Day 3: Wednesday, August 23

8:00-8:30 Morning Coffee

Vaccine Production Logistics

8:30 - 8:35 Chairperson's Remarks 

9:05 - 9:35 Deceptive Imprinting and Immune Refocusing Technology-The next Generation of Discovery and Development in Vaccines
Peter L. Nara, M.Sc.,D.V.M., Ph.D., President & CEO, Biological Mimetics, Inc.

9:35 - 10:05 New Adjuvants and Delivery Systems: EU Regulatory Developments 
Dorothea Sesardic, Ph.D., Principal Scientist, National Institute for Biological Standards and Control (NIBSC)
Interest in vaccine adjuvants and delivery systems has grown rapidly over the past few years providing new opportunities as well as challenges for manufacturers and regulators. Vaccines for many non-infectious but preventable conditions are in progress for which new adjuvants are considered. Regulatory requirements for pharmaceutical and pre-clinical safety assessment of vaccines were considered insufficient. Several initiatives are in place within the framework of the European Medicines Evaluation Agency and European Pharmacopoeia to provide new guidelines for pre-clinical testing and for adjuvants for human use, as well as updates on the general monograph for vaccines for human use. 

10:05 - 10:45 Coffee Break in the Exhibit Hall

Readying Vaccines for Market

10:45 - 11:15 Development and Testing of a Recombinant Protective Antigen (PA) Derivative as a Vaccine Against Anthrax 
Harry Kleanthous, Ph.D., Senior Director, Acambis plc.
The use of anthrax as a bioterrorist weapon has moved from hypothetical concern to reality, with reports of anthrax exposures as a result of terrorism. The only US licensed anthrax vaccine to prevent such measures is an alum-adsorbed, formaldehyde inactivated cell-free filtrate, known as ‘Alum Vaccine Adsorbed’ (Biothrax), and that is produced from a sporogenic proficient, toxigenic, non-encapsulating B. anthracis culture (V770-NP1-R). There have been several reports of reactogenicity with this vaccine that requires multiple booster doses to induce immunity. We report on a recombinant sub-unit vaccine approach using ‘Protective Antigen’ (PA) as the sole antigen as an alternative to AVA. The advantage of this approach is a safe, high-yield E. coli production strain that yields gram quantities of soluble protein. Our target antigen is a mutant derivative of PA termed PA-SNKE-FF-E308D. It is completely non-toxic and has been shown to retain its immunogenic properties when formulated with aluminum hydroxide (alum). We present data for bench-scale fermentation and purification of this product and pre-clinical studies comparing the immunogenicity of mutant PA with wild type protein. The mutant product is demonstrated to induce in mice comparable anti-toxin immunity to wild type recombinant PA at an equivalent dose, and elevated responses in comparison to the licensed vaccine.

11:15 - 11:45 Bringing Recombinant Adeno-Associated Viral Vector-Based HIV Vaccines to Clinic: A Summary of Product and Clinical Development
Pervin Anklesaria, Ph.D., Vice President, Therapeutic Development, Targeted Genetics Corporation 
The International AIDS Vaccine Initiative, IAVI, (New York, NY USA, Amsterdam, Netherlands, Nairobi, Kenya and New Delhi, India), Children’s Hospital of Philadelphia, CHOP, (Philadelphia, PA USA) and Targeted Genetics Corporation, TGC, (Seattle, WA USA) are developing a vaccine for HIV prophylaxis in developing countries based on an adeno-associated virus vector (AAV). The initial vaccine, tgAAC09, contains single stranded DNA from Clade C HIV-1 genes packaged in an AAV serotype 2 protein capsid. Clade C HIV-1 is responsible for approximately half of all HIV infections worldwide.
A Phase 1 clinical trial in Germany, Belgium, and India has been conducted. A Phase 2 study is also underway in South Africa, Uganda, and Zambia to further investigate safety and immunogenicity as well as the optimal dose and schedule. I will discuss data generated to navigate the regulatory process to initiate clinical trials of a novel vaccine based on rAAV. I will also discuss available preclinical and clinical data.

11:45 - 12:15 Promising New Recombinant Hemagglutinin Influenza Vaccine 
Manon M.J. Cox, Ph.D., Chief Operations Officer, Protein Sciences Corporation
FluBlok, a trivalent recombinant influenza vaccine, has been developed by Protein Sciences utilizing the production of hemagglutinin in insect cells. FluBlok protected all healthy adults against influenza in a field study. Clinical study results of FluBlok obtained in the elderly and immune-comprised will be discussed. In addition, this novel approach was also used to produce the first avian influenza vaccine to enter human clinical trials. 

