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Investing in Vaccines Day Monday 20 April 2009
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8am | Registration and morning coffee
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9am | Chairman's opening remarks
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| GOVERNMENTAL AND PHILANTHROPIC FUNDING |
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9.10am | The NIH grants process for promoting vaccine research
- Establishing the technical merit and feasibility of proposed research effort and quality of performance
- Pursuing commercialisation of the results of research or R&D funded in Phases I and II
- Developing technology in-house through federal funding beyond Phase II
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| | Dr Marvin Kalt, Director, Division of Extramural Activities, NIAID, National Institutes of Health
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9.40am | Panel session: eye of the beholder – leveraging SBIR grant
success
- Real-world experiences with successful SBIR applications
- Using results from Phase I grants to demonstrate commercial potential for additional SBIR funding phases
- Examples of strategies and techniques for developingcompelling and competitive SBIR/STTR proposals
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10.25am | Flexible and rapid-response funding for pioneering vaccine
research
IAVI Innovation Fund and identifying breakthrough concepts
Identifying novel technologies and accelerating the most promising public private partnership model
Aiming at bolstering broader strategy and dedicated
significant R&D investments |
| | Ms Michelle Dees, Director, Innovation Fund, International AIDS Vaccine Initiative
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10.55am | Morning coffee
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| CORPORATE VENTURE CAPITAL - DIVIDENDS ‘BEYOND THE BOTTOM LINE’ |
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11.25am | Panel session: corporate venture capital, value creation and strategic advantage
- Balancing high cost of drug development against gaining a marketable vaccine candidate; corporate VC rationale
- Corporate VC funding as alternatives to traditional VC funding and ‘de-risked’ investments
- When and where does corporate venture capital investment create firm value?
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12.05pm | Panel session: the transition to private equity markets
- Evolving from government grants and non-dilutive funding into the world of venture capital
- Generating interest from the investor community; balancing institutional and strategic investment sources
- Strategies to maintaining first mover advantage with domain specific VC expertise
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12.45pm | Lunch
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| NAVIGATING THE VENTURE PATH: THE QUICKEST ROUTE TO MONEY? |
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2pm | Panel session: invention to venture: securing series A
funding
- Key considerations for investor and company representation when raising series A funding
- Raising series A funding and outlining the key deal terms
- Influence of VC investment and how corporate strategy differs after receiving venture capital funding
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2.40pm | Panel session: raising late stage follow-on funding – when is the right time?
- Process of raising additional VC funding and follow-on rounds of capital
- What to know about timing, dilution and new deal term strategies and alternative financing options
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3.20pm | Afternoon tea
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3.50pm | Panel session: rules of engagement – from first round to
follow-on funding
Forecasting what deal structures will be palatable in the early, mid and late-stage
Balancing collaborative strategic corporate goals, term sheets and financial ROI |
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4.30pm | Panel session: this way out: exit strategies and exit values
- Overcoming obstacles that VC-Funded company executives face in growing a business expected to eventually achieve an exit strategy
- Successful investment exit strategies – how do you find one for both company and VC?
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| | Bartosz Ostenda, Vice President, Healthcare Investment Banking, Goldman Sachs & Co.
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5.10pm | Close of pre-congress day followed by drinks reception
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Congress Day 1 Tuesday 21 April 2009
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8am | Registration and morning coffee
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| VACCINES: WHO’S CALLING THE SHOTS? |
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9am | Chairman’s opening remarks
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| | Jim Keminar, President and Chief Executive Officer, Biologics Consulting Group
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9.05am | Keynote address: vaccine innovation and evolution: new
scientific concepts aligning with government and industry
practices
- Defining issues for the future of vaccinology
- The role of immunogenetics and the emerging field of vaccinomics
- Forward looking developments with therapeutics,
- prophylactics, adult, pediatric and personalised medicine
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| | Dr Gregory Poland, Professor of Medicine and Infectious Disease, College of Medicine, Mayo Clinic, Rochester, Mn.
