When private equity firms pursue life sciences industry targets, attorney Amy Dow provides a clear picture of the potential regulatory and compliance impacts of their investments. Investors appreciate Amy’s measured approach to addressing risk and her ability to explain challenges in a commercial context.
She quickly assembles multidisciplinary teams of lawyers and technical advisors to provide a complete view of a target company’s regulatory risk profile, including existing investigations and enforcement, FDA inspection history, quality and compliance obligations, data privacy and security practices, and litigation risk. Whether she’s advising on a current regulatory enforcement action or recommending post-acquisition compliance program enhancements, Amy tailors solutions to her clients' risk tolerance and investment objectives.
Pharmaceutical, biotechnology, and medical device companies regularly call on Amy’s counsel to support development and commercialization of their products. Her practical advice helps development-stage companies intensify their compliance efforts as they expand their operations, develop promotional strategies, and launch sales teams. Amy frequently helps non-U.S. companies entering the U.S. market to prepare for heightened compliance expectations, tough regulatory scrutiny of their drug and medical device products and the U.S. reimbursement environment. For established companies, she leads teams of lawyers and former in-house compliance officers who assess their existing compliance programs, spot weaknesses, and implement strategies to mitigate future risks. Sponsors, contract research organizations, and clinical research services providers also rely on her advice when structuring relationships for product development and clinical research services.
Amy serves as a member of the firm’s Board of Directors and as a Chair of Epstein Becker Green’s National Health Care & Life Sciences Steering Committee. Before she became a lawyer, Amy worked for five years as a senior clinical research associate at a large contract research organization, where she monitored pharmaceutical clinical trials and led regulatory compliance training programs. A graduate of the University of Arizona, Amy received a Bachelor of Science, magna cum laude, in microbiology.
- Academic and Clinical Research
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Digital Health
- Drug and Medical Device Coding, Coverage, and Payment
- Drug and Medical Device Distribution
- FDA Inspections and Enforcement
- Health Care and Life Sciences Investor Services
- Health Care Mergers and Acquisitions
- Industry Research and Clinical Trials
- Internet of Things (IoT)
- Life Sciences
- Life Sciences Due Diligence
- Mergers, Acquisitions & Divestitures
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
- Advised a development-stage pharmaceutical manufacturer launching its first offering—a novel cellular therapy designated as a “Breakthrough Therapy” by the U.S. Food and Drug Administration (“FDA”)—in coordination with its global pharmaceutical manufacturer commercialization partner. Amy provided health regulatory counsel for negotiations with U.S. and global research providers and guided the expansion of the company’s corporate compliance, medical affairs and commercial operations, and scientific and commercial communications programs.
- Provided health regulatory counsel to a molecular diagnostic laboratory with a proprietary next-generation sequencing platform enabling molecular profiling of cancer patients’ tumor tissue. Having represented the client since its inception, Amy leads a team that provides health care regulatory and compliance support, privacy advice and negotiation of research collaboration partnerships.
- Supported a contract research organization’s post-transaction integration efforts, including developing enhancements to its customer and vendor contracting practices and templates for use by its U.S. and global affiliates.
- Served as U.S. regulatory counsel to a private equity firm in the proposed acquisition of a global radiopharmaceutical manufacturer and distributor. Amy led a cross-functional team of regulatory counsel and consulting resources to assess the target’s product development pipeline and the current FDA regulatory landscape for biopharmaceuticals. The team also analyzed the U.S. reimbursement landscape for certain target products and advised on remediation of recent regulatory authority actions.
- Chambers USA: America’s Leading Lawyers for Business, Illinois—Healthcare (2020); Illinois—Healthcare: Pharmaceutical/Medical Products Regulatory (2021 to 2023)
- The Legal 500 United States, M&A: Middle Market (Sub-$500 Million) (2014 to 2019, 2021 to 2023)
- Crain's Chicago Business, Notable Women in Law (2022)
- Northwestern Pritzker School of Law (J.D., cum laude, 2004)
- University of Arizona (B.S., magna cum laude, 1996)
- U.S. District Court, Northern District of Illinois
Professional & Community Involvement
- American Health Lawyers Association
- Life Sciences Law 360 Editorial Board (2015 to 2017)
- September 30, 2021