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Pre-conference workshop: Tuesday 18 November 2008 - Regulatory update for biogeneric drugs
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09.00 | Objectives
To highlight the current status of biogenic drugs in different regulatory environments, including Europe, Canada, and the United States.
• Biogenerics in Europe – a status update
• Biogenerics in Canada – a status update
• Biogenerics in the United States – regulatory and legislative considerations
• Technical and quality components
• Biogenerics and comparability requirements
o Chemical comparability
o Immunochemical comparability
• cGMP requirements
• Bioequivalence testing
• International harmonization for biogenerics
• Where is the FDA going with their approval?
Agenda outline and structure:
Presentations and panel discussion with interactions with workshop participants to cover the above noted topics
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Day One Morning Plenary – Wednesday 19 November 2008
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07.15 | Registration
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07.50 | Opening remarks from the Chair
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| | Mr Vijay Karwal, Managing Director - Healthcare Sector, The Royal Bank of Scotland
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08.00 | Congressional update and Q&A on Hatch-Waxman reforms
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08.40 | Update on Federal Trade Commission’s actions affecting generic medicines
The U.S. Federal Trade Commission has been actively investigating and monitoring developments in the pharmaceutical industry for many years, employing a broad range of tools, including law enforcement, research and study, and advocacy. This session will provide an update on the FTC’s actions affecting generic medicines, including, among other things:
- Recent developments in the brand-generic patent litigation settlement cases
- Actions to prevent generic drug companies from hindering generic competition
- Views concerning the competitive implications of authorized generics
- Findings from the drug company agreements filed with the FTC under the Medicare Modernization Act of 2003
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09.20 | Health economics, price controls and the impact of MediCare Part D on the generics market – payers’ perspective
- An integrated view of the total cost of healthcare and the role that generic medicines can play
- What are the purchasing criteria for generics and how will this evolve in the short and long term?
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| | Dr Jeffrey Kelman, Chief Medical Officer, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services
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09.50 | Purchasing power – what is driving the purchasing decisions of pharmaceutical wholesalers, distributors and pharmacies?
- What are decisions that big wholesalers make when selecting the generic label in their market – what are their criteria?
- 180 day exclusivity - how much influence does that really have on purchasing decisions?
- How much do patients care about the brand?
- How do they see the generic medicines market evolving in the short and long term?
- How are wholesalers and pharmacy chains competing with generic manufacturers?
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| | Mr Tony Foreman, CEO Almus and and Director of Commercial Affairs, Alliance Healthcare, United Kingdom
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10.20 | Speed networking
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11.05 | Coffee
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11.35 | Industry keynote: US generics market – opportunities and risks through the near horizon
• US health care dynamics
• Political/economic drivers
• Customer/supplier/partner models
• Pipeline considerations
• Sourcing/supply chain options
• Summary and outlook
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12.05 | Industry keynote: Global expansion - building scale, market share and value in today’s global generics market
- Access strategies for new markets
- Operating globally, while conducting business locally
- Executing on complex opportunities and a few of the keys to success
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12.35 | Lunch
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Day One Afternoon Stream A: IP strategy, legal issues and patent reform
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01.45 | Challenges in the global generic market place - IP in a dynamic environment
- Barriers to entry
- New problematic patent strategies
- Different laws in different countries
- Legislative changes in different countries, proposed data exclusivity, pediatric legislation
- Recent developments in selected countries that affect execution
- Who is the troublemaker? The brand or other generics?
- Managing the cost from an internal counsel perspective
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02.15 | Hatch-Waxman First-to-File Marketing Exclusivity, getting it, keeping it & avoiding forfeiture
- What is the 180-day marketing exclusivity and how can I get it?
- Avoiding forfeiture
- Future of forfeiture
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| | Mr Stephen R Auten, Vice-President, Legal — Intellectual Property, Sandoz, Inc. (Princeton, NJ)
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02.45 | Afternoon tea
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03.15 | Strategies to defeat the lifecycle management challenges for global generics manufacturers
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| | Mr Vijay Soni, Executive Vice President – IP, Glenmark Pharmaceuticals
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03.45 | Panel discussion: what is on the horizon for IP strategists to deal with in 2009-10?
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04.15 | Close of day one
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04.30 | Afternoon drinks reception
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Day One Afternoon Stream B: Globalization
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01.45 | How to grow from a regional to a multi national company
- Sales and market segmentation
- Generic branding
- Stake holders satisfaction
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02.15 | China – new trends and opportunities for the generics pharmaceutical industry
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02.45 | Afternoon tea
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03.15 | India – new trends and opportunities for the generics pharmaceutical industry
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| | Dr CB Rao, Deputy Managing Director , Orchid Chemicals & Pharmaceuticals, India
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03.45 | Panel discussion: how do those looking in view the US generics market?
