Profil
Chia-Feng Lu guides life sciences and emerging technology companies, as well as industry associations, through the regulatory and transactional law surrounding life sciences and emerging technologies. He represents companies in strategic regulatory and legislative processes before various government agencies, to guide and develop new legislation and policy, to frame effective approaches to working with the various agencies on compliance and investigation issues, and to help clients develop strategic plans to obtain the regulator’s favorable view on their innovative products or ideas. This includes his providing counsel on the development and commercialization of novel technology products, such as cell therapy, cancer immunotherapy, mobile health and digital health products, microorganism, precision medicine-related products and services, regenerative medicine, 3D-printing, artificial intelligence, etc. Among all his representations, Chiafeng has been involved in several products based on Nobel-winning science in the past two decades respectively, and one of them has successfully reached the blockbuster status.
Focusing on corporate and regulatory law that applies to technology-driven transactions in the life sciences industry and other fields of emerging technology, Chiafeng provides guidance to clients on matters including corporate development and licensing, partnership and alliance, regulatory compliance, mergers and acquisitions, life cycle management, and pricing and reimbursement with the goal of addressing complex and fluid legal paradigms across multiple jurisdictions.
Chiafeng provides clients with guidance on global trade policies in relation to emerging or critical technology. In addition to advising clients’ business in the United States, Chiafeng regularly assists life sciences companies entering into other markets, such as the Asia Pacific region through his representations and deep familiarity with the policy and regulatory environments in countries or territories such as ASEAN, Australia, China, Japan, South Korea, and Taiwan. He also assists investment banks, private equity firms, and venture capital groups in their evaluations of regulatory developments and the resulting business impacts, as well as regulatory uncertainty with respect to novel technology and compliance. Chiafeng also represents life sciences companies in high-profile matters in connection with their corporate strategy planning, partnerships, licensing, and M&A.
Chiafeng has developed his profound understanding of his client’s specific needs and challenges at the organization level through his prior in-house experience with a U.S.-based global biotechnology company and a Japan-based global pharmaceutical company. He has served as an adjunct faculty member for a number of leading academic institutions, has sit on the advisory committee of a U.S. regenerative medicine company, and remain in the advisory committee positions to several governments for the policy making related to artificial intelligence, internet of things, digital health, precision medicine, and cell/gene therapy.
Concentrations
- Innovation and commercialization of life sciences and emerging technology
- Overseas market entry
- Strategic transactions in life sciences and emerging technology
- Regulatory laws
- Pricing and reimbursement
- Corporate compliance and governance
- Export control and international trade
- Intellectual property and privacy
Kompetencje
Doświadczenie
- Represented a leading Japanese pharma’s acquisition of a NASDAQ-listed biotech company focusing on cancer therapies and treatments in a cash tender offer followed by a merger for a total equity value of $2.4 billion, as well as relevant post-merger work.
- Advised a leading Boston-based biotechnology company on the regulatory strategy of its leading neurodegenerative medicine.
- Advised a leading bioventure in anti-infectious diseases area on its dispute with global contract research organization.
- Advised a leading IoT company on development of its compliance program across multiple jurisdictions in the U.S. and in Europe from regulatory, antitrust, and data privacy perspectives.
- Advised a bioventure on its license of its early-stage asset in Kennedy's disease to a NASDAQ-listed biotech company.
- Advised a leading pharmaceutical company on the co-development strategy for a drug-biologic combination regime from the regulatory and market access perspectives in the U.S. and in Europe.
- Advised a leading pharmaceutical company on its introduction of AI tool in empowerment of its drug discovery activity and on its partnership with such AI company for the license.
- Advised on a leading technology conglomerate on its acquisition of a laboratory-developed testing company in the United States.
- Advised a leading biotech company on its risk-sharing clinical trial collaboration with a contract research organization on its lead ophthalmology product, including the investment from such contract research organization.
- Advised a leading pharmaceutical company on its novel cell therapy portfolio’s regulatory strategy, policy advocacies, life cycle management approach, and strategic partnership transactions in multiple jurisdictions.°
- Represented a U.S. and a Japanese pharmaceutical company in their co-developed cancer immunotherapy regarding legal matters related to the product launch in multiple jurisdictions.
- Advised on various legal and regulatory issues underlying the product development of a digital health product, including its AI component, developed by a U.S. technology conglomerate in more than thirty jurisdictions.°
- Represented a U.S. global biotechnology company in its contract manufacturing partnership negotiation with several contract development and manufacturing organizations for its CAR-T therapy in multiple jurisdictions.°
- Led the regulatory, policy, and legal advisory to a leading U.S. biotechnology company's launch of SiRNA therapy in several jurisdictions.°
- Led a strategic investment in a microbio company together with leading venture capitals and the Bill & Melinda Gates Foundation.°
- Advised a Japanese conglomerate on its acquisition of a U.S. diagnostic company to increase its precision medicine capacity in the US, the following post-merger integration, as well as the relevant FDA regulatory issues of the development of the novel diagnostics.°
- Represented a global biotech company to resolve its dispute with its regional partner on a co-promotion partnership of its blockbuster.
- 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, cross-border data transfer, hotline/helpline, on behalf of multiple top global pharmaceutical companies.°
- Defended a lead biotechnology company against a government's investigation concerning its unfair competition practices, which was raised from its competitor.°
- Advised a U.S. health care conglomerate on numerous legal issues surrounding its establishment of an innovation incubation center affiliated with a health care institution in Gulf area.°
- Advised on a leading biotechnology company's authorized generic strategy of its blockbuster cancer product.°
- Served as the external general counsel to numerous biotech or emerging technology companies in the U.S. and in Europe.°
°The above representations were handled by Mr. Lu prior to his joining Greenberg Traurig, LLP.
- Takeda Pharmaceutical Company
- Celgene
Sukcesy i wyróżnienia
- Listed, Chambers USA Guide, "Up and Coming," Healthcare: Pharmaceutical/Medical Products Regulatory, 2024
- Shortlisted, LMG Life Sciences, 2023-2024
- "US Rising Star – Regulatory," 2023
- "US Rising Star – Financial & Corporate," 2024
- Listed, The Best Lawyers in America, "Ones to Watch," Health Care Law, 2021-2025
- Listed, The Legal 500 United States,
- Healthcare: Life Sciences, 2024
- Healthcare: Service Providers, 2022 and 2023
- NOME Mentor, Nordic Mentor Network for Entrepreneurship (NOME)
Kwalifikacje
- J.D., University of Houston Law Center
- B.S., Pharmacy, with Distinction in All Subjects, National Taiwan University
- District of Columbia
- New York
- angielski, biegły
- Japanese, konwersacyjny
- Chinese (Mandarin), ojczysty
- Chinese (Cantonese), Basic
- Taiwanese, ojczysty