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TUESDAY, JUNE 23, 2015 5:45-8:45pm | DINNER WORKSHOP

Rapid Sample Preparation for Pathogen Detection 

This workshop will discuss sample preparation technologies for detection, identification and analysis of biomedical, biological and chemical agents, biothreats in point-of-care, laboratory and field settings. It will review the novel and rapid technologies for sample preparation, application of analytical strategies and automation in biodetection.

Topics to be covered include:

  • Why efficient sample prep is critical in biodefense applications
  • Strategies for concentrating sample and faster pathogen recovery.
  • Development of qualification methods and protocols

Dave Alburty, CEO, InnovaPrep LLC

Anubhav Tripathi, Ph.D., Professor of Engineering, Professor of Molecular Pharmacology, Physiology and Biotechnology, Director of Biomedical Engineering, Brown University


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THURSDAY, JUNE 25, 2015 5:30-8:30 pm | DINNER WORKSHOP

How to Launch a Laboratory Test: Everything You Wanted to Know But Were Afraid to Ask 

The workshop is designed to give a clear and complete overview / as well as guidance for any company or researcher who is planning to bring a molecular test to the market. In this session, the instructors will begin with a discussion covering FDA approval pathways, recent updates to molecular diagnostics regulations, the different levels of evidence that drive FDA approval and payer coverage, reimbursement fundamentals and the latest coding updates and laws that will impact coverage and payment across the diagnostics industry.

Following the presentation will be an interactive case study activity for participants to exercise their new knowledge of regulatory and reimbursement considerations for diagnostic tests. Participants will work together to determine whether diagnostic test cases would or would not have successful commercialization and why, and finally regroup to discuss the actual outcomes.

Topics to be covered include:

  • Analytical validity, clinical validity and clinical utility
  • CLIA certification
  • FDA approval
  • Third party payers – CPT coding and reimbursement/billing

Steven Gutman, M.D., Strategic Advisor, NA, Myraqa, Inc.

Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP


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FRIDAY, JUNE 26, 2015 1:00-4:00 pm | WORKSHOP

Rapid Vaccine Technologies: Therapeutics for Emerging & Re-Emerging Infectious Diseases 

The need for the rapid formulation of novel vaccines in response to emerging pathogens is critical to public health and safety. The vaccines developed should elicit protective immune responses and be unaffected by pre-existing immunity to vaccine components. In addition, these treatments should be amenable to combination and multi-agent formulation, and should be safe for all populations and the environment.

Topics to be covered include:

  • Status of Vaccines for Ebola
  • Vaccines for Bacterial Pathogens
  • Advances in Rational Vaccine Design and Development Role of Adjuvants in Developing More Effective Vaccines

Matthew Coats, Program Manager, Office of University Programs, Science and Technology Directorate, U.S. Department of Homeland Security

Leslie Lobel, M.D., Ph.D., Department of Microbiology, Immunology and Genetics Faculty of Health Sciences, Ben Gurion University of the Negev, Israel

Willy Valdivia-Granda, Ph.D., CEO, Orion Integrated Biosciences

Darrell R. Galloway, Ph.D., Adjunct Professor of Pharmaceutical Chemistry, Department of Pharmaceutical Chemistry, University of Utah

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* Separate registration required for workshops


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Sample Prep Technologies Brochure  





Biodefense World Summit 

Food and Safety