Ascent’s team of regulatory and drug development professionals are experts in establishing and implementing regulatory and development strategies that optimally integrate Japan/ PMDA and China/NMPA into global drug development.
Of equal importance, Ascent’s team brings deep experience and understanding related to regulatory strategy and drug development from the perspectives of the US/FDA and EU/EMA. The Ascent team always strives to understand its clients’ overarching global strategy and accordingly develops a plan for the optimal integration of Asia.
Kazuhiro Kanmuri, PhD
Managing Director and Head of Clinical Development APAC
Dr. Kanmuri has over 25 years of extensive clinical development expertise covering indications for cardiovascular and cerebrovascular diseases, renal diseases, endocrinology disease, hepatic diseases, women’s health related diseases, obesity, cancer diseases and respiratory/infectious disease in addition to various rare disease applications including gene therapies/gene editing product and vaccine products.
After receiving his Master’s degree in Organic Chemistry from the Graduate School of Pharmaceutical Sciences at Showa University in 1997, Dr. Kanmuri began his career at Sankyo where he spent 10 years engaging in drug development projects for cardiovascular and other disease areas as a CRA, Clinician, Project Management and Integrated Project Team Leader.
Dr. Kanmuri has worked at Pfizer Japan/Pfizer US since 2007 in positions of increasing responsibility in the field of clinical research focusing primarily on products indicated for cardiovascular metabolic diseases and rare diseases. While with Pfizer, Dr. Kanmuri earned his PhD in Clinical Medicine (Regulatory Science in Pharmaceutical Medicine) from the Graduate School of Pharmaceutical Sciences at Kitasato University in 2013, and also completed the Pfizer Business School master course in 2013. In 2014, Dr. Kanmuri was granted the 2014 People Award in Development Japan.
Dr. Kanmuri is now serving as a professional trainer/talent development consultant at his own firm, Inter-Professional.
Dr. Kanmuri has been registered as a pharmacist in Japan since 1995. While working within the pharmaceutical industry, he also served as a Research Fellow at various academic organizations (Showa university, Kitasato University, Kyoto University and Hosei University), provided lectures for the industry and for graduate students, published scientific papers, performed peer journal reviews, served as an ICH-E7 expert, and has also been serving key roles in DIA Japan including Contents Committee member since 2014 and regional editorial member for DIA Global Forum, and served as vice program committee chairperson for DIA Japan Annual meeting in 2018 as well as serving as chairperson of program committee for DIA Japan Cutting-Edge Series Symposium focused Al and digital technology since 2019.
Robert Teoh, MBBS MD FRCP
Chief Medical Officer
Dr. Teoh brings unique expertise and experience for establishing Pan Asian medical and development for Ascent clients. Dr. Teoh has over 25 years of experience in the biopharmaceutical industry and in clinical contract research organizations (CRO) in East Asia, Switzerland and the USA. Robert worked for Sandoz now Novartis, Tanox Biosystems, Quintiles, and in three CROs which he founded and subsequently sold as growing entities to PPD, United Health, and Chiltern International, respectively.
Robert qualified in medicine from the University of Newcastle upon Tyne, and trained in neurology in Newcastle and at the National Hospital for Nervous Diseases, Royal Postgraduate Medical School, Hammersmith Hospital, and Guys Hospital, London. Following a UK Medical Research Council fellowship, he held a visiting faculty position at Johns Hopkins University, Baltimore, followed by a tenured post at the Chinese University of Hong Kong. He has published over 55 papers in peer reviewed journals and three chapters in books.
He currently sits on the Court of the University of Newcastle upon Tyne, England and on the Central Institutional Review Board (ethics committee) of SingHealth, the largest government hospital group in Singapore.
Yuki Kurai
Vice President, Regulatory Affairs
Ms. Kurai has spent over 20 years in the pharmaceutical and medical device industries, with wide range of experience covering development project management, regulatory affairs, quality system management and supply management.
After receiving her Bachelor’s degree in Literature from Keio University, Ms. Kurai began her career at a major Japanese pharmaceutical company as a purchasing planner, where she worked to control purchase of hundreds of pharmaceutical ingredients and negotiated purchasing conditions mainly with overseas licensers while establishing and maintaining good business relationship.
Ms. Kurai left the company to enrich her English skills and earned a Master’s degree in Interpreting and Translating from University of Bath, UK in 2002, after which she entered the medical device industry. Ms. Kurai spent nearly 10 years in the industry expanding her experience from supply management to international and domestic marketing, R&D management, regulatory affairs and quality system management.
Since 2012, Ms. Kurai served as a project manager of drug development consulting programs at Integrated Development Associates (IDA), where she was responsible for managing programs across both the regulatory strategy and clinical trial startup phases on behalf of overseas pharmaceutical companies seeking new drug development in Japan.
Ms. Kurai remotely joined Ascent in early 2018 while she was spending a year in Singapore providing translating services for pharmaceutical and medical device firms. She has relocated to Tokyo and now serves as a Vice President of Regulatory Affairs to take care of strategy/regulatory management and business/corporate management.
