fromthe cell

The GeneArt Precision gRNA Synthe-sis Kit is a complete system for rapid synthesis of guide RNA (gRNA), ready to complex with GeneArt Plati-num Cas9 Nuclease for transfection-ready Cas9 protein/gRNA ribonu-cleoprotein (Cas9 RNP). Features and benefits include:

Fast assembly and synthesis of any gRNA target in as little as four hours, including template assembly

High yield (>10 µg) and concen-tration (> 200 ng/µL) ofgRNA

The Lipofectamine CRISPRMAX Cas9 Transfection Reagent is the first optimized lipid nanoparticle trans-fection reagent for CRISPR-Cas9 protein delivery, providing the cleav-age efficiency of electroporation with the simplicity and scalability of a re-agent. Lipofectamine CRISPRMAX transfection reagent is an idealal

THE PERFECTPAIRINGWe have paired the CRISPR-Cas9 format and delivery method for scientists to ensure the highestefficiencies.


CoverStory

ternative to electroporation as it is gentleron cells and more cost effec-tive overall (Figure 3). Features and benefits include:

Demonstrated cleavage efficiency tested in more than 20 cell types including iPSC, mESC, N2A, CHO, A549, HCT116, HeLa, HEK293, and several others

Low cell toxicity—fewer cells needed to initiate your experi-ment

Cost savings—including both cost-per-reaction and initial invest-ment

Easy scalability—an ideal deliv-ery solution for high-throughput experiments

Advances in genome modulation and editing have the potential to change the way we create energy, produce food, optimize industrial processing, and detect, prevent, and cure diseas-es — improving the human condition and the world around us. Thermo Fisher’s trusted products harness the power of science to transform lives.Its instruments, routine tools, and services offer high-quality, innova-tive life science solutions for every-lab. BS

WORKFLOW

Advances in genome moudulation and editing have the potential to change the way we create energy, produce food, oprtimize industrial processing, and cure diseases

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CoverStory

CRISPR–Cas9: a new hope for drug discovery

Dr Ceri Wiggins Team Leader, Horizon Discovery

Thought to be devoid of the caveats

associated with siRNA and shRNA reagents the hope is that novel targets can be uncovered The repurposing of

a primitive adap-tive immune re-sponse in bacteria, known as CRISPR (clustered regularly

interspaced short palindromic re-peat), has revolutionized gene edit-ing and provides a new and power-ful tool to interrogate gene function on a genome-wide level. Indeed, the contribution of this technology to drug discovery looks, from our current vantage point, to be sub-stantial. The application CRISPR–Cas9 technology to whole genome screening is transforming our abil-ity to perform target identification

experiments and to understand complex biological processes, such as drug resistance. Thought to be devoid of the caveats associated with siRNA and shRNA reagents, the hope is that novel targets can be uncovered and rigorously validated using CRISPR–Cas9, and that a pipeline of innovative and validat-ed targets will enter drug discovery programs.

Indels are crucial: CRIS-PR–Cas9 screens make use ofshort guide RNAs (sgRNAs) and Cas9 nuclease, two components ofthe CRISPR machinery in bacteria. The sgRNA, which Cas9 binds to, con-tains a protospacer adjacent motif (PAM) site and this enables the tar-geting of Cas9 to the RNA:DNA hy-brid. Once bound, the Cas9 nucle-ase generates DNA double strand breaks precisely 3 base pairs away from the PAM site. These double strand breaks are repaired by non-

Dr Steffen Lawo Senior Scientist, Horizon Discovery

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Ceri Wiggins is a Team Leader at Horizon Discovery, currently responsible for the internal synthetic lethal CRISPR screening and target identification/validation team.

Steffen Lawo joined Horizon Discovery GroupasSenior Scientist in 2013.

As Country Head at Horizon Discovery, Narinder is responsible for business development of Horizon’s product and service portfolioacross India and Middle East.

BRIEF PROFILE BRIEF PROFILE BRIEF PROFILE

DR CERI WIGGINS DR STEFFEN LAWO NARINDER SINGH

homologous end joining (NHEJ), which frequently results in small nu-cleotide insertions and or deletions (indels) that can lead to the inter-ruption of the normal reading frame, thereby disrupting gene function.

Pooling resources: Using lentiviral transduction to deliver both the Cas9 nuclease and sgRNAs into cells, Horizon Discovery has adapted a pool-based screening protocol to examine the effect on cell survival of knocking out thousands of individual genes. The sgRNAs are designed to direct Cas9 to exons at the start of the open reading frame, such that any out-of-frame indels will result in gene disruption. The screen analysis is based on data from cells collected

at the start of the screen (3–5 days after transduction) compared with cells collected at the end of a screen that have been exposed to a drug of interest, for example. The next gen-eration sequencing (NGS) data from the initial time point acts as a com-parator for the NGS data collected at the end of the screen, such that sgRNA loss and gain over the time of the screen can be established. We use a dedicated CRISPR–Cas9 screening analysis platform, adapted from the MAGeCK workflow (Li et al., 2014), which enables individual sgRNAs and gene hits to be ranked.

Resistance discovery ahead of the clinicMany of the initial screens that Ho-rizon Discovery has undertaken for a number of clients from the phar-maceutical industry have examined mechanisms of drug sensitivity and resistance. Indeed, for our initial proof of concept studies we, like oth-ers, examined mechanisms of resis-tance to vemurafenib, a drug that targets the BRAFV600E activating mutation. The GeCKOv2 genome wide library, which contains 6 guide RNAs against 19,050 genes (San-janaet al., 2014), was transduced into BRAFV600E mutant A375 melanoma cells and the cells were treated with vemurafenib. A comparison of the abundance of each guide RNA at the start and end of the screen was used to assess whether drop out or enrich-

ment of guide RNAs had occurred over the course of the screen. Over 228 guides were shown to be >100-fold enriched, with several sgRNAs targeting the same genes. Using our analysis platform, the highest rank-ing targeted genes (MED12, NF1, CUL3, NF2, TADA2B and TADA1) were those whose loss is known to confer resistance. These findings repeated previously published data (Shalemet al., 2013, Huang et al., 2012, Whittaker et al., 2013).

Interestingly, when the sgRNAs for each of these hits were evaluated individually, it was clear that not all guides performed equally well in the screen. This emphasises that for suc-cessful screening, the library compo-sition and complexity are key consid-erations.

Increasing the odds with a haploid approachEngineered from KBM7 fibroblasts, eHAP cells are a fully haploid cell line and are particularly suited to CRISPR–Cas9 screens because there is only one copy of any given gene to edit. We used the eHAP cells to ex-amine the mechanisms of resistance to 6-thioguanine (6-TG), a purine antimetabolite that is used in the treatment of leukaemia. The biology of the DNA mismatch repair (MMR) system and factors that mediate resis-tance to 6-TG have been extensively studied and as such provide an ex-


CoverStory

cellent paradigm to test the power of CRISPR–Cas9 resistance screens in haploid cells. eHAP cells were infect-ed with the whole genome GeCKOv2 library and were exposed to either 500 nM 6-TG or vehicle control and maintained in culture to allow sgRNA enrichment and depletion to occur.As expected, NGS analysis revealed that sgRNAs targeting MLH1, MSH2 and MSH6, three genes that encode MMR proteins, were enriched in the screen (Branch et al., 1993; de Wind et al., 1995, Abuinet al., 2000, Buermeyeret al., 1999). To validate these targets as 6-TG resistance factors, MLH1 and MSH6 knockout HAP1 cells were generated using a CRISPR–Cas9 ap-proach. These cells were able to pro-liferate in the presence of 6-TG unlike the parental cell line. Thus, CRISPR–Cas9 approaches were used to both identify the mechanisms of resistance

and to validate them.

The future looks brightCRISPR–Cas9 is a fast moving technology that has been embraced across the board. As discussed above, it has been used to successfully iden-tify mechanisms of drug resistance in whole genome screens, but its applications extend further into ani-mal model generation and genetic

therapies. Its use, particularly in hu-mans, is the subject of much debate that looks set to continue for years to come. However, in terms of drug discovery, CRISPR–Cas9 technolo-gies look poised to replace RNAi as a new avenue for more effective drug discovery. Thanks to NGS, we are starting to catalogue the plethora of mutational changes that occur in the genome of any cancer cell. With this knowledge comes potential – novel mutated genes and the proteins that they encode, are candidates for prog-nostic markers and/or new drug tar-gets. With the ability to rapidly engi-neer cells (and animal models) using CRISPR–Cas9 technologies, the gen-eration of robust models needed for improved target identification and validation promise to be attainable. BS

The generation of robust models needed for improved target identification and validation promise to be attainable.


CoverStory

Triumph of high precision parallel bioreactors over conventional systems

D. MuruganandPhD., Vice President – Marketing, Eppendorf India, Chennai

Scientists and investors are looking

forward to shorter timeframes in getting results and the product of interest launched in the market respectively The biopharma in-

dustry is growing steadily at a sig-nificant pace and so are their invest-ments in research

and development. Investment in biologics like vaccine, biosimilars, novel biopharmaceuticals, cell and gene-based therapeutic products are seeing a never before trend.The stakeholders, both scientists and investors, are looking forward to shorter timeframes in getting results and the product of interest launched in the market respec-tively. As these processes involve cell culture or microbial fermenta-tion, the need for dedicated mini-bioreactor systems for process de-velopment and critical parameter

optimizations in low volume ranges are certainly creating interest com-pared to the conventional fermen-ters and bioreactors. With time being very critical, the single use vessels are also gaining more at-tention over autoclavable formats among the biopharma users.

From conventional shake flasks to parallel bioreactorsWhile initial bioprocess develop-ment involving microbial or cell culture involves several steps like cell line optimization,clone selec-tion, screening for media and feed components along with other pro-cess conditions,conventional shake flasks arestill used foroptimizing these early steps. Though widely used, shake flask formats onlyal-low identifying temperature, am-bientgas mix and agitation rates-but poselimitation upon reaching scalable levels with respect to the industry standard monitoring and control requirements. Critical pro-cess parameters like pH, dissolved


CoverStory

oxygen (DO), gas flow rates and feed schedules of media components are beyond the capabilities of shake flask format.Moreover equipment used for screening or optimization in the earlier steps should mimic the physi-cal and mechanical characteristics of productionscale reactors to the greatest degree possible,toensure consistency throughout development phases.Theparallel bioreactor system provides all essential features in a compact and comprehensive design with flexibility to optimize and un-derstand parameters that influence growth kinetics, productivity, prod-uct quality and stability.

Parallel bioreactors over the micro/mini bioreactor Though micro and mini bioreac-tor systems address the basic needs of media selection and optimiza-tions they still do not support when it comes to scalable proportions and concerns over unconventional formats are not uncommon.Lower-volumeby itself seems to limit for applications where the processes requirements are not flexible.Feed rates, sampling volumes to mention a few could be mandatory in these critical steps of characterization or optimization.Hence selection of an ideal system for lower volumes is no different from the standard volumes when it comes to the expectations of the process outcome.

Expectations in a parallel bioreactor systemWith more manufacturers getting in-tothis spaceexpectations also grow-from the user end.Hence the demand for compact, comprehensive and flexible system to adapt to present and future needs is on the cards.While deciding the number of vessels the primary requirement starts with a compact and less space occupy-ing system.But when coming to the

process needs features like flexibility for upgrades to enhance or extend the configuration to meet evolving needs,minimum level of scalability in working volumes to establish proof of concepts, possibility for seamless integration to downstream equip-mentare certainly the priorities.Above all a simple and user friendly supervisory control and data acqui-sition (SCADA) software convenient for data acquisition, monitoring and processing becomes mandatory.

Parallel bioreactors from EppendorfDASGIPparallel bioreactor systems for microbial or cell culture applica-tions from Eppendorfcombinethead-vantages of small working volumes with the full functionality of indus-trial bioreactors.The modular design allows expanding the system capa-bilities in 4,8,12 or 16 parallel vessels format controlled by single operating system.The vessels are the industry standard stirred tank reactors with different workings volumes ranging from 60 mL to 3.8 L.

The modular system provides the flexibility to configure to the needs of user with respect to number of pumps, gases and their flow rates.The availability of single use vessels of different volumes have provided users the flexibility to choose be-tween autoclavable and single use vessels in both microbial and cell cul-

ture applications.

DASBOXparallel mini bioreactor sys-tem for microbial or cell culture has the option to use a dedicated vessel volume with working volume rang-ing from 60-250 mL. These systems are also designed to operate in mod-ules of 4, 8, 12 or more vessels.With both autoclavable and single use ves-sel formats available,the user has the choice to select.Availability of Photo-synthetic light module can make it a convenient choice for users working either with plant cells or for biofuel.

Both DASGIPandDASBOXsystems can be calibrated in parallel for pumps and sensors making the ves-sels perform as replicates.Though designed for parallel reactions, these can also be controlled independently for maintaining completely different parameters.

DASGIPcontrol software allows par-allel monitoring,data capture with online analysis options. Combined with other software options, the system can be integrated with third party equipment like metabolite ana-lyzer, Raman spectrometer etc. The DAS ware software platform pro-vides larger integration and analysis flexibilities like Design of Experi-ment (DoE), remote monitoring and controlling, communicating with third party OPC compliant systems and more. BS

PARALLEL BIOREACTOR SYSTEMS


CoverStory

Single use micro scale bioreactor enables higher productivityDr Barney Zoroambr 15 Product Manager, Sartorius-Stedim Biotech, Royston, UK

A strategy for reducing manufacturing

COGs is to use advanced automated micro and mini bioreactor models to improve upstream cell culture productivity Wo r l d w i d e

sales of bio-logic drugs, i n c l u d i n g monoclonal antibodies

(mAbs), fusion proteins and thera-peutic enzymes now exceeds $120 billion per year. These therapies cost more than small molecules, in part because they are more ex-pensive to manufacture. A strategy for reducing manufacturing COGs (cost of goods) is to use advanced automated micro and mini biore-actor models to improve upstream cell culture productivity by select-ing better clones and enabling more efficient optimisation of media, feed and culture conditions.

