Health Network Communications, Washington
7/09/2011
Day One Tuesday 15 November 2011
8am Registration and coffee9am Opening remarks from the Chair› Richard Diccico, Chairman, Harvest Moon Pharma GENERIC INDUSTRY HEALTH CHECK9.15am Strategic analysis of the global generic industry from Wall Street's perspective• An overview of consolidation trends in the industry
• Key factors driving valuation in the sector
• Assessment of Investor & Market sentiment towards the sector Healthcare Investment Banking, Jefferies & Company 9.45am KEYNOTE: Global generic market review: industry development, challenges and opportunities• Building a second generation generics company
• New times – new approaches
• Alvogen’s Roadmap to growth Executive chairman, Alvogen 10.15am How sustainable is the current generic use?• Role of generic medicine in a sustainable health care system
• Finding the balancing between innovation & generic competition
• Options to improve generic competition 10.45am Speed Networking followed by morning refreshments11.45am KEYNOTE: Considerations for diversifying into biosimilars• What are the capabilities required for success in the development, manufacture and marketing of biosimilars? Head of Global R&D Biologics, Mylan 12.15pm Are biosimilars really new and will we see a biosimilar approved under the recently established pathway in the next 5 years?• Understand which disease states currently have approved biologics with multiple competitors who are “similar” in nature and gain insight into how companies have differentiated themselves in an undifferentiated marketplace
• What are the commercial implications a biosimilar manufactures faces when deciding to gain approval via the BLA pathway versus Biosimilar pathway?
• Discuss the opportunities and challenges a manufacture will experience to successfully launch a biosimilar from a managed care, marketing, sales force and medical perspective Executive Director Orencia, BMS 12.45pm Emerging business models for commercial success in biosimilars• Which are the key strategic level success factors to win in the biosimilar space?
• What are emerging business models and how do they help biosimilar players to address key success factors?
• How, if at all, does a winning business model have to differ by market? Director, Strategic Commercial Effectiveness, Biogen Idec US INDUSTRIAL POLICY FOR GENERIC DRUGS2.15pm KEYNOTE: Congressional update and Q&A session• Competition vs access to affordable medicines
• Update on legislative pathway for biosimilars in USA Member of Congress, United States Congress 2.45pm KEYNOTE: Strategic look at the generics industry in the US• Role of generic medicines in the provision of affordable and effective healthcare
• Future strategic drivers in the US generics market Executive Vice President of Americas sales, Actavis 3.15pm Update on US Health Care Reform and impact of recent US legislation on generics• Update on the implementation of health care reform
• Prospects for health care legislation this year › Lori Neal Bowman, Director, Federal Government Affairs, Hospira 3.45pm FTC actions affecting the generic industry• The latest on patent settlements
• Authorized generics Attorney, Health Care Division, Federal Trade Commission 4.15pm Afternoon refreshmentsMAKE YOUR VOICE HEARD- INTERACTIVE SESSION4.45pm ROUNDTABLE: Choose and join in-depth discussion sessions led by industry leading expertsA - Overcoming the barriers of entry into the biosimilars market
• Is it a viable proposition to be in the US biosimilars market
both in thet short and the long term?
Led by Richard Dicicco, Chairman, Harvest Moon
Pharmaceuticals B - Partnering in the global generics market
• M&A and collaborations are a prominent part of the industry
as a route to faster market access and better efficiencies.
• What do you need to consider for strategic partnering?
Led by Robert Steininger, Healthcare Investment Banking,
Jefferies & Company, Inc. C - Strategies and considerations for entering high
growth markets
• In this ever expanding global market, what are the benefits
and challenges of concentrating on emerging, high growth
markets vs more established western markets?
Led by Marcio C. O. e Silva, Branded Generics Coordinator /
Policy & Intelligence, GlaxoSmithKline Brazil › Richard Diccico, Chairman, Harvest Moon Pharma Healthcare Investment Banking, Jefferies & Company › Marcio CO Silva, Regulatory Affairs - Branded Generics Coordinator, GlaxoSmithKline 5.15pm Day Two Wednesday 16 November 2011
9.10am Generic medications - predictors, perceptions and policies• Explore patient and physician perceptions of generic use
• Describe the clinical implications of generic medication use
• Discuss the effects of numerous policies on generic use Director of the Rapid-Cycle Evaluation Group, Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital Harvard Medical School 9.40am Purchasing power: what is driving the purchasing decisions of the pharmaceutical supply chain?• Role of value vs price
• Role of adherence in driving better outcomes
• What payors will want from biosimilars (research and HEOR
data) President, Global Pharma Strategies, Medco INTERNATIONAL MARKET REVIEW10.10am Market dynamics in Africa: show me the money!• Trends & opportunities: where is the money?
• Challenges & constraints: how to get the money?
• Way forward: who can get the money? 10.40am Morning refreshments11.10am Opportunities and challenges for generics in Brazil• Changing market structure and present landscape in Brazil
• Regulatory and patent environment
• Competitive dynamics in generic launches
• Opportunities and challenges for new entrants Vice President Operations, EMS 11.40am Commercial opportunities of generics and biosimilars in emerging markets• Market opportunity
• Growth drivers
• Key success factors influencing product uptake Chief Executive Officer, Celestial Biologicals and Chief Commercial Officer, Celestial Biologicals, Intas Biopharmaceuticals 12.10pm Strategies and opportunities for smaller and niche generic companies working in the biosimilars and biobetters space• Commercializing biobetters derived from biosimilars
• Opportunites in novel drug formulation technologies and drug delivery technologies will be applied to biosimilars
• Compass case study: combining outsourced API with patented formulation and/or delivery technologies to derive biobetters with characteristics such as improved stability, improved half-life, improved patient compliance, and lower cost to the patient or provider
• The role partnering can play in global commercialization Founder / Director, Compass Biotechnologies 12.40pm An investor’s perspective on biosimilars• Views on the investment opportunities and challenges in biosimilars
• Suggestions for effective fund-raising 2.10pm PANEL SESSION: What does the industry need to do to drive the evolution of biosimilars?› Bill Haddad, Founder & CEO, Biogenerics Vice President U.S. Regulatory Policy, Global Industry Regulatory Affairs, Sanofi-Aventis 2.40pm Commercial success from biosimilars – Is it possible?• The landscape for biosimilars: what currently exists in terms of the commercial landscape?
• Biosimilars should provide patients with access to quality affordable medicines in an age of cost constraints; payor implications
• Why Pfizer is in the mix?
• Learnings from the past will shape the future
• Commercial planning – the right mix General Manager, Biosimilars, Pfizer 3.10pm Regulation of Subsequent Entry Biologics (SEBs) in Canada• HC has developed a “Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)” in order to enable sponsors to satisfy the information and regulatory requirements under the Food & Drugs Act and Regulations for the authorization of SEBs in Canada
• Case study: Omnitrope, the first SEB filed and authorized for marketing in Canada
• At the end of the review, Omnitrope was granted marketing authorization with two indications, same as those authorized for the comparator in Canada Chief, Pre-market Clinical Evalutation Division, Biologics and Genetic Therapies Directorate, Health Canada 3.40pm Portfolio development considerations biologics• Product selection and prioritization for biosimialar product portfolio
• Product and portfolio valuation Associate Director, Portfolio Development - Biologics, Dr. Reddy's Laboratories 4.10pm Biosimilars quality considerations – do the same rules for generics apply to biosimilars?4.40pm Closing remarks from the chair |
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