March 10, 2015
11 am to 12 pm EDT

Sponsored by
Precision for Medicine

Webinar Description:

Next Generation Sequencing (NGS) technologies have progressed significantly in recent years, readying them for use beyond research and drug discovery. As companies look to introduce NGS and its potential into routine clinical use, they must begin to interface with the U.S. Food and Drug Administration (FDA) and meet the requirements applicable to marketed diagnostic medical devices. However, FDA recognizes that NGS-based diagnostics require a new approach to regulation, and that the traditional one-test, one-disease model will need to be rethought. Discover FDA’s latest thinking on this and related regulatory initiatives (including Laboratory Developed Tests) in order to learn how to best prepare for FDA pre-market authorization and quality systems requirements.

Learning Objectives:

  • Understand FDA’s recent proposal for a regulatory framework for NGS-based diagnostics
  • Discover the main discussion points and public comments from FDA’s February 2015 Public Workshop on NGS
  • Learn how FDA’s initiative to regulate Laboratory Developed Tests (LDTs) may impact lab-based NGS products
  • Consider other related government initiatives that may affect NGS regulation going forward, including President Obama’s Precision Medicine Initiative and pending congressional legislation
  • Given this regulatory context, review strategies to prepare for pre-market and quality systems requirements for NGS-based diagnostics

Who should attend:

  • VP/Director, Regulatory/Quality
  • VP/Director, Translational Medicine
  • VP/Director, Clinical Affairs
  • Director, Product Development / Product Manager
  • NGS Company Executives and Investors

Speakers:

Austin Speier
Director, Emerging Technologies, Precision for Medicine

Austin Speier is Director, Emerging Technologies at Precision for Medicine. He specializes in the design and execution of development and to-market strategies for complex or first-in-class FDA-regulated products. Austin has extensive FDA regulatory experience, including drafting regulatory strategies, preparing submissions and clinical protocols, and facilitating FDA meetings and negotiations. He regularly works with early-stage and venture-backed clients, as well as corporate innovation and accelerator groups, to develop and implement innovative product development plans, as well as to perform due diligence on potential market strategies and product technologies. His experience spans a range of product categories and therapeutic areas, including work with numerous cardiovascular, neurology, wound care, gastroenterology, oncology, drug delivery, women’s health, digital health, diagnostic, and consumer products.

Jared Kohler, Ph.D.,
Managing Director, Analytics, Precision for Medicine

Jared has led scientific operations that delivered on over 150 translational medicine efforts in clinical drug development, specializing in the analytics of personalized medicine and providing strategic guidance in biomarker research. He has authored or co-authored various peer-reviewed manuscripts in the space of personalized medicine and significantly contributed to over 200 confidential technical documents such as statistical analysis plans (SAPs), clinical study reports (CSRs), and other FDA and EMA submission documents. Jared completed his PhD in human genetics with a concentration in statistical genetics at The Johns Hopkins University School of Medicine.

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