Traditionally, cell culture develop-ment for bioprocessing begins with

screening to find clones that express the most protein. This is usually per-formed in small volumes of 0.1mL to 6mL using a multiwell plate for-mat. Because of the need to conduct large numbers of experiments this has resulted in the development of systems based on 24 well single-use multiwell plate. These have the advantage of being quick and easy to set up and use and because the multiwell plate are pre-sterilised there is no pre-process preparation and as they are single-use there is no post-run cleaning. Some of these multiwell plate systems do provide monitoring and some control of dissolved oxygen (DO) and pH but have the drawback that they do not mimic the sparging or stirring ac-tion of a large scale bioreactor as they rely on shaking for mixing. Ad-ditionally, they do not provide auto-mated feeding and have a working volume of less than 6mL, which lim-its the amount of analytical testing possible.

Clone selection and early process development to identify the most productive clones and define op-

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C Abhaykumar & Co.117, Hindustan Kohinoor Indust. ComL B S Marg, Vikhroli (W)Mumbai 400083 (India)tel: +91-22-40764-700/701email: [email protected]

Shreetech Associates156/5120 PrasadNew Tilaknagar, Chembur,Mumbai 400089 (India)tel: +91-22-6522 5762email: [email protected]

Our authorized partners in India:

AkzoNobel / KromasilSeparation Products, SE445 80 Bohus, Sweden, tel: +46 31 58 70 00, email: [email protected]


CoverStory

timal media or culture conditions is typically performed in shake flasks with two or three top clones carried forward for evaluation in bench top bioreactors. Using shake flasks and bench top bioreactors is very labour intensive and as they are generally made of glass, require time consum-ing pre and post-process cleaning and sterilisation for every experi-mental run.

Shake flasks provide no active control of pH and DO, relying on the buffer-ing capacity of the media and the gas environment of the incubator. The mixing environment is unlike that in a bioreactor as there is no impeller. Ad-ditionally, shake flasks are often ma-nipulated by hand, making it difficult to perform nutrient feeding or sam-pling without introducing variability. Hence, the use of shake flasks can of-ten result in different cell growth and titre profiles to those seen after scale-up in a bioreactor. Data published in Cytology of a study at Genentech demonstrates that when cultured in shake flasks, Chinese Hamster Ovary (CHO) clones expressing mAbs do not show comparable culture perfor-mance with those grown in 2L bench top bioreactors.

Using bench top bioreactors does

mimic the sparging and stirring ac-tion of a large scale bioreactor but they require considerable amount of time for set-up, operation and post-experimental cleaning and ster-ilisation. Therefore, the amount of available resource often limits use of bench top bioreactors requiring that researchers have to select only their top clones to test in this way. This can lead to the final choice of clone sometimes performing sub-optimally upon scale-up, adversely affecting yield and titre. If a larger number of runs could be performed during clone selection under condi-tions which are representative of the scale-up bioreactor environment, then it should be possible to isolate a better performing clone for use in manufacturing and potentially save thousands of dollars in manufactur-ing COGs.

To meet the need for a single-use bio-reactor model that provides compa-rable mixing, gassing and sampling parameters to be used in place of shake flasks and bench top bioreac-tors, the advanced micro and mini scale bioreactor systems, ambr 15 and ambr 250 (Sartorius-Stedim Biotech) have been developed. These integrat-ed systems combine 10-15mL or 100-250mL single-use bioreactor, with an

automated liquid handling work-station and dedi-cated control and analysis soft-ware. Critical to the use of these systems as bio-reactor models is the geometric similarity to larg-er bioreactors and that their contents are stirred by an im-peller and gases can be supplied

by sparging. In addition, the software control systems and integrated single use sensors enable these systems to control the culture conditions in a similar way to large scale systems en-suring scalability.

Each workstation maintains aseptic conditions using a HEPPA filtered environment (ambr 15 can be in-stalled in a standard biological safety cabinet and the ambr 250 includes an integrated system) and provides independent parallel control of either 12 or 24 (ambr 250), 24 or 48 (ambr 15) bioreactors. The workstation con-trols the stir speed, gas supply and temperature and also provides liquid handling automation functions for the bioreactors, each of which can have its own medium, feed, inoculum and sampling strategy. Each bioreac-tor also incorporates sensors for real-time measurement and bioreactor-specific automated control of DO and pH and set points.

A major contract research organisa-tion (CRO) compared the timelines for clone selection and early process development of a mAb expressing (CHO) clone using shake flasks and bench top bioreactors with the auto-mated micro bioreactor. The results showed that with reusable shake


CoverStory

flasks and bench top bioreactors, clone selection and early process development took around 22 weeks, whereas using the single-use micro bioreactors and a confirmatory run in a reusable bench top bioreactor

ambr15 operators examining full 96 well plate Picture

this was reduced to six weeks.

Single-use micro and mini bioreac-tor technology can provide an ac-curate prediction of cell growth and protein titre achieved in bench top

bioreactors. Setting up and running reusable shake flasks and bench top bioreactors is manually intensive, while the fully automated single-use micro and mini bioreactor is more convenient, taking much less time to set-up and run, as well as requiring no time consuming post run cleaning and sterilising. Thus clone selection and early process development can be performed rapidly and efficiently, increasing the number of clones that can be evaluated by up to ten fold. This improves the chances of select-ing a clone with optimal growth and protein expression. The automated system makes it easy to implement DoE into the work flow and the geo-metric similarity of the platforms re-duces the risks for scale-up to larger single-use pilot and manufacturing scale stirred bioreactors, reducing time-lines and saving cost. BS


CoverStory

AcquityQDa: Separating beyond questionManu GroverProduct Manager-Pharmaceutical Market, Waters India.

One of the complicated process in

analytical industry was handling of Mass detection technologies. The research is still on to find the most sensitive Mass spectrometer or detector. When Albert

E i n s t e i n forged the b e d r o c k t h e o r y of mod-

ern physics 100 years ago, he had no computer,nointernet and few homes had telephones. Yet it took one of the most sophisticated sci-ence tools ever built, at a cost of hundreds of millions of dollars, to prove an idea the scientist had crafted with little more than paper, a fountain pen, hard work and a mind sharper than most. Recently physicists announced they had de-tected gravitational waves, hitherto

a key unproven element of Ein-stein’s general theory of relativity.

It is not always the complicated pro-cess work better but simple tools and process are faster and accurate too. Waters also with same philoso-phy started searching for simple answers for complicated questions. One of the complicated process in analytical industry was handling of Mass detection technologies. The research is still on, to find the most sensitive Mass spectrometer or de-tector. Waters thought differently and focussed on simplifying the usage of the Mass detector tech-nology so that it reaches to masses and today we have world’s smallest, sensitive enough, very robust, and highly user friendly Mass detector – AcquityQDa.

The product istrulyan industry changing technology. The idea was to empower and enable chromatog-


CoverStory

ra-phers with ac-cessible mass data, without the training, without the complex-ity, without extensive compound-specific optimisation. This is realised through the AcquityQDa detector which is now revolutionizing prac-tices within laboratories in India and globally. Within India we have more than 20 companies using the technology in different areas of R&D, Quality Control, Drug Discovery etc.

The vision of the AcquityQDa was born through the unmet need of the analytical scientists. Today many prestigious scientists and multi-na-tional companies are thrilled with its impact on quality of data. The QDa has been recognized throughout the industry both in India and globally garnering very positive reviews and winning multiple awards for innova-tion. AcquityQDa was listed as one of the top 15 innovative products of the year.

Increased efficiency is coming from dramatic innovation. The result of over 30 patented Waters innovations, this the only mass detector that fits on top of your instrument stack. Us-ing less bench space and less energy than a traditional mass spectrometer, it fits easily within your existing lab

set up as part of your

regular workflow. Even most cleaning and routine mainte-nance have been innovated away, maximizing your uptime. This is fun-damentally different from any expe-rience one would have had with MS.

In any analytical development we majorly rely on UV/PDA detector as detector of choice and live with the limitations of same. To have more confidence in data, to understand the development process better and to resolve the complex cases of mass balance we need to have orthogonal analytical detectors like AcquityQDa in our development process. The usage of the detector ensures confi-dence in the data and hence ‘Right time-first time’.

The challenges in UV/PDA based developments can be resolved using this orthogonal detector AcquityQDa Mass Detector, which have been pur-posefully designed to enable analysts to readily incorporate mass detection within a UV/PDA chromatographic workflow. The simplicity of this Sin-gle Quadrapole Mass detector is such that it can be handled easily by the chromatographers who have no MS training and are only UV/PDA users. AcquityQDa has the quickest start time, once switched on, the detector

is ready to use in less than 25 min-utes. AcquityQDa through Empower CDS software can enable scientists to do tasks like peak tracking, identify-impurities/peaks, analyze non-chro-mophoric impurities, understand-mass-balance related issues, perform MS finger printing, confirm peak pu-rity data, etc.

With recent interest of many organi-zations in Biologics and Biopharma-ceuticals, AcquityQDa has emerged to be quite useful in these areas as well. AcquityQDa enables greater selectivity, faster – high throughput methods, and mass confirmation for greater certainty and productivity in routine ‘Glycan monitoring’.

AcquityQDa is being utilized by many organizations to monitor pep-tides over a wide molecular weight range. The addition of mass detec-tion allowed scientists to monitor and quantify peptides with greater specificity. AcquityQDa expands the sensitivity currently available with optical only workflows. The addition of AcquityQDa to existing workflows allows scientists to selectively detect and monitor co-elution species. And perhaps most importantly, Acqui-tyQDa works with both TFA and FA based separations.

Recent publications like “HILIC-MS Determination of Genotoxic Impu-rity of 2-Chloro-N-(2-Chloroethyl)Ethanamine in the Vortioxetine Manufacturing Process” by Zentiva (Sanofi), “Implemenation of a single quad MS detector in high-through-put transdermal research of plant extracts” by University of Ghent and ‘‘A novel compact mass detection tool for the open access (OA) envi-ronment in drug discovery and early development” by Merck use Acquity-QDa technology and hence exhibiting the potential of this simple and pow-erful tool. BS


CoverStory

Exploring new frontiers in biological science using Mass SpectrometrySharad MishraSr. Product Manager, life sciences mass spectrometry, Thermo Fisher ScientificScientists and

biologists face many

challenges in functional biology studies that require the observation of proteomes over many time points

Future of bioscience through its potential utility in R&D where pharmaceutical in-dustries increase in-vestment to achieve

discovery of novel compounds. This technology will continue to drive high-throughput screening of candidate molecules together with advances in ‘omics’ technologies (genomics, transcriptomics, pro-teomics, metabolomics) and bio-marker identification.Innovation is shrinking industrial machines and medical devices to the scale of atoms and molecules. Mass spec-trometry is one of the important

and versatile tools that will drive the

Mass Spectrometry is used in in-dustrial and academic fields for both routine and research purpos-es. Today, there is no single area of experimental science where mass spectroscopy is not being used. It is used to understand the fundamen-tal atomic and molecular processes and, at the same time, those of im-mediate relevance to events within cells. As a technique, it helps to control processes in chemical and biological industries, diagnose dis-eases, discover new drugs, protect the environment and explore mys-teries of nature.

Scientists and biologists face many challenges in functional biology studies that require the observa-tion of proteomes over many time points, precise spatial distribution of proteins and different cellular


CoverStory

states. These issues translated into the analytical challenge of perform-ing reproducible and precise quan-tification of a few selected biological components in the presence of very complex background.

One of the major challenges in pro-teomics is the quantification of low abundance proteins and peptides of biological relevance such as tran-scription factors or low stoichiometry post translational modified proteins. The quantification of these analytes of interest is complicated by the very large dynamic range observed for cel-lular protein expression, especially in humans. With the development of new generations of mass spectrom-etry platforms providing high resolu-tion and multiple detector versatility, new strategies are available to push the limits of quantification.

This new technology ensures that scientists don’t miss anything in their area of research and provides a strong platform, combining next-generation screening techniques with advanced targeted methods for protein quantitation. It is designed to expand researchers’ capabilities in advanced proteomics and me-

This new technology ensures that scientists don’t miss anything in their area of research and provides a strong platform

tabolomics applications, including targeted, data-independent acquisi-tion (DIA) and top-down analyses with the industry’s highest level of sensitivity. This delivers more com-plete sequence coverage and allows scientists to perform more inclusive analyses.

On January 27, 2016, Thermo Fisher Scientific’s Orbitrap Fusion Lumos Tribrid Mass Spectrometer received the SelectScience Scientists’ Choice Award for Best New Drug Discov-ery Product of 2015. This award cel-ebrates the new technologies that made the biggest impact in drug dis-covery and development research in 2015. The awards are unique in this industry as they empower scientists to nominate and vote for their favor-ite new product, allowing them to have their say about which manufac-turers have truly enabled their work.

We’re seeing first hand how Orbi-trap mass spectrometry is driving the future of bioscience, helping scien-tists push the limits of quantitation and protein characterization further and faster. It is ideal for laborato-ries that require more extensive and more profound analytical informa-

tion from their sample, especially lower limits of detection and better sequence coverage when characteriz-ing proteoforms, which was not pos-sible with other high-resolution mass spectrometry systems.

