|
Pre-congress briefing - Monday 21 April 2008
|
| VACCINES AND MONEY - INVESTING IN VACCINES |
|
09.00 | Chairman’s opening remarks |
| | Dr Thomas Monath, Partner, Pandemic and Biodefense Fund, Kleiner Perkins Caufield & Byers
|
09.10 | Keynote presentation: investing in vaccines – where the smart money’s going
- The vaccine business model regaining interest within the investment community
- What does this mean for private biopharmaceutical companies?
- Vaccine private investment for considerably broader horizons. What is the future?
|
| |
|
09.40 | Large pharmaceutical corporate venture arms - investing in early stage biotech ventures
- Seeking out early-stage companies with drugs that could become part of their pipelines through future licensing deals or collaborations
- What are the unique issues which emerge for small biotech companies through these types of investments?
- Joining with corporate venture arms for syndicate investing: establishing the role of traditional venture capitalists in conjunction with corporate venture arms
|
| |
|
10.10 | Morning coffee
|
| VACCINE FUNDING MECHANISMS - MEETING INVESTOR EXPECTATIONS |
|
10.55 | Panel session: investment trends, financing opportunities and challenges in today’s vaccine market
- The comparative advantages for investment in vaccines. Where is the attraction?
- Where are investors currently placing their bets?
- What can be learned from previous successes and failures?
|
| | Moderator: Dr Thomas Monath, Partner, Pandemic and Biodefense Fund, Kleiner Perkins Caufield & Byers Michelle Dees, Director, Innovation Fund, International AIDS Vaccine Initiative
|
11.40 | Panel session: invention to venture - funding early stage vaccine innovation
- The boundary between early and late stage investors has blurred. Is this a good thing?
- Are all “products” created equal from an investor and return viewpoint?
- Reflecting on business models that have and have not worked for investors and companies alike
|
| | Moderator: Dr Thomas Monath, Partner, Pandemic and Biodefense Fund, Kleiner Perkins Caufield & Byers
|
12.25 | Lunch
|
13.40 | Panel session: validation considerations of early stage biotech ventures - what are investors looking for?
- What is most important to investors when considering their next investment?
- What criteria biotech investors use to evaluate and fund investment-grade projects?
- What are the crucial factors to VCs when shaping their economic vaccine winners and losers
|
| | Moderator: Dr Thomas Monath, Partner, Pandemic and Biodefense Fund, Kleiner Perkins Caufield & Byers Confirmed: Mr Robert Paull, Managing General Partner, Lux Capital Management
|
14.25 | Panel session: raising biotech finance and attracting new investment - innovative business models
- What are biotech looking for when raising Series financing?
- How can biotech learn to focus on appropriate funding sources and position their companies to be attractive to investors?
- What are some of the common stumbling blocks during negotiations? How to overcome them
|
| | Moderator: Dr Thomas Monath, Partner, Pandemic and Biodefense Fund, Kleiner Perkins Caufield & Byers
|
15.10 | Afternoon tea
|
15.40 | Panel session: venture funded vaccine companies - challenges faced by financed growth companies
- How can companies bridge the investment gap? – increasing the level of investor interest
- Negotiating the early financing rounds and experiences with securing funding
- What are the considerations for future funding stages? How do you approach later financing through the use of creative programs?
|
| | Moderator: Dr Thomas Monath, Partner, Pandemic and Biodefense Fund, Kleiner Perkins Caufield & Byers
|
16.25 | Panel session: vaccine partnerships and intellectual property management
- When does IP management become a critical stage for commercialisation and investment?
- Challenges impacting the vaccine IP environment through private investment
- What does it mean to both the investor and investee when engaging in partnerships?
|
| | Moderator: Dr Thomas Monath, Partner, Pandemic and Biodefense Fund, Kleiner Perkins Caufield & Byers Confirmed: Mr George Xixis, Partner, Intellectual Property Group and Member, Life Sciences Practice Group, Nutter, McClennan & Fish Confirmed: Mr Scott Alban, Director, Intellectual Property Counsel, MedImmune
|
17.10 | Close of pre-congress day followed by drinks reception
|
|
Congress day one - plenary morning - Tuesday 22 April 2008
|
| VACCINES - THE NEW HEROES OF PHARMA INNOVATION AND PROFIT |
|
08.00 | Registration and morning coffee
|
08.50 | Chairman’s opening remarks
|
| |
|
09.00 | Keynote address: strategic pandemic and all-hazards preparedness in a national setting
- Ongoing cooperation and interaction with other government departments
- Delivering a strategic outlook and following a roadmap for vaccine development
- Engagement with industry following development and collaborative relations on procurement initiatives
|
| | Dr Tevi Troy, Deputy Secretary, US Department for Health and Human Services
|
09.30 | The golden age of vaccines – combining innovation with new opportunities
- Is this a new dawn for vaccines? Are we looking at the golden age of vaccinology?
