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Tuesday, June 18 • 1:15pm - 2:15pm
#251: Enabling Patient Access Worldwide Including Japan or Other Countries to Innovative Drugs Through Global Development Strategy

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-589-L04-P; CME 1.00; RN 1.00

This forum will present the considerations in global development strategy to approach to broader market including Japan for maximizing worldwide patient access and business opportunity. The panelists are from pharma and biotech.

Learning Objectives

Describe how to maximize the value of innovative products for the global market and benefit patients worldwide; Discuss how to apply the learnings to the clinical development strategy to expand target market effectively considering patient access to innovative drugs; Identify how to influence to regulators, industry, and trial sites to improve local environment to reduce hurdles and enhance global simultaneous development.

Chair

Eri Sekine

Speaker

Panelist
Leyna Mulholland, PharmD, PhD, MS

Panelist
Toshiharu Sano, RPh

Panelist
Xiaojun (Wendy) Yan, MD, MBA


Speakers
avatar for Eri Sekine

Eri Sekine

Executive Vice President, CMIC Group, Japan
Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes Clinical Data Management, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing Management and Quality Management. Eri Sekine has over 30 years' experience in various... Read More →
LM

Leyna Mulholland

Executive Director, Global Regulatory Affairs, Transent Group, United States
Leyna is a registered pharmacist in Japan and obtained PharmD, MS/PhD in Toxicology from the University of Michigan. Her career started in academic research focused on gene mutations and carcinogenicity in the Med School at the U of M and graduate courses teaching at Indiana University... Read More →
avatar for Toshiharu Sano

Toshiharu Sano

Associate Vice President, Head of Clinical Operation Area, MSD K.K., Japan
Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →
TS

Toshihiro Sano

Associate Vice President, Head of Clinical Operations, Merck Sharp & Dohme LLC , United States
avatar for Xiaojun (Wendy) Yan

Xiaojun (Wendy) Yan

Senior Vice President, Chief Regulatory Officer, BeiGene (Beijing) Co., Ltd., China
Wendy is a pharmacist by training, having graduated from Beijing Traditional Chinese Medicine University (China) and received an MBA from Staffordshire University (UK).  She began her career in Beijing Drug Control Institute, subordinate organization of China NMPA in 1988. Since... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  07: ProjectManagement-StrategicPlanning, Forum