Terrapinn Ltd, Palais des Congrès de Lyon
3-5 October 2005
Pre-conference briefing: biodefenseSeparately bookable Monday 3rd October 2005 8:15 Registration 9:00 Chairperson’s opening remarks
Dr Klaus Neurohr, Head of Quality and Regulatory Affairs, Avecia
BIODEFENSE VACCINE DEVELOPMENT ISSUES
9:10 Leveraging the value of a single product to build a sustainable biodefense business
• Strategies for 'evergreening' of the existing product
• The development of next generation products
• Building a portfolio in biodefense vaccines and therapies
Dr Stephen Chatfield, Chief Scientific Officer, Emergent Biosolutions
9:40 Building a biodefense vaccine industry in Europe: what steps are required?
• What do companies require from NGO’s and governmental organisations in order to make this a viable option?
• What requirements are needed by governments to address the industry’s concerns: liability and IP protection?
• What incentives and assurances are in place to attract companies to develop biodefense vaccines?
Kim Bush, President Vaccines SBU, Baxter Healthcare Corporation
10:10 Overview and update on Project BioShield
• What is the global importance of Project BioShield?
• What steps have been taken so far?
• Are the initiatives working?
• What is the next stage in the program?
Gregory Levine, Partner, Arnold and Porter LLP 10:40 Morning coffee QUALITY AND REGULATORY ISSUES WITHIN BIODEFENSE 11:25 Clinical development of biodefense vaccines
• The FDA's approach to clinical development and related policies
• New approaches being taken
• Considerations for fast-track
Dr Jeff Brady, Medical Officer, FDA 11:55 Quality and regulatory aspects of biodefense vaccines
• Regulatory framework for Biodefense vaccine licensing in the US and EU
• Measures of Efficacy/Protective Effects: In-vitro and in-vivo assays
• Avecia's Anthrax and Plague vaccine programs
Dr Klaus Neurohr, Head of Quality and Regulatory Affairs, Avecia 12:25 Lunch 14:00 Panel session: will fast-tracking vaccines lead to greater problems down the line?
• What are the safety implications of fast tracking?
• What are the ethical considerations?
• What happens if the wrong decision is made?
Dr Klaus Neurohr, Head of quality and regulatory Affairs, Avecia
Lance Gordon, President, Vaxgen
Dr Trevor Marks, Business Development Manager, Health Protection Agency, Porton Down
Dr Jeff Brady, Medical Officer, FDA 14:45 Effective vaccine distribution strategies in the event of biodefense vaccine demand
• Lessons to be learned from the flu vaccine shortage
• When should the decision be taken to immunise?
• Are we prepared?
Lance Gordon, President, Vaxgen 15:15 Afternoon tea BIODEFENSE VACCINE PROCESS DEVELOPMENT 15:45 Anthrax vaccine; past, present and future
• Current products - how long are they needed?
• The next generation - where are we?
• Beyond the next generation - what are the new products in development?
• Who is driving the development of these products?
Dr Trevor Marks, Business Development Manager, Health Protection Agency, Porton Down 16:15 Case study – Ebola
• What new developments have been made?
• Overview of ebola
• Current research findings
Dr Jaap Goudsmit, Chief Scientific Officer, Crucell NV 16:45 Biodefense response – optimising manufacturing/delivery processes
• Necessity for regional/national stockpiles
• Stockpile formulary drivers
• Local planning for distributing stockpiles
• Rapid deployment at minimal cost-stockpile imperatives
Richard Nolan, Senior Advisor to the Director Strategic National Stockpile, CDC BIODEFENSE MODELLING STRATEGIES 17:15 Overview of the Animal Rule as a route to licensure
• Requirements for use of the Animal Rule
• Issues that should be addressed when designing the animal studies
• Approach to bridging the animal data to humans
• Update on animal models currently being used
Dr Mark Abdy, Veterinary Medical Officer, FDA-CBER 17:45 Close of briefing 17:45 Pre-congress registration and welcome cocktail reception sponsored by:
JRH Biosciences Day one Tuesday 4th October 2005 Plenary 8:00 Registration and coffee 8:45 Chairperson’s opening remarks
Dr Una Ryan, President and CEO, AVANT Immunotherapeutics VACCINE FUNDING 9.00 Keynote presentation: vaccine-funding initiatives
• International development assistance to meet the millennium development goals
• What is the future of vaccine funding
• Funding principles
Dr. Lob-Levyt, CEO, The Vaccine Fund, Executive Secretary, GAVI
9:30 New partnerships for development between NGOs, PPPs and the vaccine industry
• New vaccines for new markets
• Pricing models
• Advanced purchase contracts
Jacques-Francois Martin, President, Parteurop 10:00 Panel session: what direction should vaccine funding take?
• What are the key areas lacking funding?
