 | 6th Annual Biosimilars Conference
Revolutionizing biosimilars market - debates, challenges and innovations 2nd - 4th March 2010, Boston, USA
Background InfoKey Speakers
• Tina S. Morris, Vice President, Biologics and Biotechnology, United States Pharmacopeial Convention
• Yining Zhao, Associate Research Fellow, Strategy Management Group, Pfizer
• Dr. David L. Gollaher, President and Chief Executive Officer, California Healthcare Institute
• Les Jordan, CTO, Life Sciences Industry Unit, Microsoft
• Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP
• James Harris, CEO, Healthcare Economics LLC
• Clifford S. Mintz, Founder, BioInsights
• Mateja Urlep, Director, TikhePharma
• Dr Duu-Gong Wu, Executive Director, Pharmanet
• Brian J. Del Buono, Director, Sterne, Kessler, Goldstein & Fox
• Dr. Fethi Trabelsi, Director, Scientific & Regulatory Affairs, Anapharm
• Roger Lias, President, Eden Biodesign
• Senior Representative, Paraxel Consulting "The US biosimilar market, generating $0.06bn sales in 2008, will achieve significant revenues only after expected implementation of a biosimilar regulatory pathway in 2013, visiongain predicts. If this occurs, the US biosimilar market will increase to annual revenues of $1.95bn in 2014" (Source: Visiongain Report ‘Biosimilars and Follow-on Biologics 2009-2024’ Published: April 2009 Biologics constitutes a major share of expenditure in the USA and globally. It is one of the fastest growing sectors of the pharmaceutical industry which corresponds to over 15% of the total pharmaceutical market. There is a large and potentially lucrative demand for lower cost biological drugs worldwide. With favourable regulatory developments, the biosimilar sector should pick up significantly, however, forming an important developing pharma market. Visiongain's 6th Annual Biosimilars Conference will feature keynote addresses, presentations, case studies and interactive discussions from regulatory issues to manufacturing process, clinical assessment, commercialization and pricing. This three day event is an ideal forum for experts from the industry and academy sector together to discuss and share their experience and best practices. Why Attend?
• Discover the key strategies for process development/manufacturing of biosimilars
• Discuss the key regulatory and scientific issues of biosimilars and follow-on biologics
• Examine commercialisation of biosimilars
• Understand the development and marketing of biosimilars
• Assessing impact of IT driven patient adherence methodologies on biologics and biosimilars
• Learn how to develop and create strategic outsourcing strategies for biosimilars
• Network and discuss ideas with the leaders in the field Who should attend?
Branded Biotechnology, Pharmaceuticals & Generic Pharmaceutical Companies, Drug Regulators, Healthcare Agencies, Government Departments, Contract Research/Bio manufacturing, Organisations, Regulatory Affairs, Pharmacovigilance
VPs, Directors, Heads, Managers of:
• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Legal Affairs
• Intellectual Property
• Health Economics
• Pricing and Reimbursement
• Biopharmaceuticals/ Biotherapeutics
• Clinical Immunology
• Principal Scientist
• Payers
• Chief Scientific Officer
• Process Control and Analytical Technologies
• Analytical Characterisation
• Regulatory Compliance
• Pharmacovigilance
• Drug Safety & Risk Management
• Quality Affairs/ Quality Control
• New Product Development
• Process Science
• Portfolio Management
• Research & Development
• Business Development
• Business Operations
• Scientific Affairs
• Commercial Affairs
• Marketing
Workshop Pre-Conference Interactive Workshop, Tuesday 2nd March 2010, Boston, USA Creating confidence in a new wave of biologics therapy - Overcoming barriers to entry Led by: Gil Bashe, Executive Vice President, Makovsky + Co
Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, sanofi-aventis
Kristie Kuhl, JD, Senior Vice President, Makovsky + Company
Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks
Agenda:
Legislative pathways for biosimilar regulatory approval may provide significant implementation confusion. The wrong path to biosimilar approval may jeopardize ability to develop future advancements and place obstacles in the path to reducing healthcare costs. The debate on whether legislation is pro-innovator or biogenerics entrepreneur may overshadow addressing key concerns for future success. This workshop will summarize the key concerns and enable participants to tackle these issues. Discussions include:
• How much authority will FDA have to make case-by-case approval decisions?
