|
Agenda
« View Day1 | View Day 3 »
|
Day 2 | Thursday, May 15th 2008
|
| 7.30 |
Registration & buffet breakfast in the exhibition area |
|
Morning plenary session
Anticipating and accessing emerging vaccine markets to secure long-term competitive advantage
|
| 9.00 |
Chair's introduction
Where the public sector can play a role
- Research into existing and emerging disease
- Generation of IP
- Translational research – bridging the development gap
- Adding value for partnering
- Improving global health
Dr Steve Chatfield, Director, Centre for Emergency Preparedness & Response, Health Protection Agency
|
| 9.20 |
Questions & discussion |
| 9.25 |
CDC perspective
- Which indications will we prioritise and support?
- What is our current thinking regarding the adoption of a quadrivalent seasonal influenza vaccine?
Dr Melinda Wharton, Captain, United States Public Health Service (USPHS), Deputy Director, National Center for Immunization & Respiratory Diseases, Centers for Disease Control & Prevention
|
| 9.45 |
Questions & discussion |
| 9.50 |
BARDA perspective
How will we drive vaccine innovation and market development through the coming decade and beyond?
- What strategic planning initiatives has the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) undertaken to increase transparency and promote partnerships?
- What initiatives does the PHEMCE plan to support in the near-, mid-, and long-term?
- What steps is the federal government taking to help bridge the "Valley of Death"?
- What advanced development and acquisition initiatives have BARDA undertaken, and what are the possibilities for the future?
- How has the U.S. Department of Health & Human Services (HHS) addressed barriers to industry engagement in biodefense?
Monique K. Mansoura, PhD, Acting Deputy Director for Policy, Planning & Requirements, Office of the Biomedical Advanced Research & Development Authority (BARDA), Office of the Assistant Secretary for Preparedness & Response (ASPR), US Department of Health & Human Services
|
| 10.10 |
Playing your cards right: Managing investor expectations in biodefence
- The discussion will focus on how Wall Street and the investment community currently views companies pursuing biodefence funding through the United States Government, including both HHS and DOD. It will also provide practical tips, based on actual case studies, to avoid pitfalls that may create unrealistic expectations by the markets, as well as touch upon how the USG's contracting process actually works, in practice, as compared to a commercial transaction
John M. Clerici, Partner, McKenna Long & Aldridge LLP
|
| 10.25 |
Questions & discussion |
| 10.30 |
Morning coffee in the exhibition area
|
|
Keynote industry perspectives
|
| 11.10 |
Adapting the R&D organisation to drive the evolution of new vaccine targets and markets
- Merck has moved to a matrix-driven organization based around six franchises.
- Vaccines are part of the "Vaccines and Infectious Diseases" franchise
- This structure permits prioritisation of needs for vaccines, monoclonal antibodies and small molecule drugs on a pathogen by pathogen basis
- Prioritisation amongst new vaccine projects is based upon customer, commercial and technical inputs
Dr Anthony Ford-Hutchinson, Franchise Head, Vaccines & Infectious Diseases, Merck Research Laboratories
|
| 11.35 |
Questions & discussion
|
| 11.40 |
Exploring issues and opportunities in developing and accessing the European vaccine market
- Vaccines: A strategic area for Europe
- Heterogeneous market access across Europe for vaccines
- Support for continued success of vaccines in Europe
Dr Didier Hoch, President of the Board, sanofi pasteur MSD & President, European Vaccine Manufacturers (EVM)
|
| 12.00 |
Questions & discussion |
| 12.05 |
Short presentations & panel discussion
Assessing potentially key target applications and populations of the future
- What will be the next blockbuster vaccines?
- Case studies: What are the strategic drivers behind, and the keys to successfully instigating and maintaining, partnerships between West and East? How do you integrate such partnerships into your overall business model?
- How, and in what timescale, will the private sector vaccine markets in China and India develop sufficiently to present a significant opportunity to the global vaccine sector?
- How will the markets for, and prices of, vaccines develop in these countries?
- What role will local industry play in competition to, and in partnership with, US and European vaccine companies?
- Which existing and forthcoming vaccines (eg. traveller's vaccines) will gain new significance as global markets open up, and how will the challenges presented by potentially vast market expansion be addressed?
