Pre-Conference Workshop | Day 1 | Day 2 | Download Brochure
Sunday, August 16, 2009
Pre-Conference Short Courses
2:00-5:00pm – Separate Registration Required
Short Course #1:
Vaccine Business Opportunities: Collaborations, Mergers and Acquisitions
Successful Strategies for your Product and Technology
For full programming, please click here
Short Course #2:
Managing Process Change in Vaccine Manufacturing
Successful regulatory submissions throughout the product life-cycle
For full programming, please click here
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Monday, August 17, 2009
7:30am Registration and Morning Coffee
8:20 Chairperson’s Opening Remarks
William M. Egan, Ph.D., Vice President, PharmaNet Consulting
8:30 Plenary Keynote Presentation
Vaccines: Challenges for the Future
Norman Baylor, Ph.D., Director, Office of Vaccines Research & Review, CBER, FDA
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9:15 Plenary Featured Presentation
Risk-Based Modelling for Vaccine Supply Chain Capacity Assessment
Susan Behrens, Ph.D., Senior Director, Biological Sciences & Strategy, Merck & Co., Inc.
Vaccine manufacturing requires a series of complex productions steps to deliver final product to meet customer demands. It is important to consider both uncertainty in demand and impact of operational risks on supply when establishing the appropriate capacity targets for capital investment. A Monte-Carlo based model has been used to compare the potential for under-utilized assets, which will result in increased cost of goods to insufficient capacity, which can result in lost revenue. The basic considerations for supply chain design will be reviewed as they relate to the capacity assessment model.
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10:00 Networking Coffee Break with Exhibit and Poster Viewing
11:00 Chairperson’s Remarks
William M. Egan, Ph.D., Vice President, PharmaNet Consulting
11:05 Vaccine Industry’s Contribution to Global Pandemic Preparedness
Norbert W. Hehme, Ph.D., Vice President, Flu Manufacturing Strategy, GSK Biologicals; Chair, IFPMA’s IVS International Task Force
Tremendous efforts have been made by the vaccine industry to contribute to global preparedness plans for an influenza pandemic. The Influenza Vaccine Supply (IVS) International Task Force of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) represents 16 research-based vaccine manufacturers from around the world and works closely together with international stakeholders to address the advocacy, communication, policymaking, regulatory, scientific and technical issues related to seasonal and pandemic influenza vaccines. 11:35 Vaccines and Immunotherapeutics Against Influenza: Technologies, Needs, Demands, and Future
11:35 Vaccines and Immunotherapeutics Against Influenza: Technologies, Needs, Demands, and Future
Suryaprakash Sambhara, D.V.M., Ph.D., Chief Immunology, Influenza Division, Centers for Disease Control and Prevention (CDC)
Influenza virus continues to be a significant public health problem worldwide and The World Health Organisation estimates that epidemic influenza infects around 5-15% of the global population annually, and is responsible for up to 3-5 million cases of severe disease and 500,000 deaths per year. In the United States alone, over 35,000 deaths per year are attributed due to complications arising from influenza viral infections, particularly in the older adult population. Furthermore, emergence of a new antigenic subtype could lead to a pandemic with devastating consequences and we experienced three pandemics in the last century. Fortunately, the pandemic with the triple reassortant 2009 H1N1 virus so far did not appear to cause the most feared scenario repeating the magnitude and intensity of previous pandemics. Vaccination is the primary strategy for reducing the morbidity and mortality associated with epidemic and pandemic influenza. However, pre-pandemic avian influenza H5N1 vaccines are poorly immunogenic even at high doses in the absence of an adjuvant even in healthy adults. In addition, vaccines manufactured by traditional methods, i.e. embryonated chicken eggs, may take up to six months. Therefore, pandemic vaccines may not be available during the pandemic. Hence, it is crucial to explore egg-independent technologies to manufacture vaccines as well as novel adjuvants and formulations which form the basis of my talk.
Since the immunogenicity of the vaccines is suboptimal in infants and young children, individuals with immune disorders, transplant recipients, and older adults, passive immunization strategy with human polyclonal antibodies or a cocktail of human monoclonal antibodies offers potential prophylactic option for these populations. Besides, this strategy also offers a therapeutic option as an adjunct to antiviral therapy. I will briefly cover several technologies that are currently being used to generate human antibodies.
