bsi_june 2016_raj gunashekar

1www.biospectrumindia.com | June 2016 | BioSpectrum

2 BioSpectrum | June 2016 | www.biospectrumindia.com

BioTalk


Biopreneur

The

fightersFA

BIOSPECIAL

PRECISIONMEDICINE

INITIATIVE

DOES INDIA NEED

Volume 14 Issue 6 June 2016

3D PRINTING revolutionizing healthcare

ARE THESE PERFORMANCE MATERIAL IN MEDICAL DEVICES SAFE?

CoverDesign by:sareeta sajjan

BioContents

32

COVERSTORY 24

Precision Medicine

Does India need

InitiativeDuring his State of the Union address in January

2015 at the White House, American President Barack Obama announced the launch of the most ambitious healthcare initiative called the Precision Medicine Initiative (PMI), with a mission to usher

the US into a new era of medicine where patients will enjoy individualized and tailor-made treatment

for various ailments.

Both Dr Fathima Benazir and Alex Paul were schoolmates and best childhood buddies. She was a post doctoral research fellow at Indian Institute of Science (IISc), Bangalore, and was keenly looking out for opportunities abroad. She approached Alex and sent him her portfolio.

Alex D Paul, Co-founder & President, Azooka Life Sciences

Dr Fathima, Co-founder & CEO, Azooka Life Sciences

A saga of the world’s fastest DNA, RNA stainAzOOkA LIfe ScIenceS


Biopreneur

BioContents

RegulaRs

7 Bioedit

08 BioMail

12 BioNews

50 BioPeople

52 Biosupplier News

64 BookReview

Can IndIa domInate the bIosImIlar market?

BioTalk Biosimilars

‘We aIm’ to make bIopharma more affordable’Racho JordanovPresident and CEO, JHL Biotech

‘IndIa Is a key opportunIty market’A Narayanaswamy, Managing Director, Essentra Packaging

‘there Is a huge unmet need for affordable bIologICs In ChIna’ Jan Mäkelä, GM, BioProcess business, GE Healthcare’s Life Sciences business

09 36

46

34

48

20

40

Are tHeSe PerfOrMAnce MAterIAL In MeDIcAL DevIceS SAfe?

3D PRiNtiNg revolutionizing healthcare

the Fat FighteRs revolutionizing healthcare

Biospecial

Meet the Robotic Surgeons who conducted

nearly 4,000 procedures in 30 hospitals spread

across the country during 2015 to help cut flab.

After dominating generic drug industry for decades, can India become a leader in developing this new class of drugs too?

‘Notification will shut the door for future licensing’

The recent notification of the Ministry of Agriculture for compulsory licensing of agriculture technologies is a major blow for the responsible deployment of innovation in the agriculture and food sector


China’s 13th five-year-plan (2016-20) document, that was released recently, puts greater emphasis on

healthcare industry which is esti-mated to be valued at eight trillion yuan by the end of the plan period.This will be an interesting and im-portant period for the healthcare sector as drugs worth of $250 bil-lion are estimated to expire in next five years and their market share

will be taken by generic drugs. And for this peri-od China has emphasized on changing the mod-el from research and development to innovation with focus on making breakthroughs in biolog-ics medicine and to facilitate better protection of intellectual property rights. Its further plan is to step up production for special APIs, improve development of new drugs and speed up the reg-istration process to expand export.

Interestingly, the plan document coincides with the release of Thomson Reuters report describ-ing China as the global leader of pharmaceutical innovation. During 2015, five of the top 10 glob-al organizations for filing pharma patents were located in China and from 2005 to 2015, three of the top 10 organizations for publishing papers about drugs and disease were China institutes.

Both the reports need a careful watch and scru-tiny from the Indian side as both the countries had been in a race during the past few years in faster economic development in general and in biotech, pharmacy and healthcare sectors in particular. India has to particularly take the plan document seriously as China has been relatively successful in achieving its broadly outlined goals in previous five year plans. That may continue with this plan document also.

An important development from the India’s side is that it has announced its Intellectual

Property Right (IPR) policy, which is very cru-cial in the pharma sector. The production of cheap generic drugs in India is the only hope for many poor patients and that is possible only due toIndia’s IPR policy. Through this policy, India has shown its independence and thus, no wonder, the policy has come under severe criticism from US and some other countries.Apparently these countries are exerting pres-sure on India to amend the policy to suit their companies.

On this backdrop, India continues to closely studyand scrutinize the Chinese plan docu-ment and its likely impact in view of the race between the two countries. But at the same time both the countries can also explore pos-sibilities of co-operation than racing with each other. Not only bio and pharma industry lead-ers from both the sides, but even independent observers have been expressing similar opin-ion.Both have their own strengths and weak-nesses.Chinese industry feels India has speed-ed up development of talent pool, registration and certification process and its growth in ge-neric business is phenomenal and impressive.

On the other hand a PWC report in 2010had said that China was entering a ‘golden age’ of the biopharmaceutical sector – facilitated by substantial investment, patent protection and strong regulation by the central government.ThomsonReuters report adds over that at-tributing China’s success to pharma industry innovation,scientific research and fostered a healthy mix of partnerships.

Indian industry feels that two-way trade be-tween India and China in formulations and APIs, in which each of the country is dominant respec-tively, and contract manufacturing is possible. There are some hurdles,but if efforts are made to remove them, there could be a way for partner-ship, making both the countries stronger.

Milind KokjeChief Editor

[email protected]

Race or partnership?

Bioedit


Vol 14; Issue 6; June 2016

shoolini University I am happy to know that you highlighted Modi govern-ment’s initiative to establish country’s first interdisciplin-ary university for life sciences and biotechnology. Shoolini University of Biotechnology and Management Sciences is the first national-level interdisciplinary biotechnology uni-versity established in 2009 as per the notification of the Government of Himachal Pradesh and recognized by UGC.In a short span of five years, Shoolini University of Biotech-nology and Management Sciences has been ranked 66th po-sition in India by NIRF, MHRD, GoI survey, April 2016.

Also, our School of Pharmaceutical Sciences has been ranked 19thamongst the pharmacy institutes in the coun-try. As biotechnology is an interdisciplinary field, we offer undergraduate, postgraduate, MPhil and PhD programs in biotechnology, microbiology, food sciences, basic sciences and pharmaceutical sciences.The established biotechnol-ogy university was to harness the potential of Himalayan

flora and fauna for sustainable development and societal benefits. Shoolini University is a research oriented Uni-versity and envisions to be amongst top 200 global uni-versities by 2022. We have made giant strides towards our vision. To cite the key ones, we have published more than 300 research papers in journals of national and in-ternational repute, with h-index of 20, which is the high-est amongst the same age public and private universities including IITs and Central Universities. More than 60 students have completed PhD degree from this University and of this, 50 are in biotechnology and related sciences. Our PhD program utilizes rigorous standards, with one of the thesis examiner being chosen from out of the country and a rider of at least two publications for PhD thesis that are indexed in Thomson and Reuter or Scopus database. Our research has been endorsed by various government funding agencies such as DAE, DST, DBT, DRDO, ICMR, and DAE. We have been recognized by DST for FIST grants and by MoF-PI for setting up food testing lab.

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

Volume 14 Issue 5 May 2016 www.biospectrumindia.com

An Publication

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EMERGINGNEW WAVE OF

THERANOSTICS

‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR ELECTRONIC WEARABLE INJECTOR A REALITY

BIOANALYSIS BIOSUPPLIERS

A COMBINATION OF DIAGNOSIS WITH THERAPY GEARED TO REVOLUTIONIZE

THE WORLD OF HEALTHCARE.

Vol 14; Issue 6; June 2016

Publisher and Managing Editor: Vijay Thombre

Editorial:Chief Editor: Milind KokjeExecutive Editor: Srinivas RasoorSenior Correspondent: Raj GunashekarChief of Bureau (Goa): Suuhas TenddulkarProduction:Sr. Assistant Editor: Ajay GhatageSub Editor: Ayesha SiddiquiDesign: Sareeta SajjanSales and Marketing:Associate Vice-President -Sales and Marketing: Gurunath AngadiGM – International Sales, Delhi: Vikas MongaAssistant Manager, Mumbai – Sandeep ShetyeSr. Executive, Digital Marketing – Sayali DamleConsultant, Global Market Development: Kavita PoteSr. Product Executive: Pavana PraveenAPAC Region:Vice President: Kingshuk SircarSr. Assistant Editor: Amrita TejasviCirculation:GM, Print Services: T SrirenganCirculation and Subscription:C Ramachandran, Raghavendra, S Raju SalveAudience Service: Sarita ShridharMIS & Database: RavikanthPress Coordinator: Harak Singh

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Several Asian companies have been increasing their focus on biosimilars, terming it a long term prospect. Although currently small and focused on few diseases, the biosimilars’ opportunity is

all set to grow, thanks to the unprecedented patent cliff and rising healthcare costs. Biosimilars are an affordable option for Asia’s growing healthcare needs and this has offered a clear potential for players in emerging Asian countries to set up operations and leverage this lucrative opportunity.

One such interesting company is a start-up in Taiwan – JHL Biotech, which aims to build a biotech industry in China. Founded in 2012, by two former Genentech col-leagues, JHL Biotech has already received the EU ap-proval to perform clinical trials for its biosimilar ritux-imab and is planning to file an (Investigational New Drug) IND for its upcoming orphan drug biosimilar by the end of this year.

JHL is the first Chinese company to file a clinical trial for biosimilar in Europe. The company has two factories, one for clinical manufacturing and development in Hsinchu in Taiwan, and one for commercial manufacturing and pro-cess development in Wuhan. JHL is also the first to use

‘We aim' to make biopharma more affordable’

Led by an experienced team of

Genentech and Amgen veterans, and

funded by top-tier venture capital firms

including Kleiner Perkins Caufield &

Byers (KPCB), Sequoia Capital, Biomark

Capital and CDIB, JHL Biotech aims

to make biopharmaceuticals affordable

and accessible to all patients through

manufacturing innovation.

Racho JordanovPresident and CEO, JHL Biotech

Interview

Biotalk


GE Healthcare’s KuBio factory design, that can be built and dispatched anywhere in the world in just 18 months.

Racho Jordanov, President and CEO, JHL Biotech, in an interview with BioSpectrum Asia spoke at length on the company.

When and how was JHL Biotech founded?

A JHL was founded in late 2012. Ms Rose Lin, general manager, JHL Biotech, and I realized that there was

need in Asia for the kind of expertise we had acquired throughout our careers at Genentech, and more impor-tantly, we saw an opportunity to make biologics more af-fordable. We put together a slide deck and quickly secured KPCB as a cornerstone investor. After that, we attracted more funding and set in motion our plans to construct a pilot facility in Taiwan and a full scale plant in China.

Tell us about the biosimilars facility in China.

A Our campus is in a government-backed biotech park in Wuhan. It is called ‘JHL-1’, with the ‘1’ indi-

cating that we have ambitious expansion plans. JHL-1 has space for utilities, two commercial scale API plants, a fill-finish site, and an administration building that also contains space for process development and analytical work. We just celebrated the opening of our first API plant and look forward to breaking ground on the second API plant and fill-finish facilities in the near future.

Our newly opened JHL-1 API facility is built to compliance with the highest standards. It is remarkable for a number of reasons. We are the first to utilize a revolutionary GE mod-ular construction technology called KUBio. It is the larg-est single-use mammalian cell culture facility in Asia. Our whole site was finished in about 18 months, and we spent about 1/3 of what is typical for an mAb site of this scale. I am excited to say that we will soon be starting production in Wuhan. Our site is close to being fully operational and I am very proud of the devotion of our team there.

How important are biosimilars for the Asian market?

A Biosimilars are very important to the Asian phar-maceutical market. This is due to population and

average income. Depending on how you define ‘Asia’, nearly 1/4th of the world's population lives in this part of the world. This also means that the incidence of disease is greater than in other regions; moreover, in the next two decades, the number of new cancer cases here is expected to rise 70 percent. So, we have this massive population, but at the same time, many earn significantly less than their counterparts in the West. Innovator drugs are priced very high in many Asian markets, making it com-paratively more difficult for locals to access these thera-

pies. Biosimilars will be priced much lower and will therefore greatly increase options for patients.

What are the challenges you see in commercializing biosimilars?

A There exist three big challenges. In order of impor-tance: Regulatory, Economic, Manufacturing. Reg-

ulatory challenges are first and foremost, as biosimilars are new and approval pathways are still in development. We have a great regulatory team that has strong relation-ships with relevant authorities. Each of our biosimilars will be approved first in the EU and China, then later, in the US. When our treatments are approved, the econom-ics of biosimilars also dictate that, in markets where mul-tiple biosimilars are competing for market share, success will be driven by price, which means that we have to be able to manufacture more efficiently than anyone else. This plays to JHL's strengths and is at the core of why we will be a dominant biosimilars player: we have world class expertise in the manufacture of these molecules. We also have our own manufacturing facilities. This vertical integration allows us to focus on process innovation, which leads to steep reductions in cost of goods.

Your thoughts on regulatory hurdles in biosimilars space.

A The two biggest issues currently under debate are interchangeability and extrapolation. We do not

believe that, in the near term, any regulators will allow interchangeability. This said, after a significant body of efficacy and safety data are available, which could take a decade or longer, we think regulators will start to con-sider interchangeability. Extrapolation is already allowed in some markets for products that have shown safety and efficacy in the indications most ‘difficult’ to treat. Long term, we believe interchangeability and extrapolation will become common due to the fact that regulators, doctors, and payers will gain comfort with biosimilars.

Could you share with us the impact in China from structural reforms?

A Sure. I shall focus on two groups: government and consumers. On the government side, impact comes

from support for the biotech industry and overhauls to the social security and drug administration systems. On the consumer side, the biggest impacts from reform are due to the effect rising wages and higher quality stan-dards will have on demand for great medical products. The Chinese government has made the biotech industry a key focus of its 13th five-year plan and its ‘Made in China 2025’ plan. This was central to our decision to start JHL in Asia and put our landmark facility in China. The Hubei government, by way of the Biolake biotech development zone, provided strong support to us. For example, aside

Biotalk


from our API facility, all buildings at JHL-1 were built for us by the local government.

In addition to government incentives, the Chinese social security and drug administration systems are undergoing great change. In 2009, the government allocated $125 bil-lion to various levels of government to upgrade hospitals, reduce imbalance in medical care between rural and urban areas, and decrease the burden of medical expenses to indi-viduals. Likewise, since we started working in China three years ago, we have begun to see changes in the tendering process and means of getting on the reimbursable drug lists.

On the consumer side, reforms are underway to make the Chinese economy one driven by consumption. We believe that the growth of service industries and a gradual rise in salaries will, over the long term, drive the new middle and upper class to demand higher qualities of care than currently available. Our biosimilars will make world class therapies affordable to this population.

In your opinion which are the countries poised to ride successfully in the biosimilars wave?

A We have seen great development in every Asian country. Korean firms like Samsung and Celltrion

have invested massively in biologics and biosimilars de-velopment. India has a mature generics industry and very talented people, and we are watching the Indian market closely. JHL has held conversations with Vietnamese au-thorities regarding the possibility of operations in Viet-nam. As you might also guess, we are especially bullish on China. China's regulators have made huge steps towards a biosimilars regulatory framework. The Chinese govern-ment heavily supports development of the biotech indus-try, and, finally, China has a deep and fast growing pool of talented biotechnology experts.

What makes biosimilars an attractive investment option?

A Biosimilars have a lower risk profile than innovator compounds, lower capital costs, and great econom-

ic prospects. Risk in biosimilar development is inherently lower than new entities because the compound has al-ready been discovered and proven. In biosimilar develop-ment, regulators place great value on analytical data and PK/PD efficacy. Unlike a traditional drug development process, in which risk increases with each development phase, much of the risk in biosimilar development is front-end loaded. Thus, investors have an idea of whether a therapy and company are worth investing in much ear-lier than is the case with new entities. Likewise, biosimi-lars development takes about 7-8 years, while new enti-ties can take 15-20 years. Additionally, innovator compounds can cost billions to go from concept to prod-

uct. The capital required for us to go from concept to product is an order of magnitude lower.

