Phacilitate Vaccine Forum Baltimore 2006
Presentations
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Pre Conference Workshop
Monday, January 30th, 2006
Morning Plenary Session
End-to-end development and early stage partnering to streamline R&D
Chair's introduction
Bill Helming
US GOVERNMENT KEYNOTE
How can the government facilitate end-to-end development of vaccines?
Phillip L. Gomez III, PhD, MBA
INDUSTRY KEYNOTE
How is industry approaching early stage decision-making and partnering to maximize ROI?
Dr Hartmut Ehrlich
Presentation & panel discussion
Improving the immunogenicity of your vaccine candidate
New technologies for improved vaccines
Dr Jeffrey B. Ulmer
Panel discussion
Monitoring and evaluating alternatives to antibody response
Dr William Gruber – NO SLIDES PRESENTED
Dr John Shiver – NO SLIDES PRESENTED
Dr Jeffrey Chodakewitz – NO SLIDES PRESENTED
Dr Jeffrey B. Ulmer – NO SLIDES PRESENTED
Workshop 1
Optimizing end-to-end product development and manufacture to maximize yield at minimum cost
Moderator's introduction
Dr John P. Hennessey Jnr – NO SLIDES PRESENTED
Development cycle for HPV and rotavirus vaccines
Dr Barry C. Buckland
Case study
New build, newly validated plant – SME
Raafat E. F. Fahim, PhD
Case study
Newly validated plant, retrofit
Introducing disposable technologies in an existing vaccine manufacturing processes: Validation and costing issues
Hélène Pora, PhD
Panel discussion
Integrating product development and manufacturing planning into your overall development strategy
NO SLIDES PRESENTED
Workshop 2
Increasing the predictive value of animal studies for vaccine development
Moderator's introduction
Dr Jeffrey Chodakewitz – NO SLIDES PRESENTED
Gaining a better understanding of which animal models are predictive for vaccine safety in humans – vaccine design and potency models for both viral and bacterial infections
Dr Steve Udem – AVAILABLE SOON
Clarification of the regulatory position regarding the use of animal studies to bring vaccines to licensure
Mark Abdy, DVM, PhD
Case study
Update from USAMRIID on use of the Animal Rule
M. Louise M. Pitt, PhD
Case study
Points to consider for clinical trial design and latest data from Anthrax vaccine studies
Faruk Sinangil, PhD
Panel discussion
Where might the Animal Rule be applied next?
NO SLIDES PRESENTED
Workshop 3
Latest update on progress with virus and genetically vectored vaccines
Moderator's introduction
Dr Hartmut Ehrlich – NO SLIDES PRESENTED
Case study
Design and development of alphavirus replicon vaccines
Dr Jonathan Smith
Immune responses mediated by recombinant viruses and plasmid DNA vaccine vectors
Dr John Shiver
Development of formulated plasmid-based vaccines: A multivalent vaccine for the prevention of human cytomegalovirus-associated diseases
Alain Rolland, PharmD, PhD
Gene transfer mediated active and passive immunization: New options for preventing infectious diseases
Philip R. Johnson, MD
Panel discussion
How will the development of novel vectors assist with tackling remaining difficult vaccine targets?
NO SLIDES PRESENTED
Afternoon plenary session
Panel discussion
Overcoming the challenges in developing vaccines for the developing world-beyond AIDS, malaria and TB: diarrheal diseases
Dr Una S. Ryan
Dr Jeffrey Chodakewitz – NO SLIDES PRESENTED
Dr Mark Kane – NO SLIDES PRESENTED
Main Conference - Day 1
Tuesday, January 31st, 2006
Morning plenary session
How are the US FDA and NIH evolving to boost R&D productivity in the life sciences industry?
Chair's introduction
Dr Barrie Carter – NO SLIDES PRESENTED
FDA KEYNOTE ADDRESS
Facilitating development of new vaccines and cell and gene therapies
Dr Karen Midthun
NIH KEYNOTE ADDRESS
How will NIH funding reforms and a new focus on product development and translational research benefit industry?
Dr Barbara M. Alving
Chair's introduction
Dr Jerald C. Sadoff – NO SLIDES PRESENTED
US government update – what are the latest plans and policies for the development of key
vaccine areas?
Robert Kadlec, MD
Building a successful biodefense business for the long-term
Chandresh Harjivan
New partners for the public sector in developing, funding and delivering vaccines for the developing world
Dr Mark Kane
Panel discussion
How should vaccine development be financed - what are the pros and cons of different investment approaches?
Dr Jerald C. Sadoff – NO SLIDES PRESENTED
Michael G Kurilla, MD, PhD – NO SLIDES PRESENTED
Michael Lytton – NO SLIDES PRESENTED
Main afternoon session
Progressing the biodefense industry – update on long-term business models, simplified procurement procedures and accessing remaining government funding opportunities
Moderator's introduction
Tom Fuerst, PhD
Analyzing the business model of a company that has received biodefense funding – what are their growth plans?
