Harvey Arbit, PhD, MBA

Dr. Harvey Arbit received his bachelor’s degree in pharmacy from Albany College of Pharmacy and Health Sciences, PharmD from Duquesne University, School of Pharmacy, and MBA from Northern Illinois University, College of Business. He completed a residency in clinical hospital pharmacy at UPMC Mercy Hospital in Pittsburgh, Pennsylvania.

He joined the pharmaceutical industry straight from graduate school and has spent over 40 years there in the areas of regulatory affairs, clinical research, quality assurance, and product development. 

Dr. Arbit has served as Manager of Regulatory Affairs and Clinical Development for Baxter Travenol Laboratories; Manager of Regulatory Affairs and Clinical Research for 3M Medical Products; Vice President of Regulatory Affairs for Upsher-Smith Laboratories; Executive Vice President for Denvey Pharmaceuticals; Director of Formulary Compliance for SmithKline Beecham’s Diversified Pharmaceutical Services; and Vice President of Research & Development for Coloplast Skin Care. 

In 2002 the University of Minnesota Academic Health Center established the IND/IDE Assistance Program. Dr. Arbit joined the University of Minnesota to head up this new program, develop its policies, procedures, guidance documents and algorithms, and to launch the program university-wide. This program has been recognized as a model for providing regulatory support for investigator-initiated research in academic institutions. He also served as the Leader for Regulatory Knowledge and Support in the Clinical and Translational Science Institute. Dr. Arbit also provided oversight of the IND/IDE Assessment Program in the Research Integrity and Oversight Programs in the Office of the Vice President for Research. He currently is an adjunct professor in the Department of Pharmaceutical Care and Health Systems at the University of Minnesota College of Pharmacy. In 2010 Dr. Arbit retired from the University of Minnesota and established Arbit Consulting, LLC, specializing in providing strategy and support for industry, academia, and investigator-initiated sponsored clinical research. He served as its President and CEO until 2023 when he transferred the consultancy to his business partner and now serves as its Founder and Consulting Partner. In 2022 Dr. Arbit was invited to serve on the faculty of Albany College of Pharmacy and Health Sciences as an adjunct professor in the Department of Pharmaceutical Sciences and the Center for Biopharmaceutical Education and Training. He is also assisting in the development of a certificate program for regulatory affairs/regulatory sciences at ACPHS.

Dr. Arbit is an active member of several professional associations in pharmacy, regulatory affairs and clinical research. He has his Regulatory Affairs Certification (RAC emeritus) through Regulatory Affairs Professionals Society (RAPS life member) and his Clinical Research Professional Certification (CCRP) through Society of Clinical Research Associates (SoCRA). He has served on SoCRA’s board of directors as a board member and officer. He has published many articles and given numerous presentations and workshops related to his areas of expertise. Dr. Arbit is a pharmacy preceptor and mentor to PharmD students.

• RAPS
• SOCRA

Research Interests

• Regulatory Affairs
• Clinical Research
• Drug product development and FDA approval process
• Medical device product development and FDA approval process
• Food and Drug Administration (FDA)

Research Projects

• Regulatory Aspects of Investigator-Initiated and Sponsored Clinical Research

PubMed

Arbit HM, Teeple, WM. Chapter 3 – New Drug Application, Chapter 9 – Investigator-Initiated and Sponsored Research. In “FDA Clearance: Integrated Clinical, Engineering, and Business Approaches”. Rosen Y, Elman N and Gurman P, eds., CRC Press, Taylor & Francis Group. (November 2024.)

Mézes M, Arbit HM. Chapter 31 – Regulatory Affairs: The Investigator-Initiated Oncology Trial. In “Oncology Clinical Trials: Successful Design, Conduct and Analysis”. Kelly WK and Halabi S, eds., Demos Medical Publishing, 2010.

Arbit HM, Paller MS. A program to provide regulatory support for investigator-initiated clinical research. Acad Med. Management Series: Managing the Research Enterprise. 30-37, 2007 May.

Arbit HM, Paller MS. Regulatory support for investigator-initiated clinical research. RA Focus. 12(2):23-28, 2007 Feb. Arbit HM, Paller MS. A program to provide regulatory support for investigator-initiated clinical research. Acad Med. 81(2):146-153, 2006 Feb.

Lu L, Arbit HM, Herrick JL, Segovis SG, Maran A, Yaszemski MJ. Tissue engineered constructs: Prospectives on clinical translation. Ann Biomed Eng. 43(3):7\96-804. 2015 Mar.