Finally, biosimilars are also attractive because of the eco-nomics. We can sell at a sizable discount to innovator compounds and still deliver 80-90% margins. To sweeten the deal, barriers to entry are very high because biosimi-lars are regulated drugs and the development of them re-quires great technical expertise. From an investor's point of view, this combination of lower risk, lower capital in-tensity, and high margins is difficult to beat.

What are the key trends in Asia’s biotech space?Without doubt, the key trend is the growth of world class biotech firms in Asia. Along with this, another very impor-tant trend is the growth of companies making therapies specifically targeting Asian indications. JHL is develop-ing biosimilars for the Chinese and global market, and we also do CMO work for select domestic and international partners. We are working on three projects for BeiGene, China's premier drug discovery company. One of our early investors from Sequoia started ZaiLabs, another company focused on developing new molecular entities, with a focus on entities targeting China and Asia-specific ailments. Every day, we hold meetings with well-funded entrepreneurs looking for assistance in the development of their innovative biologics. We are honored to support this new wave of companies and excited to play a role in the growth of China's biopharma industry.

Could you talk about your product portfolio in depth?

A I love discussing our products, but unfortunately, I cannot say too much, as details of our pipeline are

confidential. Here is what I will tell you, though: our cor-porate goal is to file two-to-three biosimilar INDs per year (China, Europe, and US). At the end of 2015, we filed an IND for our rituximab biosimilar with the UKMHRA, and we have already received approval to perform human clinical trials of it in Europe. We are on track to file an-other IND at the end of this year for an orphan drug bio-similar, and we believe the quality of that product will be so great, it will go straight to Phase III trials. Stay tuned!

Can you elaborate your expansion plans?

A Our first concern is ensuring successful startup of our new API plant. Once done, however, we will

soon start construction of our next API plant and our fill-finish facility. We are also discussing possible locations for our next JHL site, JHL-2. We have a strong product pipeline and see great demand for our products, and we will be expanding aggressively in this decade to ensure we can meet the needs of global consumers. BS

AishwAryA VenkAtesh

Biotalk


Monsanto rejects Bayer offerMonsanto,the world’s largest seed company, has turned down Bayer AG’s $62 billion acquisition bid as ‘incom-plete and financially inadequate’ but said it was open to engage further in negotiations.Earlier Bayer had made a bid to acquire Monsanto for $62 billion.

The combination is expected to provide Bayer’s share-holders with accretion to core EPS by a mid-single-digit percentage in the first full year after closing and a dou-ble-digit percentage thereafter.Initially, Bayer expects annual earnings contributions from total synergies of ap-proximately $1.5 billion after year three plus additional integrated offer benefits in future years. “We have long respected Monsanto’s business and share their vision to create an integrated business that we believe is capable of generating substantial value for both companies’ share-holders,” said Werner Baumann, CEO of Bayer AG.

“Together we would draw on the collective expertise of both companies to build a leading agriculture player with exceptional innovation capabilities to the benefit of farm-ers, consumers, our employees and the communities in which we operate.” This transaction would bring together leading Seeds & Traits, Crop Protection, Biologics, and Digital Farming platforms.

Specifically, the combined business would benefit from Monsanto’s leadership in Seeds & Traits and Bayer’s broad Crop Protection product line across a comprehen-sive range of indications and crops. The combination would also be truly complementary from a geographic perspective, significantly expanding Bayer’s long-stand-ing presence in the Americas and its position in Europe and Asia/Pacific.

Customers of both companies would benefit from the broad product portfolio and the deep R&D pipeline. “Bayer is committed to enabling farmers to sustainably produce enough healthy, safe and affordable food capa-ble of feeding the world’s growing population,” said Liam Condon, member of the Board of Management of Bayer AG and head of the Crop Science Division.

BioNewsDr Reddy’s acquires six OtC brandsDr Reddy’s Laboratories has announced the acquisi-tion of an eminent portfolio of over-the-counter (OTC) brands in the cough-and-cold, pain, and dermatology categories. The company acquired six OTC brands from Ducere Pharma, including DOAN’S, BUFFERIN, NUP-ERCAINAL Ointment, CRUEX Nail Gel, COMTREX, and MYOFLEX.

“These legacy products enjoy strong brand equity built over several decades,” explains Alok Sonig, executive vice president and head of Dr Reddy’s in the US. “We are ex-tremely excited to be entering the branded consumer health arena through these brands and embarking upon the next avenue of growth for our OTC business in the US.”

According to Sonig, Dr Reddy’s will build upon the sales and marketing efforts for these brands and continue to focus on their expansion into existing and new market channels. Sonig commends the marketing and brand-building efforts of Ducere Pharma, recognizing the or-ganization’s role in successfully revitalizing the brands through improved distribution and promotional efforts.

Aurobindo Pharma is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and mar-ket Fenofibrate Tablets, 48 mg and 145 mg. This product is expected to

be launched in Q1 FY16-17. The approved ANDA is bio-equivalent and therapeutically equivalent to the refer-ence listed drug product (RLD) Tricor Tablets of AbbVie. Fenofibrate Tablet is used to treat high level of choles-terol and triglyceride in the blood. The approved product has an estimated market size of $412 million for the 12 months ending March 2016 according to IMS.

aurobindo Pharma receives FDa approval for Fenofibrate Tablets


Indian drug giant SunPharma has inked a deal with global non-profit Inter-national Centre for Genetic Engineering and Biotechnology (ICGEB) to de-velop a novel botanical drug that can combat the menace of dengue. The drug, Cipa, has its roots in traditional Ayurvedic medicine. The project is backed and supported by the Department of Biotechnology (DBT) and Ministry of Science and Technology. The Cipa drug also aims to push towards traditional medicine by the current government,as acknowledged by Dr Khanna and Dr Altaf Lal, senior advisor with Sun Pharma. The eight year long research is led by Dr Naveen Khanna of the ICGEB. Speaking to the media Khanna said, “It is time India woke up and create these drugs with the help of modern science. USFDA approved four botanical drugs from China last year. Four years from now, India could have a pill for curative and even preventive dengue therapy.”

Nearly 10,000 cases of dengue were reported from the national capital last year in one of the worst ever outbreaks of dengue in the country. The drug, Khanna explained, is derived from the plant Cissampelos pareira Linn, com-monly known as abuta, and laghu patha in ayurveda. Its extract has shown to inhibit all four strains of dengue (DENVs). The team from both the ICGEB and Sun Pharma lay much emphasis on supporting any ‘holistic’ medicine with the clinical trials of modern science, so that, as Khanna said, such a drug could be prescribed by all doctors, not just AYUSH practitioners.

india turns to ayurveda to curb dengueshoolini University

Editorresponse

In order to take our research to the end users, we have filed 26 patents in the emerging areas of biotech, such as drug resistance, nanotech, vac-cine development, novel Enzymes, water purification, therapeutics and diagnostics. So in real sense, Shoolini University of Biotechnology is the first interdisciplinary university at the national level. I,therefore, submit you this note as letter to the editor in claiming its right to be the first Bio-technology University of the country, not a footprint of Himachal Pradesh.

Prof PK Khosla, Vice Chancellor, Shoolini UniversityEditor Response(Shoolini has management courses too whereas RCB will be a pureplay, interdisci-plinary public university for biotech.)


Suven secures four product patentsSuven Life Sciences(Suven) an-nounced that they secured product patents in Australia(2012388383), Eurasia (22746), Israel (228019) and USA (9328092) to their New Chemi-cal Entities (NCE’s) for CNS therapy through mechanism of action - H3 Inverse agonist and these patents are valid until 2032, 2030, 2031 and 2032 respectively. The granted claims of the patent include the class of selective H3 ligands discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impair-

ment associated with neurodegen-erative disorders.

With these new patents, Suven has a total of24granted patents from Aus-tralia, 17granted patents from Eur-asia, Nine granted patents from Is-rael and24granted patents from USA.

These granted patents are exclusive intellectual property of Suven and are achieved through the internal discov-ery research efforts. Products out of these inventions may be out-licensed at various phases of clinical develop-

ment like at Phase-I or Phase-II.

Suven Life Science is a biopharma-ceutical company focused on discov-ering, developing and commercial-izing novel pharmaceutical products, which are first in class or best in class CNS therapies through the use of GPCR targets. Suven has 3 clinical stage compounds, a Phase 2 under-going candidate SUVN-502,Phase 1 completed candidate SUVN-G3031 and Phase 1 undergoing candidate SUVN-D4010 for Alzheimer’s dis-ease and Schizophrenia.

dBT launched indigenously developed stool Management Kit

Worldwide hundred mil-lion bedridden patients suf-fer from inadequate bowel management. Impaired bowel control and diarrhoea in bedridden patients pose significant challenges for patients and care providers alike. Patients with faecal incontinence and diarrhoea have 22 times higher odds of developing facil-ity acquired pressure ulcers (FAPU), which increase to37.5 times higher odds if they are also immobile.

Traditional bowel mismanagement cannot even lead to an increased length of stay but also an increase in avoidable healthcare expenditure due to complications such as pres-sure ulcers and nosocomial infec-tions

Till date only few measures are avail-able for management of faecal in-continence and diarrhoea includes absorbent pads and adult diapers.

Though these methods are not so ex-pensive, but obviously these methods are time consuming, labour inten-sive, and lead to costly complications, such as incontinence associated der-matitis (IAD), facility acquired pres-sure ulcers (FAPU), and spread of nosocomial infections.

Indwelling balloon cuf-based fae-cal management systems have been shown to reduce risk of complica-tions such as infection and skin breakdown. However, since these devices anchor on the pressure-sen-sitive anorectic junction, they put patients at risk of new complications, involving injury to the rectal mucosa

and sphincter dysfunction.

Qora is a closed-system stool management kit that hygieni-cally contains liquid to semi-formed stool. It reduces the risk of complications associ-ated with traditional bowel management. The kit mini-

mizes nursing time and effort spent on stool management.It also opti-mizes safety and comfort for bedrid-den patients suffering from impaired bowel control. It has proprietary lat-tice diverter conforms to rectal wall at rest and during peristalsis, divert-ing faecal exudates while minimizing leakage.

With this it has indwelling compo-nent designed to function in patients with all kinds of sphincter tone and without inhibiting normal anorectic physiology. Qora is innovative, pa-tient-friendly applicator minimizes exposure to effluents and contami-nants during device insertion.

Bionews


Mapmygenome launches Babymap carrier & newborn screening

Recommended for newborns, expecting par-ents, and people planning a pregnancy, this test screens for 71+ metabolic conditions that can be treated in newborns.

Ms Anu Acharya, CEO of Mapmygenome an-nounced this news, adding, “Pregnancy and parenthood are among the most joyful expe-riences in a person’s life. We want to make these experiences healthy and tension-free. Babymap allows parents to make informed choices to ensure their newborns and future children stay healthy.”

Dr Radha Rama Devi, MD (Peds) at Rainbow Hospital, who was instrumental in setting up the first Newborn Screening for preventable causes of mental retardation in India and published the first data on the prevalence of these disorders in the Indian population, said, “Babymap

Piramal to acquire four brands from Pfizer

Piramal Enterprises’ Consumer Products Division has entered into an agreement to acquire four brands from Pfizer for a consideration of `110 crore. The acquisition includes brands namely:Ferradol, Neko, Sloan’s and Wa-terbury’s Compound. Additionally the agreement also in-cludes the trademark rights for Ferradol and Waterbury’s Compound in Bangladesh and Sri Lanka.

These brands hold a rich legacy and have a high consum-er pull and are available in India for the past 30+ years✓ Ferradol launched in 1982, is a leading nutritional

supplement for children and adults.✓ Neko launched in 1967, is a medicated soap indicated

for body odor and minor skin infections. ✓ Sloan’s launched in 1982, is muscular pain reliever

that is available in balm and liniment forms. ✓ Waterbury’s Compound launched in 1970, is used for

building cough and cold immunity.

These products currently operate in a market which is cur-rently estimated at `7000 crore. Completion of the deal is subject to certain conditions including regulatory approvals.

Ms Nandini Piramal, executive director, Piramal En-terprises said, “Our aim is to be a significant player in every business under the healthcare vertical of Piramal Enterprises Limited. We are one of the large custom manufacturing companies and have manufacturing bases in North America, European Union and Asia. Our critical care business is the third largest player in the global inhalation anesthesia market. The Consumer Products Division of the company currently ranks 7th in India; but we aim to be a top 3 player in the OTC market by 2020. Acquisition is one of the important routes to help us achieve our goal and in the last 6 months we have done two acquisitions in the consumer products business. The first one was the Littles baby care range of brands and second was the gastro-intestinal portfolio of brands from MSD. We believe these brands from Pfizer will fit our portfolio and also strategically help us move closer towards our stated objective. The combination of growing our existing core brands and strategically ac-quiring accretive brands has helped us create a unique business which has a powerful portfolio of OTC brands in India.”

is an excellent idea and will replace the newborn screening tests cur-rently used”.

Babymap test requires blood samples for genetic testing us-ing the technology platform Next Generation Sequencing for over 31,000 pathogenic single nucleo-tide variants and minor insertions and deletions. Following analysis,

a session with Mapmygenome’s genetic counsellors al-lows parents to learn about their carrier status and future course of action.

This test starts at `30,000 for individuals, with attrac-tive pricing options for couples and parents of newborns. Mapmygenome plans to market this test through their healthcare partners.

Bionews


Dr Harsh Vardhan inaugurates Biotech Infrastructure Facility

Union Minister for Science & Technology and Earth Sciences, Dr Harsh Vardhan in-augurated the Department of Biotechnology (DBT) funded Biotech Infrastructure Facil-ity (BIF) at ICAR-National Research Cen-tre on Mithun (ICAR-NRCM), Jharnapani, Medziphema, Nagaland. Mithun is a unique large semi-domesticated animal of the bo-vine family, endemic to the North-Eastern

States of India.

The minister remarked that as Mithun touches every Naga household economi-cally, socially and emotionally, it could not only become the symbol of the Naga people but also exemplify India’s unity in diversity by strengthening the bond-age between different communities. Dr Harsh Vardhan acknowledged that ICAR-NRCM is the only institute of its kind in the world solely dedicated to the conservation, propagation and development of Mithun which itself is geo-graphically limited to Arunachal Pradesh, Nagaland, Manipur and Mizoram.

The ICAR-NRCM farm has established modern scientific facilities for the rearing of Mithun under a semi-intensive system that comprises of various farmer-friendly technologies developed by the institute namely feed block, mineral block, area specific mineral mixture and low-cost feed formulation using industrial by-products. Dr Harsh Vardhan, expressing strong convic-tion said that this BIF facility will prove beneficial for young researchers of the North-eastern region. During the interaction with scientific staff of the institute he emphasized at working on research projects that are beneficial for farmers and implementable at the grassroot level.

ge healthcare partners withheritage Valley health system

Heritage Valley Health System has announced an innovative, strategic alliance with GE Healthcare aimed to propel the health system’s momen-tum of obtaining advanced medical equipment over the next 14 years.

Heritage Valley Health System and GE Healthcare entered an agreement that initially includes new, state-of-the-art MRI and CT scanners for Heritage Valley Beaver and Heritage Valley Sewickley hospitals, new ul-

trasound equipment for Heritage Valley’s hospital and medical neigh-borhood locations, upgrades to an existing GE CT scanner and the addi-tion of nuclear imaging cameras.

This alliance marks GE Healthcare’s first Managed Equipment Service (MES) agreement in the US. The company anticipates that, with this announcement, it launches the first of many MES solutions across the country.

infosys Foundation inks pact with iiseR-Pune

Infosys Foundation, the philan-thropic arm of Infosys, has signed a Memorandum of Understand-ing (MoU) with Indian Institute of Science Education and Research (IISER), Pune, a leading science institute in the country, to provide opportunities for economically weaker students to pursue high quality science education and re-search through scholarships, fellow-ships and travel awards.

As part of the MoU, the corpus fund of `5 crore named as ‘The Infosys Foundation Endowment Fund’, will continue in perpetuity to benefit a minimum of 50 students annually.

