ChiaFengLu

Chia-Feng Lu

Associate
Baker & McKenzie LLP
Not admitted to practice law in this jurisdiction

Biography

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 Toronto office. He has been seconded to one of the largest multinational pharmaceutical companies for two years.

Chia Feng is an adjunct faculty member in Kyoto University and Kitasato University in Japan. He also sits in the advisory committee of a US regenerative medicine company. He is also involved in a number of legislation processes of healthcare-related laws. Prior to joining the Firm, he worked at two multinational pharmaceutical companies and a consulting company, handling market entry, product life-cycle management and R&D portfolio assessment.

Practice Focus

Chia Feng focuses on general corporate and regulatory law 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, product launches, and pricing and reimbursement. He is experienced in devising compliance programs and regulatory vehicles to sustain business growth and commercial success. Currently, he also provides guidance to companies introducing novel technology products, such as mobile health and digital health products, cell therapy, precision medicine-related products and services, as well as regenerative medicine.

Representative Legal Matters

  • Assisted a US biotechnology company in its co-development and licensing deal for its novel immunotherapy product in China, Japan, the US and Latin America.
  • Advised a US biotechnology company in a co-development and co-commercialization transaction of an orphan therapy with a Japanese pharmaceutical company.
  • Counseled a leading Japanese pharmaceutical company in general corporate matters, market entry/access, business development and licensing, and regulatory compliance involved in the expansion of its in vitro diagnostic business to Asia Pacific.
  • Assisted a Japanese pharmaceutical company in its post-merger integration with a European pharmaceutical company.
  • Advised a US healthcare conglomerate in its establishment of an innovation incubation center affiliated with a healthcare institution in Abu Dhabi.
  • Assisted a leading US technology company in its development and product launch of healthcare software and wearable technology in the US and Japan.
  • Advised a Japanese specialty pharmaceutical company in its negotiations with regulatory agencies in multiple jurisdictions concerning product approval and risk mitigation plans for its novel cancer immunotherapy.
  • Assisted a Japanese pharmaceutical company on the product launch of its novel cell and gene therapy product portfolio, including issues related to regulatory approval and clearance by international regulatory bodies, pricing and reimbursement by public and private insurers and distribution.
  • Counseled a diagnostic company on the introduction of its next-generation sequencing test service in the US and Japan in addition to the relevant life cycle management matters.
  • Assisted several multinational pharmaceutical and biotechnology companies in global compliance initiatives regarding fair market value, data privacy, transparency and interactions with healthcare professionals.

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