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概述

Bianca Lewis’ broad transactional and regulatory practice focuses on matters at the intersection of technology, media, advertising and data privacy, with a special interest in life sciences. As part of her broad practice, she advises clients on a wide array of complex privacy, data security and FDA and health care regulatory issues.

Regularly working with clients in the life sciences, consumer products, entertainment and media and software and technology industries, Bianca has experience drafting and negotiating commercial agreements for clients in the real estate, entertainment and media industries, clinical trial agreements for pharmaceutical and biotechnology companies seeking FDA approval of therapeutic products, and advising multi-national pharmaceutical company on HIPAA compliance training, as well as agreements involving mergers and acquisitions in life sciences, employment matters and asset purchases, among others. Bianca regularly advises clients on issues pertaining to U.S. and global data privacy laws and regulations, including the GDPR, HIPAA, CCPA and CPRA.

As part of her Mergers & Acquisitions practice, she assists clients with understanding the privacy and FDA regulatory considerations for various acquisitions. She also advises clients on FDA regulatory pathway strategies and FDA compliance issues for mergers and acquisitions deals, public offerings and commercial disputes for clients in the biopharmaceutical, medical device and tobacco product industries. In addition, Bianca counsels clients on corporate governance, business entity formation, corporate policies, as well as assisting with debt capital market transactions, including convertible note offerings.

Select examples of representative FDA regulatory experience include:

  • Advocated on behalf of a leading national manufacturer to successfully resolve a dispute over the FDA regulatory status of one of its flagship products. 
  • Advising an underwriter client on complex FDA regulatory compliance issues for a proposed IPO of a multi-national client in a highly-regulated industry. 
  • Advised acquirer on FDA regulatory clearance and compliance issues in a proposed merger with a medical device company. 
  • Advised a SPAC acquirer on FDA regulatory approval pathways and compliance issues in connection with a merger with a biopharmaceutical company with clinical stage Orphan Designated biologic drug candidates.
 

教育背景

  • 纽约法学院, 法学博士
  • SUNY Old Westbury, 文学学士, cum laude

执业资格

  • 纽约州

承认

  • Named to Best Lawyers: Ones to Watch list in Financial Services Regulation Law (2021-2023) and Health Care Law (2023)

联系

  • Member, American Bar Association
  • Judicial Intern, The Honorable Judge Michael A. Shipp, U.S. District Court for the District of New Jersey