12:05pm PATH’s Influenza Vaccine Program: Vaccine Development for People in Developing Countries
Rick Bright, Ph.D., Scientific Director, Influenza Vaccine Project, Vaccine Development Global Program, PATH
The current influenza vaccines are difficult to produce quickly and in large quantities, in part because most are made from embryonated chicken eggs. If an avian influenza strain is the cause of the next pandemic, the reduced availability of chicken eggs could further challenge the production of adequate supplies of vaccine. Innovative, alternative vaccine strategies are needed that could produce much greater quantities of vaccine at a price that is affordable to the global population. PATH is collaborating with public- and private-sector partners to advance the development of promising new vaccines, focusing on novel technologies that could more easily be used in case of an influenza pandemic.
12:35 Lunch on Your Own (Lunch Presentation Opportunity Available)
1:55 Chairperson’s Remarks
Eid Haddad, M.Sc., Ph.D., Vice President, Research & Development, ImmunoBiosciences, Inc.
2:00 Passive Vaccination Using Redirected, Genetically Engineered, Designer T-Cells for Immunotherapy
Zelig Eshhar, Ph.D., Professor of Immunology, Weizmann Institute
Active vaccination of cancer has proved very limited and so far unsuccessful. Designer T-cells are genetically engineered T-cells redirected with TCR or antibody-based chimeric receptors that hold promise for passive vaccination. Such engineered T cells can be redirected to several incurable targets (e.g., solid and spread cancers), and have proved effective in early clinical trials. These are emerging technologies with a potential for treatment of other, yet not curable diseases such as HIV.
2:30 Live Bacterial Vaccines: The Use of Bioengineered Listeria Monocytogenes in the Clinic
John Rothman, Ph.D., Executive Vice President, Science & Operations, Advaxis, Inc.
Advaxis has completed a Phase 1 trial of a live Listeria vaccine for the treatment of advanced metastatic cervical cancer. Bacterial vectors offer unique advantages other vectors do not. I propose to describe these advantages for the treatment of cancer, infectious disease and other immunological conditions, as well as the work that supports them, and to discuss the first clinical use of Listeria to treat cancer.
3:00 Sponsored Presentation (Opportunity Available)
3:15 Networking Refreshment Break with Exhibit and Poster Viewing
4:00 Structure-Based Rational Design of HIV Env Immunogens for Vaccine Development
Indresh Srivastava, Ph.D., Associate Director, Vaccines Research, Novartis Vaccines & Diagnostics, Inc.
The generation of broadly neutralizing antibody responses against diverse primary HIV isolates has been an elusive target. Therefore, the aim of the HIV project at Novartis Vaccines is to design and evaluate novel Env immunogens for their ability to induce broadly neutralizing antibody responses against diverse primary isolates. We have expressed a total of 44 novel immunogens in 293 cells and determined their level of expression, and purified them, using a two-step purification strategy. Based on pre-determined criteria, we have selected the top seven immunogens for evaluation in rabbits for their ability to induce the breadth of neutralizing antibody responses.
4:30 The HIV-1 gp120 C5 Region as a Candidate Therapeutic Vaccine to Prevent Disease Progression
Angus Dalgleish, M.D., Foundation Professor of Oncology, Department of Oncology, St. George’s University of London
The failure of the prophylactic vaccines has prompted a major reassessment of future stratagems. The C5 region is the most conserved region of gp120, has major HLA class 1 and 2 homologies and hence could be the major “immune activator” that determines disease. Analysis of LTNP’s show that they have high antibody responses to C5 which if lost leads to disease progression. They are non neutralising and hence ignored but are clearly associated with non or slow disease progression. Induction of these antibodies could delay disease progression.
5:00 Strategies for Effective Gene-Based Vaccines: Results from Clinical and Pre-Clinical Studies
Margaret A. Liu, M.D., ProTherImmune; Adjunct Professor, Department of Microbiology, Tumor and Cell Biology, Karolinska Institute
New technologies and strategies for gene-based vaccines have resulted in significant increases in their potency. Three promising approaches will be discussed including: heterologous prime-boosts, electroporation, and targeting epitopes of HIV-drug-resistant mutants. These strategies are applicable to a variety of vaccines, including diseases that remain the most challenging for vaccine development, and will be discussed in terms of their potential application to other vaccine targets.
5:30-6:30 Reception with Exhibit and Poster Viewing