Phacilitate Vaccine Forum Spring 2003
Presentations
If you would like to purchase the documentation (Only available on CD) please email team@phacilitate.co.uk and we will confirm a price with you.
Pre-conference Regulatory Workshop
A highly interactive, workshop-driven day designed for the discussion of novel regulatory guidelines and legislation, and their impact on the European and global vaccine communities
What are the latest steps towards global regulatory harmonisation?
Office of Vaccines Research & Review: International activities
Dr Jon R. Daugherty
European perspective
Dr Michael Schwanig
Industry response
Challenges for vaccine manufacturers in the face of differences in regulatory
requirements. How to gain efficiencies to obtain rapid global approval and improve continuity of supply
Johan van Hoof, MD
Workshop 1
Adapting the CTD for a vaccine
A step-by-step practical guide to navigating the Common Technical Document
Moderator:
Dr Chris Holloway
Speakers:
Dr Michael Schwanig
Philippa A. Whiteside MA (Cantab)
Workshop 2
Working through novel regulatory guidelines for variations
An interactive session led by EU policy-makers from both government and industry, exploring the latest in vaccine-specific regulations regarding variations
Chair's Introduction
Variations to biological medicinal products: The future
Anne-Marie Georges
Variations to vaccines: the VAMF system
Mats Welin
A new EU proposal for agreeing on a timeline for implementation during variation approval procedure
Dr Roland Dobbelaer
Main Conference Day 1
Which novel and re-emerging vaccines and disease areas offer the greatest commercial potential for your organisation?
How will the vaccine industry take full advantage of novel market opportunities?
‘Getting Ahead of the Curve’ – a strategy for health protection
Dr David Salisbury
US perspective
Dr Brian W. J. Mahy
The biotech response to emerging and re-emerging threats
Professor Jaap Goudsmit
Getting a grip on TB vaccine development
Dr Carol Nacy
Case study
Implementing an R&D strategy to exploit a burgeoning vaccine market
Dr Una S. Ryan OBE
Malaria vaccine update
An assessment of global funding for malaria vaccine R&D
Dr Melinda Moree
Why has sequencing the Plasmodium falciparum genome led to increased interest in an attenuated whole parasite malaria vaccine?
Stephen L. Hoffman
Case study
What are the major obstacles in clinical development? How might these be overcome?
Professor Adrian Hill
Bioterrorism breakout
Global stockpile situation for smallpox and anthrax vaccines
Jan Hendriks
Safety and "surrogate"efficacy data of next generation smallpox vaccines
Dr Jens Vollmar
Bioterror threat agents: Hype or reality?
Dr Peter Hambleton
Afternoon plenary
Licensing & Partnering Roundtable: What are the major vaccine manufacturers looking for in terms of novel vaccine technologies?
Moderator:
Robert S. Becker
Panellists:
David Tomasso
Main Conference Day 2
Maximising efficiency across your product development portfolio
Delivering practical solutions to your vaccine development challenges
Optimising R&D portfolio decision-making processes to maintain excellence in development
Dr Ronald W. Ellis
KEYNOTE ADDRESS
Meeting the challenges posed to the industry by the requirement for increasingly large clinical databases
Dr Hartmut Ehrlich
Maintaining required efficacy standards with a next-generation vaccine in the face of increasingly stringent safety requirements for materials
Dr Reinhard Glück
Advanced development and evaluation of the AIDSVAX HIV/AIDS vaccine
Dr Lance K. Gordon, CEO, VaxGen, Inc
Strategic and tactical issues in the development of travel vaccines - case study: Yellow fever vaccine
Dr Philip Bedford
Considerations for the development of influenza vaccines
Dr Bram Palache
Licensing & partnership's breakout
A novel partnership for clinical development: The Berna Biotech -
Hesperion case study
Dr Vincent Charlon
Professor Achim Kaufhold
Oxxon Pharmaccines and the Malaria Vaccine Initiative
Dr Mark Payton
Therapeutic vaccines: Creating an R&D blueprint for future market success
Addressing the strategic and regulatory challenges in therapeutic vaccine R&D
Chair’s introduction
Is the expansion of therapeutic vaccine development justified?
Robert S. Becker, PhD, MBA,
KEYNOTE ADDRESS
How do you balance therapeutic and prophylactic vaccine candidates within your R&D pipeline?
Brenda Reynolds
What is the real potential for therapeutic vaccines to replace increasingly impotent antibiotics?
Thomas McLain
Due to the file size of Tom McLain's presentation, it will not be available on this site. Please contact Laura Atrache at laura@phacilitate.co.uk to obtain a copy of this presentation
Regulatory pitfalls in the early-stage development of therapeutic vaccines
Dr Chris Holloway
Philippa A. Whiteside MA (Cantab)
Regulatory challenges in therapeutic vaccine development from the perspective of a small biotech organisation
Birgitta Hedin
Optimise your cancer vaccine clinical development strategy
Case study
Development of recombinant poxvirus-based cancer vaccines: Preclinical and clinical experience
Dennis Panicali, PhD
Case Study
Testing of cancer vaccines in the minimal residual disease setting
Dr Gottfried Himmler
Case study
Dendritic cell immunotherapy of cancer
Dr Reiner Laus
Therapeutic vaccine approaches to Hepatitis B and C
Moderator’s introduction
Analysing the potential of therapeutic vaccine candidates for hepatitis B and C
Dr Michael Buschle
Case study
Progress and issues with HBV therapeutic vaccines
Dr Deirdre Gillespie
Case study
A peptide based vaccine for hepatitis C treatment to enter clinic
Dr Juergen Frisch