This technology also enables scien-tists to:

Confidently quantify low-level analytes, low atomic LOQ in nLC analysis and fg in high flow analysis;

Be more selective about which instruments they perform their MS/MS experiments on;

Characterize intact proteins with top down on LC time scale, which means lower detection limits and higher throughput; and

Elucidate structures more thor-oughly and easily by using any fragmentation mode, at any stage of MSn analysis, with detection by either analyzer, which maxi-mizes structural information from metabolites, glycans, PTMs, and sequence polymorphisms. BS


BioTalk

2016 Padma Bhushan Awardee, Dr Alla Venkata Rama Rao

Scientific Research and Entrepreneurship does not go hand-in-hand

Dr Alla Venkata Rama Rao (Dr AV Rama Rao) needs no introduction. Rama Rao is the only Fellow of the Indian National Science Academy (FNA) who has trained 112 PhD students, published more than 250 papers in reputed international scientific journals, developed over 30 process technologies for making life saving drugs more affordable and finally after retiring as Director of Indian Institute of Chemical Technology, built a multi-million dollar pharmaceutical company (Avra Laboratories) that currently has over 550 employees.

I initiated process chemistry and came out with a novel process for manufacturing Diazepam


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BioTalk

Q Congratulations on the prestigious Padma Bhushanaward. Please

describe your journey so far.Dr AV Rama Rao: I was born and brought up in Guntur (AP) and did my graduation (chemistry) in 1956 from A.C. College. After working for two years as demonstrator and tech-nical assistant in A.C. College and Agricultural College, Bapatla, respec-tively, I joined Bombay University Department of Chemical Technology (BUDCT) in 1958 for my graduation in Chemical Technology with special-ization in pharmaceuticals and fine chemicals. I continued my career as a PhD student at National Chemical Laboratory (NCL) under the guid-ance of Prof. K Venkataraman, the then Director of NCL and obtained my degree, PhD (Tech.) in 1964.

Unlike many who go abroad to pur-sue their post-doctoral career, I fol-lowed Prof. Venkataraman’s advice to stay at NCL and worked on the structure of lac dye, an age old prob-lem unsolved for almost 100 years. I was offered Scientist B at NCL in 1965, without crossing the seas. For the next 7 years, I was totally com-mitted to academic research and be-lieved that industrial research means a mediocre work that was carried out by industrial laboratories. In 1973 based on CSIR directive I initiated, process chemistry and came out with a novel process for manufacturing Diazepam, an anti-anxiety agent and used widely the world over. During that period I met Dr Y K Hamied, the present Chairman of Cipla, who showed keen interest to commercial-ize my process without wasting much time. This was the first example of a CSIR Technology transfer to industry and successfully commercialized in 1973. Since then I brought the cul-ture of institutions and industry in-teraction and helped pharmaceutical industries in several ways.

In 1975, I felt the need to spend two years at Harvard University in Prof. E J Corey’s group (Nobel Laureate in Chemistry in 1991) to enhance my skills in organic synthesis. This ex-posure brought a big change in my outlook on scientific and industrial research. I was selected as head of the organic chemistry division at NCL in 1980. I established in India for the first time a school of excel-lence for the synthesis of bio-func-tional molecules such as anti-tumor antibiotics, immuno suppressants, cyclic peptides including vancomycin etc. I moved to Hyderabad in 1985 as Director of RRL and transformed the Regional Research Laboratory (RRL) into more globally respected Indian Institute of Chemical Technology.

I was the first Indian scientist to take the lead in nurturing and fostering integration in basic science, technol-ogy development and engineering design to provide complete package for commercial exploitation. I was also instrumental in pioneering the concept of institution and industrial interaction with several leading phar-maceutical industries such as Cipla, Lupin, Cadila, Dr Reddy’s, FDC etc.I was also responsible in developing alternative affordable technologies for several essential drugs includ-ing anti-HIV drugs which enabled the Indian pharmaceutical industry to introduce them in the market at a fraction of the prevailing interna-tional prices.

Q You are one of the few scientists entrepreneur who have successfully

commercialized research. What is the secret recipe of your success?Dr AV Rama Rao: While working at NCL, I started working as a con-sultant to Indian pharmaceutical in-dustries. I had long association with Cipla and interacted closely with Dr

Y K Hamied on various aspects on products from the concept of iden-tifying the compound, developing laboratory scale suitable process that can be adopted by the indus-try and finally marketing the same. This knowledge enabled me to at-tract funds from private industries. It is essential to have close links with the manufacturing chemists and en-gineers and incorporating various parameters that go into smooth com-mercialization. Before we undertake lab work, I also insist on my collegues to work out paper technology taking into account the cost of raw material, alternative affordable technologies and finally transfer to industry. I al-ways believe that the success of tech-nology depends on many people who are working on the shop floor and if it fails, I used to take the entire blame but never happened.

Most of our scientists have to learn several lessons concerning com-mercialization of a product such as sourcing raw material, simple con-cepts of scaling up the process, haz-ards involved and safety aspects of it etc. This is mostly lacking among our scientists. Doing science is great but taking it to commercialization is not easy. I was the first academician to realize the potential and commer-cial opportunity in providing chemi-cal research services (now referred as CRAMS) to various international pharmaceutical companies by start-ing such programs after my retire-ment as Director IICT. Following my example, today there are more than 500 such companies operating in In-dia. Avra Laboratories, the company I founded in 1995 with no external investment, has grown significantly and now has over 550 employees. Avra is the first chemical company to receive CSIR Diamond Jubilee Tech-nology Award for 2014 (Rs 10 lakh-cash award to be given by the Prime Minister of India).


BioTalk

For a successful industrial research, choosing a good industrial project for commercial research is very impor-tant, secondly one should know the cost involved, third thing is to know how to scale it up in the industry and finally, one should also look at the market within India and outside. Some of these aspects, pure scientists have no idea, and that’s why indus-trial projects generally are not suc-cessful.

Also it happened that, I came from chemical technology background I had a basic understanding of chemi-cal engineering and also my personal interest I used to keep track of what drugs are coming in the market, how important they are and how best we can manufacture them.

It was a purely personal interest-which made me a successful indus-trialist.

My advice would be to interact with the industry as much as possible and try to understand the problems that the industry is facing and coming up with solutions for them.

Q You have had a very envious and an illustrious career both in research

and as an entrepreneur. Which is easy to break in – research or entrepreneurship?Dr AV Rama Rao: These are two different things. Fundamentally, I am a researcher, I liked to do re-search. I received several offers from industry during my career. Although the offers were very attractive, but I refused, because when we do science we get satisfaction and we feel happy.

Research and entrepreneurship do not go hand-in-hand. It worked out in my case. 30 years of research ex-posure and also because I was a consultant to various pharma com-

panies, I learnt the tools of the trade i.e. how to translate science to tech-nology and transfer to industry, and how to commercialize research, how to market the product etc.

Q Could you please share a turning point in your

professional life? Dr AV Rama Rao: My exposure to scientific research in Prof. E J Corey’s group gave me the confidence in car-rying out research in relevant areas to society. It was also my elevation from Scientist E to Head of the or-ganic chemistry division by the then Director of NCL, Dr L K Doraiswamy and the then DG, CSIR, Prof. M G K Menon gave me the desired opportu-nity to do research in areas that are being carried out in various reputed universities world over.

The next major turning point in my career was moving from Pune to Hyderabad as Director of Regional Research Laboratory (RRL), Hy-derabad, at the instance of Prof. M M Sharma, the former Director of UDCT. As Director of IICT (1985–1995), I was involved in several ma-jor national projects. I also served several national and international policy making organizations such as World Health Organization and Ozone cell of United Nations Envi-ronments Protectives agency etc.

Q What you like to do when you aren’t working?

Dr AV Rama Rao: I used to spend most of my time in the laboratory and do not have much free time. Only on Sundays, I used to go with family

to city, eat out and see a movie etc. I also love spending time with my dog.

For me my research students are a big asset, we used to discuss not only work, but general subjects as well. My students still remember me very fondly. We are like a family, but in the process my wife has to carry on all the responsibilities and take care of our kids in a way single handedly.

What are your thoughts on the quality of research

stemming from India?

Dr AV Rama Rao: When I was studying, the state universities, like Andhra, Osmania, Pune, Mumbai, Madras, etc were world-class and were involved in very good research.We used to read scientific journals to know what research was coming out of these universities. Today, unfortu-nately, research in state universities has totally vanished. They are fo-cused now only on teaching. In allthe state universities the quality of edu-cation and research has gone down mainly because of inbreeding. A person joined as a lecturer becomes a reader after 10 years, no posts get advertised. Earlier, most of the uni-versities used to attract the best available talent as professor. Today, most of the state universities, do not hire people from outside.

Number of research papers published are increasing but unfortunately quality of research is decreasing.

Today, the opportunities for re-searchers in any field are ample. In chemistry alone, we don’t find many suitable candidates to take up teaching in universities or to work in pharma and fine chemical industries. Science is not any more an attractive subject. BS

Ayesha Siddiqui

Research papers published are increasing but quality is decreasing

Q


BioTalk

‘I did not want to follow the convention’

2016 Padma Shri Awardee, Prof. Veena Tandon

In her illustrious career, Dr Tandon held many prominent positions including member of Scientific Advisory Committee to the Cabinet, Govt. of India, headed by Dr APJ Abdul Kalam, Task Force of Department of Biotechnology


BioTalk

Q Congratulations on winning thePadma Shri

Award.Please tell us about your research work.Prof.Tandon: During my long (<40 years) science and research career, I worked in the field of Parasitology, especially linked to the area of health and hygiene implicating worm infec-tions that are part of everyday life. In Northeast India, in particular, these infections, especially of the liver,lung and intestine, are a poten-tial threat to human health and affect a major section of the population via animal to human transfer as they are linked to socio-economic and socio-cultural factors−mainly hygiene and sanitation,traditional food practices and culinary habits of many native societies−in endemic areas.

While surveying various animals of food value in that area, I could de-cipher the whole spectrum of worm parasites that exist in the northeast-ern region.Iidentified some worm infections, particularly parasites of lungs, liver and intestine that are transmitted to humans because of

their preferred foods being shrimp, crabs, fish or in some places aquatic vegetation or contaminated water.These worm infections naturally oc-cur in animals, fish etc. and through food the infective stages can enter humans and develop into full-grown worms and become problematic for them.

Q What were the real world applications of your research work?

Prof.Tandon: It was first to give the basic information about the kind of (worm) infections that prevail in various groups of animals. Nar-rowing down to those, which could have health implications for hu-mans and to study their transmis-sions dynamics,i.e., how these in-fections are passed on from natural animal host to humans, what are the routes,which they take to reach hu-man hosts. Humans may not be the primary host to these parasites; they get secondarily involved, when they share the same environment with the natural animal hosts and at times consume the animals that harbor the

Prof. Veena Tandon isex-professor of Zoology, North-Eastern Hill University, Shillong. She now works as a Senior Scientist under the National Academy of Sciences India (NASI) Platinum Jubilee Scheme at Biotech Park, Lucknow.

Her research on worm infections has led to the better understanding of various kinds of parasitic infection in animals,particularly animals of food value,that can be transmitted to humans and helped doctors in better and efficient identification and treatment of worm infections.

Prof. Tandon did her PhD in Zoology (Parasitology) from Panjab University,followed by Post-doc at Department of Molecular Biology &Biochemistry, University of California, Irvine, USA.

In an exclusive interview with BioSpectrum, Dr Tandon shares her long journey as a scientist.Excerpts:

infective stages of these worms.

Q Would you share with us a turning pointin your

work?Prof. Tandon: During my four-decades long research career, I could provide a complete spectrum of worm infections prevalent in animals of food value (e.g., livestock, poultry, frogs, fishes and crabs) in the north-eastern region, and their implication to human health. The turning point as you say was when I diversified a little more, to find out markers for their diagnosis at the genetic level or at the molecular level using DNA-based techniques.

I say authentic diagnosis is impor-tant because in many areas where these infections prevail, the physi-cians may not be familiar with or aware of them and may not know what exactly is the cause of ailment in their patients.

I also got recognition when I worked with doctors form Arvind Eye Hospi-tal, Madurai,and identified the novel


BioTalk

causative agent (worm) of granulo-matous uveitis in children in Tamil Nadu and Kerala, South India.

Thus, using a range of approaches from empirical experiments to mod-ern genomic technologies my re-search work has provided valuable information for use by the research community and society at large and a greater understanding of the etiol-ogy of food-borne tropical parasitic diseases, which is important for the development of interventions and ef-fective control strategies.

Q What is your favorite aspect of research?

Prof. Tandon: The flat worms (or the tremadotes and tapeworms) and roundworms (the nematodes). My involvement has been more to find the diversity of worms in different animals like fishes, frogs, reptiles, birds, mammals etc, finally narrow-ing down to humans. Because, many of these infections occur in humans and are categorized as ‘neglected tropical diseases’ (NTDs). This term is given by WHO, and a lot of at-tentionis being paid for control and prevention of these infections. NTDs are the diseases of the poor and usu-ally occur in lower socio-economic groups, living in inadequate hygiene and sanitation conditions.

QYour journey so far.

Prof. Tandon:Initially, when I first started it was through surveys identification (or simple taxono-my) and distribution of the lowly organisms,worm parasites,among different groups of animals.From this entire spectrum of worm infections, potential infections of medico-veter-inary significance could be revealed.Once I could pin point the infections that could prevail in humans the next thing was to know how people in af-fected areas are handling such ail-

ments. In the Northeast, as my expe-rience goes, the different tribal people follow their own strong traditional medicine system; they depend on the plant-derived medicines to cure various ailments. Besides working on the biology and the epidemiology of worm infection, I extended my hori-zons towards screening those puta-tive medicinal plants that are used by various tribes for curing worm infec-tions. I extensively investigated the efficacy of many medicinal plants to scientifically authenticate their ver-micidal/vermifugal potential. Such plant-based cures can offer valuable therapeutic alternatives of affordable healthcare to socio-economically un-derprivileged and rural societies.

For last several years I have been deeply involved in conducting sci-ence promotion and awareness pro-grammes for school children in less privileged or facilities-deprived edu-cational institutions in rural and re-mote areas of the northeastern states of the country.

Given the potential magnitude of these infections, my research has helped various native communities and has a far-reaching impact on society.

Q Did you always wanted to be a scientist?

