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Suzanne M. Sensabaugh CV – Expert Witness Services

Suzanne M. Sensabaugh

Suzanne M. Sensabaugh 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. Suzanne has assisted in the development of hundreds of products. She prepares and evaluates FDA submissions. Suzanne conducts FDA GMP audits, to include preapproval inspections (PAI), and provides GMP compliance consulting. Suzanne has deep knowledge of FDA regulations, guidance documents and standards, especially in the area of cGMP. In addition, she provides FDA regulatory expertise to product development advisory boards, investment management and venture capital firms, and global management consulting firms. She serves 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. She has received numerous honors and awards for her work from FDA and HHS.

EMPLOYMENT HISTORY

HartmannWillner                                                                                             2009-present

President and Principal Consultant

  • Provides advice to clients on regulatory affairs, drug development, and quality compliance matters involving the Food and Drug Administration (FDA) for traditional biologics, biotechnology, biosimilars, and biologic/device combination products.
  • Since 2009, assisted in the development of over 120 products and conducted over 30 FDA GMP audits, to include preapproval inspections (PAI), and provided GMP compliance consulting.
  • Provides expertise to product development advisory boards, investment management and venture capital firms, and global management consulting firms.
  • Serves as an expert witness and prepares expert opinion on FDA regulatory affairs and GMP compliance matters.
  • Serves as a subject matter expert for NIH and OS/ASPR/BARDA Special Emphasis Panels for contract and proposal reviews for drug development funding.
  • 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.
  • Resolves FDA compliance issues involving 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.

 

Panacea Pharmaceuticals, Inc.                                                                               2008-2009

VP, Regulatory Affairs

  • Responsible for designing and managing regulatory strategies and submissions for biological products and in vitro diagnostics for oncology
  • Provided regulatory guidance to ensure the company and its products comply with FDA regulations and Guidelines
  • Served as direct contact with FDA

 

MDS Pharma Services                                                                                             2006 – 2008

VP, Biopharmaceutical Development                                                           

  • Managed and directed the Biopharmaceutical Development regulatory affairs consultants. Established and led the biotechnology consulting services group, supervised staff, evaluated market and developed business.
  • Preparation and evaluation of chemistry, manufacturing, and controls (CMC) documentation for INDs, BLAs, including preparation of Quality Overall Summaries.  Conducted gap analyses.
  • Conducted immunogenicity risk assessments, due diligence activities, provided responses to Form FDA 483 and Warning Letters, communicated directly with FDA, provided technical and regulatory advice, drafted FDA meeting requests and briefing documents, and membership on company boards.
  • Conducted mock FDA audits and FDA PAI to determine if the facility manufacturing biological products was operating in compliance with the laws, regulations, and standards for GMP. Provided GMP compliance consulting services.
  • Formulated development and regulatory strategies encompassing the full continuum of drug development with a focus on the early stage of research
  • Conducted risk assessments of all healthy volunteer studies for biopharmaceuticals. Authored white paper and draft ACRO Best Practice Guideline for First-in-Human studies.

 

Teva 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.

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

  • Evaluated chemistry, manufacturing, and controls (CMC) data and information for biological products
  • Built, structured, and managed RA & Quality Unit for biotech acquisition in Lithuania; served as Qualified Person (QP). Responsible for release of products.
  • Responsible for RA & Quality Unit staff at biotech F/F site in Mexico
  • Led change from single to multi-product facility, including introduction of mammalian cell-derived product.
  • Designed and implemented Quality Management systems according to EMEA/FDA standards; obtained GMP certificates from TGA.
  • Developed and implemented global regulatory strategy for biosimilar 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.
  • Worked closely with FDA/EMEA on approval pathways for biosimilars.

 

Genzyme Corporation, Cambridge, MA                                                               1999 – 2002

Associate Director, Regulatory Affairs

  • Responsible for providing technical and strategic advice to gain approval for global submissions, including FDA and EMA, for enzyme replacement therapies, specifically for Ceredase, Cerezyme, and Aldurazyme. Gained 148 approvals in 35 countries; 11 were new countries.
  • Managed global staff; established needs, goals, and managed consultants; contributed to departmental budget for capital expenditures and headcount.  Member of a 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

  • Authored FDA regulations and over 50 Guidance documents, including ICH and FDA SOPs, which interpreted and implemented PDUFA and FDAMA
  • Member of numerous internal committees:
    • Chemistry, Manufacturing and Controls Coordinating Committee (CBER)
    • Review Management Coordinating Committee (CBER)
    • Review Management (Joint CBER/CDER)
    • FDA Medication Errors Working Group

Associate Director for Review Management, Office of Vaccines and Review        

Division of Allergenic Products and Parasitology                                                      1992 – 1996

  • Conducted scientific and regulatory review of over 150 industry submissions for biological products, to include Investigational New Drug applications (IND), amendments, Biological License Applications (BLA), and supplements specifically in the area of chemistry, manufacture, and controls (CMC)
  • Performed the duties of chairperson for 75 review committees
  • FDA credentialed inspector who conducted inspections of manufacturing and testing facilities; issued Form FDA 483s and assisted in their resolution; drafted FDA enforcement actions, including Warning Letters, in conjunction with CBER’s Office of Compliance and General Counsel 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 Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act).

 

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.

EDUCATION

M.B.A.    General Management, Duke University, 2001

M.S.        Biotechnology, The Johns Hopkins University, 1998

B.S.         Zoology, The University of Maryland at College Park, 1989

 ACADEMIC POSITIONS

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”

RECENT PUBLICATIONS

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

 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 PUBLICATIONS

 “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

Company-Sponsored Symposia/Presentations

“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

OTHER

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”, second chair (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