Timothy R. Franson M.D.

Principal - Faegre Baker Daniels Consulting

Overview

Dr. Tim Franson helps pharmaceutical and health and biosciences companies navigate regulatory interactions, challenges and developments. Drawing from extensive clinical and regulatory experience — including five years as VP of global regulatory affairs at Eli Lilly and Company —  Tim guides clients through all pre- and post-approval phases of pharmaceutical development, particularly related to interactions with the Food & Drug Administration (FDA) and global regulators. 

Drug & Biologics Development

Tim provides clinical and regulatory guidance for drug and biologics development (including strategy, planning, training and issues management), post-approval advice (REM's, labeling and compliance) and due diligence. During his time at Lilly, Tim was directly responsible for the company’s FDA submissions (NDAs and supplements), which involved more than 20 major submission reviews and approvals. He also played a leadership role in regulatory compliance and policy matters.

Rare Disease Work

Tim has worked to advance the objectives of various rare disease communities. He sat on the steering committee for the Duchenne Patient Community Draft Guidance submitted to the FDA, served as an advisor to the ALS Community Draft Guidance to the FDA, and advised the Lupus community in the externally led FDA patient-focused drug development (PFDD) workshop, as well as serving as moderator for the 2019 FDA externally facilitated PFDD public meeting for the Niemann Pick Type C disease community.

Industry Advisor to Congress and Federal Agencies

Tim has been a leader in many legislative and regulatory initiatives impacting the pharmaceutical and health and biosciences industries. 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 industry stakeholders, at several congressional hearings.

Tim also co-chaired an FDA industry safety interventions working group, was a member of the AAMC-PhRMA Clinical Trials Forum and of the Regulatory Advisory Board for the Centre for Medicines Research International from 2003 to 2008. He also served on the NIH-NCATS Treatment of Rare Diseases (TRND) review panel.

Prior Experience

Tim served as chief medical officer at YourEncore from 2014 to 2019. He also served as VP of global regulatory affairs at Lilly from 2003 to 2008. From 1997 to 2003, he served as Lilly’s VP of clinical research and regulatory affairs.

Tim has authored more than 50 articles in the fields of regulatory affairs, infectious disease, epidemiology, pharmacoeconomics and antibiotic utilization.

Faculty Positions

  • Indiana University School of Medicine — Volunteer Assistant Professor of Medicine, 1987-2008; Adjunct Professor of Medicine (Clinical Pharmacology) 2014-present
  • Medical College of Wisconsin — Assistant Professor of Medicine and Hospital Epidemiologist, 1983-86 (National Institutes of Health Funded Investigator, 1984-86)

Personal Interests

Tim enjoys golf, jet skiing and spending time with his five grandchildren.

Tim is a consulting professional within Faegre Baker Daniels Consulting, and does not act as a lawyer for clients. Learn more about the Faegre Baker Daniels Consulting practice.

Credentials

Certifications
  • Internal Medicine and Infectious Diseases — Board Certified
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)

Insights & Events

Other Perspectives
  • The Practicing Clinician and Regulatory Safety Concerns
    Co-author with R.G. McAllister and Carl N. Kraus, Current Drug Safety, Vol. 8, No. 1, 2013
  • Leadership Opportunities in Pharmacy — USP, Drug Development and Advocacy
    Weaver Medal of Honor Lecture, Drake University, April 24, 2013, and Drake College of Pharmacy & Health Sciences Student Forum, April 25, 2013
  • Drug Development, USP Standard Setting and Leadership Opportunities
    University of Iowa College of Pharmacy Advocacy and Leadership Class, April 23, 2013
  • USP's Role in Standards, Shortages and Professional Collaborations
    Butler College of Pharmacy and Health Sciences Dean's Forum, March 28, 2013
  • The Evolving Lessons Learned From Negotiating User Fees
    Panelist, Food and Drug Law Institute (FDLI) Annual Conference, Washington, D.C., April 5, 2011
  • 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

Leadership & Community

Professional Associations

  • Critical Path Institute — Chair, Board of Directors (Tucson, AZ), 2016-present
  • U.S. Pharmacopeia Convention — President, 2010-15 (Board of Directors; Executive Committee; and Council of Convention, Chair); Immediate Past President and Board of Directors, 2015-present
  • NIH NCATS Treatment of Rare Diseases (TRND) — Review Panel,2010-12
  • 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

  • Board of Trustees, Christian Theological Seminary, Indianapolis, 2019-present
  • University of Iowa College of Pharmacy — Executive Leadership Board, 2018-present
  • Villages of Indiana (Child Welfare Services) — Board of Directors 2001-2018 (Chair, 2005-06)
  • 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

Honors

  • University of Iowa College of Pharmacy — Commencement speaker, 2017
  • National Alumni Achievement Award, Drake University, 2016
  • Weaver Medal of Honor (Drake University College of Pharmacy and Health Sciences), 2013
  • Sagamore of the Wabash (Presented by Indiana Governor Mitch Daniels), 2008
  • Ovation Award (Presented by Eli Lilly and Company Chairman), 2002
  • James Scholar (University of Illinois College of Medicine), 1977-78
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