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9.35am | Panel session: federal progress in medical countermeasure
preparedness
- BARDA strategies to further advance the science, technology, policies, planning, and response capabilities
- BARDA anticipated near-term medical countermeasure advanced development and acquisition plans
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| | Dr Monique Mansoura, Director of Policy, Planning and Requirements, BARDA, ASPR, US Department of Health and Human Services Dr Gerald Kovacs, Director of CBRN, BARDA, ASPR, US Department of Health and Human Services Dr Michael Perdue, Director, Influenza and Emerging Diseases Program, BARDA, ASPR, US Department of Health and Human Services
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10.20am | Panel session: vaccine financing strategies and industry
research opportunities
- A strategic outlook and roadmap for domestic vaccine financing initiatives
- Evolving financing and realms of reimbursement from payers
- Clarifying the scale, scope, timing and eligibility of financing of domestic vaccines
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| | Dr Gus Birkhead, Deputy Commissioner of the Office of Public Health, New York State Department of Health CDR Angela Shen, Vaccine Specialist, NVPO, US Department of Health and Human Services
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11.05am | Morning coffee
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11.35am | Panel session: facilitating vaccine industry safety and
surveillance processes
- Anticipating and addressing the safety and regulatory issues for new vaccines relating to the national vaccine plan
- Government role when expediting vaccine safety research priorities
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| | Dr Bruce Gellin, Director, National Vaccine Program Office, US Department of Health and Human Services Dr Robert Ball, Director, Office of Biostatistics and Epidemiology, CBER, FDA
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12.20pm | Status, trends and options for vaccine manufacturing
- The vaccine market - how market dynamics affect the choice and requirements of manufacturing technology
- New approaches: development and deployment of innovative solutions in vaccine manufacturing
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| | Dr Nigel Darby, General Manager Biotechnologies and Chief Technology Officer, GE Healthcare Life Sciences
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12.50pm | Lunch
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| INDUSTRY INJECTION – A ROLE FOR PHARMA |
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2.10pm | Vaccine manufacturer implementation of NVP activities
- Comparing current and future planned activities against the National Vaccine Plan
- Key challenges faced by manufacturers surrounding achieving plan action points
- Importance and role of manufacturers in ongoing communication and collaboration with US government planning
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| | Mr Dean Mason, Assistant Vice President, Global Vaccine Policy, Wyeth Ms Margeurite Baxter, Vice President and Head, Global Public Affairs, Novartis Vaccines and Diagnostics Philip Hosbach, Vice President, Immunization Policy and Government Relations, sanofi pasteur
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2.55pm | Opportunities and challenges for vaccines in global markets
- Responding to current and future demographic and economic demands on vaccine markets
- Creating effective, efficient and sustainable commercial models around research, development and marketing
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| | Margie McGlynn, President, Merck Vaccines & Infectious Diseases, Merck & Co.
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3.25pm | Diversifying and derisking; expanding corporate horizons
- A changing environment; demand for innovative medicines and vaccines
- Expanding global reach and presence across significant immediate opportunities and emerging markets
- Addressing increasing challenges; cost containment, regulatory pressures and competition
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| | Alan Taggart, Vice President of Government Project Management, MedImmune
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3.55pm | Speed Networking
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4.55pm | Afternoon tea
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| GLOBAL HEALTH: MAKING PARTNERSHIPS WORK |
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5.25pm | Panel session: global health initiatives and crafting industry partnerships in vaccines
- Where are advances in vaccine policies that are enhancing and have the potential to advance global health?
- Coveting strong R&D partnerships: considerations for structuring innovation
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| | Dr Seth Berkley, President and Chief Executive Officer, International AIDS Vaccine Initiative Wendy Taylor, Founder & VP Strategy and Operations, BIO Ventures for Global Health Dr Rick Bright, Scientific Director, Influenza Vaccine Project, Vaccine Development Global Program, PATH
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6pm | Close of Congress Day 1 followed by networking drinks
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7.15pm | ViE Awards champagne reception
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8pm | ViE Awards dinner and ceremony
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Congress Day 2 Wednesday 22 April 2009: MORNING PLENARY SESSION
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8am | Registration and morning coffee
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9am | Chairman's opening remarks
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| | Dr Una Ryan, Chief Executive Officer, Waltham Technologies
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9.10am | Keynote speaker panel session: addressing significant unmet needs through world class vaccine pipelines
- Therapeutics over prophylactics: where the future lies and novel research programs expecting to drive sustained future growth
- Importance of novel technologies making new targets possible, and emerging early and late stage pipeline development
- How are big pharma aligning R&D efforts and commercial operations?