• Is this funding sustainable?
• Are the correct projects receiving money?
Jacques-Francois Martin, President, Parteurop
Dr JM Okwo-Bele, Director of the Department of Immunization, Vaccines and Biologicals, WHO
Dr Wayne Koff, Vice President, The International AIDS Vaccine Initiative 10:45 Morning coffee GLOBAL VACCINE DEVELOPMENT 11:30 Challenges of vaccine manufacture in developing countries
• Market drivers - impact on technology, manufacturing scales and costs
• Intellectual property rights - impact on innovation ability.
• Regulatory environment - new challenges and impact on costs.
• Funding - prospects and ground realities.
KV Balasubramaniam, Managing Director, Indian Immunologicals 12:00 Global immunisation vision and strategies 2006-2015 and WHO role to support its implementation
• Protecting more people in a changing world
• Introducing new vaccines and technologies
• Linking immunisation to other interventions
• Immunisation and surveillance in the health systems context
• Immunising in a context of global interdependence
Dr JM Okwo-Bele, Director of the Department of Immunization, Vaccines and Biologicals, WHO 12:30 Lunch
Working Session 1 – ISSUES CONCERNING INFLUENZA AND AVAIN FLU
14:00 Moderator’s opening remarks
Dr Reinhard Glück, Director of Research and Development, Berna Biotech 14:15 Human infections with avian influenza A H5N1: what do we know, and not know?
• What is the clinical spectrum and pathogenesis?
• What is the extent of bird-to-human transmission?
• What is the likelihood of human-to-human transmission?
• Treatment and prevention?
Dr Menno de Jong, Clinical Virologist, Oxford University Clinical Research Unit, Hospital for Tropical Diseases Viet Nam 14:45 Vaccines which can limit the spread of Influenza virus
• The characteristics of current influenza vaccines
• The characteristics of new influenza vaccines in development
• What kind of research in vaccinology is further needed
Dr Reinhard Glück, Director of Research and Development, Berna Biotech 15:15 Lessons to be learned from the Influenza vaccine shortage
• Was the panic justified?
• Was the response appropriate and have the initial enforced restrictions caused a decrease in vaccine uptake?
• What is being done with regard to surplus stocks in some areas and adequate stocks in other?
Dr Klaus Stohr, Coordinator, Global Influenza Programme, WHO 15:45 Speed networking 16:45 Afternoon tea 17:15 Discussion session: what is the likelihood of human-to- human transmission?
• What is the general feeling within the scientific community?
• What research needs to be carried out?
• What implications will this have on existing health care services?
Dr Menno de Jong, Head of Virology, Oxford University Clinical Research Unit, Hospital for Tropical for Tropical Diseases Viet Nam
Dr Bram Palache, Global Medical Affairs Director, Influenza Vaccines, Solvay Pharmaceuticals
Dr Klaus Stohr, Coordinator Global Influenza Programme, WHO 18:00 Advances in cell culture technologies
• What advances have been made?
• Vaccines in development
• Decreasing timelines
• Increasing stability and chances of mutations
Dr Ronald Neeleman, Manager Influenza Vaccine Development, Solvay Pharmaceuticals B.V. 18:30 Close of day one and cocktail reception sponsored by:
Lyon Bioadvisor logo
Working Session 2 – VACCINE DELIVERY AND ADJUVANTS
14:00 Moderator’s opening remarks
Prof. Alexander Von Gabin, Chief Executive Officer, Intercell 14:15 Adjuvants, antigens and intranasal delivery
• Specific immune response
• Protective antigens
• Safety and drug master file
Prof. Alexander von Gabain, Chief Executive Officer, Intercell 14:45 The biological and industrial challenge of new adjuvants for vaccines
• New adjuvants in development
• Optimisation of immune response
• Challenges faced with regard to safety, efficacy and industrial production
Gwyn Davies, Director Research and Development, OM Pharmaceuticals 15:15 Case study: transcutaneous vaccine delivery
• New developments in patch technology
• Mode of action
• Possibilities – travellers vaccines, cancer and infectious disease
Dr Mark Kendall, Associate Director, Medical Engineering Unit, University of Oxford 15:45 Speed networking 16:45 Afternoon tea 17:15 Discussion session: is needle free vaccine delivery the future?
• Have the new methods advanced enough?
• Overcoming the problem of working against a proven method
• What is the feeling within the industry?
• Can this be a reality?
