Speaker Profile

Gretchen Bowker

Chief Operating Officer and Co-Founder, Pearl Pathways

Gretchen Bowker serves as Chief Operating Officer for Pearl Pathways and has over 25 years experience in the development of drugs, biologics and devices. She is a recognized leader in regulatory, bioethics, and compliance. She has extensive experience in working in an academic research setting, large pharmaceutical companies, small biotechs, and large device companies. Gretchen spent over 15 years of her career in large sponsor company environments working at both Eli Lilly and Roche Diagnostics (formerly Boehringer Mannheim). She also has real world small start up experience having led the regulatory, quality compliance and clinical teams at a small biotech startup. Throughout her career, she has successfully assembled teams of experts, driven organizational growth, developed processes and procedures, and implemented strategic plans, which ensured successful product development of drug, device and diagnostic products.

Prior to co-founding Pearl Pathways, Gretchen served as Director of Regulatory and Compliance Service Delivery at a Midwest consulting company where she served institutions, sponsors, and CROs. Gretchen is an experienced team leader with specific expertise in meeting global regulatory body expectations, clinical development, and regulatory compliance. At Pearl Pathways Gretchen oversees the company’s commercial IRB Board, oversees all client consulting engagements, and serves as the company’s Quality Director.

Gretchen has lent her talents as a guest speaker on quality and regulatory topics for Indiana University, Purdue University and multiple national healthcare and pharmaceutical conferences, and is the current Chair of the Indiana Chapter of RAPS. She has held the position of Adjunct Professor of Clinical Research and Regulatory at The George Washington Medical School. She also serves as the Chair of the Indiana RAPS Chapter and is on the Indiana Health Industry Forum’s Clinical Trials Alliance. Gretchen earned an M.S. in Biology from Purdue University, a B.S. in Biology from Indiana University, and has been RAC certified since 2002 and a RAPS fellow since 2011.



Speakers
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Biopharmaceutics vs. Medical Devices: Similarities and Differences in the FDA Regulatory Paths

Why are FDA regulatory submission requirements so different for biopharmaceuticals and devices? This webinar will review FDA regulatory requirements for approval of drugs and biologics and the clearance of medical devices. You will gain an understanding of the Centers for Drugs (CDER), Devices (CDRH), and Biologics (CBER), their requirements for clinical research (IND vs. IDE), as well as the path for approval or clearance to sell product in the US.

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