- Forward looking developments with therapeutic vs. prophylactic, adult vs. adolescent and personalised vaccines
|
| | Dr Gregory Poland, Professor of Medicine and Infectious Disease, College of Medicine, Mayo Clinic, Rochester, Mn.
|
10.00 | Speed networking
|
11.00 | Morning coffee
|
11.20 | Keynote address: seizing the moment – capitalising on vaccine innovation and market opportunities
- Laying the foundations for continued vaccine development – fostering innovation through vaccine renaissance
- A new approach for science and industry – changes in public and private sector involvement
- The value in understanding future market opportunities, financing, policy and new science challenges
|
| | Dr Richard Klausner, former Director, National Cancer Institute and former Executive Director, Global Health, Bill and Melinda Gates Foundation, and Managing Partner, The Column Group
|
11.50 | Panel session: innovating to another level – the bigger picture for vaccines profit and public health
- What are the reasons for the heightened interest in vaccines now? Fresh approaches to business development in vaccines
- 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
|
| | Confirmed: Dr Richard Klausner, former Director, National Cancer Institute and former Executive Director, Global Health, Bill and Melinda Gates Foundation, and Managing Partner, The Column Group Confirmed: Dr Michael Watson , Executive Vice President, Research & Development, Acambis Dr Una Ryan, President and Chief Executive Officer, AVANT Immunotherapeutics
|
12.25 | Giving vaccines a shot in the arm – grasping the opportunity to grow biotech pipelines
- The role of biotech, the need for and the prospects of new and improved vaccines
- Adapting to new realities – the vision and flexibility towards investing in novel vaccine research
- Profiting from innovation - examining the inherent challenges and strategic opportunities
|
| |
|
12.50 | Lunch
|
|
Congress day one - breakout stream 1 DIPLOMATIC IMMUNITY - WHERE GOVERNMENT CONTRACTS AND REGULATION IS HEADING
|
13.50 | Session chairman |
| |
|
13.55 | Funding priorities and strategies for domestic vaccine initiatives
- The value to industry of government funding mechanisms – where is this heading in the near term?
- Funding initiatives for global health vaccines: What direction is government taking?
- Clarifying the scale, scope, timing and eligibility of funding for new infectious diseases
|
| | Dr Michael Kurilla, Director, Office of Biodefense Research Affairs, Associate Director for Biodefense Product Development, DMID, NIAID, NIH, , US Department for Health and Human Services Dr Marbara Mulach, Director, Office of Scientific Coordination and Program Operations, Division of Microbiology and Infectious Diseases, NIAID, NIH, US Department for Health and Human Services
|
14.45 | Deploying vaccine regulation in line with national and domestic strategy and with industry expectation
- FDA role in facilitating development of new vaccines
- Regulatory criteria attaining to the development of new vaccines
- Funding and procurement update from government – how is regulation tying with strategy?
|
| | Dr Karen Midthun, Deputy Director, Vaccines and Immunization, CBER, US Federal Drug Administration
|
15.10 | Panel session: improving industry value proposition in pursuing global health initiatives
- How can advances in vaccine innovation advance global health?
- How can new impetus on R&D for developing markets be promoted amongst industry?
- How are partnerships between public and private stakeholders driving progress?
|
| | Moderator: Mr Christopher Holloway, Group Director of Regulatory Affairs and Chief Scientific Officer, ERA Consulting Confirmed: Dr Seth Berkley, President and Chief Executive Officer, International AIDS Vaccine Initiative Confirmed: Dr Douglas Holtzman, Senior Program Officer, Infectious Diseases, Global Health Program, Bill and Melinda Gates Foundation Confirmed: Dr Una Ryan, President and Chief Executive Officer, AVANT Immunotherapeutics
|
15.55 | Afternoon tea
|
| NEW MARKETS, NEW OPPORTUNITIES |
|
16.25 | Session chairman
|
| |
|
16.30 | Rising market opportunities, entry challenges and its impact on the shape of the Asian vaccine industry
- What are the most anticipated market trends and growth in the Asian vaccine market?
