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Tuesday, August 14
FROM MECHANISM OF ACTION TO A NEXT
GENERATION VACCINE
8:00 Morning Coffee
8:20 am Chairperson’s Comments:
Arthur M. Krieg, M.D., Senior Vice President & Chief Scientific Officer, R&D, Coley Pharmaceutical Group
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8:30 Concepts and Strategies for Public Health Preparedness
Michael G. Kurilla, M.D., Ph.D., Director, Office of BioDefense Research Affairs, Associate Director for BioDefense Product Development, DMID, NIAID, NIH, DHHS
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While successful in the past, the traditional approach to infectious disease interventions that focuses efforts towards vaccines, therapeutics, and diagnostics by targeting the infectious agent itself has displayed increasing limitations due to a combination of factors, including lengthened product development cycles due to increased regulatory requirements coupled with global lifestyles conditions that favor more rapid spread of infectious agents. In order to stay at least one half step ahead of current, evolving infectious agents as well as address as yet unknown emerging infectious threats, new concepts and strategies are needed to create a new paradigm for designing and developing medical interventions. Examples of next generation, 21st century medicine will be presented and outlined.
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9:00 Enhancement of the Human Immune Response to Vaccines Using CPG 7909
Carl J. Nielsen, M.S., Ph.D., Clinical Research Management, Consultant to the U.S. Army Medical Materiel Development Activity
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A number of recent clinical studies with a variety of vaccines have demonstrated a pronounced effect on the speed and magnitude of the human immune response to them provided by the addition of CPG 7909. These observations can be of value to rapidly protecting individuals in the event of a bioterror attack. Details of a recently completed proof-of-concept clinical study combining the licensed anthrax vaccine, BioThrax, with CPG 7909 will be presented. The results of this study point to the need to refine this concept to provide finished vaccine products for licensed use. In addition, it is hoped that this work will stimulate additional studies to better understand the mechanism of this effect.
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9:30 CpG Oligonucleotides as Adjuvants for AVA
Dennis M. Klinman, M.D., Ph.D., Principle Investigator, Laboratory of Experimental Immunology, National Cancer Institute
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Toll-like receptor 9. The ability of CpG ODN to act as immune adjuvants has been examined in mice, macaques and humans. Results indicate that CpG ODN significantly accelerate and magnify the immune response elicited by a wide variety of vaccines. For example, adding CpG ODN to AVA (the licensed human anthrax vaccine) increases the speed, magnitude, and protective activity of the resultant immune response. CpG ODN is effective when co-delivered with a wide variety of vaccines and delivered by multiple routes and formulations.
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10:00 Poster Session with Coffee and Exhibit Viewing
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10:30 Non-clinical Study Results Evaluating the Effect of CpG Co-administered with the Licensed Anthrax Vaccine
BioThrax®
(Anthrax Vaccine Adsorbed)
Michael J. Langford, DVM, Ph.D., President, Emergent BioSolutions
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In 2003 the Defense Advanced Research Projects Agency (DARPA) awarded a 2-year contract to evaluate the immunogenicity and efficacy of prototype anthrax vaccines composed of
BioThrax® and CpG-immunostimulatory adjuvants. Various pre-clinical animal models were employed to test the potential utility of these prototype
BioThrax® + CpG vaccines. While several CpG adjuvant molecules were evaluated for their immune stimulating proprieties, the majority of studies focused on defining the immune enhancing effects imparted by CPG7909
(VaxImmune®, Coley Pharmaceutical Group) when co-administered with
BioThrax®. This presentation will discuss the results of these studies.
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11:00 Mucosal Mindedness for Productive Immunity and Vaccine
Hiroshi Kiyono, D.D.S., Ph.D., Professor and Chairman, Department of Microbiology and Immunology, The Institute of Medical Science, The University of Tokyo
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The mucosal immune system provides a first line of defense against most causative pathogens for emerging and reemerging infectious diseases. Using the concept of common mucosal immune system (CMIS), mucosal vaccine has been shown to be effective in the induction of active immunity in both mucosaland
systemic compartments for the creation of two layers of protection against pathogens. Recent advances in the fundamental aspect of the mucosal immune system, one has to consider the presence of CMIS independent pathway in addition to the traditional CMIS dependent pathway for the mucosal vaccine development. I will discuss new fundamental developments in the field of mucosal immunology and its application for the development of biodefense mucosal vaccine.