Dr Gregory Glenn, Senior Vice President and Chief Scientific Officer, Iomai Corporation
Gwyn Davies, Director Research and Development, OM Pharmaceuticals
Dr Mark Kendall, Associate Director, Medical Engineering Unit, University of Oxford
Dr Jill Makin, Director of Product Development, Microscience 18:00 Oral delivery of antibiotic free live attenuated bacterial vaccines
• Delivery of large numbers of antigens
• Increased stability
• Implications for infectious disease prevention and treatment
• Overcoming problems of antibiotic compromised environments
Dr Jill Makin, Director of Product Development, Microscience
18:30 Close of day one and cocktail reception sponsored by
Lyon Bioadvisor
Working Session 3 – THERAPEUTIC AND PROPHYLATIC VACCINES
14:00 Moderator’s opening remarks
Dr Luc Hessel, Executive Director Medical and Public Affairs, sanofi pasteur 14:15 Therapeutic vaccines: have the promises been delivered?
• Has all the “hype” been justified?
• Updates on advances in this sector
• Do we have a full understanding of virus/host interactions?
• Do we have and understanding of their mechanisms of evasion?
Dr Jean-Yves Bonnefoy, Chief Scientific Officer, Transgene S.A. 14:45 Therapeutic vaccines: recent developments in HIV and cancer
• What are the current vaccines in development/on the market?
• What are the results so far?
• What are the timeline involved?
Dr Reiner Laus, President and CEO, BN ImmunoTherapeutics 15:15 Prophylactic vaccines: are these the realistic future?
• HIV vaccines which way is best?
• What is the future of prophylactic vaccines?
• What new vaccines have come on to the market?
• Are lifestyle vaccines the more profitable option?
• New Japanese Encephalitis Vaccines
Dr Michael Buschle, Chief Technology Officer, Intercell 15:45 Speed networking 16:45 Afternoon tea 17:15 Discussion session: have therapeutic vaccines lived up to their promises?
• What is the general feeling within the industry?
• Could these be the future?
• Chronic viral diseases
Dr Reiner Laus, President and CEO, BN ImmunoTherapeutics
Prof. Alexander Von Gabin, Chief Executive Officer, Intercell
Dr Jean-Yves Bonnefoy, Chief Scientific Officer, Transgene S.A. 18:00 Comparison of the product development challenges of prophylatic vs. therapeutic vaccines
• Is there an actual choice between developing a prophylactic vs. therapeutic vaccine?
• What are the manufacturing implications?
• When should the decision be made?
• Is it simply a question of cost?
Crawford Brown, Chief Executive, Eden Biodesign
18:30 Close of day one and cocktail reception sponsored by
Lyon Bioadvisor
Day two Wednesday 5th October 2005
8:00 Registration and coffee
CLINICAL DEVELOPMENT 8:30 Chairperson’s opening remarks
Charles M Proby, Vice President Sales and Marketing, Biotechnology and Life Sciences, Cardinal Health 8:40 Vaccine clinical trial design considerations
• Safety considerations
• Ethical issues
• Choosing the most appropriate cohort
• Setting timelines and end points
Professor Angus Dalgleish, Research Director, Onyvax
9:10 Optimising antigen selection for novel vaccines
• Methodologies for T-cell epitope discovery and enhancement
• CTL versus humoral response
• Development of "polypeptide vaccines"
• Presentation of selected cases
Philippe Stas, Chief Operating Officer, AlgoNomics MANUFACTURING STRATEGIES 9:40 Acceptable safety limit for residual DNA from continuous cell substrates in
an oral vaccine: studies supporting licensure of a Pentavalent Rotavirus
Vaccine
• Brief description of Merck's Rotavirus Vaccine
• Overview of residual DNA limits in vaccines
• Proposal for new oral limit for the level of residual DNA in an oral
vaccine
Dr Jose Lebron, Research Fellow, Department of Preclinical Safety Assessment, Merck Research Laboratories 10.10 State of the art prefilled syringe line
• Barrier technology
• Level of automation
• Labeling and packing considerations
• Regulatory compliance
Guy Mahieu, Director of Marketing, Cardinal Health 10:40 Morning coffee 11:30 Scale-up manufacturing and vaccines for global health
• Predictive and analytical risk assessment tools
• Ensuring a smooth transition from research to production scale manufacture
• How to improve timelines?
Dr Una Ryan, President and CEO, AVANT Immunotherapeutics 12:00 Panel session: developing novel vaccines what is the need for risk assessment and regulation?
• Does the regulatory process hinder vaccine development?
• What impact does this have on cost and timelines?
• What improvements can be made to avoid conflict and allow development?
