Natasha Leskovsek

Partner at Cooley LLP

Natasha Leskovsek

Natasha Leskovsek

Partner at Cooley LLP

Biography

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 entering legal practice, 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 JD from Georgetown University Law Center in 1996 and her MBA and MPM in 1991 from the University of Maryland, College Park. She received her BSN 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 Food and Drug Law Institute and 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, 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

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Partner at Cooley LLP

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Partner at Cooley LLP

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Partner at Cooley LLP

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Partner-Securities Regulation at Cooley LLP

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Special Counsel at Cooley LLP

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Partner at Cooley LLP

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Partner at Cooley LLP

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Partner at Cooley LLP

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Partner at Cooley LLP

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Partner at Cooley LLP

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In The News
The Deal Pipeline
September 23, 2016
Pfizer gets regulatory nod for Medivation buy
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July 15, 2013
Abbott Labs makes two deals for $700M
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Natasha Leskovsek
Partner at Cooley LLP
Career History
Partner
2008 - Current

Cooley LLP is a provider of strategic litigation and business transaction services and is a representative of private and public companies, financial institutions, venture capital firms and nonprofit organizations. The company was founded in 1920 and is headquartered in New York, NY.

Transactions
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Iterum Therapeutics Plc issued Ordinary Shares

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Aslan Pharmaceuticals Ltd. issued American Depositary Shares (ADS)

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Galena Biopharma, Inc. purchases Sellas Life Sciences Group Ltd.

Other Affiliations

Natasha Leskovsek is affiliated with Cooley LLP

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