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Harvey M Arbit


Harvey M Arbit, PharmD, MBA


Education

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.

Experience

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 control, 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 launch the program university-wide. This program is recognized as a model for IND/IDE assistance in academic institutions. He was also the Leader for Regulatory Knowledge and Support in the Clinical and Translational Science Institute. He had oversight of the IND/IDE Assessment Program in the Research Integrity and Oversight Programs in the Office of the Vice President for Research. He continues to hold a faculty appointment as adjunct professor in the Department of Pharmaceutical Care and Health Systems at the University of Minnesota, College of Pharmacy. He also is a relief pharmacist for Target Pharmacies. 


Professional Affiliations

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 the board of directors of SOCRA as a board member and officer.


Books

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.)

E-publications


Arbit HM. Significant risk / non-significant risk determination and IDE applicability. (http://www.imarcresearch.com/blog/bid/133211/Significant-Risk-Non-Significant-Risk-Determination-Whitepaper). IMARC Research, Inc. Fairview Park, OH. April 16, 2012.

Arbit HM. Clinical Trials e-Alert. Weekly publication for PIs in clinical trials. Principal Investigators Association. Naples, FL. 2010.
PI bears heavy responsibility in medical device Study. No. 12: August 16-20, 2010.
Why it's best to respond in writing to FDA's Form 483. No. 11: July 19-23, 2010.
Is an IND necessary for pregabalin and paclitaxel studies? No. 10: July 5-12, 2010.
What to do when the researcher is the only study subject. No. 9: July 2-5, 2010.
Who is responsible for an IND annual report? No. 8: June 28-July 2, 2010.
When is an IND necessary? No. 7: June 21-25, 2010.
Conducting a multi-site trial with individual IND applications. No. 6: June 14-18, 2010.
Why it's best to cooperate with an unannounced FDA inspection. No. 5: June 7-11, 2010.
Does study of botanical product require an IND? No. 4: May 31-June 4, 2010.
Marketed drug for cancer treatment. No. 3: May 24-28, 2010.
Medical practice vs. clinical research. No. 2: May 17-20, 2010.
Faulty transfer triggers IND termination. No. 1: May 10-14, 2010.

Journals


Lu L, Arbit HM, Herrick JL, Segovis SG, Maran A, Yaszemski MJ. Tissue engineered constructs: Prospectives on clinical translation. Ann Biomed Eng. Accepted for publication. 2015 Feb.

Arbit HM. Determining whether human research can be conducted without an IND.   SoCRA Source. 79(1):13-17. 2014 Feb. 

Arbit HM. Basic physiological research with devices: 21 CFR 812 does not apply. SoCRA Source. 70(4):61-64. 2011 Nov.

Arbit HM. Regulatory support in an academic health center. SoCRA Source. 69(3):28-33. 2011 Aug.

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.

Van Buskirk GA, Arbit HM, et al.  Scale-up of liquid and semisolid disperse systems. Pharm Res. 11:1216-1220, 1994.

Cloyd J, Arbit H, Beniak T, Freeman R, Jones-Saete C, Lalonde R. Rectal diazepam: absolute bioavailability and cognitive effects in healthy volunteers. Epilepsia. 34(Suppl 2):123, 1993.

Skelly JP, Arbit HM, et al.  Scale-up of immediate - release oral solid dosage forms. Pharm Res. 10:313-316, 1993.

Skelly JP, Arbit HM, et al.  Scale-up of oral extended - release dosage forms. Pharm Res. 10:800-1805, 1993.

Arbit HM. Regulatory aspects of investigational new drugs. Amer J Hosp Pharm. 35:81-85, 1978.


Teaching - Online Lectures


Arbit HM. Supporting Investigator-Initiated Clinical Trials. Audio conference. Fx Conferences. November 27, December 10, and December 12, 2012.

Arbit HM. Preparing for FDA visits. SoCRA On-demand webinar. Continuing education credits for SoCRA CE, Nurse CNE, and AMA PRA Category 1 Credits. March 2011.
    
Arbit HM. Assistance in an Academic Health Center. SoCRA On-demand webinar. Continuing education credits for SoCRA CE, Nurse CNE, and AMA PRA Category 1 Credits. March 2011.

Arbit HM. CGMP for Investigational New Drugs (IND) in Phase 1 Clinical Trials. SoCRA On-demand webinar. Continuing education credits for SoCRA CE, Nurse CNE, and AMA PRA Category 1 Credits. March 2011.

