Anna Zhao

Expertise Anna Advises Experience Highlights Career History

Partner

Life Sciences

Office : New York

(646) 222-5893

Expertise

Anna advises clients on a broad range of life sciences regulatory, compliance, transactional and legislative matters. With over 10 years’ experience, Anna provides practical and strategic advice to clients on pharmaceuticals, devices, food, cosmetics, and other regulated products across critical regulatory issues under the Federal Food, Drug, and Cosmetic Act and related laws.  Anna is passionate about supporting life sciences companies as they navigate intricate legal issues to minimize risks and operate in a compliant manner within highly regulated environments in the U.S. and China.

Anna’s expertise intersects between regulatory, commercial transactions, and policy matters. Drawing on her regulatory expertise, Anna regularly assists companies in negotiating and drafting an array of life sciences agreements, such as research agreements, clinical trial agreements, expanded access agreements, manufacturing and quality agreements, and collaboration and licensing agreements.

Anna also advises clients on corporate and commercial transactions, including mergers and acquisitions, capital market transactions, and life sciences collaboration and licensing transactions.  She assists clients in identifying and assessing key regulatory issues and crafting solutions to mitigate potential transactional risks and achieve transactional goals. In addition, Anna counsels clients on regulatory issues arising from litigation matters and represents companies and individuals in responding to government enforcement action and conducting internal investigations.

A native mandarin Chinese speaker, Anna has significant experience advising global life sciences and consumer product companies in compliance with Chinese laws and regulations. With her bilingual background, Anna is well-positioned to help clients navigate complex regulatory frameworks in the U.S. and China and address challenges presented by the life sciences technologies and regulatory developments.

Anna Advises

  • Biopharmaceutical manufacturers
  • Emerging biotech companies and start-ups
  • Investment firms
  • Industry associations
  • Consumer product brands
  • Founders, scientists, and corporate executives

Experience Highlights

  • Counseled clients on development and approval of pharmaceutical products, including clinical trial participant enrolment, informed consent, clinical trial conduct, expanded access, and expedited programs.
  • Advised clients on orphan-drug designation and exclusivity matters,
  • Advised clients on regulatory submissions and strategic communications with FDA.
  • Advised clients on the labelling and advertisements related to pharmaceutical products, food, dietary supplements, and cosmetic products.
  • Counsel for UCB in its $2.1 billion acquisition of Ra Pharmaceuticals.
  • Counsel for Merck in its $2.7 billion acquisition of ArQule; $1.05 billion acquisition of Peloton Therapeutics; $425 million acquisition of OncoImmune; and $11.5 billion acquisition of Acceleron Pharma Inc.
  • Counsel for Bayer in its sale of Coppertone business to Beiersdorf AG for $550 million and Dr Scholl’s foot care business to Yellow Wood Partners for $585 million.
  • Advised clients on drug safety data exchange agreements and pharmacovigilance agreements.
  • Advised an emerging cancer therapy company in its initial public offerings.
  • Conducted numerous internal investigations on behalf of major pharmaceutical companies concerning clinical trials, drug promotion, post-marketing studies, as well as sales and marketing practices.
  • Counseled major U.S. pharmaceutical and biotech companies and industry associations on regulatory and compliance matters in China, including drug application and approval, importation, clinical trials, advertising, promotion, and enforcement matters.
  • Advised major U.S. food, pharmaceutical, cosmetic companies and industry associations on advocating for legislative and regulatory changes in China, including by commenting on proposed legislation and policies.
  • Advised clients on cosmetic ingredients, testing, labeling, promotion, and marketing matters.
  • Advised medical device companies on classification and registration of medical device products in China, including mobile apps and fitness products.
  • Counseled dietary supplement manufacturers on product registration, importation, and labeling issues in China.
  • Advised a major U.S. beverage company in defending consumer product litigation proceeding.
  • Advised technologies and consumer product companies on product safety reporting and conducting product recalls.
  • Conducted internal investigations for multinational life sciences companies in connection with potential Foreign Corrupt Practices Act violations.
  • Advised government agencies on the compliance of China’s export restriction and technology transfer measures with the World Trade Organization rules.

Career History

Previous Law firms

  • Covington & Burling LLP, Washington D.C., 2015-2022
  • Covington & Burling LLP, Beijing, 2011-2014

Memberships

  • District of Columbia Bar
  • New York State Bar, Food, Drug and Cosmetic Law Section & Health Law Section
  • Food and Drug Law Institute, Peer Review Committee
  • Sino-American Pharmaceutical Professionals Association (SAPA)

Education

  • The University of Chicago Law School, LL.M., 2015
  • China University of Political Sciences and Law, Master of Law, 2011
  • China University of Political Sciences and Law, B.A., 2009

Other

  • “Legal and Ethical Considerations for Offering Clinical Trial Recruitment Payments and Enrollment Incentives,” FDLI, Update Magazine (Summer Issue, 2024)
  • “What’s the Future of Marketing Applications Based Solely on Foreign Clinical Trial Data?” Food and Drug Law Journal (Upcoming)

Expertise

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Anna advises clients on a broad range of life sciences regulatory, compliance, transactional and legislative matters. With over 10 years’ experience, Anna provides practical and strategic advice to clients on pharmaceuticals, devices, food, cosmetics, and other regulated products across critical regulatory issues under the Federal Food, Drug, and Cosmetic Act and related laws.  Anna is passionate about supporting life sciences companies as they navigate intricate legal issues to minimize risks and operate in a compliant manner within highly regulated environments in the U.S. and China.

