Hiromichi Shirasawa, MD

Transcription

1 Hiromichi Shirasawa, MD MSD office: Kudan-kita Chiyoda-ku Tokyo Japan # Office: +81 (0) Mobile: +81 (0) Summary of Profile Received an M.D. from Keio University School of Medicine followed by 4 years training in internal medicine and pulmonology. 16 years of experience in Clinical Development, Regulatory Affairs, Drug Safety and Medical Affairs at Pfizer and Merck/MSD both in Japan and at US headquarters with increasing responsibilities. More than 6 years of hands-on experience in leading clinical development programs as a development team leader from early stage development to successful J-NDA registration and approval in Respiratory and Infectious Disease. 10 years of large organizational management experiences in Japan, the US and Asia-Pacific region as the head of Development Operations, the head of Regulatory Affairs, the head of Medical Affairs at Pfizer and as VP head of Japan Development and Drug Safety at Merck/MSD. Understanding of Sales and Marketing aspect of pharmaceutical business of Japan and Asia Pacific through two years experience in Pfizer Specialty Care Business Unit as the head of Medical Affairs and a member of Asia Pacific regional business unit Leadership Team and Japan Business Unit Leadership Team. Understanding of corporate management and pharmaceutical business of Japan affiliate within the environment of global pharmaceutical company through managing MSD Japan as one of top senior executive member of Japan. Qualification in finance and accounting Fluent in English for business communications Entrepreneurship Present Position - Vice President, head of Japan Development and Pharmacovigilance, Merck Research Laboratories - Executive Corporate Officer, MSD Japan

2 Professional Experience Merck/MSD - Vice President, head of Japan Development and Pharmacovigilance, Merck Research Laboratories - Executive Corporate Officer, MSD Japan March Present Approximately 450 people and more than $100M budget are under my responsibly. The division has full functional areas for drug development and post approval safety risk management Clinical Research, Clinical Pharmacology, Regulatory Affairs, Regulatory CMC, Pre-Clinical Regulatory, Project Management, Clinical Operations, Biostatistics/Programing/Data Management, Pharmacovigilance and Post Marketing Surveillance. As an executive corporate officer of MSD Japan, this position is also responsible for strategy and execution of multiple MSD Japan activities beyond drug development like commercial aspect of pharmaceutical business, HR activities, government relations, media relations, academia relations and interactions with corporate functions of Merck US headquarters. Pfizer Head of Medical Affairs, Japan & Asia-Pacific Region, Pfizer Specialty Care Business Unit January 2010 February 2012 The role and responsibility of Medical Affairs organization was evolving at that time and covering: data generation (investigator initiated research and Phase IV study), data dissemination (publication, conference presentation and advisory board), KOL management, medico-marketing, field force training, medical and ethical compliance, grant and donation management, promotional material review, medical support for pipeline products, Life Cycle planning and Business Development, representation of Pfizer for risk / benefit communication and ensuring safe and effective use of our products. In Specialty Care BU, we were managing diverse therapeutic areas like Vaccine, Rheumatology / Auto-Immune disease, Endocrinology, Ophthalmology, Hematology, Infectious Disease and Pulmonary Vascular Disease. I was leading 48 people including 37 in Japan and approximately $17M for research activities in Asia Pacific (total budget was $29.5M in 2011). My role was the head of Japan and the regional head of Asia Pacific in Specialty Care Business Unit with Medical Director of Korea and Medical Director of Australia/NZ reporting to me. We conducted approximately 40 investigator initiated research in the region both in 2010 and 2011.

3 Executive Director, Head of Regulatory Affairs Department, Development Japan, Pfizer Global R&D March 2008 December 2009 Regulatory Affairs Department in Development Japan was responsible for Regulatory Strategy, Regulatory Operations, Clinical Safety, Medical Writing and Quality Assurance. With having approximately 100 people and 7 direct reports in the organization, I led all of drug development activities related to the Japanese regulatory authorities (PMDA and MHLW). In addition, another important area of business is influencing external environment by closely working with key external stakeholders and through industry associations like PhRMA, DIA, etc.. Regulatory responsibility for marketed/in-line products also came under me on September 1, I was reporting to the head of Development Japan with dotted line reporting to the worldwide head of Regulatory & QA enabling work as a global management team member of World Wide Regulatory Affairs & QA of headquarters. I directly worked for strategy and negotiation for major PMDA interactions in this role. Executive Director, Head of Development Operations Japan, Development Japan, Pfizer Global R&D September 2005 February 2008 Development Operations Japan was an organization of more than 170 headcounts and 8B Yen budget (in 2007: study grants, outsourcing, compensation and discretionary). Major functions in this organization ware Study Management, Monitoring, Document Management, Biostatistics & Programming, Data Management and SOP Management. This organization managed approximately studies including Phase I-IV studies in a year by closely working with the line of Japan Project Team Leaders. Workloads equivalent to 1.5B Yen were managed by outsourcing. Majority of studies were conducted in Japanese study sites as local studies or by participating into globally led multinational trials. However some of Japan led studies involved study sites in Asian countries like Korea, Hong Kong and Taiwan. I reported to the head of Development Japan. In addition, I was reporting to the World Wide head of Development Operations in the US headquarter to work as global management team of WW Development Operations. There were five direct reports to me. Development Operations worked for 51 projects and 44 studies in All of 2007 key project / study milestones were met on time without any quality issues in spite that we increased the number of study by 66% under flat headcount. I was very successful to keep people highly motivated and engaged under this environment. The voluntary turn over rate in my organization was lower than 5% per year both in 2006 and As a Development organization management team member, I attended PMDA consultation for most of key projects in There were several key strategic organizational initiatives I successfully initiated and implemented from the beginning of 2006 to the end of 2007.

