Many COVID-19 diagnostics programs have been delayed or derailed because of unanticipated challenges. COVID-19 success will require overcoming a variety of obstacles, from assay design and regulatory hurdles to sample sourcing and reimbursement considerations. This webinar will explore real-world examples that will help you anticipate pitfalls, mitigate risk and accelerate development.

As part of the life sciences community, Precision wants you to succeed in the fight against COVID-19. Use the valuable insights we’ve gained from participation in multiple COVID-19 research studies to understand the contingencies for success and, just as critical, to anticipate pitfalls that can be avoided.

Understand how to:

  • Build a biospecimen foundation for diagnostic development and 510(k) submission
  • Navigate the regulatory landscape for serology tests, from EUA to 510(k)
  • Leverage important design considerations for market access

Recommended for:

  • Biotech R&D teams developing COVID-19 antibody tests
  • Clinical operations specialists managing studies for 510(k) submission
  • Regulatory affairs teams working on EUAs or formal submissions to the FDA
  • Procurement specialists looking to identify appropriate specimens for their research

Featured Speakers

Karen Richards

Senior Vice President, In Vitro Diagnostics and Quality
Precision for Medicine

Karen is a leader and innovator in the GMP/ISO/FDA/EU-regulated in vitro diagnostic (IVD) industry. She is in charge of regulatory approvals worldwide for both novel and traditional IVD assays and products, as well as laboratory developed tests in the United States. She also builds ground-up quality systems, meeting the requirements of US FDA, ISO 13485, CLIA, and CAP.

Jim Boushell

Vice President, Biospecimens Solutions
Precision for Medicine

Jim guides the integration of Precision for Medicine’s partner network across engagement through real time supply and biologistics. Long recognized as a leader in clinical study solutions, Jim co-founded ProMedDx in 1998 and helped shepherd its inclusion in the Precision family in 2019.

David Parker, PhD

Senior Vice President, Diagnostics Solutions
Precision for Medicine

David’s expertise encompasses all aspects of market access, reimbursement, and evidence development strategy, with a particular focus on personalized medicine, advanced molecular and companion diagnostics, and targeted therapies.

NOW AVAILABLE ON-DEMAND

Register now for this webinar