th biosimilars asia 2013 - giievent · “i improved my understanding of biosimilars development...

LifeSciences

Biosimilars Asia2013

REGISTER NOW! Customer Service Hotline: +65 6508 2401 / +86 21 2326 3680

International MarketingPartner:

www.biosimilarsasia.com

Knowledge Partner:

Produced by:

20 – 23 May 2013 | Grand Hyatt Shanghai, China

Biosimilars Asia2013

4TH ANNUAL4TH ANNUAL

Strategies for Successful Launches andManufacturing of mAbs

Featuring DistinguishedIndustry Leaders:

Dr Georg FegerHead of Preclinical Research, Biosimilars,Merck Serono, Switzerland

Dinkar SindhuSenior Director and Head,Merck Serono Alliance,Dr Reddy’s Laboratories, India

Dr Michel MikhailChief Regulatory Officer, Executive Vice President,Global Regulatory Affairs, Fresenius Kabi,Germany & Member, Executive Committee andBoard, European Generic Medicines

Association (EGA), Belgium

Dr Ning LiAVP and Head of Asia Regulatoryand Medical Policy,Sanofi Asia, China

Rustom Mody, Senior Vice President and Head of R&D, Lupin, IndiaRafael Mendoza, EP Director, Emerging Asia, Pfizer, ChinaHideaki Nomura, President & CEO, Fujifilm Kyowa Kirin Biologics, JapanDr Kyoung Kim, Vice President, Business Development, Hanwha ChemicalBiologics, South KoreaSimone Song, Executive Director, IBD, Goldman Sachs (Asia) L.L.C, HongKongDr Paul Cornes, Consultant Clinical Oncologist, Bristol Oncology Centre, UKAmongst Others...

• NEW, MUST ATTEND for CSOs, Heads of R&D andManufacturing! Focused technical know-how oncomplex biosimilars in a separate new track

• Keynote plenary sessions + 2 tracks: CommercialStrategy + Biomanufacturing and Production of mAbs

• Reformulated 2013 Agenda on the rise of authorizedbiosimilars, market acceptance & productionstandards for successful manufacturing of mAbs

• Asia’s BIGGEST meeting on Biosimilars: 40+ globaland regional speakers in over 30 sessions

• IN-DEPTH technical case studies, EXCLUSIVE 1STTIME joint presentation by Merck Serono andDr Reddy’s

• PRESCRIBER & PAYER perspectives in the quest formore affordable & accessible biologic medicines

• DEEP-DIVE workshops to boost your successin biosimilars

• GREATER networking and collaborationopportunities from 3 co-located conferences underone roof!

Asia’s PREMIERBiosimilars Conference

Has Grown LARGER:

Co-located with:

www.chinapharmard.com www.pharmalegalasia.com

21 – 23 MAY 2013 | GRAND HYATT SHANGHAI, CHINA

Developing Market Share & Asset Protection in Emerging Market Frameworks

Register & Pay by 8 March to save up to US$300 / CNY1,000 each

Pre-Conference Workshops – 20 May 2013

A: Essentials to Compete Profitably with AuthorizedBiosimilars

B: The Art of Guanxi – Principles for SuccessfulBusiness in China

Post-Conference Workshops – 23 May 2013

C: Due Diligence for PharmaBiotech Collaborationand R&D Agreement

D: Gaining Biosimilars Approval in US and EU

Session Spotlight Sponsors:

Media Partners:CanBiotech

R&D OutsourcingCapital Sourcing

Competitive Intelligence

|

Supporting Associations:

2013

Exhibitor:

Bronze Sponsor: Panel Sponsor:

REGISTER TODAY! +65 6508 2401 / +86 21 2326 3680 [email protected] www.biosimilarsasia.com

“Excellent conference”~ Hefez, Merck Serono SA

“I improved my understanding of biosimilars development and gained real insights”~ Fujishiro, Daiichi Sankyo

“I walked away with indepth understanding of trends in biologics/biosimilars,regulatory hurdles, market access”

~ Yeo, Besins

4th Annual Biosimilars Asia 2013

By 2015, sales of biosimilars are expected to reach between US$1.9-2.6 billion, from US$378 million for the year to the first half of 2011.However, the reality of commercial success is hindered by originatormoves into authorized biosimilars, costly and complex manufacturingand market factors.

