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, 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 transaction in life sciences and emerging technology
- Regulatory laws
- Pricing and reimbursement
- Corporate compliance and governance
- Export control and international trade
- Intellectual property and privacy