- Allocating resources and balancing risks across a variety of opportunities
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| | Dr Anthony Ford-Hutchinson, Senior Vice President and Franchise Head, Vaccines and Infectious Disease, Merck Research Laboratories Dr Robert Ryall, Director, External Research and Development, sanofi pasteur Dr Philippe Monteyne, Senior Vice President, Head Global Vaccine Development, GlaxoSmithKline Biologicals Dr Bruce Forrest, Senior Vice President of Late Phase Vaccine Development Programs, Wyeth Vaccines Dr Christian Mandl, Head of Research and Global Head, Viral Vaccine Projects, Novartis Vaccines and Diagnostics
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10.30am | Improving the safety of vaccination and drug administration practices
- A survivor's story: an overview of the largest healthcare transmission outbreak of hepatitis C
- Injection safety implications in traditional and emerging healthcare settings
- An examination of novel vaccine and drug delivery solutions to address injection safety concerns
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11am | Morning coffee
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Congress Day 2 Wednesday 22 April 2009: Stream A
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| REDRAWING THE VACCINE FRONTIER |
Chairman:
Dr Una Ryan, Chief Executive Officer, Waltham Technologies
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11.30am | New vaccine opportunities ahead – new targets, new
markets
- Vaccines market set to expand: new disease targets,broader age groups vaccinated
- What are the current opportunities and challenges of the US vaccine market and further afield ie. BRIC?
- Aligning efforts and commercial operations for best fit
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| | Dr Peter Khoury, Vice President, Global Marketing, Vaccines, Baxter Bioscience
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12pm | Developing new, inexpensive technology to bring vaccines for infectious bacteria to the developing world |
| | Dr. Kevin Killeen, Vice-President Research & Business Development, Matrivax Corporation
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12.30pm | Strategies for primary packaging selection and qualification
- Regulatory expectations continue to evolve around the scientific understanding of delivery systems
- Historical approaches for primary packaging qualification tend to provide little room for changes post-launch
- Strategic methodologies and programs, which ensure a high degree of qualification success and flexibility, will be presented
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| | Dr Justin Wright, Manager, Bio-Analytical Sciences, BD Medical - Pharmaceutical Systems
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1pm | Lunch
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| TAKING AIM AT NOVEL MARKETS |
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2pm | Nosocomial vaccines market – goldmine or minefield?
- Rationale for vaccine development - protection against the next potential ‘superbug’
- Overview of epidemiology and key targets for vaccine development
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2.25pm | Human monoclonal antibodies against emerging
infectious diseases
- Current global threats and application of vaccines
- First monoclonal antibody cocktail for post-exposure prophylaxis against rabies
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2.50pm | Panel session: the therapeutic vaccine frontier and
unlimited opportunities
- Igniting the market with nicotine conjugate vaccines
- Primary endpoints for autoimmune vaccine studies
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3.30pm | Advancing vaccine development for developing markets
- Status reports on new and promising vaccine studies
- Current goals, immunological design and evaluation
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| | Carla Botting, Director, Commercial Affairs and Product Development - Malaria Vaccine Initiative, PATH
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4pm | Afternoon tea
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| REGULATORY PATHWAYS TO APPROVA |
Chairman:
Dr William Egan, Vice President, PharmaNet Consulting
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4.30pm | A route to approval for domestic vaccine programmes
- Regulatory pathways in the US evolving to enable the development of vaccines
- Streamline regulatory authority to ensure reliable production of safe and effective vaccines
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5pm | Barriers and overcomign barriers in the vaccine approval pathway |
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5.15pm | Strategies for novel vaccine development and
introduction in North America
- Development and harmonisation of regulations in key areas of concern for the vaccine industry
- Challenges to establishing a presence in the NA market
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6pm | Close of Congress Day 2 followed by networking drinks
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Congress Day 2 Wednesday 22 April 2009: Stream B
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| INFLUENZA EVOLUTION |
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11.30am | Chairman's opening remarks
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| | Dr Klaus Stohr, Director, Influenza Vaccine Franchises, Novartis Vaccines and Diagnostics
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11.45am | Domestic vaccine development and contracting
- How are the government’s strategy and plans creating opportunities for companies at all steps in the end-to-end preparedness framework?
