Phacilitate Vaccine Forum Spring 2005
Presentations
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Monday May 23rd 2005 | Pre-conference Workshop
Morning plenary session
Clarifying and comparing the latest regulatory requirements in US and Europe
Chair’s introduction
What compliance and standardisation issues are manufacturers currently finding the most challenging?
Dr Jack Love
Navigating the evolving European regulatory landscape – from approved principles to new strategic priorities
Dr Michael Pfleiderer
FDA Update: Initiatives & programmes related to clinical trial conduct
Patricia A. Cleveland PhD
Presentation & panel discussion
Update on EMEA’s new approach to Risk Assessment and Management and its proposed impact on vaccine development
Dr Brigitte Keller-Stanislawski
Fast-track case study under the new risk management approach
Dr Thomas Steinbach
Workshop 1
Monitoring and proving vaccine safety and compliance post-licensure
Moderator’s introduction
What are the key differences in vaccine safety reporting requirements post-licensure across Europe?
Dr Brigitte Keller-Stanislawski
Issues relating to the revision of the CPMP New Vaccines Guidelines
A.C. G. Voordouw, MD, MPH
Case study from post-marketing surveillance – vaccine recall due to contamination
Renald Hennig MD MBA
Case study - RotaShield
Dr Dennis Foley
Nasal Flu: Post-marketing analysis and non-relicensure
Dr Katharina Hartmann
Case study
Unexpected reactogenicity of a vaccine - a pharmacovigilance case study
Dr Rudolf Schosser
Workshop 2
The EU Clinical Trials Directive one year on
Moderator’s introduction
What are the key differences in interpretation of the EU CTD to be aware of when filing for multi-site trials?
Dr Michael Pfleiderer
Case study
First experiences with the initiation of a vaccine clinical trial under the new Directive
Greg Berezuk
Case study
Running a phase III trial simultaneously in Europe and North America
Dr Erich Tauber
Case study
Electronic Reporting for Clinical Trials to Eudravigilance
Dr Thomas Steinbach
Panel discussion
What impact has the EU CTD had on costs, timelines and cGMP?
No Slides Presented
Workshop 3
Integrating analytical development and product characterisation with clinical development
Moderator’s introduction
Establishing the clinical relevance of analytical test strategies for vaccines
Dr John P. Hennessey
Characterisation data – how much is required and how do the requirements differ between the US FDA and the EU?
Patricia A. Cleveland, PhD
Case study
Using of analytical characterisation to support the development and licensure of an HPV vaccine
Dr Robert Sitrin
Case study
Using of analytical characterisation to support the development and licensure of a biodefence vaccine – the impact of the 2 animal rule
Dr Lance K. Gordon
Case study
Pneumococcal and Group A Strep vaccines based on novel recombinant chimeric proteins
Ronald W. Ellis, PhD
Case study
Characterisation of a pentavalent rotavirus vaccine (RotaTeqTM): defining measures relevant to clinical performance
Dr John P. Hennessey
Panel discussion
Developing vaccine test strategies that are more clinically relevant
Dr William Egan
Afternoon plenary session
Wrap up session
Moderator:
Dr Jack Love
Panellists:
Dr John P. Hennessey
Dr Brigitte Keller-Stanislawski
Dr Michael Pfleiderer
Wrap Up Clinical Trials Directive
Tuesday May 24th 2005 | Main conference day 1
Interfacing R&D strategy with commercial considerations to optimise the value of your portfolio
Morning plenary session
Improving portfolio management and sharpening decision making to maximise returns on R&D investment in vaccines
Chair’s introduction
Optimising the R&D/commercialisation interface - what strategic approach is a large vaccine company taking to the commercialisation of vaccine R&D programmes?
Dr Peter Khoury
Optimising the value of the R&D portfolio - Strategy for building a vaccine pipeline in a mid size vaccine company
Dr Steve Chatfield
New paediatric meningococcal vaccines – challenges for their development and licensing
Anne-Marie George
Case study
Overcoming the challenges which impact new vaccine product uptake
Dr Kathleen Coelingh
Panel discussion
Implementing effective portfolio management strategies to ensure optimal prioritisation of projects/candidate vaccines and resource allocation, and to improve operational efficiency
Moderator:
Dr Peter Khoury
Panellist:
Jonathan Pockson
No slides Presented
Main afternoon session
Effectively applying predictive modelling, surrogates and correlates at the preclinical / phase I clinical interface to optimise decision-making and clinical trial design
Chair’s introduction
Dr John Shiver
No Slides Presented
Preclinical safety studies for vaccines: Clarifying the requirements and recommendations of the regulator
Dr Marion Gruber
How are biomarkers being effectively applied as surrogates or correlates of efficacy in vaccine clinical trials?
