Phacilitate Vaccine Forum Baltimore 2006
Presentations
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Monday January 22nd 2007
Pre-conference Workshop
Morning plenary session
Government, industry and regulatory perspectives on funding, licensing, stockpiling, pre-pandemic priming, research priorities, and technology choices for pandemic influenza preparedness
Chair’s introduction
Bill Helming, PRTM
What have been the outputs from the most recent round of US Government funding?
Dr Robert Kadlec, PRTM (formerly Staff Director, US Senate Bioterrorism & Public Health Preparedness Subcommittee)
How does the financial market view the opportunities and risks present in the influenza vaccine sector?
Matthew Geller, PhD, Rodman & Renshaw, LLC
Industry panel discussion
Leveraging recent funding to advance pandemic influenza R&D
Panellists:
Lota Zoth, MedImmune, Inc - NO SLIDES PRESENTED
Dr Vincent I. Ahonkhai, GlaxoSmithKline
Dr Bram Palache, Solvay Pharmaceuticals BV
Short presentations & panel discussion
What is the progress with Crisis Management Plans for pandemic influenza preparedness? Comparing US with Europe and Asia
Panellists:
Capt. Raymond A. Strikas, MD, Department of Health & Human Services
Dr Masato Tashiro, WHO Collaborating Centre for Reference & Research of Influenza
Bettie Voordouw, MD, PhD, MPH, Medicines Evaluation Board, The Netherlands & Member, Vaccines Working Party, EMEA
Workshop 1
Regulator / industry interface
Moderator’s introduction:
Overview of current regulatory strategies for pandemic and pre-pandemic influenza vaccines
Dr Norman W. Baylor, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
Clinical scenarios for pandemic influenza vaccines
Bettie Voordouw, MD, PhD, MPH, Medicines Evaluation Board, The Netherlands & Member, Vaccines Working Party, EMEA
International standardization of pandemic influenza vaccines: Japanese experience
Dr Masato Tashiro, WHO Collaborating Centre for Reference & Research of Influenza
Panel discussion - consider two perspectives:
- We have time to follow a "typical" regulatory path that checks all the boxes but at a faster than formal pace
- The pandemic starts tomorrow!
Panel comprised of the speakers of the session - NO SLIDES PRESENTED
Workshop 2
Harnessing novel influenza vaccine manufacturing technologies to address global shortages: Making the business case for building capacity with new technology
Leading cell culture manufacture technologies – scalability, capacity and performance
Moderator’s introduction
Dr Ali Alloueche, Novartis Vaccines – NOT AVAILABLE
Case study
The role of cell culture technology for the control of pandemic influenza
Dr Bram Palache, Solvay Pharmaceuticals BV
Case study
A recombinant hemagglutinin protein vaccine for influenza produced in insect cells
Drs Manon Cox, MBA, Protein Sciences Corporation
Case study
Update on leading live, attenuated vaccine manufacturing – scalability, capacity and performance
Drs Ben Machielse, MedImmune, Inc
Case study
Dr Gregory M. Glenn, IOMAI Corporation – NOT AVAILABLE
Workshop 3
Latest preclinical and clinical trial results for pandemic and inter-pandemic influenza vaccines
Moderator’s introduction
Case study
Baxter's whole virus, cell-culture derived H5N1 pandemic influenza vaccine
Greg Berezuk, Baxter BioScience – NOT AVAILABLE
Case study
Common epitope vaccine – what’s coming out of research?
Danilo Casimiro, PhD, Merck & Co, Inc
Case study
Virus-like Particle (VLP) vaccines for seasonal and pandemic influenza
Dr Rick Bright, Novavax Inc
Case study
Dose-sparing strategies for pandemic influenza vaccines
Professor Jaap Goudsmit, Crucell - NOT AVAILABLE
Afternoon plenary session
Panel discussion
Comparing international approaches to pre-pandemic vaccine benefit/risk assessment
Moderator:
Capt. Raymond A. Strikas, MD, Department of Health & Human Services – NO SLIDES PRESENTED
Panellists:
Dr Norman W. Baylor, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration – NO SLIDES PRESENTED
Bettie Voordouw, MD, PhD, MPH, Medicines Evaluation Board, The Netherlands & Member, Vaccines Working Party, EMEA – NO SLIDES PRESENTED
Professor Jaap Goudsmit, Crucell – NO SLIDES PRESENTED
Tuesday January 23rd 2007
Main Conference – Day 1
Morning plenary session
Leveraging public and private funding, procurement and distribution mechanisms for western and developing world vaccines
Chair’s introduction
Dr Allan P. Jarvis, Corporate Development, sanofi pasteur – NO SLIDES PRESENTED
Panel discussion
Update on BioShield II
Moderator:
John M. Clerici, McKenna Long & Aldridge LLP
Panellists:
Thomas R. Fuerst, PhD, US Department of Health & Human Services
Kevin Price, Avecia Biologics Ltd
Dr Robert Kadlec, PRTM
Panel discussion
How does the financial community assess the short- and long-term profitability of vaccine candidates and vaccine biotechs?
