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Renee J. Boerner, PhD

VP, Regulatory Affairs

Renee has over 25 years of experience in the pharmaceutical and biotechnology industries. She is a highly regarded Regulatory Affairs, CMC, and Quality professional with proven success in investigational and marketing regulatory applications for small and mid-sized companies across multiple therapeutic areas, including oncology, CNS, and infectious diseases.

Renee has served as a regulatory lead or significant contributor for the approval of four US commercial products, including the primary FDA contact for 1 NDA and 1 BLA and collaborating with commercial partners for approvals in Europe, Taiwan, and South Korea.

At Syner-G, Renee is responsible for establishing standards and strategies for worldwide regulatory submissions supporting multiple therapeutic areas across all stages of development (IND, CTA/IMPD, BLA, NDA, MAA). She also provides strategic regulatory support, specializing in biologics and advanced therapies (vaccines, cellular-derived products including extracellular vesicles, and gene therapies).

Before joining Syner-G, she utilized her regulatory expertise at several organizations, including Bavarian Nordic, Argos Therapeutics, and BioDelivery Sciences International, where her responsibilities included establishing and leading regulatory teams, creating and implementing regulatory strategies, and contributing to Modules 1-5. Prior to Regulatory Affairs, Renee was responsible for the Analytical and Formulation development group supporting the clinical development of numerous biopharmaceuticals at Diosynth Biotechnology.

Renee earned her PhD in Biochemistry from the University of Minnesota, Twin Cities, MN, and a BS in Biochemistry from the University of Wisconsin, Madison, WI.

Renee J. Boerner, PhD's Recent Articles

Conducting Clinical Trials in Australia

05 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner Have you ever wondered why some companies choose to do their first in human clinical trials in Australia? Are there any real advantages or are people just looking for an…

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Potency Assurance for Cellular and Gene Therapy Products

One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the FDA released the Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, which supported a phase appropriate approach…

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