IBC’s 4th Annual Biosimilars Asia 2013 is the region’s largest targetedgathering of leading and future stakeholders. In keeping up withdevelopments in biosimilars, this year heralds a new dedicated bio-manufacturing track. While still addressing the latest commercial andbusiness strategies, Biosimilars Asia 2013 will now also include thetechnical reality of making biosimilars, with a special focus onmonoclonal antibodies (mAbs).

Why Biosimilars Asia 2013 is Your Must-Attend Event:Authorized biosimilars are threatening the livelihood of pure biosimilar companies – how can you fight back?Comprehensive agenda highlighting key industry challenges from commercialization and market access to efficient bio-manufacturingand ensuring qualityLearn from detailed case study experiences globally and in emerging marketsGather the latest market intelligence and analysis to develop your positioning for successGain unique insights and engage with senior executives from major stakeholders spanning biosimilar to innovator companiesIBC’s Biosimilars Asia 2013 addresses the toughest questions with in-depth analysis and no-holds-barred discussions!

SPONSORSHIP OPPORTUNITIESRaise awareness for your services available to Asian pharmaceuticals!

• Do you find difficulty in reaching senior decisionmakers and successfully stimulating interest for yourservices?

• Are you trying to raise awareness of the value ofyour company’s expertise and services?

• Or are you finding it difficult to differentiate yourcompany from your competition?

Perhaps what you need is a branding opportunity at this event! Increase yourreach through our extensive marketing campaign, targeted at your qualifiedbusiness audience.

For information about placing your brand & profile top-of-mind to key buyers,contact Yvonne Leong, Business Development Manager on Tel: + 65 6508 2489or Email: [email protected]

GE Healthcare Life Sciences provides tools andtechnologies, solutions and expertise whichenable the biopharmaceutical industry to developand manufacture biotherapeutic medicines andvaccines cost-effectively. Our products andplatform solutions are designed to meet the keychallenges posed at every stage in thebiomanufacturing process, delivering the desiredproduct at the required purity and safety: all withfast development and integrated solutions inmind. Across the bioprocessing spectrum, ourfocus is on supporting you from idea to result.

ABOUT THE SPONSOR:


20 – 23 May 2013 | Grand Hyatt, Shanghai, China

21 – 23 MAY 2013 | GRAND HYATT SHANGHAI, CHINA

Developing Market Share & Asset Protection in Emerging Market Frameworks

Register & Pay by 8 March to save up to US$300 / CNY1,000 each

Drug Discovery and Development Week: Programme at a Glance

Wednesday22 May 2013

CONFERENCE DAY 2

JOINT NETWORKING LUNCHEON

Successful Scaling up Conditions Compliance With Latest Pharma Legislation

CHINA PHARMAR&D SUMMIT

BIOSIMILARS: STRATEGYBIOSIMILARS:

BIOMANUFACTURINGPHARMA LEGAL

AFFAIRS ASIA

PRE-CONFERENCE WORKSHOPSA: Essentials to Compete Profitably with Authorized BiosimilarsB: The Art of Guanxi – Principles for Successful Business in China

Monday20 May 2013

Tuesday21 May 2013

CONFERENCE DAY 1

China Healthcare Policy – Impact on Innovation Biosimilars Plenary: Successful Navigation of the Evolving Biosimilars LandscapeRegional Legal Framework Update

JOINT NETWORKING LUNCHEON

SPONSORED EVENING COCKTAIL RECEPTION

The Role of Asia in Global Drug Development

Developing Sustainable Competitive Strategies

Increasing Cost Efficiencies

Thursday23 May 2013

POST-CONFERENCE WORKSHOPSC: Due Diligence for PharmaBiotech Collaboration and R&D Agreement

D: Gaining Biosimilars Approval in US and EU

China Pharma R&D and Biosimilars Joint Plenary Session: The Global Pharmaceutical Landscape

Science and Innovation ShowcaseProduct Development & New Market Expansion

Risk & Returns to Consider Before Entry

Preparations Before Embarking onBiomanufacturing

IP Loss Prevention and Enforcement

Strategic Collaborations to StrengthenValue Chain

Biosimilars Plenary: Global Regulatory Guidelines Overview

Legal Issues in Pharma Commercial Contracts

R&D Partnerships Between East and West

The Future of Medicine and Direction of R&D

Who Should Attend:

