Phacilitate Vaccine Forum Spring 2006
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.
DAY 1 | Monday, June 19th 2006
Morning plenary session
Preparing the world for pandemic influenza
• Delivering a strategy for a coordinated global response to the next pandemic
Chair's opening address
Influenza pandemic vaccines: current challenges
Dr Klaus Stöhr
US Government perspective
Dr Robin Robinson
What role does the ECDC play in preparing Europe for the next influenza pandemic?
Professor Johan Giesecke
EMEA update
Dr John Purves
Global stakeholders' presentations & panel discussion
Dr Norman Baylor
Dr Philip van Dalen
Dr Luc Hessel
Professor Ben van der Zeijst
Dr Edwin Tsui
Main afternoon session
Assessing the short and long term potential of the influenza vaccine market for your company
Chair's introduction
Dr Luc Hessel
Defining the vaccine industry's role in countering pandemic and interpandemic influenza on a global scale
Dr James T. Matthews
Analyst's perspective
Short and long term influenza vaccine market assessment
David Beadle
Pandemic vaccine development and supply: opportunities and hurdles
Dr Mark Armitage
Case study
Pandemic strain vaccines
Dr Linda Lambert
Case study
Novel influenza vaccines: challenges and opportunities
Dr John Beadle
Breakout session 1
What are the next steps forward for novel viral vector and DNA technology platforms in clinical development?
Moderator's introduction
Dr C. Richter King
Case study
The effect of pre-existing immunity on adenovirus vector vaccines
Dr John Shiver
Case study
Recombinant replication-deficient viral vaccines: poxviruses and adenoviruses
Dr Sarah Gilbert
Case study - DNA vaccination
Dr David C. Kaslow
Case study
Electroporation mediated DNA immunisation
Drew Hannaman
Breakout session 2
EU Regulatory workshop
• An in-depth, interactive session exploring key elements of European regulatory guidelines/legislation from both regulator and industry perspectives
- EU CTD
- Conditional approval
- Centralised vs. de-centralised procedure
Moderator's introduction
Preparing an eCTD for EU and US licensure
Dr Erich Tauber
Conditional approval - in what circumstances might it be applicable to vaccines and what data is required to qualify for it?
Dr John Purves
Clinical regulatory requirements for new vaccines
A. C. G. Voordouw, MD, PhD, MPH
Defining the merits and de-merits of the centralised vs. de-centralised procedure
Dr Christa Schröder
Afternoon plenary session
Panel discussion
Understanding the US's Project BioShield: A possible model for international development and stockpiling of countermeasures
Moderator:
Frank M. Rapoport
Panellist:
William C. Bertrand Jr
Day 2 | Tuesday, June 20th 2006
Morning plenary session
How can the vaccine industry and the public sector work together to meet major public health needs on a global scale?
• Optimising global markets for existing developing world vaccines, as well as those in the R&D pipeline
Chair's introduction
Dr Steve Chatfield
Increasing the impact of vaccine research: A funder's perspective
Dr Ted Bianco
IAVI perspective
Incentives for vaccine development and delivery
Dr Frans van den Boom
Panel discussion
How can industry and NGOs collaborate to make the money work harder?
Business and development strategy for new vaccines intended for both the developed and developing worlds
Dr Ronald W. Ellis
Case study
How can the traveller's vaccine market in the developed world support a developing world commercialisation strategy?
Denis Cavert
Short presentations & panel discussion
Panellist:
Dr John Purves
Main afternoon session
Harnessing novel influenza vaccine manufacturing technologies to address global shortages
• Building sufficient capacity to meet demand in both pandemic and interpandemic scenarios
Chair's introduction
Tony Colegate
Case study
Implementing high throughput processing technologies in the manufacture of novel vaccines
Hélène Pora, PhD
Case study
Production and distribution of pandemic vaccines: state-of-the-art and critical issues
Dr Bram Palache
Case study
PER.C6 cell technology: Application in the area of avian 'flu
Professor Jaap Goudsmit
Case study
Influenza vaccines production using MDCK cells: Technological and regulatory challenges
Dr Ulrich Valley
Panel discussion
Breakout session 1
Partnering session: How can your organisation harness cost-saving opportunities in India and the Far East?
Moderator's introduction
Assessing the potential financial benefits to your business from offshoring or outsourcing to India and the Far East
Stephen M. Sammut
Perspective from a leading Asian vaccine manufacturer
Dr Krishna M. Ella
Case study
Introducing a modern vaccine in Asia - key factors for a successful local partnership
Martin Götting
Case study
Fostering research partnerships for AIDS vaccine R&D
Antara Sinha
Breakout session 2
Workshop: Delivering a strategy to efficiently meet evolving post-licensure commitments
Moderator's introduction
Post-licensure commitments - rationales and outcomes: a critical look at the role and the future of pharmacovigilance
Renald Hennig, MD, MBA
Early experiences of meeting the novel European regulatory requirements for post licensure risk management and pharmacovigilance strategies
Dr Thomas Verstraeten
The evolving pandemic influenza vaccine pharmacovigilance system - an industry perspective
Dominique Millet
Panel discussion
Panellist:
Dr Norman Baylor
Afternoon plenary session
Panel discussion
What are the keys to successfully securing financing for your organisation?
Slides
Day 3 | Wednesday, June 21st 2006
Morning plenary session
What will the vaccine market and industry model look like in 2010?
Chair's introduction
Dr Ronald W. Ellis
How can you accurately predict what the market for a vaccine for an emerging disease will look like?
Dr Allan P. Jarvis
The evolving paradigm for biodefense vaccines
Dr Robert V. House
Case study
The role of new vaccine technologies in developing future products
Dr Steve Chatfield
Panel discussion
How should you adapt your R&D and business strategy with the key emerging market trends and opportunities?
Breakout session 1
Delivering strategies to optimise the immunogenicity of pandemic and interpandemic influenza vaccines
Moderator's introduction
Dr Luc Hessel – no slides presented
Case study
Dose sparing tactics using the skin
Dr Gregory M. Glenn – Slides not available
Case study
Developing adjuvanted H5N1 avian ‘flu vaccines
Dr Steve Bell
NIAID perspective on dose sparing with infuenza vaccines
Dr Linda Lambert
Breakout session 2
What common lessons may be taken from the development of different therapeutic vaccines to aid R&D and eventual licensure?
Moderator's introduction
Case study: Provenge, a cancer vaccine for the treatment of prostate cancer
Dr David L. Urdal
Case study
Challenges in therapeutic vaccine development: HepB and HepC as examples
Dr Guy Buyens
Case study
Anti-nicotine vaccine for smoking cessation
Raafat E. F. Fahim, PhD
Case study
Anti-allergy vaccine
Dr Philipp Mueller
Top