The grant will be used towards the establishment of Infosys Foundation Scholarships which will be awarded to BS-MS students, Infosys Foundation Fellowships endowed to integrated PhD students and Infosys Founda-tion Travel Awards to PhD students who have excelled in their research work. The grant is aimed at fulfilling the Foundation’s objective of creating equal opportunities for students from poorer backgrounds and advancing the quality of research done at Indian institutions. The establishment of scholarships, fellowships and travel awards provides opportunities for students at different academic levels to gain from the grant.

Bionews


Bionews

Pharma exports growth heading for a sharp declineCRISIL Research foresees exports growth in formula-tions (in US dollar terms) decling sharply to 10-125 an-nually over the next 5 years, compared with a growth of 19% seen in the last decade.

Exports of generics have been the growth engine of the industry for a long while now, but the script is changing because the value of drugs going off patent is declining even as pricing pressures are increasing.

For example, annual sales growth of generic drugsin US is seen slowing to 8-9% over the next five years, and de-celerate even more after that. Therefore, for growth to sustain beyond 2020, domestic companies will have to step up investments in new molecules and draw up a roadmap to deal with lower generics growth.

In the past decade and more, what came in handy was process chemistry skills--which helped companies clone drugs going off-patent by tweaking their molecules--and low-cost manufacturing. But competition has been in-tensfying, particularly for the large players, because of

the huge number of abbreviated new drug applications (ANDAs) being filed with the USFDA, including by mid-sized domestic ones looking to step up presence in the biggest market.

Furthermore, consolidation of distribution channels in the US could reduce the pricing power of domestic drug makers. Says Ajay Srinivasan, Director CRISIL Research, “Sharper focus on innovation and R&D has become an imperative. Our analysis of new drug applications ap-proved by USFDA reveals that Indian companies got ap-provals for just 26 products between January 2006 and June 2015-a fraction of the 840 garnered by global phar-ma companies. Their global generic competitors such as Teva and Mylan has 48 and 33 NDAs to their credit as of February 2016.”

To be sure, Indian companies have indeed increased their R&D spend; for the top 30, it has shot up to 6.5% of rev-enue fiscal 2015 from 3.8% a decade back. However, this pales in comparison with global majors, who spend close to 16%.

WhO south-east asia Region on track for implementing polio endgame strategy

Implementing a monumental change in vaccination that is expected to bring the world closer to eradicat-ing all types of polio, all 11 countries in the WHO South-East Asia Region have ‘switched’ from using the tra-ditionally used trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV) that protects against the remaining wild poliovirus strains.

The vaccine switch removing ‘type 2’ component of the oral polio vaccine follows global certification of eradi-cation of type 2 wild poliovirus last year.

The switch also aims at drastically reducing the rare risk of children get-ting paralysis by oral polio vaccine.

“The world is closer than ever before

to ending polio. The switch is a criti-cal step in the Polio Endgame Strat-egy towards achieving a world free of all types of polioviruses,” said Dr Poonam Singh, WHO Regional Di-rector for South-East Asia.

The polio vaccine switch, which is complemented with introduction of injectable inactivated polio vaccine (IPV), will boost the Region’s efforts to protect children against polio un-til the crippling disease is eradicated globally.

“The Region was certified polio-free in March 2014 and continues to maintain the polio-free status, de-spite the risk of importation from the polio-endemic countries. Efforts are ongoing to protect children with po-lio vaccine,” she added.

Biocon to set up a new manufacturing facilityThe Karnataka State government has cleared biotechnology major Biocon’s Rs1,060croreinvestment proposal for setting up a new pharmaceutical plant on the outskirts of Bangalore.

The new unit, that will come up on leased plots at the new KIADB Indus-trial Area in Jigani, few kilometers from the Biocon Park in Bangalore, will produce injectables, monoclonal antibodies and oral solid dosage.

The facility is expected to generate at least 750 jobs immediately. Biocon’s investment proposal was approved by the State High Level Clearance Committee (SHLCC) chaired by Kar-nataka Chief Minister Siddaramaiah at a meeting on May 25, 2016.


In the manufacturing context, additive manufac-turing for medical applications is significant when compared to other popular industries such as elec-trical and electronics, aerospace, automotive etc, since there is the invaluable human element pres-

ent in all healthcare applications, where often cost takes a backseat compared to a successful outcome that saves a life or greatly improves the quality of health.

Today, 3D printing is an emerging technology to produce cost effective, efficient and customized body parts and medical devices such as dental implants, hearing aids, prostheses, custom made knee and hip implants, and surgical instruments. A 14-year-old boy from the United States has become the first person to undergo a success-ful nose transplant using 3D printing technology. Also recently, 3D printing has helped surgeons to successfully transplant a kidney to a toddler from Northern Ireland. 3D printing (3DP) technology has progressed rapidly in recent years, and its medical applications are lead-ing to some of the most significant deployments of the technology.

3D printing and growing need for right performance material3D printing (3DP) is a term used to describe several dif-ferent technologies and techniques used to create 3D ob-jects. Currently there are several different technologies, which perform this function in a variety of different ways such as steriolithography, fused deposition modeling (FDM), selective laser sintering (SLS), 3D microfabrica-tion, and electron beam melting (EBM). These process-es are substantial for creating prototypes and end-use production parts using several polymeric and metallic material.

The technology is emerging as a cost effective, efficient solution and provides customized manufacturing option

for the medical devices industry. It promises to deliver on various counts such as personalization according to pa-tients or users, flexibility in design and manufacturing, decreased material wastage, elimination of specialized tooling, and low lifecycle costs.

Combined with the maturity of the 3D printing process (in terms of better material, machines, and technologi-cal innovations), the technology can be used to develop many new medical devices that were earlier deemed dif-ficult to create, expensive, or not patient friendly. The advancements in additive manufacturing along with the advancements in material evolutions have provided a spring-board for increasing use of 3DP in healthcare in-dustry.

Material selection is a critical step in any product devel-opment cycle. The material selection criteria are always derived from the requirements identified during the de-sign stage of the component or end-product. For mate-rial used in medical devices, mechanical performance requirements combined with bio-compatibility, steriliza-tion capabilities, fire retardency, smoke toxicity, chemical resistance, etc., may be detrimental for safe performance of medical devices. Therefore, when choosing a material and the 3D printing process for the device, it is important to ensure the material can deliver one or more of these property requirements driven by the design, application and function of the product.

Several thermoplastic material which are currently in use with traditional manufacturing like injection molding or extrusion can be modified to be used in 3DP applications (ex., FDM, SLS). Polycarbonates (PC), PEI, ABS, ASA, Polyamide, Polysulfide etc., are some of the thermoplas-tic material types that are often used with FDM process. These materials should also meet the bio-compatibility needs along with the other safety needs that are demand-ed by the function of 3DP parts.

are these performance material in medical devices safe?

3D PRiNtiNg revolutionizing healthcare

Biospecial


There are several safety standards that are currently available to qualify these material for safety require-ments. The ISO 10993 series of standards describe meth-ods for evaluating material for biocompatibility in medi-cal devices. There are other UL safety standards such as UL 94 and UL 746A to evaluate material for flammability, mechanical and electrical performances.

Current challengesOne of the key aspects affecting the industry has been the safety associated with the performance material. This will have maximum impact on the medical device sector, due to the usage of a considerable volume of polymers. Safety has also been an issue when it comes to polymer material se-lection for a medical device. While high performance ma-terial such as polyetheretherketone (PEEK) are rendered safe compared to commodity thermoplastics, the high cost of PEEK often pushes medical device manufacturers to use cheaper material which has a good degree of biocompat-ibility and regulatory compliance. Striking a balance be-tween cost and performance is usually a challenge.

In spite of its state-of-the-art technology, 3D printing has its own challenges. While it allows medical practitioners to print their own devices, it provides a challenge to regu-latory authorities in enforcing adherence to quality stan-dards. This brings another challenge to the forefront - en-suring traceability of the device throughout its lifecycle, right from the patient-identification stage. This would re-quire extension of the Unique Device Identification phi-losophy to 3D printed devices. Unapproved devices that need to be implanted into the patient’s body on an emer-gency basis may have to go through emergency approval processes. It is important for users to exercise extreme caution to ensure there are no regulatory violations.

Mechanical testing and bio-compatibility questions may arise with medical devices produced using 3DP tech-nique. Therefore, Food and Drug Administration (FDA) has been monitoring the mechanical and bio-compatibil-ity requirements for the medical devices that are manu-factured using this technology. Hence, crossing the strin-gent regulatory barrier is a challenge for the performance material industry. Further research is necessary to obtain solutions for these challenges. Even though there are sev-eral safety standards currently available, relevance of the test methods to 3DP process needs further study. There-fore, direct use of these safety standards for evaluating material for 3DP application is still questionable.

safety and regulationsWhat happens when entirely new material is subjected to

newer manufacturing and processing methods? With 3D printing and such other newer technologies, such ques-tions only seem to be scratching the surface. Given the strict regulatory environment and lack of relevance of existing standards for 3DP application, it is critical and important that material considerations are thoroughly examined when producing medical devices using 3DP.

A systematic material assessment that focuses on require-ments, screening, manufacturability, and ranking will help the manufacturer meet regulations and avoid poten-tial liability while delivering innovative, safe, and effec-tive medical devices to patients. While medical devices in the US and EU are regulated by the Food and Drug Administration (FDA) and the CE mark approval respec-tively, in India, medical devices in general and those with newer performance material face a tougher challenge. This is largely due to sketchy regulatory framework and the still to be implemented Drug and Cosmetic (Amend-ment) Bill.

With the constantly evolving landscape in the medical de-vices sector, new material, new processes and new equip-ment are emerging at a dizzying pace. As with any new or emerging technology like 3DP that has advantages like reduction in manufacturing cost and faster time-to-mar-ket, there are associated new challenges with respect to selection of right material that meets both performance and safety requirements. Lack of test methods to catego-rize and rank material suitable for 3DP add more chal-lenges in selecting right material for healthcare applica-tion. Existence of such challenges does raise concerns on the safety aspects of 3DP parts.

In spite of its state-of-the-art technology, 3D printing has its own challenges. While it allows medical practitioners to print their own devices, it provides a challenge to regulatory authorities in enforcing adherence to quality standards.

Prasad ShankarappaPrincipal Engineer – Performance Materials, UL South Asia

Biospecial


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Precision Medicine

During his State of the Union

address in January 2015 at the

White House, American President

Barack Obama announced the

launch of the most ambitious

healthcare initiative called the

Precision Medicine Initiative (PMI),

with a mission to usher the US

into a new era of medicine where

patients will enjoy individualized

and tailor-made treatment for

various ailments.

Does India need

Initiative


Obama said, “Doctors have always recognized that every patient is

unique, and doctors have always tried to tailor their treatment as

best they can to individuals. You can match a blood transfusion to a

blood type — that was an important discovery. What if matching a

cancer cure to our genetic code was just as easy, just as standard?

What if figuring out the right dose of medicine was as simple as

taking our temperature?”

Coverstory


Precision medicine is an emerging approach of medicine which looks at the root cause of an illness, rather than addressing the

symptoms alone. Precision medicine may not be very well known as Per-sonalized Medicine. But they are one and the same. It takes into account individual variability in genes, envi-ronment, and lifestyle for each per-son. The need and its potential in the Indian healthcare scenario is high, considering that the system is under great pressure due to sheer numbers.

Precision Medicine in the country is considered to be at an early adoption stage. A diverse country like India, with over 4,000 population groups, and a significant percentage of con-sanguineous marriages presents a high-risk and prevalence of inherited genetic disorders that require atten-tion for early diagnosis, right treat-ment, and management. India has a heavy burden of inherited diseases driven by the unique genetic charac-teristics in the population. With 1.4 billion people, the absolute number of patients suffering from diseases in which genetics play a role is signifi-cantly large.

It is reported that Indians witness a loss of around $23 billion from their annual income in treating or getting tested for non-communicable diseases.

The global genomics industry is pre-dicted to grow at around 18 percent in the next 10 years, and India is expect-ed to be a major stakeholder. Reve-nue growth in molecular diagnostics in 2013 was reported to be around 15 percent. Clinical diagnostics in one of the fastest growing fields which may cross $2 billion by 2018. Preventive healthcare is growing at the rate of 25 percent, which will boost healthcare revenue and the country’s Precision Medicine scenario.

“Genetic testing is slowly getting ac-ceptance among our clinicians. The challenges are about creating the awareness for wide-spread adoption. It is not at all too early for the coun-try to embrace precision medicine. This is primarily because India is an emerging market for genomics. A ris-ing middle-class, state-of-art health-care facilities and expert physicians are driving the growth of the indus-try in India…. I expect the industry to attain double digit growth,” says Sam Santhosh, Chairman & Global CEO, MedGenome.

Dr Saleem Mohammed, CEO & Founder, Xcode Life Sciences, agrees that India has a strong need for Pre-cision Medicine which will signifi-cantly reduce its healthcare burden.

“It is estimated that only around 40 percent of the medicines we take are effective and appropriate for us. To-day, we practice trial-and-error med-icine which does not consider in de-tail the person-to-person variability, which is a key source of variation for the effectiveness of drugs. You can imagine being dosed and prescribed by taking into account various factors such as age, gender, genetics, medical conditions and usage of other drugs. That is the promise of personalized medicine, and India needs to take leadership in this domain,” he adds.

In India, Precision Medicine is be-ing practiced in several specialties

like oncology, cardiology, psychiatry and diabetology. It is already being embraced in India to a reasonable extent, especially in cancer.

“Each individual is an island, and so now that the molecular complexity of disease has been deciphered, the role of genetics, environment and epigenetics are clearly telling us that that we all need to receive treatment designed for our physiology and body type,” remarks Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen.

Indian healthcare institutions are fast adopting technologies that can make them on par with the best in the world. The need to modernize, and be on par with global standards can be seen amongst large hospitals and private medical institutions.

Explains Dr Kalyanasundaram Sub-ramanian, CSO, Strand Life Sciences, “There are several targeted therapies that work only on patients who have a specific genotype or genomic varia-tion. So, patients are tested before the therapy is prescribed. Cancer is probably the disease in which pre-cision medicine is most advanced. However, there are several other dis-eases - cardiac, ophthalmic, and cer-tain types of diabetes, where knowing the genetic background of the disease can help with disease management. Here the field is not as advanced.”

Like most technologies, India is ex-

Precision Medicine in the country is considered to be at an early adoption stage. A diverse country like india, with over 4,000 population groups, and a significant percentage of consanguineous marriages presents a high-risk and preva-lence of inherited genetic disorders that require attention for early diagnosis, right treatment, and management. india has a heavy burden of inherited diseases driven by the unique genetic characteristics in the population.

Coverstory


pected to be a follower-market in Precision Medicine. Doctors would like approval from USFDA or the American Medical Association (AMA) for it to become mainstream in their practice.

But the challenge is that the West is going to fund studies in Caucasian population and not the Indian. In fact, most drugs are designed and manufactured for Caucasian popu-lation. Unless India accelerates re-search in this space, validation in the Indian context will always be questionable.

“Precision Medicine is badly needed to move towards personalized medi-cine and personalized diagnostics, which has a huge potential to reduce the burden of national healthcare costs,” points Dr Amit Kumar, CEO & CSO, BioAxis DNA Research Cen-tre. “At several instances, this results in patients selling assets or borrow-ing money to pay incurring medi-cal expenses. Precision medicine is the best available tool and remedy for combating this huge economic burden.”

Cost of these tests are a concern still, given India is largely a self-paid economy. But as technologies improve, the cost of sequencing is seen to reduce. Precision Medicine offers a possible answer by reducing the costs of hospice stay, and reduc-ing the overall financial, physical and psychological costs of the try-and-test approach of medicine.

“The infrastructure needed for pre-cision medicine is taking shape in India. There are certain issues to be addressed for it to gain the needed momentum,” opines Samarth, CEO & Founder, Positive Bioscience.

“The key is also the analysis of ge-nomics data, which as we automate will provide higher efficiency in the

entire data analysis process, thereby making tests more affordable. We do need more baseline genomics data of Indian origin which will help us in re-fining our analysis on clinical cases in the country,” comments Sam.

Targeted therapies like Imatinib have been around for 40 years. This has changed the prognosis of Chronic Myeloid Leukemia (CML) in children.