8th International China PharmaceuticalR&D Summit is a premier industry eventbringing together leaders from across Eastand West, pharma and biotech, discoveryand clinical to discuss the future ofinnovation and map the growth potentialfor the industry in Asia as well as Asia’scontribution to global R&D.www.chinapharmard.com

2nd Pharma Legal Affairs Asia 2013features a distinguished speaker faculty ofpharmaceutical and biotech counselcoupled with legal experts. It provides aunique forum for dealmakers and legalminds to address the industry’s mostcompelling and current legal issues.www.pharmalegalasia.com

Strategy/Commercialisation/Licensing 15%

By Industry:

Originators 35%

Biotech10%

Legal 10%

Solution Providers 5%

Generics &Biosimilars 30%

Academic10%

By Country:

China 40%

SE Asia5%

USA 10%

Rest of World 5%

India 15%

Europe10%

Rest of NorthAsia 15%

By Job Function:

R&D/Innovation20%

BusinessDevelopment15%

Regulatory 5%

Academia 5%

Biomanufacturing 15% Legal 10%

Clinical5%

Sales andMarketing10%

By Job Title

• CEO, CSO, VPs, Directors & Heads ofResearch & Development

• Business Development & Strategy• Strategy Planning & Development• Follow-on Biologics/Biosimilars Licensing• Sales & Marketing• Product Development

• Biologics/Biotechnology/BiogenericsManufacturing

• IP Director/Counsel Lawyer & PatentAttorney

• Procurement/Sourcing• External Manufacturing Clinical Trials• Biomedical Materials

• Collaborative Research• CMO Account Management• External Resourcing• Quality Assurance/Quality Control• Technology Transfer• Bioprocessing

IBC Life Sciences’ Drug Discovery & DevelopmentWeek brings together international and regionaldecision makers to address the industry’s mostpressing concerns. Whether from innovators inpharmaceutical R&D to developers of biologicsand biosimilars, this is China’s most targeted worldclass forum providing the latest strategies,expertise, technologies and solutions.www.drugdiscovery-china.com

@IBCPharmaAsia



Conference Day One: Tuesday, 21 May 2013

08:00 Registration & Welcome Coffee

PLENARY KEYNOTE SESSIONS: THE GLOBAL PHARMACEUTICAL LANDSCAPE

08:30 Welcome and Opening Remarks from the ChairCarl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, Singapore

08:40 State of Play: Where is the Pharmaceutical Industry Heading?• Defining the market factors which have influenced the growth or posed hindrance to the

pharmaceutical industry• The opportunities of new markets in the midst of an economic downturn• Managing clinical needs rather than cost in areas of terminal care where advances arises

from biologicals offering improved life expectancy

Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, UK

09:15 Integrative Medicine for the New Century: A U.S. – China Perspective• Overview of Integrative Medicine in the U.S. and in China• Chinese healthcare system and its current development• Peeking into the emerging role of integrative medicine in global healthcare

Ka-Kit Hui, MD, FACP, Wallis Annenberg Chair in Integrative East-West Medicine,Chair, Collaborative Centers for Integrative Medicine, Professor, Founder & Director,Center for East-West Medicine, Department of Medicine, UCLA, USA

09:50 Emerging Trends in Investments: Alternative Funding and StrategicPortfolio Management• How can companies be attractive to investors?• Best practices for investors to choose the molecule to invest in• Diversifying the investment portfolio – How much should I invest in each portfolio?• Analyzing the biosimilars prospects and what is the true potential?

Moderator:Simone Song, Executive Director, IBD, Goldman Sachs (Asia) L.L.C, Hong KongPanelists:David Wang, Senior Managing Director, OrbiMed Asia, ChinaWu Chun, Partner and Managing Director, Boston Consulting Group, Hong KongDianna Qian, Principal, FIL Capital Management, ChinaJames Huang, Managing Partner, KPCB, China

10:35 Opening of Exhibits & Morning Refreshments

** End of Plenary Keynote Sessions **

11:05 Chairperson’s Opening RemarksRichard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA

BIOSIMILARS PLENARY: SUCCESSFUL NAVIGATION OFTHE EVOLVING BIOSIMILARS LANDSCAPE

11:15 The Global Inception of BiosimilarsSpeaker Pending Confirmation, for updates please visit www.biosimilarsasia.com

