When private equity firms pursue life sciences industry targets, 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 and biotechnology companies regularly call on Amy’s compliance 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 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. Clinical research providers also rely on her advice when structuring relationships with pharmaceutical and medical device companies.
Amy received an undergraduate degree in microbiology. Before she became a lawyer, she 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.
- 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.
- Provides 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 regulatory and health care compliance support, privacy advice and negotiation of research collaboration partnerships.
- 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.
- Served as regulatory counsel to a large private equity firm in its $3 billion bid to acquire a leading provider of institutional review board, institutional biosafety committee, and compliance and regulatory consulting services in the United States and Canada. Amy and her team provided regulatory due diligence of the target’s operations to assess federal and state compliance risks associated with human research subject protections, conflicts of interest, and health information privacy.
- Provided regulatory counsel to a private equity firm investing in a multinational provider of pre-clinical and clinical research, laboratory testing, and consulting services to the medical device industry. Amy led a cross-functional team to perform a regulatory due diligence review of the target’s compliance with requirements of the FDA, U.S. Department of Agriculture, and other regulatory authorities that involved visits by regulatory, quality, and animal welfare consultants.
- Performed regulatory due diligence for a private equity firm and its portfolio company in the acquisition of a large contract non-prescription drug and personal care manufacturer with operations in the United States and Canada. Amy and her team assessed the target company’s compliance with FDA and other international consumer and health care product regulations and supplied strategies to mitigate future regulatory enforcement risk.
- Northwestern Pritzker School of Law (J.D., 2004)
- cum laude
- University of Arizona (B.S., 1996)
- magna cum laude, Microbiology
- U.S. District Court, Northern District of Illinois
- American Health Lawyers Association
- Life Sciences Law 360 Editorial Board
- Chambers USA: America’s Leading Lawyers for Business, Leader in Illinois Healthcare (2020)
- The Legal 500 United States, M&A: Middle Market (Sub-$500 Million) (2014 to 2019)