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11:30 Panel Dissusion
12:00 pm Luncheon Workshop (Sponsorship Available)
or Lunch on Your Own
BRIDGING BIODEFENSE AND CLINICAL APPLICATIONS
Combined Session with Enabling Point-of-Care Diagnostics
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1:45 Chairperson’s Comments
John C. Carrano, Ph.D., Vice President, Research and Development, Luminex Corporation
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1:50 Global Health Diagnostics
Steven Buchsbaum, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation
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This talk will provide a brief introduction to the Global Health program at the Bill and Melinda Gates Foundation and describe the foundation’s priorities for the development of diagnostics. In particular, the talk will focus on opportunities for the development of Point-of-Care diagnostics appropriate for developing country settings and where there are common technological challenges in biodefense and therefore the potential to leverage biodefense investments.
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2:20 FIND: Bridging the Gaps in the Development and Rollout of Innovative Diagnostics for Poverty Related Diseases
Gerd Michel, Ph.D., Senior Technology Officer, R&D, Foundation for
Innovative Diagnostics
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New technologies have revolutionized the simplicity, speed, and accuracy of diagnostic tools for identifying diseases in the developed world. However, the developing world, especially the public health sector, has yet to benefit from this technological revolution. A critical factor affecting the development of technologies for diseases of the poor is the absence of a bridge that can effectively link academic research and the diagnostic industry to the specific needs of developing countries. FIND provides this bridge by leveraging the strengths of its diverse range of partners to develop technological platforms for diagnosis of poverty-related diseases for the public as well as the non-profit private health sector in the developing world.
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2:50 In Vitro Diagnostic (IVD) POC Devices: How They Differ from Other Devices and how the FDA Regulates Them
Sally A. Hojvat, MSc, Ph.D., Director, Division of Microbiology Devices, Food and Drug Administration
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This presentation will cover the FDA’s role in assuring the safety and efficacy of a POC device from product development phase to post market product surveillance. The new CLIA waiver review process, required for all POC products, will also be discussed.
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3:20 Poster Session with Refreshments and Exhibit Viewing
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3:50 A Unified Technological Approach to Point-of-Care Diagnostics and Biological Sensing
John C. Carrano, Ph.D., Vice President, Research and Development, Luminex Corporation
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During the past several years, we have witnessed an explosive growth in the development of rather sophisticated biological detection technologies. This has been driven, in part, by a least two major needs. The first is the desire to greatly reduce healthcare costs by developing simple to use, yet accurate, point-of-care diagnostic instruments which would allow a clinician to rapidly diagnose, and prescribe treatment for a wide variety of diseases. The second driver is the unfortunate and growing threat of bio-terrorism. Convolved with these two driving forces is the significant pressure on companies to keep research and development costs under control, and focused on high margin products. Although the government has stepped in with vast sums for funding research into technologies related to bio-defense; and, despite the growing interest of some major philanthropic organizations in sponsoring research to mitigate the ravages of disease, the reality is that these technologies will only become available as products if companies see a beneficial long-term return-on-investment. Hence the motivation to pursue a unified technological approach to point-of-care diagnostics and biological sensing. In this talk we will present novel technological approaches using bead-based multiplexing of biological assays to address the compelling, yet at times seemingly contradictory requirements for the development of advanced products for both biological agent sensing and point-of-care diagnostics. In so doing, we describe a pragmatic path toward the productization of technologies critical to humanitarian and bio-security needs, while allowing for a major commercial market driver.
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Featured Speaker
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4:20
Biothreat Detection and Diagnosis: The Joint Biological Agent Identification and Diagnostic System
(JBAIDS)—Current Status and Future Vision
Donna Boston, JBAIDS Program Manager, Office of the Joint Project Manager Chemical Biological Medical Systems
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The Joint Biological Agent Identification and Diagnostic System (JBAIDS) is the U.S. Department of Defense program of record for the detection and diagnosis of biothreat agents. JBAIDS provides a standardized, validated and FDA-cleared, multi-service solution that is ruggedized, deployable, and provides demonstrated capability for pathogen identification in both environmental and clinical sample types. This presentation will describe the current JBAIDS technology and discuss a vision for the future. |
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4:50 Semi-homogeneous Fluidic Force Discrimination Assays for Attomolar
Diagnostics
Lloyd J. Whitman, Ph.D., Head, Surface Nanoscience and Sensor Technology Section, Naval Research Laboratory |
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5:05 Expert Panel: Bullet Proof Approval Process
- How are multiplex assays going to be approved?
- CMS and Reimbursement- will they pay for additional tests?
- How will Doctors interpret results to change the course of treatment?
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Andrew I. Brooks, Ph.D., Associate Professor, Environmental Medicine and Genetics, and Director, Bionomics Research and Technology Center (BRTC), Environmental and Occupational Health Science Institute, University of Medicine and Dentistry of New Jersey; Associate Director, Technology Development, Rutgers University Cell and DNA Repository (RUCDR), Rutgers University
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5:30 Close of Systems Integration in Biodefense Conference
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