- How is market entry strategy fundamental to bringing new vaccines to market?
- How does external industry intervention affect vaccine development?
|
| |
|
16.55 | Key stage business planning and the introduction of new vaccines to Asia
- What is the status of the emerging pipeline of an innovative influenza vaccine and its market promise in Asia?
- How can you maximise the strategic advantages open to cell culture-based influenza vaccines over the traditional?
- What are the challenges and strategies to penetrate into the private and public flu vaccine market of Asia?
|
| |
|
17.20 | Emerging vaccine R&D and alliance opportunities to tap into market potentials
- What are the foreseeable future market and investment opportunities for vaccine industry development?
- How can non-regional stakeholders gain access to the regional vaccine market? The role of technology transfer and licensing
- What can you expect from a strategic partnership? How do partners need differ and where are they similar? Recent examples of successful collaborations
|
| | Moderator: Mr Christopher Holloway, Group Director of Regulatory Affairs and Chief Scientific Officer, ERA Consulting Confirmed: Dr Sy-dar Wang, Chief Technology Officer and Acting Chief Executive Officer, Adimmune Corporation
|
18.05 | Harnessing the strategic and economic benefits from Asian market involvement
- How can you take advantage of Asia’s growing position within the vaccine world community?
- What are the strategic and technological advantages of entry in the Asian vaccine market?
- How can you benefit from industry partnerships to improve vaccine quality, compliance and validation practices?
|
| |
|
18.30 | Close of day one
|
19.30 | The ViE Awards Ceremony and Gala Dinner
|
|
Congress day one - breakout stream 2 THERAPEUTIC R&D - WHERE THE SMART MONEY’S AT
|
13.50 | Session chairman |
| |
|
13.55 | Investment areas for developing new vaccine products
- The changing landscape - what are the drivers behind these changes and what are the challenges that have been encountered to date?
- What benefits have been realised?
- How is the role of vaccines evolving within the business model of the company as a whole?
|
| | Dr Allan Jarvis, Senior Vice President, Corporate Development, Sanofi Pasteur
|
14.20 | Panel session: sustainable strategies behind the implementation of vaccine R&D programs
- What is big pharma’s current perception of investment in new vaccine product development?
- How are pharma aligning R&D efforts and commercial operations?
- How are pharma allocating resources to balance risk and return across a variety of opportunities?
|
| | Confirmed: Dr Rino Rappuoli, Global Head Vaccines Research, Novartis Vaccines & Diagnostics Dr Allan Jarvis, Senior Vice President, Corporate Development, Sanofi Pasteur
|
15.05 | A new R&D model and the paradigm shift to in-licensing
- What are the challenges that face industry in terms of developing, manufacturing and delivering vaccines and other technologies?
- How are industry approaching changing times and business partnerships pertaining to R&D?
- How is licensing have a major role in large pharma developments going forward?
|
| | Dr Douglas Pon, Assistant Vice President, Vaccine Licensing, Global Business Development, Wyeth Pharmaceuticals
|
15.30 | Setting a new collaborative paradigm for contract research involvement in vaccine R&D
- How is the current business environment affecting vaccine partnership models?
- How do you qualify the role of each party in managing new and ongoing relationships?
- What can you do to ensure a streamlined process? What to do when things go wrong?
|
| | Dr Jeffrey Stoddard, Vice President of Medical and Scientific Affairs, Risk Management and Post Marketing Programs, Covance
|
15.55 | Afternoon tea
|
16.25 | Session chairman |
| |
|
16.30 | Government plans and priorities for Biodefense
- What are the governmental efforts to accelerate the development of national Biodefense?
- What are the existing late stage biodefense vaccines and therapeutics in development?
- How are governmental agencies interacting to enhance collaboration?
|
| | Dr Monique Mansoura, Acting Deputy Director for Policy, Planning and Requirements, Office of Public Health Emergency Medical Countermeasures, US Department for Health and Human Services
|
16.55 | Opportunities for early, mid and late-stage Biodefense research development
- What are the key countermeasure priorities for R&D at the NIAID?
- What is the critical timing for procuring these technologies? What are the stages of development?