Panellists:
Stephen M. Sammut, Wharton Health Care Systems & Burrill International
Fuad El-Hibri, Emergent BioSolutions – NO SLIDES PRESENTED
Thomas P. Monath, MD, Kleiner Perkins Caufield & Byers, Pandemic & Biodefense Fund – NO SLIDES PRESENTED
Dr Navdeep S. Jaikaria, Rodman & Renshaw – NO SLIDES PRESENTED
Perspective on neglected diseases
Funding and incentives update: What are the current strategies and priorities for funding innovation and delivery?
Christopher D. Earl, PhD, BIO Ventures for Global Health – NOT AVAILABLE
Panel discussion
Making adult and pediatric vaccines available, and affordable, for the developing world
Panellists:
Mark Feinberg, MD, PhD, Merck Vaccine Division – NO SLIDES PRESENTED
Amie Batson, World Bank
Béatrice De Vos, MD, BCPM, GlaxoSmithKline Biologicals – NO SLIDES PRESENTED
Myron M. Levine, MD, DTPH, University of Maryland School of Medicine – NO SLIDES PRESENTED
Dr Luis Jodar, The International Vaccine Institute – NO SLIDES PRESENTED
Christopher D. Earl, PhD, BIO Ventures for Global Health – NO SLIDES PRESENTED
Lunch Briefing
Sponsored by Covance Research Products
Optimizing your preclincal vaccine testing strategy
Speaker:
Dr Rangappa Ramachandra, Covance Research Products
Main afternoon session
Delivering new adult and pediatric vaccines into the developing world: Tackling efficiency, effectiveness and economic challenges
Chair’s introduction & case study
Enteric disease targets and approaches to development and commercialization
Dr Ronald W. Ellis, AVANT Immunotherapeutics, Inc
Case study
Vaccine clinical manufacture and scale-up strategies with particular emphasis on high-risk candidate vaccines for HIV/biodefense where their primary use might be in the developing world
Phillip L. Gomez III, PhD, MBA, Vaccine Research Center, NIAID, NIH – NOT AVAILABLE
Case study
Assessing the worldwide market for a new tuberculosis vaccine
Wendy Taylor, Founder, BIO Ventures for Global Health – NOT AVAILABLE
Next generation of pediatric vaccines for the developing world
Donald W. Kelemen, PhD, The PATH Malaria Vaccine Initiative
Panel discussion
How can industry, government and NGOs work together to tackle the efficiency issues?
Panellist:
Dr Luis Jodar, The International Vaccine Institute – NO SLIDES PRESENTED
Workshop 1
Applying translational medicine and biomarkers to improve the safety and efficacy of vaccine candidates: How might they be used to predict and assess clinical adverse events?
Moderator’s introduction
How close are we to the application of translation medicine and biomarkers for vaccines in a way that has been used in oncology for some time?
Danilo Casimiro, PhD, Merck & Co, Inc
Case study
Biomarkers associated with Anti-Ab1-42 immunotherapy in patients with Alzheimer’s disease
Garvin L. Warner, PhD, Wyeth Research
Case study
Biomarkers for protein-based subunit vaccines
Eszter Nagy, MD, PhD, Intercell AG
Short presentation followed by panel discussion
How will the use of biomarkers impact the ability to assess clinical adverse events?
Moderator:
Wade Bolton, PhD, Beckman Coulter, Inc
Panellist:
William M. Egan, PhD, PharmaNet Consulting – NO SLIDES PRESENTED
Workshop 2
Eliminating points of failure at the manufacturing stage: Optimizing process validation, consistency and stability to speed up commercialization
Chair’s opening remarks
Overview of the main issues encountered during vaccines manufacturing
Dr Hélène Pora, Pall Life Sciences
Optimizing clinical product development and manufacturing strategy using impact analysis tool on proposed FDA cGMP regulations
Luc Dubois, Validapro BioSciences
Purification challenges and strategies in vaccine manufacturing
Dr John X. Zeng, Shire Pharmaceutical, Inc
Case study
A holistic vaccine solution to the pandemic influenza threat
Dr Rahul Singhvi, Novavax Inc
Afternoon plenary session
Optimizing partnership strategies to build and strengthen R&D pipelines for both large and small vaccine companies
Chair’s introduction
Douglas J. Pon, PhD, Wyeth Pharmaceuticals – NO SLIDES PRESENTED
How are R&D partnerships driving new product development in the vaccine industry – for both developed and developing world need?
Dr Allan Jarvis, sanofi Pasteur
Panel discussion
Debating the partnership and business development strategies in the vaccine value chain – how should smaller companies optimize links with antigen-focused traditional vaccine companies?