Prof. Tandon: Oh, yes. My dream was to go into medical science. When I passed my +12, I was only 14 and half years old, and the cut off at that time for MBBS course was 17. So, the next suggestion in my family was to go in for animal sciences and then there was no looking back. I did my BSc, MSc, PhD in Zoology.

I was studying in Panjab University where as a convention toppers would always choose Cytogenetics as their preferred specialization for MSc.Contrary to this, I opted for Para-sitology as the main subject; there were not many students in this field.

QWhat are your thoughts on the quality of research stemming from India?

Prof. Tandon: In Central Universi-ties and national research labs by and large the standard is good. The op-portunities are many and the funding is also very good, which has increased several folds in recent times.

But in most state universities the standard is not all that good. For this, there can be many reasons - the se-lection process for faculty positions, financial crunch, lack of zeal or mo-tivation among the younger genera-tion, etc. In most institutions, par-ticularly where there is not much of a competition, the teachers/research-ers feel contended with mediocrity and bother more about their pay structure rather than their academic and research contributions.

Q Do awards validate your research?

Prof.Tandon: Sometimes recogni-tion in early career could be helpful. But I think once you reach a certain stature, awards don’t really matter.What matters is the satisfaction you get from your work, seeing your stu-dents doing well etc.

For research grants, at the senior level it is the quality of your research work that is taken into consideration. Awards do add upto your reputation.But ultimately your research work and its relevance is what is more im-portant for securing grants. BS

Ayesha Siddiqui

In Central Universities and national labs the standard is good.


BioTalk

2016 Padma Shri Awardee, Prof. Dipankar Chatterji

‘We have performed extraordinarily well’

We are far away in biology, but enventually we will get it. I think this is the only field in India which is close to getting Nobel Prize


BioTalk

Q Tell us about your research work. What do you want to achieve with your research?

Prof. Chatterji: I work on bacterial gene expression for several decades now. I worked with CCMB before joining IISc, where I was working on E.coli under stress and after coming to Bangalore in 1999, I shifted to Mycobacterium smegmatis because it is a very good model system.

My whole emphasis is how the regulation of gene expres-sion takes place, how many proteins are expressed, how the protein functions within a system and interact with enzyme like RNA polymerase and how they influence the expression pattern. In the process, we identified few small molecules which are known as second messengers, these help in signal transduction for bacterial communi-cation, stress response and these are cyclic AMP, Cyclic di-GMP etc.

AMPs and ppGpp bind RNA polymerase and modulate its activities. In fact we were the first to show that ppGpp binds RNA polymerase in 1995, nobody believed it then but now everybody accepts it.

Cyclic di-GMP, on the other hand, does not bind RNA polymerase, at least no evidence yet but there are lots of effector molecule which finally bind them and modulate gene expression.

Under difficult situations like lack of oxygen, food etc how bacteria survive? This survival under stringent condition is good for them but not for us, therefore, we should know how to prevent them from doing so that they die. Under stressful condition they are very infectious. Knowing the

details of these pathways will ultimately lead us to ma-nipulate them in such a way that they do not survive even under stressful situations.

I have also identified proteins that get expressed under starvation conditions and bind to DNA very tightly so that the all important genetic material does not get dam-aged by free radicals.

Q How many processes or mechanism you have identified so far?

Prof. Chatterji: We have worked on stringent response and quorum sensing in mycobacteria. We have found two enzymes, the regulation and published several papers. We wanted to develop inhibitors of ppGpp by way of mimicking the structure.

Such inhibitor is available in the literature, but it works at high concentration and we are trying to modify it. We have done some interesting work like cell membrane mimicks which can stop the GPL synthesis. We have some leads that tell us that Vitamin C may act as an in-hibitor for stringent response.

Q What could be the real world applications of the research (your work) in molecular

biology?Prof. Chatterji: I would like to say that knowing this mechanism will lead us to some inhibitors which will in-terfere with the maintenance of the stationary phase, or dormant bacteria under stressful conditions. These bacte-ria are also called dormant, and take part in biofilms pro-duction. My current work is to look at biofilms inhibitors.

Prof. Dipankar Chatterji is professor at Molecular Biophysics Unit, Indian Institute of Science (IISc), Bangalore. Prof. Chatterji works on bacterial gene regulation under stringent conditions. Before Joining IISc, Prof. Chatterji worked for 15 years at CCMB, Hyderabad.

Prof. Chatterji got his PhD from IISc Bangalore followed by Post-doc at Albert Einstein Medical College, New York and State University of New York at Stony Brook, New York.

He spoke about his passion for research, Nobel Prize, awards, and research scenario across the country. Excerpts:


BioTalk

Q How has research in molecular biology evolved over the years in India?

Prof. Chatterji: Oh, now India is doing well. Globally, it is not very competitive, yet there are certain sectors that have performed well. But let me put it very categorically, that we have performed extraordinary well considering the kind of inputs we have financially.

Q Did you always want to become a scientist? What drew you to this field?

Prof. Chatterji: Until my MSc, I was really not moti-vated enough for science. For my PhD, I came to IISc and that is when the whole world of science opened up for me. This institute gave me the first exposure of international science.

The mentors, ambience, good friends, all play important role in shaping your career. This institute provided me the best of these and inspired me to pursue science as a career. I knew nothing about many things but I could listen to talks of big and great people. This drove me to think that I should take up this profession and what could be a better career than where you are getting paid for your hobby.

QWhat is your favourite aspect of research?

Prof. Chatterji: One is stringent response or stress re-sponse in which I showed that ppGpp binds to RNA poly-merase and regulates gene expression.

Recently, we did some work on RNA polymerase subunit called omega and function of omega subunit. Nobody gives much importance to this subunit because people think that it is redundant subunit and has no biological function. We showed how important it is.

Q Would you share with us a turning point in your work as a scientist?

Prof. Chatterji: I would say my research work on strin-

gent response where I showed that ppGpp binds to RNA polymerase and regulate gene expression, really gave me some international recognition.

Q You have received many prestigious awards like IISc Alumni Award for

Excellence in Research, UGC-J C Bose Award and the latest Padma Shri award. Do the awards give more validity to research? Are they helpful in any way? Does this make it easier for you to secure grants, etc.?Prof. Chatterji: It does definitely, but it is not the only thing. The most important thing is peer recognition, and what your fellow scientists think of you. Award, recogni-tion at International level is very good.

Padma Shri is also very good, in a way your country tells you that you are an important Indian. It makes me very humble.

Q We do see a lot of NRIs getting prestigious awards like Nobel Prize. However, we are

yet to see Indians working here bagging the prize. Your comments.Prof. Chatterji: I think we are far away. China wanted it for so long and they spend so much money on research and they got it last year. We do not spend enough money on research. I personally believe Nobel Prize is directly proportional to the amount of money spent on research and international network. Instead of this question we should ask first, how many of us get call for plenary talks in major international meetings?

We are far way in biology, but eventually we will get it. We are close in physics, we have done some really great and path breaking work. I think this is the only field in In-dia, in my opinion, which is close to getting Nobel Prize.

Q What are your thoughts on the quality of research stemming from India?

Prof. Chatterji: We are not very good yet. The quality is not that great. Of course there are certain places which are doing some great work. But overall it is abysmal. The rea-son being of course not enough amount of funding. BS

Ayesha Siddiqui

The mentors, ambience, good friends, all play important role in shaping your career.


BioCluster

Scientists welcome National Biotechnology Development Strategy

BioCluster

Scientists have over-whelmingly given their thumbs up to the Na-tional Biotechnology Development Strategy 2015-20 unveiled by

Union Minister for Science and Tech-nology and Earth Science Dr Harsh Vardhan recently.The Strategy aims to establish India as a world class biomanufacturing hub. It intends to launch a major mission, backed with significant investments, for the cre-ation of new biotech products, create a strong infrastructure for R&D and commercialization, and empower In-dia’s human resources scientifically and technologically.

The key elements of the strategy are:

Building a skilled workforce and leadership

Revitalizing the knowledge envi-ronment at par with the growing bio-economy

Enhance research opportunities in basic, disciplinary and inter-disciplinary sciences

Focus on biotechnology tools for inclusive development

BioCluster

The key elements would be implemented in collaboration and partnership

Satyen Mohapatra

Nurturing innovation, translation-al capacity and entrepreneurship

Ensuring a transparent,efficient and globally best regulatory sys-tem and communication strategy

Biotechnology cooperation - fos-tering global and national alli-ances

Strengthen Institutional Capac-ity with redesigned governance

models

Create a matrix of measurement of processes as well as outcome

The key elements would be imple-mented in collaboration and part-nership with other ministries, departments, state governments and international agencies towards achieving:

Making India ready to meet the challenge of achieving $100 bil-lion by 2025

Launching four major missions – healthcare, food and nutrition, clean energy and education

Creating a technology develop-ment and translation network across the country with global partnership - 5 new clusters, 40 biotech incubators, 150 TTOs, 20 bio-connect centres

Creating a life sciences and bio-technology education council

Establish a National Council for Biosciences and Bioengineering

Setting up of a national centre for drug discovery


BioCluster

Setting up a national institute on marine biotechnology

Establishment of biotechnology institute on rural development

Kiran Mazumdar-Shaw, Chairman and managing director of Biocon, speaking on theNational Biotechnol-ogy Development Strategy said, “It will set the biotech agenda for the country and will help in India’s evo-lution as the biotech hub & the pre-ferred destination for innovation.”

“The National Biotechnology Devel-opment Strategy (NBDS) in its pres-ent form is a step in the right direc-tion as it aims to provide an enabling and facilitating framework for pre-paring the Indian biotech industry to meet its aspirational target of $100 billion by 2025.”

Dr Shaw felt that the strategy would pave the way for addressing various challenges associated with the Indian biotech sector.

“We are hopeful that this strategic road map will lead to effective on-ground implementation creating an optimal ecosystem that encourages innovation in the country and en-ables biotech sector to address some of the challenges that the nation is facing today in terms of food, energy

DBT’s long term vision for research."

Dr Dhawan pointed out that while investing on high tech research, DBT has not lost sight of importance of biotechnology for rural communities and thus has committed setting up of institutions for research & training for technologies important for rural upliftment and sustainable growth.

Further, she said, to bridge the gap between research and its commer-cialization, setting up of 100 TTOs (Technology Transfer Offices) & BIO-CONNECT will help biotech industry flourish and become major driver of country’s economic growth.

According to Dr Dhawan, “The strat-egy paper is a well thought of docu-ment based on the emerging national priorities. The issues related to estab-lishment of research infrastructure and training of research profession-als at different stages of career has been addressed through plans for the establishment of world class infra-structure; internship and exchange programs; refresher course for the faculty; and Chairs with provision of inviting world renowned scientists.”

Commenting on the NBDS, renowned scientist and JNU Vice-Chancellor Dr Sudhir Kumar Sopory said emphasis has been given to basic research,

and healthcare.”

Access to capital, quality infrastruc-ture, high-end talent are some of the immediate needs of the sector which are likely to be eased with the implementation of this roadmap, she added.

Distinguished Fellow and Senior Di-rector The Energy & Resources Insti-tute (TERI) Dr Vibha Dhawan, said the strategy gives due emphasis to the country’s strength in biodiversity and its exploitation for developing products & processes and conserva-tion.

“In the past, benefits of biotechnol-ogy, unfortunately, have not been reaped by the society one of the ma-jor reasons being lack of understand-ing and certain misconceptions. “To address this issue Department of Biotechnology now plans to invest in communication and would be using the latest communication tools to do so, she added.

Appreciating importance of the pri-vate sector, Dr Dhawan said, DBT’s commitment of involving and sup-porting them is a commendable step for the nascent biotech industry. “Commitment to invest in newer technologies such as clean fuel & nanotechnology further reiterates

Harsh Vardhan unveils India's National Biotechnology Development Strategy 2015-2020


BioCluster

which is required to make the coun-try self assertive in generating new knowledge, and translational work. “There are many other initiatives which deserve appreciation. Howev-er, my main concern is the financial commitment, and implementation of ideas and programs.”

He said the mission programs and key elements have been very well thought of in the National Biotech-nology Development Strategy 2015-2020. “The idea of new cluster de-velopments is very good but it will require insightful thinking on their locations and the theme of research.I had suggested long back to have one around JNU as there are already many good institutes, like ICGEB, NII, NIPGR, IIT in and around the university,” he added.

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It will set the biotech agenda for the country and will help in India’s evolution as the biotech hub & the preferred destination for innovation.

Kiran Mazumdar-Shaw CMD, Biocon

Dr T R Sharma, Director, National Research Centre on Plant Biotechnol-ogy, said earlier lot of emphasis was given to only basic research but now Department of Biotechnology is giv-ing emphasis on basic research which can be translated in the form of prod-ucts like crop varieties which are re-sistant to biotic and abiotic stresses, climate resistant varieties, etc.

Indian Agriculture Research Insti-tute Director Trilochan Mohapatra said “It’s a comprehensive document covering all sectors - animals and plants, bio safety, GM crops, drug design, nano biotechnology, immune diagnostics including new areas like modification technology.”

Dr Mohapatra stressing the need for judicious opening of institutions, cautioned, “as funds and human re-sources are limited instead of con-tinuously adding and increasing the number of fresh institutions empha-sis should be on strengthening ex-isting institutions and collaboration among institutions.” He said efforts should be made so that private fund-ing is available for biotechnology re-search or drug development from the initial stage itself. BS


BioAnalysis

Introducing the ‘PfizerKline Empire’

Industry scions believe that it makes perfect sense for Pfizer to bid for GlaxoSmithKline (GSK) and there are many merits to a Pfizer-GSK acquisition.

BioCluster

I n 2015, Deutsche Bank analyst Mr Gregg Gilbert sent a note to the clients writing, ‘Introducing PfizerKline’, catalyzing an unprece-dented adrenalin rush among pharmaceutical industry giants and investors around the world. “….As evidenced by Pfizer's interest in AstraZeneca last year, one important goal for Pfizer has been to seek a deal that would maximize access to its balance sheet and improve

its tax structure,” Mr Gilbert wrote.