Teaching - In Person Lectures

Society of Clinical Research Associates – Pre-conference seminars. “Investigator-initiated sponsored research"

University of Minnesota College of Pharmacy – Lecturer on regulatory affairs and drug development

University of Minnesota School of Public Health – Lecturer on regulatory affairs, FDA inspection process, and clinical research

University of Minnesota Carlson School of Management – Lecturer on pharmaceutical business and drug development

North Hennepin Community College. Regulatory Affairs Certificate Program – program coordinator, advisory committee member, and lecturer


Presentations

Invited speaker – “Health Canada and FDA perspectives on homeopathic products.” Society of Clinical Research Associates. 2016 Annual Conference. September, 2016. Montreal, Canada.

Invited speaker – “Investigator-initiated trials: Do you have what it takes?” Medical College of Wisconsin. Second Annual Clinical Research Symposium. October 3, 2015. Milwaukee, WI.

Invited speaker – “FDA inspections: Be prepared.” Medical College of Wisconsin. Second Annual Clinical Research Symposium. October 3, 2015. Milwaukee, WI.

Invited speaker – “IND expanded access programs.” Society of Clinical Research Associates. 2015 Annual Conference. September 18, 2015. Denver, CO.

Invited speaker - Pre-conference workshop. – “Investigator-initiated sponsored research.” Society of Clinical Research Associates. 2015 Annual Conference. September 17, 2015. Denver, CO.

Invited speaker – “When alternative medicine may be a drug.” Society of Clinical Research Associates. 2014 Annual Conference. September 20, 2014. Orlando, FL.

Invited speaker. Full-day workshop. – “Investigator-initiated research. The IND application, process, and responsibilities.” Universidad Central del Caribe School of Medicine. May 23, 2014. Bayamόn, PR.

Invited moderator – “Key initiatives for industry partners to overcome investigator challenges that are regulatory and beyond in scope.” CBI. IISR 2014: Investigator-Initiated & Sponsored Research. March 19, 2014. Philadelphia, PA.

Invited speaker – “Sponsor-Investigator: Obligations and compliance.” CBI. IISR 2014: Investigator-Initiated & Sponsored Research. March 19, 2014. Philadelphia, PA.

Invited panelist – “Models of shared responsibility between investigators and manufacturers.” Q1 Productions. Third Annual Medical Device Investigator Initiated Studies. February 10, 2014. Raleigh-Durham, NC.

Invited opening plenary speaker – “Blurred lines: The role of ‘sponsorship’ defined.” Q1 Productions. Third Annual Medical Device Investigator Initiated Studies. February 10, 2014. Raleigh-Durham, NC.

Invited speaker - "FDA inspections: Preparation-Expectation-Follow up." Society of Clinical Research Associates. 2013 Fall Educational Conference. October 26, 2013. Rochester, MN.

Invited speaker – “What every IRB member needs to know about device review.” Society of Clinical Research Associates. 2013 Annual Conference. September 28, 2013. New Orleans, LA.

Invited speaker – “IDE assessment: A walk through the decision process.” Society of Clinical Research Associates. 2013 Medical Device Conference. May 9, 2013. Scottsdale, AZ.

Invited workshop presenter – “Investigator-initiated trials: Who-What-Why.” ExL Pharma. Medical Affairs Strategic Summit. April 16, 2013. Philadelphia, PA.

Invited speaker – “Pharmacists in research: Interactions with clinical staff.” Society of Clinical Research Associates. 2012 Annual Conference. September 22, 2012. Las Vegas, NV.

Invited speaker – “Determining whether human research can be conducted without an IND.” Society of Clinical Research Associates. 2012 Annual Conference. September 21, 2012. Las Vegas, NV.

Invited speaker – “Investigator-initiated trials: Preparing not to fail – Do you have what it takes?” MAGI’s Clinical Research Conference 2011 West. October 24, 2011. Las Vegas, NV.

Invited speaker – “What every IRB member needs to know about device review.” Northwestern University Office of Research. 2011 IRB Member Retreat. October 14, 2011. Chicago, IL.

Invited speaker – “Understanding the value an investigator gains from working on IITs and meeting their expectations.” ExL Pharma. 14th Investigator Initiated Trials. September 27, 2011. San Diego, CA.

Invited speaker – “Translational research-What is being translated?” Society of Clinical Research Associates. 2011 Annual Conference. September 24, 2011. San Diego, CA.