Dr William Gruber
Optional 20-minute Company Showcase
Alfa Wassermann's position in continuous flow ultracentrifugation
Dr Mats Falk
No Slides Presented
Strategies for HIV-1 vaccine development
Dr John Shiver
Panel discussion
Applying translational medicine to develop predictive models which can be applied at the preclinical / phase 1 interface
Panellists:
Professor Angus Dalgleish
Dr Stephen Lockhart
No Slides Presented
Afternoon breakout session
What are the real opportunities in the biodefence sector?
Moderator’s introduction
Update on recent procurement decisions in the US
Dr Thomas Fuerst
Biodefence vaccine procurement and stockpiling as a function of European bio-terrorism crisis management policy: setting standards and building capacity
Drs Jill Dekker-Bellamy
How are vaccines for biodefence going to be regulated? – US perspective
Dr Lydia Falk
Panel discussion
Making the business case for investment in biodefence vaccine R&D – balancing short and long-term risks and opportunities
Panellist:
Dr Steve Chatfield
No Slides Presented
Afternoon breakout session
Satisfying basic demand for influenza vaccine and ensuring pandemic preparedness
Moderator’s introduction
Addressing the lack of funding and incentives for influenza vaccine manufacturers – learning lessons from the winter shortages in the US
Dr David Salisbury CB
Slides Available Soon
Establishing an inter-pandemic framework for clinical and deployment strategies prior to outbreak, and for times of vaccine shortfall
Dr David Fedson
WHO perspective on flu vaccine shortages and pandemic preparedness
Dr Klaus Stöhr
Slides Available Soon
Why influenza pandemic preparedness is directly linked to the use of influenza vaccines during the inter-pandemic period
Dr Luc Hessel
Update on R&D programmes focusing on avian flu strains
Dr Guiseppe Del Giudice
Panel discussion
What new opportunities might arise out of the recent turmoil in the flu vaccine sector?
No Slides Presented
Afternoon plenary session
Panel discussion
Learning lessons from chronic vaccine shortages: Failure of industry, regulation or public policy?
Moderator:
David Salisbury CB
Panellists:
Dr Timothy Cooke
Dr Luc Hessel
Dr William Egan
No Slides Presented
Wednesday May 25th 2005 | Main conference day 2
Where do the next opportunities lie for profitable vaccine development?
Morning plenary session
Identifying the remaining high value targets, and developing sustainable business models which attract funding
Chair’s introduction
How much focus should big pharma put on vaccines?
Dr Allan P. Jarvis
No slides Presented
Financial analyst’s view: What are the private funding options for prophylactic and therapeutic vaccines and how can you increase your chances of accessing them?
Peter Welford
VC panel discussion
What does it take for them to invest in vaccines?
Moderator:
Paul Kirkconnell
Slides not available
Panellists:
Dr Jeremy Reffin
François Thomas
Case study
Leveraging resources to fund the development of a proprietary manufacturing business
Dr Lance K. Gordon
PRESENTATION & PANEL DISCUSSION
Where should you be investing your vaccine R&D budget next?
Moderator’s introduction
Dr Timothy Cooke
No slides Presented
Vaccines against drug induced addictions, life style disease and old age
Professor Ben van der Zeijst
Panel discussion
Panellists:
Dr Henrik S. Rasmussen
Dr Allan P. Jarvis
Dr Daniel J. Carucci
Dr Alexander von Gabain
Dr Lance K. Gordon
Main afternoon session
Progressing through the clinic: Scaling up production capacity to reach and run phase III trials
Chair’s introduction
Progressing through the clinic: Scaling up production capacity to reach and run phase III trials
Dr Stephen Lockhart
Case study
Towards testing combination vaccines for malaria
Professor Adrian V. S. Hill
Case study
HPV-16/18 L1 Virus-like particle cervical cancer vaccine: From process development to clinical trials
Dr Martine Wettendorff
Slides Not Available
Case study
Development of NicVAX, a vaccine for smoking cessation: challenges of developing a ‘non-traditional’ vaccine for an indication where vaccine approaches have never been used
Dr Henrik S. Rasmussen
Afternoon breakout session
Planning a partnering and licensing strategy which supports your approach to portfolio management
Moderator’s introduction
What should biotechs be focusing on in the short and long-term?
Jan Reid
Case study
Licensing strategies of small companies and optimisation of their portfolio values
Dr Alexander von Gabain
Case study
Licensing strategy of a mid-sized vaccine company
Dr Anya Ramalho
Panel discussion
Reviewing alternative approaches to partnering and licensing – what has the ‘Auction Model’ achieved for partners to date?
No Slides Presented
Afternoon breakout session
Therapeutic cancer vaccine late stage results
Moderator’s introduction & case study
Update on phase III clinical trials using autologous dendritic cancer vaccine therapy – what can cell based vaccine companies learn from them?
David L. Urdal, PhD
Case study
From IND to Phase III in one year: The development of Therion’s pancreatic cancer vaccine
Mark Leuchtenberger
Current problems in the development of cancer vaccines
Professor Angus Dalgleish