“People used to think that the role of genetics ended with hereditary disease. Today we know that every response our body makes has a ge-netic fingerprint to it. We can now predict response to different thera-pies, and thus avoid trial-and-error medicine which is both costly, time consuming, and puts an unnecessary drug and hospitalization burden on the patient,” comments Dr Sooraj Ratnakumar, Founder & Scientist, Swagene.

The US and EU markets do have a head start in Personalized Medicine in terms of accessibility to resources and raw material, government fund-ing, and regulations.

“There is also greater awareness among the people there about the benefits of personalized medicine. In India, we have an excellent gene pool of biotech and IT professionals. With government interest, we can easily build India as the hub of personal-ized medicine,” expresses Ms Anu Acharya, CEO, Mapmygenome.

President, CEO & Founder of Geno-typic Technology Raja Mugasiman-galam says that Precision Medicine is too early for India at the moment. “Precision Medicine is an emerging field and sufficient success should be shown by the western world for India to embrace it. It is in its early phase, and there is not sufficient govern-ment support in the form of research grants in this space,” he adds.

Overly hyped?The way Precision Medicine can help transform healthcare, especially treatment and management of dead-ly non-communicable diseases is tre-mendous, and stalwarts opine that it is not an overly hyped concept.

“The field of Precision Medicine is

“Each individual is an island, and so now that the mo-lecular complexity of disease has been deciphered, the role of genetics, environment and epigenetics are clearly telling us that that we all need to receive treatment de-signed for our physiology and body type,”

Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen

Coverstory


still in a nascent stage in India, and much needs to be done to create awareness. So the concept cannot be called as overly hyped, but rather passionately acclaimed in the medi-cal and scientific fraternity. Any de-velopment in the science and medical space that revolutionizes how medi-cine will be practiced in the future naturally generates a buzz around it. Yes, the concept is quite novel at this point of time but its scope is tremen-dous. While we may lack the band-width to carry out all the exceptional research at this point in time, slowly it will happen. And once it happens, the impact will be more than just overwhelming. However, there are certain roadblocks that we cannot ignore. But limitations and challenge begets innovation and development,” opines Samarth.

“I see Precision Medicine as a new hope rather than a hype,” Dr Amit states. “Some of our clients say that research insights of the genomics da-ta-related to lifestyle, diet, and clini-cal methods have been very useful in making a decision faster based on a patient’s personalized genetic infor-mation.”

More than hype, Precision Medicine is said to be more of plain, pure com-mon sense. For thousands of years, humans have known that there is inter-individual variability when it comes to things ingested, be it medi-cine or food. Why then patients pop an over-the-counter pill? Or even wonder whether it will work on them or not?

In a recent study by Johns Hopkins University (USA), medical error was suspected to be the third leading cause of death in the US. Many of them are related to improper drugs and improper drug dosages.

“It’s sort of like ‘death by medicine’. Can you imagine what the statistics

are in India? asks Dr Saleem. “Today, we don’t question why the outcome was negative for a patient. We as-sume that the medical establishment did the best they can in good faith. With increasing prevalence of clini-cal decision support systems, and in-surance insisting on good practices, you will see things improve. Com-mon sense dictates that precision medicine is the only way medicine should be practiced and not by trial-and-error.”

Dr Binay Panda, Chief Officer & Head, Ganit Labs, also states that the problem in India is that Precision Medicine is hyped by people who un-derstand little about it.

“Look around and you will find folks who talk about Precision Medicine, who understand little about it or have very little practical and scien-tific experience on developing preci-sion medicine tests. We need rigor-ous scientific minds to talk about the utility of Precision Medicine, like in the West, and not those who use the term as a buzz word or a part of mar-keting supplements only,” clarifies Dr Binay.

India’s research sceneThe research scene for Precision Medicine in India is largely in the be-ginning stage. Some studies are being carried out in various translational research centres across the country.

There are several Government labo-ratories such as IGIB (Institute of Genomics & Integrative Biology),

CCMB (Centre for Cellular and Mo-lecular Biology), hospitals such as CMC Vellore, LV Prasad Eye Insti-tute and other organizations, where research is being conducted. “How-ever, it would be fair to say that the research is fragmented and indi-vidual researcher-driven, and not yet translated to patient care in a big way,” points Dr Kalyanasundaram.

Research is also being carried out at Sir Gangaram Hospital (Delhi), Ma-dras Diabetes Research Foundation (MDRF) (Chennai), Indian Council of Medical Research (ICMR), Insti-tute of Bioinformatics (IOB) (Banga-lore), and Government institutions such as National Institute of Biomed-ical Genomics (NIBMG) and Center for Genome Research.

Large government hospitals like Tata Memorial Hospital, National Insti-tute of Mental Health and Neurosci-ences (NIMHANS), and All India In-stitute of Medical Sciences (AIIMS) are also involved in the identification of new disease genes and biomarkers by applying Genomics.

Dr Mallik Sundaram, Co-founder, President & CEO, Mitra Biotech, says, “The western markets have em-braced it quickly because healthcare is more organized there with the pay-ers being the government or insur-ance companies, thereby translating the benefits of decreased healthcare costs while improving treatment suc-cess rates using Precision Medicine. In countries like India with frag-mented healthcare, and the patient

It is estimated that only around 40 percent of the medi-cines we take are effective and appropriate for us. To-day, we practice trial-and-error medicine which does not consider in detail the person-to-person variability, which is a key source of variation for the effectiveness of drugs.

Dr Saleem Mohammed, CEO & Founder, Xcode Life Sciences

Coverstory


frequently being the payer, while the benefits remain the same, but ac-knowledging and translating them is more piecemeal.”

India, like many other developing countries, is following success stories of the West.

“Success in Precision Medicine de-pends on several factors includ-ing availability of tests on Precision Medicine, system on which medical payment is made — out-of-pocket versus insurance-based versus gov-ernment-sponsored — overall posi-tive atmosphere in the country to-wards embracing new tests, previous success stories, availability of skilled manpower and the presence of the right environment. On all these ac-counts, we in India, have miles to go. However, we have excellence in pockets, which include brilliant peo-ple who are capable of doing all that. The trick is to encourage those few to develop tests for the Indian popula-tion,” Dr Binay explains.

Paradoxical elementsThe use of Precision Medicine is a lit-tle tricky and paradoxical, say experts.

“It has lot of social impact. But some-one has to draw a line to the extent one should use it. One single muta-tion is responsible for more than one medical condition and vice versa; it may also create confusion and mis-leading interpretations. Precision Medicine may be only a corrobora-tive aspect until we have more con-fidence, and accurate outcomes get-ting reported across the globe,” Dr Amit reveals.

Dr Kalyanasundaram says that the challenge is in marrying personaliza-tion of medicine with reduced drug costs to an individual patient.

“Currently, most of the best genome-based medicines are expensive and

out-of-reach for the average Indian. The other worrying aspect is that none of these medicines are avail-able in India. Imagine the plight of a patient who realizes that there are medicines that may work for him but is unable to access it,” he observes.

Also, the discussion of paradoxes of Precision Medicine often revolves around the cost, i.e., spending more and more to identify therapies that applies to fewer and fewer.

Samarth adds, “This paradox can be compared to the cost of any IT initiative in the eighties era using mainframe computers, and specially created buildings for housing them versus, even higher computational processing being available today in a mobile system; or 3D printing to give a more recent example. As there is a change in approach and increase in use of the technologies, there will be a reduction in costs.”

What Is needed?In Precision Medicine, for success-ful commercialization, many things have to come together.

“There has to be a way of leveraging all the information and insights that is generated in other populations from around the world. The Indian government should be setting up large genomic studies in various dis-ease populations. Indian scientific establishments need to view this as a challenge, and work with physicians to understand the diseases that are most likely to have benefits quick-

ly, and work towards problems in those areas. Indian funding agencies should be funding large translation-al projects with a clear clinical aim. There should be clear frameworks that allow industry to access these in-sights to convert them to products,” urges Dr Kalyanasundaram.

Both Sam and Samarth agree that in-creasing the awareness levels of Pre-cision Medicine among the general population, clinicians and doctors is much needed.

“In our country, the depth and width of the healthcare system is very large, often unorganized, and under tre-mendous pressure. To bring in a new approach to the practice of medicine will need full participation and edu-cation of patients, drug developing pharma companies in pharmacoge-nomics, change in the practices and process of hospitals and clinics, good regulatory framework and the sup-port of the government in building the research infrastructure. Further in order to translate the bench re-search to bedside care, it is important for research academics and medical market players join hands,” suggests Samarth.

Collaboration of genetic testing labo-ratories, hospitals, and medical doc-tors may be the starting point, says Dr Amit. “We require huge genetic, clinical and lifestyle data from India, and this can only be reached if gov-ernmental programs backup such kind of association and research. With the fast decreasing cost of DNA

Precision Medicine is badly needed to move towards per-sonalized medicine and personalized diagnostics, which has a huge potential to reduce the burden of national healthcare costs,

Dr Amit Kumar CEO & CSO, BioAxis DNA Research Centre

Coverstory


sequencing of a person’s genome, a model shall be framed which should have genetic medicine and precision therapy as one of the most important inclusion. Government may think of including genetic tests under the insurance coverage, starting with critical illnesses. If we have enough country data, it may offer a lot of very important medical insights.”

According to Dr Binay, India needs 4 Ps to make Precision Medicine suc-ceed. “They are people, processes, protocols and pricing. People mean-ing encouraging and aiding brilliant minds to be involved in developing new and innovative tests; processes meaning developing the right clini-cal and scientific processes or SOPs; protocols meaning coming up with the right regulatory…,” he lists.

Dr Saleem believes that the medical community should actively collabo-rate with genetic service providers to validate concepts in the Indian population.

“We operate in a highly cost-sensi-tive environment. A key barrier to adoption is cost of the test…. In the long-term, genetics should become a major part of the medical curricu-lum. Genetics should get its due im-portance given that we live in an era where we are talking about actively editing genes to cure major diseases,” he notes.

Sam recommends public-private partnerships (PPP) between aca-demic institutes and the industry to promote genomic research in the country.

“Partnerships with private enterpris-es that have already taken the leap into genomics research and are pro-viding solutions to address health-care needs in India…. In addition to this, initiatives like setting up of elec-tronic medical records, and popula-

tion level genome sequencing will go a long way in helping commercial success. It will also be useful to chart out a comprehensive plan to identify key disease areas in India with un-derlying genetic reasons that have high unmet medical need and to al-locate government funds to promote education, research and innovation in these areas,” he stresses.

Should India ape the US?India may follow something similar to PMI launched by Obama, but on a pilot scale.

“The government can play a key role by allocating research funding to this area. Precision Medicine is go-ing to have a tremendous impact on our nation’s healthcare and will im-prove health outcomes while mini-mizing the costs. But someone has to make the investment in accelerating the creation of know-how, and the knowledge base that is specific to In-dia. Given the significance of health for a nation’s economic and social de-velopment, I would say that prioritiz-ing of government grant funding to this area will be highly useful. The US again has taken leadership in this so far with the Precision Medicine un-der the Obamacare,” voices Samarth.

In an interview with BioSpectrum, Dr Mandar Kulkarni, CTO, Cancer Genetics India, states, “I think this is a big challenge even in the US, where most diagnostic testing is paid through insurance reimburse-ments, which are driven by FDA-approvals.”

He further expresses, “Currently, the FDA is reviewing the guidelines and ensuring that the testing is not wasteful. On the other hand, a major advantage for such testing in the US is the availability of well-curated da-tabases that define the effect of mu-tations on the disease-state in terms of prognosis, clinical outcome and treatment options. Unless we adopt the tests and begin this exercise, we will not be able to identify epidemio-logical and etiological differences that contribute to cancer in India.”

Though India’s limited studies in this area show that while the Indian genome has many similarities to the Caucasian, there are significant dif-ferences as well. “So it is absolutely essential that a similar and large PMI be launched in India given the genomic diversity here,” justifies Dr Kalyanasundaram.

Sam also agrees that a initiative like PMI will be useful to India’s Health-care. ‘‘If a similar program is initi-ated, it has to be designed keeping in mind the state of the economy, and the public health issues of the Indian population, and the diseases or disor-ders plaguing our society. The Geno-meAsia 100K consortium is one such initiative in the region,” he urges.

Starting anything new is good, but India needs to revive and encourage what it already has, and have a long-term vision for Personalized Medi-cine.

“Science does not bear fruit over-

The western markets have embraced it quickly because healthcare is more organized there with the payers being the government or insurance companies, thereby translat-ing the benefits of decreased healthcare costs while im-proving treatment success rates using Precision Medicine.

Dr Mallik Sundaram President & CEO, Mitra Biotech

Coverstory


night,” Dr Binay adds. “One needs to be patient and encourage fund-ing the right talent in this direction. First and foremost, we need to en-courage young minds to pursue sci-ence and be more meritocratic in our institutions.”

Dr Amit emphasizes that both ICMR (Indian Council of Medical Research) and CSIR (Council of Scientific and Industrial Research) need to play a very important role in framing the in-sights related to pharmacogenomics, genetic variation-related drug stud-ies, and population-wise human SNP validation, if India wants a mean-ingful outcomes from such a diverse population.

Dr Raja says that India doesn’t have to ape the West.

One might consider a PMI in India as an overly zealous move for a country where malnutrition and poverty collec-tively kills more people than diseases.

“At the right time we can definitely think of taking a step towards PMI for our own country just like America. India is already the diabetes capital of the world and is slowly inching in vying the top spot for heart ailments and cancer too. I think we all have come to appreciate the fact that all these diseases are genetic-driven by a combination of several mutations in different genes. Precision Medicine guided by genomics not only allows us to diagnose and prevent these dis-eases but also treat and manage them effectively,” elaborates Samarth.

Regulatory woesGenomic information is critical since it not only affects an individual but potentially their family as well. There are legal, technical, social, and po-litical hurdles which needs to be ad-dressed.

Dr Kalyanasundaram stresses, “It

needs to be clear who owns this in-formation, what are the limitations under which researchers get access to it, and how can this information be used and misused. These issues are all critical and need to be addressed by the law.”

However, the current regulatory frameworks are inadequate in terms of providing guidelines for Precision Medicine initiatives.

Information is required on how to bring in a population level-approach for genomics research. Also, policy revisions to support the industry from import duties on reagents are a need of the hour.

“Intellectual property rights and pat-ent policies are not very well defined in the area of Precision Medicine and predictive genomics. This could be a challenge to further innovation. Also, reimbursement from insurance com-panies is another key factor that will

determine the growth of this indus-try. In the western world, insurers have started accepting genomic tests in their formulary as it is expected to reduce the cost of down-the-line treatment. In India the option is to bring the test at affordable prices and foster innovation to reduce the cost of genomic diagnosis,” Sam ex-presses.

Precision Medicine is dependent on the DNA study of an individual, and India does not have a DNA usage policy yet.

“We are hoping for the best since this important master molecule has caught the attention of our PM Na-rendra Modi, and he has announced to put all the efforts towards the DNA Bill of India. Again, draft of this Bill also needs to be concreted by includ-ing insights from industry experts, academicians, research organiza-tions, laboratories and judiciaries,” justifies Dr Amit.

Currently, most of the best genome-based medicines are expensive and out-of-reach for the average Indian. The other worrying aspect is that none of these medicines are available in India. Imagine the plight of a patient who realizes that there are medicines that may work for him but is unable to access it,

Dr Kalyanasundaram Subramanian CSO, Strand Life Sciences

Coverstory


Dr Binay strongly supports in having strong ethical guidelines to practice Precision Medicine.

Degree of impact Just imagine a patient taking a sim-ple blood or saliva test at a labora-tory, and in the next meeting his or her physician is very well prepared with the patient’s genetic horoscope including the information on chemi-cal compounds, or combination of drugs useful or harmful to him, based on the tried-and-tested genetic test report.

“We will be able to minimize side ef-fects with very beautiful and faster accurate therapies that too at af-fordable costs if Precision Medicine boosts up in India….. If used respon-sibly, it can do wonders and contrib-ute towards every individual’s good health,” notes Dr Amit.

Precision Medicine can also trans-form the national economy, espe-cially in a population whose average lifespan is increasing.