He also pointed that this potential combination could be ‘materially accretive’ to earnings per share and discounted cashflow. According to the calculations, the deal would be valued at an enormous $146 billion.

Appealing British cosThe deal would grant Pfizer major tax benefits, as the company would move its legal address to the UK instead of the US, lowering its corporate tax rate

BioAnalysis


BioAnalysis

in the process.

British drug makers seem appealing mainly because they are in a lower corporate tax region compared to the US.

Estimates have put Pfizer’s offshore cash at nearly $70 billion, which is held outside the US, so the company does not pay the 35 percent US corporate tax rate.

“This is not the first time that Pfizer has attempted a tax-inversion deal, however. In 2014, the US drug giant was in a hostile pursuit of UK drug maker AstraZeneca (AZ), in a deal worth nearly $120 billion. This would have been the industry’s biggest ever acquisition. However, Pfizer faced stiff opposition from the US Treasury, which had tightened regulations and effectively made it disadvanta-geous for Pfizer to go ahead with the deal,” explained Mr Gianfranco Zeppetelli, deals analyst, GlobalData, a global research and consulting firm.

If Pfizer were to proceed with a GSK takeover, it could face similar opposition from UK politicians, much like it did with the AstraZeneca deal.

Both companies have overlapping development programs and Pfizer would gain access to GSK’s newly revamped respiratory portfolio, whilst strengthening its vaccine pipeline, potentially making the combined company a vaccine and consumer health powerhouse.

Mr Zeppetelli said that GSK has been looking more and more vulnerable recently as sales continue to decline, most notably from its once best-selling respiratory prod-uct, Advair, amidst increasing generic competition.

“Dutch rival Mylan NV is the latest competitor to add another nail in the coffin, and has recently launched the first bioequivalent copy of Advair, known as Sirdupla,” he pointed.

GSK’s battleIn 2015, GSK’s first-quarter earnings were unimpressive, and its strategy, headed by its CEO Mr Andrew Witty, is one that leans on slow but steady growth, emphasizing volume sales over highly-priced medicines.

However, this tepid growth strategy has not been popular with investors who want ROI in the near term, said the analyst.

In addition, GSK’s consumer health and vaccines busi-nesses, which the company recently talked up via its sale and swap with Novartis, are lower-margin businesses, meaning that they do not have as high a financial impact as branded prescription drugs.

Fallen revenuesDuring the past few years, patent exclusivity losses have hit Pfizer really hard.

Since 2010, Pfizer’s prescription sales have fallen from $58 billion to $46 billion in 2014, as a result of patents expiring on key drugs, such as Lipitor, Caduet, Xalatan, Geodon, Celebrex, and Viagra.

Pfizer’s licensing agreement with Boehringer Ingelheim (BI) to market the COPD (chronic obstructive pulmonary disease) drug Spiriva terminated on a country-by-coun-try basis in 2012, which resulted in a decline in Pfizer’s share of Spiriva revenue. This dragged down Pfizer’s alli-ance revenue related to the drug.

Based on the midpoint of Pfizer’s estimated prescription drug sales of $43 billion for 2015, the company’s Rx sales

Both companies have overlapping development programs and Pfizer would gain access to GSK’s newly revamped respiratory portfolio, whilst strengthening its vaccine pipeline

THE BIG BOY

What motivates Pfizer to go really big on its acquisitions like AZ, Hospira and now GSK? The main driving force behind these large acquisitions is Pfizer’s key strategy of buying assets that have the potential for creating value in the short term, allowing the company to boost sales rather than sign deals for long-term drug development.

“Additionally, Pfizer has seen a shortfall in its topline revenue since its patents on Lipitor and Caduet expired. It will also witness a continued drop in sales due to pending and future patent losses on top-selling drugs Celebrex, Viagra, and Zyvox,” revealed Mr Zeppetelli.


BioAnalysis

will have dropped by nearly $15 billion since 2010.

Overlapping strengthsRespiratory drugs and vaccines for infectious diseases are two main therapeutic areas which overlap between the two pipelines of the duos.

GSK is one of the market leaders in respiratory drugs, and its lead product Advair/Seretide accounted for ap-proximately 23 percent of its total revenue in 2014.

The British drug maker is also counting on four co-devel-oped COPD/asthma products (Breo/Anoro, Ellipta, In-cruse, and Arnuity) to drive growth over the next decade, which would fit nicely with Pfizer's product portfolio.

GSK has also strengthened its position as one of the lead-ers in vaccines, after acquiring the global vaccine busi-ness from Novartis last year.

Pfizer has found incredible success with its Prevnar vac-cine line and, in buying GSK, would truly solidify the combined entity as a vaccine powerhouse.

Impact on Indian cosPfizerKline specifically would not have a large impact on the Indian drug market.

“However, we do expect that Pfizer would be carving out

its Global Established Products (GEP) business unit, which is largely comprised of its generic drugs, along with some biosimilars, and injectables platforms. This segment achieved combined sales of $25 billion in 2014,” Mr Zeppetelli noted.

The divesture would be similar to when Pfizer spun off its animal health (Zoetis), nutrition, and Capsugel business units.

If the deal is a success, PfizerKline’s competitors will re-main in the branded drug space in continental Europe. These include AstraZeneca, Novartis, Bayer and, to some extent, Roche, Novo Nordisk and Sanofi.

Will GSK give in?Given GSK’s financial struggles, loss in market cap, and recent announcements of lay-offs and restructuring, the company’s board might be more open to a deal with Pfiz-er.

“The key sticking point will be the political pressure and regulatory hurdles in the UK. GSK has a deeply imbed-ded infrastructure in the UK, and it will be hard for the citizenry to lose one of its top employers,” he commented.

Will Pfizer eye Indian drug makers next? “Not really,” Mr Zeppetelli added. “We are talking about branded or in-novator companies and not generic drug makers. We do expect Pfizer to spin off its GEP business as a separate generics business entity. This business unit will com-pete directly with the global generic drug manufacturers, namely Teva, Mylan, Sun, Lupin, Cipla and, to some ex-tent, Actavis and Valeant -- although these companies are shifting strategy to more branded drugs.”

Will Pfizer eye Bristol-Myers Squibb (BMS) in the future? Or will it approach AZ again later this year? “I don’t be-lieve so,” concluded Mr Zeppetelli. BS

We are talking about branded or innovator companies and not generic drug makers. This business unit will compete directly with global generic drug manufacturers

Raj Gunashekar

WHY OVERSEAS FIRMS?

One of the main reasons for companies to acquire overseas firms is to move their legal addresses away from the US, thereby lowering their corporate tax rates by a significant margin.

Mr Zeppetelli explained, “This enables companies to free up more money, which can be used for other deals, R&D spend, or to return to investors in the form of dividends.”

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BANGALORE INDIA NANO 2016

Envisioning nano horizons

T he 8th edition of India’s flagship Nano-technology and Nanoscience event – Bangalore India Nano 2016 was held on March 3-4, 2016. An initiative powered by the Department of IT, Biotechnology and Science & Technology, Government of Kar-

nataka and Vision Group on Nanotechnology, is one of its unique event that is a refined blend of academia, research and industry to showcase never seen before nanotechnol-ogy applications.

The inaugural ceremony was attended by Chairman of Vi-sion Group on Nanotechnology and Science & Technology, Bharat Ratna Prof. C N R Rao, FRS, Shri SR Patil, Minister for Information Technology, Biotechnology and Science & Technology; Planning & Statistics, and Ms Manjula, IAS, Principal Secretary, Department of Information Technolo-gy, Biotechnology and Science & Technology, Government of Karnataka were the other dignitaries.

During the inaugural function Dr V Ramgopal Rao received the Prof C N R Rao Bangalore INDIA NANO Science Award for the exceptional work carried out in the Nano electronics

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space. Prof Ramgopal Rao is a P K Kelkar Chair Professor in the Department of Electrical Engineering and the Chief Investigator for the Centre of Excellence in Nanoelectron-ics project at IIT Bombay.

The Bangalore INDIA NANO conference addressed the lat-est trends in Nanotechnology covering Healthcare, Clean Water, Energy, Manufacturing, Research Industry Col-laboration Hub, Keynote Lectures over 13+ sessions and saw participation of over 600 delegates and 2,000 busi-ness visitors from across 9 countries (UK, USA, Germany, Canada, Korea, Bulgaria, France, Poland, Singapore) with participation of over 200 organizations.

The event also comprised of a research industry collabora-tion hub (RICH) - a unique platform designed for the bene-fit of young researchers, emerging entrepreneurs, potential investors, heads of large R&D labs, venture capitalists and industry captains.

The Nano event also witnessed product and technology ex-hibition showcasing innovative nanotechnology adopted by over 45 distinct exhibitors in nanotechnology and allied


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sectors.

The exhibition allowed participation of 14 organizations under DST NANO MISSION Pavilion, institutes of national importance like IITs, NIT, IISc, INST along with other cor-porates.

The major highlight included ‘Nano SparX’, a platform for students to PhD scholars to encourage entrepreneurship in nanotechnology where ideas were presented on nanotech-nology with social relevance.

The inauguration was followed by two Keynote lectures.The first lecture conducted byDr Clement Sanchez focused on how mankind has evolved using tools from stones to copper, iron, glass, and now designing and applying nano material across sectors.

The second lecture led by Prof Young Hee Lee, Professor of Physics, Sungkyunkwan University, South Korea, gave an insight on the introduction of new material for semicon-ducting by synthesizing in labs. Another exclusive feature of this edition was the launch of India’s first CVD Reactor by Prof CNR Rao as part of the product and technology ex-hibition.

The Clean Water Technology and Healthcare solutions ses-sions saw jam-packed audience. The Clean Water Technol-ogy enlightened the attendees on new nanotechnology-based solutions that are needed for sensing and remote monitoring to ensure that solutions are functioning and people are benefiting.

The Healthcare session covered recent results on the de-velopment of Carbon Nanotubes (CNT) using biological re-ceptors such as aptamers, antibodies and binding proteins.

Sessions on Nano Manufacturing and Nano Energy were delivered by experts. While Nano Manufacturing covered topics such as large scale manufacturing, large area Nano fabrication self-cleaning anti-microbial surfaces, and Sci-ence and Technology of micro manufacturing, the Nano Energy focused on graphene applications, transition metal nitride and carbides and the use of carbon-based materia-lin energy storage.

The Nano Excellence Awards included Prof C N R Rao Bangalore INDIA NANO Science Award; Bangalore INDIA NANO Innovation Award; Malhotra Weikfield Foundation-Nano Science Fellowship Awards; Best Poster Awards and Best Exhibitor Awards and many more.

The Bangalore India Nano Innovation Award 2015 was bestowed to Indian Oil R&D Center for their innovation ‘NANOCUT’, a High-ThermIndane Cutting Gas for high temperature industrial applications in metal cutting seg-ment. The ‘Nano for the Young’ program was attended by 500 undergrad students who were introduced to the fasci-nating world of nanoscience and nanotechnology by expert speakers.

Another major highlight was a ‘Poster – Walkway of Dis-covery’ which attracted over 100 young researchers who presented new ideas in Nanoscience and Nanotechnology. Ten best poster presenters were awarded Rs 20,000 cash prize each.

The event culminated with a valedictory ceremony ad-dressed by Shri Bharat Lal Meena, IAS, Additional Chief Secretary, Higher Education Department, Government of Karnataka, and Ms V Manjula, IAS, Principal Secretary to Government Department of IT, Biotechnology and Science & Technology Government of Karnataka. BS


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Thermo Fisher Scientific offers anti-Zika virus test kits

Thermo Fisher Scientific is now of-fering the first test kits available in the US to enable serological detec-tion of the Zika virus in research ap-plications.The kits, manufactured by EUROIMMUN AG, can differentiate between Zika, dengue and chikungu-nya viruses.

These tests also enable researchers to detect the virus in samples over a much longer period of time than is possible with current direct-detec-tion assays.

The EUROIMMUN Anti-Zika Virus ELISA and indirect immunofluores-cence (IFA) test formats allow re-searchers to detect specific antibod-ies (IgM and IgG) in blood samples.

The highly specific viral antigen used in the assays virtually eliminates cross reactivity with other flavivirus antibodies that are known to interact with the Zika virus,enabling reliable differentiation from viruses such as dengue fever. The EUROIMMUN antibody detection test kits can be run on fully automated analyzers, al-lowing researchers to work with large

volumes of samples to better under-stand the virus.

“Since first learning about the Zika outbreak, we’ve worked closely with our colleagues at EUROIMMUN to mobilize resources and address this urgent need,” said Mark Zacur, vice president and general manager of Thermo Fisher’s healthcare market channel.

‘‘The test kits are an important step forward in the ongoing Zika response by facilitating better understanding of the virus. We are pleased to have been chosen as their exclusive chan-nel for making these tests available to our clinical research customers across the US.”

Pfizer has anew MD“Pfizer has announced that the Board of Directors of the company has ap-pointed S Sridhar as the Managing Director of the company, with effect from March 18, 2016 for a period of 5 years,” the company said in a filing to BSE.

“The appointment of Sridhar will be subject to approval of shareholders at the ensuing Annual General Meeting of the company,” it added.

Sridhar joined Pfizer in June 2008. He assumed additional respon-sibility of the distribution func-tion from May 2013. Before join-ing Pfizer, Sridhar was the Finance Director in India Hub of Diageo India. Sridhar was appointed to the Board on May 14, 2013.

Siemens to sell its healthcare businessThe Board of Directors of Siemens has approved the sale and transfer of its healthcare undertaking, as a going concern on a slump sale basis, for a sale consideration of Rs 30,500 million,to Siemens Healthcare, a subsidiary of Siemens AG.The transaction is subject to requisite regulatory, statutory and shareholder approvals.