4 1. Creating functional service providers (FSP) for Monitoring activities. FSP monitors worked under Pfizer SOP, Systems and Processes like natural extension of Pfizer monitors based on Master Service Agreement. Resource can be flexibly allocated across studies based on work orders. This initiative led to just in time flexibility of monitoring resource and 35% reduction of monitoring unit cost by keeping quality. 2. Streamlining processes and systems between Japan and Western major R&D sites. Through this initiative all of clinical trial related systems including that of electronic data capture, language, SOPs and drug supply processes became the same, enabling easier conduct of multinational clinical trials. We became working under a single standard, the same systems and processes around the globe. 3. Off-shoring of non core Biometrics Operations activities to Shanghai China. I initiated building up of a Japan support group in Shanghai China as our Biometircs Operations off shore center in late This center successfully worked and delivered high quality data timely and cost effectively. 4. Cost reduction in Per Subject Cost (PSC) in clinical trials. Cost containment processes became in place in the organization. 4-5 years before that, Japanese PSC was 4-5 times higher than that of the West. Now it became less than 2, on average , sometimes less than Productivity increase thorough individual capability development and continuous process improvement. All lines in my organization had clear metrics to measure output per headcount (including outsourcing). We have achieved more than 10% improvement in all lines both in 2006 and Speed initiative. We have set Speed goals in all of cycle times in clinical trials (e.g. LSLV to DB Lock). We are now the best in Japan as long as we know from CMR benchmark data and better than Pfizer Western R&D sites. 7. Enhanced Clinical Trial Design initiative. This is a joint effort between Statisticians, Clinicians and Clinical Pharmacologists. Adaptive study design and statistical modeling in study design are now business as usual. 8. Zero study failure philosophy. Our ultimate goal is to win in all of clinical trials. In 2006 and 2007, we have achieved 100% study success by sophisticated study design and thoughtful data / subjects monitoring / corrective actions during study conduct. Vice President, Groton/New London Site Head of Development Operations, CT, USA, World Wide Development, Pfizer Global R&D November 2004 July 2005 Major functions in this organization were Study Management, USA Monitoring, Biostatistics & Programming, Data Management, Medical Writing, SOP management and Operations Team Leaders Group. With approximately $160M annual budget and 600 colleagues (in 2005), I was responsible for execution of projects by closely working with Clinical Research Group (MD clinicians) and Development Team Leaders with focus on operational excellence in cost, speed and quality.

5 We managed more than 300 studies in a year, approximately 40% of Pfizer Global R&D studies in those days. In 1Q and 2Q 2005, the term of my responsibility, the schedule was on time in approximately 95% of projects in spite that cost reduction initiatives like aggressive outsourcing and off shoring to low cost countries were implemented. Japan Development Team Leader for Voriconazole, Clinical Research Group, Development Japan, Pfizer Global R&D June April 2005 Voriconazole is an Oral and IV antifungal drug in a class called triazole. I worked as the Japan development team leader of this compound under the global development team closely aligned with Commercial. I made the development plan of the program, ran studies, wrote and submitted the J-NDA in June 2003, wrote and managed responses to regulatory queries and led the project to approval in April 2005 through the cross functional team that consists of approximately 30 colleagues. I also worked for pricing negotiations with MHLW with Market Access group, key opinion leaders management and publication and symposium in academic societies. I managed both timeline and budget very well. I led the team to obtain great label that is very attractive by meeting expectations from Commercial. While I was in the US as the site head of Development Operations, I worked in the both positions concurrently until the approval of Voriconazole in Japan on April In addition, in 2001, I worked for due diligence of Japanese clinical programs for Spiriva in-licensing from Boehringer-Ingelheim to Pfizer. Japan Development Team Leader for Azithromycin Atherosclerosis Program, Clinical Research Group, Development Japan, Pfizer Global R&D January 2000 June 2000 As one of new indication exploration, azithromycin, a macrolide antibiotic, was evaluated for the treatment of atherosclerosis based on the hypothesis that chronic infection of Chlamydia pneumoniae is one of causes for atherosclerosis. I worked as a Japan development team leader for this program in Japan by making the development plan in line with the global development plan. The program was terminated in late 2000 because the efficacy did not meet predefined GO decision criteria in the West.

6 Japan Development Team Leader for CJ-13, 610, Clinical Research Group, Pfizer Global R&D May 1999 December 1999 CJ-13, 610, a 5-lipoxygenase inhibitor, is a compound discovered in legacy Nagoya Pfizer laboratories in Japan. I worked as an exploratory development team leader of this compound in Japan by making the development plan of the program in line with the global development plan. Since the program did not reach POC in neither Asthma nor COPD, the development program was terminated in December Medical training at an academic institution Residency and training in internal medicine and pulmonology, Kawakita General Hospital, Tokyo Japan April 1995 April 1999 Residency and specialty training in internal medicine and pulmonology including out patients management, hospitalized patients management, critical care medicine and invasive procedures like GI endoscopies and bronchial endoscopies at a teaching hospital in Suginami Tokyo Japan. Education April 1989 March 1995: Keio University School of Medicine, Tokyo Qualification April 1995: Medical Doctor (Japanese License Number: ) November 1998: 1 st grade certificate in Finance and Accounting, the Japan Chamber of Commerce and Industry