- How can industry progress further from candidate to advanced developer?
|
| | Dr Michael Kurilla, Director, Office of Biodefense Research Affairs, Associate Director for Biodefense Product Development, DMID, NIAID, NIH, , US Department for Health and Human Services
|
17.20 | Clinical development of CBRN and pandemic countermeasures: challenges and solutions from a CRO perspective
- CBRN and pandemic countermeasures tend to be “niche” products, funded primarily from government sources
- Medical, regulatory, and business issues peculiar to this environment may pose significant challenges to successful clinical development
- A clinical partner with the appropriate expertise, experience and capabilities can greatly facilitate efficient, cost-effective, and successful clinical development of these important products
|
| | Dr Kelly McKee, Executive Director, Operations, Quintiles Public Health and Government Services
|
17.45 | Panel session: turning biodefense dollars into products and driving product development
- What are the Government actions leveraging the participation and support of pharma and biotech?
- What are the key requirements to increasing and maintaining successful industry participation?
- How is industry meeting the needs of government whilst remaining competitive?
|
| | Moderator: Dr Clement Lewin, Vice President of Marketing, Policy & Strategy, Acambis Mr Hal Siegel, Vice President and Chief Scientific Officer, ImmuneRegen
|
18.30 | Close of day one
|
19.30 | The ViE Awards Ceremony & Gala Dinner
|
|
Congress day two - breakout stream 1 INFLUENZA PREPAREDNESS - HOW READY ARE WE?
|
08.00 | Registration and coffee
|
09.00 | Chairman’s opening remarks |
| | Dr Klaus Stohr, Director, Influenza Vaccine Franchises, Novartis Vaccines & Diagnostics
|
09.10 | Pandemic influenza preparedness evolution
- How are lessons from recent collaborations helping to form the government’s plans for pandemic influenza?
- 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?
|
| | Dr Robin Robinson, Deputy Director - BARDA Influenza & Emerging Diseases, HHS/ASPR/BARDA
|
09.40 | Emerging vaccine technologies influence on pandemic preparedness policy and the pandemic influenza market
- What are the key characteristics of FluMist?
- How does it compare to the traditional inactivated injectable influenza vaccine?
- What is the potential significance of effectiveness against drifted strains?
|
| |
|
10.10 | Coordinating for global preparedness through public-private collaboration
- What is the government's industrial policy for pandemic production? How much industry is too much?
- How is industry working with government to support pandemic preparedness?
- What are the means to successful partnership strategies?
|
| | Mr Thomas Shin, Manager, Vaccines Contracting, Baxter Healthcare Corporation
|
10.40 | Morning coffee
|
11.10 | Panel session: key considerations for vaccine production in a pandemic setting
- What is the government's industrial policy for pandemic production - how is industry working towards this?
- What level of surge production capacity is required? How is government working with industry to bring it online?
- When rapid scale-up of production is required, how will it be achieved?
|
| | Dr Klaus Stohr, Director, Influenza Vaccine Franchises, Novartis Vaccines & Diagnostics Dr Jeroen Medema, Principal Scientist, Scientific Information Manager, Influenza, Solvay Pharmaceuticals
|
11.50 | How to supply flu vaccines in a pandemic situation
- What are the steps in the pandemic supply chain, and how is preparedness creating opportunities for industry?
- How will the government and other organizations purchase vaccines, drugs, and other supplies, and how will purchasing decisions be made?
- How important is effective communication across drug manufacturers, distributors, and public entities?
|
| | Dr Luc Hessel, Executive Director, Medical and Public Affairs, Europe , sanofi pasteur MSD
|
12.15 | Maximizing vaccine availability while minimizing risk
- What role can drug packaging play in maximizing the availability of high-demand, short-supply vaccines?
- Solutions for facilitating vaccination during seasonal and mass immunisation
- Methods for improving safety during vaccination
|
| |
|
12.40 | Lunch
|
| ADJUVANTS AND DELIVERY - EFFECTIVE TECHNOLOGIES |
|
13.40 | Session chairman |
| | Dr Ronald Ellis, Senior Vice President and Chief Technology Officer, NasVax
|
13.45 | MF59; a new generation vaccine adjuvant for enhanced responses to flu vaccines
- MF59 adjuvant, safe and effective for all age groups
- Improved protection against flu, including ‘drifted’ strains
- Creates a local immune potentiating environment in the muscle following injection
|
| | Dr Derek O'Hagan, Vice President, Vaccine Delivery Research, Novartis Vaccines & Diagnostics
|
14.10 | Novel adjuvant systems technology
- What is GSK’s history of adjuvant system development?