Panel to be comprised of the speakers of the session, plus:
Guy Buyens, MD, CEO, GENimmune NV
Dr Jennifer Hannesschlager, Senior Advisor, McKenna Long & Aldridge LLP
|
| 12.45 |
Buffet lunch in the exhibition area
|
|
Followed by your choice of 3 parallel sessions:
|
|
Focus session 1
Delivering the latest market expectations and clinical data for vaccines against nosocomial infections
|
| 1.55 |
Moderator's introduction
Examining the latest epidemiology data for major bacterial pathogens
- In light of the latest antimicrobial drug resistance surveillance data, how significant a role will vaccines play in countering the major nosocomial infections moving forwards?
Dr Steve Chatfield, Director, Centre for Emergency Preparedness & Response, Health Protection Agency
|
| 2.05 |
Questions & discussion |
| 2.10 |
Analyst's perspective
The nosocomial vaccines market
- The antibacterial vaccines market – sales estimates & forecast, patient potential and key target groups
- Analysis of key opportunities and unmet needs – which vaccines will add significant value to current hospital practice?
- Overview of the late-stage pipeline
Hedwig Kresse, MPhil, MSc, Senior Analyst, Infectious Diseases, Datamonitor plc
|
| 2.30 |
Questions & discussion
|
|
Industry case studies: What is the latest progress in the clinic for leading vaccine candidates against key nosocomial targets?
- Which approaches are optimal for discovering antigens for multiple strains?
- How are the specific challenges in designing and implementing clinical trials for these applications being addressed?
|
| 2.35 |
Case study
Vaccines - a new strategy against multidrug-resistant nosocomial pathogens
Professor Alexander von Gabain, CSO, Intercell AG
|
| 2.55 |
Case study
Staphylococcus aureus; are we closer to developing an effective vaccine
- S.aureus background and epidemiology
- Vaccine targets and development status of leading candidate vaccines
- Nabi's new StaphVAX vaccine candidate
Raafat E. F. Fahim, PhD, President & CEO, Nabi Biopharmaceuticals
|
| 3.15 |
Case study
Clostridium difficile: An emerged disease with an emerging solution
- A threat from emergence and resistance
- A new target through an established approach
- Clinical development design and planning
- The importance of partnership
Dr Michael Watson, Executive Vice President, R&D, Acambis
|
| 3.35 |
Questions for the speakers & panel discussion
What are the technological keys to optimising the identification of antigens in complex bacterial pathogens?
- How are genomics and proteomics tools evolving to drive the discovery and development of effective antibacterial vaccines?
Panel to be comprised of the speakers of the session
|
| 4.05 |
End of session - afternoon tea in the exhibition area |
|
Or | Focus session 2
Therapeutic vaccines update: What is the latest progress with leading candidates in clinical development?
• How and when will they reach the market?
|
| 1.55 |
Moderator's introduction
Big pharma perspective: Examining a recent partnering deal in the therapeutic vaccine area
- What are the specific expectations and drivers that were behind it?
- Why is the therapeutic vaccine area suddenly so attractive to big pharma?
Dr Karen J. Huebscher, Global Head of Business Development & Licensing, Novartis Vaccines and Diagnostics
|
|
Industry case studies
Updates on the most advanced immunotherapeutic candidates for various indications in clinical development
- How are regulatory requirements impacting ongoing clinical trial designs and overall development strategies?
- What impact are novel adjuvants having on safety and efficacy?
- How might these vaccines fit into treatment
|
| 2.10 |
Case study
Progress in the development of Sipuleucel-T for the active immunotherapy of prostate cancer
- Introduction to prostate cancer
- Background on Sipuleucel-T development
- Clinical trial results
- Discussion of regulatory milestones and path to market
David L. Urdal, PhD, Chief Scientific Officer, Dendreon Corporation
|
| 2.30 |
Questions & discussion |
| 2.35 |
Case study
Therapeutic vaccines: Next therapeutic breakthrough
- Exploring the promising clinical responses
- Utilising new scientific knowledge for best advantage
- Identifying ways to improve efficiency
- Creating synergy with other cancer treatments
Dr Jean-Yves Bonnefoy, Vice President, R&D, Transgene SA
|
| 2.50 |
Questions & discussion |
| 3.00 |
Case study
In pursuit of an Alzheimer’s therapeutic vaccine
- The impact and biology of AD
- The science underlying anti-amyloid therapies
- The initial clinical results with AN1792
- Design and status of ACC-001, the second generation vaccine
- The future of immunotherapy
James Callaway, PhD, Senior Vice President, Alzheimer’s Immunotherapy Program, Elan Pharmaceuticials
|
| 3.20 |
Questions & discussion |
| 3.25 |
Case study
Therapeutic vaccines for chronic infectious diseases: Will we get there?