Sam explains, “From an individual’s perspective, it has the potential to make genetic diagnosis of diseases more efficient and cost-effective, by reducing genetic testing to a single analysis, which informs individuals throughout their life. Since it uses state-of-the-art genomic technolo-gies, rich medical record data, tissue and blood banks, and clinical knowl-edge that will allow clinicians and payers to tailor treatments to individ-uals, it can greatly reduce costs of in-effective therapies incurred through the current trial-and-error clinical paradigm.”

The impact can be great, where pa-tients get the right medications, have better outcomes and lower side ef-fects, feels Dr Kalyanasundaram. “This would lead to healthier popula-

tions with better overall health eco-nomics. To make this possible, lots of information needs to be collected, analyzed and translated. Medicines that can exploit the genetic differ-ences need to be present. So the task is formidable but the payoffs are po-tentially enormous.”

Precision Medicine will also allow reduced morbidity, specifically in on-cology cases, help in preventing high burden of genetic diseases, and man-aging high-risk cases with increased surveillance.

It will also have a major impact on the economy by reducing productiv-ity losses, and decreasing costs of treating disease, thereby reducing overall costs on Indian healthcare.

“The internet will further accelerate adoption of precision medicine by empowering patients and doctors who are already demanding more to fight India’s unique challenges with diabetes, heart disease and tobacco use,” said Dr Sooraj.

In 2012, Futures Group predicted a new perspective to healthcare by 2050, where gaps between medical practice, healthcare, and personal health will be bridged.

Another prediction is the predomi-nance of preventive healthcare, where individuals take charge of their health by harnessing the power of technology. Genomic tests – single nucleotide polymorphism and whole

genome sequencing – will be the key catalysts to this change.

“We have seen the beginning of this change. Wellness was once a fancy word. Today, it is part of every hos-pital’s business strategy to engage a new generation of customers, who are actively pursuing wellness us-ing social apps for various reasons – right from fitness and diet to finding the best doctor,” opines Ms Anu.

In India, diseases have a profound physical, psychological and social impact. Most of healthcare costs are paid not out of insurance, but out of pockets.

The impact of illness in one person in the family has a domino effect on the family and the community. “The cost of treatment, for diseases like cancer, cardiac diseases, diabetes, asthma, and the impact of the side effects of medication taken has often seen fam-ilies, even amongst middle class and higher middle class, needing to take loans, or family members having to leave jobs,” Samarth states. “Just the simple factor of reducing treatment time and side effects will have a sig-nificant impact on the socio-econom-ic situation of an individual.”

So, diseases that were previously a death sentence will be manageable, or even curable, because we will be able to individualize therapy for each patient. BS

People used to think that the role of genetics ended with hereditary disease. Today we know that every response our body makes has a genetic fingerprint to it, and thus avoid trial-and-error medicine which is both costly, time consuming, and puts an unnecessary drug and hospitaliza-tion burden on the patient,

Dr Sooraj Ratnakumar Founder & Scientist, Swagene

rAj GunAshekAr & AyeshA siddiqui

Coverstory


Why India is not on the bio-similars’ radar?Over the last 15 years, Indian phar-maceutical industry from having less than 5 percent market share in the US generic market, now has more than 25 percent. But we are yet to see the same advancements in biosimilars.

The major bottleneck for developing biosimilar molecules in India lies in the regulatory challenges, says Dr Sunit Maity, AVP, product develop-ment, Theramyt Novobiologics.

He added, “Currently BioPharma com-panies which are developing biosimi-lars, must receive approval from multi-ple government agencies, significantly increasing the overall time it will take to bring the product to market.A sin-gle-window agency and streamlined approval process will reduce the com-plexity and encourage the players to develop the biosimilar molecule.”

Cost and complexity of developing biosimilars poses another challenge. “Biosimilars are large and complex molecules compared to generic phar-maceuticals.Therefore, development

can india dominate the biosimilar market?

After dominating generic drug industry for decades, can India become a leader in developing this new class of drugs too? Read on to find out.

and manufacturing of biosimilars is capital intensive and the overall commercialization timelines are 5-7 years, even for launch in domestic market,said Mr KVSubramaniam, president, Reliance Life Sciences.

He further added,“Very few generic pharmaceutical companies have ca-pabilities and competencies in R&D and manufacturing of biosimilars.”

Dr Murtaza Khorakiwala, managing director, Wockhardt, provides an-other view, “The Biosimilar industry even in the regulated markets is still in a nascent infancy stage and ac-counts for less than 5% of total bio-technology market. However, there are at least 8-10 corporates from In-dia that have significant progress in developing and launching biosimi-lars in India and emerging markets.”

Challenges in development of BiosimilarsBiosimilars manufacturing is capital intensive. The development of bio-similars requires extensive preclini-cal and clinical trials.Thus, theinvest-ments required for development and commercialization of these products is quite high.

“The investments in biogenerics are very high when compared to conven-tional generics. The development is itself lengthy and expensive; a suc-cessful biosimilar manufacturer has to have good science and manufac-turing technology, and the capability to deal with complex regulations,” said Rajiv Malik, president, Mylan.

The development of biosimilars is also much more challenging due to the greater complexity of biological drugs and the complex manufactur-ing process.

“The major challenges would be sig-nificantly higher barriers to entry in

indian biotech industry is very well developed otherwise we could not become world leader in vaccine industry.SUnIT MAITy AVP, product development, Theramyt novobiologics

Biosimilars


can india dominate the biosimilar market?

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terms of – capital investments in sci-entific/clinical development and man-ufacturing capacities,evolving regula-tory process and still to mature market development strategies and also avail-ability and accessibility of people capa-bility and depth,” said Dr Khorakiwala.

Another big challenge is on the com-petency front says Subramaniam. He added, “Very few companies today possess the competencies and capa-bilities required for development and manufacturing of biosimilars.”

Dr Maity pointed out that an in-depth understanding of the product and manufacturing process, as well as highly specialized analytical tool are required for development of bio-similar molecule.

Cost and complexity deterrentThe development of biosimilars is much more challenging due togreater complexity of biological drugs and the high cost of development.Could these be a deterrent for Indian companies?

“This is partially true. Small generic pharma companies may not have where withal to develop biosimilars given the capital outlay for commer-cialization of these molecules. For large companies, it largely depends on their overall strategy and capital allocation for these new class of mol-ecules,” said Subramaniam.

Cost of conducting clinical trial for biosimilar is a huge burden on the developers. “It has also been deliber-ated that maybe it is better to develop biobetters or novel biologics than bi-osimilar. It is possible then to launch a product with improved efficacy and immunogenicity profile which can get branded product pricing and it can potentially replace the previous product and will get a major market share,” said Dr Maity.

Lack of biotech boom a barrier?Part of the problemthat India has not made significant mark in biosimi-lar is said to be that, biotechnology is not as well developed in India as chemistry. “It is partially true that ca-pabilities in applied research in biol-ogy limited India’s growth with regard to biological drug development,” said Subramaniam. He continues, “The other key issue was that the generic pharmaceutical industry was ‘behind

the curve’ on this front, as it was al-ways focused on generic pharmaceu-ticals development, which did not require large capital and had shorter commercialization timelines.”

However, Dr Maity absolutely dis-agrees with this view. He said, “In-dian biotech industry is very well developed otherwise we could not become world leader in vaccine in-dustry.” Does India have the exper-tise to dominate biosmilars industry? “India does have the expertise in bio-generics and recognises the poten-tials with biosimilars, as was done in the generics industry, and make bio-generic manufacturing an important part of the Make in India movement,” Rajiv Malik, president, Mylan.

Biotech requires specialization and is not as job intensive as compared to pharmaceuticals. “State-of-the-art production facility dedicated to manu-facturing of only biotech products are now available with many Indian com-panies focusing on biosimilars. Indian biotech industry is thriving resulting in launch of more than 50 biosimilars till the date,” said Dr Khorakiwala.

One of the major advantages we have is the significant success and expe-rience in pharmaceutical manufac-turing that has been achieved over the last 2 decades.That has brought in rich experience in topics such as GMP manufacturing, documentation practices, scale up, technology trans-fer and validation.

“Indian biopharma industry today has all of the essential pre-requisites that are essential for it to emerge as a global manufacturer of economical, safe and efficacious biotech thera-peutic products,” said Dr Maity.

Can India dominate global biosimilars market?“Yes absolutely, if we can become

india does have the expertise in biogenerics and recognises the potentials with biosimilars, as was done in the generics industry, and make bio-generic manufacturing an important part of the Make in india movement

india has immense potential to become one of the key players in the development and manufacture of biosimilar drugs

RAjIV MALIK president, Mylan

DR MURTAzA KhoRAKIwALA managing director, wockhardt

Biosimilars


world leader in generics and vac-cines then why not in biosimilar. We need to make a concentrated effort in every level to achieve this,” said Dr Maity.

“India has immense potential to be-come one of the key players in the development and manufacture of biosimilar drugs,” says Dr Khoraki-wala. “There have been many Indian companies who are developing this portfolio & have sold biosimilars in emerging markets. Identifying port-folio with well-laid strategy to devel-op, manufacture and commercializa-tion of the products in key markets is very essential. The key is investing in research & development,” he added.

However, Indian companies would have to overcome the challenges mentioned to manufacture high-

quality, cost-competitive products. “The companies also would need to invest significantly in talent develop-ment specifically in the area of mo-lecular biology,process development and manufacturing of biosimilars,” said Subramaniam.

“Biosimilars are going to be the next big growth driver in India, play-ing a major role in offering quality and affordable solutions for disease management,” said Malik. New ‘Bio-similar Guidelines’ of India provides similarity in approach with those in the USand Europe, certainly a step in the right direction. In addition, DBT has launched schemes to promote the development of biosimilars. Given this scenario, India is set to make its mark in the biosimilars market. BS

AyeshA siddiqui

Biocon’s insulin glargine receives regulatory approval in Japan and is also gearing up for the us launch.

intas Pharmaceuticals launched iNtaCePt, the first etanercept biosimilar. It is also expecting us approval of their Neulasta biosimilar soon.

Wockhardt is said to be the first in India to launch recombinant human insulin “Wosulin, recombinant insulin glargine‘glaritus’ and recombinant human erythropoietin ‘Wepox’.

hetero launched biosimilar ‘Rituximab’ under the brand name ‘MaBall’.

Dr Reddy’s launched the first biosimilar filgrastim (G-CSF) in India, first biosimilar MAb (Rituximab) and biosmilar darbepoetinalfa-Cresp.

Reliance life sciences markets, ReliFeron (Recombinant Interferon α), ReliPoietin (Recombinant Erythropoietin), ReliGrast (Recombinant Granulocyte colony stimulating factor) and MIRel (Recombinant Reteplase - tissue plasminogen activator), among others biosimilars in india and overseas market.

sOMe iNDiaN COMPaNies iN BiOsiMilaR sPaCe

Biosimilars


Believe it or not India is the third fattest nation in the world with over 30 million or 3.8 percent of the adult population here grappling with obe-sity. Globally a third of the world’s population

are overweight or obese with the United States leading the charge.

Today it is a well recognized fact that obesity is not a mere cosmetic problem, but is the mother of all important dis-eases, including type 2 diabetes, high blood pressure, ischemic heart disease, sleep apnea, and even some can-cers. “There are over two dozen medical conditions that are associated with obesity,” says Dr Arun Prasad, Ro-botic Surgeon, Institute of Robotic Surgery at the Delhi-based Indraprastha Apollo Hospitals.

While the ideal situation is to lose weight through physi-cal fitness measures, often the morbidly obese are trapped in a vicious cycle – their legs cannot support their weight inhibiting them from prolonged exercise, which leads to increased weight gain.

Take Chandrika Jayna, (name changed) who had severe joint pain in her knees and unable to walk had been gain-ing increasing weight. This led to a host of complications.

For people like Jayna bariatric surgery is a life-enhancing procedure. There was a time when there was a lot of stig-ma associated with opting for bariatric surgery, but today as well known names go openly under the scalpel to trim their flab, the benefits are becoming acknowledged.

Meet the Robotic Surgeons who conducted nearly 4,000 procedures in 30 hospitals spread across the country during 2015 to help cut flab. Earlier doctors were using laparoscopic techniques to perform gastric bypass surgery. Today, robotic surgery is the more preferred method.

The

fightersFA

Biospecial


Doctors admit that bariatric procedures should be the last option and only undergone after all other weight loss measures tried, but they also point out that for the su-per obese it is now an imperative. The good news is that with the advent of surgical robots, bariatric procedures are now becoming safer and cutting down healing time.

How it worksDepending on the case, there are different surgical proce-dures that bariatric surgeons use. But the most common one is gastric bypass surgery. Describing it in layman’s terms, Dr Prasad, who has done over 1,000 bariatric sur-geries in the last 12 years, says this surgery makes the stomach smaller and allows food to bypass part of the small intestine. The stomach is made smaller by creating a small pouch at the top using surgical staples or a plastic band. The smaller stomach is connected directly to the middle portion of the small intestine, bypassing the rest of the stomach and the upper portion of the small intes-tine. As a result, the patient will feel full more quickly, thereby cutting down on food intake and thus the calories consumed. Bypassing part of the intestine also results in fewer calories being absorbed. This leads to weight loss.

Earlier doctors were using laparoscopic techniques to perform gastric bypass surgery. Today, robotic surgery is the more preferred method. Robots operate in 360 de-gree mode and can reach deeper getting to difficult-to-ac-cess parts such as the stomach blood vessels easily. Also, with the flexible robotic equipment suturing is far more accurate than with old straight shaped equipment. There is less blood loss and faster recovery besides leaving prac-tically no scars.

“We call ourselves fat fighters,” says Dr Parveen Bhatia, chairman, Institute of Minimal Access Metabolic and Bariatric Surgery, Institute of Robotic Surgery (IRS), Sir Ganga Ram Hospital.

Bhatia rues at the growing obesity in India. “One quarter of what you eat keeps you alive, the other three quarters

of what you eat keeps doctors alive,” he says. He distin-guishes the super obese as those with BMI more than 50. And ‘super super obesity’ is defined as those with BMI of more than 60 kg/m2.

According to Dr Arun Prasad, “In cases where the patient is super obese, weighing over 200 kgs, the robot is useful in lifting the stomach. However much we may gym, a half hour long procedure involving lifting of stomach becomes tiring for the doctor.”

Compared to laparoscopic procedures where it takes 3-4 days of hospital stay and over a month long rest period, those undergoing robotic surgeries can go back home in 2 to 3 days and return to normal activities within three weeks or so.

Risks and outcomesNo surgery comes without risks, though these are mini-mized in the case of robotic procedures. Bariatric surgery does carry some risks as most of the patients undergoing these have co-morbid conditions like diabetes, hyperten-sion and sleep apnea adding to the complexity. Post op-eration, one possible risk is of nutritional deficiency. Iron and Vitamin B12 deficiency can occur leading to anaemia. However, these can be handled during periodic follow-up consultations.

But increasingly benefits are outweighing the risks. Rare-ly is weight regained. Most people continue to lose weight for a good 12 months after the procedure before settling down to an optimum weight. Ravi Narayan has lost 35 kgs in six months after surgery.

India today has just 190 trained robotic surgeons who conducted nearly 4,000 surgeries in 30 hospitals spread across during 2015. Bulk of these procedures related to urology, gynaecology, thoracic, and head and neck and general surgery areas. BS

(names of patients have been changed to protect their privacy).

In cases where the patient is super obese, weighing over 200 kgs, the robot is useful in lifting the stomach. However much we may gym, a half hour long procedure involving lifting of stomach becomes tiring for the doctor

Biospectrum BureAu

Biospecial


BioTalk

India is a key opportunity market’

A NarayanaswamyManaging Director, Essentra Packaging

Head quartered in the UK, Essen-tra Packaging is a global provider of healthcare packaging solutions, which recently spread its footprint in India, with the acquisition of Kams-ri Printing and Packaging in 2015 in

Bangalore.

The company’s MD for India, A Narayanaswamy, exclu-sively spoke to BioSpectrum about why India serves as its key business market, its future acquisition plans and expansion, competition strategies, and future growth.

