APAC expert insights for biotech drug development and regulatory strategy: Ethnobridging study design and the PMDA

Virtual

September 28, 2022

Virtual |

Get valuable insights from industry experts

Japan and China expert Insights for biotech drug development and regulatory strategy with Ethnobridging study design and PMDA pathway

On September 28th, Parexel Biotech will host a panel discussion on “Japan and China expert Insights for biotech drug development and regulatory strategy with Ethnobridging study design and PMDA pathway.” Parexel experts will share insights and first-hand experiences in this educational session to inform a more comprehensive APAC development strategy.

Key topics will include:

  • Understanding the regulatory landscape in China and Japan
  • How to manage the timelines and requirements in China and Japan
  • The benefits of incorporating Ethnobridging in your clinical development strategy
  • Considerations when running trials in China and Japan 

Details:

Date: September 28th, 2022

Time: 4.00pm – 5.00pm PDT

Location: virtual event

Hear from Parexel

Stan Jhee.png

Stan Jhee
Pharm.D., Corporate Vice President, Scientific Affairs, Parexel

Dr. Stan Jhee is a clinical pharmacologist with more than 24 years of drug development experience. His expertise is in a wide range of early drug development studies, emphasizing neuropsychiatric disorders, from first-in-human through proof-of-concept. In 2000, Dr. Jhee pioneered the concept of collecting Japanese data in Los Angeles to help pharmaceutical companies gain entry into Asian development, coining the term “Ethnobridging.” He received his Doctor of Pharmacy from the University of Southern California.

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Yoshitaka Ando
Senior Director, Head of Regulatory & Access, Parexel

Yoshitaka has more than 25 years of experience in drug development, from early stage of drug development to commercialization of the product (including translational studies, phase 1-3 studies, JNDA, and an observational study to obtain RWE) in both pharmaceutical companies and global CROs. He is the regulatory lead function at Parexel, in charge of Japan's regulatory consulting and market access team. Yoshitaka graduated from the University of Tokyo (majored in Applied Microbiology) and completed the executive MBA program at Harvard Business School.

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Yajie Li
M.D., Vice President, Regulatory & Access, Parexel

Yajie Li leads the China regulatory strategy consulting team and is responsible for providing strategic technical guidance on various aspects of drug development. She has more than 20 years of clinical and drug development experience, including hospital clinical practice, R&D experience in big and start-up pharma companies, China NMPA Clinical review experience, and regulatory consulting experience in a global CRO. Yajie worked for more than ten years in the pharmaceutical industry, including Merck (China), Innovent (Suzhou), J&J (China), and Xuanzhu Pharm. Yajie received her M.D. from Beijing Medical University and majored in Rheumatology and Immunology at Peking Union Medical College (PUMC).

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