The consideration for the proposed transaction, recommended by the audit committee, is based on the valuation undertaken by two independent valuers - Deloitte Touche Tohmatsu Indiaand KPMG India.Citigroup Global Markets India is acting as the transaction advisor to Siemens.

Sunil Mathur, managing director and chief executive officer, Siemens, said, ‘‘This transaction, follows Siemens AG’s global strategy of managing its healthcare business under a separately-managed company. Over 85 percent of Siemens Healthcare revenue is currently derived from products imported from Siemens AG. Significant management focus, including investments will be needed in finding appropriate products and solutions to meet the grow-ing demands of the Indian market. As there are limited synergies between healthcare and other businesses of Siemens, this transaction will enable Sie-mens to increase its focus on, and capital allocation to Power Generation, Transmission and Distribution, Mobility, Industrial Automation and Smart Cities segments while enabling Siemens AG to further strengthen its focus on the healthcare segment in India, by aligning it with its global strategy and management framework.”


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MedTech Industry seeks roll back of import duty increaseIndian Medical Device and Equipment sector is largely supported by imports for meeting the healthcare needs of the country. FICCI welcomes government’s recent move to relax import duty on spare and parts used to manufacture and maintain medical devices in India. This was long awaited to give necessary impetus to in-digenous industry.

However, a simultaneous hike in import duty of medi-cal equipment and devices and the resultant cost im-plications on care provision are likely to affect afford-ability of medical care in the country.

This sector being highly technology intensive, thrives on innovations which require an ecosystem for devel-opment and manufacturing complex medical devices and equipment.

The 7 percent increase in duty hike coupled by high foreign exchange related pricing pressures puts med tech industry under stress.

Agilent launches platform for analyzing cell-free DNAAgilent Technologies has introduced OneSight, a new software platform designed to help researchers visual-ize and analyze chromosomal aneuploidies in cell-free DNA sequencing data.

“The study of cell-free DNA is a very active area of re-search, and we expect growth in applications such as analysis of liquid biopsies and cell-free fetal DNA,” said Herman Verrelst, Agilent vice president and gen-eral manager of the company’s Genomics Solutions Division and Clinical Applications Division.” With OneSight, researchers will be able to gain a deeper understanding of their sequencing data and apply that to a wide range of applications, from the early detec-tion of cancer to screening for fetal abnormalities.”

Verrelst noted that OneSight offers genetics laborato-ries a cost-effective way to perform high-quality, cell-free DNA analysis in-house (which used to require an often-prohibitive investment).


BioSuppliers

Shimadzu launches new ICPMSShimadzu, one of the world’s fastest growing mass spectrometry compa-nies, announced the introduction of the Shimadzu ICPMS-2030 Induc-tively Coupled Plasma Mass Spec-trometer. The new ICPMS-2030 is designed to respond to the ICH (In-ternational Conference on Harmoni-sation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Q3D guidelines for el-emental impurities in pharmaceuti-cal products.

The ICH Q3D specifies allowable lim-its of daily intake of 24 elements of toxicological concern, and requires high sensitive and high precision measurement of such elements.The ICPMS-2030 satisfies these require-ments with ppt level high sensitivity, which is achieved by newly developed collision cell and optimized internal structure, offering FDA 21 CFR Part 11 compliance, automated analytical method development function, and unique measurement result evalu-ation function to provide analytical results with high reliability.

US pharmacopoeia indicates limits of elemental impurities(USP < 232>)and detection technique by ICP-MS (USP < 233>), which will be in effect in January 2018. In USP < 735>, X-ray Fluorescence Spectrometry is ad-opted as general analytical method. For those demands, Shimadzu offers total solution for elemental impuri-ties analysis.

Sartorius introduces assaysfor testing biosimilarityof three leading biologicsThe new assays, launched by SSB’s subsidiary Sartorius Stedim BioOutsource, will allow biopharma manufacturers to generate accurate comparability re-sults rapidly and cost-effectively.

Utilizing its extensive expertise in the development, optimisation and qualifi-cation of a wide range of different types of binding assays and immunoassays, the ready-to-use assays have been developed to ensure accurate comparabil-ity results for biosimilars to Actemra, Stelara and Lucentis. The new assays available include: Actemra IL-6R neutralization Bioassays; an Actemra IL-6R Binding ELISA; Stelara IL-12/IL-23 Binding Assays; a Stelara C1q Binding Assay; a Stelara neutralization bioassay; Lucentis VEGF Binding Assays and a Lucentis VEGF neutralization Bioassay.

These pre-developed assays complement BioOutsource’s existing portfolio of assays and expands the number of molecules the company can now support to more than nine molecules.The availability of pre-qualified off-the-shelf as-says provides biosimilar developers the opportunity to quickly and cost ef-fectively test a wide range of biosimilars utilising assays from just one trusted supplier.

Carestream’s cone beam CT system to offer 3D extremity images Carestream showcased its CARESTREAM OnSight 3D Extremity System that uses cone beam CT (CBCT) technology to capture weight-bearing and other types of extremity exams at the American Academy of OrthopaedicSurgeons (AAOS) annual meeting and exhibit held from 2ndMarch 2016 to 4thMarch 2016.

This affordable system is intended to offer high-quality, low-dose 3D imaging for orthopaedic practices and other healthcare providers.The CBCT system (INVESTIGATIONAL: Not available for commercial sale) is being designed to include advanced image reconstruction and artifact correction technology.

“Our CBCT system is designed to allow orthopaedic practices to capture high-quality 3D extremity images and conduct a patient consultation in a single visit,” said Helen Titus, Carestream’s Worldwide Marketing Director for X-ray & Ultrasound solutions. “This is highly productive for orthopaedic spe-cialists while simultaneously delivering greater patient convenience. Pre-sur-gical and post-surgical exams can also be performed by this system.”

She adds that orthopaedics is a major area of focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages. The company is currently conducting trials and research studies of the CBCT sys-tem in the United States and Europe. UBMD Orthopaedics & Sports Medicine (Buffalo, N.Y.), Erie County Medical Center (Buffalo, N.Y.).


AwardsAppointments

Merck appoints Chattopadhyay presidentMerck has appointed SanatChattopadhyay as executive vice president and president of Merck Manufacturing Division (MMD), effective April 1,2016.Chattopadhyay will succeed Willie A Deese who will retire on June 1, 2016 after 12 years with the company.

With more than 30 years of biopharmaceutical industry experience, Sanat has a proven track record of commercialization, manufacturing and supply chain excellence in therapeutic proteins, vaccines and pharmaceuticals.

‘Maker in India’ award for Vazirani

The SOL Lions Gold Awards held every year, are a tribute to individuals from different walks of life who have made

an outstanding contribution to the society.

Vazirani won the ‘Maker in India’ award for his outstanding efforts in design, innovation and sustainability over last 36 years that has helped place India on the global diagnostic industry map. The award was presented by Raju V Manwani, International Director of Lions Club International (2013-15).

Prof. Satyajit Mayor awarded Margdarshi fellowship

The Margdarshi f e l l o w s h i p i s aimed at using the expertise of a visionary scien-tist to seed new areas of research in India by men-

toring young researchers while also building partnerships both within the Indian scientific community and globally. Prof. Mayor is one of only three recipients of this highly competitive scheme awarded by the Wellcome Trust/DBT India Alliance.

Pfizer announces new managing director“Pfizer has announced that the Board of Directors of the company has ap-pointed Mr S Sridhar as the Managing Director of the company, with effect from March 18, 2016 for a period of 5 years,” the company said in a filing to BSE.

“The appointment of MrSridhar will be subject toapproval of shareholders at the ensuing Annual General Meeting of the company,” it added.

Koontz president of GE Healthcare IT

GE Healthcare has announced the appointment of Charles Koontz as presi-dent and CEO of GE Healthcare IT and GE Healthcare chief digital officer, effective March 14. Koontz succeeds Jan De Witte, who is leaving GE.

Koontz joins GE from Computer Sciences Corp (CSC) and CSRA, where he was executive vice president of the Federal Civilian Agencies Group. As VP and general manager of the healthcare group at CSC, Charles focused on tran-sitioning healthcare clients to next generation IT.

Sanofi appoints Dr Ameet Nathwani as EVPDr Ameet Nathwani will be responsible for enterprise-wide medical, patient safety, medical quality assurance and will insure the highest standard of transparency and compliance in Sanofi’s interactions with healthcare provid-ers, patients and medical organizations.

He will work in cooperation with Global R&D and the Global Business Units.Dr Nathwani succeeds Dr Paul Chew who has served as senior vice president, Chief Medical Officer since January 2013 and plans to retire later this year.

BioPeople

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BioPharma & Healthcare Summit on June 2 in US

T he USA-India Cham-ber of Commerce (USAIC) will organize its 10th annual Bio-Pharma & Healthcare Summit on June 2 at

the Marriott Cambridge, Massachu-setts, USA. USAIC’s BioPharma & Healthcare Summit 2016 will bring together key stakeholders from the industry, academia, investors, foun-dations and government to engage in active debate and idea generation on ways for successful collaboration be-tween global BioPharma companies, academia and India’s BioPharma in-dustry and academia.

Dr Andrew Plump, Chief Medical & Scientific Officer and Board Member, Takeda Pharmaceuticals, will be the

Master of Ceremonies (Emcee).

The summit will focus on BioPharma R&D strategy & trends; role of genet-ics in the therapeutic areas of Cardio-vascular & Metabolic Diseases; On-cology; Neurodegenerative diseases; along with discussions on Industry-Academic Partnerships, India Clini-cal Research update, Global Part-nerships and Funding Innovation.Role of CRISPR, AGCTs and Immune Checkpoint Inhibitor Therapy will be discussed by the most renowned people in BioPharma.

The annual summit is a must attend gathering for global BioPharma in-dustry leaders, academicians and in-vestors. This will be the 10th annual summit. We have been talking about

The annual summit is a must attend gathering for global BioPharma industry leaders, academicians and investors. It is an invaluable forum to discuss emergent

science and brainstorm new opportunities.

Amrit Ray Andy Plump Karun Rishi Kiran Mazumdar-Shaw

‘Ecosystem’, ‘Innovation’ and ‘Start-ups’ for the last ten years at our an-nual summit. It is heartening to see Prime Minister Narendra Modi ac-tively trying to make this a reality in India. This will have a huge economic impact creating high paying jobs, in-tellectual property and the real pos-sibility of India able to play a leading role in innovative drug discovery and development. Indian and global pa-tients will be the real beneficiaries of these pragmatic policies. Connecting India’s evolving innovation ecosys-tem with global networks will be key to its success said Karun Rishi, Presi-dent of the USA India Chamber of Commerce.

“Today’s biopharmaceutical industry is less an ‘industry’ and much more


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an ‘ecosystem,’ in which partnerships between industry, academia, finance and policy makers are essential for success,” said Andy Plump, MD, PhD, Chief Medical and Scientific Officer and Director, Takeda Pharmaceuti-cals, and Master of Ceremonies of the summit. “In this environment, forums like the 10th US-India BioPharma & Healthcare Summit are an invaluable forum to discuss emergent science and brainstorm new opportunities.”

“Human genetics plays a significant role in the pathophysiology of many rare and devastating diseases,” said Martin Mackay, PhD, Global Head of R&D at Alexion and USAIC Advisory Board member.

“Those of us working to develop transformative medicines for pa-tients suffering with these diseases understand that global collaboration among scientists, the pharmaceutical industry and government agencies is increasingly necessary to bring for-ward new treatments. As a member of the Board of the 10th Annual Bio-Pharma and Healthcare Summit, I look forward to bringing together a multi-disciplinary group from across the globe to foster collaboration, partnership and innovation with the ultimate aim of developing new therapies and providing hope to pa-tients”.

“Access and affordability are the two pivotal points around which health economics revolves today. Given their complementary strengths, India and the US have an unencumbered

boundaries will be the key ingredi-ents for success. We congratulate the USA India Chamber of Commerce for organizing the 10th US-India Bio-Pharma Summit which will provide a strong platform for exploring these important issues,” commented Dr Michael Rosenblatt, Executive Vice-President, Merck & Co. and USAIC Advisory Board member.

“At Janssen, we are committed to supporting innovative partnerships

and research collaborations in India to improve access, advance new drug regimens and ensure responsible and appropriate use. Janssen will con-tinue to strengthen its future leader-ship in innovation through an excit-ing late-stage pipeline and medicines under submission for approval in neuroscience, immunology, oncol-ogy, diabetes and infectious disease.We are committed to bringing these medicines to India to meet growing patient needs” said Dr Amrit Ray, Chief Medical Officer, Janssen Phar-maceutical Companies of Johnson & Johnson.

For Summit information and regis-tration, please visit www.usaindiachamber.org

Email: [email protected] BS

opportunity to partner in building a sustainable and affordable global healthcare paradigm. This summit is an ideal platform for catalyzing col-laborative innovation that can accel-erate the delivery of affordable drugs to patients the world over said Ki-ranMazumdar-Shaw, CMD, Biocon and USAIC Advisory Board member.Some of the most distinguished peo-ple in Biopharma will be discussing the role of latest technologies like CRISPR, Immune Checkpoint Inhib-

itor Therapy, Stem Cell Therapy etc., in changing the treatment paradigm of chronic diseases like cancer, neu-rodegenerative and some other rare diseases.”

“We believe India has a strong poten-tial to become a hub for bio-pharma innovation and play a leading role in collaborative research for the same.There is a need for enhanced part-nerships between Indian innovators, Government and academia as well as their American counterparts in order to realize India’s true potential as a bio-pharma hub.

''Now is the time for India to emerge as an innovator nation in the bio-pharmaceutical domain. Cultivating talent, setting goals, and collaborat-ing across companies, the academia — industry interface, and national

USAIC - 10TH ANNUAL BIOPHARMA & HEALTHCARE SUMMIT


BioIT

In recent years, Internet of Things (IoT) has emerged as a buzzword, with both service providers and businesses, exploring possibilities connected devices can bring to the services they render and the way they conduct their businesses. IoT solutions are impacting the healthcare in a significant manner.

