Suzanne Sensabaugh Appointed to Chair the Member Services Committee

Suzanne Sensabaugh has filled the position of Chairman of the Member Services Committee, a position held by Alan Anderson prior to his election as the FDAAA President. Suzanne has plans to grow the size of the organization and is particularly interested in recruiting current Agency employees and FDA alumni that now live outside the DC metropolitan area.

At the FDA Center for Biologics Evaluation and Research (CBER), Suzanne was a member of internal committees that drafted and finalized laws, regulations, and Guidance documents (Guidelines) interpreting and implementing the Prescription Drug User Fee Act (PDUFA) and FDA Modernization Act (FDAMA). These include Special Protocol Assessment; Submitting and Reviewing Complete Responses to Clinical Holds; Formal Dispute Resolution; Pediatric Use Supplements; Submission of Chemistry, Manufacturing, and Controls (CMC) Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use; Changes to an Approved Application: Biological Products; and Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations.

Suzanne was lead author on the Guidance for Industry on the Content and Format of CMC Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test. For her work, she received an award from the Health and Human Services (HHS) Secretary and the FDA Commissioner for leadership and accomplishments. This document guided the contents of other Guidance documents for the CMC and Establishment Description Information for non-recombinant biologics.

While at CBER, she served as a product and GMP inspector. Working closely with Office of Chief Counsel (OCC) and CBER Office of Compliance, her audits led to enforcement actions, such as Warning Letters and Notice of Intent to Revoke (NOIR) letters. In addition, letters interpreting and reiterating the regulatory requirements were issued to Allergenic Product manufacturers and source material suppliers.

Suzanne was global regulatory lead for an Orphan Drug Product from preclinical into Phase III. The BLA was filed and approved within 1.5 years. This product resulted in revenues of $16m in 2006.

Serving as global regulatory lead for an approved biotechnology-derived product, Suzanne’s regulatory strategy resulted in over 148 approvals in two years including introduction into 35 new countries. In 2007, this product resulted in over $1B in revenues for the company.

Suzanne was regulatory lead for the first biosimilar G-CSF (Filgrastim) from preclinical through Phase III trials. Suzanne worked closely with the European Medicines Agency (EMEA) in the development of scientific and regulatory requirements for this new product area. This product is approved in the European Union (EU) and a BLA has been filed in the US.

Serving as lead communicator to the FDA, Suzanne handles the regulatory issues for her clients. Her successes include gaining approval for the initiation of a First in Man study with only one animal species for toxicology, lifting of a Phase I clinical hold due to product stability issues, and negotiating issues to insure that a clinical trial started during the flu season.

Suzanne built and structured Quality Assurance (QA) and Quality Control (QC) groups and Quality Management Systems for biotech start-ups located in the EU and Mexico. She conducted personal training on GMPs, drafted new SOPs, implemented a raw material qualification program, drafted Master Production Records for 3 new products, and introduced the first mammalian-cell derived product to a bacterial manufacturing plant. Drug product manufactured through this system is marketed globally including in the EU.

Suzanne led a major business project while in FDA/CBER that resulted in a redesign of the Center’s review process. This effort was so successful that it was nominated for VP Gore’s Hammer Award. Suzanne received a FDA Group Award for her achievement.

Suzanne is currently the founder and member of Hartmann Willner LLC, a global regulatory consulting firm.