Harvey Arbit, PhD, MBA

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

He joined the pharmaceutical industry straight from graduate school and has spent over 30 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’s 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 and guidance documents, and to launch the program university-wide. This program is recognized as a model for IND/IDE assistance in academic institutions. He also served as the Leader for Regulatory Knowledge and Support in the Clinical and Translational Science Institute. Dr. Arbit was the director of this program until 2009 when he 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 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 is president of Arbit Consulting, LLC, specializing in regulatory strategy and support for industry, academia, and investigator-initiated clinical research. He also is a relief pharmacist for Target Pharmacies.

Dr. Arbit is an active member of several professional associations in pharmacy, regulatory affairs and clinical research. He has his Regulatory Affairs Certification (RAC) through RAPS and his Clinical Research Certification (CCRP) through SoCRA. He has served on SoCRA’s board of directors as a board member and its treasurer. He has published many articles and given numerous presentations related to his areas of expertise.

President, Arbit Consulting- LLC

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

• Mézes M, Arbit HM. 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.
• Spilker B. Guide to Drug Development: A Comprehensive Review and Assessment. Wolters Kluwer Health, Lippincott, Williams & Wilkins. 2009. (Reviewed and edited 4 chapters.)
• Arbit HM. How to prepare for an FDA inspection. SoCRA Source. 65(3):61-66. 2010 Aug.
• Arbit HM. How to prepare an investigational device exemption (IDE) as a sponsor-investigator. SoCRA Source. 62(4):58-63. 2009 Nov.
• Arbit HM. Investigator-initiated research. J Clin Res Best Prac. 4(6):1-6. 2008 Jun.
• Arbit HM. Investigator-initiated research: The IND and IDE processes. SoCRA Source. 53(3):19-24. 2007 Aug.
• 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.