Today, enterprises are realizing that the adoption of IoT in their operations will not only lead to increased productivity and process efficiencies, but also a reduction of costs.

While IoT is still at its nascent stages in India, the potential is tremendous.

India’s trillion-dollar opportunities in ICT, IoT

As a society, we are becoming more connected and the pace at which new technology is im-pacting our every-

day lives is increasing at lightning speeds.

Over the next decade, the IoT and M2M (machine-to-machine) are ex-pected to bring billions of data-gen-erating devices online, and connect a vast stream of data with people, processes and other devices. There are some niche applications such as sensors record, ambulatory medi-cal record (AMR) modem, and asset tracking.

BioIT


BioIT

“In the pharma and healthcare in-dustries,” says Mr Sai Pratyush, Ad-ditional VP, Managed Services, Tata Teleservices, “we see the increasing use of IoT in the form of people con-necting to various healthcare devices. Also the use of wireless technology will allow healthcare workers and pa-tients to rapidly access information. M2M communication connected

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wirelessly via sensors that transfer data automatically will improve ef-ficiencies.”

The healthcare industry has long been overburdened by slow moving innovation due to the complexity of the medical ecosystem that’s chang-ing aggressively, and IoT and M2M solutions are playing a catalyst role

in this change and revolutionizing the pharma sector.

“It will also be helpful in providing better medication-management and will be the fastest growing segment in the whole IoT market,” predicts Mr Pratyush.

Technology is playing a significant role in improving the quality of healthcare, cost efficiency, precision performance, proactive and on-time care, real-time communication and most importantly, saving lives.

Tata Teleservices is working with partners to develop scalable ICT (In-formation and Communication Tech-nologies) and IoT solutions across the healthcare value chain which in-cludes hospitals, vendor ecosystem, doctors and individuals.

Technology is playing a significant role in improving the quality of healthcare.

Mr Sai Pratyush Additional VP, Managed Services, Tata Teleservices


BioIT

The following are few areas which will see innovation, and will benefit both the industry as well as patients: Outpatient monitoring Wearables Remote monitoring or rural

healthcare mHealth

Location based services

ICT Trends In Indian HealthcareICT and IoT solutions are impacting the healthcare in a significant man-ner.

There is the wearables space which is enabling and pushing ordinary peo-ple to maintain a healthy lifestyle, and then, there are those simple in-novations which are enabling the healthcare industry to provide better quality of care to its patients.

Outpatient monitoring and telemedi-cine applications are introducing the healthcare industry to newer ways of interaction with patients and en-abling them to not only monitor pa-tients on a continuous basis but also respond more quickly to situations that need their attention.

“As an example, a monitoring device is given to the patient at the time of discharge for a limited timeframe, which helps the doctor to continue to monitor the patient and suggest cor-rective actions during the patient’s recovery,” states Mr Pratyush.

As per a Deloitte Report, telemedi-cine is witnessing fast adoption in In-dia. In 2012, the telemedicine market in India was worth $7.5 million, and it is expected to rise 20% annually to $18.7 million by 2017.

Telemedicine can provide low-cost consultation and diagnostic facilities to the remotest areas via high-speed

The major users of ICT include big pharmaceutical companies, cor-porate hospitals and other private health sector institutions, while the public healthcare sector is lagging way behind in IT utilization. But the good news is that the situation is changing.

Mr Pratyush mentions, “Though ICT solutions have had a positive im-pact on the healthcare sector, there are some challenges that need to be overcome in order to provide afford-able, high quality healthcare solu-tions, and innovations to hospitals and their vendor ecosystem, doctors, and eventually the citizens of this country.”

The government is now cognizant that technology can help overcome challenges arising due to geographi-cal size, high-population density, lack of healthcare infrastructure, in-accessibility in rural India, poor nu-tritional conditions, and low literacy, among others.

Furthermore, the National Health Policy endorsed by the Parliament of India encourages the introduction of electronic communication media in health sector.

The Government of India also brought in the National Rural Health Mission for delivering the best-in-class healthcare facilities to the rural population.

The Ministry of Health and Family Welfare and the Ministry of Com-munication and Information Tech-nology are jointly creating a national health information infrastructure for easy capture and dissemination of health information.

Like all new disruptive technolo-gies, IoT deployments face numerous challenges.

internet and telecommunications, thus, bridging the rural-urban divide.

In addition, India’s extensive mobile technology infrastructure and better connectivity infrastructure is expect-ed to drive mobile health (mHealth) adoption further.

He points, “Several people in our country do not have ready access to decent healthcare. There are many challenges to set up a full-fledged hospital at remote and rural loca-tions.

"However, IoT-based wireless solu-tions are now making it possible for doctors based in cities to monitor patients located in remote villages. Now, villagers need not travel long distances to get a simple diagnosis done.”

Mr Pratyush feels that solutions need not involve complex ICT infrastruc-ture.

“SMS-based solutions are enabling doctors and hospitals to send re-minders and alerts to their patients on medication or health checkups. “This management of medication through SMS platform ensures doc-tors and hospitals provide best pos-sible care to their patients,” he adds.

Challenges to disruptionDespite being an IT-enabled servic-es behemoth, the use of ICT in the healthcare sector is limited in India.

The government is now cognizant that technology can help overcome challenges arising due to geographical size, high population density


BioIT

THE CLOUD ADOPTION

Though cloud computing is still a concept that exists only in theory for the Indian healthcare industry, the healthcare vertical has made it to the potential list of every cloud vendor and service provider.

Mr Pratyush says, “It is not surprising, given the general opinion that healthcare industry is rapidly automating itself, and soon enough, will be leapfrogging towards the cloud.”

Research agencies like Zinnov have derived that the healthcare industry currently spends only about 2% of their total budgets on IT. This figure is set to grow to 15 to 20% in 2015, and up to 40% in 2020, purely to-wards adoption of cloud services.

This will mean that the cloud opportunity within the healthcare seg-ment could touch $600 million in 2020. At a CAGR growth rate pegged at 25%, healthcare is definitely one of the most promising segments as far as cloud adoption is concerned.

“With connected IoT devices, reliable bidirectional signaling is essential for collecting and routing data between devices. You need to be 100% sure that that stream of data is going to arrive at its destination every time,” emphasizes Mr Pratyush.

Security is another important factor in IoT connectivity.

“What good is a smart home if any-one can unlock your doors, or for that matter anyone can access your health records?” asks Mr Pratyush. “Solutions need to ensure that when sending or receiving a stream of data, the IoT device or server has proper authorization to send or receive that stream of data, and most important-ly, you need end-to-end encryption between devices and servers.”

Huge and uninterrupted power consumption is also seen to pose challenges. “Billions of IoT devices which are required to transmit data between one another will require un-interrupted power either through the grid or battery bank,” he stresses.

Currently most solutions deployed in the country are based on proprietary technologies which make it difficult for customers to scale or opt out in case the solutions are not working for them.

Tata Teleservices is working with partners to create innovative ICT so-lutions for the healthcare industry.These solutions address the basic needs of providing telecom infra-structure as well as more complex IoT solutions such as LBS (Location-based services) or healthcare-related applications.

Trillion dollar opportunity As far as the IoT market opportunity is concerned, while findings of market research companies may vary, they are unanimous in their conclusion that this is a trillion dollar opportu-nity in terms of revenue potential.

A recent study by a global network-ing major predicted that there will be 25 billion devices connected to the internet by 2015, and 50 billion by 2020, thus highlighting its promi-

nence in the coming decade.

Mr Pratyush explains, “We have seen IoT and M2M deployments primar-ily in the utilities and transportation space, but that is changing slowly. As the devices, sensors and applica-tion ecosystems grow, we are seeing investments being made across BFSI (Banking, Financial Services and In-surance), retail, healthcare and even the home and building management space. The Government of India is also playing a significant role in adopting ‘smart IoT technologies’. The ‘Smart Cities’ program as well as ‘Digital India’ is leading entre-preneurs to make substantial invest-ments in this space.”

Globally, IoT has seen deployment across transport, utilities, retail, logis-tics, home automation and security.

“The West is definitely a few steps ahead in terms of use cases and scale of deployments, but it would be in-correct to say that we are ‘very’ far be-hind,” he opines. “The next few years will be critical for India, and I believe we have a good opportunity to bridge the gap. The Government’s ‘Digital India’ program and ‘Smart Cities’ ini-tiatives will further the cause of IoT substantially.”

Tata Teleservices has been develop-ing IoT solutions for its customers across a host of use cases and indus-tries which includes the healthcare industry.

“Our solutions encompass not only the telecom infrastructure but the de-vices and application as well in select verticals. Healthcare is a key vertical, and we are working with partners to create solutions which will be benefi-cial for our customers,” concludes Mr Pratyush. BS

Raj Gunashekar


Biopreneur

‘Believe and take the leap of faith’

‘Believe and take the leap of faith’

What happens when three dynamic trios come together with similar interests and passion coupled with innate entrepreneurial attributes? The result — A hot emerging start-up!

Established in 2011, Bionivid Technology, located in the happening start-up hub of Bangalore, is a genomics and informatics start-up, jointly cofounded by Madavan

Vasudevan, Hitesh Goswami and Rohit Nandan Shukla.

Biopreneur

Mr Madavan is a qualified mi-crobiologist-turned-bioin-formatic ian; his partner Mr

Rohit Nandan Shukla is also a quali-fied bioinformatician and a certified programmer; and Mr Hitesh Gos-wami is a neurobiologist with a fine business acumen. All three of them make a perfect ingredient for raising

a hot bioinformatics start-up.

Bottlenecks in Big Data: The compa-ny’s key focus is on providing infor-matics solutions for data generated through high throughput genomics technologies including Microarrays and Next Generation Sequencing.

Well, what drove the trios into their entrepreneurial venture? “It is purely a ‘Team, Trust, Talent and Tempera-

ment’ combination that drove us together. ‘Time’ was also a critical factor as affordability and acceptabil-ity of genomics data was at the right place during our initiative,” voiced Mr Vasudevan, who is the director of research and operations at Bionivid.

When most of the major genomics service providers in India were mov-ing towards establishing high-end genomics laboratory-based services


Biopreneur

in producing heaps of genomics data, Bionivid was able to identify the bot-tleneck in Big Data, and establish a foray of solutions.

Lack of PhDs“Our age, inexperience and lack of PhD degrees was a major bottleneck when we started off initially. Many of our detractors had written us off stat-ing we were too young, inexperienced and unqualified to provide such high-end and scientifically profound ser-vices. It was quite a challenge to over-come all the criticisms and hurdles and focus on working hard towards success,” recalled Hitesh Goswami, who oversees the company’s business strategy and planning.

Funding was another major chal-lenge faced by the company since genomics industry was quite niche and futuristic. “Not many investors and angels are aware of the fortune and promises ahead in this industry,” Hitesh pointed.

For most part, the entrepreneurs managed borrowing a small sum of money from their families, primarily to rent an office space, and setting up minimally required computing envi-ronment.

“Our 100% YoY growth helped us in securing a soft loan from govern-ment agencies like National Science & Technology Entrepreneurship De-velopment Board (NSTDEB) who promote start-ups,” expressed Rohit, who is the director of training and development at the company.

Focus, defocusThough the company didn’t face any major setbacks ever since its incep-tion, it had to focus and defocus its verticals routinely due to varying market demands.

“This led to disproportionate growth

of our verticals namely services, products, training and consultancy. Rather, this phenomenon led us to identify and add newer verticals like hardware and databases to increase the sustainability and valuation,” opined Hitesh.

ClienteleBionivid’s clients’ are majorly from iconic academic research institutes like Jawaharlal Nehru Centre for Advanced Scientific Research (JN-CASR), Indian Institute of Science (IISc), CSIR-Institute of Genomics & Integrative Biology (IGIB), Inter-national Centre for Genetic Engi-neering and Biotechnology (ICGEB), University of Delhi – South Campus (UDSC) and many more.

Talking about clinical genomics, Ma-davan added, “Industrial research in-volving genomics and informatics is puny at the moment. However, huge initiatives are already under way ag-gressively with respect to clinical genomics. We are looking forward to cater to the upcoming clinical ge-nomics segment that will help us achieve one of our goal of taking in-formatics from bench-to-bedside.”

World’s genome informatics kernelIn the future, Bionivid is looking to expand its core IT capabilities in terms of product development.

“We have initiated a series of activi-ties related to development of inno-vation-driven products and solutions that might revolutionize the genom-ics data analysis and research,” re-marked Rohit. The company also dreams to make India as the most preferred genome informatics kernel of the world.

“We have initiated discussions with major Universities in the country to

Bionivid is coming up with 3 distinct products which it believes will revolutionize the genomics research industry:

Genome Stations – Bespoke computer hardware solution for handling NGS data sup-ported with customized, vali-dated and calibrated analysis pipeline

SQ-IT – A sequence analysis workbench which will give user the ease of commercial NGS analysis software with power and flexibility of the open source tools and algo-rithms

SQ-DB – A very unique sequence data management query and retrieval solution for NGS users

On the horizon

Our 100% YoY growth helped us in securing a soft loan from government agen-

cies like National Science & Technology Entrepreneurship Development Board (NSTDEB)

who promote start-ups


Biopreneur

collaboratively offer first-of-its-kind ‘Genome Informatics’ course, which will help us in developing human resources to cater to the futuristic needs of the industry and academic research,” held Hitesh.

Innovation vs Protocols vs SOPsAccording to the company, innova-tion and science go hand-in-hand due to heterogeneity.

“At Bionivid, we routinely motivate and encourage our team to explore and add new dimensions to genome analytics, rather than working on defined protocols and SOPs,” men-tioned Madavan.

