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Preclinical Clinical Development of Novel Vaccines 09

 

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 


Tuesday, August 18, 2009

 

IMMUNE RESPONSE BIOMARKERS

12:30pm Registration

1:40 Chairperson’s Opening Remarks

Lisa H. Butterfield, Ph.D., Assistant Professor, Departments of Medicine, Surgery, and Immunology, University of Pittsburgh School of Medicine; Associate Director, UPCI Immune Monitoring Laboratory

1:45 A Systematic Approach to Biomarker Discovery: Preamble to “iSBTc-FDA Taskforce on Immunotherapy Biomarkers”

Lisa H. Butterfield, Ph.D., Assistant Professor, Departments of Medicine, Surgery, and Immunology, University of Pittsburgh School of Medicine; Associate Director, UPCI Immune Monitoring Laboratory

The International Society for the Biological Therapy of Cancer (iSBTc) has initiated, in collaboration with the US FDA, a programmatic look at innovative avenues for the identification of relevant parameters to assist clinical and basic scientists who study the natural course of host/tumor interactions or their response to immune manipulation. The task force has two primary goals: 1) identify best practices of standardized and validated immune monitoring procedures and assays to promote inter-trial comparisons and 2) develop strategies for the identification of novel biomarkers that may enhance our understating of principles governing human cancer immune biology and, consequently, implement their clinical application.

2:15 Complexities of Clinical Assay Development and Optimization Prior to First-in-Man Immunization Trials - A Description of Immunogenicity Assay Development for the Testing of Samples from a Phase 1 Alzheimer’s Vaccine Trial

Olivia Hammond, M.S., Research Biochemist, Vaccine and Biologics Lab, PPD, Inc. (formerly Merck)

Immunogenicity is often a critical clinical endpoint in the assessment of vaccines prior to submission to the FDA. As a result, the assays used must be highly characterized, well-controlled and statistically supported. Here we outline two applications on the use of DOE in the development and optimization of a clinical immunogenicity assay.

2:45 Development of Bioassays to Measure Immune Responses

Sylvia Janetzki, M.D., Coordinator of the CVC Assay Working Group, The Cancer Vaccine Consortium (C.V.C.), Cancer Research Institute (C.R.I.)

The assessment of early immune responses in patients treated within immunotherapeutical vaccine programs has the potential of providing insight about the success or failure of vaccination, hence bears early biomarker potential. A limited number of well-defined bioassays exist to date. Despite technological advances, these bioassays are marked by intra- and inter-laboratory variability, a feature that has provoked skepticism especially from industry and regulatory authorities. The CVC has initiated a proficiency panel program for the most commonly used bioassays with more than 80 international laboratories from academia, biotechnology, pharmaceutical and government settings. The goal is to harmonize assays across the field and to offer an external quality assurance program. Driven by the data of multiple rounds of panel testing, initial harmonization guidelines were established. Implementation of these harmonization guidelines within the context of panel participation led to dramatically decreased variability and improved performance by panelists. Further, crucial protocol variables are systematically investigated, and specific recommendations are formulated for the enhancement of the immune monitoring field.

3:15 Ice Cream Bar Refreshment Break with Exhibit and Poster Viewing

ENHANCING THE IMMUNE RESPONSE – PRECLINICAL CASE STUDIES

4:00 Chairperson's Remarks

Atsuo Ochi, Ph.D., Founder and Chief Scientist, Research by Discovery

4:05 Fusion Protein Vaccine with Built-in Adjuvant

Atsuo Ochi, Ph.D., Founder and Chief Scientist, Research by Discovery

We have generated a mitogen fusion protein with powerful adjuvant properties: CD40L-FasL-IgFc. We found that this protein stimulates CD40+ cells at a level nearly equal to LPS stimulation in proliferation assay. When tested in vivo, the influenza HA vaccine response was largely enhanced by co-administration of the fusion protein. Moreover the administration of the DNA expression plasmid, that encodes the fusion protein, significantly boosted the vaccine response.

4:30 Immunization via a Novel Intradermal Particle Delivery System

Martin Brouillette, Ph.D., Professor, Mechanical Engineering, Université de Sherbrooke

We present the results of animal studies of influenza and hepatitis immunization using a new particle-based intradermal delivery system. It is found that, at the same dosage, this delivery method is more efficient than subcutaneous liquid vaccine delivery without adjuvant. Clinical studies of pain and local tolerance also show a marked preference for this delivery system as compared to conventional needle injection.

5:00 Preclinical Development of Broadly Protective Heat Shock Proteins Based Meningitis Vaccine

Sue Clarke, Ph.D., Head, Project Management & Development, ImmunoBiology Ltd.

Although Neisseria meningitidis B vaccines have been produced in response to specific epidemics, they are not broadly protective and there remains an urgent need for a vaccine protective against multiple serogroup B strains. Heat shock proteins are multifunctional ubiquitous proteins. When acting as chaperones, heat shock proteins facilitate the folding and unfolding of proteins in the cell and therefore are always found complexed to other protein cargos. In the context of infectious diseases, these heat shock protein antigen complexes from the pathogen are critical to immunity, bridging between the innate response and the induction of specific responses to the cargo antigens including cross-presentation on MHC class 1 molecules on antigen presenting cells. We have produced a HspC-based vaccine from heat shocked Neisseria meningitidis using chromatographic methods. The ability of this vaccine to induce broad responses in mice has been demonstrated by serum opsonophagocytosis activity against a panel of Neisseria strains. 

5:30 End of Day