4 Ways to Ensure the Success of Your COVID-19 Trial

COVID-19 has challenged the way the pharmaceutical industry thinks about and adapts typical strategies for conducting vaccine and therapeutic trials. This is especially apparent in trials for COVID-19 therapies and vaccines. Important questions have been raised concerning patient engagement, testing strategies, regulatory considerations, and operational aspects of these trials. So, how can you ensure the success of your COVID-19 trial?

Leveraging their experience with clinical development and laboratory services through all development phases, PPD’s experts discuss four common patterns that have emerged from day-to-day involvement with COVID trials that can help ensure the success of your next program.

1.  Specialized, innovative and well-informed protocols
2.  A variety of COVID-19 testing capabilities, technologies and applications
3.  Consideration for rapid global regulatory changes
4.  Partnership with a contract research organization (CRO) to shorten development timelines

Speakers

Carol Olson, MD, PhD, Vice President, Global Product Development, Therapeutic Area Head, Infectious & Respiratory Diseases and Vaccines, PPD

Dr. Carol Olson, M.D., Ph.D. serves as the vice president and infectious diseases therapeutic area head in global product development for PPD. She has been with PPD for seven years with five years of experience in pharma and CROs. In this role, she is responsible for supporting pharmaceutical development consulting services focused on antibacterial product development strategies. Dr. Olson is an infectious diseases physician with extensive pharmaceutical development experience. Her primary area of expertise includes strategic planning and execution of clinical programs from drug candidate status through registration, launch and post-approval.

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Heather Myler, Senior Director, Lab Operations, PPD Laboratories Bioanalytical Lab

Dr. Heather Myler currently serves as the director of R&D, immunochemistry at PPD (NC, USA), leading a group of scientists responsible for bioanalytical and biomarker method development, validation and automation supporting gene and cell therapies, biosimilars and novel biologics. Dr. Myler has 18 years bioanalytical experience and has been with PPD Laboratories for 3 years.

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Katie Matys, Director, Lab Operations, PPD Laboratories Biomarker Lab

Katie Matys has over 15 years of experience in the pharmaceutical industry. In 2002, she started with Centocor in the core molecular and flow cytometry laboratories and transitioned to Merck in 2005, where she was part of the vaccine sciences department, developing and validating ligand binding methods in support of Gardasil®. In 2009, she joined PPD and has held a variety of roles and titles, with the most recent as director of the biomarker group.

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