- How is proof of concept being carried out on the technologies?
- What is GSK’s future vaccine pipeline in adjuvant systems technology?
|
| | Dr Nathalie Garcon, Vice President, Head of Research and North America Research and Development, GlaxoSmithKline Biologicals
|
14.35 | Recent advances in the discovery and delivery of vaccine delivery systems
- What is the importance being placed on developing novel delivery systems in tandem with new vaccines?
- How can new skin patch delivery systems boost the strength of vaccines under development?
- What are the implications on the expansion of effective vaccine stockpiles?
|
| |
|
15.00 | Panel session: new recombinant vaccine technology, VLPs and DNA vaccines
- Outlining faster vaccine development using alternative vaccine technologies
- Technical and economic advantages not feasible with conventional methods
- Platforms for future vaccine discovery and emerging trends and challenges
|
| | Moderator: Dr Ronald Ellis, Senior Vice President and Chief Technology Officer, NasVax Dr Carl Alving, Chief, Department of Adjuvant & Antigen Research, Division of Retrovirology, U.S. Military HIV Research Program, Walter Reed Army Institute of Research Dr Derek O'Hagan, Vice President, Vaccine Delivery Research, Novartis Vaccines & Diagnostics
|
15.45 | Afternoon tea
|
| VACCINE SAFETY EVALUATION - REDUCING THE RISKS |
|
16.15 | Session chairman |
| | Dr Jeffrey Stoddard, Vice President of Medical and Scientific Affairs, Risk Management and Post Marketing Programs, Covance
|
16.20 | Vaccine safety systems from the perspective of the Department of Health and Human Services
- What does the federal system look like in general?
- Coordinating federal vaccine safety systems
|
| | Dr Daniel Salmon, Vaccine Safety Specialist, National Vaccine Program Office, US Department for Health and Human Services
|
16.45 | Regulatory considerations for non-clinical vaccine safety assessment
- Most important issues for nonclinical development in our current understanding of vaccines
- What are the key components to vaccine safety evaluation within the FDA?
- What are the major design considerations for vaccines with toxicity studies?
|
| | Dr Marion Gruber, Director for Regulatory Policy, OVRR, CBER, US Federal Drug Administration
|
17.10 | Panel session: post marketing vaccine safety and risk management
- How are the current CDC and industry post-licensure vaccine safety activities performing?
- What are the new approaches to emerging vaccine safety issues?
- How is vaccine risk assessment currently achieved? How are key partnerships being made and priorities set?
|
| | Moderator: Dr Jeffrey Stoddard, Vice President of Medical and Scientific Affairs, Risk Management and Post Marketing Programs, Covance Confirmed: Dr John Iskander, Acting Director, Immunization Safety Office, Office of the Chief Science Officer, Centers for Disease Control and Prevention Confirmed: Dr Adrian Dana, Senior Director of Clinical Risk Management & Safety Surveillance, Merck Research Laboratories Dr Daniel Salmon, Vaccine Safety Specialist, National Vaccine Program Office, US Department for Health and Human Services Dr Marion Gruber, Director for Regulatory Policy, OVRR, CBER, US Federal Drug Administration
|
17.55 | Close of day two
|
|
Congress day two - breakout stream 2 NEXT GENERATION VACCINE INTRODUCTION - WHAT DOES THE FUTURE HOLD?
|
08.00 | Registration and coffee
|
09.00 | Chairman’s opening remarks |
| |
|
09.10 | Current status of GSK HPV vaccine Cervarix and introductory plans
- Reviewing the clinical phase activities and commercialisation strategies for Cervarix
- Exploring the pathway to approval and development with post licensure studies
- Addressing Cervarix vaccine introduction challenges
|
| | Dr Gary Dubin, Vice President and Director, Clinical Development, Prophylactic Vaccines, GlaxoSmithKline
|
09.40 | Conjugate vaccines against N. meningitis ACWY and N. meningitis B late-stage vaccine development
- What is the rationale behind the development of meningococcal vaccines for both developed and developing markets
- What is in the pipeline for Meningococcal conjugate vaccines development?