QTell us about Essentra’s business in India. What were your market entry challenges?

a Our first investment in India was through a JV with ITC for manufacturing cigarette filters. Es-sentra first started serving the packaging market

in India 16 years ago with its tear tape portfolio. Over time, the company has grown from a position of just trading to outright manufacturing. In 2013, Essentra opened its 70,000 sq. ft. state-of-the-art site in Bangalore.

In healthcare packaging, the assets acquired from Kam-sri Printing & Packaging have already been transferred to Essentra’s site, in addition to which the company has invested in a second carton manufacturing line.

QWhat are the major growth drivers for the healthcare packaging industry in India?

a Investment in India is a key focus area for Essen-tra, as there are opportunities for growth in terms of pharma market expansion driven by strong un-

derlying market drivers including economic develop-ment and urbanization; increasing GDP and income levels; increased accessibility for non-traditional busi-ness models by reachingtier II or rural areas; health insurance market penetration and increase in govern-ment spending; and consumer healthcare growth.


QWhich are the biggest markets for Essentra? Which markets contribute majorly to your business, and how much

of it from the Indian market?

a India is a key opportunity market for Essentra, as the end markets for the company’s specialty com-ponents – such as healthcare and industrial prod-

ucts – are sizeable and well-established, exhibiting growth of up to 20%. Regarding healthcare packaging specifically, we view India as an important dynamic mar-ket, both for the production, consumption and export of pharmaceuticals based on the investment and economic development occurring in the region.

Q How do you intend to expand further in India?

a Going forward, we will continue to look to invest based on our understanding of the requirements of the market in India to bring our product range in line

– to the extent appropriate - with our total global offering.

More generally, however, India is a key opportunity mar-ket for Essentra.The endmarkets for the company’s spe-cialty components – such as industrial products – are sizeable and well-established, exhibiting annual growth of up to 20%.Accordingly, we will continue to invest – as appropriate – to support these future revenue growth op-portunities, in pursuit of our overall group objectives.

Q Who are your competitors in the global and developing markets?

a In the specialist secondary healthcare packaging space, our multi-region or global competitors would include companies such as Multi Packaging Solu-

tions International (MPS), WestRock, and Edelmann. In India, the main competitors would be local packaging companies like Global Packaging,Noble Packaging, Tem-ple Packaging and Ansapack.

Q Tell us about your innovative products.

aEssentra has just launched a line of cartons and la-

bels designed to support the emerging regulatory require-ments for serialization and tamper verification. We are also working on more innovative designs to support pa-tient compliance. Essentra will bring a global perspective to the local market in India by sharing best practices and learnings from our business in North America and Eu-rope.

In particular, we will be bringing unique carton designs forward that support compliance and tamper verification

requirements. We will also be sharing information on trends relating to packaging and literature.

Q Financially, how did Essentra perform in the last fiscal?

a Globally, Essentra’s packaging business unit had a turnover of £394.4 millionin 2015. Of this, approxi-mately 75% of the business is related to the health

and personal care industries.

Q Any acquisitions planned?

a While M&A is an important part of our global growth strategy, we do not comment on deals until

formally announced to the financial markets.

Q Starting from 2016, where does your biggest opportunities exist?

a Prior to the acquisition, Essentra was not in a posi-tion to service the secondary pharma packaging market with local carton manufacturing, so the ac-

quisition expands Essentra’s offering to pharma compa-nies in India.

This will enable us to better service the needs of customer locations in India – improving delivery times and our ability to respond to market requirements.

Q Future plans in India and APAC?

aWe expect continued growth in the secondary

healthcare packaging industry. On a global basis, growth is expected to be approximately 3% between 2014 and 2018.Within India, the overall pharma market is expect to grow with a CAGR from 2015 to 2020 between 10% and 17%. Healthcare packaging will continue to be strong-ly influenced by regulatory factors, patient compliance, and authentication or anti-counterfeiting efforts.

From a regulatory standpoint, governments are seeking to implement a mix of changes to packaging from includ-ing serialization codes on packaging to tamper verifica-tion features. These regulations will take effect over the next several years and vary by country.

Patient compliance will also continue to be a focus area for manufacturers as if patients do not take the drugs, then their efficacy is challenged which can then lead to a lack of support for certain drugs within the public health system. In addition, an aging population will need special consideration when it comes to the design of pharmaceu-tical packaging. BS

rAj GunAshekAr

Biotalk


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‘Notification will shut the door for future licensing’

The recent notification of the Ministry of Agriculture for compulsory licensing of agriculture technolo-

gies is a major blow for the respon-sible deployment of innovation in the agriculture and food sector. This will deny the seed industry in the country access to critical upstream as well as downstream

technologies.

The Indian seed industry is currently major recipient of international technologies far beyond the access to older generation of genes providing insect resistance in cotton crop. Number of domestic seed industry players, young and established, have accessed invaluable genes from international inventors from the publicand private research ventures for deployment in their own product development programs.

The current notification will shut the door for all such future licensing. Home grown innovation by way of pat-ent filed by Indian research organization too will be in-accessible as the public sector will have no control on the responsible deployment of these technologies in the individual seed company deployment plan. Indian seed industry will be isolated, denied of core technologies and put to retrograde situation due to the draconian nature of this notification.

Countries have exercised prudently the compulsory li-censing and price control regulations for making essential technologies accessible for common public good. How-ever, countries have not adopted compulsory licensing to enrich the coffers of the few private sector by provid-ing uniform access to all technologies to all the players.That will nullify the very meaning of intellectual property and their responsible deployment in any country bring-ing such notification. The incentive will be to those seed industries who do not invest in innovation and revoke the

compulsory licensing provisions to secure the competitor technologies.

While exercising the compulsory licensing criteria, coun-tries do notify that the recipient must demonstrate that they have the technical and the economic capacity to uti-lize the technology and that they will be responsible for the prudent and binding stipulations for the application of technology. The government order indicates that the licensing will be compulsory irrespective of the licensee’s ability or competency to absorb the technology.

In my assessment, a large number of seed industry play-ers in India are not adequately prepared to adopt the biotechnology solutions and have no capability to as-sume stewardship responsibilities. Providing them tech-nology, without their adequate capacity enhancement will be harmful to the responsible deployment of these technologies.

Compulsory licensing provisions have been exercised prudently where the platform technologies widely needed for application by cross section of industry is required to be accessed by wide section of downstream product in-novators, where such platform technologies remain with monopoly entities.

Currently the genes of interest deployed in Indian cotton and other crops are widely accessible not only from for-eign sources but from domestic sources. When the com-pulsory licensing is applied to downstream products, that scuttles innovation completely and enriches the laggards in innovation with access to most contemporary innova-tion through the enforcement of the provision of compul-sory licensing.

While the stewardship responsibility is equally applica-ble to the licensor,the compulsory licensing makes this responsibility defunct,as the licensor has no control on determining the competency of the licensee to absorb technology.

Biospecial


Indian seed industry has received numerous licensing from International academic bodies on a nominal royalty or pro bono and this notification will completely shut the door for any such future technology transfer. No academic institu-tion will provide access to their genes and genetic engineer-ing technologies or discovery tools to myriads of players who are not bound by the need to demonstrate their com-petency for responsible deployment of technologies.

This move is going to isolate the seed industry and per-haps the whole of the agriculture sector far away from accessing contemporary technologies and cross-licensing within the homegrown players and licensing from inter-national players to domestic players will cease to occur any more. I wish the Ministry of Agriculture will review the provisions and bring in more rational approach to encouraging innovation in the country for the benefit of Indian agriculture. BS

indian seed industry has received numerous licensing from international academic bodies on a nominal royalty or pro bono and this notification will com-pletely shut the door for any such future technology transfer.

K VijayaraghavanFounder and CEo, Sathguru

Biospecial


early stages of cell expansion all the way through to the downstream chromatography steps. This includes technologies such as mixers, bioreactors, filtration and chromatography systems which are integrated through a single automation platform (such as WonderWare or DeltaV).

Using standardized equipment and an optimized layout also provides the bio manufacturer with a facility that can be replicated at multiple sites, for easy tech-transfer and scale-up.

KUBio’s key benefit is rapid construction, and corre-sponding reduction in risk. In comparison to the 2-3 years of design and construction which is typical for con-ventional stick-built bio manufacturing facilities, KUBio is ready-to-run in 14 to 18 months, translating to a faster time to market. This timeline includes every phase of the build including design, construction and full fit-out with bioprocessing equipment.

Every stage of the project is supported by GE technical expertise, including facility design, procuring and pro-duction of process equipment, installation, qualification, staff training, technical support and project manage-ment. Financial guidance is also part of the offering.

‘There is a huge unmet need for affordable biologics in China’

Jan MäkeläGM, BioProcess business, GE Healthcare’s Life Sciences business

Interview

On May 10, 2016, JHL Biotech (JHL), opened the world’s first KUBio biopharmaceutical manufacturing facility in Wuhan, China.

GE Healthcare’s KUBio is a fully functional off-the-shelf bioprocessing facility specifically designed to meet cGMP requirements while optimizing manufac-turing flexibility and productivity. The facility is pre-fab-ricated and delivered with a complete ready-to-use pro-duction line, based on GE Healthcare’s Ready-to-Process single-use technologies.

In an email interaction with BioSpectrum, Jan Mäkelä, General Manager for the BioProcess business at GE Healthcare’s Life Sciences business, talks about this in-novative facility.

Please throw some light on KUBio manufacturing solution. What is KUBio's core technology and what are its benefits?

A GE Healthcare's KUBio is a prefabricated modular facility based on single-use technologies for mono-

clonal antibody production.

The facility is installed with the Flex Factory platform, which comprises of bioprocessing equipment from the

Biotalk


What are some of the most pervasive operating challenges afflicting biopharma manufacturing today?

A There is an increasing demand for biopharmaceuti-cals worldwide. Seven of the top 10 selling medi-

cines by revenue are in a new class of drug called biolog-ics, sales of which, over the past six years, have grown at 10% per annum to $170 billion, primarily because of the expansion of new treatments for cancer and demand for insulin. Biopharmaceutical manufacturers are looking for ways to expand their capacity and enter markets that have previously been difficult to access due to location. KUBio was launched to address these needs. The speed and flexibility of single-use components is now well-rec-ognized across the industry – and GE Healthcare’s know-how in the sector and global footprint makes us ideally-placed to harness this potential and package it for rapid deployment wherever a customer requires.

Share with us list of your clients that have utilized KUBio's? How has been the reception/feedback by these companies?

A This is the world’s first KUBio, so JHL Biotech are the only owners of one these facilities at present.

GE is now building another KUBio (purchaser has not yet been publicly announced) and is discussing project op-portunities in countries such as Brazil, Mexico, South Ko-rea and Saudi Arabia, among other places.

What are the major markets for KUBio’s in Asia and what is the demand in these countries?

A Currently in China, there is a huge unmet need for affordable biologics. China accounts for 20 percent

of worldwide cancer incidence, the second-highest rate in the world. In 2015, around 4.3 million new cancer cases were reported in the country.

Biologics hold significant promise in their ability to treat cancer, and are especially strong for targeted therapy in specific areas. Today, biologics account only for 4 percent of the medicines prescribed in China (vs. 22 percent in the US).

In a drive to encourage biological medicine and medical device innovation in the region, a number of action plans have been issued by the region, pledging significant fund-ing on the development of new therapeutics and placing a focus on biosimilars.

For example China's State Council’s 10-year action plan ‘Made in China 2025’ recognizes biological medicines and medical devices as one of its key industrial focus ar-eas. The market is growing rapidly in China and, reaching

approximately $350 million in 2019, up from $44 million in 2009.

KUBio offers global biopharmaceutical manufacturers the ability to reproduce world class quality, standardized facilities, anywhere in the world. There is interest coming from both the developed and developing countries.

What are the current trends in biopharmaceutical manufacturing industry and how is GE Healthcare positioned to address the changes?

A The industry movement towards developing and producing more targeted (personalized) treatments

for specific patient groups, has led to a need for more flex-ible facilities to allow manufacturers to quickly switch from manufacturing one product to another one. Flex-Factory uses predominantly disposable, single-use tech-nologies, eliminating cleaning validation steps reducing the risk of cross-contamination, and providing significant time and cost savings.

How is Asia positioned as a hub for biologics manufacturing?

A Due to a large and aging population, coupled with the rising cancer rates and low penetration of bio-

logic medicines, there is a huge demand for biologics in China. A highly skilled workforce as well as the introduc-tion of a number of government funding initiatives to drive biopharmaceutical development provide significant opportunity in the region.

Are Asian markets going to influence biopharmaceutical development around the world?

A The Chinese government has invested heavily in specific initiatives to drive the development of new

therapeutics. MNDIP (Major New Drug Innovation Pro-gram) was the first initiative to change China from a man-ufacturing center for drugs to a center of innovation for new drugs. Started in 2009, this initiative has attracted $4.5 billion from 2009-2012.

JHL Biotech, owner of the first KUBio, announced earlier this year that it has received authorization from the Unit-ed Kingdom's Medicines and Healthcare Products Regu-latory Agency (MHRA) to begin clinical trial for JHL1101, arituximab biosimilar to treat rheumatoid arthritis. JHL is the first company from the Greater China region to re-ceive European approval for clinical trial of a monoclonal antibody biosimilar. Whether this is the beginning of a larger trend is too early to say. BS

AyeshA siddiqui

Biotalk


narayanan sureshnew coo of ABLe

Narayanan Suresh has joined as the Chief Operating Of-ficer (COO) of the Associa-tion of Biotechnology-Led Enterprises (ABLE).For more than 13 years, as an Editor of BioSpectrum, he had worked closely with the biotech sector when the magazine under his leadership played a catalytic

role in the growth of the industry in both India and in Asia-Pacific.

ABLE recognized the efforts of BioSpectrum by present-ing it with an ABLE President’s Award for Excellence during the organization’s 10th Anniversary Celebrations in March 2013.

A veteran science journalist, Suresh has been instru-mental in establishing BioSpectrum as India’s leading biotech magazine. Under his leadership, the magazine has emerged as successful media platform to engage the biotech industry and has enjoyed the position of being India’s number one biotech magazine for more than a decade.

He has also played key role in launching BioSpectrum Asia edition, Top 20 industry survey, CRO survey, con-nect with student academia network and many more. Through the years, he has come to be regarded as one of the most important person in biotech sector, analyzing trends, and gauging the pulse of the industry.

As a COO of ABLE his responsibilities include ensuring an orderly growth of the industry, increase the engage-ment levels within and outside the industry, set up a ro-bust information sharing network, interface with policy makers, regulators and the wide range of stakeholders and make the organization the hub of activities for the hundreds of Startups in the biotech sector.

raj ketkar named ceOof Arcadia Biosciences

Arcadia Biosciences, an agricultural technology company that creates value for farmers while benefitting the envi-ronment and enhancing human health, announced that Raj Ketkar will join the company as president and chief execu-

tive officer. Ketkar will replace Roger Salameh, who has served as interim president and CEO since Feb-ruary. Salameh will take on a new role as chief oper-ating officer for the company, reporting to the CEO.

Ketkar brings nearly 35 years of agriculture and agri-cultural biotechnology business experience in the US and internationally. He spent more than 30 years in a variety of business, operations, and strategy roles for Monsanto Company, during which time he dem-onstrated successes in agricultural trait commercial-ization and growth around the globe. As managing director of the Mahyco-Monsanto joint venture in In-dia, Ketkar led the launch of Bt cotton, the country’s first agricultural biotechnology product. In addition to his operations and trait commercialization experi-ence, Ketkar was also director of biotechnology strat-egy for Monsanto, where he led the development of the company’s trait stacking technology.

Ms Darby Shupp, Chair of Arcadia’s board of direc-tors, remarked, “Raj has a well-established track re-cord of building strategic partnerships and launching innovative agricultural technologies in multiple geog-raphies. He is a proven leader with the unique set of skills and experience Arcadia needs to grow the busi-ness and commercialize the company’s rich and robust trait pipeline. The Board would like to thank Roger for guiding the company through this important transi-tion. We are fortunate that we will have the benefit of his continued contributions as chief operating officer of Arcadia. He, Raj, and the rest of the executive man-agement team provide a solid foundation to help de-liver on our shared vision for the company” he added.