• What should the clinical data requirements be for approval, immunogenicity and subsequent interchangeability?
• Class and product-specific naming
• How should market exclusivity address ever greening?
• How does patent law affect FOBs entry into the market?
• What should the nomenclature system be to reduce confusion and promote patient safety? About your workshop leaders: Gil Bashe, Executive Vice President, Makovsky + Co
Workshop Leader
Mr. Bashe is counselor to pharmaceutical, biotechnology, medical-device manufacturers and patient advocacy groups. He has advised clients on follow-on-biologic (FOB) policies and reimbursement, first in Europe and now in the United States. Mr. Bashe is a limited partner with GTCR Golder Rauner, one of the nation’s leading private-equity firms and was CEO of CommonHealth, a WPP Group company, having served as at sister-company Hill and Knowlton as Worldwide Health Practice director overseeing policy, provider and product communications. Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, sanofi-aventis
Dr. Harvey leads the sanofi-aventis Corporate Regulatory Affairs (CRA) office in Bethesda, Maryland and interacts with the Food and Drug Administration (FDA), C-Path Institute and key industry representatives on behalf of sanofi-aventis. He represents sanofi on PhRMA, Regulatory Affairs Coordination Committee, and BIO’s Regulatory Affairs Committee. Prior to joining sanofi, Dr. Harvey worked at the FDA in CDRH, CBER and CDER centers for more than 11 years and worked on health issues in the U.S. Senate. Dr. Harvey completed his Ph.D. in biochemistry and his M.D. degree at the University of Connecticut. Kristie Kuhl, JD, Senior Vice President, Makovsky + Company
Kristie Kuhl provides counsel on issues that impact biotechnology, specialty pharma, dietary supplements and medical devices. Her legal and communication skills provide keen insight in bringing together communities with diverse interests especially important in the FOB arena. She has provided counsel on the issues surrounding biosimilar approvals in Europe including communicating the differences between biosimilars and generic drugs. Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy
Dr. Francis Palumbo is both a lawyer and registered pharmacist and approaches biosimilars with a unique perspective. He has a strong interest in pharmacy and food and drug law, pharmacoeconomics, pharmacoepidemiology and health services research. As an adjunct professor at the Maryland School of Law, he teaches a course in food and drug law, including content on foods, dietary supplements, drugs and other products regulated by the FDA and its sister agencies. Dr. Palumbo received his B.S. in Pharmacy from the Medical University of South Carolina, M.S. and Ph.D. in Health Care Administration from the University of Mississippi and J.D. from the University of Baltimore Law Center. About: Makovsky + Co
Founded in 1979, Makovsky + Company is today one of the nation’s leading independent global public relations consultancies. The firm attributes its success to its original vision: that the Power of Specialized ThinkingTM is the best way to build reputation, sales and fair valuation for a client. Celebrating its 30th year in 2009, Makovsky has received numerous industry accolades including; the American Business Awards 2009 PR Agency of the Year and Holmes Report 2009 Multispecialist Agency of the Year. Based in New York City, the firm has agency partners in more than 26 countries and in 35 U.S. cities through IPREX, the third largest worldwide public relations agency partnership, of which Makovsky is a founder.
For further information, please visit: www.makovsky.com Day 1Day 1, Wednesday 3rd March 2010, Boston, USA 09:30 Registration and refreshments 10:00 Opening address from the chair James Harris
CEO
Healthcare Economics LLC 10:10 Opportunities and challenges for biosimilars in the global market
• Assessing the promise and potential for biosimilars
• Latest progress in biosimilars development
• Regulatory update on bioequivalence, interchangeability and substitution for biosimilars
• Provider perspectives and acceptance of biosimilars
• Payer perspectives and formulary acceptance
• Examining the viability of biosimilars & ROI considerations James Harris
CEO
Healthcare Economics LLC 10:50 Commercializing biosimilars: Will they really be able to compete?