Invited speaker and session chair – “Understanding regulatory challenges involved in device company / investigator relationships.” Q1Productions. Medical device investigator initiated studies. September 19, 2011. Chicago, IL.

Invited speaker - "IDE assessment: A walk through the decision process." Air Force Research Laboratory. IRB Town Hall Meeting. September 9, 2011. Wright-Patterson Air Force Base, OH.

Invited speaker – “Selection of investigational sites.” Society of Clinical Research Associates. Device Research Conference. FDA IDE Interactive Case. May 20, 2011. Las Vegas, NV.

Invited speaker – “Basic physiological research – 21CFR812 does not apply.” Society of Clinical Research Associates. Device Research Conference. Regulations and Guidance for Device Clinical Research. May 19, 2011. Las Vegas, NV.

Invited speaker. Webinar – “When IND/IDE research and FDA inspections intersect: How to prepare. What to expect.” Principal Investigators Association. November 11, 2010. Naples, FL. (Cancelled due to technical difficulties)

Invited speaker – “Industry-supported, investigator-sponsored clinical trials.” MAGI’s Clinical Research Conference. October 25, 2010. San Francisco, CA.

Invited plenary speaker – “Investigator-initiated clinical trials: Where do I start?” SUNY-Stony Brook. 4th ICB&DD Annual Symposium. October 14, 2010. Stony Brook, NY.

Invited speaker – “Basic physiological research – 21CFR812 does not apply.” Society of Clinical Research Associates. 2010 Annual Conference. September 25, 2010. Dallas, TX.

Invited speaker. 3 hour workshop. – “Investigator-initiated research – Oversight and responsibilities at an academic institution.” Investigator Initiated and Sponsored Research Association. 2010 Conference. April 29, 2010. Arlington, VA.

Invited speaker – “Investigator-initiated research at an academic institution – oversight and responsibilities.” Medtronic, Inc. Medtronic Neuro Forum Chapter. January 29, 2010. Minneapolis, MN.

Invited speaker – “Current good manufacturing practices for phase 1 clinical trials.” Society of Clinical Research Associates. 2009 Annual Conference. September 26, 2009. Nashville, TN.

Invited speaker – “Regulatory support in an academic health center.” Society of Clinical Research Associates. 2009 Annual Conference. September 26, 2009. Nashville, TN.

Invited speaker – “What you should know before the FDA arrives.” Society of Clinical Research Associates. 2009 Annual Conference. September 25, 2009. Nashville, TN.

Invited speaker – “Investigator-initiated research at an academic institution.” Investigator Initiated and Sponsored Research Association. 2009 Conference. September 16, 2009. San Diego, CA.

Invited speaker – “How to prepare an IDE as a sponsor-investigator.” Society of Clinical Research Associates. 2009 Medical Device Conference. May 21, 2009. Chicago, IL.

Invited speaker – “How to prepare for an FDA inspection.” Society of Clinical Research Associates. Southeast Minnesota Chapter Meeting. May 18, 2009. Rochester, MN.

Invited speaker. 4 hour workshop. – “Investigator-initiated research and the IND application process.” Universidad Central del Caribe School of Medicine. October 17, 2008. Bayam?n, PR. (Cancelled due to hurricane) 

Invited speaker – “Investigator-initiated drug trials – When investigators become sponsors they accept additional responsibilities.” MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference - West. October 14, 2008. Las Vegas, NV.

Invited speaker. 4 hour workshop. – “Investigator-initiated research: The INDependent world of sponsor-investigators.” MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference - West. October 12, 2008. Las Vegas, NV.

Invited speaker – “Step-by-step process on how to prepare an IDE as a sponsor-investigator.” Society of Clinical Research Associates. 2008 Annual Conference. September 27, 2008. Vancouver, BC, Canada.

Invited speaker – “Investigator-initiated drug trials – Obligations of an IND sponsor-investigator.” MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference - East. May 20, 2008. Arlington, VA.

Invited speaker – “Filing an investigator-initiated IND.” Association of Clinical Research Professionals. Global Conference. April 27, 2008. Boston, MA.

Invited speaker – “The difference between practice and research – What the FDA expects you to understand.” University of Cincinnati. Research, etc Symposium. November 16, 2007. Cincinnati, OH.

Invited speaker – “IND/IDE overview.” Society of Clinical Research Associates. 2007 Annual Conference. September 27, 2007. Denver, CO.

Invited speaker – “Investigator-initiated IND and IDE: Assessment and responsibility.” Mayo Clinic. Clinical Research Workshop. July 11, 2007. Rochester, MN.