A PPOINTMENTS

BioPeople


Prof. Satyajit Mayor, Director, National Centre for Biological Sciences (NCBS) and Institute for Stem Cell Biology and Regenerative Medicine (inStem), has been elected a Foreign Associate of the US National Academy of Sciences (NAS).

An election to NAS is recognition of a scientist’s distin-guished and continuing achievements in research. With this announcement, Prof. Mayor joins the list of other illustrious NAS fellows from NCBS, former director of NCBS, late Prof. Obaid Siddiqi, former director and cur-rent DBT Secretary Prof. K. VijayRaghavan.

“Satyajit Mayor’s election to the US National Academy of Sciences is recognition of the extraordinary science that has come from his lab over the past couple of de-cades. His superb science has defined new directions in cell-biology and has been combined with leading an awe-some team of imaging-scientists and technologists to make the National Centre for Biological Sciences one of

dr satyajit mayor elected foreign associate of nas

the best places for microscopy research and training in the world. His passionate leadership as Director of NCBS and inStem has created a vibrant Bangalore BioCluster that everyone was once sceptical about and now people all over India and the world want to emulate. The US Na-tional Science Academy is very lucky to have him in the club. I am sure we will hear a lot more about Jitu’s sci-ence and scientific-leadership in the coming years. India should also be proud of the election of Manindra Agarwal of IIT/Kanpur, one of our best mathematician-computer scientists.” says Prof K. VijayRaghavan.

Prof Mayor’s research uses multi-disciplinary approach combining cell biology with physics and chemistry to understand the molecular mechanisms of endocytosis in metazoan cells and to study this phenomenon at many scales. Prof. Mayor is also the recipient of national and international awards such as the Wellcome Trust Inter-national Senior Research Fellowship, Swarnajayanti Fel-lowship, Shanti Swarup Bhatnagar Award and the JC Bose Fellowship and Infosys Prize for Life Sciences.

Biopeople


Medtronic launches Spine EssentialsMedtronic has announced the US launch of Spine Essen-tials, a new platform of spinal implants and instruments designed to make the most common cervical spine fu-sion procedures more efficient and help hospital systems manage costs, while maintaining quality.

The goal of Spine Essentials is to help surgeons and their staffs streamline the most common spinal fusions, by providing the exact tools in the right quantities needed to perform 1- and 2-level cervical spinal fusions, while re-ducing the costs and time required for instrument steril-ization, case set up and inventory management.

Spine Essentials was developed in collaboration with leading surgeons and administrators and launched at the Ambulatory Surgical Center Association (ASCA) annual meeting in Dallas.

“As a surgeon who routinely performs these types of sur-geries, it’s helpful to optimize the implants and tools, so we’re being as efficient as possible to provide the best care possible to our patients,” said Dr Richard NW Wohns, or-thopedic surgeon at neoSpine in Puyallup, WA and one of the physicians who collaborated with Medtronic to de-velop the platform.

To develop Spine Essentials, Medtronic partnered with healthcare systems across the US to evaluate unmet needs and identify efficiencies.

Spine Essentials implant sets include the most commonly used implant sizes for 1- and 2-level fusions of the neck (anterior cervical discectomy and fusions) and are sterile packaged with smaller instrument sets; thereby reducing the amount of inventory a hospital needs to sterilize, set up and store.

This platform will reduce sterilization costs associated with the procedure, including:

BioSuppliersMedtronic, Qualcomm collaborate for diabetesMedtronic and Qualcomm through its wholly-owned subsidiary, Qualcomm Life, announced a global, multi-year collaboration to jointly develop future generation continuous glucose monitoring (CGM) systems that aim to improve health outcomes for people with diabe-tes.By giving insights to doctors and people with type 2 diabetes concerning glucose levels,the companies in-tend to enable more informed care, especially for those who do not have control of their diabetes today.

The collaboration seeks to leverage Medtronic’s mar-ket-leadership in diabetes management and Qual-comm Life’s expertise in developing reference designs for wireless,single-use and small integrated mod-ules to create more affordable, easier-to-use CGM systems,including a new sensor and smaller design that can provide near real-time and retrospective glu-cose data.

The initial focus of the collaboration will be to develop a single-use CGM system designed for broader prac-tice by general practitioners who manage care for the vast majority of the 400 million people worldwide with type 2 diabetes.

Leveraging Qualcomm Life’s deep wireless expertise and technologies, 2net(TM) design is a platform for designing the communications components of con-nected medical devices, including disposable drug delivery devices and disposable diagnostic devices for condition specific connected therapies.

“We believe that glucose should be a vital sign of dia-betes health. Professional CGM is an increasingly used diagnostic tool that empowers physicians and patients with meaningful glucose data to tackle glucose control. Our solutions go beyond delivering data and provide automated observations and clinical decision support to help create a personalized care plan,” said Ms Laura Stoltenberg, vice president and general manager, Non-Intensive Diabetes Therapies at Medtronic.”


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Quadio launches hearing app for Android and iOS in IndiaQuadio Devices has intro-duced for the first time their path breaking Q+ hearing app in Mumbai on Android and iOS platforms. The app prom-ises to be a holistic mobile-based hearing solution com-plete with all the features of a conventional hearing tool.

The Q+ app is a first of its kind free application that is ultra-advanced besides be-ing affordable, accessible, controllable and customizable. Quadio uses the latest internet and mobile technology to push the boundaries of telemedicine and hearing care and merge the worlds of healthcare and technology.

The Q+ app harnesses the processing power of your smart phone to enable it to be used as a complete and fully-functional hearing mechanism. It is designed to maximize the listening experience based on the results of a simple interactive hearing test. The app also gives you the ability to control and customize sound quality by in-telligently enhancing hearing sounds and speech.

With the Q+ app you can easily follow conversations us-ing the phone headset in both quiet and noisy environ-

It is unique and bold and best describes the healthcare organization and its people - the people accompanying, serving and inspiring customers - the people behind out-standing products and solutions.

“We have an exceptional track record of engineering and scientific excellence and are consistently at the forefront of developing innovative clinical solutions that enable providers to offer efficient, high quality patient care. Go-ing forward as Siemens Healthineers, we will leverage this expertise to provide a wider range of customized clin-ical solutions that support our customers business holis-tically. We are confident in our capability to become their inspiring partner on our customers’ journey to success”, explainedBernd Montag, CEO of the company. “Our new

ments, and control the sound quality to customize it to your preference. The inbuilt hearing test in Q+ is calibrated for accuracy as per ANSI standards for audiometry.

Sharing his excitement at the app launch, Neeraj Dotel, CEO, Quadio Devices, said, “Hearing loss is the second largest disability in the coun-try that affects more than 120 million

lives with majority sufferers over the age of 60.There are less than 2,000 practicing audiologists in India and there-fore most people have never actually received treatment until their hearing has degraded severely with age. The Q+ app is a stellar example of the innovative capabilities of Quadio where our customers don’t have to shell out big bucks for hearing care and anyone with a smartphone can now have access to high-quality hearing mechanism.”

One of India’s finest ENT specialists, Padma Shri award-ee Dr Milind Kirtane, consultant ENT surgeon at Hinduja Hospital said, “I would say it would be ideal that univer-sal newborn hearing screening be made compulsory or obligatory, because early detection and therefore early intervention, can really make a significant difference in the life of a person affected with hearing loss.”

Siemens Healthineers - new brand for Siemens’ healthcare business

brand is a bold signal for our ambition and expresses our identity as a people company - 45,000 employees world-wide who are passionate about empowering healthcare providers to optimally serve their patients.”

As part of its Vision 2020 strategy Siemens AG an-nounced nearly two years ago that its healthcare busi-ness would be separately managed as a company within the company with a new organizational setup. Siemens Healthineers will continue to strengthen its leading port-folio across the medical imaging and laboratory diagnos-tics business while adding new offerings such as managed services, consulting and digital services as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Biosuppliers


Biosuppliers

Medtronic has received the US Food and Drug Adminis-tration (US FDA) approval for the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators (ICDs). The Visia AF devices can detect pre-viously undiagnosed and/or asymptomatic atrial fibril-lation (AF) and monitor re-current AF, while treating life-threatening rhythms in the lower chambers of the heart. The Visia AF ICD systems will be com-mercially available in early summer.

AF is a condition that in-volves an irregular quiver-ing or rapid heart rhythm in the upper chambers (atria) of the heart. Be-cause many patients do not experience symptoms, the condition frequently goes undetected,even with traditional external monitors.

When left untreated, patients with AF are five times more likely to have a stroke and three times more likely to de-velop heart failure.

The Visia AF ICDs include a proprietary algorithm that detects AF episodes (without a lead in the atrium) and captures AF frequency and duration, information that helps physicians identify AF and tailor treatment for these patients. More than half of all new ICD implants in the US are single-chamber devices.

Built on the proven performance of the Medtronic Evera family of ICDs, the Visia AF ICDs include:

SureScan Labeling: Approved for MRI scans on any part of the body without positioning restrictions, as well as for MRI scans in 1.5 Tesla (magnet strength) machines

Physio Curve Design: A contoured shape with thin, smooth edges that increases patient comfort by reducing skin pressure by 30 percent

Greater Battery Longevity: Industry-leading battery longevity (up to 11 years)

fda nod for medtronic’s single-chamber ICdsSprint Quattro Leads: Paired with the Sprint Quattro family of leads, the most frequently prescribed lead, with more than 10 years of proven performance with active monitoring

SmartShock 2.0: An ex-clusive shock reduction algorithm that enables the device to better differentiate between dangerous and harm-less heart rhythms, delivering a 98 percent inappropriate shock-free rate at one year.

In addition, remote monitoring through the Medtronic CareLink Net-work is available with the Visia AF ICDs, connect-ing patients to their clin-ics from home or away.

“Early detection of AF is vital to assist physicians in mak-ing treatment decisions that can reduce stroke and heart failure risk,” said Dr John Liddicoat, senior vice presi-dent, Medtronic, and president of the Cardiac Rhythm and Heart Failure division.

“These single chamber defibrillators with AF detection capabilities, utilizing our proven Quattro lead - alongside our overall portfolio of AF detection devices-demonstrate our commitment to providing cardiac patients with the latest technology to improve their health” he added.

The Visia AF ICDs received CE Mark in 2015.This FDA approval further expands the Medtronic portfolio of MR-conditional cardiac rhythm and heart failure devices, which includes MR-conditional pacemakers, ICDs, in-sertable cardiac monitors (ICMs) and cardiac resynchro-nization therapy defibrillators (CRT-Ds).


Thermo Fisher Scientific highlighted its bioprocessing production capabilities ‘built for biopharma’,at the Inter-national Pharmaceutical Expo (INTERPHEX) to support its expanding customer base of global biopharmaceutical manufacturers. New products at the show include inno-vations in single-use technologies, cell culture, protein purification and mass spectrometry.

“Emerging markets for precision medicine, continued growth for biotherapeutics and a renewed focus on cost, increase pressure on customers to identify efficiencies in their production processes,” said Cory Stevenson, presi-dent of Thermo Fisher’s bio production business. “Our emphasis on best-in-class products across the workflow helps our customers to accelerate innovation and in-crease productivity.”

Thermo Fisher has de-veloped a comprehensive protein analytics platform to support microbial and process quality when accu-racy and time-to-results are critical. The Applied Bio-systems ProteinSEQ Protein Quantitation System, a breakthrough immuno-PCR plat-form for residual host-cell protein (HCP) and protein A quantitation, is designed for sensitive and robust protein quantitation with dynamic range, providing four orders of magnitude of greater confidence and quality of data throughout the production process.

Glycosylation is one of the key critical quality attributes of monoclonal antibody-based biotherapeutics, affecting a biological drug’s safety, efficacy, clearance and immu-nogenicity. The new Applied Biosystems Glycan Assure Glycan Analysis and Quantitation System is the first solu-tion to combine high-throughput and high-data quality in an integrated platform.

This helps save labor, time and analysis cost by using a simple sample preparation, a multi-capillary CE instru-ment and assay-specific software.

To enhance productivity while improving protein quality,

Thermo Fisher Scientific introducesnew products for Biopharma

Thermo Fisher introduced Gibco GlycanTune, a feeding supplement engineered to provide precision and control in predictively shifting glycan profiles. Based on Efficient Feed technology, the feed also enables a multi-fold in-crease in titers and maximizes bioreactor utilization.

Thermo Fisher’s single-use technologies comprise best-in-class bioreactors, mixers, fermentors and ancillary products that enable efficiency, speed and reproducible results. At the core are both standard and custom-built BioProcess Containers, which are specially engineered films configured to fit customers’ unique applications and provide process flexibility.

Overcoming technical and economic challenges in the purification process to address downstream purification challenges, new Thermo Scientific POROS Capture Se-

lect AAV8 and POROS Capture Select AAV9 Affinity Resins are en-gineered to address the high selectivity and capacity requirements needed for the purifi-

cation of adeno-associ-ated virus types 8 and 9, which are often used for gene therapy applications.

Also featured at INTERPHEX is a novel approach to protein A capture chromatography. Thermo Scientific POROS Mab Capture A Select Resin combines high-throughput purification performance at a lower price to reduce the cost of pre-clinical development and process-scale manufacturing.

Finally, regulatory changes and increased competition from biosimilar products continue to pressure biothera-peutic drug manufacturers to streamline their analytical processes.

The recently launched Thermo Scientific Vanquish Flex system is a UHPLC instrument with a fully biocompatible flow path, sample pre-compression and a broad range of detectors to suit biotherapeutic analysis from intact pro-teins to unlabeled free glycans.

Biosuppliers


Agilent introduces atomic spectroscopy platformAgilent Technologies has introduced a new addition to its lineup of induc-tively coupled plasma-optical emis-sion spectrometers. The Agilent 5110 ICP-OES will enable scientists to perform faster, more precise ICP-OES analysis than ever before in food, environmental and pharma-ceutical testing as well as for mining and industrial applications.

The new system builds on the company’s breakthrough 5100 ICP-OES, which captures axial and radial views of plasma in a single measurement, enabling laboratories to use half as much argon in the process, saving both time and money. The new system is also a dual-view system. Unlike ICP-OES systems from other vendors, the 5110 enables laboratories to increase throughput without com-promising on precision.

Biosuppliers

“The Agilent 5100 revolutionized the ICP-OES market, delivering significant value in terms of cost of ownership, performance, and ease of use,” said Philip Binns, Agilent’s vice president of spectroscopy products. “The new Agilent 5110 extends that revolution with more cutting-edge in-novations.” The 5110 includes advances, a fully integrated Advanced Valve System with unique hardware and soft-ware technologies that enable ultra-high throughput with excellent precision and ease of use, IntelliQuant measure-ment for rapid sample screening and simple method de-velopment and new diagnostic capabilities that maximize instrument uptime and simplify troubleshooting.

“With the introduction of the 5110 ICP-OES we continue to lead the way in elemental analysis innovation,” said Binns. “Our atomic spectroscopy portfolio offers the most diverse application coverage for AA, ICP-OES, and ICP-MS, while our unique MP-AES and ICP-QQQ technolo-gies help customers redefine the way they work.”


AzOOkA LIfe ScIenceS

A saga of the world’s fastest DnA, rnA stain

Both Dr fathima Benazir and Alex Paul were schoolmates and best childhood buddies. She was a post doctoral research fellow at Indian Institute of Science (IISc), Bangalore, and

was keenly looking out for opportunities abroad. She approached Alex and sent him her portfolio.


Alex D Paul,Co-founder & President, Azooka Life Sciences

“Start-ups never die. They commit suicide…”

BioPreneur


Intrigued by her profile and research accomplishments, Alex persuaded her to apply her research to solve prob-lems in different areas of Life

Sciences.

“I always wanted to be a passionate scientist rather than an entrepre-neur,” says Dr Fathima, Co-founder & CEO, Azooka Life Sciences.

After several discussions and advice from her IISc mentors including Prof. HS Savithri, Department of Biochemistry; Prof. M R N Murthy, Molecular Biophysics Unit; and Dr C V Natraj, Advisor, Society for In-novation and Development (SID) IISc, she teamed up with co-found-er Alex and started Azooka Life Sci-ences in 2015.