• The need for enhanced scientific expertise
• Risk/benefit ratio of public health intervention
Dr Reinhard Glück, Director of Research and Development, Berna Biotech
Dr Luc Hessel, Executive Director Medical and Public Affairs, sanofi pasteur
Dr Una Ryan, President and CEO, AVANT Immunotherapeutics 12:45 Lunch
14:15 Chairpersons opening remarks
Dr Helene Pora, Vaccine Application Development Director, Pall Life Sciences
UPDATES ON VACCINES IN CLINICAL DEVELOPMENT 14:25 Case study: The RTS,S/AS02A Malaria vaccine candidate
• Overview of malaria vaccine field
• Update on RTS,S/AS02A clinical development & findings
• Future plans
Dr Joe Cohen, Vice President – Research & Development, Vaccines for Emerging Diseases and HIV, GlaxoSmithKline Biologicals S.A. 14:45 Case study: Rotavirus
• Overview of rotavirus infection
• Updates on current findings
Dr John Wecker, ADIP Director, PATH 15:05 Case study: HPV vaccine
• AS04, a new adjuvant system for prophylactic vaccines
• Overview of adjuvant development
Dr Nathalie Garcon, Director, Research and New Technologies, GlaxoSmithKline Biologicals 15:25 Q&A session 15:45 Afternoon tea 16:15 Case study: TB subunit vaccines - status and remaining problems
• Antigen discovery in the post genomic era
• The influence of delivery systems
• Animal models
Dr Peter Andersen, Director Dept. of Infectious Disease Immunology,
Statens Serum Institut 16:50 Case study: Poxvirus Vaccine Strategies for the Treatment of Cancer
• Overview on how the vaccine works
• Update on trial results
Dr Howard Kaufman, Vice Chairman, Surgical Oncology, New York Presbyterian Hospital- Columbia Campus 17:10 Case study: HIV
• Overview of HIV to date
• What is the current status?
• What is the future?
Dr Wayne Koff, Senior Vice President, Vaccine Research International AIDS Vaccine Institute 17:30 Case study: LAG-3 (IMP321) - a human protein used as a vaccine adjuvant to induce T-cell responses
• Overview of LAG-3
• Preclinical studies with IMP321
• Results of two large randomised phase I/II trials with IMP321
Dr Frédéric Triebel, Scientific and Medical Director, Immutep S.A. 17:50 Q&A session 18:00 Close of conference Post-conference workshop Thursday 6th October 2005
NEGOTATING PARTNERSHIP DEALS
Benefits of attending the workshop This highly interactive workshop will allow delegates to put into practice negotiating strategies, enable them to identify problems in complicated legal documentation and come to mutually acceptable solutions. Who should attend? This workshop would be of great benefit to delegates who are new to contract formation and negotiations in the vaccines industry. It will also be of benefit to delegates that require a refresher course, to help stay up to date in this constantly developing field. Your workshop leader: Simon Portman is Partner and Head of Life Sciences Department at Hewistons. He joined in 1996 and specialised in commercial and intellectual property law, largely for life science clients in the UK, Europe and the US. He sits on the Intellectual Property Advisory Committee of the Bioindustry Association, is a member of the Eastern Region Biotechnology Initiative (ERBI) and the Oxfordshire Bioscience Network and regularly gives seminars in the UK and internationally. He is co-author of the book “Commercial Issues for Lifescience Companies” and is currently co-writing the book “Intellectual Property: the Lifeblood of Your Company” with a colleague. 9:00 An opening presentation summarizing the key issues which arise when one is negotiating a drug development collaboration such as:- • Getting to the deal and picking the right partner
• Confidentiality agreements, materials transfer agreements, heads of terms
• The allocation of roles and risk between the parties
• Regulatory issues
• The use of management committees to coordinate projects, market products, formulate patent filing and defense strategy and solve disputes
• Intellectual property licensing, development, ownership and enforcement
• Different methods of payment – royalties, milestone payments, upfront fees, equity
• Sanctions in the event of a breach – built-in contractual remedies, damages, injunctions, specific performance
• When to terminate and what happens on termination
• Different methods of dispute resolution – mediation, arbitration, litigation
• Choice of law and jurisdiction
• How business practices and negotiating tactics vary from country to country – Northern and Southern Europe, USA, Japan, China, Middle East
10.30 Morning coffee
11:00 Working groups • Delegates will be presented with the imaginary scenario of a drug development collaboration between a large US pharmaceutical company and a smaller European biotech company.
• It is proposed in the scenario that the US company’s drug delivery device will be sold in combination with the European company’s vaccine and joint developmental work will be carried out to make this possible.
• The delegates will be split into two groups each representing one side of the collaboration.
• Each group will be given a list of the aims of the collaboration from its point of view and a copy of the proposed agreement between the parties, drafted by US pharma.
• The delegates will then review the agreement, discuss it among others in their group and formulate a negotiating strategy. 13:00 Lunch 14:30 Negotiating the contract • Delegates will negotiate the contract with the other side in teams.
16:00 Coffee break
16:30 Review of the negotiation and points of interest raised • Once the session is completed, delegates will give a resume of what they agreed and how they felt they did in the negotiation
• Delegates will be given a run-down of any other pertinent issues which they may have missed
17:00 Close of workshop
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