12:15 - 1:40 Luncheon Technology Workshop or Lunch on Your Own 
(Sponsorship Available) 

Bringing Needed Vaccines to Patients Around the World

1:40 - 1:45 Chairperson's Remarks

1:45 - 2:15 DNA Vaccines in 2006
Thomas G. Evans, M.D., Head of Infectious Disease, Novartis Institutes for BioMedical Research
The use of DNA vaccination has entered its second decade, and some success has been achieved with licensure of DNA vaccines in fish and horses. Both antibody and T cell responses have been induced in man, but we still remain far away from a licensed vaccine in man. This stems in part from the difficulty in achieving a proof of concept study in a T-cell mediated disease. I will review the status of the field for IM vaccination- the successes, failures and challenges of moving this technology into a commercial setting. 

2:15 - 2:45 Vaccine Development for Neglected Diseases
Douglas Holtzman, Ph.D., M.P.H., Senior Program Officer, Infectious Diseases, Global Health Program, Bill & Melinda Gates Foundation
New global efforts are underway to tackle diseases of poverty, and vaccines are central to the strategy for solving a number of these health challenges. Public-private partnerships play a critical role by providing public-sector resources to link discovery research efforts to private-sector product development capabilities. Significant progress has been made in a number of key disease areas. New technologies and new insights from innate immunity should transform vaccine development in the next decade and hold great promise for reducing the burden of disease in low-income countries. 

2:45 - 3:15 Stable Vaccines for Developing Country Immunization Programs
Dexiang Chen, Ph.D., Senior Technical Officer, Technology Solutions, Program for Appropriate Technology in Health (PATH)
Thermostable vaccines could extend immunizations to areas of the world where there is no cold-chain and help ensure that immunized individuals receive potent products. Vaccine stabilization often involves changes not only to the formulation and manufacturing process, but also to the delivery system and administration method. Each of these changes has important implications for the development pathway and for the adoption, introduction, and affordability of the stabilized vaccine. Vaccine stabilization technologies that hold promise for developing country immunization programs will be discussed.

3:15 - 4:00 Refreshment Break in the Exhibit Hall 

Novel Methods for Administering Vaccines

4:00 - 4:30 Unlocking the Potential of the Skin Immune System for ETEC and Influenza Vaccines
Gregory M. Glenn, M.D., Chief Scientific Officer, IOMAI Corporation
Delivery of vaccines and adjuvants to the skin in a patch provide potent immune stimulation in a safe, and easy to use manner. The IOMAI formulated, dry patch is an efficient delivery vehicle as well as an optimal environment for stabilizing vaccines. A vaccine patch for traveler’s diarrhea is in late Phase 2 development. A similar patch, containing the adjuvant LT, can be used for immune stimulation to accompany the injected vaccine, enhancing the immune response in the elderly, and for antigen sparing for pandemic influenza vaccines. Finally, a self-administered room temperature stable vaccine may be possible in the future for influenza, both annual and pandemic vaccines, and is aimed at increasing the usage and convenience of influenza vaccines.

4:30 - 5:00 Mass Immunization of Poultry against Bird Flu by Rapid Production of RCA-Free AdHigh-Vectored Vaccines in Conjunction with Streamlined in ovo Inoculation 
De-chu C. Tang, Ph.D., Founder, Vice President & Chief Technology Officer, Vaxin Inc.
In addition to vaccinating humans against influenza following intranasal and topical application of an adenovirus (Ad)-vectored vaccine, we recently demonstrated that chickens could be well protected against bird flu by in ovo immunization of 18-day-old embryonated eggs with a human Ad serotype 5-derived vector encoding an avian influenza virus hemagglutinin. The AdHigh system was developed for rapid production of replication-competent Ad (RCA)-free Ad vectors in PER.C6 cells in response to a surge in demand without the biohazard associated with RCA contamination. It is conceivable that the AdHigh-vectored in ovo vaccine may emerge as a promising approach for mitigating bird flu due to timely production of RCA-free Ad vectors when a new strain is identified, followed by mass-administration into eggs using a robotic injector in a time- and labor-saving manner within the context of an excellent safety profile. 

5:00 End of Conference 

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