The name ‘Azooka’ is derived from the Spanish word Azúcar, which means sugar in Brazil.

Significance of Nucleic Acid stainThe Bangalore-based start-up is said to be the discoverer of a patent-pending nucleic acid gel stain devel-oped from a plant source used as a food additive. The fluorescent dye named ‘tinto rang’ is a nucleic acid dye available for applications in Bi-ological Sciences and Genomics.

Nucleic acid stains are a vital part of DNA-based disease detection com-pared blood-based disease diagnos-tics. These stains are vital chemi-cals used in identifying diseases in human, animal and crop diseases. In fact, Nucleic Acid-based Testing (NAT) is a USFDA (United States Food and Drug Administration) ap-proved and globally accepted meth-odology for non-invasive and rapid disease detection

NAT is said to be a precise and pain-

less molecular testing technique. It is commonly available in the Ameri-cas, Europe, Malaysia and Thailand. “However, this is not prevalent in India due to the high cost of the as-says and devices used in nucleic acid testing,” Alex comments.

On an average, the NAT can cost any-where between `5,000 to `15,000, and can go up to `25,000, given that only expensive hospitals in cities pro-vide the facility.

“The conventional methods are infe-rior compared to NAT. It takes longer time, and the results can be negative because of longer incubation periods.Certainly nucleic acid tests are very specific, faster, accurate and way of the future,” Dr Fathima voices.

India’s problem is that ithas to im-port nucleic acids stains – mainly from the US or Germany.

As a result, there is a payment of 40 to 50 percent import duty including

Wisdom Pills For Start-ups

✓ Associating with right business partners, marketers

✓ Expertise in chosen field

✓ Finding good patent lawyers

✓ Finding passionate team, right advisors

✓ Good fund management

✓ Regulatory awareness

transportation. Most nucleic acid stains are biohazards, toxic, carcino-genic, and mutagenic, and demands careful handling and disposal post experimentation.

Nucleic acid stains are used on a daily basis in disease detection and DNA forensics, so disposing carcino-genic and hazardous substances is a major challenge.

World’s safest dyeRight now, there are around 30 nucleic acid stains in the world that bind to DNA and RNA. They are widely used in DNA and RNA extraction,visualization and exten-sively in DNA Forensics, sequencing and genomic studies.

Azooka claims its fluorescent dye as the world’s safest and fastest DNA and RNA stain. It was conceived out

of Dr Fathima’s PhD research, and was launched in March 2016, after threelong years ofwork and research.

“Our nucleic acid stain is purely an Indian product, and our customers can save big on import duties. Our stain is the first nucleic acid stain to be reported in India and APAC,” adds Alex.

The stain is said to be the safest and fastest DNA stain available in the market. “Our dye is faster than the market leading stains like Ethidium Bromide which takes 10 to 40 min-utes to stain. Our dye consumes only 30 seconds,” Alex points.

The start-up is planning a worldwide product launch by theend of 2016. “Our commercial wing Bhoot Enter-prises will fulfil the product manu-facturing, distribution, marketing, and sales in India. There are some regulatory and IP challenges in tak-ing our products to market, but we are working under the guidance of

Biopreneur


SID…” Alex reveals.

Comparing NAT and ELISA (En-zyme-Linked Immunosorbent As-say), a test that detects and measures antibodies in the blood, the latter’s test timeline can vary anywhere be-tween 3 to 6 months.

Azooka would focus on developing fluorescent dyes that can be used in multicolor labeling experiments such as FISH (Fluorescence in situ hybrid-ization), FACS (fluorescence-activat-ed cell sorting), chromosomal imag-ing, cell imaging, sequencing and other pharmacogenomics studies.

“We are incubated for social impact, and we have a big mission. Our re-search is cutting-edge, but we didn’t find the right market in India be-

cause molecular diagnostics is still nascent in the country. SID played an important role and recognized our innovation,” she adds.

Currently Azooka is seed funded and incubated at SID, IISc. The start-up operatesonly on research and inno-vation grants.

“We want to purely be an IP- and

I always wanted to be a passionate scientist rather than

an entrepreneur,


R&D-based company by creating IPs and values.It is a big mistake to ap-proach VCs immediately after con-ceiving your ideas.Once you discuss your ideas with VCs and if they are not convinced, you lose your ideas,” he cautions. He emphasizes that once venture capitalists (VC) enter a start-up’s picture, the focus of research changes.

Alex conceptualized most of the company’s products, including the market research and the direction the start-up would take in the future. Prior to this, he was the director of product management and marketing at Zoho Corporation.

chasing challengesDNA-based diagnoses is not so popu-lar in India unlike it is in the US, Eu-

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Biopreneur


rope or Australia.

“Educating the market about what we do is a challenge. Finding the right talent is another daunting task,”Alex shares.

Since India does not have proper mo-lecular diagnostic system in place, many times HIV-infected blood, for example, were given to kids. In such circumstances, Azooka’s dye is said to play a crucial role in detecting such diabolical elements in samples.

Funding dramasAzooka’s initial attempts to win grants proved tougher. “We were told to sell-off our technology and get settled for life. We were already running out of cash, and had a zero bank balance. But we didn’t give up. We wanted to bring and build our in-novative technology – the country’s first nucleic acid stain — right here in India,” Dr Fathima states.

While seeking funding, the start-up’s final proposal was rejected by the

committee since they claimed their technology as ‘no novelty’ status.

“The committee comprises of teach-ers and academicians who have very less knowledge about markets and entrepreneurship. Thus winning a grant is a challenge. The right system is not in place, and we had to pay a steep price,” Alex stresses.

Azooka’s products are targeted at blood banks, disease detection kit manufacturers, DNA-based diagnos-tic labs, DNA Forensics, academic institutions, universities, research labs, and companies in the pharma-cogenomics space, seed companies in crop breeding and crop improve-ment, and medical device vendors.

“We are also looking forward for Pat-ent Cooperation Treaty (PCT) to pro-tect our molecule for 30 months all across the world in 160 countries,” Alex comments.

At IISc, Azooka has over 20 custom-ers already. “We want to first win the home ground before a global launch. We also want to partner with kit vendors and molecular diagnostics device manufacturers,” Dr Fathima opines.

The start-up expressed interest in working with Roche Diagnostics, Danaher Corporation, Thermo Fish-er Scientific, Qiagen and Bio-Rad among others.

Myths To Debunk

✓ Impossible to transition from IT to Life Sciences

✓ Product development takes 10 to 20 years

'We were told to sell-off our technology and get settled for life. We

were already running out of cash, and had a zero bank balance. But we

didn't give up. We wanted to bring and build our innovative technology -

the country's first nucleic acid stain - right here

in India,


Grantsworth `200 croreKarnataka’s Millennium Biotech Policy is seen as a fantastic initiative by the government.Start-ups believe that if the policy is executed well, it will further elevate Bangalore to a greater position.

“About `200 crore government grants went unclaimed last year,” re-veals Alex. “We need a one-window clearance system for start-ups. Cur-rently there are no channels or ways through which entrepreneurs can know about availability of such fund-ings or accessing them. There is no proper communication between the government and entrepreneurs to get those funds for research. There are fundings available in India and we want a place to go and look what is available. We want a portal where all the funding information is available. Applying for such funds are compli-cated. And most of them are archaic and old. Patenting and regulatory clearances seem expensive.”

In India, a mid-size DNA lab can cost up to $10 million. “…There is no proper ecosystem in the country in the area of application and the whole conducive ecosystem is missing. So all the great scientists go abroad, and also many companies hesitate to en-ter India,” Alex says.

In the West, entrepreneurs are seen to bootstrap and create value through their start-ups, or even just start off with uncertainties and slowly execute their strategy. “It is all about impacting billions and not put-ting billions into your bank account,” Alex mentions.

Bare ecosystemHe feels that the country does not even have websites to gain knowl-edge on trends happening in Biologi-cal Sciences. “The whole ecosystem is bare. We are following trends abroad.

Biopreneur


rAj GunAshekAr

Personalization of medicine is cre-ating a major trend globally. Gene banking is coming to India through Apollo Hospitals and Narayana Hru-dayalaya where genes are going to be stored. We also do not have enough news and publications to know what is happening in our space and what companies are working on,” he ex-presses.

He says that in-vitro diagnostic de-vice (IVD) and in-vivo imaging space is very nascent in India. “I wish a lot of start-ups would venture in to it. We need an ecosystem where re-agents are made by ourselves which would bring down costs of research and diagnosis.We need to push the government to make NAT manda-tory. Most Life Sciences companies explore NGS or bigdata and are not product-based by creating IPs. IPs should stay within India rather than other countries trying to take it, like in the case of Turmeric and Neem,” Alex suggests.

“Indian patent laws are stringent, and this is what is helping the coun-try not lose its IPs and natural re-sources to other countries,” notes Dr Fathima.

Biggest lessonsAlex says that an entrepreneur needs tons of patience and perseverance in the journey.

“Unlike IT, there are no alpha or beta versions of products in Life Sciences and medicine. Products need to be specific and stable,” he advises.

He advises start-ups to try their hands at funding methods like gov-ernment grants which isvalued at around `800 crore. He also says that for biotech start-ups, Bangalore is the best place to begin. Ahmedabad and Hyderabad are seen favorable for pharma start-ups.

“A start-up is a small slice of the problem where an entrepreneur tries to solve it. Start-ups never die. They commit suicide.When people in a start-up stop caring about it, it even-tually dies,” says Alex, quoting his ex-CEO Sridhar Vembu of Zoho Corp.

As for Alex, association with SID and IISc has a left a lasting impact on his career direction.“In a typical IT start-up, the pinnacle of success is seen as landing a job at Silicon Valley at companies like Microsoft, Google or Facebook or a unicorn start-up with billion dollar evaluations;or having millions of dollars in the bank; or even being featured on the cover page of popular magazines,” saysAlex.

He explains, “But my journey led me to meet scientists at IISc, who were solving the world’s toughest prob-lems like curing diseases or finding drugs and vaccines in India.A silent fight to make India a better place.They are the really happy people.They are humbled by the problems of the world,and try to helphumanity. Our families had a tough time com-prehending what we were doing.

“Being an expert in the IT services management, I even got a perma-

We are incubated for social impact, and we

have a big mission. Our research is cutting-edge, but we didn't

find the right market in India because molecular

diagnostics is still nascent in the country

Alex D Paul,Co-founder & President, Azooka Life Sciences

nent residency to Australia. But we wanted to create a huge social impact in our homeland. People today will instantly judge you by looks. There is so much prejudice even before you hit the market. And Dr Fathima is a role model.There are women entre-preneurs struggling to make it in this space. But she made it despite chal-lenges!”

Being a woman, the journey had been quite uniquely challenging for Dr Fa-thima. “It takes a lot of courage be-cause it isn’t easy for a researcher to make a switch from being a scientist to an entrepreneur. Single-minded focus is also very important. You will encounter failures but every time you have to continue to move on no mat-ter what. It is important to have pas-sionate co-founders; to some extent you have to be selfless. For a Life Sci-ences start-up, it may at least take 5 years to get the product to the mar-ket,” she elaborates.

“It has been challenging personally and professionally. The first best les-son I have learnt is to believe in my-self. Believing in what I did. I believe that attitude will take you from where you are to where you want to go. Don’t let your circumstances, fam-ily, or society pressurize you to lose that faith in yourself. That’s the big-gest battle I fought. I isolated myself from shame and insults and believed in what I did.

“Once you lose faith in what you are doing then the purpose is lost. Asso-ciate with people who believe in you. For us, this is just the beginning of the journey. We have a lot to learn. It’s a team work. My parents too gave me the liberty to do what I wanted to do. Never allow anyone to dic-tate your dreams,” ends Dr Fathima gracefully. She is a mother of 2 kids and enjoys cooking and knitting. BS

Biopreneur


This well-written biography with its catchy title, gives readers a cogent answer to the question, who is Kiran Mazumdar-Shaw, as well as its corol-lary, what is Biocon all about. Actu-ally, it leans more towards tracking of the business rather than delving too deeply into the personality traits of its founder but then, the best busi-ness biographies do just that.

So, who is Kiran Mazumdar-Shaw? Myth-breaker. Risk-taker. A woman who was not an engineer and who did not come from a business fam-ily, yet started and steadily grew a ground-breaking business. Initial-ly setting out to be a professional brewmaster, Mazumdar-Shaw faced so much hostility and gender bias that she turned to Plan B: to start a biotech start-up instead, where she could leverage her fermentation knowledge to produce enzymes and

AgAinst Considerable OddsMyth Breaker Kiran Mazumdar-Shaw and the Story of Indian Biotech By Seema Singh

Collins Business/Rs 599/324 pages

biopharmaceuticals instead of beer. Mazumdar-Shaw`s father Rasendra Mazumdar was India`s first brew master and that definitely helped shape her initial interests in brew-ing. Her mother helped, too; in the early years, when Mazumdar-Shaw was going to coastal towns secur-ing fish maw supplies, in Delhi, her mother Yamini Mazumdar, would head to the fish market near the Jama Masjid once every ten days and buy a few hundred kilos of the fish maws, then ship the stock to her daughter in Bangalore.

Her mentor and one-time partner in business, Leslie Auchincloss, de-scribes Mazumdar-Shaw thusly, after his first meeting with her: a fantastic, enthusiastic, ass-kicking woman who is aggressive, demanding and would make a great partner for Biocon Ireland.

Pioneer? That`s a given. Pugna-cious? Yes, if the situation calls for it. Ready to ward off challenges that comes in the form of dirty deeds done by corporate rivals, like the filing of PILs. Ready to take on the Chinese goods wall. Once this businesswom-an bought into some idea, concept or project, she moved forward with lightning speed;witness the setting up of the Mazumdar-Shaw Cancer Centre, together with the renowned cardiologist Dr Devi Shetty.And in John Shaw, she has a spouse and staunch supporter who is more than willing to stay in the shadows and let all the limelight fall on Kiran. As a fi-nance person, he had some pithy ad-vice to give his wife: be adventurous in your science but be very conserva-tive in your finance. That advice has held good.

So, what exactly is Biocon? A research

Bookreview


BIOSPECTRUM

BIOCON SPIN

-OFFS

MAY 2014


company that is running a number of programmes to bring new drugs to change the course of the disease. Bit by steady bit, the concern has grown incrementally, added technical and managerial muscle to its manufac-turing, started to supply an iron com-plex, Serratio, then statins, and then, insulin. Today this mid-sized compa-ny does novel biologics while earning the margins of speciality generics, even as it harbours ambitions of an innovator company.

Not all roses, though; here are some interesting facts: Biocon took ten years to become the largest Indian insulin brand but still has only 6.5 percent share in the overall insulin market, and 10 percent in the rep-resented market.When Biocon went public in 2004, people were sure it would pave the way for other bio-technology companies to follow suit.

Not a single firm did. It has been a hard climb but if ever anyone was up to the challenge, it was and continues to be, Kiran Mazumdar-Shaw.

The book is a dispassionate collation of Biocon stories, and introduces to the reader the whole team that pulled its considerable weight and helped Mazumdar-Shaw put her company on the biotech map. Author Seema Singh, former bureau chief of Forbes India and a MacArthur grant award-ee, said the book took two years to write and involved over 200 inter-views. It takes the reader through an interconnected maze involving a feisty woman with a definite vision and the perseverance to stay the long course.

Verily the face of the biotech indus-try in India now,Mazumdar-Shaw is in her early sixties and still going

strong, her business acumen as well as her vision for her enterprise as sharp and clear as it was 37 years ago. Mazumdar-Shaw is all set to take Biocon’s biopharma business to the next level, with the focus on the new field of immuno-oncology. Which is a good thing considering the TINA factor here. There is no alternative to Mazumdar-Shaw as yet. As GS Krish-nan of Novozymes says: ‘If today Ki-ran chooses to say `enough of indus-try leadership` and steps back, there is nobody to talk to the government on behalf of Indian biotech.’ BS

Sheila Kumar

Sheila Kumar is an independent writer and manuscript editor, as well as author of a collection of short stories titled Kith and Kin Chronicles of a Clan.

Photos: Ajay Ghatage

Bookreview


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