Jake Leys
Associate Attorney
O: 651.583.7896
M: 989.763.0149
Jake Leys advises companies in the medtech, biotech, and pharma industries on clinical, commercial, regulatory, privacy, and compliance matters across the product life cycle. He brings in-house and private practice experience spanning medtech, pharma, clinical trials, healthcare compliance, and transactional work. Jake provides practical, business-focused guidance that helps clients advance business objectives while managing legal and regulatory risk.
Before joining Gardner Law, Jake served as corporate counsel at Edwards Lifesciences, where he advised on clinical, commercial, regulatory, privacy, and compliance matters and prior to that, supported a business through commercialization and acquisition. He also brings private practice experience from Ropes & Gray, where he worked on a breadth of matters for companies in highly regulated industries.
With an earlier background in microbiology and the pharma industry, Jake offers clients a practical, well-rounded perspective grounded in both science and law. That combination enables him to translate effectively between technical teams and business leaders and to help clients address compliance challenges with clear judgment, operational awareness, and a strong understanding of the realities behind the legal issues.
Focus Areas
- Regulatory and healthcare compliance counseling for medtech, biotech, and pharma
- FDA regulatory strategy across product development and commercialization
- Clinical and commercial contracting, including clinical trial and vendor agreements
- Healthcare fraud and abuse analysis, including Anti-Kickback Statute considerations
- Due diligence and transactional support for regulated companies
Representative Experience
- Advises on clinical and commercial contracting for medical device and digital health programs
- Counsels cross-functional teams on regulatory risk, contract structure, and compliance considerations involving clinical, commercial, marketing, and research activities
- Supported a clinical-stage medical device company through commercialization and acquisition by a global medical device company
- Led contracting and site activation for a global clinical study involving a connected device and digital health platform
- Drafts and negotiates clinical trial, SaaS, supplier, commercial, and data privacy agreements
Differentiators
- In-house experience at Edwards Lifesciences, advising on clinical, commercial, regulatory, compliance, and intellectual property matters across the product lifecycle
- Private practice experience at Ropes & Gray, with a focus on transactional and intellectual property matters for companies in highly regulated industries
- Experience advising on intellectual property strategy and risk, including IP diligence, licensing, and transactional support in the context of product development and commercialization
- Regulatory and quality assurance experience in the pharma industry, including work supporting FDA and global compliance requirements and manufacturing quality systems
- Scientific background in microbiology, providing a strong foundation for advising on complex, technical products and regulatory frameworks
Thought Leadership, Teaching, & Ventures
- Co-author, “Variability in snake skin microbial assemblages across spatial scales and disease states,” ISME Journal (2019)
- Co-author, “Common cutaneous bacteria isolated from snakes inhibit growth of Ophidiomyces ophiodiicola,” EcoHealth (2018)
- Co-author, “Host and geographic range of Snake Fungal Disease in Tennessee, USA,” Herpetological Review (2018)
- Co-author, “Methodological considerations for detection of terrestrial small-body salamander eDNA and implications for biodiversity conservation,” Molecular Ecology Resources (2017)
Education
- J.D., Boston University School of Law
- M.S., Biology/Microbial Ecology, Tennessee Technological University
- B.A., Biology/Microbiology, Chemistry Minor, Northern Michigan University
Admissions & Affiliations
- Michigan
- Secretary, Board of Directors, Trillium House
Personal
Outside of his legal practice, Jake enjoys backpacking and exploring Michigan’s Upper Peninsula, where he takes full advantage of everything the region has to offer. He stays active through weightlifting, enjoys writing in his spare time, and values life at home with his wife and their two dogs.