Phacilitate Vaccine Forum Geneva 2008

Agenda

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Day 3 \| Friday, May 16th 2008
8.00	Registration & buffet breakfast in the exhibition area
Morning plenary session Moving forwards, how can the industry best demonstrate the value of novel vaccines...
9.00	Chair's introduction Jan M. Reid, Senior Director, Vaccines Licensing, Wyeth Global Business Development
...to regulators?
European and US regulators' perspectives
9.10	EMEA perspective Experience, current and future considerations Review of evolution and experience in the centralised procedure Review what has been done with influenza pandemic vaccines, etc Speculation about future opportunities Dr John Purves, Head of Sector, Quality of Medicines, European Medicines Agency
9.35	Questions & discussion
9.40	US FDA perspective Defining the pre-pandemic vs pandemic influenza vaccine strategy from the US FDA perspective Considerations for evaluating the safety and efficacy of pre-pandemic influenza vaccines Regulatory challenges in evaluating adjuvanted pandemic influenza vaccines Considerations for licensing pandemic influenza vaccines that use novel technologies such as recombinant vaccines, non-egg based vaccines, non-HA vaccines, etc Dr Norman W. Baylor, Director, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
10.05	Questions & discussion
...to payers and patients?
10.10	Public sector perspective Discussing the evaluation process for novel vaccines in general, and HPV in particular Overview of vaccine evaluation in the UK The role of modelling and economic analysis Application to HPV vaccination: incorporating uncertainty in the evaluation John Edmunds, Head, Modelling & Economics Unit, Health Protection Agency
10.35	Questions & discussion
10.40	Roundtable discussion How can industry and public sector alike ensure that vaccines are best placed to drive the general shift in focus within the healthcare system at large from treatment to prevention? Panel to be comprised of the speakers of the session
11.00	Morning coffee in the exhibition area
Followed by your choice of 3 parallel sessions:

Focus session 1 What progress is being made in developing and harmonising regulations in key areas of concern for the vaccine industry?
11.40	Moderator's introduction François Verdier, Associate Vice President, Regulatory Affairs, sanofi pasteur
11.50	Perspective on the implementation of the EU Paediatric Investigation Plan (PIP) Clarifying the role of the 'Paediatric Network' - how will it facilitate the clinical development process? How will vaccines that are already licensed, but that are seeking broader applications/indications, be prioritised and addressed? What about the backlog for vaccines already in trials at the time of implementation? William M. Egan, PhD, Executive Director, PharmaNet Consulting
12.15	Industry perspective What are the main points to be aware of when designing a development strategy for a novel vaccine in Europe? Frank Vandendriessche, Pharmacist, PhD, Director, Regulatory Affairs Europe, Vaccines/Biologics, Merck Sharp & Dome (Europe) Inc
12.40	Questions & discussion
12.55	Lunch
Regulatory harmonisation for influenza vaccines
2.00	Industry perspective Overcoming the challenges in developing influenza vaccines in the US and Europe How do you balance the different timeframes for review and feedback within your overall development strategy? Dr Klaus Stöhr, Director, Influenza Franchise, Novartis Vaccines & Diagnostics
2.20	Questions & discussion
2.25	Presentations & panel discussion US and EU regulatory pathways for pandemic and pre-pandemic influenza vaccines Key areas of focus for harmonisation and progress Data requirements for pre-pandemic vaccines Speakers to include: Dr John Purves, Head of Sector, Quality of Medicines, European Medicines Agency Dr Norman W. Baylor, Director, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
3.10	Afternoon tea & close of the Phacilitate Vaccine Forum Geneva 2008

Or \| Focus session 2 Which vaccine manufacturing technologies hold the key to delivering reductions in cost and time-to-market?
11.40	Moderator's introduction Technologies for faster vaccine process development Integrated approach Process analytical technology High-throughput technology Disposable technology Platform technology Dr Leo A. van der Pol, Head, Process Development Department, Netherlands Vaccine Institute
12.05	Questions & discussion
Case studies: Comparing and contrasting cell culture manufacturing systems and technologies in development How are they performing in terms of yield, scaleability, flexibility (especially between normal and emergency demand situations) and the efficiency with which they can potentially be transported and established?
12.10	Case study An engineering approach to medium exchange process development A review of the Baculovirus expression system for vaccine production, An outline of media exchange process parameters Discussion on scale-up parameters and manufacturing considerations Colleen Sico, Manager, Upstream Development, Novavax, Inc
12.30	Case study The PER.C6 cell line - a rationally developed versatile platform for the manufacture of rAd vectors, classical vaccines and monoclonal antibodies Professor Jaap Goudsmit, Chief Scientific Officer, Crucell
12.50	Question & discussion
12.55	Lunch
2.00	Case study Large-scale vero cell culture for the production of influenza vaccines Serum-free Vero cell culture Platform technology Large-scale manufacturing Seasonal and pandemic influenza production Dr Manfred Reiter, Head of Upstream Development Group, Baxter BioScience
2.20	Question & discussion
2.25	Case study What progress is being made in the emerging field of nonculture, plant-based vaccine manufacturing systems? How are they comparing in performance to the traditional culture-based systems? Technical feasibility Environmental concerns Regulatory issues Business and market consideration The Center’s technology and its value in addressing issues related to safety, capacity, time efficiency and cost Technology transfer and implementation. Dr Vidadi Yusibov, Executive Director, Fraunhofer Center for Molecular Biotechnology
2.45	Questions & discussion
2.50	Panel discussion What challenges and opportunities remain in optimising disposable manufacturing and filtration technologies? Panel to be comprised of the speakers of the session, plus: Panellist: Dr Raf Lemmens, R&D Vaccine Program Leader, GE Healthcare Life Sciences
3.10	Afternoon tea & close of the Phacilitate Vaccine Forum Geneva 2008

Or \| Workshop What is the business/value proposition for your organisation in utilising a novel adjuvant? (Highly interactive session for a limited number of attendees)
11.40	Moderator's opening address: New paradigms and market opportunities in use of novel adjuvants to rejuvenate old vaccines Meeting the need for better vaccine adjuvants Detrimental adjuvant-antigen interactions Do adjuvants exist which don't cause excess vaccine reactogenicity? Successful navigation of FDA hurdles for new adjuvant-vaccine combinations Professor Nikolai Petrovsky, CSO, Vaxine Pty Ltd
11.55	Title to be announced Heather L. Davis, PhD, Site Head, Ottawa Laboratories, Vaccines Research, Pfizer Global R&D
12.20	Questions & discussion
12.25	Case study Examining the strategy behind a recent adjuvant deal - what is in it for both parties? The value and importance of adjuvants in new vaccines The features of Intercell's adjuvant IC31 Strategies to commercialise and partner a new adjuvant Case studies on adjuvant partnering deals Andreas Meinke, Head of Alliance & Grant Management, Intercell AG
12.50	Questions & discussion
12.55	Lunch
2.00	Panel discussion Defining the pros and cons of adjuvant use as a whole - what can an adjuvant do, and what can it not do, in reality? What impact will novel adjuvants have on the price of vaccines? Will their application price these vaccines out of the market for most of the world? How will we ensure an adequate supply of novel adjuvants in a mass-production scenario, such as a pandemic influenza outbreak? How easily can they be stockpiled? What about scaling-up issues? Panel to be comprised of the speakers of the session, plus: Dr Sarah A. Frech, Vice President, Clinical Development, IOMAI Corporation
3.10	Afternoon tea & close of the Phacilitate Vaccine Forum Geneva 2008

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