#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
- Vice President, Regulatory Strategy and Policy
- Synchrogenix, a Certara Company, United States
Elaine Taylor, VP, Regulatory Strategy and Policy at Synchrogenix, a Certara company, has more than 30 years of experience in the pharmaceutical industry and has extensive experience in developing and providing strategic guidance and regulatory advice at all stages of product development. She began her career in nonclinical (pharmacology, toxicology) research and then moved to clinical research and regulatory affairs. Ms. Taylor’s specialties include creating innovative and efficient regulatory strategies for drug development programs, including 505(b)(2) programs, and conducting gap analysis; advising on regulatory agency meetings, responses to regulatory agencies; and preparation and submission of INDs, NDAs, and BLAs.
Kathryn Wekselman, PhD, RN
- Senior Director, Regulatory and Scientific Affairs
- CTI Clinical Trial and Consulting Services, United States
Kathryn Wekselman is Senior Director of Scientific and Regulatory Affairs at CTI Clinical Trial and Consulting Services in Cincinnati, OH. Before joining CTI in 2012, she worked for 5 years at CROs as a Director and Senior Director of regulatory consulting and submissions for pharmaceutical and biotechnology company clients and for 9 years at Procter & Gamble Pharmaceuticals, where she held positions as a Senior Scientist in medical writing, medical monitoring, and project leadership. She has extensive experience in strategic drug development planning, clinical protocol development and execution, interactions with regulatory authorities, and development and submission of regulatory documents for FDA, EMA, and Health Canada.