Curriculum Vitae

Suzanne M. Sensabaugh

President

T: 202-484-1362
M: 240-565-1757
E: smsensabaugh@hartmannwillner.com

Suzanne focuses on regulatory affairs, drug development, and compliance matters involving the Food and Drug Administration (FDA). She provides professional advice to clients with a focus in biologics, biotechnology, biosimilars, and biologic/device combination products. Suzanne has provided expert advice for many compliance issues, including Good Manufacturing Practices (GMP) inspections, 483 and warning letter responses, and conducts cGMP inspections and audits.

Experience

  • 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)
  • Good Manufacturing Practices (GMP)
  • Preclinical (pharmacology/toxicology)
  • Good Laboratory Practices (GLP) 
  • Orphan Drug designations
  • Product labeling
  • Clinical Laboratory Improvement Amendments (CLIA)

Technology and therapeutic areas of expertise

  • Development of hormones [Human Growth Hormone (HGH),Follicle Stimulating Hormone (FSH)]
  • Replacement therapies [Erythropoietin Stimulating Agents (EPO), Filgrastim (Granulocyte-Colony Stimulating Factor, G-CSF)]
  • Monoclonal antibodies and fragments (anti-inflammatories, anti-toxins, oncology)
  • Immunotherapies [Interferons (IFN), allergenic vaccines (extracts)]
  • Enzyme replacement therapies
  • Peptides
  • Numerous novel drugs, to include sustained release, long-acting drugs, and alternate routes of administration, for endocrinology, metabolic disorders, reproduction, oncology, inflammation, anti-viral, and counterterrorism agents (biodefense)
  • Medical devices, including in vitro diagnostics

Background

  • 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 FDA credentialed (certified) 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 review of pre-IND issues to insure the company received input early enough to begin the clinical trial 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 outside of the US. 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.

Recent Publications

  • Sensabaugh, S.M. Requirements for Biosimilar/Interchangeable Biological Drugs in the US: In Plain Language. Drug Information Journal, March 2011.
  • Recombinant Biogenerics: An introduction to manufacture and quality. In Generic Drug Product Development: Specialty Drug Products, Publishers: Taylor & Francis, 2010
  • Driving development: Using biomarkers to expedite drug development. European Biopharmaceutical Review. Autumn, 2007

Selected Presentations

  • Regulatory Update on FDA Considerations for Biosimilars”, IIR Business of Biosimilars and Biobetters, September 20, 2011
  • Quality by Design”, Allergen Products for Diagnosis and Therapy: Regulation and Science, 13th International Paul-Ehrlich Seminar, September 14, 2011
  • “What FDA Expects in your Submissions”, BARDA Industry Day,June 9, 2011
  • Biosimilars Symposium Co-chair, AAPS National Biotechnology Conference, May 16-18, 2011
  • “Clinical Considerations: Post Approval Issues”, DIA/FDLI: The Future of Biosimilars in the US: Legal, Regulatory, Scientific, Clinical and Payor Issues, May 5, 2011
  • “Preparing for FDA Approval”, Biosimilars and Follow-on Biologics, VisionGain, February 2, 2011
  • “The Investigational New Drug Application / Quality Section for the IND and BLA”, Medicademy Master of Science Program in Regulatory Affairs (sponsors: LIF, the Danish Pharmaceutical Manufacturers Association, and the Royal Danish College of Pharmacy; October 7, 2010
  • “Assembling the BLA for your Biologics, Biosimilar and Biobetter”, The Business of Biosimilars, IIR, September 20, 2010
  •   “The Importance of Planning for Preclinical and Clinical Development” and session chair, Preclinical and Clinical Development of Therapeutic Antibodies, PEGS Summit, Cambridge Healthcare Institute, April 6, 2009
  • “Building a Quality Unit to Meet Global GMP Requirements”, 13th Annual GMP By The Sea (sponsored by the University of Rhode Island College of Pharmacy);August 26, 2008
  • “Follow-on Biologics: Drug development strategies to enable First-in-Human Studies” and session chair “International Strategies and Experience in Biosimilars, Biosames, and Biobetter”; Global Follow-on Biologics, IBC Life Sciences; December 2007
  • “Scientific and Regulatory Considerations For Biological Generics”; Biosimilarity vs. Bioequivalence; Therapeutic Equivalence of Proteins and Peptides, Canadian Society of Pharmaceutical Sciences; June 2007
  • “Development Strategies for Biosimilars”; Cambridge Healthtech Institute’s Second Annual Engineering Protein Therapeutics for Delivery, Biosimilar Approaches to Comparability: Best Practices; May 2007
  • “Biogenerics”, Panel Member; Piper Jaffray’s Annual Investor Health Care Conference; November 2006
  • “Greeting the Arrival of Biogenerics”, Panel Member; BioNetwork 2006; October 2006

Industry Committee Assignments

  • Association of Clinical Research Organizations (ACRO) Ethics and Clinical Practice Committee
  • ACRO representative to EMEA Workshop on Draft Guideline on Requirements for First-in-Man Clinical Trials for Potential High-Risk Medicinal Products
  • MIT Center for Biomedical Innovation Stakeholder Summit Follow on Biologics Working Group
  • ICH Biotechnology Working Group (IGPA representative)
  • Canadian Generic Pharmaceutical Association (CGPA) Generic Biologics Committee
  • European Generics Association (EGA), Biotechnology and Biosimilars Committee
  • Generic Pharmaceutical Association (GPhA), Biologics Working Group, Science

Education

 MBA     Duke University

 MS       Johns Hopkins University

 BS        University of Maryland

Academic Affiliation

Adjunct Faculty, Johns Hopkins University, Zanvyl Krieger School of Arts and Sciences, “Clinical Development of Drugs and Biologics”, "Introduction to cGMPs" and “Introduction to Regulatory Affairs”. Guest Lecturer "Food and Drug Law" and the Johns Hopkins Carey Business School.

Professional Activities and Interests

  • Drug Information Association
  • FDA Alumni Association
  • Food and Drug Law Institute
  • Regulatory Affairs Professional Society
  • Women In Bio