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Published by: SMI Publishing, Ltd
Published: May. 22, 2006
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Mr Frank Rapoport, Managing Partner, McKenna Long & Aldridge LLP.
- 9.10 KEYNOTE ADDRESS - VACCINE PROCESS DEVELOPMENT
- A Merck case study - Rotateq (r) and GARDASIL (r)
- Rotateq (r), for the prevention of rotavirus disease
- Process scale up issues
- Development of the potency assay
- Support for the large safety study
- GARDASIL (r), for the prevention of HPV and cervical cancer
- Developing the manufacturing process
- Characterisation of the product
- Development of the potency assay
- Dr Robert Sitrin, Executive Director, Bioprocess & Bioanalytical Research, Merck Co Inc.
- 9.50 THERAPEUTIC VACCINATION
- Developing vaccinations from smoking cessation to obesity
- The major causes of preventable death world-wide - smoking and obesity as chronic diseases
- Current therapies and the requirement for a novel strategy of treatment
- An overview of the therapeutic vaccines against both smoking and obesity
- Preclinical and clinical evidence to support the induction of antibodies to nicotine and the regulatory hormones involved
- Regulatory compliance
- Dr Martin Bachmann, Executive Vice President & Chief Executive Officer, Cytos Biotechnology A G.
- 10.30 Morning Coffee
- 11.00 DNA VACCINES
- State of the art
- Mechanism of action
- Limitations
- Rational approaches to enhanced potency
- Prospects for widespread utility
- Dr Jeffrey Ulmer, Executive Director & Head, Immunology & Cell Biology, Chiron Corporation.
- 11.40 DEVELOPMENT OF NOVEL VACCINES IN THE TRIANGLE OF NOVEL TECHNOLOGIES, PHARMA PARTNERS AND NGOS
- A paradigm for biotech companies
- New vaccine technologies
- Costs and benefits to partner with established commercial vaccine players
- Strengths and weaknesses of partnerships with NGOs
- Is there a win-win situation for a triangle between biotech, NGOs and big pharma in the development of novel vaccines?
- Professor Alexander von Gabain, Chief Scientific Officer, Pelias Biotechnologies Gmbh.
- 12.10 THE DEVELOPMENT AND PRODUCTION OF A MULTIVALENT VACCINE
- cAdVax - a case study
- The need for a vaccine against multiple strains of Marburg, Ebola and Dengue viruses
- Creating multiple serotype vaccines
- Creating a safe and effective multivalent vaccine against some of the most dangerous infectious diseases
- Demonstrating the induction of potent humoral and cell-mediated immune responses
- Looking to the future using lessons learned from cAdVax
- Dr John Dong, President & Chief Scientific Officer, Gen Phar Inc.
- 12.50 Networking Lunch
- 2.20 PANEL DISCUSSION
- Understanding project bioshield and beyond - government & industry perspectives about the development of vaccines to counter bioterorrism
- US government purchase of vaccines against bioterrorism and infectious diseases
- Hear how federal regulators have implemented Project Bioshield
- Understanding how to get US funds for your vaccine research
- Availability of money for influenza countermeasures from HHS, NIH, CDC, Department of Homeland Security, Department of Defence
- Key issues regarding the availability of vaccines
- The history and purpose of developing such a vaccine
- Strategies to achieve legislative conformity
- Mr Frank Rapoport, Managing Partner, McKenna Long & Aldridge LLP.
- Mr John Clerici, Managing Partner, McKenna Long & Aldridge LLP.
- Dr Thomas Fuerst, Director, Vaccines & Biologics, US Dept of Health & Human Services.
- Dr Ed Nuzum, Chief Biodefense Vaccines & Other Biological Products Development Section, O B R A.
- Dr Rajan George, Vice President, Vi Rexx Medical Corp.
- 3.20 Afternoon Tea
- 3.40 A BIODEFENCE CASE STUDY
- Development of conventional and MVA smallpox vaccines for the US Government
- The necessity for a smallpox vaccine stockpile and the US Governments strategy for filling the need
- Process for delivery of 180 million doses of conventional smallpox vaccine to the strategic national stockpile and next steps
- Development of an MVA vaccine for the US Government
- Differences between the two programmes and lessons learned in developing vaccines for the US government
- Dr Clement Lewin, Vice President, US Government Affairs & Strategy, Acambis.
- 4.20 CHIMIGEN™ VACCINE PLATFORM: A NOVEL, VERSATILE AND ADAPTABLE PLATFORM FOR VACCINE DEVELOPMENT
- Chimigen™ Vacine Platform
- Dendritic cell receptor-targeted vaccines
- Advantages of both antigen and antibody
- Unique chimeric design facilitates formation of antibody like structure and appropriate antigen presentation
- Soluble antigen, no added adjuvant necessary
- Produced in insect cells, with higher immunogenicity
- Generates broad immune responses, both Cellular & humoural
- Can be used for the development of therapeutic and prophylactic vaccines
- HepaVaxx B, ViRexx’s first ChimigenTM vaccine candidate, a therapeutic vaccine for the treatment of chronic hepatitis B virus infection, approved for Phase I clinical trial
- Dr Rajan George, Vice President, Vi Rexx Medical Corp.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Stephen Lockhart, Assistant Vice President & Head, Bacterial Clinical Research, Wyeth Vaccines Research.
- 9.10 NEW MARKETS FOR VACCINES
- Implications and issues
- Vaccines - small commercial opportunity?
