Japan is clearly more open than ever to new biopharmaceutical products because the MHLW is intent on reducing the  2-4 year "drug lag" vs. other developed markets.  MHLW/PMDA's announcement in September 2007 that Japan is keen to participate in global clinical trials of innovative products and not be relegated to waiting until sponsors had received US/EU approval and got around to conducting "bridging studies" has translated into a more open attitude towards sponsors, greater readiness to dialogue during all stages of drug development, and the inclusion of Japanese patients in multinational clinical trials with PMDA's full blessing and receptivity to considering the results for registration in Japan.As a further reflection of the new mindset, MHLW approved Japan's first biosimilar product in June 2009. 

This presentation will focus on the new opportunity, current regulatory environment and strategies for successful product development in Japan. Whether you are considering Japan market approval on its own, or as part of a larger global global brand expansion strategy, this meeting should be informative and helpful to your efforts.

An in-country regulatory affairs and product development expert, Dr. Yoshitaka (Yoshi)  Aida, Director PAREXEL Consulting, Japan, will provide insight and answer your questions on the topic. Alberto Grignolo, Corporate Vice President, PAREXEL will kick things off and facilitate an interactive Q&A session after Dr. Aida's presentation.

Main Presentation By:

Yoshitaka Aida, DVM, PhD is Director, PAREXEL Consulting, Japan where he assists companies based both outside and inside Japan to develop and commercialize biopharmaceutical and medical device products for the Japanese market. Dr. Aida's areas of specialization include  Regulatory Affairs, Drug Safety, Pharmacology, Toxicology, Drug Metabolism, Formulation and Chemical Analysis.

Prior to joining PAREXEL in 2009, Dr. Aida was Japanese Representative for NOTOX a preclinical CRO based  in the Netherlands. Throughout the course of his career he  has worked in industry at the Senior Director and Director Level for various companies in Japan including: Bausch & Lomb, UCB, Upjohn/ Pharmacia & Upjohn and Tsukuba Research Laboratories.

Prior to industry Dr Aida was at the National Institute of Health Sciences in Tokyo from April 1973 to May 1995. There he served as Senior Research Scientist for the  Division of Chemical Risk Assessment and the Division of Chemical Safety Information and Research Scientist/Senior Research Scientist at the Division of Toxicology

He earned a Masters, PhD and DVM in Veterinary Medicine from Nihon University.

Introductions and Q&A:

Alberto Grignolo, Ph.D. is a Corporate Vice President at PAREXEL Consulting.  An eighteen-year veteran of the firm, he is now responsible for the firm's Global Strategy and Services with a particular focus on Asia Pacific, Latin America and other emerging markets.  He advises clients in the areas of drug development strategy, regulatory negotiation and best regulatory and clinical practices.

Dr. Grignolo is a Member of the Executive Committee of the Clinical Trials Transformation Initiative (CTTI), he was an Expert Adviser to the Institute of Medicine's "Committee on Assessing the System for Protecting Human Research Participants" in 2000-2002.  He is a past Chairman of the Board of the Regulatory Affairs Professionals Society (RAPS), and was the recipient of the 1995 Richard E. Greco Professional of the Year Award from RAPS.  He has been an active member of the Drug Information Association (DIA) since 1984, served on the DIA Board from 2000 until 2004, was the Chair of the Regulatory Track of the 2001, 2002 and 2003 DIA Annual Meetings, was the Chair of the 2007 DIA Annual Meeting and is an Instructor on the DIA Regulatory Training Faculty.  He serves on the Graduate Faculty of the Massachusetts College of Pharmacy and Health Sciences in Boston as an Adjunct Associate Professor.

Prior to joining PAREXEL Consulting, Dr. Grignolo served as President of FIDIA Pharmaceutical Corporation and held regulatory positions at SmithKline & French Laboratories.  After completing his undergraduate degree at Duke University, he earned a doctorate in Experimental Psychology from the University of North Carolina and conducted postdoctoral research in neuropharmacology at Duke University Medical Center.