Suzanne M. Sensabaugh CV – Expert Witness Services
Suzanne M. Sensabaugh
Seasoned FDA regulatory affairs and compliance professional with over 25 years of experience with biologics, biosimilars and biologic/device combination products. Experience gained in the FDA, pharmaceutical industry, and consulting environments. Successfully created and built Regulatory Affairs and Quality business units which met the requirements in major markets as verified through a strong approval track record, successful regulatory agency inspections, and positive responses to regulatory agency actions.
EMPLOYMENT HISTORY 2009-PRESENT
President and Principal Consultant
Provides advice to clients on regulatory affairs, drug development, and compliance matters involving the Food and Drug Administration (FDA) for traditional biologics, biotechnology, biosimilars, and biologic/device combination products.
Served as an expert witness and prepared expert opinion on FDA GMP compliance matters.
Served as a subject matter expert for NIH and OS/ASPR/BARDA Special Emphasis Panels for contract and proposal reviews for drug development funding.
PANACEA PHARMACEUTICALS, INC. 2008-2009
VP, Regulatory Affairs
- Recommended changes to preclinical development programs for a monoclonal antibody oncology therapeutic and a small molecule drug indicated for stroke which resulted in resource savings.
- Interacted directly with FDA with the outcome of gaining 3 meetings in 4 months leading to a revision in the regulatory and clinical programs for an in vitro diagnostic which met FDA acceptance and company business goals. Strategy can be applied to entire in vitro diagnostic product line.
- Provided guidance to scientific staff on the preclinical development and regulatory requirements for a novel therapeutic technology. Guidance has a high level of FDA acceptance for support of Phase I clinical studies.
MDS PHARMA SERVICES 2006 – 2008
VP, Biopharmaceutical Development
- Established and led the group, supervised staff, evaluated market and developed business. Formulated development and regulatory strategies encompassing the full continuum of drug development with a focus on the early stage of research, performed technical writing (CMC/Quality sections) and due diligence activities, provided responses to Agency correspondence, communicated directly with Agency officials, provided ad hoc scientific and regulatory advice, and membership on company boards.
- Conducted risk assessments of all healthy volunteer studies for biopharmaceuticals.
- Lead author of internal white paper and draft ACRO Best Practice Guideline for First-in-Human studies.
TTeva Pharmaceuticals Industries, Ltd. 2002 – 2006
VP, US RA and Senior Director Global Biogenerics 2005 – 2006
- Responsible for global regulatory activities for biosimilars, including promotion of global positions on government policies relating to public health, regulatory frameworks, and market forces. Developed and oversaw regulatory strategies and contributed to drug development programs for innovative natural and recombinant biologics, biological/device combination products, and synthetic peptides.
- Worked globally and locally with key regulatory decision makers, industry organizations, other external organizations, and Teva BUs to enable regulatory standard setting for biosimilars.
Sicor Inc., Biotechnology Division (acquired by Teva Pharmaceuticals Industries, Ltd.)
VP, Regulatory Affairs & Quality 2002 – 2005
Interim Director, Regulatory Affairs & Quality Unit 2002 – 2004
Interim Head, QA/QC 2002 – 2004
- Built, structured, and managed RA & Quality Unit for biotech acquisition in Lithuania; served as QP.
- Led change from single to multi-product facility, including introduction of mammalian cell-derived product.
- Indirect reporting for RA & Quality Unit staff at biotech F/F site in Mexico
- Designed and implemented Quality Management systems according to EMEA/FDA standards; obtained GMP certificates from TGA.
- Developed and implemented global regulatory strategy for biogeneric and innovative biotech product lines (12 submissions, 8 approvals).
- Led successful FDA/EMEA meetings, including scientific advice.
- Implemented quality activities for EU accession.
- Provided expertise for due diligence exercises.
- Compiled and managed budget; work closely with FDA/EMEA on approval pathways for biosimilars.
GENZYME CORPORATION, Cambridge, MA 1999 – 2002
Associate Director, Regulatory Affairs
- Assisted in directing, planning, and implementing regulatory activities spanning the drug development process for enzyme replacement therapies.
- Responsible for global regulatory affairs for Ceredase, Cerezyme, and Aldurazyme (148 approvals in 35 countries; 11 new countries).
- Successful meeting with HPB allowing IND filing; managed global staff (13); established needs, goals, and managed consultants; contributed to departmental budget for capital expenditures and headcount. Member of multi-disciplinary group consisting of Medical Affairs, Clinical, and Marketing responsible for strategy and positioning of Cerezyme. Responsible for evaluation and submission of worldwide AERs and PSURs for Cerezyme and Ceredase.
FDA, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, Bethesda, MD 1990 – 1999
Special Assistant to the Associate Director for Policy 1996 – 1999
- Drafted, developed, recommended, and implemented scientific, regulatory and compliance policies and procedures, especially as related to PDUFA II and FDAMA (>50 Guidance/ICH/SOPs).
- Member of numerous internal committees; responsible for major project in which the review process was documented and streamlined.