- What is the government’s strategy for purchasing products and services for preparedness, and how is that strategy evolving?
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| | Dr Michael Perdue, Director, Influenza and Emerging Diseases Program, BARDA, ASPR, US Department of Health and Human Services
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12.10pm | Clarifying current strategies for pandemic and prepandemic
influenza
- Designing risk management plans for pandemic vaccines: spontaneous reporting and safety exchange, signal detection, safety studies, post- licensure commitments
- Pre-pandemic approaches: are they scientifically supported? How can they be implemented?
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12.35pm | Adjuvants provide an avenue to improved vaccines in the elderly
- Introduction to saponin based adjuvants
- The science supporting ISCOMATRIX® vaccines
- Overview of results of a Phase II study
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| | Debbie Drane, Vice President, Research and Development & Divisional Manager, CSL
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1pm | Lunch
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2pm | Developing cell culture derived pandemic vaccines
- Using the Vero cell platform for influenza vaccines
- Immunogenicity and cross protection in animals
- Clinical trial strategy and first data in humans – safety plus pre-clinical and manufacturing processes
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| | Dr Noel Barrett, Vice President, Research and Development, Baxter Bioscience
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2.25pm | MDCK cells for manufacture of live attenuated Influenza
virus vaccines
- Cell culture-based vaccines: an alternative to egg-derived influenza vaccines and its business and operational values
- The next generation of vaccines: development of cell culture-based live attenuated influenza vaccine
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2.50pm | Integrating recombinant virus like particles to exploit
therapeutic influenza vaccines
- Development of proprietary virus-like particle technology
- Clinical development of a VLP vaccine against influenza
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2.50pm | Virosome-based influenza vaccine development
- Prospects for improved influenza vaccine development and manufacture
- Proprietary virosome-based technology platforms to the development of efficient and safe vaccines
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3.15pm | Panel session: facilitating vaccine research, development
and manufacture
- Needed/improved assays, reagents, virus strains for development, manufacturing and release
- "Holy grail" vaccines: cross-protective antigens
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4pm | Afternoon tea
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| TARGETING BIODEFENSE MARKETS |
Chairman:
Dr Brad Smith, Associate Director, Center for Biosecurity of UPMC
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4.30pm | Medical countermeasure development and acquisition - path forward under the PHEMCE strategy
- Project BioShield and the barriers to the development of a robust program
- BARDA Strategic Plan allowing for private industry business planning
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| | Dr Gerald Kovacs, Director of CBRN, BARDA, ASPR, US Department of Health and Human Services
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4.55pm | Biodefense research and development priorities and
programs
- Key countermeasure priorities for R&D at the NIAID and where focus is aimed
- Critical timing milestones for procuring these technologies. What are the stages of development?
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| | Dr Michael Kurilla, Director, Office of Biodefense Research Activities in the Division of Microbiology and Infectious Diseases, Associate Director for Biodefense Product Development, NIAID, National Institutes of Health
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5.20pm | Panel session: turning biodefense dollars into products
and driving product development
- How are Government actions leveraging the participation and support of pharma and biotech?
- How is industry meeting the needs of government whilst remaining competitive?
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6pm | Close of Congress Day 2 followed by networking drinks
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Congress Day 3 Thursday 23 April: Stream A
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8am | Registration and morning coffee
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| R&D GROWTH STRATEGIES |
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9am | Chairman's opening remarks
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| | Mr Charles Farkas, Partner and Head, North American Healthcare Practice, Bain & Company
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9.10am | Leveraging the established vaccine franchise: accessing
external innovation and pharma unit capabilities
- What role will collaborative strategies play in shaping our future vaccines business model?