Panellists:
Thomas Lingelbach, Intercell AG
Dr Rahul Singhvi, Novavax Inc
Dr Julie A. Waterbury, Merck & Co, Inc
Wednesday January 24th 2007
Main Conference – Day 2
Morning plenary session
Focusing on the short- and long-term vaccine pipeline: Prioritizing your next targets based on development pathways, launch strategies and reimbursement
Chair’s introduction
What is the current status of the vaccine industry pipeline?
Bill Helming, PRTM – NO SLIDES PRESENTED
CMS perspective: Reimbursement models for novel vaccines
Jeffrey Kelman, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services – NO SLIDES PRESENTED
Application of technology to develop a vaccine pipeline
Dr Steve Chatfield, Emergent BioSolutions
Building and delivering a rich vaccine pipeline for all
Béatrice De Vos, MD, BCPM, GlaxoSmithKline Biologicals – NOT AVAILABLE
Case study
Learning from recent adult / adolescent vaccine launches: Comparing lifecycle development, routes to approval and marketing/pricing strategies
Mark Feinberg, MD, PhD, Vice President, Policy, Public Health & Medical Affairs, Merck Vaccine Division
Panel discussion
Which emerging vaccine markets hold most promise over the next 5 and 10 years?
Moderator:
Myron M. Levine, MD, DTPH, University of Maryland School of Medicine – NO SLIDES PRESENTED
Panellists:
Eszter Nagy, MD, PhD, Intercell AG – NO SLIDES PRESENTED
Dr Ronald W. Ellis, AVANT Immunotherapeutics, Inc – NO SLIDES PRESENTED
Main afternoon session
Evaluating progress with innate versus adaptive immunity and next generation immunostimulants/adjuvants
Chair’s introduction
To what extent do we understand the role of innate versus adaptive immunity – what degree of control has been demonstrated to date?
Dr Jeffrey B. Ulmer, Novartis Vaccines – NOT AVAILABLE
Regulatory considerations in the safety assessment of adjuvanted preventive vaccines
Dr Elizabeth M. Sutkowski, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
Next generation adjuvants – what’s in the pipeline?
Case study
Development of VaxImmune, a CpG ODN TLR9 agonist that bridges innate and adaptive immunity, as a vaccine adjuvant for prophylactic and therapeutic vaccines
Dr Heather L. Davis, Coley Pharmaceutical Canada
Case study
The use of TLR7/8 agonists as vaccine adjuvants
Dr Mark A. Tomai, 3M Pharmaceuticals
Case study
Rapid acting vaccines: Bridging the gap between innate and adaptive mucosal immune responses
Jay T. Evans, PhD, GlaxoSmithKline
Workshop 1
Update on late stage clinical trials results for therapeutic and prophylactic cancer vaccines
Moderator’s introduction
Sharon R. Seiler, PhD, Punk, Ziegel & Company
Case study
Development of the GSK cervical cancer candidate vaccine
James P. Tursi, MD, FACOG, GlaxoSmithKline
Case study
Update on Phase III trials of GVAX® immunotherapy for prostate cancer
Dr Natalie Sacks, Cell Genesys – NOT AVAILABLE
Case study
Progress in the development of Provenge (sipuleucel-T) for the active immunotherapy of prostate cancer
Dr David L. Urdal, Dendreon
Case study
Testing the efficacy of vaccitherapy with heat shock protein peptide complex-96 (Oncophage) in adjuvant renal cell carcinoma: Results of a randomized Phase III trial
Kerry A. Wentworth, Antigenics, Inc
Panel discussion
Comparing and contrasting routes to market strategies for prophylactic and therapeutic cancer vaccines
Workshop 2
Long-term follow up for new and existing vaccines: To what extent is current pharmacovigilance practice adequate?
Chair’s introduction
Robert L. Davis, MD, MPH, Centers for Disease Control & Prevention
Reviewing the FDAs current pharmacovigilance practice guidances for vaccines - what are the current plans for assessing adverse events?
Dr Robert Ball, OBE, CBER, The Food & Drug Administration
What post-licensing commitments are in place for recently approved vaccine components? Are they being driven by industry or the regulator?
Case study
Risk management planning - recent experience
Adrian Dana, MD, FAAP, Merck Research Laboratories
Case study
6 Years of post-licensure vaccine pharmacovigilance by industry: Lessons learned
Michael D. Blum, MD, MPH, Wyeth Research
Case study
Postmarketing assessment of vaccine safety during pregnancy
Harry A. Seifert, MD, MSCE, GlaxoSmithKline Biologicals
Panel discussion
Addressing the challenges in the long-term follow up of vaccines
Panellist:
William M. Egan, PhD, PharmaNet Consulting – NO SLIDES PRESENTED
