Phacilitate Vaccine Forum Fall 2003
Presentations
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Monday, 17th November
Morning plenary session
Minimising development timelines and costs in the face of increasingly stringent regulatory requirements
Chair's introduction
Efficient product development
Dr Ronald W. Ellis
KEYNOTE ADDRESS
Delivering a clinical R&D strategy to meet global regulatory requirements for vaccine safety
Greg Berezuk
Vaccine safety and public health:
risk-benefit considerations on development of prophylactic and therapeutic vaccines
Dr Carlo Russo
Safety issues for live bacterial vaccines
Dr Myron Levine
Workshop 1
Meeting safety requirements in preclinical vaccine development
Moderator's introduction
Dr Carlo Russo
FDA/CBER perspective
Approaches to nonclinical safety evaluation of vaccines:
Clarifying the latest amendments to nonclinical safety evaluation guidelines and documents
Dr Marion Gruber
Case study
Non-clinical safety assessment of adenovirus-vectored HIV-1 vaccines
Dr Brian Ledwith
Case study
Strategy for demonstrating non-clinical safety of a live attenuated Salmonella vaccine
Dr Steve Chatfield
Workshop 2
Addressing the key concerns over the safety of vaccine adjuvants
Moderator's introduction
Dr Elizabeth Leininger
US FDA perspective:
Regulatory considerations in the nonclinical safety assessment of adjuvanted preventive vaccines
Dr Elizabeth M. Sutkowski
Safety of vaccine adjuvants - update from the European Union
Anne-Marie Georges
Overcoming the challenges in proving adjuvant safety:
a strategy for evaluation
Dr Garvin L. Warner
Panel discussion
Setting the agenda for future discussions between industry and the international regulatory community around the regulation of adjuvants
Moderator
Dr Elizabeth Leininger
Tuesday, 18th November
Morning plenary session
What is the true worth of the biodefense market to the vaccine industry?
Chair's introduction
How effective has the US Government been in supporting the development of a biodefense industry?
Dr Una S. Ryan OBE
KEYNOTE ADDRESS
The role of the Department of Health and Human Services in acquisition of medical countermeasures to bioterrorism
Maj. Gen. Philip K. Russell, MD
What future does the NIH see for biodefense vaccine R&D?
Dr John LaMontagne
FDA: Meeting the challenges of and enabling rapid responses to crisis situations
Dr Julianne C. M. Clifford
Exploring the biodefence vaccine market from an industry perspective – how long will it last, and what are the repercussions for the overall R&D pipeline? How do you build a business case for a biodefence vaccine R&D programme?
Peter Wulff
Plenary panel discussion
Moving forward, how can industry and public sector alike prepare to meet the major issues in biopreparedness?
Moderator:
Dr Una S. Ryan OBE
Panellists:
Dr Joan Fusco
Biodefense vaccines clinical trial update
Case studies detailing the strategies behind the implementation of biodefense vaccine R&D programs and the latest clinical trial results
Case study
Maintaining the current generation anthrax vaccines
Dr Tim Brooks
Case study
A new template for biodefense vaccine development
Dr Lance K. Gordon
Data presentation
Update on progress in the clinical development of third generation smallpox vaccines
Dr Paul Chaplin
Case study
Delivering a development strategy for novel biodefense vaccine candidates - the prime systems approach to vaccine development
Dr Robert Hopkins
Licensing and partnering breakout
Exploring the strategies implemented by biotech companies to provide key technologies to big vaccine manufacturers - what deal structures are most beneficial to both parties and where can compromise be found?
Moderator's introduction
Dr Tim Howe
Panellists:
David Tomasso
Thomas Ittelson
Wednesday, 19th November
Morning Plenary Session
What will the vaccine industry R&D model look like in ten years?
Financial analyst's perspective:
Is the current vaccine R&D model sustainable?
Dr Sharon R. Seiler
KEYNOTE ADDRESS
Overcoming the major challenges in vaccine clinical development
William C. Gruber, MD
Case study
Exploring an alternative R&D and commercial model
- the co-development of a vaccine and a delivery device
Russell Wilson
Integrating your manufacturing strategy with your early stage development strategy - a basis of competition in the vaccine industry of the future?
Bill Helming
Overcoming the key challenges in designing and implementing R&D strategies for the development of vaccines against emerging and re-emerging threats
• Optimising the role of public-private partnerships
Case study
What are the key technological and strategic assets needed for a vaccine R&D program against a novel threat?
Dr C. Richter King
TB update
What is the latest progress in the development of next generation TB vaccines?
Dr Lawrence Geiter
Case study
Addressing an emerging infectious disease: West Nile virus
Dr John Brown
Manufacturing breakout
How will your organization meet the challenge of overcoming capacity constraint in an expanding industry?
Moderator's introduction
Bill Helming
Case study
Capacity strategies to support the launch and post-launch growth of a novel influenza vaccine
Edward J. Arcuri, PhD
Case study
Avecia's Advanced Biologics Centre:
Taking a multi-product biologics manufacturing facility from initial concept to full operation in less than 3 years
Dr Mark Carver
Case study
Make or buy; elements of the manufacturing decision
Dr Raafat E. F. Fahim
What are the scale-up requirements of three differing vaccine development organisations and how do you serve these distinct needs as a contract manufacturer? Three case studies
Dr Joachim Schorr
Afternoon plenary session
Closing panel discussion
Given the ever-increasing list of novel threats, (such as SARS), and novel technology areas, (such as therapeutic vaccines), how do you make good R&D portfolio decisions?
Moderator:
Dr Una S. Ryan OBE
Thursday, 20th November
Post-conference Cancer Vaccines Symposium
How do potential stakeholders in thge cancer vaccine market of the future view current progress in R&D
Building an R&D strategy to support a successful cancer vaccine portfolio
Dr Alem Truneh
Regulatory strategies for dendritic cell based immunotherapy
Dr Marnix Bosch
Opportunities and challenges in cancer vaccine development:
integration of cancer vaccines with conventional anti-cancer therapies
Dr Jeffrey Schlom (Presented by Dr James Hodge)
Overview of the NCI cancer vaccine portfolio and potential future directions
Dr Howard Streicher
TEIPP immunotherapy - a unique approach against tumor immune escape
Dr Per Grufman
Panel discussion
How will the vaccine industry meet the challenge of stimulating a
safe, effective therapeutic immune response in cancer patients?
Moderator:
Professor Angus Dalgleish
Exploring diverse clinical programs and examining the latest trial data to deliver the optimal clinical strategy for your cancer vaccine candidate
Chair's introduction
Prostate cancer clinical trials
Professor Angus Dalgleish
Case study
Towards a commercial cancer immunotherapy:
lessons from the development of a melanoma DC vaccine
Dr Margarita Salcedo
Case study
Targeted immunotherapy of prostate cancer
Dr Reiner Laus
Case study
Developing products to treat early stages of cancer and precancer
Dr Robert G. Urban
Case Study
The evolution of a pancreatic cancer vaccine - PANVAC-VF
Richard Woodrich