- Need for therapeutic vaccines
- Rationale
- Lessons from the past
- Current status
- The future
Guy Buyens, MD, CEO, GENimmune NV
|
| 3.45 |
Questions & discussion |
| 3.50 |
Questions for the speakers & panel discussion
- What is the path forward to demonstrate sufficient efficacy with cell-mediated immunity approaches in the therapeutic vaccine field?
- What is the best/optimal method to induce CMI?
Panel to be comprised of the speakers of the session
|
| 4.05 |
End of session - afternoon tea in the exhibition area |
|
Or | Workshop
How can we improve immune response in elderly and immunosuppressed populations?
(Highly interactive session for a limited number of attendees)
|
| 1.55 |
Moderator's introduction
What initiatives are being developed and implemented to meet the challenges of prioritising and delivering novel, effective vaccines to special populations, such as the elderly and immunosuppressed?
Dr Melinda Wharton, Captain, United States Public Health Service (USPHS), Deputy Director, National Center for Immunization & Respiratory Diseases, Centers for Disease Control & Prevention
|
| 2.05 |
Changes in CD8+ T cells in elderly persons and their impact for vaccination
Dr Birgit Weinberger, Immunology Division, Institute for Biomedical Aging Research, Austrian Academy of Sciences
|
| 2.30 |
Questions & discussion
|
|
Industry case studies: Examining clinical trial design strategies for, and the latest data from, vaccine candidates in development against major health threats to elderly and immuno-compromised populations
- Are potential enabling technologies, such as adjuvants and alternative delivery devices, having an impact on immune response? What is the role of formulation in this context?
|
| 2.35 |
Case study
FluBlok, a high dose recombinant hemagglutinin influenza vaccine
- Four ways to improve immune response in the elderly or immunocompromised
- Safety, immunogenicity and efficacy of high dose vaccine in various population
- Overall status update on FluBlok licensure
Drs Manon Cox, MBA, Chief Operating Officer, Protein Sciences Corporation
|
| 3.00 |
Questions & discussion
|
| 3.05 |
Immunogenicity and safety of a licensed adjuvanted seasonal influenza vaccine in elderly and immunosuppressed subjects
Dr Volker Brauer, Medical Manager, CRD & MA Northern/Western Europe, Novartis Vaccines and Diagnostics GmbH & Co. KG
|
| 3.30 |
Questions & discussion |
| 3.35 |
Panel discussion
- Which vaccines in addition to those discussed previously should the industry target for the elderly population?
- How can we create a better understanding of why the elderly have a generally poor response to vaccines?
- What are the root causes and how might they be addressed to improve understanding of optimal dosage, for instance?
Panel to be comprised of the speakers of the session
|
| 4.05 |
End of session - afternoon tea in the exhibition area
|
|
Then | Afternoon plenary session
Honing your corporate development model in light of ongoing partnering trends in the vaccine sector
|
| 4.40 |
Chair's introduction
Examining recent and ongoing partnering trends in the vaccine sector
- Where are the new vaccine products coming from?
- What are the business structures that are most often used to accelerate product development?
- What are the rationales behind the different models of partnering?
- What can we project for partnering activities in the future?
- How can we improve the possiblity of product development success in partnerships
Dr Allan P. Jarvis, Senior Vice President, Corporate Development, sanofi pasteur
|
| 5.05 |
Questions & discussion
|
| 5.10 |
Panel discussion
- How many new big pharma players can the sector support? What will be the implications of this trend for biotech?
- Will there be room for small and mid-sized vaccine companies in the marketplace of the future? What will be the predominant corporate development model for independent vaccine companies moving forwards?
Panel to be comprised of the speakers of the session, plus:
Jan M. Reid, Senior Director, Vaccines Licensing, Wyeth Global Business Development
Professor Alexander von Gabain, CSO, Intercell AG
|
| 5.45 |
Close of day 2 followed by a cocktail reception in the exhibition area
|
|
|
View Day1 | View Day 3 »
^
|
