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2013 Archived Content

August 13-15, 2013

Eighth Annual
Novel Vaccines: Innovations & Adjuvants

The eighth annual Novel Vaccines meeting will explore the innovations that are creating more efficacious vaccines against the most pernicious diseases in the world, including breakthrough approaches such as using systems biology or personalized medicine to help "design" better vaccines.  How adjuvants are being employed to enhance vaccines will also be addressed, along with adjuvant safety and mode of action.  Novel ways to deliver vaccines and technology innovations will also be presented, along with discussions about DNA vaccines.

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Tuesday, August 13

7:30 am Main Conference Registration and Morning Coffee

 


INFLUENZA 

8:30 Opening Chairperson’s Remarks 

Nathalie Garçon, Ph.D., Vice President and Head, Global Center for Adjuvants and Technology Innovation, GlaxoSmithKline Biologicals

 

KEYNOTE SESSION

8:40 The Compelling Need for Game-Changing Influenza Vaccines

Michael OsterholmMichael T. Osterholm, Ph.D., MPH, Director, Center for Infectious Disease Research and Policy (CIDRAP), Professor, Environmental Health Sciences, School of Public Health, University of Minnesota

Current hemagglutinin (HA)-head antigen influenza vaccines, regardless of the platform in which they are manufactured, are inadequate to provide robust clinical protection across multiple strains or long-term protection. Evidence for consistent high-level protection is elusive for the present generation of vaccines, especially in individuals at risk of medical complications or those 65 years old or older. The ongoing public health burden caused by seasonal influenza and the potential global effect of a severe pandemic create an urgent need for a new generation of highly effective and cross-protective vaccines that can be manufactured rapidly. A universal vaccine should be the goal, with a novel-antigen game-changing vaccine the minimum requirement.

9:20 Toward a Universal Influenza Virus Vaccine

Peter PalesePeter Palese, Ph.D., Horace W. Goldsmith Professor and Chair, Microbiology, Professor, Department of Medicine, Icahn School of Medicine at Mount Sinai Biography 

Influenza vaccination programs require yearly reimmunizations because of the antigenic drift of the viruses circulating in humans. Recent reports on broadly neutralizing anti-influenza hemagglutinin antibodies suggest that eliciting broad-spectrum humoral immunity against influenza viruses should be possible, given the right immunogen. We have designed different hemagglutinin-based viral constructs (for example, headless hemagglutinins, chimeric hemagglutinins), which direct the immune response against the stalk domain of the hemagglutinin, efficiently boosting a cross-reactive immune response. The development of a universal influenza virus vaccine that - like other viral vaccines - requires a single or only a few immunizations would represent a major advance towards the control of influenza worldwide.


10:00 Coffee Break


10:30 Featured Presentation

Flublok, the First FDA Approved Recombinant Influenza Vaccine

Manon CoxManon Cox, Ph.D., CEO, Protein Sciences Biography 

Flublok is a recombinant hemagglutinin influenza vaccine produced in this production platform and provides an attractive alternative to the current egg-based influenza vaccine (TIV) manufacturing process. Protein Sciences Corporation was awarded a contract in June 2009 from the U.S. Department of Health and Human Services to further develop this technology for the production of recombinant influenza vaccines for pandemic preparedness and FDA granted approval of Flublok for the prevention of influenza in adults (18 - 49 Years) on January 16, 2013. Dr. Cox will discuss the challenges on the path to approval and the manufacturing process for Flublok/Panblok, in particular how the annual changes in vaccine composition are being handled.

11:00 Cell Culture-Based Influenza Vaccine, Current and Future Prospects

Theodore TsaiTheodore Tsai, M.D., Senior Vice President, Scientific Affairs, Novartis Vaccines

Three cell-culture based seasonal influenza vaccines now are licensed and others are in development.   These cell culture-based processes are handicapped however, by the reliance of all manufacturers on WHO-supplied candidate vaccine viruses (CVV) that are egg-derived.  Egg-adaptive changes in the derivation of human influenza viruses through egg-passage can lead to antigenic changes in the CVVs that compromise vaccine efficacy.  Derivation of CVVs in certified cell lines can mitigate host cell adaptive changes and potentially improve influenza vaccine efficacy.

 

11:30 New Influenza Vaccines; This Should Be Easy!

Alan ShawAlan Shaw, Ph.D., President and CEO, Vedantra  Biography 

Influenza virus was isolated in 1933, and vaccines were put to use in the mid-1940s, initially in military personnel. Inactivated, egg-grown virus vaccines were developed in the 1960s, and these vaccines have been used with some success ever since. New interest in flu vaccines, driven by events in Asia, has brought a variety of technologies to bear on the quest for a better flu vaccine.