11:50 The Reality of Bringing Next Generation Biosimilars to Market• Solving the contradictory goal of producing quality complex bio-products in a volume

business• An overview of the challenges and opportunities in bio-manufacturing with a special focus

on mAbs• Key factors needed to be implemented before proceeding with scaling up

Abdullah Baaj, CEO, Boston Oncology, USA

12:25 Successful Establishment of a Biosimilars / Biologics Plant in China• Setting up a USFDA/EMA standard, production facility in China – Is it really that difficult?• What are the difficult interfaces bridging West and East (engineering and regulatory)?• Practical tips and lessons learnt

Shmulik Hess, CEO, Valin Technologies, Israel & Director, Vanir Bio, Singapore

13:00 End of Biosimilars Plenary Session followed by Networking Lunch

KEY

NO

TEPA

NEL

DIS

CUSS

ION

TRACK 2: Biomanufacturing & Production of mAbs

Chairperson: Dr Noelle Sunstrom, Chief Executive Officer, Neuclone, Australia

TRACK 1: Strategy & Commercial Success of Biosimilars

Chairperson: Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA

PRODUCT DEVELOPMENT & NEW MARKET EXPANSION

14:15 Will Biosimilars Be the Saviour of Big Pharma in Emerging Markets?• Why multi-national companies (MNCs) have not been performing in emerging markets?• Will MNCs learn from their generic mistakes and approach biosimilars in an innovative

way?• Will authorized biosimilars signal the end of biosimilar companies?

Moderator:Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, UKPanelists:Rafael Mendoza, EP Director, Emerging Asia, Pfizer, ChinaDr Joe Zhou, CEO, Genor Biopharma, ChinaParth Chakrabarti, Director, Marketing, Biosimilars, Baxter Healthcare, USAKhai Meng Ang, VP Asia, Hospira, Australia

15:00 Differentiated Biosimilars: Applying New Novel Drug Delivery Systems• How are drug delivery devices changing the game?• Similar to super-generics, will “super-biosimilars” be the next trend?• Establishing a strategic and successful alliance between drugs and devices• Are there any case studies of a successfully commercialized differentiated biosimilar?

Dr Seth Goldenberg, Senior Principal Scientist, NAMSA, USA

15:35 Afternoon Refreshments

16:05 Seal of Quality: Japanese Made Biosimilars for Overseas Sales?• Current environment in Japan for biosimilars development• Taking advantage of the quality associated with “Made in Japan”• Which markets can Japanese-made or Korean-made biosimilars be best valued at?

Hideaki Nomura, President & CEO, Fujifilm Kyowa Kirin Biologics, Japan

RISKS & RETURNS TO CONSIDER BEFORE ENTRY

16:40 Can You Ever be Too Late to the Game? What Are the Risks/Returns if YouAre Not the First to File?• Studying and strategically catering to the needs of emerging markets• If you’re not among the first to file, should you proceed or withdraw?• How to develop the most strategic positioning?• Scoping out your market potential and what’s left of the pie – will the market grow and

accommodate more than 10 players?• Lessons learned in the launching of biosimilars

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA

PAN

EL D

ISCU

SSIO

NCA

SE S

TUD

Y

PREPARATIONS BEFORE EMBARKING ON BIOMANUFACTURING

14:15 Ensuring Quality CMC in Place Before Embarking on mAb Production• Up-to-date assay validation

• Establishing consistent quality output

Rustom Mody, Senior Vice President and Head of R&D, Lupin, India

14:55 Selecting the Most Efficient Recovery & Purification Methods forBioproducts• Strategies to recovery and purification

• Challenges and most critical steps

• Which methods work best for the different types of molecules and quantity required?

Jason Li, Senior Director, Downstream Processing, Genor BioPharma, China


16:05 Achieving Successful Biosimilarity• Parallel process and clone development for maximizing success of achieving biosimilarity

• Defining preliminary CQA via RMP survey to guide clone and process selection

• Statistical approaches to document biosimilarity

• How much in vitro and vivo pharmacololgy is needed?

• 21st century immunogenicity assays

Dr Georg Feger, Head of Preclinical Research, Biosimilars, Merck Serono,Switzerland

16:45 Selecting the Right Cell-line• What are the selection challenges?

• General practices for cell-line selection

• How to choose the best clone selection?

