Overview

Lee Tumminello advises life sciences stakeholders on a variety of regulatory and compliance matters related to the clinical development and marketing of pharmaceuticals, biologics and medical devices, as well as general corporate and commercial matters.

Product Development and Marketing

Lee has nearly 30 years of legal experience counseling life sciences companies both in private practice and as corporate counsel. Before her association with Faegre Baker Daniels, she was Associate General Counsel for Eli Lilly and Company, working with laws and regulations related to development and marketing of pharmaceuticals in a variety of disease state areas. Lee advises companies in developing, researching and obtaining necessary regulatory clearances and approvals for their medical devices, drugs (including OTC), biologics, tissue (HCT/Ps) and combination products (drug/device). Lee works with major pharmaceutical, biotech and medical device manufacturers, as well as startup ventures, providing advice on product labeling and advertising matters, including social media tactics and use of endorsements/testimonials.

Regulatory Compliance

Compliance is another area of focus in Lee's practice. She conducts training and advises on compliance issues, including development of internal compliance plans, as well as FDA and fraud and abuse issues associated with use of advisors/consultants, discount/rebate/coupon practices, grants and support of CME, and medical affairs and medical information functions. Lee assists clients with federal and state reporting and transparency laws such as the Physician Payments Sunshine Act (U.S. Open Payments). Lee also works on a variety of commercial agreements for life sciences clients, including clinical research, product and services supply agreements, as well as agreements and regulatory due diligence associated with mergers, acquisitions and strategic alliances.

Personal Interests

Lee and her husband recently returned from living in Basel, Switzerland. Lee loves to travel and enjoy new foods and cultures. She is an avid fan of podcasts and is always looking for a new one to follow!

Credentials

Bar Admissions

Indiana

Education

University of Michigan Law School
J.D. (1987)

Indiana University, Bloomington
B.S. in Accounting, with highest distinction (1984)

Insights & Events

Other Perspectives
  • Intellectual Property and FDA Considerations for Biotechnology and Medical Device Projects
    Co-presenter with Brian Lefort, Medical Alley Association, Golden Valley, Minnesota, February 2016
  • Sales & Marketing of Medical Devices
    Presenter, Indiana Medical Device Manufacturers Council, Regulatory 102, September 2015
  • Patient Focused Development: New Approaches at the FDA
    Co-Presenter, Colorado Bioscience Association Spring Symposium, May 2015
  • Working With Advocacy Groups & Advisory Boards: Top 5 Compliance & Operational Best Practices
    Co-presenter, MichBioU Webinar, April 2015
  • Evolving FDA Regulations: Apps, Device and Data
    Co-presenter, Women in Bio (WIB), Chicago, March 2015
  • Marketing FDA Regulated Products Through Social Media
    Panelist, Colorado BioScience Association (CBSA) Regulatory Symposium, Westminster, Colorado, October 2014
  • Understanding Your Product's Regulatory Pathway
    Panelist, Colorado BioScience Association (CBSA) Regulatory Symposium, Westminster, Colorado, October 2014
  • FDA Post-Marketing Enforcement
    Presenter, Indiana Medical Device Manufacturers Council, Regulatory 101 Course, August 2014

Leadership & Community

Pro Bono

 

Civic Activities

  • Outrun the Sun, Inc. — Past National Board of Directors
  • Leadership Council on Legal Diversity — Law School Mentoring Program
  • Appalachia Service Project, Inc. — Past National Board of Trustees 
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