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Day 2: Tuesday, August 22
8:00 - 8:30 Registration and Morning Coffee
(Breakfast Workshop Sponsorship
Available)
8:30 - 8:35 Chairperson's Remarks
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KEYNOTE PRESENTATION
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8:35 - 9:05 Development of a Production Process
for an ALVAC Vaccine Candidate
Kim Wong, Ph.D., Director, Cell & Viral Culture, Process Development, sanofi pasteur Ltd.
The development of a manufacturing process for a biopharmaceutical product candidate is resource intensive and time consuming. At sanofi
pasteur, this is a function that is performed by the Process Development department with input from other functional units including Research, Intellectual Property, Regulatory Affairs, Quality Assurance, and Industrial Operations. A description of the factors and steps involved with producing clinical trial material for an ALVAC vaccine candidate will be presented.
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9:05 - 9:35 Vero Cell Culture Platform for Development of Vaccines against Emerging Viral Diseases and Bioterrorism Agents
Leopold Grillberger, Ph.D., Senior Manager of Cell Culture Fermentation, Baxter BioScience
The presentation describes Baxter´s Vero Cell Culture Platform, which was developed from the ATCC CCL81 African Green Monkey kidney cell line in an animal- and protein-free medium. This platform was recently used for the development of several inactivated whole virus or attenuated live virus candidate vaccines against emerging diseases such as interpandemic and pandemic Influenza (e.g. H5N1), SARS, West Nile, Ross River, and Japanese Encephalitis, or for the development of a live virus vaccine against a potential Bioterrorism agent (Smallpox). The combination of a generic manufacturing process with an integrated concept for research and process development allows a fast track development of safe and efficacious vaccine candidates. The presentation describes the basic concept of the technology platform, from the cell and virus banking concept up to the successful scale-up to 6000L stirred tank reactors, the applied inactivation procedures for the manufacture of the inactivated whole virus vaccines and some case studies of promising candidate vaccine development.
9:35 - 10:05
TBA
10:05 - 10:45 Coffee Break in the Exhibit Hall
Enhanced Magnitude & Functionality
10:45 - 11:15 Adenoviral Vector Vaccines
Hildegund C.J. Ertl, M.D., Leader, Immunology Program, The Wistar Institute
E1-deleted adenovirus vectors derived from chimpanzee viruses were vectored as vaccine carriers and tested in preclinical models for induction of T and B cell responses to the vaccine antigen. Data showed that the chimpanzee-derived adenovirus vector vaccines performed well in the presence of pre-existing neutralizing antibodies to adenoviruses that are commonly found in humans. Vectors induced potent and sustained transgene product-specific CD8+ T cell responses that could be enhanced both with regard to magnitude and functionality by prime boost regimens. E1-deleted adenovirus vectors derived from chimpanzee viruses were vectored as vaccine carriers and tested in preclinical models for induction of T and B cell responses to the vaccine antigen. Data showed that the chimpanzee-derived adenovirus vector vaccines performed well in the presence of pre-existing neutralizing antibodies to adenoviruses that are commonly found in humans. The vectors induced potent and sustained transgene product-specific CD8+ T cell responses that could be enhanced both with regard to magnitude and functionality by prime boost regimens.
11:15 - 11:30 Rapid and Efficient Production of Vaccines using a Novel Lentiviral Vector-based Manufacturing Platform
Dr. Boro Dropulic, Founder & CEO, Lentigen Corporation
Lentiviral Vectors are increasingly being used in research and biomedicine. Lentigen has developed a proprietary platform for the rapid and efficient production of vaccines using its LentiMax™ Lentiviral vector gene delivery platform. This platform is currently being used for the development of a H5N1 influenza virus vaccine. The vaccine is a virus-like particle (VLP) which is generated from mammalian cell lines after transduction with LentiMax™ vectors expressing H5, N1 and Matrix proteins. These H5N1 Influenza VLP vaccines are genetically inactive and require no inactivation step, while maintaining structural conformation characteristics most favorable to illicit a potent immune response. VLPs have been shown to be highly effective, most prominently with the recent FDA-approved VLP-based cancer vaccine for the prevention of Papilloma virus-induced Cervical Carcinoma. The LentiMax™ manufacturing platform allows for the rapid and efficient production of any subunit or VLP vaccine from any mammalian cell line with a linear path to scale-up and commercialization.
11:30-11:45 Technology Trends
(Sponsorship Available)
11:45 - 12:15 Enhancing Vaccines with
MolecularBreedingTM Technologies
Robert G. Whalen, D.Sc., Director of Infectious Diseases, Maxygen, Inc.