- Innovation through acquisition: how are we seeking to retain the qualities of nimbleness and R&D innovation
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9.40am | Innovation and strategic partnerships – the key to success
for pharma and biotech models
- Strategic alliances shaping the vaccine industry
- Pharma / Biotech approaches to strategic alliances
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10.10am | Growth through innovation: responding to emerging
opportunities organically
- What are the new prophylactic and therapeutic applications for which vaccines hold great promise?
- Balancing a vaccine development portfolio that targets major medical needs but minimises risk
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| | Dr Clement Lewin, Head, Strategic Immunization Planning, Novartis Vaccines and Diagnostics
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10.40am | Morning coffee
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11.10am | Approaching vaccine manufacturers with alliance development opportunities
- What opportunities exist for vaccine SME’s through alliance development
- What decisions need to be made from each party and how can you create a win-win collaborative relationship?
- Recent examples with AlphaVax and other SME partnering experiences
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11.40am | Emerging vaccine R&D and alliance opportunities to tap into market potentials in Asia
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12.10pm | Panel session: optimising new vaccine development strategies |
| | Dr Clement Lewin, Head, Strategic Immunization Planning, Novartis Vaccines and Diagnostics
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12.50pm | Lunch
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| HIV VACCINES – PROGRESS AND PROSPECTS |
Chairman:
Dr Alan Bernstein, Executive Director, Global HIV Vaccine
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1.50pm | Stream keynote: HIV vaccine research; time for re-evaluation?
- Have we hit the wall in HIV vaccine development; what now for research portfolios?
- Fostering renewed innovation in HIV vaccine discovery
- Monitoring vaccine discovery efforts and related basic research within NIH, nationally and internationally
- Determining funding priorities for vaccine discovery research
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| | Dr Jorge Flores, Deputy Director of the Vaccine Research Program and Acting Chief, Vaccine Discovery Branch, Vaccine Research Program, DAIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health
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2.20pm | Translating new knowledge to foster fruitful research collaborations
- Evaluating current approaches to HIV vaccine research and development, what is limiting progress?
- Pushing the envelope of HIV vaccines; next steps for vaccine development
- Plan, develop, implement and evaluate extramural grants and contracts to support research
- Fostering the development and supply of necessary research reagents and other resources
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| | Jim Bradac, Chief, Preclinical Research and Development Branch, Vaccine Research Program, Division of AIDS, National Institutes of Health
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2.45pm | Encouraging innovation in vaccine development and
global health solutions
- Models, key players and financial incentives needed to advance current AIDS vaccine research and development
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| | Dr Seth Berkley, President and Chief Executive Officer, International AIDS Vaccine Initiative
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3.10pm | Panel session: where now for HIV vaccine clinical
research?
- Key industry investigations for HIV vaccine development
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| | Dr John Shiver, Vice President, Worldwide Basic Research Franchise Head, Vaccines, Merck Research Laboratories Dr Jorge Flores, Deputy Director of the Vaccine Research Program and Acting Chief, Vaccine Discovery Branch, Vaccine Research Program, DAIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health
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3.50pm | Afternoon tea
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| CANCER VACCINES AND IMMUNOTHERAPY |
Chairman:
Dr Neil Berinstein, Head, Cancer Vaccine Program, sanofi pasteur
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4.05pm | Clinical response to the MAGE-A3 immunotherapeutic in
metastatic melanoma
- Lung phase III program and future perspectives with MAGE-A3 and other antigens
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| | Dr Frederic Lehmann, Director, Head of Early Clinical Development WW, Cancer Immunotherapeutics, GlaxoSmithKline Biologicals
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4.30pm | Re-defining clinical endpoints for cancer immunotherapy
- Clinical paradigms for immunotherapy: novel endpoints
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| | Dr Axel Hoos, Medical Lead, Immunology / Oncology, Bristol-Myers Squibb
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4.55pm | Cancer vaccines - best candidates in our effort to stop the epidemic of cancer deaths
- Rationale for cancer vaccines in earlier stage disease
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5.20pm | Panel session: cancer vaccine technology evolution
- Emerging targets and technologies for cancer vaccines
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6pm | Close of congress
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Congress Day 3 Thursday 23 April: Stream B
