Tim Franson

1st Term: 1/1/2014 – 12/31/2016
Chief Medical Officer
YourEncore
Indianapolis, IN

Degree(s):
B.S. Pharmacy, 1974, Drake University
M.D., 1978, University of Illinois

Education:

• Medical College of Wisconsin-Fellowship in Infectious Diseases and Epidemiology (1983)
• University of Iowa-Internal Medicine Training (1981)
• University of Illinois College of Medicine-M.D., with honors (1978)
• Drake University-B.S. in Pharmacy, with honors (1974)

Background:
Dr. Timothy Franson is a Principal in FaegreBD Consulting's health and biosciences sector and leads the firm's regulatory affairs practice. This group provides traditional comprehensive regulatory pre-approval and postmarketing regulatory advice as well as bundled strategic consulting with regulatory reimbursement and media training components. He has extensive clinical and regulatory experience in all pre- and post-approval phases of pharmaceutical development (small and large molecule) relating to interactions with FDA for policy and product issues, as well as interactions with global regulators.

Dr. Franson was the founder and president of Franson PharmAdvisors LLC, a clinical and regulatory pharmaceutical development consulting firm. The company merged with FaegreBD Consulting when Dr. Franson moved from Senior Advisor to Senior Vice President at FaegreBD Consulting. His consulting practice provides clinical and regulatory professional services for drug and biologics development (strategy, planning, training, and issues management) post-approval advise (REM's, labeling, compliance) and due diligence for venture capital firms.

Before joining FaegreBD Consulting, Dr. Franson was Vice President of Global Regulatory Affairs at Lilly Research Laboratories (Eli Lilly and Company), responsible for all regulatory and patient safety activities from 2003 until his retirement from Lilly in June 2008. He joined Eli Lilly and Company in 1986. From 1997 to 2003, Dr. Franson was Vice President of Clinical Research and Regulatory Affairs-U.S. for Lilly. In regulatory affairs from 1995 to 2008, Dr. Franson was directly responsible for Lilly's FDA submissions (NDAs, supplements), which involved more than 20 major submission reviews and approvals, as well as regulatory compliance and policy matters.

Dr. Franson has been a leader in many industry initiatives. He was co-chair of the joint FDA-industry working group addressing clinical aspects of the FDA Modernization Act of 1997, including the Prescription Drug User Fee Act (PDUFA) renewal. From 2000 to 2003, he co-chaired industry-FDA committees for PDUFA-3 renewal and has testified, on behalf of the industry, at several congressional hearings. Dr. Franson also co-chaired an FDA-industry safety interventions working group, was a member of the AAMC-PhRMA Clinical Trials Forum and was a member of the Regulatory Advisory Board for the Centre for Medicines Research International from 2003 to 2008. Franson recently served on the NIH-NCATS Treatment of Rare Diseases (TRND) review panel.

Dr. Franson has authored more than 50 articles in the fields of infectious disease, epidemiology, pharmacoeconomics, and antibiotic utilization.

Certifications

• Internal Medicine and Infectious Diseases — Board Certified

Honors

• Ovation Award (Presented by Eli Lilly and Company Chairman), 2002
• James Scholar (University of Illinois College of Medicine), 1977-78
• Sagamore of the Wabash (Presented by Indiana Governor Mitch Daniels), 2008
• Weaver Medal of Honor (Drake University College of Pharmacy and Health Sciences), 2013

Professional Associations

• U.S. Pharmacopeia Convention — President, 2010-15 (Board of Directors; Executive Committee; and Council of Convention, Chair)
• NIH NCATS Treatment of Rare Diseases (TRND) — Review Panel, 2012
• Pharmaceutical Research and Manufacturers' Association (PhRMA) — FDA Committee Staff Work Group (Chair, 1997-2008); Clinical Steering Committee (Past Chair); GMP Steering Committee (Past Chair); Regulatory Affairs Coordinating Committee (Member)
• National Patient Safety Foundation (NPSF) — Board of Directors, 2001-06
• Editorial Advisory Board for FDA Advertising & Promotional Manual, 1997-2005
• American Association of Colleges of Pharmacy — Professional Education Advisory Council, 2005-08
• Infectious Diseases Society of America (IDSA) — Fellow
• American College of Physicians — Fellow
• FDA/IDSA Antimicrobial Guidelines Working Group, 1990-93

Civic Activities

• Villages of Indiana (child welfare services) — Board of Directors
• Little Red Door Cancer Agency — Board of Directors (Executive Committee)
• Indiana State Museum Foundation — Board of Directors
• Xavier University (Louisiana) — Board of Trustees, 2002-08
• Auburn University — College of Pharmacy, Dean's Advisory Board, 2004-08
• State of Wisconsin — Governors Task Force on AIDS, 1984-86

Faculty Positions

• Indiana University School of Medicine — Volunteer Assistant Professor of Medicine, 1987-2008
• Medical College of Wisconsin — Assistant Professor of Medicine and Hospital Epidemiologist, 1983-86 (National Institutes of Health funded investigator, 1984-86)

Recent Publications

• Presenting the Blueprint: Synthesizing Lessons Learned for Mutually Advantageous Negotiations
Chapter co-author with Nancy Bradish Myers, PDUFA & the Expansion of FDA User Fees: Lessons from Negotiators, published by Food and Drug Law Institute, April 2011
• Has the FDA Amendments Act of 2007 Impaired Drug Development?

  Clinical Pharmacology & Therapeutics, Vol. 89, No. 2, February 2011

Click here to return to National Advisory Council