- Performed domestic and international inspections.
- Associate Director for Review Management, Office of Vaccines and Review
- Division of Allergenic Products and Parasitology 1992 – 1996
- Conducted scientific and regulatory reviews (>150) of MFs, INDs, PLAs, ELAs, and product labeling.
- Performed the duties of chairperson for 75 review committees
- Researched, drafted and implemented regulatory and scientific policy.
- Conducted domestic and international inspections, including issuance/resolution of titled and untitled letters.
- Managed review workload and inspection program for Division.
- Biologist, Office of Biologics Research
Division of Biochemistry and Biophysics 1990 – 1992
Conducted independent laboratory studies in Drosophila using recombinant DNA methodology for the purposes of providing regulatory insight into the problems of retroviral vectors used in human gene therapy.
M.B.A. General Management, Duke University, 2001
M.S. Biotechnology, The Johns Hopkins University, 1998
B.S. Zoology, University of Maryland at College Park, 1989
Adjunct Professor, Johns Hopkins University
– Zanvyl Krieger School of Arts and Sciences, “Clinical Development of Drugs and Biologics”, “Introduction to Regulatory Affairs”, and “Introduction to cGMPs”
– Carey Business School, “Product Development and Approval”
Sensabaugh, S.M. (2011). Requirements for Biosimilar/Interchangeable Biological Drugs in the US: In Plain Language. Drug Information Journal.
Sensabaugh, S.M. (2010). Recombinant biogenerics: An introduction to manufacture and quality. In GENERIC DRUG PRODUCT DEVELOPMENT: SPECIALTY DRUG PRODUCTS, Publishers: Taylor & Francis
Sensabaugh, S.M. (2008). Following a Similar Path. European Biopharmaceutical Review. Spring.
Sensabaugh, S.M. (2007). Biological generics: A business case. Journal of Generic Medicines. 4, 186-199.
HONORS AND AWARDS
- 2015—Biomedical Advanced Research and Development Authority Appreciation of Service (New medical countermeasures were approved by the FDA for clinical investigation in the U.S. and West Africa during the Ebola response of 2014-15. The BARDA recognizes this outstanding achievement …to assist in the preparation and review of regulatory submissions…for these Ebola medical countermeasures.)
- 2014— US Department of Health and Human Services Certificate of Appreciation, ASPR Medical Countermeasures Team, Secretary’s Award for Distinguished Service for “recognition of sustained excellence and efficiency in accomplishing the mission and goals of HHS”.
- 2013—Biomedical Advanced Research and Development Authority Appreciation of Service (In recognition of your outstanding contributions for achieving a major milestone in US pandemic preparedness with the licensure of FluBlok on January 13, 2013. This is the first recombinant-based influenza vaccine licensed in the US and is key to providing more and better vaccine sooner in the US for an influenza pandemic as well as seasonal epidemics…)
- 2012—Biomedical Advanced Research and Development Authority Appreciation of Service (Through your hard work, dedication and attention to detail, the FDA joint Advisory Committee Meeting was accomplished with the utmost professionalism. The BARDA Advisory Committee meeting package was well crafted, comprehensive, and clearly recanted the BARDA/ASPR position…)
- 2011—Biomedical Advanced Research and Development Authority Special Recognition Award (In recognition of your extraordinary accomplishments during the period of August 1, 2011-September 7, 2011. The BARDA awarded 2 contracts for the advanced research and development of drugs to treat injury from exposure to deadly chemical agents. Your contributions were invaluable in the contract award to Contractor 1 and Contractor 2. Your efforts reflect great credit upon yourself, the BARDA, OASPR, and DHHS)
- 1999—FDA Group Recognition Award as a member of the Project Management Workshop Planning Group for “superlative teamwork and exceptional performance demonstrated during creative development and implementation of four educational units of the FDA/DIA Joint Project Management Workshop”.
- 1998—FDA Group Recognition Award as a member of CBER’s Managed Review Committee for “demonstrating exceptional and collaborative efforts, which brought honor to CBER, the Public Health Service, and the Department of Health and Human Services.”
- 1997—Public Health Achievement Award (Major Contributors to Grass Standardization Program – For demonstrating exceptional and collaborative efforts, which brought honor to CBER, the Public Health Service, and the Department of Health and Human Services.)
- 1997—FDA Group Recognition Award as a member of the Product Comparability Group for “outstanding efforts in preparation of a guidance document on product comparability to ensure the continued improvement and availability of biological products.”
- 1994—HHS Secretary’s Employee of the Month Award (given by the Commissioner of FDA for outstanding leadership and accomplishment)
- 1991—FDA Outstanding Achievement Award (In recognition for outstanding performance in planning, organizing and conducting laboratory experiments.)
