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 He sat on the steering committee for the Duchenne Patient Community Draft Guidance submitted to the FDA, served as an advisor to the ALS Community Draft Guidance to the FDA, and advised the Lupus community in the externally led FDA patient-focused drug development (PFDD) workshop, as well as serving as moderator for the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.
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.
- 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)
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.