Dr Noelle Sunstrom, Chief Executive Officer, Neuclone, Australia

17:15 Closing Remarks from the Chair and End of Day 1 followed by Networking Drinks Reception

Strategies for Successful Launches and Manufacturing of mAbs

INCREASING COST EFFICIENCIES

11:00 Ensuring a Smooth, Successful and Efficient Internal Technology Transfer• Structuring a comprehensive intermediate process development stage

• Challenges in the different stages of internal technology transfer from research labs to

manufacturing plant

• Working alongside R&D to ensure clarity in process design

Dr Jayanth Sridhar, Senior Director, Manufacturing, Biocon, India

11:40 Establishing Biomanufacturing Capacity in Asia• Current healthcare and market challenges

• Managing the facility delivery life-cycle – from process development to operation

• Innovative facility delivery models: standardized facilities equipped with single-use

technology

John Machulski, Head of Sales, Enterprise Solutions, GE Healthcare LifeSciences, Singapore

12:15 Networking Lunch

SUCCESSFUL SCALING UP CONDITIONS

13:45 Spotlight SessionThis session may be hosted by a leading company who operates in the field of bio-manufacturing. It is an opportunity to showcase the latest development and technicaladvancements in the industry. For details about speaking in this session or othersponsorship opportunities, please contact Yvonne Leong, Tel: +65 6508 2489, Email:[email protected]

14:15 Assessing Scale-Up Capabilities for mAbs• What are the common challenges?

• Elements of manufacturing preparation that can be done ahead to ensure successful

scale up

• Implementing best practices

Speakers Pending Confirmation, for updates please visitwww.biosimilarsasia.com

14:55 Selection and Optimization of Cell Culture Media• The costs, regulatory, quantity and process considerations towards media choice

Speakers Pending Confirmation, for updates please visitwww.biosimilarsasia.com

Conference Day Two: Wednesday, 22 May 2013

08:30 Chairperson’s Opening RemarksRichard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA

08:40 Global Regulatory Guidelines Overview PlenaryEach representative will present a 15min update followed by a panel discussionEU – Dr Michel Mikhail, Chief Regulatory Officer, Executive Vice President, GlobalRegulatory Affairs, Fresenius Kabi, Germany & Member, Executive Committee andBoard, European Generic Medicines Association (EGA), Belgium

India – Dr SR Rao, Advisor, Department of Biotechnology (DBT), Ministryof Science & Technology, Government of India

China – Dr Ning Li, AVP and Head of Asia Regulatory and Medical Policy,Sanofi Asia, China

US* Speakers Pending Confirmation, for updates please visitSoutheast Asia* www.biosimilarsasia.com

Compliance and Embracing Regulations to Minimize Time to Market• What is the difference between developed and emerging market regulations?• How to strategically navigate regulations in order to optimize development plans?• Will there be greater streamlining towards a global standard of regulations?• Are there any reference regulations and regional transfer of dossier approved in one country

compared to others?• Why have companies stopped at Phase 3 trials?

Moderator:Dr Michel Mikhail, Chief Regulatory Officer, Executive Vice President, GlobalRegulatory Affairs, Fresenius Kabi, Germany & Member, Executive Committee andBoard, European Generic Medicines Association (EGA), BelgiumPanelists:Dr SR Rao, Advisor, Department of Biotechnology (DBT), Ministry of Science& Technology, Government of IndiaDr Ning Li, AVP and Head of Asia Regulatory and Medical Policy, Sanofi Asia, China

10:30 End of Biosimilars Plenary Session followed by Morning Refreshments

TRACK 2: Biomanufacturing & Production of mAbs

Chairperson: Dr Noelle Sunstrom, Chief Executive Officer, Neuclone, Australia

TRACK 1: Strategy & Commercial Success of Biosimilars

Chairperson: Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA

STRATEGIC COLLABORATIONS TO STRENGTHEN VALUE CHAIN

11:00 Strategic Alliances – Is This The Way to Win the Biosimilar Global Market?• The global biosimilar market opportunity for mAbs• The key drivers to partnering on a global scale, the Innovator Pharma vs the Generic Player

point of view• The key success factors to a multi-cultural collaboration• Case Study: Merck Serono – Dr Reddy’s Laboratories strategic alliance• Deal structure - who carries the risks and when?• Alliance management the driver following signatureYariv Hefez, Vice President, Business Development and Alliance Management,Biosimilars, Merck Serono, Switzerland &Dinkar Sindhu, Senior Director and Head, Merck Serono Alliance, Dr Reddy’sLaboratories, India

