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Natasha Leskovsek is a partner in the Business Department. She joined the firm in 2008 and is resident in the Washington, DC office.
Ms. Leskovsek advises pharmaceutical, biotechnology, medical device and food/dietary supplement industry clients on FDA regulatory and clinical development matters. She also conducts regulatory diligence on behalf of entities investing in FDA-regulated companies.
Before joining Cooley, Ms. Leskovsek was a shareholder at Heller Ehrman. Prior to entering the law, Ms. Leskovsek worked as a registered nurse in pediatric oncology research at the National Institutes of Health (NIH) and with adult medical and surgical patients. Ms. Leskovsek worked as a consultant for international pharmaceutical and biotech clients while attending Georgetown University Law Center. Her direct clinical trial experience in nursing and project management offers her a unique perspective in advising clients on the conduct of clinical trials in product development and postmarketing studies. She has authored numerous healthcare and FDA-related publications and regularly speaks on a broad range of FDA regulatory topics for national conferences and meetings.
Ms. Leskovsek received her J.D. from Georgetown University Law Center in 1996 and her M.B.A and M.P.M in 1991 from the University of Maryland, College Park. She received her B.S.N. from University of Maryland, Baltimore in 1989.
Ms. Leskovsek is admitted to practice in the District of Columbia and Maryland and is a member of the editorial advisory board of the Food and Drug Law Institute and a member of the American Health Lawyers Association.
Representative Engagements:
- Development of product approval and lifecycle management strategies for prescription and OTC drugs, medical devices, and biologics
- Counseling on clinical trial issues, including clinical trial agreements, master service agreements, informed consent terms, HIPAA/data privacy, reporting of AEs and clinical hold issues
- Preparation of orphan designation requests
- Preparation of sponsors for face-to-face meetings with FDA and participation at FDA meetings to ensure that client rights are preserved
- Advise on compliance strategies for federal and state regulatory matters, including advertising and promotional materials, labeling review, records retention and state permitting requirements
- Development and drafting of comments to FDA proposed rules and Citizen Petitions
- Draft and review FDA regulatory representations, warranties and milestones in licenses and other transactional documents
- Conduct FDA regulatory due diligence and provide opinions on same for venture capital and public financing, both as corporate and underwriter's counsel
- Coordinate with patent counsel on patent term restoration requests and Hatch-Waxman litigation
- Respond to FDA inspection reports and warning letters, as well as preparing clients for inspections and audits
Education- Georgetown University Law Center
JD, 1996 - University of Maryland, College Park
MBA, 1991 - University of Maryland, College Park
MPM, 1991 - University of Maryland, Baltimore County
BS, 1989
Admissions
- District of Columbia
- Maryland
Memberships
- American Health Lawyers Association
- Food and Drug Law Institute
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