MolecularBreedingTM directed molecular evolution technologies involving in vitro DNA recombination offer a powerful way to enhance many properties of vaccines and their vectors. Large-scale in vivo screening is a key to success with this technology, and the recursive use of directed molecular evolution provides an obvious way to build upon incremental improvements. Several different immunogens produced by the
MolecularBreedingTM approach are more immunogenic or demonstrate polyvalent
immunogenicity.
12:15 - 1:40 Lunch on Your Own or Luncheon Technology Workshop
(Sponsorship Available)
1:40 - 1:45 Chairperson's Remarks
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KEYNOTE
PRESENTATION |
1:45 - 2:30 New
Vaccine Technologies: A Regulatory Perspective
Jon R. Daugherty, Ph.D., U.S. Public Health Service, Senior Regulatory Review Officer, Office of Vaccines Research and Review, CBER / FDA
The Office of Vaccines Research and Review (OVRR) is responsible for regulatory review of Investigational New Drug (IND) Applications and Biologics License Applications (BLAs) for preventive vaccines and related products. Through this review process, OVRR ensures that these products are safe, pure, potent and effective. This presentation will focus initially on regulatory considerations for the development of preventive vaccine candidates in general, including adventitious agents, preservatives, adjuvants, and toxicology studies. The second part of the discussion will cover regulatory issues specific to development of newer, non-traditional, preventive vaccine technologies. Examples of these include novel adjuvants, DNA vaccines, live attenuated strains, intracellular bacterial vaccine vectors, non-replicating antigen delivery systems and needle-free delivery systems. |
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Immunomodulators / Adjuvants
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FEATURED
PRESENTATION: |
2:30 - 3:15
Adjuvanting DNA Based Therapeutics and
Vaccines
Kenneth E. Ugen, Ph.D., Professor, Center for Molecular Delivery and Department of Molecular Medicine, University of South Florida College of Medicine
Naked DNA based therapeutics and vaccines are promising technologies for delivering therapies and inducing specific immune responses in humans. Although to date the safety profile in humans obtained with these technologies has been excellent, there is a need to enhance the immune potency of these reagents including the inclusion of immunomodulatory cytokines as adjuvants (i.e. molecular adjuvants) to drive specific immune responses. Several additional techniques have been utilized to enhance multiple aspects of the plasmid technology. These include the modification of the molecular adjuvants and vaccine antigens themselves, the use of unique formulations and delivery platforms, including in vivo electroporation. In this presentation we will discuss the use of “adjuvanting” DNA-based therapeutics and vaccines against infectious agents and cancers and their implications for future clinical use. |
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3:15 - 4:00 Refreshment Break in the Exhibit Hall
4:00 - 4:30 Advances in Delivery Systems and Immunopotentiators for Vaccines
Manmohan Singh, Ph.D., Associate Director, Vaccine Delivery Group, Chiron Vaccines
New generation vaccines have a strong need for an optimal delivery system to carry the antigens to the target cell population. In some cases, inclusion of a secondary immunopotentiator along with the selected delivery system enables the generation of a potent B and T cell response with these antigens. The presentation will cover recent advances in vaccine delivery systems and review current immunopotentiators in clinical trials.
Autologous Cell Technologies
4:30 - 5:00 Active Immunotherapy of Prostate Cancer with Provenge
(sipuleucel-T)
David L. Urdal, Ph.D., Chief Scientific Officer, Dendreon Corporation
Sipuleucel-T is an autologous active cellular immunotherapy being developed by Dendreon Corporation for men with advanced prostate cancer. Phase III trials have been completed and show that treatment with sipuleucel-T resulted in a significant overall survival advantage compared with placebo. The history of development of this product candidate will be discussed.
5:00 - 5:30 Heat Shock Protein Peptide Complexes as the Basis for Immunotherapy of Human Cancer
Roman M. Chicz, Ph.D., Senior Vice President, Research & Preclinical Development, Antigenics Inc.
The role of heat shock proteins in the activation of targeted cellular immune responses will be presented. Preclinical data in support of cancer vaccine development and the recent clinical responses to an autologous vaccine approach will be discussed.
5:30 - 6:30 Happy Hour in the Exhibit Hall
For more information, please contact:
Mary Ruberry, Conference Producer
Phone: 781-972-5421 • E-mail: mruberry@healthtech.com
For exhibit and sponsorship information, please contact:
Suzanne Carroll, Manager, Business Development
Phone: 781-972-5452 • E-mail: scarroll@healthtech.com
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