11:45 Future-Proofing Your Licensing Strategies to Align Your Goals asLicensee / Licensor• Evolving past 1st Generation biosimilars, how are licensing agreements more flexible and

involving greater risk sharing?• What are the different partnership models to consider in the co-development / co-

commercializing of biosimilars?• Market considerations in a structure-value proposition• Perspective of licensor: How to segment markets? Regional vs Global?• Perspective of licensee: What can be done to increase own attractiveness?

~ What other services can be offered?Moderator:Yariv Hefez, Vice President, Business Development and Alliance Management,Biosimilars, Merck Serono, SwitzerlandPanelists:Tadashi Matsumoto, President, ReqMed, JapanDr Kyoung Kim, Vice President, Business Development, Hanwha ChemicalBiologics, South KoreaDr Robin Zhang, Senior Strategic Marketing Manager, Bayer Healthcare, ChinaDr Jimmy Zhang, Managing Director, MSD Early Investments – Greater China,Merck & Co, ChinaImtiaz Razzaq, Head of Business Development, Getz Pharma, Pakistan

12:30 Networking Lunch

13:45 Cautionary Tales: Strategic Considerations for Generic Companies Enteringinto Biosimilars• How do generic companies perceive the biosimilars opportunity?• What are the key considerations generics companies should take note of before entry into

biosimilars?• Key lessons learnt and practical applications from alliances in the biosimilars spaceAbhayan Jawaharlal, Chief Legal Officer, Cipla Limited, India

14:20 Considerations in Establishing a Global Alliance• Positioning your company for global alliances• Identifying goals for entry• Entering a partnership with an exit clause in the prenup – IP challenges in global alliances• Lessons learned from cross-border/cross-cultural alliancesModerator:Dr Janet McNicholas, Partner, Jones Day, USAPanelists:Robert Chen, Senior Director, Global Strategy & Partnering, Genor BioPharma,ChinaPaul Kim, Managing Advisor & CEO, POSCO BioVentures, KoreaDr Tong Zhang, Senior Director, Business Development, MSD, ChinaPedro Morfin, Managing Director, Sanape, USA

DEVELOPING SUSTAINABLE COMPETITIVE STRATEGIES

15:05 From a Molecule to the Market, What Would it Take to SuccessfullyCommercialize a Biosimilar?• Developing a comprehensive and integrated commercialization plan to increase market

access• Key factors to successfully commercialize biosimilars• Comparing the difference in commercialization plans of launch in developed markets vs

emerging marketsDr Shahzad Khan, Director, Marketing & Sales, Getz Pharma, Pakistan

FEAT

UR

ED C

ASE

STU

DY

PAN

EL D

ISCU

SSIO

NPA

NEL

DIS

CUSS

ION

REG

ULA

TOR

Y PA

NEL

DIS

CUSS

ION



TRACK 2: Biomanufacturing & Production of mAbsTRACK 1: Strategy & Commercial Success of Biosimilars


16:10 Honing Marketing Tactics to Achieve Accelerated Sales in Biosimilars• Expanding untapped population in emerging markets through demand generation• Addressing perception between developed and emerging markets• Practical ways to understand key success factors for your product• Adapting marketing strategies between out of pocket and reimbursed markets

Dr Andree Bates, CEO, Eularis, Hong Kong

16:40 The Global Biosimilars UptakeHear from Prescribers on the following issues:• What is the current perception of biosimilars?• What will drive the change in prescriptions?• Does a cheaper price translate to greater attraction towards biosimilars?

Prof Dr Purvish M Parikh, Managing Trustee, Indian Cancer Society & Founder,Trustee of Indian Cooperative Oncology Network, IndiaDr Paul Cornes, Consultant Clinical Oncologist, Bristol Oncology Centre, UK

17:30 Closing Remarks from the Chair & End of Conference


16:10 Setting up the Complex Biosimilars Assessment• Which range is acceptable?• Conducting extensive similarity assessment for regulated markets

Jing Rong Li, Executive Director, Simcere Pharmaceutical, China

16:45 Tapping the Biosimilars Opportunity – How Can Biomanufacturers beFlexible and Meet Future Demands?• How will mAbs change the biomanufacturing landscape?• Which countries will lead the race?• While handling multiple bio-product manufacturing, which cost saving platform technology

should be considered?• How to handle process deviations and which risk analysis tools to use?