• Size and location of markets
• Manufacturing and distribution challenges
• Interchangability and substitution issues
• Branding and pricing concerns
• Market penetration and physician uptake Clifford S. Mintz
Founder
BioInsights 11:30 Morning refreshments 11:50 Demystifying the market aspects/implications of follow on biologics
• Market positioning and attractiveness
• Strategies
• Commercial operations R.T. (Terry) Hisey
Vice Chairman and U.S. Life Sciences Leader
Deloitte LLP 12:30 Presentation to be announced Dr. David L. Gollaher
President and Chief Executive Officer
California Healthcare Institute (CHI) 13:10 Networking lunch 14:30 The impact of a patient centric viewpoint on biosimilars
• Review of emerging PHR and patient centric healthcare information technology (HIT) and how it applies to biosimilars
• Includes a discussion of the effect of IT driven patient adherence methodologies on biologics and biosimilars Les Jordan
CTO, Life Sciences Industry Unit
Microsoft 15:10 Strategies for process development/manufacturing of biosimilars (for global markets)
• The biosimilar CMC section - what does it look like?
• Where (if anywhere) can time be saved when developing a biosimilar production process?
• Derivation of cell lines and materials
• The importance of analytics and comparability protocols
• Early mistakes can be expensive - what to be aware of Dr. Roger Lias
President
Eden Biodesign 15:50 Afternoon refreshments 16:10 Presentation to be announced Senior Representative
Parexel 16:50 Acceptance criteria for immunogenicity of Biosimilars
• Assessing the risk of strategies of immunogenicity
• Evaluating the potential of immunogenetic response 17:30 Closing remarks from the chair 17:35 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting Day 2Day 2, Thursday 4th March 2010, Boston, USA 09:30 Registration and refreshments 10:00 Opening address from the chair 10:10 Role of USP standards in the quality assessment of biological medicines
• Role of the official compendial and standard-setting process
• Value of public standards and monographs
• Quality assessment of biological medicines
• Analytical challenges and future developments Tina S. Morris
Vice President, Biologics and Biotechnology
United States Pharmacopeial Convention 10:50 An overview on regulatory and scientific issues of biosimiars and follow-on biologics
• Updates on regulatory and, scientific issues related to biosimilars and follow-on biologics
• Discussions on technical challenges for the approval of biosimilars/follow-on biologics
• Requirements of CMC, pre-clinical and clinical studies using examples of approved products in both US and Europe Dr. Duu-Gong Wu
Executive Director, Consulting Division
PharmaNet 11:30 Morning refreshments 11:50 Legislative and regulatory developments impacting the biologics and biosimilars marketplace
• Update on progress of biosimilars legislation through the U.S. House and Senate
• Analysis of the provisions of the competing U.S. bills
• Comparison of the proposed biosimilars legislation to small molecule regulation under Hatch-Waxman
• Views of affected constituencies (biopharma companies, generics companies, health care providers, patients)
• Comparison of the proposed US regulatory scheme to those in other parts of the world (especially Europe and Japan) Brian J. Del Buono
Director
Sterne, Kessler, Goldstein & Fox 12:30 Trends and technical challenges for the development of biosimilars in China
• Understanding the current competitive landscaping of China’s biosimilars market
• Addressing the critical issues and gaps of China’s biologics R&D and manufacturing capabilities
• Discussing the trends and opportunities of the biosimilars/biobetters in China Yining Zhao
Associate Research Fellow, Strategy Management Group
Pfizer James Leung
Founder
James Leung Consulting 13:10 Networking lunch 14:30 Pharmacovigilance and risk management plans
• Evaluating key challenges
• Thorough risk-benefit analysis
• Need for a robust pharmacovigilance plan 15:10 Biosimilars - Succeeding in the market of the future
• From dream to reality
• The global biosimilars market today
• Lessons learned so far
• Evolving business models
• Delivering against the promise? Mateja Urlep
Founder, Tikhe Pharma
Former Global Head of Marketing and Medical, Sandoz 15:50 Afternoon refreshments 16:10 Clinical Phase 1 PK/PD trials for biosimilar/follow-on products
• The clinical comparability exercise
• PK/PD studies for early efficacy and safety assessment
• Study design challenges with some particular specific biosimilars Dr. Fethi Trabelsi
Director, Scientific & Regulatory Affairs
Anapharm 16:50 Presentation to be announced 17:30 Chair’s closing remarks 17:40 End of Conference
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