Tina Wu is an associate in our life sciences group. She has extensive experience in advising pharmaceutical, biotechnology, medical device and healthcare clients on a wide variety of matters arising from the entire product life cycle, including regulatory issues concerning clinical and non-clinical research, data privacy, digital health, product development and market access strategies, M&A, collaboration, partnership and licensing deals, post-market compliance and enforcement actions, telemedicine and healthcare services.
Prior to joining Ropes & Gray, she worked at a leading international law firm, advising multi-national companies on regulatory, intellectual property and compliance matters, with a particular focus on the healthcare and life science industry.
She passed the PRC Bar Exam in 2006 and the New York State Bar Exam in 2014.
- Assisted a leading US pharmaceutical company with the divestiture of certain business units in China, and provided legal advice on relevant pharmaceutical regulatory matters.
- Assisted multiple innovative biopharmaceutical companies with the transaction in connection with collaboration development, licensing and product localization arrangements, and provided legal advice on relevant regulatory matters.
- Assisted a venture fund with its investment in a PRC pharmaceutical company to assess the product portfolio and regulatory risks.
- Advised a leading US pharmaceutical company on its drug development collaboration with a China based CAR-T Biotech Company, and provided legal advice on relevant pharmaceutical regulatory affairs.
- Assisted a world leading biopharmaceutical company in regulatory due diligence in relation to its collaboration with a Chinese partner for developing and commercializing its biological products in China.
- Assisted a PRC pharmaceutical company with the acquisition of foreign generic drug business, and provided legal advice on relevant pharmaceutical regulatory matters.
- Advised multinational pharmaceutical companies and investment companies on the collection, use, transfer and cross-border transfer of healthcare data and patient data.
- Assisted a private equity firm in data compliance due diligence on a leading oncology big data company in China.
- Advised numerous multinational pharmaceutical and medical device companies on their clinical and non-clinical research projects involving use of Chinese human genetic resources and biological samples.
- Assisted a leading US medical devices company with M&A transactions in connection with PRC-related products, and provided legal advice on relevant regulatory affairs.
- Advised several renowned US medical centers on the feasibility and legal risks of telemedicine services targeted toward PRC patients.
- Advised several leading medical devices companies on potential business models and implications under the Market Authorization Holder system.
- Advised a leading US medical devices company on the marketing model and legal risks associated with the two-invoice system and other matters.
- Advised a leading US medical devices company on post-market surveillance of its products, including its strategies of communication with law enforcement agencies and legal risks associated with relevant matters.
- Co-author, “China's New Drug Administration Law Frames A Promising Regulatory Landscape,” Asia-Pacific Biotech News (December 9, 2019)
- Co-author, “Building a “Healthy China” Through Innovation and Compliance,” Ropes & Gray (September 20, 2019)
- Quoted, “Attorneys Urge Chinese Regulator to Engage More With Industry,” International Devices & Diagnostics Monitor (September 7, 2018)
- Co-author, “Public Private Collaboration to Advance Medtech Regulation Reform,” (September 5, 2018)
- LLM, Columbia Law School, 2014
- LLM, Peking University Law School, 2008
- BA, China Pharmaceutical University, 2005