Phacilitate Vaccine Forum Spring 2004
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.
Monday, May 10th 2004
Morning plenary
Optimising your clinical trial design and management strategy in the light of changing regulatory demands
KEYNOTE ADDRESS
Building a strategy to increase efficiency at each phase of clinical development
Professor Friedrich Dorner
Integration of clinical and analytical development activities for more efficient development of vaccines
Dr John P. Hennessey
Workshop 1
Understanding and complying with the EU Clinical Trial Directive: A practical guide for vaccine companies
Moderators
Dr Chris Holloway,
Dr Allison Wyndham,
Dr Gill Pearce,
6 Presentations
Workshop 2
Reducing clinical timelines and maximising the potential commercial value of novel adjuvants in development
Chair's introduction
Heather L. Davis, PhD,
Regulators' perspectives
Europe: How will the novel EU guidelines affect adjuvant development processes and timelines?
Dr Roland Dobbelaer
Case study
From promise to reality: proving the safety and efficacy of TLR4 agonists as novel adjuvants
Dr Kent Myers,
Exploring the role of novel TLR7 and 8 agonists in connecting innate and adaptive immunities as a strategy for vaccination and tumour therapy
Dr Sefik S. Alkan
Toward the development of potent adjuvants and delivery systems for vaccines and therapies
Dr Jeffrey B. Ulmer
Tuesday, May 11th 2004
Morning plenary
Exploring trends in global vaccine funding, supply and take-up - what will be the impact on industry R&D?
Strategies for optimising the value of R&D funding for a vaccine for the developing world
Dr Frans van den Boom
KEYNOTE ADDRESS
Is the development of new vaccines specifically for the developing world utopic or realistic?
Johan van Hoof, MD
How to prepare for new infectious diseases?
Dr Ben van der Zeijst
Are industry and the public sector prepared to deal with the next pandemic?
Dr David Fedson
Plenary panel discussion
Analysing public and private sector preparations for pandemic influenza and SARS - what are the key lessons to be applied in any future public health emergency?
Panellist
Anne-Marie Georges
Exploring the strategies behind vaccine R&D programmes against unmet threats to public health
Implementing strategies to define and meet the demands of a new vaccine market:
Emerging diseases, emerging technologies, emerging opportunities
Dr David Persing
Development strategy for a pipeline of chronic disease vaccines
Dr Wolfgang A. Renner
Case study: Anti-cholesterol vaccine
Charles Rittershaus
Case studies
Quantifying potential returns from a new market and planning your R&D programme accordingly
Dr Philip Bedford
Biodefence Business Models Breakout
Moderator's introduction
Maximising a biodefence opportunity
Dr Alan Lamont
Case study
Examining the strategies behind a mutually-beneficial, public-private partnership
to develop a biodefence vaccine - what are the keys to success in this scenario?
Dr Lance K. Gordon
Dr John LaMontagne
Case study
How do you decide if a biodefence vaccine R&D project represents a long-term or
short-term commercial opportunity, and how do you balance your risk accordingly?
Dr Andreas Hartmann
Afternoon plenary
Closing panel discussion
Defining a pathway for the development and commercialisation of a vaccine
for the developing world - what role for industry, regulator and NGO?
Panellist
Anne-Marie Georges
Wednesday, May 12th 2004
Morning plenary
Blending R&D strategy with commercial considerations to optimise the value of your portfolio
Chair's introduction
Robert S. Becker, PhD, MBA
KEYNOTE ADDRESS
Achieving a successful marriage of commercial, regulatory and R&D strategies
from discovery through to the marketplace
George R. Siber, MD
What are the key strategic drivers behind successful vaccine product development?
Chair's introduction
Dr Steve Chatfield
Case study
Pneumococcal protein vaccine - integration of product development
considerations throughout all stages of R&D
Dr Ronald W. Ellis
Aligning the product development strategy to the regulatory requirements
at each stage of the development process
Dr Raafat E. F. Fahim
Licensing & Partnering Breakout - platform technologies
Exploring the case for maintaining in-house development of platform technologies
Daniel D. Adams
Building a partnering strategy to facilitate the development of an alternative delivery technology
Dr Gregory M. Glenn
Delivering solutions to the key challenges in vector-based vaccine development
Chair's introduction
Professor Gordon Dougan
Investing in vectors as novel platform technologies - assessing risk versus potential without value benchmarks
Peter F. Young
What is the latest progress in the development of pox virus vectors?
Dr Dennis Panicali
The scientific and business forces driving the development of vector technology advancements for vaccine applications
Dr C. Richter King
What strategic preparations can be made early in development against potential future challenges in gaining regulatory approval for bacterial vectors?
Dr Steve Chatfield
Therapeutic vaccine licensing & partnering breakout
Moderator's introduction
Robert S. Becker, PhD, MBA
What are the key elements in a therapeutic vaccine development model that
boost value for all collaborators?
Dr Mark Payton
What factors define the ideal timing for therapeutic vaccine licensing/partnering?
Dr Michel Baijot
Leveraging experience in the commercialisation of a cancer therapeutic to optimise your
immunotherapy licensing strategy - a non-vaccine company perspective
Dr Michael J. Hope
Thursday, May 13th 2004
Morning plenary
Overcoming the major strategic challenges in vaccine manufacture
Chair's introduction
Dr Joan Fusco
KEYNOTE ADDRESS
How do you define the strategic importance of manufacturing to your
organisation and implement a strategy to create a competitive advantage?
Edward J. Arcuri, PhD
Case study
Fast track design, construction and qualification of a multi-purpose biologics facility to manufacture recombinant proteins for both therapeutic and vaccine uses
Dr Kevin Price
GMP and clinical trials
Dr Huib van de Donk
Which manufacturing technology should you employ for a specific vaccine type and why?
Chair's introduction
Dr Crawford Brown
What are the key regulatory and quality control issues with differing manufacturing systems?
Barbara K. Immel
Case study: Mammalian cell
Dr Jean-Yves Guichoux
Case study: Cell-based influenza versus eggs
Dr Friso van Voorthuizen
Case study: Edible
Dr Stephen J. Streatfield
Partnering for manufacturing breakout
Moderator's introduction
Dr Zbigniew Janowicz
Contract manufacturing: Building partnerships for success
Mariel Peterson
How to add value to your vaccine business by establishing a contract manufacturing unit
Dr Oliver Bartelsen
Manufacturing development is a journey - a rocky road!
Dr Kevin Price
Afternoon plenary
Closing panel discussion
How will the expanding vaccine industry and public sector stakeholders address the increasing global shortage of scale-up manufacturing capacity?
Moderator
Dr Crawford Brown