- What alternative approaches for development of vaccines against Meningococcus B are currently being examined?
|
| | Dr Peter Dull, Head of Development, Meningococcal Conjugate Vaccines , Novartis Vaccines & Diagnostics
|
10.10 | Developing a strategic roadmap for Rotavirus vaccine introduction
- A global outlook - what is happening with Rotavirus introduction around the world?
- What is the scale of ongoing clinical trials to investigate areas that require further scrutiny after initial licensure?
- What is currently in place to maintain post marketing safety surveillance?
|
| | Dr Leonard Friedland, Senior Director, Vaccines, Clinical R&D and Medical Affairs, GlaxoSmithKline Biologicals
|
10.40 | Morning coffee
|
11.10 | Cancer vaccines - best candidates in our effort to stop the epidemic of cancer deaths
- Early therapeutic intervention in cancer represents a significant unmet need
- Limitations of current cancer treatments and the rationale for use of cancer vaccines in earlier stage disease
- Development and regulatory challenges and the potential solutions
|
| |
|
11.35 | Adenoviral vaccines against emerging and poverty-related diseases
- Development of Ebola, Malaria and Tuberculosis vaccines based on identification of protective antigens and immune correlates
- Delivery technology and route based on inclusion of protective antigen and induction of the appropriate protective immunity
- Specifications for EBO, MAL and TB vaccines based on non-human primate and/or human challenge models
|
| |
|
12.00 | Panel session: creating a blueprint for HIV, Tuberculosis and Malaria vaccine development
- What is the current thinking behind the role of vaccines in treating HIV, TB and malaria?
- What is the status of new and promising vaccines for these targets?
- How is product development shaping up through the collaboration of industry, government and NGO?
|
| | Confirmed: Dr John Shiver, Vice President, Worldwide Basic Research Franchise Head, Vaccines, Merck Research Laboratories Confirmed: Dr Joe Cohen, Vice President R&D, Head of Vaccines for Emerging Diseases and HIV, GlaxoSmithKline Biologicals
|
12.40 | Lunch
|
| VACCINE PRODUCTION TECHNOLOGIES - BIGGER, BETTER, FASTER |
|
13.40 | Session chairman
|
| |
|
13.45 | Integrating modern technologies for economical vaccine manufacturing
- Improving analytical tools as a dose-sparing strategy
- Combining disposable manufacturing technologies towards the mobile plant
- Applying lessons-learnt from biopharmaceutical manufacturing on vaccine production
|
| | Dr Gerard Gach, Global Product Platform Director , GE Healthcare Life Sciences
|
14.10 | Vaccine manufacturing trends - long term viable vaccine manufacturing solutions
- Plan for Success; planning of production capacity prior to launch
- Managing successful commercial production at your CMO; the logistical challenges
- Batch production forecasting and long term planning
|
| |
|
14.35 | Flexibility and capacity for the manufacture of vaccines; can new technologies contribute to address these issues?
- Main issues for vaccine development and manufacturing; can modern technologies contribute to help?
- What would be the implications on validation and development time?
- What could be the benefits; time, robustness and costs
|
| | Dr Helene Pora, Vaccine Application Development, Director, Pall Life Sciences
|
15.00 | Panel session: technology solutions to critical vaccine production processes
- Overcoming the engineering challenges with processes for manufacture of vaccines
- How is technology for aiding the manufacture of vaccines progressing and being applied?
- Future validation of commercial scale technologies and manufacturing processes
|
| | Confirmed: Dr Ranjit Deshmukh, Director, Global Technology Transfer Vaccine Technology, Biotech and Engineering, Wyeth Pharmaceuticals Confirmed: Mr Rick Hancock, Executive Vice President, Chief Operating Officer, Althea Technologies
|
15.45 | Afternoon tea
|
| ECONOMIC MANUFACTURING STRATEGIES - READY TO REACT |
|
16.20 | Accelerating vaccine development from bench to clinic - pandemic influenza vaccine
- Development of a scalable manufacturing process
- Leveraging existing pre-clinical safety data for related products
- Managing concurrent production and regulatory activities
|
| |
|
16.45 | Economic vaccine manufacture and scale-up strategies - evolving global manufacturing
- How can organisation’s prepare for sufficient vaccine production capacity during uneven levels of demand?
- What novel approaches can be used to speed up vaccine production to address a shortfall in supply?
- How are novel technologies aiding the scale-up in production of vaccines?
|
| | Mr Raafat Fahim, President & Chief Executive Officer, Nabi Biopharmaceuticals
|
17.10 | 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?