Anna’s expertise intersects between regulatory, commercial transactions, and policy matters. Drawing on her regulatory expertise, Anna regularly assists companies in negotiating and drafting an array of life sciences agreements, such as research agreements, clinical trial agreements, expanded access agreements, manufacturing and quality agreements, and collaboration and licensing agreements.

Anna also advises clients on corporate and commercial transactions, including mergers and acquisitions, capital market transactions, and life sciences collaboration and licensing transactions.  She assists clients in identifying and assessing key regulatory issues and crafting solutions to mitigate potential transactional risks and achieve transactional goals. In addition, Anna counsels clients on regulatory issues arising from litigation matters and represents companies and individuals in responding to government enforcement action and conducting internal investigations.

A native mandarin Chinese speaker, Anna has significant experience advising global life sciences and consumer product companies in compliance with Chinese laws and regulations. With her bilingual background, Anna is well-positioned to help clients navigate complex regulatory frameworks in the U.S. and China and address challenges presented by the life sciences technologies and regulatory developments.

Anna Advises

Back to top
  • Biopharmaceutical manufacturers
  • Emerging biotech companies and start-ups
  • Investment firms
  • Industry associations
  • Consumer product brands
  • Founders, scientists, and corporate executives

Experience Highlights

Back to top
  • Counseled clients on development and approval of pharmaceutical products, including clinical trial participant enrolment, informed consent, clinical trial conduct, expanded access, and expedited programs.
  • Advised clients on orphan-drug designation and exclusivity matters,
  • Advised clients on regulatory submissions and strategic communications with FDA.
  • Advised clients on the labelling and advertisements related to pharmaceutical products, food, dietary supplements, and cosmetic products.
  • Counsel for UCB in its $2.1 billion acquisition of Ra Pharmaceuticals.
  • Counsel for Merck in its $2.7 billion acquisition of ArQule; $1.05 billion acquisition of Peloton Therapeutics; $425 million acquisition of OncoImmune; and $11.5 billion acquisition of Acceleron Pharma Inc.
  • Counsel for Bayer in its sale of Coppertone business to Beiersdorf AG for $550 million and Dr Scholl’s foot care business to Yellow Wood Partners for $585 million.
  • Advised clients on drug safety data exchange agreements and pharmacovigilance agreements.
  • Advised an emerging cancer therapy company in its initial public offerings.
  • Conducted numerous internal investigations on behalf of major pharmaceutical companies concerning clinical trials, drug promotion, post-marketing studies, as well as sales and marketing practices.
  • Counseled major U.S. pharmaceutical and biotech companies and industry associations on regulatory and compliance matters in China, including drug application and approval, importation, clinical trials, advertising, promotion, and enforcement matters.
  • Advised major U.S. food, pharmaceutical, cosmetic companies and industry associations on advocating for legislative and regulatory changes in China, including by commenting on proposed legislation and policies.
  • Advised clients on cosmetic ingredients, testing, labeling, promotion, and marketing matters.
  • Advised medical device companies on classification and registration of medical device products in China, including mobile apps and fitness products.
  • Counseled dietary supplement manufacturers on product registration, importation, and labeling issues in China.
  • Advised a major U.S. beverage company in defending consumer product litigation proceeding.
  • Advised technologies and consumer product companies on product safety reporting and conducting product recalls.
  • Conducted internal investigations for multinational life sciences companies in connection with potential Foreign Corrupt Practices Act violations.
  • Advised government agencies on the compliance of China’s export restriction and technology transfer measures with the World Trade Organization rules.

Career History

Back to top

Previous Law firms

  • Covington & Burling LLP, Washington D.C., 2015-2022
  • Covington & Burling LLP, Beijing, 2011-2014

Memberships

  • District of Columbia Bar
  • New York State Bar, Food, Drug and Cosmetic Law Section & Health Law Section
  • Food and Drug Law Institute, Peer Review Committee
  • Sino-American Pharmaceutical Professionals Association (SAPA)

Education

  • The University of Chicago Law School, LL.M., 2015
  • China University of Political Sciences and Law, Master of Law, 2011
  • China University of Political Sciences and Law, B.A., 2009

Other

  • “Legal and Ethical Considerations for Offering Clinical Trial Recruitment Payments and Enrollment Incentives,” FDLI, Update Magazine (Summer Issue, 2024)
  • “What’s the Future of Marketing Applications Based Solely on Foreign Clinical Trial Data?” Food and Drug Law Journal (Upcoming)