Chia Feng Lu is a member of the Corporate/Mergers & Acquisitions Practice Group, the Intellectual Property Practice Group and the Pharmaceuticals, Healthcare and Life Sciences Industry Group in Baker McKenzie's Washington, DC office. In addition to his latest affiliation with Washington, DC office, he spent a substantial amount of time working in Tokyo and Toronto offices before.
He has profound understanding of life sciences industry’s business model and in-house counsel’s needs and challenges by being seconded to one of the largest multinational pharmaceutical companies for two years, and working in a leading biotechnology company’s legal department in Europe. Prior to joining the Firm, he also worked at a consulting company’s healthcare industry team, advising the life sciences clients on their product launch strategy, product life-cycle management approach, and R&D portfolio assessment.
Chia Feng is recognized in the policy making and regulatory fields. He has served as an adjunct faculty member in numerous universities in the US and in Japan. He sits in the advisory committee of a US regenerative medicine company. He is also invited to be involved in a number of legislation processes of healthcare-related laws particularly related to precision medicine, digital health, and cell/gene therapy by a number of the governments. He has been the judge for a renowned writing competition in FDA regulatory law area several times.
Chia Feng focuses on general corporate, regulatory law, and technology-driven transactions in the life sciences industry. He advises drug, biotech, diagnostics and device companies on a broad range of commercial and regulatory matters in relation to corporate development and licensing, partnership and alliance, data privacy, regulatory compliance, merger and acquisition, life cycle management, and pricing and reimbursement. He is experienced in devising healthcare compliance programs and regulatory vehicles for life sciences companies to their sustain business growth and commercial success by addressing complex legal paradigms across multiple jurisdictions.
Currently, he also provides guidance to companies developing and commercialization novel technology products, such as mobile health and digital health products, cell therapy, precision medicine-related products and services, as well as regenerative medicine. Beside his strong expertise in the US-related legal matters, he also acquires intensive experience in assisting the life sciences companies entering into Asia Pacific region, such as Australia, China, Japan, Indonesia, Singapore, South Korea, and Taiwan through his numerous representations and deep connections with the policy makers and regulators in those Asia Pacific countries.
Representative Legal Matters
Licensing & Transaction
- Advised a US biotechnology company on its co-development and licensing deal for its novel immunotherapy product in China, Japan, the US and Latin America.
- Advised a Japanese conglomerate on its acquisition of a US diagnostic company to build up its precision medicine capacity in the US.
- Represented a US biotechnology company to frame a global supply framework with a major pharmaceutical company regarding its newly approved orphan drug.
- Represented a Japanese pharmaceutical company in its interactions with the regulatory agencies regarding numerous guidance documents impacting the product development of its cell/gene therapy products.
- Advised a leading in vitro diagnostics company on its PMA process of a next-generation sequencing product.
- Led the initiative to prepare and implement global policies and procedures, such as anti-bribery, sponsorship, donation, fair market value, transparency, interactions with the stakeholders, on behalf of a leading pharmaceutical companies.
- Led the investigation on behalf of a global biotechnology company regarding any potential FCPA violations of its overseas distributor.
- Helped defend a global medical device company against the investigation concerning its unfair competition practices.
Intellectual Property & Data Privacy
- Developed a trade secrets protection program to leading pharmaceutical company’s emerging technology business division.
- Advised a US healthcare conglomerate in its establishment of an innovation incubation center affiliated with a healthcare institution in Abu Dhabi regarding technology transfer and intellectual property protection.
- District of Columbia~United States (2017)
- New York~United States (2012)
- University of Houston Law Center (J.D.) (2011)
- National Taiwan University (B.S. Pharmacy, Economics) (2004)
Author, "Japan- A Better Environment," UPDATE Food and Drug Law, Regulation and Education, Food and Drug Law Institute, November/December 2017
Author, "Japan’s Sakigake Designation System: Promoting Innovation," UPDATE Food and Drug Law, Regulation and Education, Food and Drug Law Institute, July/August 2016
Keynote speaker, "Envision the Precision Medicine Launch Strategy – How We Adapt Ourselves to the New Paradigms Across the Globe Governing the Market Entry and Market Access," Covance Annual Symposium, 22 May 2018
Presenter, "Navigate the latest thinking of the US regulators and policy makers - translate the innovation into the commercial excellence," 6th Mizuho Biotechnology Conference, 15 December 2017
Presenter and Moderator, "FDA Regulation and Cutting Edge Technology – What Pharmaceutical and Medical Device Companies Should Know," Eighteenth Annual Pharmaceutical and Medical Device Compliance Congress, 7 November 2017