The afternoon speakers will be joined by: |
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04.15 | Close of day one
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04.30 | Afternoon drinks reception
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Day Two - Thursday 20 November 2008
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08.00 | Registration
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09.00 | Opening remarks from the chair
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| | Mr Vijay Karwal, Managing Director - Healthcare Sector, The Royal Bank of Scotland
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09.10 | A Wall Street view of the generics industry - the challenges & opportunities
- Patent expiration outlook - where will the attractive opportunities be?
- Industry consolidation - what should we expect and will it happen?
- Competitive environment & outlook - how to be a viable competitor and is it changing?
- Brand defense strategies - what's working and what's not?
- Forecasting & valuation - how does Wall Street address the challenges of the business model?
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09.40 | How does private equity view the success of growth strategies to date and what will they be looking for from generics companies going forward?
- M&A outlook – what determines their success?
- Integration strategies – what do they favour?
- Who will be the winners and losers?
- What will it take to attract private equity funding?
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10.10 | R&D’s position in today’s generics companies
- Traditional role and hierarchy in organization
- New expanded role
- Expanded demands on innovation
- IP interpretation and support
- Business opportunities assessments
- Risk analysis
- Technology transfer
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10.40 | Morning coffee
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11.10 | Industry keynote: diversifying into generic biologics - a case study on entering the biogenerics market
This presentation will highlight:
- The current state of the global biogenerics market and its future outlook
- How to develop a clear strategy for entering the biogenerics market
- The evaluation/nurturing of skills needed to manufacture, develop and market generic biologics
- Other key considerations for entering the emerging biogenerics market
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12.40 | Industry keynote: generic biologics - how has the industry dealt with this new opportunity so far?
- Reviewing different business models that have been implemented so far
- What are potential market entry strategies in the near future?
- Justifying the risk exposure and cost of investment in new skills and processes
- How affordable is a biologics strategy?
- Developing a very clear strategy for how you are going to enter the market – do you have the skill sets required?
- How big is this market expected to be and how many players can it support?
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| | Mr Patrick Vink, Senior Vice President, Global Head of Biologics, Mylan Inc , Switzerland
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13.10 | Lunch
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14.20 | The role of R&D within generic companies - how the R&D model is changing with the generic business environment
- What is life cycle management of generics
- Role of R&D in generic lifecycle management.
- R&D / business strategies for generic portfolio management
-Internal / external
-505b2 strategies
- Role of innovation & creativity
- Optimizing R&D value and productivity within a generic environment
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| | Dr Eric Mittleberg, Executive Vice President, Pharmaceutical Research & Development,, Par Pharmaceutical Companies, Inc.
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14.50 | What are big pharmaceutical companies plans for generics?
- Big pharmaceutical companies reactions to the growth of generic drugs
- Redefining the value proposition hurdle
- Identifying sustainable options to extend brand life cycle
- Looking for synergies with generics
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| | Dr Tony Ellery, Head Life Cycle Management , Novartis Pharma Portfolio Management, Switzerland
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15.20 | Subsequent entry (generic) biologics: a Canadian perspective of the scientific basis for regulation and guidance development
The talk will give
- An update on the status of regulation and guidance development in Canada
- An overview of the similarities and key differences between the Canadian and European systems
- An outline of the basic policy principles and scientific principles used in the development of regulatory guidance
- Perspectives on demonstrations of biosimilarity, including a brief overview of related, in-house research at Health Canada.
- A brief survey of “thorny issues” from the scientific and policy standpoint
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| | Ms Mary Alice Hefford, Research Scientist, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, , Health Canada , Canada
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15.50 | Chair’s closing summary
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16.00 | Tea and end of conference
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Post-conference workshop: Friday 21 November 2008 - Lifecycle management techniques applied to generics / super generics
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09.00 | Objectives
To understand the advantages of lifecycle management for generics, identifying key development requirements and regulatory strategies. A global perspective, interlinked with commercial and patent strategies, will ensure the ability to differentiate products within the current competitive market.
The workshop will examine the potential for new dosage forms, including:
- New routes – nasal spray / patches / needless injections
- New indications – increased patient populations / paediatric use
- New dosage forms
- New strengths
- Combination treatments
- Switch to OTC
Agenda outline and structure:
Presentations, interactive style, with practical sessions mixed with real examples covering:
- Regulatory environment for generics
- Lifecycle management for generics
- 505 (B)2– supergenerics / ANDA
- US and Europe - strategy for global development
- Clinical requirements to supergenerics / global considerations
- Practical exercises - developing a supergeneric
- Intellectual property and data exclusivity - global overview
- Information – gather and interpret
- Developing for a niche market – practical exercise
- Conclusions - differentiate to succeed
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| | Mr Andrew Willis, Vice President, Regulatory Affairs & Consulting Services, , Catalent Pharma Solutions, United Kingdom Mr James Baker, US Regulatory Affairs and Clinical Operations Director , Catalent Pharma Solutions
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