Invited speaker – “Investigator-initiated IDE at University of Minnesota.” Society of Clinical Research Associates. Device Workshop: Clinical Research Guidance for Research Professionals. June 22, 2007. Baltimore, MD.

Session chair and speaker – “Establishing a clinical trial monitoring service at an academic health center.” Association of Clinical Research Professionals. Global Conference. April, 2007. Seattle, WA.

Invited speaker – “IND applicability.” University of Arkansas for Medical Sciences. Navigating the Sponsor-Investigator IND Minefield. April 16, 2007. Little Rock, AR.

Invited speaker – “Academic research and an industry partner.” Cincinnati Children’s Hospital Medical Center. The Future of Research in Academic Settings. March 26, 2007. Cincinnati, OH.

Invited speaker – “Investigational new drug applications: What, why, and how?” Mayo Clinic and University of Minnesota. Current Issues in Clinical Research. October 5, 2006. Minneapolis, MN.

Invited speaker – “IND/IDE regulations and investigator initiated research.” Society of Clinical Research Associates. 2006 Annual Conference. September 22, 2006. Chicago, IL.

Invited speaker – “IND applicability: A University of Minnesota perspective.” University of Florida. IRB Retreat 2006. August 30, 2006. Gainesville, FL.

Session chair and speaker – “How to prepare for and conduct investigator-initiated research.” Drug Information Association. 42nd Annual Meeting. June 21, 2006. Philadelphia, PA.

Session chair and speaker – “IND exemptions – The determination process.” Drug Information Association. 42nd Annual Meeting. June 21, 2006. Philadelphia, PA.

Invited speaker – “Common issues and concerns in academic research.” Association of Clinical Research Professionals Global Conference. May 1, 2006. Phoenix, AZ.

Invited speaker – “How to determine if your protocol needs an IND/IDE.” Washington Information Source Expert Briefing. Audio conference. November 22, 2005.

Invited moderator and speaker – “Regulatory Obligations of an IND Sponsor-Investigator.” Drug Information Association. Webinar. October 7, 2005.

Invited speaker – “Investigator INDs – Overview and Application.” Advocate Center for Pediatric Research. 2nd Annual Conference. Advancing Excellence in Clinical Research – Scientific, Ethical and Operational Considerations. September 30, 2005. Chicago, IL.

Invited speaker – “The ABC’s of Regulatory Issues.” Association of University Technology Managers. Central Division Conference. July 19, 2005. Detroit, MI.

Session chair and speaker – “Regulatory Obligations of an IND Sponsor-Investigator.” Drug Information Association. 41st Annual Meeting. June 30, 2005. Washington, DC.

Session chair and speaker – “Regulatory Obligations of Investigator Sponsored IND Research.” Association of Clinical Research Professionals. 29th Annual Conference. April 3, 2005. Orlando, FL.

Invited speaker – “Understanding the IND and IDE Processes.” Hot Topics in Research. SUNY-Upstate Medical University. March 24, 2005. Syracuse, NY.

Invited keynote speaker – “Managing the Rapids of Change.” Destination Discovery ’05. SUNY-Binghamton. March 24, 2005. Binghamton, NY.

Invited speaker – “The Investigator as IND Sponsor.” Association of Clinical Research Professionals. 2nd Annual Smooth Sailing in Clinical Research Trials. February 20, 2005. Tampa, FL.

Invited speaker – “Investigator Sponsored Research.” Society of Research Administrators. 2004 Annual Meeting. October 27, 2004. Salt Lake City, UT.

Invited speaker – “What do I need to do to get this orphan drug on the market?” National Organization of Rare Diseases. 2004 Family Conference. October 15, 2004. Minneapolis, MN.

Session chair and speaker – “Investigator Sponsored IND Research.” Drug Information Association. 40th Annual Meeting. June 16, 2004. Washington, DC.

Invited speaker – “Drug/Botanical Drug Development Process: The IND Application.” Minnesota Consortium for CAM Clinical Research. November 4, 2003. Minneapolis, MN.

Invited speaker – “Academia & Industry: Together is Better.” Medical Alley. July 9, 2003. Minneapolis, MN.

Invited speaker – “IND/IDE – What, Why, When, How.” Association of Clinical Research Professionals. February 20, 2003. Minneapolis, MN.

Invited speaker – “Investigator Initiated Clinical Trials.” MedicalSuds. January 30, 2003. Minneapolis, MN.
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