Phacilitate Vaccine Forum Fall 2004
Presentations
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Pre-conference Workshop | Tuesday, November 2, 2004
Morning Plenary
Navigating the global regulatory environment - optimising clinical timelines
Chair's introduction
Dr Wilfried Dalemans
Opening address
Implementing strategies to minimise the costs of proving safety on a global scale
Dr Hartmut Ehrlich
KEYNOTE ADDRESS
FDA viewpoint
What recommendations does the FDA have for speeding up the vaccine licensure process?
Dr William M. Egan
European regulatory update
How is EU legislation pertaining to vaccine safety evolving in parallel to the latest changes in US FDA regulations?
Dr Brigitte Keller-Stanislawski
Workshop 1
Understanding and complying with the European Clinical Trials Directive 2001/20/EC: A practical guide for vaccine companies
Introduction to the EU Clinical Trials Directive
Dr Chris Holloway
Implementing the Clinical Trials Directive: Where are we now?
Dr Allison Wyndham
CMC implications of the Clinical Trials Directive: Technical content of product dossier
Dr Chris Holloway
Case study
Trials and tribulations – a biotech's approach to the new Directive
Dr Richard T. Kenney
Role of the Qualified Person (QP) for Investigational Medicinal Products (IMPs): Relevance for vaccines
Dr Chris Holloway
GCP and reporting responsibilities: Compliance under Directive 2001/20/EC
Dr Allison Wyndham
Workshop 2
Case study
Dr Jeffrey B. Ulmer
Case study
Synthetic DNA adjuvants: Agonists of toll-like receptors
Dr Sudhir Agrawal
Case study
Mucosal vaccines: Scientific and regulatory challenges in addressing the balance between safety and immunogenicity
Dr Jean-Francois Viret
Case study
Introducing a new adjuvant with B and T cell immunity into a novel vaccine development program
Dr Gerd Zettlmeissl
Afternoon plenary session
Panel discussion
How can you maximise the value of biomarkers to predict safety and efficacy in the clinic?
Moderator
Dr Alem Truneh
Main Conference Day 1 | Wednesday, November 3, 2004
Morning Plenary
Securing the future of vaccine industry R&D
Chair's introduction
An analyst's perspective: What will the vaccine industry look like in ten years time?
Mark Augustine
Accelerating global efforts in AIDS vaccine development: IAVI's social venture capital plus virtual vaccine company model
Dr Timothy J. Zamb
Acquisition of medical countermeasures for biodefense
Dr Monique Mansoura
Panel discussion
Prioritising vaccine R&D - how should investment be divided? Is it allocated where it does the most good?
Moderator
Dr Lance Gordon
Lunch Briefing
Building a fully-integrated biopharmaceutical company through partnership and acquisitions
Speakers
Fuad El-Hibri & Robert Kramer
Main afternoon session
Adapting R&D and commercialisation strategies for the evolving regulatory environment and vaccine marketplace
Chair's introduction
Dr Ronald W. Ellis
Case study
Development of a live attenuated Salmonella vector - meeting the product development challenges
Dr John St. Clair Roberts
Partnerships: Expanding R&D capabilities to address changing market needs
Dr Robert S. Becker
Optimising the commercial-R&D interface
Dr Una S. Ryan
Is there room for more than the Big 5?
Gordon Cameron
Afternoon Breakout
What future for the biodefense vaccine market?
Moderator's introduction
Dr Thomas R. Fuerst
How is the competitive industry structure going to play out in the biodefense sphere?
Kim C. Bush
Case study
Exploring regulatory, commercialisation/product development and technology transfer issues and processes in the biodefense vaccine area, where government is the only buyer
Terry Irgens
Legal perspective
Biodefense tool box: the nuts and bolts of bidding and negotiating biodefense contracts under Project BioShield
John M. Clerici
European perspective
How is the European marketplace for biodefense vaccines developing?