12:00pm Sponsored Presentation (Opportunity Available)

Novozymes12:15 Recombumin - Superior Stabilization for Robust Cellular Immunotherapy Formulations

Randall Engler, Director, Strategic Accounts, Sales, Novozymes Biopharma US

Albumin is used in a number of ways in development and commercialization of therapeutic product formulations, including autologous and allogeneic cellular therapeutics as well as a number of steps in other vaccine formulations. Novozymes Recombumin USP-NF provides an attractive alternative to HSA.
 

12:30 Luncheon Presentation (Opportunity Available) or Lunch on Your Own


CONQUERING DISEASE 

1:55 Chairperson’s Remarks

William M. Egan, Ph.D., Senior Tech Expert, Novartis Vaccines & Diagnostics, Inc. 

2:00 TB Vaccine Development

 Jerald SadoffJerald Sadoff, M.D., Head, Early Development, Crucell Vaccine Institute

 

 

 

2:30 A Safe, Efficacious & Superior Cationic Lipid DNA Complex Adjuvanted HSV-2 Vaccine

David ZarlingDavid A. Zarling, Ph.D., Co-Founder, President and CEO, Colby Pharmaceutical Company

A safe, efficacious, molecularly-targeted, imidazole-modified, cationic lipid DNA complex (JVRS-100 CLDC) adjuvant and a new vaccination route are in development for herpes simplex virus (HSV) and certain other chronic infections.  Parenteral JVRS-100-HSV-2 vaccination is superior to both Lipid A-HSV-2, LipidA/Alum-HSV-2 and non-adjuvanted HSV-2 vaccine in mice for (1) reducing viral shedding, (2) inducing both high titers of virus neutralizing IgG and HSV-specific T-cell responses, as well as (3) decreasing disease progression.  JVRS-100-HSV-2 completely (100%) protects mice against virus infection vs. Lipid A-HSV-2 (60%) or unadjuvanted HSV-2 (20%).  A significantly more efficacious, rapid, and safe adjuvanted immunization route, that can be applied to human HSV-2 vaccination, will be discussed with potential for preventing chronic infection/disease.

3:00 GeoVax Aids Vaccine, Progress towards Prevention of Infection

Harriet RobinsonHarriet Robinson, Ph.D., CSO, GeoVax Labs, Inc.  Biography 

GeoVax is advancing an HIV/AIDS vaccine that consists of priming with a recombinant DNA and boosting with a recombinant modified vaccinia Ankara (MVA). Both components express non-infectious virus like particles. The DNA component co-expresses granulocyte macrophage colony stimulating factor (GM-CSF) that enhances serum Ab, mucosal Ab and prevention of infection in preclinical studies. The prototype SIV vaccine demonstrated protection against multiple (42) rectal challenges over a 3 year period, achieving by far the best prevention of infection observed in the field. Clinical studies, advancing through the US government-sponsored HIV Vaccine Trials Network, have shown excellent safety, reproducible immunogenicity, and “best in class” Ab responses for the non-GM-CSF co-expressing precursor to the GM-CSF co-expressing vaccine and are showing excellent safety for the GM-CSF co-expressing vaccine.

3:30 Refreshment Break

4:00 Development of a Novel Vaccine for the Prevention of Clostridium difficile Infection

Jon HeinrichsJon Heinrichs, Ph.D., Director, Microbial Vaccines, Vaccines Research, Merck & Co., Inc.  Biography 

Clostridium difficile is a major cause of antibiotic-associated diarrhea, particularly in nosocomial settings. Recently, the incidence of C. difficile disease has been on the rise due largely to the emergence of the epidemic NAP1 strain. We have developed a vaccine targeting not only the large clostridial toxins TcdA and TcdB, but also a third toxin, referred to as binary toxin, that may be associated with more severe disease. This vaccine provides enhanced efficacy for NAP1 infection in a hamster model and may provide increased protection from C. difficile infection in at-risk patients.

4:30 Panel Discussion:  Strategies to Develop More Efficacious Influenza Vaccines 

 

 

Moderator: 

William Egan William M. Egan, Ph.D., Senior Tech Expert, Novartis Vaccines & Diagnostics, Inc.

 



 

 

 

Panelists: 

    -- Manon Cox, Ph.D., CEO, Protein Sciences

    -- Alan Shaw, Ph.D., President and CEO, Vedantra
    -- Theodore Tsai, M.D., Senior Vice President, Scientific Affairs, Novartis Vaccines

    -- Peter Palese, Ph.D., Horace W. Goldsmith Professor and Chair, Microbiology, Professor, Department of Medicine, Icahn    School of Medicine at Mount Sinai 

 

The Panel will discuss: 

  • Efficacy issues with the current influenza vaccines, particularly in special populations.

  • Strategies to improve efficacy and effectiveness of influenza vaccines, including the use mammalian cell-derived or synthetic seeds .

  • The HAI titer as a correlate of immunity and the role of cell mediated immunity in vaccine efficacy.

  • The increased use of adjuvants with influenza vaccines – are they needed

  • Vaccine efficacy and the role of HA glycosylation

5:30 Opening Reception with Poster and Exhibit Viewing

6:30 Close of Day



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