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8am | Registration and morning coffee
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| VACCINE CLINICAL TRIALS AND TRIBULATIONS |
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9am | Chairman's opening remarks
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9.05am | Panel session: clinical trial evolution for vaccines
- Streamlining late-stage clinical development processes to speed regulatory submission and approval
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| | Dr Karen Near, Medical Director, Vaccine and Immunologic Products, Baxter Bioscience Dr Luwy Musey, Director, Clinical Research, Merck Research Laboratories
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| PRODUCTION, MANUFACTURE AND CAPACITY |
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9.35am | Economical and capacity driven vaccine manufacturing
- Challenge of LAIV manufacturing: facility design, maintaining cold chain throughout manufacturing process
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| | James Merck, Manufacturing Collaborator, Vaccines, MedImmune
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10am | Sustainable vaccine production and manufacture
- Managing successful internal production and manufacture
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10.25am | Microbial metabolism and manufacturing vessels
- Customer / CMO benefits of disposable manufacturing
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10.50am | Morning coffee
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11.20am | Commercialisation of virus-like particle vaccines using
disposable manufacturing systems
- Recombinant VLP vaccines in disposable systems
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11.45am | Upstream, downstream and even in final fill, new
technologies for flexible vaccine manufacture
- What technologies are available at what scale: how easy is it to evaluate at the research and development level?
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| | Ms Helène Pora, Vaccine Application Development Director, Pall Lifesciences
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12.10pm | Panel session: strategic and economic challenges for
companies looking to increase supply of vaccine products
- Improving speed to market: what are the challenges in development and manufacturing of modern vaccines?
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| | James Wong, Manufacturing Collaborator, Vaccines, Medimmune
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12.50pm | Lunch
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| ADJUVANTS AND DELIVERY TECHNOLOGIES |
Chairman:
Dr William Warren, Chief Executive Officer, VaxDesign
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1.50pm | Highlighting viable technologies for improved vaccines
- Examining the current state of DNA vaccines and adjuvants
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| | Dr Christian Mandl, Head of Research and Global Head, Viral Vaccine Projects, Novartis Vaccines and Diagnostics
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2.15pm | Panel session: TLR-dependent/independent adjuvants
- Developing strategies to maximise chances of approval for novel adjuvants
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| | Debbie Drane, Vice President, Research and Development & Divisional Manager, CSL
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2.55pm | Nanoemulsion as a novel safe adjuvant for nasal vaccine
- Nanoemulsion characteristics and mechanisms of action
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3.20pm | Bridging the gap between adjuvant discovery and
adjuvant development
- Enabling characterisation and optimisation of adjuvant formulations and their immune cell targeting
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3.50pm | Afternoon tea
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| POST MARKET EVALUATION |
Chairman:
Dr Danilo Casimiro, Director, Vaccine Basic Research, Merck Research Laboratories.
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4.05pm | Enhancing post-marketing vaccine safety surveillance
- Policy and procedures governing the post-market review and evaluation of vaccines
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| | Dr Hector Izurieta, Chief, Vaccine Safety Branch, Office of Biostatistics and Epidemiology, CBER, FDA
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4.35pm | Vaccine safety surveillance in the 21st century: lessons
learned and challenges for the future
- Individual variability in vaccine efficacy and the role of dose response relationships to side effect severity
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| | Dr Renata Engler, Director, Vaccine Healthcare Centers Network, Walter Reed Army Medical Center
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5.05pm | Post-marketing safety data and pharmacovigilance
planning
- Pharmacovigilance for vaccines and methods applied to safety
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| | Dr Harry Seifert, Senior Director, North America Safety Evaluation & Risk Management, GlaxoSmithKline Biologicals
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5.35pm | Vaccine pharmacovigilance and post market product
monitoring
- A comparison of the Brighton Collaboration Definition and the standardized MedDRA query for anaphylaxis
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| | Dr Ann Strauss, Senior Director, Neuroscience and GI, Medical Pharmacovigilance, Wyeth Research
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6pm | Close of congress
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