Overview
Amy has been representing FDA-regulated clients for more than 22 years. She works with a range of clients, including large and small companies, pharmaceuticals, devices, biotech, diagnostics, and research institutions, providing advice on clinical research, FDA interactions, and FDA-regulated products. She also helps clients navigate related CMS issues, including CMS reimbursement of clinical research and compliance with CMS requirements, such as Section 111 obligations for clinical trial sponsors and Open Payments (Sunshine) reporting.
In-House Counsel Experience
Before joining Faegre Drinker, Amy practiced in house for 11 years, where she served as lead legal counsel for the development and marketing of portfolios of products, including negotiating label and advertising issues with global regulators and competitors. Amy’s in house responsibilities also included serving as lead legal counsel for many types of clinical trials, spanning thousands of patients, dozens of countries, and partnerships with government and academic institutions.
Faculty Positions
- Indiana University Robert H. McKinney School of Law — Adjunct Faculty
Services & Industries
Credentials
Bar Admissions
Indiana
Court Admissions
U.S. District Court for the Southern District of Indiana
Clerkships
U.S. District Court for the Southern District of Indiana, Hon. Sarah Evans Barker, 1994-1995
Education
University of Michigan Law School
J.D. cum laude (1992)
Denison University
B.A. magna cum laude (1989)
Experience
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2019 1 min readHealth System Navigates Human Research WorkHealth and Life Sciences Clinical Research Hospitals and Health Systems Government and Regulatory Affairs FDA-Regulated Products
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2019 1 min readMedical Device Manufacturer Performs Global Clinical TrialsMedical Devices and Products Health and Life Sciences Government and Regulatory Affairs FDA-Regulated Products Public Companies and Governance
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2019 1 min readPharmaceutical Company Updates Global Website and Clinical Pipeline PagePharmaceuticals and Biologics Health and Life Sciences Government and Regulatory Affairs
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2019 1 min readVenture Capital Investment Team Completes Regulatory Due Diligence for Investment in Company with FDA-Regulated ProductsHealth and Life Sciences Government and Regulatory Affairs FDA-Regulated Products Corporate Group Venture Capital
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2019 1 min readMedical Diagnostic Company Navigates Promotional Issues with Product MarketingMedical Devices and Products Health and Life Sciences Corporate Group
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December 2018 1 min readEndocyte Enters Into $2.1B Agreement to Be Acquired by NovartisPharmaceuticals and Biologics Health and Life Sciences Corporate Group Antitrust Mergers and Acquisitions
Insights & Events
Latest
Other Perspectives
- Clarifying the Clinical Trial Process for Drugs and Biologics
FDA Boot Camp, New York City, March 8, 2018 - Clinical Research and IDEs
Indiana Medical Device Manufacturers Council Regulatory Workshop, Indianapolis, May 17, 2017 - Coming Soon to Research Near You! Major Changes in Human Research Rules!
Co-presenter, Indianapolis, December 8, 2016 - Introduction to FDA-Regulated Clinical Research
Indianapolis Bar Association CLE, May 11, 2016 - Clinical Trials/IDEs
Indiana Medical Device Manufacturers Council, April 21, 2016 - Drug Development
ALS Association Educational and Scientific Symposium, Chicago, October 21, 2015 - Clinical Trials and IDEs
Indiana Medical Device Manufacturers Council Conference, Indianapolis, June 25, 2015 - Biologics, Biosimilars and Beyond: Key Concepts, Regulatory Issues and Litigation Risks
Moderator, ABA Biotech Regional Workshop, Cambridge, Massachusetts, June 12, 2014 - Overview of Laws and Regulations Related to Billing/Reimbursement for Clinical Studies
IMDMC Regulatory 101: Overview of Laws and Regulations Relating to Billing/Reimbursement for Clinical Studies Conference, Indianapolis, May 15, 2014 - Could You Be Dealing With Regulated Research and Not Know It? Regulated Research, Ethics and FDA Basics: A Primer
- Co-presenter with Jody DeFord of Eli Lilly and Company, Expert Insights on Fraud & Abuse, Government Investigations & Regulated Research in Health Care & Life Sciences, Indianapolis Bar Association CLE Update, February 20, 2014
- Clinical Research Billing Compliance
MAGI Clinical Research Conference — 2013 West, Las Vegas, October 27, 2013
Leadership & Community
Professional Associations
- Indiana Health Industry Forum — Clinical Trials Policy Task Force, Past Member (Past Chair)
- Faegre Baker Daniels Women's Forum for Achievement — Leadership Council, 2012-present
- Indianapolis Bar Foundation — Fellow, 2018
Civic Activities
- Street Law Program — Working to educate local high school students with potential interest in a legal career about civil law topics
- Denison University — Board of Trustees, 2013-present
- Indiana University Robert H. McKinney School of Law, Hall Center for Law & Health — Health Law Advisory Board, Board Member (Past Co-Chair)
- Summer Stock Stage — Past Board Member (Past Board President)
- CICOA Foundation — Past Board Member
- JDRF, Indiana Chapter Board of Directors, 2016-present
- Julian Center — Past Board Member (Past Board Secretary)
- Women's Fund of Central Indiana OPTIONS Class of 2002
Honors
- Indianapolis Business Journal — Women of Influence
- Faegre Baker Daniels — Pro Bono Honor Roll, 2018
- Martindale-Hubbell — Peer Review Rating: AV® Preeminent™
- Phi Beta Kappa
- Mortar Board
- Denison University — President's Medal