RECENT INVITED PRESENTATIONS
“Next Generation Nanomedicines and Nanosimilars: Regulators’ Perspective”, Session Chair, DIA 2015 51st Annual Meeting, June 15, 2015
“Nanotechnology: Application to Medical Products”, Session Chair, DIA 2014 50th Annual Meeting, June 17, 2014
“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
“FDA Express Lane: Efficiently Navigating the FDA Approval Process”, UMD Technology Start-Up Bootcamp, Maryland Technology Enterprise Institute, October 23, 2009
“Insights and Updates on Biosimilars”, The Business of Biosimilars, 10th Annual Generic Drug Summit, IIR, September 25, 2009
“The Investigational New Drug Application / Quality Section for the IND and NDA (Biologics and Biotechnology Products)”, Medicademy Master of Science Program in Regulatory Affairs (sponsors: LIF, the Danish Pharmaceutical Manufacturers Association, and the Royal Danish College of Pharmacy; September 15, 2009
“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
”Post Approval and Regulatory Challenges”, Immunogenicity for Biotechnology workshop, World Research Group; January 27, 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
“Creating Appropriate Capacity for a Full Range of Clinical Service Outsourcing: Pitfalls and Possibilities”, Panel Member; Partnering in Drug Discovery, US-India Healthcare Partnerships for the Future; November 2007
“The Future of Generic Drugs: What Happening on Capital Hill”, Panel Member; IIR’s 8th Annual Generic Drug Summit; September 2007
“Follow-on Biologics: Economics and Policy Issues”; Duke Clinical Research Institute; June 2007
“An US Update: Scientific and Regulatory Considerations”; Biosimilars, IBC Life Sciences; June 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
“FOPPs, Biological Generics, and Biosimilars: a US and EU Regulatory Update”; The Follow-on Biologics Struggle Continues: The 2006 Update with Views on the Scientific, Regulatory, Economic, and Legal Dynamics Impacting the Debate; 7th Annual Generic Drugs Summit, Institute for International Research; September 2006
“Developments on Follow-on Biologics in the USA. Is a Global Approach Possible?”; Biosimilar Medicinal Products: A Reality in Europe, 4th EGA Symposium on Biosimilars; May 2006
“Laying the Groundwork for Approval of Generic Biologics”; 4th Annual Generic Drug Forum, Future Trends in the Generic Drug Industry; April 2006
“Biogenerics: a Generic Manufacturer’s Perspective” and session chair; Biogenerics: examining the latest regulatory developments and overcoming legal and production challenges; March 2006
“Case for Follow-on Biologics”; Biotechnology Community of Practice, Biotechnology Issues: Past, Present, Future, ISPE Annual Meeting; November 2005
“Biogenerics: A Generic Manufacturer’s Perspective”; Biotech and Big Pharma: What Future for Biogenerics and Healthcare Costs?, Sloan Innovation Period, MIT; October 2005
“Scientific Considerations: Where are we now? Omnitrope™ lawsuit and Citizen’s Petitions”; Follow-on Biologics: Where are we now?, 6th Annual Generic Drug Summit, Institute for International Research; September 2005
“Scientific Considerations for a Biopharmaceutical Generic, rHGH: A Case Study”; GPhA First Annual Policy Conference; September 2005
“A US Industry Regulatory Perspective on Follow-on Biologics”; Institute for International Research; April 2005
“A case study of a biogeneric: rHGH”; Scientific Considerations Related to Developing Follow-on Protein Products, FDA; September 2004
“Regulatory Pathways for Approval in Europe and in the United States”, Using Science and Experience to Maximize your ROI in Biosimilars, MDSPS Scientific Leadership Symposium; May 2008
“Strategies and Challenges in Developing Biologically Manufactured Drugs”, MDSPS Scientific Leadership Symposium; November 2007
“Generic Biologics: an introduction”, “Immunogenicity Risk Assessments”, and “Clinical Development: Generic Biologics”, Generic Biologics: Understanding the Scientific, Legal, Regulatory, Economic, and Marketing Implications, MDSPS-sponsored scientific symposium; organizer, chair and presenter; September 2007
INDUSTRY COMMITTEE ASSIGNMENTS
Preclinical and Translational Development/Early Phase Clinical Development Program Chair, DIA Annual Meeting
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
Former Head, GPhA Biologics Working Group
FDA COMMITTEE ASSIGNMENTS
Chemistry, Manufacturing and Controls Coordinating Committee (CBER)
Review Management Coordinating Committee (CBER)
Review Management (Joint CBER/CDER)
FDA Medication Errors Working Group
Scholarly Authority, Supreme Court of the US, Merck KGaA v. Integra LifeSciences I, Ltd. and The Burnham Institute, On the Writ of Certiorari to the US Court of Appeals for the Federal Circuit, February 2005
Senator Orrin Hatch Hearing, “The Law of Off-Patent Biopharmaceuticals”, scientific chair to GPHA; June 2004
Serve as a technical expert for review of white papers and full proposals for grants and contracts for HHS (NIH & BARDA). Subject matter expertise in drug development, Regulatory Affairs, and Quality.
NIH Special Emphasis Panel/Scientific Review Centers for Medical Countermeasure Against Radiation Consortium, March 2014