Panelists:Scott Liu, CEO, Henlius Biopharmaceuticals, ChinaDr Youling Wu, CEO, Zhejiang Teruisi, ChinaDr Maharaj Sahib, Director, Genomics and Biotechnology, Wockhardt, IndiaDr Roman Ivanov, Vice President, Research & Development, BIOCAD, Russia

17:35 Closing Remarks from the Chair & End of Conference

08:00

08:30

08:40

09:15

09:50

10:35

11:05

11:15

11:50

12:25

13:00

14:15

15:35

15:00

16:40

16:05

14:15

15:35

14:55

16:45

16:05

08:30

08:40

10:30

11:00

17:15

11:45

12:30

13:45

14:20

15:05

15:40

16:10

16:40

17:30

11:00

11:40

12:15

13:45

14:15

14:55

15:35

16:10

16:45

17:35

PR

ESCR

IBER

S V

IEW

PAN

EL D

ISCU

SSIO

N

PAN

EL D

ISCU

SSIO

N


20 – 23 May 2013 | Grand Hyatt, Shanghai, China

PRE-CONFERENCE WORKSHOPS: Monday | 20 May 2013

A: Essentials to Compete Profitably with Authorized Biosimilars (09:00 – 17:00)This full-day workshop will run from 09:00 – 17:00, with mid-morning and afternoon refreshment breaks and lunch. Registration begins from 08:30

• What will be the second wave of biosimilars,

where will be the country focus and which

players will be involved?

~ Infliximab?

~ Adalimumab?

~ Rituximab?

~ Trastuzumab?

• How will originators respond to the threat?

~ Litigation?

~ Authorised biosimilars?

~ Strategic pricing?

~ Life cycle management strategies?

• What will be the challenges facing players in

~ Primary care indications?

~ Secondary care indications?

• How important is interchangeability and

substitution for the second wave of biosimilars?

~ In chronic indications of RA, Psoriasis and

Crohns?

~ In oncology indications?

• What will be the role of~ Physicians?~ Pharmacists?~ Payers?~ Regulators?

• How to access regulated markets~ Partnerships?~ Out-licensing/in-licensing?

• What direction could the USA market take?• Will 351K pathway really be the route for

regulatory approval of biosimilars in the USA?• Insulins, a major opportunity or just too big a

challenge?• Is the bigger opportunity in emerging markets

and how can we evaluate?• How much of a threat is life-cycle management

by originators and what could biosimilars doto counter this?

• What future molecules should be consideredfor development and where could there besynergies?

• What are the essentials in order to successfullydevelop and launch biosimilars?

Led by:

Alan Sheppard, Global Head of Generics, Thought Leadership, IMS Health, UKAlan has over 35 years’ experience within the pharmaceutical industry covering the full

spectrum of innovative medicines, generics, biologicals, vaccines and OTC medicines. His

previous roles include Executive VP, Europe Generics, Dr Reddy’s Laboratories and VP, Global

Corporate Strategy, Pliva. Alan was a long serving member of the Prescription Medicines Code of Practice

Authority Appeals Board, Fellow of the Institute of Management, Member of Chartered Marketing and

Fellow of the International Doctors’ Association.

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USACo-founded in 2007, with a proven pipeline of products developed since 1984, HMP

develops and licenses-out to the trade, worldwide, complex generic drug products, copy

bio products and biosimilars. Rich is a member of the Editorial Board of the Journal of

Generic Medicines, a member of the Licensing Executives Society and is widely published in generics

and biosimilars.

Dr Janet M McNicholas, Partner, Jones Day, USANoted for her IP related achievements in biotech, pharma and medical products, Janet is

a registered patent attorney who has served the industry from start-up and emerging

growth companies, to private equity and venture capital investors, for over 25 years. Prior

to practicing law, she conducted research in immunology, molecular biology, biochemistry and genetics

at the University of Illinois, then at Stanford University and the California Institute of Technology as a

post-doctoral fellow of the Arthritis Foundation. Janet holds her Ph.D. in immunology and microbiology

from the University of Illinois and her J.D. from the University of Chicago Law School.