Dr Una S. Ryan
What is the business potential of the remaining category B and C targets?
Dr Roger Gilmour
Expediting the development, availability and approval of biodefense vaccines and therapeutics
Cynthia L. Kelley, MS
Panel discussion
European versus US priorities for stockpiling and planning biodefense vaccines
Jerome A. Donlon, MD, PhD
Breakout session 1
A practical guide to accessing public funding for vaccine R&D
Moderator's introduction
Overview of the sources of public funding in the US, their inter-linkages and their mechanisms for resource allocation
Michael G Kurilla, MD, PhD
Case study
Winning funding from the Gates Foundation
Myron M. Levine, MD, DTPH
Case study
Developing a recombinant Anthrax vaccine in partnership with the government
Marc Gurwith, MD
Case study
Accessing NIH product development funding
Peter Young
Panel discussion
Encouraging earlier stage public / private sector partnerships to help transition prophylactic and therapeutic vaccines into the clinic faster
Dr Kim Lyerly
Breakout session 2
Implementing creative approaches to proving vaccine efficacy
Moderator's introduction
Dr John Shiver – NO SLIDES PRESENTED
Comparing creative approaches for two remaining tough targets - taking the scale out of efficacy studies for meningococcus and pneumococcus vaccines
Dr William Gruber
How are biomarkers being effectively applied as surrogates or correlates of efficacy in vaccine clinical trials?
Daniel J. Sikkema, PhD
What is the current regulatory stance on the relative importance of clinically relevant endpoints versus alternative approaches (eg intermediate or laboratory endpoints) to demonstrate efficacy?
Jeffrey J. Stoddard, MD, FAAP
Comments on the use of surrogate markers for establishing vaccine efficacy
Dr William Egan
Panel discussion
How does the identification of surrogates / biomarkers of efficacy vary depending on target population group and vaccine type?
NO SLIDES PRESENTED
Afternoon plenary session
Panel discussion
Removing the highest hurdle: Congress acts to remove liability concerns for vaccine and biodefense providers
John M. Clerici,
Peggy Binzer
Main Conference - Day 2
Wednesday, February 1st, 2006
Morning plenary session
Identifying where the next market opportunities lie and what product launches of the future might look like
Chair’s introduction
Bruce G. Weniger, MD
Beyond paediatric and travellers markets – how robust are the opportunities in the emerging adult and elderly vaccine markets?
Geoffrey McKinley
Perception and reality: How is the stock market valuing emerging vaccines and future product launches?
Michael Leacock
The impact of new technologies in developing bacterial and viral vaccines for unmet needs
Dr Steve Chatfield
Panel discussion
Dr Steve Chatfield – NO SLIDES PRESENTED
Phillip L. Gomez III, PhD, MBA – NO SLIDES PRESENTED
Myron M. Levine, MD, DTPH – NO SLIDES PRESENTED
Dr Jerald C. Sadoff – NO SLIDES PRESENTED
Dr Timothy Cooke – NO SLIDES PRESENTED
Main afternoon session
What progress is being made with the development, regulation and commercialization of pandemic influenza strains, and cell lines for the general use flu vaccine market?
Moderator's introduction
Pandemic influenza: Federal Government preparedness and response plans
Dr Robin Robinson
Public health response to pandemic influenza threat: Programs, Policies, Science
Bruce G. Weniger, MD
Case study
The process of clinical development of cell-derived influenza vaccines
Iris de Bruijn, PhD
Panel discussion
What are the cost and regulatory implications for clinical trials incorporating new technologies for 'flu vaccines?
NO SLIDES PRESENTED
Breakout session 1
Capacity planning for SMEs – funding, building and operating strategies
Moderator's introduction
What are the incentives and disincentives for smaller companies to enter the emerging infectious diseases space?
Dr Sharon R. Seiler
Case study
How to build a vaccine company in today's challenging environment
Fuad El-Hibri
Case study
Leveraging biodefense to build a commercial vaccines company
Clement Lewin
Case study
Building capacity for live bacterial vaccines
Dr Timothy Cooke
Breakout session 2
How will you prepare your therapeutic cancer vaccine for late-phase clinical trials and the marketplace?
Moderator's introduction
Case study
Onyvax's approach to the development of cancer vaccines
Dr Robert Johnson
Case study
Progress in the treatment of prostate cancer with Provenge
Dr David L. Urdal
Case study
Late stage development of the GVAX prostate cancer vaccine
Dr Flavia Borellini
Case study
OncoVEX-GMCSF: Product and clinical development
Dr Tony Mills
Panel discussion
What are the remaining technical, regulatory and clinical challenges facing cancer vaccines in development and how might they be addressed?
NO SLIDES PRESENTED
