Suzanne M. Sensabaugh
Your Biologics Consultant
How Can I Help You?
Suzanne is the President and Principal Consultant of HartmannWillner LLC. She is a FDA regulatory affairs consultant who assists companies in advancing biologics, biosimilars, and biologic/device combination products through the FDA.
She formed HartmannWillner in 2009 as a regulatory affairs consultant. Since then, Suzanne has:
- Assisted in the development of over 130 biologics, biosimilars, and biologic/device combination products
- Conducted over 30 FDA GMP audits, including preapproval inspections (PAI), which allowed for FDA approval
- Provided GMP compliance consulting to successfully address Form FDA 483 observations and Warning Letters
- Prepared expert witness opinions and testimony in the areas of FDA regulatory affairs and GMP compliance
- Wrote and reviewed hundreds of original INDs and BLAs and amendments and supplements
Biosimilar Drug Products —
Manufacture and Quality
Manufacturing standards and quality for biosimilar drug
products are the same as for biotechnology-derived
innovative products. There are vast differences between
the manufacturing process steps of biologics and chemically
synthesized drugs, but the quality principles remain the
same. As with chemical generics, biosimilars are comparable
in quality, safety, and efficacy to the brand product(s).
Frequently Asked Questions
What are your qualifications?
Suzanne has 10 years of experience in the FDA and 10 years of experience in industry. In her 8 years as a consultant, she has advanced the development of over 130 biologics, biosimilars, and biologic/device combination products.
How many years of experience do you have?
Suzanne has over 25 years of experience in FDA regulatory affairs, drug development, and GMP compliance for biologics, biosimilars and biologic/device combination products.
What FDA experience do you have?
As a result of her ten-year employment at the FDA, Suzanne developed a deep knowledge of FDA regulations, guidance documents, and standards. While at the FDA, she:
- Specialized in biologics
- Conducted scientific and regulatory review of industry submissions for new biologics and supplements to BLAs, specifically in the area of CMC
- Conducted inspections of manufacturing and testing facilities
- Issued Form FDA 483s and assisted in their resolution
- Drafted FDA enforcement actions, including Warning Letters, and assisted in their resolution
- Evaluated protocols, data, action plans, and risk analyses in response to FDA enforcement actions
- Authored regulations and Guidance documents which interpreted the FD&C Act and the PHS Act
What industry experience do you have?
Suzanne spent many years as a senior manager and pharmaceutical industry executive. She has worked for:
- Genzyme Corporation
- Teva Pharmaceuticals lndustries Ltd
- Panacea Pharmaceuticals, lnc.
- MDS Pharma Services.
Her responsibilities in these positions have included global regulatory affairs and compliance and providing expert consultation services to the industry.
ln addition, she served as the Qualified Person. In this role, she was responsible for the review of data to determine compliance with specifications and conformance to laws and regulations in order to release investigational drugs to clinical sites and to distribute approved drugs to patients.
ln this global role, she met formally and worked with the FDA and EMA, plus other regulatory agencies throughout the world. She was the regulatory lead in a number of meetings to discuss the development of and regulatory approval for biologics, biosimilars, and biologic/device combination products.
Have you testified or been deposed as an expert witness?
Suzanne has written expert opinions and has testified in FDA regulatory affairs and GMP compliance matters.
What are your technology and therapeutic areas of expertise?
- Development of hormones
- Replacement therapies
- Monoclonal antibodies and fragments
- Allergenic vaccines
- Enzyme replacement therapies
- Cellular and gene therapies
- Stem Cells
- Numerous novel drugs, to include sustained release
- Long-acting drugs
- Alternate routes of administration
- Metabolic disorders
- Medical countermeasures
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