- How are economies of scale and vaccine economics affecting vaccine manufacture?
- What are the criteria for maintaining economic control throughout the manufacturing process?
|
| | Confirmed: Mr G S Reddy, Chief General Manager, Indian Immunologicals Confirmed: Mr Rick Hancock, Executive Vice President, Chief Operating Officer, Althea Technologies Mr Raafat Fahim, President & Chief Executive Officer, Nabi Biopharmaceuticals
|
17.55 | Close of day two
|
|
Post-congress briefing - Thursday 24 April 2008 VACCINE GROWTH – SUCCESSFUL START-UPS AND BEYOND
|
08.00 | Registration and coffee
|
09.00 | Chairman’s opening remarks |
| |
|
09.10 | Keynote address: uniting science and business – building a new vaccine company from inception
- Economic and practical aspects of starting a company in the vaccine arena and growing it
- How to overcome the challenges in building a company off the back of its technology
- Experience of growing an early-stage company in today's environment
|
| | Dr Ronald Ellis, Senior Vice President and Chief Technology Officer, NasVax
|
09.40 | Matching vaccine product portfolio development with operational strategy
- Positioning the strengths of your companies products and technologies with market demand
- How to cope with the challenges of forming a start-up. What to look out for
|
| |
|
10.10 | Morning coffee
|
10.40 | Setting direction in corporate strategy for vaccine portfolio development
- Assess the value of the current development plans and generate and assess the value of alternative development plans
- Define success criteria and assess probabilities for each alternative
- Calculate value measures for each alternative and recommend a path forward
|
| |
|
11.10 | A measure of success; from vaccine start-up to licensure
- Business design choices; making explicit or implicit choices about the design of the business model
- Developing creative, proactive go-tomarket strategies
- Global market opportunities; evaluate the impact of different product designs on the likelihood of successful development, time-tomarket and the value of first mover advantage
- Alignment of product development with operational strategy
|
| | Dr Erich Tauber, Vice President, Product Development and Medical Affairs, Intercell
|
11.40 | Panel session: sustaining product and corporate strategic growth
- Considerations on growth strategies as your company grows
- Economic and practical aspects of maintaining sustained growth in the vaccine arena
|
| | Moderator: Mr Lance Gordon, Independent Vaccine Expert, Independent Vaccine Expert Confirmed: Dr Ronald Ellis, Senior Vice President and Chief Technology Officer, NasVax Confirmed: Dr Carol Marzetta, Vice President R&D Strategy Services, Applied Strategies Confirmed: Dr Erich Tauber, Vice President, Product Development and Medical Affairs, Intercell
|
| FUNDING STRATEGIES FOR CONTROLLED GROWTH |
|
12.10 | Developing a business plan for success: the NIH grant process for vaccines
- NIH vaccine research funding opportunities and partnering with academia and industry
- NIH mechanisms for supporting vaccine research and advanced technology programmes
- Funding opportunities, grants, cooperative agreements and contract application
|
| | Dr Marbara Mulach, Director, Office of Scientific Coordination and Program Operations, Division of Microbiology and Infectious Diseases, NIAID, NIH, US Department for Health and Human Services
|
12.40 | Lunch
|
14.00 | Beyond venture capital: alternative funding strategies for development stage companies
- Traditional model – venture capital
- Out-licensing non-core technologies and securing an early partner for core programs
- Non-dilutive sources of funding – grants, government contracts and more plus an outlook on future strategy
|
| |
|
14.30 | Evaluating new and expanding on existing vaccine partnerships and alliances
- Understanding the nature of the opportunity and value drivers – increasing prevalence of alliances in the vaccine industry
- Considerations when managing alliances between biotech and mature vaccine companies – what it takes to be a good partner
- Structuring partnerships and alliances to maximise benefit and minimise risk
|
| |
|
| MANAGING SUCCESSFUL PARTNERSHIPS - CREATING A WIN-WIN STRATEGY |
|
15.00 | Afternoon tea
|
15.30 | Approaching vaccine pharmaceutical companies 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
|
| |
|
16.00 | Key biotech strengths which led to a successful vaccines partnership
- What important strengths should a biotech demonstrate?
- What qualities are particularly important to the vaccines industry?
- Examples of successful vaccines partnerships
|
| |
|
16.30 | Close of congress
|