Led By:Seth Goldenberg, Senior Principal Scientist, NAMSA, USASeth was a former regulatory chemist with the FDA, holds a Ph.D. in Pharmacology fromthe University of Washington and a M.S. from the School of Biomedical Engineering atDrexel University. Previously, he founded Asia Pacific Bio Intelligence, with offices in

Philadelphia, PA (USA) and Shanghai (China), which focused on regulatory and quality consulting withfirms in the US and China to overcome hurdles and resolve issues with regulatory bodies. Currently, Sethprovides expert regulatory, clinical, and compliance services to medical device and healthcare productmanufacturers around the world.

Angela Luo, Senior Partner, Beijing Long An Law Firm Shanghai Branch, ChinaAngela has over 16 years legal experiences in electronics industry, medical,franchising, media, trading, logistics industries, especially in providing legalservice to those wholly-foreign invested companies, joint ventures. She set up

her own law firm in 2003 which was later merged with Beijing Long An Law Firm where shebecame a senior partner.

Objectives:This workshop will address the following business complexities and offer practical solutions.

B: The Art of Guanxi – Principles for Successful Business in China (14:00-17:30)

Objectives:The success of your business in China is significantly dependent on your personal relationshipsand careful planning at the beginning to meet your long-term goals. Your ability to maintainsuccessful partnerships, develop a balanced market entry plan, and overall success in Chinawill depend on your understanding of the cross-cultural differences and unique legal andregulatory framework.

This workshop will provide critical insights on:• How to do business locally

• How to setup the right business structure to meet your goals

• How to expand your company in the region

• How to attract and retain the right staff

• How to build commercial and distribution channels

POST-CONFERENCE WORKSHOPS: Thursday | 23 May 2013

C: Due Diligence for PharmaBiotech Collaboration and R&D Agreement (09:00-12.30)

Objectives:Due diligence is the key elementary step for any successful business collaboration. Attend thisworkshop for a better understanding of key issues regarding the process.

Agenda:• Overview of legal framework regulating R&D activities in China• Pitfalls to avoid in contract negotiation

~ Liability of inventor remuneration~ Dispute on inventorship~ Dispute of ownership of resulting IP assets~ Definition of Background and Foreground IPs and scope of the license~ Restrictions on reverse-engineering

• China technology import and export regulations: what technology can be brought intoand transferred out of China?~ Overview of compliance procedures~ Applying technology export licence in China

• Points to note during on-site inspection

Led By:Lewis Ho, Partner, Dechert LLP, Hong KongLewis leads the life sciences practice in Asia, helping life science, technology companies

and their financial sponsors to capture, manage, risk assess, evaluate and monetize their

intellectual property assets. His practice focuses on structuring technology transfer

transactions and enforcing intellectual property rights.

D: Gaining Biosimilars Approval in US and EU (14:00-17:30)

Objectives:To provide an overview of the regulatory requirements for marketing approval of biosimilarsin the US and EU, along with the challenges that sponsors face in developing a biosimilar.

Agenda:I. Introduction to biosimilarsII. Analytical and functional studies recommended by EU and US regulatory authoritiesIII. Animal studies to include pharmacodynamic, pharmacokinetic and toxicology studiesIV. Clinical trials for biosimilars to include pharmacovigilance

Led by:Dr Anita O’Connor, Managing Partner, Anita O’Connor Consulting, USAAnita worked for FDA for 16 years in the Center for Biologics Evaluation and Research (CBER),

the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine

(CVM), the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of the

Commissioner (OC). From 2000 to 2005 she was a preclinical reviewer in the FDA Division of Clinical Trials

in the Center for Biologics, and later in the Center for Drugs and Research in FDA. Her practice specializes

in drug development, advising clients on the regulatory and drug development process for new molecular

entities and biosimilar drugs.

Registration begins 30 minutes prior to this half-day workshop. An afternoon refreshment break is included.

Featuring Latest UpdatedIntelligence from:

Registration begins 30 minutes prior to this half-day workshop. An afternoon refreshment break is included.

Registration begins 30 minutes prior to this workshop. Half-day workshops include a refreshment break and lunch is catered for delegates attending a full day ie morning + afternoon workshop.

th biosimilars asia 2013 - giievent · “i improved my understanding of biosimilars development...

Documents