Dr Roger H. Gilmour
Afternoon plenary session
Panel discussion
Will vaccines represent an economically viable industry opportunity in ten years time?
Moderator
Dr Una S. Ryan
Main Conference Day 2 | Thursday, November 4, 2004
Morning Plenary
Optimizing the role of public-private partnering to provide the necessary incentives for industry
Chair's introduction
Deborah E. Myers
KEYNOTE ADDRESS
Building a strategy to tackle the key challenges in vaccine research today and to prepare for the future
Dr Anthony Ford-Hutchinson
How will the vaccine industry meet the threat of pandemic influenza?
Dr Luc Hessel
KEYNOTE ADDRESS
NIAID perspective
How can push-pull mechanisms promote and maintain industry involvement in key areas of vaccine R&D?
Case study: Pandemic influenza
Dr Pamela M. McInnes
Main afternoon session
Pandemic influenza preparedness
Chair's introduction
Update on current pandemic initiatives under review
Dr Bruce Gellin
WHO perspective
How is the rest of the world preparing for pandemic influenza?
Dr Klaus Stöhr – To be available shortly
The Canadian pandemic influenza vaccine strategy:
A case study of public and private sector roles and collaboration
Dr Theresa Tam & Dr Jonathan Seals
NIAID's role in preparing a regulatory pathway to licensure for novel influenza vaccine technologies in the event of a pandemic
Dr Lydia Falk
Case study
Does reverse genetics in egg-based manufacture hold the key?
Dr Kathleen Coelingh
Addressing pandemic influenza with a cell based recombinant protein vaccine.
No eggs and no live viruses - is this the solution?
Dr Manon Cox
Afternoon breakout
Delivery an optimal development strategy for your cancer vaccine candidate
Moderator's introduction
Dr Lee M. Nadler
'The Call of the Wild': Balancing cancer vaccine targets for a product engine with broad application
Dr Frank Malinoski - Presentation not available on web
Case study: Strategies to augment the efficacy of dendritic cell-based vaccines
Dr Johannes Vieweg
Case study: BLP25 liposome vaccine – a liposomal peptide vaccine for NSCLC
Dr Alex McPherson
Case study: Therapeutic vaccines for breast and prostate cancer
Dr Reiner Laus – Awaiting presentation
Case study: Development of ProMune, an immunostimulatory CpG oligodeoxynucleotide, for therapy of cancer in vaccines or in combination with chemotherapy
Heather L. Davis, PhD
Post-conference Symposium | Friday, November 5, 2004
Morning Plenary
Progress and impact of novel delivery technologies and adjuvants
Chair's introduction
Dr John Iskander
KEYNOTE ADDRESS
Antigen, adjuvant, delivery - building an R&D licensing strategy
Barbara Yanni
What strategic steps may be taken in the later stages of vaccine development to improve manufacturing inefficiencies and reduce cost per dosage?
Dr Raafat E. F. Fahim
Examining the convergence of adjuvants and delivery devices in R&D strategy
Dr Reinhard Glück
Workshop 1
Update on novel technologies in development - are they really improving the immunogenicity of vaccines?
Chair's introduction
Dr Terry Higgins
Case study
Clinical trial design for bivalent and trivalent gene-based plasmid vaccines against human Cytomegalovirus
Dr David C. Kaslow
Case study
Development strategies for transcutaneous immunization
Dr Gregory M. Glenn - Presentation not available on the web
Case study
Development of the synthetic glycolipid RC-529 as an adjuvant for human vaccines
Dr David A. Johnson
Workshop 2
Exploring deal structures and strategies for the licensing or partnering of
novel delivery technologies. How do you gauge value and assess risk?
Moderator's introduction
Donna Martin
Partnering novel vaccine delivery technologies:Gauging value and assessing risk
Jan M. Reid
Case study
Partnering IC31TM, a novel synthetic vaccine adjuvant
Dr Gerd Zettlmeissl
Medical Technology Business Development to Support Vaccines
Dr Zeil Rosenberg
