Suzanne M. Sensabaugh – Regulatory Affairs Consultant

Suzanne M. Sensabaugh is President and Principal Consultant of HartmannWillner, where she is a regulatory affairs consultant who provides professional advice to clients. She has over 25 years of experience in regulatory affairs, drug development, and FDA compliance with a focus on biologics, biosimilars, and biologics/device combination products. Her experience was gained in the FDA, pharmaceutical industry, and as a regulatory affairs consultant.

Since forming HartmannWillner in 2009, Suzanne has assisted in the development of over 120 products as a regulatory affairs consultant. During this same time period, she has conducted over 30 FDA GMP audits, to include preapproval inspections (PAI), and provided GMP compliance consulting. In addition, she has provided FDA regulatory consultant expertise to product development advisory boards, investment management and venture capital firms, and global management consulting firms. She has served as an expert witness on FDA regulatory affairs and GMP compliance matters and as a subject matter expert for NIH and OS/ASPR/BARDA Special Emphasis Panels for contract and proposal reviews for drug development funding.

Suzanne’s experience includes Investigational Drug Applications (INDs); Biologics License Applications (BLAs); New Drug Applications (NDAs), including 505(b)(2); clinical trials; Good Clinical Practices (GCPs); chemistry, manufacturing and controls (CMC); comparability; preclinical (pharmacology/toxicology); Orphan Drug designations; product labeling; and expedited safety adverse event reporting. Suzanne has provided expert advice for many compliance issues, including Good Manufacturing Practices (GMP) inspections, Form FDA 483 and warning letter responses, and conducts cGMP inspections and audits. Technology and therapeutic areas of expertise include development of hormones, replacement therapies, monoclonal antibodies and fragments, immunotherapies, allergenic vaccines, enzyme replacement therapies, cellular and gene therapies, peptides, and numerous novel drugs, to include sustained release, long-acting drugs, and alternate routes of administration, for endocrinology, metabolic disorders, reproduction, oncology, inflammation, anti-viral, ophthalmology, cardiology, neurology, allergy, and medical countermeasures.

Suzanne has 10 years of experience at the FDA/CBER as a researcher, product reviewer, and inspector for biologics. Her industry career began at Genzyme Corporation. Suzanne has held numerous senior and executive positions in industry at Teva Pharmaceutical Industries, MDS Pharma Services, and Panacea Pharmaceuticals. She received her MBA from Duke University, MS from Johns Hopkins University, and BS from the University of Maryland. Suzanne is former Adjunct Faculty at Johns Hopkins University.

Email me at: smsensabaugh@hw-fda.com