ChiaFengLu

Chia-Feng Lu

Associate
Baker & McKenzie LLP

Biography

Chia Feng Lu practices life sciences regulatory and transaction laws. In addition to his current affiliation with the Firm's Washington, DC office, Chia Feng also worked in the Firm's Tokyo and Toronto offices, and spent two years on secondment at a large multinational pharmaceutical company directly working with a number of C-suite people on strategic initiatives. Prior to joining the Firm, Chia Feng worked for a leading European biotechnology company, and on the healthcare industry team for a leading consumer company, advising life sciences clients on their product launch strategy, product life-cycle management approach, and R&D portfolio assessment. As a result of his experience, he has a profound understanding of the life sciences industry’s business model, in-house counsel’s needs and challenges.

Chia Feng is recognized in the policy making and regulatory fields regarding emerging technologies. He served as an adjunct faculty member in numerous US and Japanese universities, sits on the advisory committee of a US regenerative medicine company, and is often invited to be involved in a number of legislation processes of healthcare-related laws particularly related to artificial intelligence, internet of things, precision medicine, digital health, 3-D printing, and cell/gene therapy by a number of the governments. Chia Feng has also judged a renowned writing competition in FDA regulatory law area several times. He is privileged to have worked on three therapies based on Nobel-wining sciences, two of which have been launched in the market.

Practice Focus

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.

Chia Feng also provides guidance to companies on the development and commercialization of novel technology products, such as mobile health and digital health products, cell therapy, precision medicine-related products and services, as well as regenerative medicine. In addition to his expertise in US-related legal matters, he also has extensive experience assisting life sciences companies entering into the Asia Pacific region, such as Australia, China, Japan, Indonesia, Malaysia, Singapore, South Korea, Taiwan, and Vietnam through his representations and deep connections with the policy makers and regulators in those countries.

Representative Legal Matters

  • Advised a Japanese conglomerate on its acquisition of a US diagnostic company to build up 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.

  • Led the regulatory, policy, and legal advisory to a leading US biotechnology company's launch of SiRNA therapy based on Nobel-winning science in several jurisdictions.

  • Represented a Japanese pharmaceutical company in its novel cell therapy based on Nobel-winning science regarding its regulatory strategy, policy advocacies, life cycle management approach, and strategic partnership transactions in the US.

  • Represented a US and a Japanese pharmaceutical company in their co-developed cancer immunotherapy based on Nobel-winning science regarding legal matters related to the product launch in multiple jurisdictions.

  • 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 top ten global pharmaceutical company; and conducted an assessment of its promotional review committee, and developed a pharmaceutical company’s compliance manual in advertisement and promotion.

  • Successfully defended a lead biotechnology company against a government's investigation concerning its unfair competition practices, which was raised from its competitor.

  • Led a strategic investment in a microbio company together with leading venture capitals and Bill & Melinda Gates Foundation.

  • 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.

  • Advised on a leading biotechnology company's authorized generic strategy of its blockbuster cancer product.

Admissions

  • District of Columbia~United States (2017)
  • New York~United States (2012)

Education

  • University of Houston Law Center (J.D.) (2011)
  • National Taiwan University (B.S. Pharmacy, Economics) (2004)

Languages

  • English
  • Japanese
  • Mandarin
  • Taiwanese

Previous Offices

  • Tokyo
  • Toronto

Publications

  • 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

  • Author, "Japan: Pharmaceutical Industry R&D Compliance under Increased Scrutiny," UPDATE Food and Drug Law, Regulation and Education, Food and Drug Law Institute, November/December 2015

  • Co-author, "FDA’s regulation of veterinary drug products" (Contributor of the Japan and Taiwan Chapters), Food and Drug Law Institute, August 2013

  • Author, "Internationalization of the regulatory agency – A submission to Japan," Regulatory Science of Medical Products, 2012