- The contribution vaccines have made to human health and longevity by reaching more individuals than any other modern health intervention
- How purchaser, legal and regulatory pressures have limited market attractiveness
- The importance of scientific advances, public sector investment and increased social awareness of vulnerability to infectious disease in changing the future of vaccines
- Vaccines - the fastest growing category in the pharmaceutical industry?
- New challenges for all participants in the value-chain
- Realising the full potential of the industry
- Mr Andrew Pasternak, Director, Mercer Management Consulting Ltd.
- 9.50 RESEARCHING MARKET REQUIREMENTS - EXISTING AND POTENTIAL VACCINES AND ANTI-VIRALS
- An insight into influenza vaccines
- Finding and developing the low hanging product fruit that has a market in healthcare - current and historical perspectives
- Comparative analysis of epidemiology, current disease management and unmet needs
- An overview of influenza vaccines and anti-virals - strengths and weaknesses and how they play out in addressing influenza pandemics
- Accelerated approval of the recombinant FluBlok influenza vaccine - how can this happen?
- Reducing the financial commitment to maximise the potential gain
- Mr Daniel Adams, President & Chief Executive Officer, Protein Sciences Corporation.
- 10.30 Morning Coffee
- 11.00 SOME UNSPOKEN PITFALLS OF DEVELOPING A THERAPEUTIC VACCINE FOR AUTOIMMUNE CONDITIONS
- A case study for a myocarditis vaccine
- The product objective from model to man
- Product specifications including the active antigenic component and adjuvant
- Defining the market
- Potential for the generation of autoimmune conditions
- Changes and common misunderstandings in the regulatory environment
- Beyond efficacy studies - financing preclinical safety / toxicology and early phase I studies
- Dr Daniel Zimmerman, Senior Vice President, Research & Development, CEL-SCI Corporation.
- 11.40 PRICING VACCINES ON VALUE
- Transforming vaccines from commodities to value priced brands
- Changes in the importance of vaccines to payers
- Consequences for revenue potential
- Move toward pricing on value
- Generic drivers of vaccine value
- Understanding the epidemiology
- Developing a standard tool set for vaccine valuation
- Dr Denis Fung, Principal Consultant, PA Consulting Group.
- 12.20 Networking Lunch
- 1.50 ISSUES IN SCALING UP FROM EARLY TO LATE PHASE CLINICAL TRIALS
- The perspective from clinical research
- Planning the size of late phase trials
- Projecting and managing the cost of late phase trials
- Interactions between clinical research and manufacturing in planning late phase trials
- Bridging studies: love them or hate them?
- Remember compliance
- Post-licensure trial commitments
- Dr Stephen Lockhart, Assistant Vice President & Head, Bacterial Clinical Research, Wyeth Vaccines Research.
- 2.30 2.30 STUDIES OF SKIN BASED AND RESPIRATORY DELIVERY OF VACCINES
- Pros and Cons of different vaccine delivery routes
- Delivery devices for intradermal and respiratory delivery of vaccines
- Dry powder formulations for nasal and reconstitution-injection delivery
- Results of in vivo studies
- Mr Vince Sullivan, , B D.
- 3.10 Afternoon Tea
- 3.40 ROUTES OF VACCINE ADMINISTRATION
- The development of needle-free systems
- A review of currently marketed formulations and products
- Factors that affect the choice of route of vaccine administration
- Alternatives to injectables: nasal and pulmonary opportunities
- Challenges of developing needle-free injection systems
- Complying to the regulatory issues
- Dr Noymer Peter, Director, Systems Engineering, Aradigm Corporation.
- 4.20 FORMULATION STRATEGIES FOR ENHANCING PULMONARY DELIVERY OF VACCINES
- Tailoring surface characteristics of the carriers for the targeting of long tissue
- Application of novel excipients to established platform polymeric delivery technologies
- Effect of process parameters on final dosage form
- An exploration of in vivo / in vitro correlation data
- Long term stability and efficacy studies
- Dr Satyanarayana Somavarapu, Research Fellow, London School Of Pharmacy.
- 5.00 Chairman’s Closing Remarks and Close of Day One
AbstractVaccine manufacture and timely immunisations are fundamental to individual and national health. Vaccine medicine has become synonymous with mainstream medical therapy and disease prevention, however it still remains one of the most controversial topics in modern medicine due to recent doubts about safety.
SMi’s conference ‘Vaccines’ aims to bring together key international leaders from major pharmaceutical companies, private-sector immunisation partners, healthcare executives and government agencies. Through plenary sessions, case studies and workshops, this event will report new scientific technologies, policies, and the development and implementation of successful immunisation programmes. Participants will gain the know how to investigate new strategies for designing and developing novel vaccines, complete all the necessary safety and legislative requirements to launch it onto the market and gain an insight into biodefence.
Hear international case studies and expert perspectives from leaders in the field, including:
- Dr Clement Lewin, Vice President, US Government Affairs & Strategy, Acambis
- Dr Stephen Lockhart, Assistant Vice President & Head, Bacterial Vaccine Clinical Research, Wyeth Vaccine Research
- Dr Jeffrey Ulmer, Executive Director & Head, Immunology & Cell Biology, Chiron Vaccines
- Dr Ed Nuzum, Chief, Biodefence Vaccines & Other Biological Products Development Section, Office of Biodefence Research Affairs, DMID/NIAID/NIH
- Daniel Adams, President & Chief Executive Officer, Protein Sciences Corporation
- Dr Martin Bachmann, Executive Vice President & Chief Scientific Officer, Cytos Biotechnology
- Dr Daniel Zimmerman, Senior Vice President, Research & Development, CEL-SCI Corporation
- Rajan George, Vice President, Division of Infectious Diseases, ViRexx
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