Due to its academic inclination, Bi-onivid actively collaborates with many scientists, both in India and abroad.

“We are actively mentored by emi-nent scientist and a Shanti Swarup Bhatnagar (SSB) awardee Prof K V S Rao. Heading our scientific advisory board is leading Epigenetics scientist and SSB awardee Prof Tapas Kundu. We are also the genome informatics partner for UDSC-MAC (University of Delhi South Campus, Microarray Facility) led by Prof Amita Gupta,” highlighted Rohit proudly.

Tax exemptionsHitesh feels that in order to boost start-ups and fuel their growth, gov-ernment and its agencies should come up with limited period sup-port schemes offering immunity from routine taxations, filings, statutory mandates and corporate regulations, which will increase focus and ensure start-ups are established successfully.

There are countries like Malaysia which have implemented lucrative schemes for biotech start-ups. For ex-ample, 10 year income tax exemption, from the day a company declares stat-

utory income. Thereafter, another 10 years of reduced tax rates, i.e., 20% (current corporate tax rates are 25%). Also there are import duty exemp-tions for equipment and key raw ma-terial, and sales tax exemptions.

Personalized genomics eraThe genomics market is said to be slowly and steadily moving towards personalized genomics in India.

“However, it is too early and sluggish now. Nevertheless, in another decade personal genome sequencing is likely to be affordable and could become a common procedure and prescrip-tion,” stressed Hitesh.

With this kind of personalized ap-plication of genomics for clinical use, the amount of data that will be gen-erated and its storage, analysis and data security will require the use of efficient cloud based solutions.

Manpower crunchThere is a huge requirement for man-power with specialized genome infor-matics skillsets.

“There is a huge market in India and abroad in terms of services like resource, staff augmentation and recruitment. There will be a lot of demand for such service wherein human resource with specialized ge-nome informatics skillsets are pro-vided on a contractual or permanent basis,” commented Rohit. Getting such human resources in genomics data analysis is a challenge.

“Even if you manage to hire and train, with the scarcity of such skillset all around the globe, they get exported abroad with lucrative positions and remuneration, which is not afford-able today for both Indian academia and industry,” stressed Hitesh.

Also, there is a huge gap in the pace

Believe in yourself and take the leap of faith

Focus on developing new strategies for customer devel-opment process.

Engage your customers, listen to their problems and de-mands, evaluate their feed-back, and provide the right training

Your employees are your first customers. Spend significant time in coaching, mentoring, engaging and training them

Identify and initiate overlap-ping verticals

killer strategies for sc

aling u

p

From a team of 3 to 30 in less than 4 years

2 offices (Bangalore and Bhubaneswar)

Contributed to the first insect genome sequence published from India (by Dr Raj Bhatnagar, ICGEB)

First company in India to deploy hybrid approach for genome assembly of a larger genome, and publish

Contributed to 35+ pub-lications in international peer reviewed journals

M i l e s t o n e s


Biopreneur

of innovation directed towards gen-erating terabytes of sequence data, and as well as the computer hard-ware innovation towards processing this huge amount of computational intensive data.

Madavan stated, “There is a huge market potential for developing pro-cessors different from that of current CPUs towards reducing the time sig-nificantly for memory intensive pro-cess, maybe something in the line of GPUs.”

IncubationHitesh strongly believes in the start-up culture in Bangalore. “It will take some time for any other city to come closer to the start-up culture of Ban-galore and Hyderabad. We don’t see it happening in the near future. May-be Pune could be the city that can rise up to the ranks,” he said.

Bionivid is supported by Kalinga In-stitute of Industrial Technology’s (KIIT) TBI, in Odisha, led by Dr Mruthyunjay (Jay) Suar. Mr Mada-van advised that it is ideal to house a start-up inside a technology business incubator (TBI) which has a genuine agenda to promote entrepreneurship.

Start-up stressHow does the trio beat and battle the start-up stress? “Start one activity and complete with perfection. Even if results are not profitable you learn perfection,” said Hitesh.

Madavan stressed on avoiding work-ing on weekends. “Have enough time for leisure and rejuvenating. Look out for social gatherings where you get to know and learn from others’ experience,” he advised.

“Travel to different places and meet all kinds of people,” Rohit ends. BS

Happy Clients – We do every-thing possible to ensure every client requirement is met in terms of agreed deliverables. It is important to clarify and docu-ment what you cannot deliver at the very beginning. There is no better brand ambassador for your company than a ‘Happy Client’.

Credibility – For any start-up credibility building is critical for establishment. Engaging with top notch scientists in the do-main is critical to build credibil-ity. Translating the solution for the research problem into a peer reviewed publication is a vivid proof of building credibility.

Conferences – Crowd pres-ence indicates sustainability and establishment. Clients would love to see you at different events. This means you are do-ing well and also fosters high level of trust.

Multi-Geographical Pres-ence – Establishing work space and teams in multiple geo-graphic locations also increases visibility and better sustain-ability. We have expanded our operations from Bangalore to Bhubaneshwar in less than 4 years of establishment.

Dynamic Sales/Marketing Team - It is important to have a highly motivated team on the move who understand your company’s culture and DNA, and are able to translate that to each and every client they meet, which spreads like wild fire.

Social Media – If used in a right way, can do wonders. However, has very limited scope when it comes to niche market.

Entrepreneurial Secrets

If you believe in your busi-ness idea and hard work, then plunge into it full-time. Part-time effort and safety net doesn’t work.

Manage finding right partners who are equally inclined, committed and share mutual trust and share a common vision. Avoid starting a company all by yourself.

Be passionate about your work, and not let bottle-necks and setbacks be excuses for not perform-ing. Avoid succumbing to daily routines and com-promised lifestyle.

Try to bring your human touch to your work. Be it making a report or meet-ing a client, or running a program or an algorithm. If you are fully involved, then it creates an aura of human touch which reflects in the quality of produce.

Understand the criticality of routine cash flow.

Be flexible.

Do not get complacent with your success. Con-tinuous learning and improvement is the key to any successful business.

Want better start-up visibility?

Raj Gunashekar

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Biopreneur

DEGREES from best schools is no guarantee for ENTREPRENEURIAL SUCCESSThe trend of spinning-off start-ups by large organizations is heating up in India. In 2014, Genotypic Technology, a genomics service enterprise, spun-off its second start-up com-pany, Dhiti Omics – a provider of precision molecular diagnostic services in multiple areas of specialization including Obstetrics or Gynecology, Pediatrics, Neurology, Cardiology, Nephrology and Oncology


Biopreneur

“Dh i t i O m i c s w a s b o r n out of a d e s i r e

to extend the expertise in genomics gained over a decade into under-standing and diagnosing disorders that are genetic in nature. We felt this was more an opportunity and a service that we could provide, not just to clinicians in India, but also in other countries who were looking for help with diagnosis and decisions related to targeted treatment for dif-ficult and incurable diseases,” ex-plained Dr Sudha Rao, founder & di-rector, Dhiti Omics, who has evolved from being a genetic researcher to an entrepreneur today.

Clinical genomicsThe company has a cross-functional team with expertise in genomics, bioinformatics, healthcare and tech-nology. One of the important aspects of clinical genomics is to efficiently analyze the data and pinpoint the disease-causing variant from giga-bytes (GB) of data.

Clinical genomics is an area that, in In-dia, is riddled with lack of regulations leading to potential non-ethical prac-tices, especially towards personalized genomics, in which, a lay person’s lack of knowledge is exploited to provide them with baseless ‘risk scores’.

She explained, “Cancer may not be cured, but knowing the specific mu-tations will enable clinicians to pre-scribe targeted drugs that work bet-ter. A couple, for example, who has lost children before due to inherited disorders, will now have an option for a pre-natal screening to see if the fetus is normal or not. A parent struggling with undiagnosed genetic disorder in a child will now be able to prepare for life ahead with clear diagnosis.”

Initial hiccupsPreviously in 2013, Genotypic spun-off India’s first agri-genomics start-up – QTLomics, which develops novel products, identifies crop traits, and aid breeding better crops. In the beginning, Dhiti faced all the initial hiccups that a start-up would do.

“However, the co-location with Geno-typic and our prior experience in es-tablishing a company in the genomics area helped mitigate a number of is-sues. Dependence on multinationals for critical reagents is still a challenge which contributes to a major factor in the cost of our services. Lack of regu-latory guidelines, shortage of trained

clinical geneticists are some of the challenges,” pointed Dr Sudha Rao.

Dhiti has been funded through angel investments. She commented, “Tra-ditional angel investing is definitely a good option. There are, today, a number of challenges and contests where one can send their ideas to, and there are possibilities for getting funding for at least a prototype devel-opment stage. There are also a num-ber of government schemes that one could leverage. Incubators within or outside institutions could also be an interesting route to adopt.”

Market expansionDr Sudha noted that India is a huge market, and the company has obliga-tions to make its tests available to all corners of India. “Our aim is to take this possibility to every corner of In-dia, so that every patient has the op-portunity to plan their treatment or manage disease better,” Dr Sudha emphasized.

Presently the start-up is working with a number of leading clinicians and hospitals in Southern India, and soon plans expanding into the rest of the country, and Asia.

“As we move along, we will be able to offer more tests to people living outside the metro or the tier-II cit-ies. That is one milestone we really look forward to achieve. There are also a number of proximal countries like Bangladesh, Sri Lanka and some of the countries in Middle-East who depend on India’s healthcare system. These countries can automatically become our target for expansion. We also have an active collaboration in the far-east Asian region for promot-ing our services,” she expressed.

According to her, a big part of the company’s revenue will be appor-tioned to create awareness about the

We have some ac-tive research col-laborations with

reputed hospitals for assay development. B2B

relationships with large diagnostics labs, and agree-ments with large corporate hospitals in Bangalore are being pursued actively. We expect to forge some of these partnerships in the next quarter

Dr Sudha Rao Founder & Director, Dhiti Omics


Biopreneur

progresses made in the field of mo-lecular diagnostics, enabling people to make studied decisions.

Currently Dhiti has collaborated with a partner in Singapore, which pro-motes its services in Singapore, Ma-laysia and Indonesia.

“We have some active research col-laborations with reputed hospitals for assay development. B2B relation-ships with large diagnostics labs, and agreements with large corporate hos-pitals in Bangalore are being pursued actively. We expect to forge some of these partnerships in the next quar-ter,” she said.

“Cities like Madurai, Roorkee, Pune, and Guwahati, among others have a thriving set of entrepreneurs, which is a very good trend for life sciences start-ups,” added Dr Sudha Rao. She feels that it is more important to have visibility among targeted stakehold-ers.

“At Dhiti, we believe that, content, more than hype, will actually help us and our stakeholders in the longer term. So all our efforts are focused in that direction,” Dr Sudha stressed, who believes that the entire ecosys-tem -- from the government to edu-cational institutions, and mentors to media — all have a role to play in supporting and encouraging new ventures in establishing and eventu-ally scaling up.

India vs WestThis researcher-turned-entrepre-neur, who loves reading Khalil Gi-bran, holds a PhD in Biotechnology from Madurai Kamaraj University in Tamil Nadu. She obtained her post-doctoral research in Neurobiology at the Medical Center in Cornell Uni-versity, New York, USA. She then worked as a consultant Neurobiolo-gist for QBI Enterprises in Israel.

“Risk-taking ability among various ecosystem players is definitely more in the West, but one sees a very vi-brant start-up ecosystem in India which is maturing. We are very en-couraged by what we see around us,” opined Dr Sudha optimistically, who loves listening to music. Dr Sudha mentioned that Big Data analytics for genomics is big and happening at the moment.

“The who’s who of IT is getting into this space. There are immense oppor-tunities for smart innovative ideas to becoming products,” she revealed.

IITs & IIMsEvery entrepreneur, regardless of in-dustry sector, needs to firmly have an ear to the ground, so the vision and ambition of the entrepreneur stays rooted in reality.

“Any entrepreneur in the technology space also needs to understand and visualize how technology can be lev-eraged better. Some institutions like the IITs and IIMs have the ecosystem in place to mentor students who are interested to start new ventures. But being an IIT or IIM alumnus, or even a degree from the best schools in the world is no guarantee for success as an entrepreneur,” Dr Sudha high-lighted.

Entrepreneurial lessonsDr Sudha, talking about her entre-preneurial lessons so far, added, “The most important lesson is that entre-preneur is not a God and should re-alize that early enough. Every person has unique skills but needs a team to complement his or her strengths. The sooner the entrepreneur realizes this and builds a strong complemen-tary team and learns to delegate, the faster he or she can develop the idea. The other lesson is the importance of partnerships. It is better to focus on one’s core strengths and rely on

other people or entities for associated work.”

To all the hot-blooded wanna-be en-trepreneurs, she advised, “Only ven-ture into a new enterprise when you are passionate about the work. It’s this passion that will help you see through many challenges, and the high and low troughs. Having some mentorship and structure in the ini-tial stages is always helpful. So if you are co-located with other technology start-ups or even established entities, there is definitely an advantage.”

Speaking about commonly commit-ted entrepreneurial mistakes, Dr Sudha pointed, “Most investments in the service industry in life sciences goes into lab infrastructure. Tech-nology obsolescence and return of investments are very important for sustainability and have to be an im-portant thing to keep in mind. Invest prudently.”

Billion-dollar secretShe also believes that there is really no rule when it comes to selling a start-up. “One should go with one’s instincts and priorities,” she stated.

How does she handle all the stress from being a mother and an entre-preneur? “I make sure I have some quiet me-time every day. It helps me disconnect and see the larger picture. I also rely on my network of friends and well-wishers, and my children, to keep me grounded and put things in perspective,” Dr Sudha observed, who says that her glorious moments in life were when her kids were born.

When asked about what is the secret strategy for becoming the next billion-dollar enterprise, she said, “That se-cret shall remain ours to become the next billion-dollar enterprise!” BS

Raj Gunashekar

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