Shimako Oishi, PhD
Vice President, Business and Strategic Development
Dr. Oishi has almost 30 years of experience in the Pharmaceutical Industry in Asia Pacific, North America, and Europe across Phase 1 to 3 studies. This includes 9 years of involvement in Clinical Research Organizations (CRO) as a Project Director, Director and Senior Director of Clinical Development. Dr. Oishi also has 20 years of experience in pharmaceutical companies as a Research Scientist, Project Lead, International Project Lead, Senior Manager and Senior Director.
She started to build her career in Japan where she worked for pharmaceutical companies and CROs after she gained her PhD in Medicinal Chemistry at the School of Pharmacy in University of Washington. Her expertise in clinical development and project management has leveraged her into many significant roles in notable companies. Her therapeutic experiences include Infectious Diseases, Autoimmune/Inflammatory Diseases, Endocrinology, Oncology, Cardiovascular, Immunology, Dermatology and Rare Diseases. She is also a Licensed Pharmacist and has authored several scientific articles from the early 90s up to recent years.
Dr. Oishi joins Ascent in 2024 as the Vice President of Business and Strategic Development.
Fengzhe Jin, PhD
Senior Director, Project Management and Clinical Development – Asia
Dr. Jin joined Ascent in April 2022 as a Senior Director of Project Management and Clinical Development Asia where he is responsible for clinical development activities across Asia Pacific outside Japan.
With over 13 years of experience in Clinical Research Organization (CRO) industry as a Project Director and a Project Manager, Dr. Jin brings to the company his expertise in scientific research, and portfolio/ project management skills spanning, clinical research, medical devices, plastics, automotive, and electronic devices.
He built his career in Project Management with increasing responsibilities to act as a Project Director in various CROs such as PAREXEL International, Quintiles Transnational Japan, INC Research Japan, and Syneos Health Clinical K.K. together with his strong scientific background, strategy planning and leadership skills. His expertise in clinical research for different indications includes Oncology, Central Nerve System, Hematology, Ophthalmology, and immunology.
Dr. Jin completed his Master’s degree and PhD in Engineering in Polymer Chemistry, Kyoto University.
Miki Kikuchi
Director, Clinical Development – Japan
Ms. Kikuchi serves as Director of Clinical Development – Japan. Ms. Kikuchi holds a Master’s degree in Pharmaceutical Sciences from the University of Shizuoka and is a licensed pharmacist in Japan. She brings 11 years of experience in clinical research and drug development activities in roles of increasing responsibility at three different companies. Ms. Kikuchi has a diverse skill set and deep experience in key functions including directing correspondence with auditors and regulatory authorities, managing safety information and ADR reporting, reviewing documentation including clinical trial protocols, organizational SOPs, and ICFs; directing subject enrollment procedures, supervising third-party vendors, and confirming site and operational feasibility.
Ms. Kikuchi started her career as a CRA at MIC Medical Corporation in 2008 on 2 Phase III trials for products targeting multiple sclerosis and osteoporosis. Ms. Kikuchi also experienced corresponding with regulators, managing ADR data collection and reporting, and reviewing CSRs. Ms. Kikuchi moved to EPMate in 2011 to assume greater responsibilities as a CRA. At EPMate, Ms. Kikuchi oversaw a broad variety of supervisory functions on 4 Phase III trials and 2 Phase II trials.
In 2017, Ms. Kikuchi joined Integrated Development Associates (IDA) first as a CTM, before being promoted to Line Manager for Clinical Operations. Her responsibilities involved all aspects of clinical trial planning and implementation, which included substantive interactions with regulatory officials. Ms. Kikuchi provided guidance in developing the skills of internal staff as well as managing external CRO staff and contractors. Ms. Kikuchi’s clinical operations experience includes managing numerous Phase III trials for product development programs targeting indications such as congenital diseases, pancreatic and colorectal cancers, diabetes mellitus, rheumatoid arthritis, renal diseases, osteoporosis, among others.
At Ascent, Ms. Kikuchi leads the Japanese clinical operations and supports organizational development of Ascent’s clinical operations team.
Saori Miyauchi
Director, Clinical Development – Japan
Ms. Miyauchi has more than 18 years of experience in the clinical trial industry with focus on strategy development and project management.
After gaining her degree in Chemistry at Keio University, Ms. Miyauchi started her career in Johnson & Johnson. She managed domestic and global clinical trials, and post-marketing surveillance of a drug and medical device where she was responsible for a variety of roles such as Clinical Trial Manager, CRA, Lead CRA, Medical Writer, Quality Control Manager. She has successfully completed large-scale (2000 cases) and long-term (5 years) post-marketing surveillance, which was the first medical device surveillance in Japan. She also managed the global clinical trial of a biologic product where she was in charge of clinical strategy development, communicating with internal and external key stakeholders.
She then worked for Medidata Solutions where she managed the accreditation program for Medidata cloud products.
After a year, she moved to Parexel International where she handled project management of several multi-national and cross-functional clinical studies. Over the years, Ms. Miyauchi has gained expertise in managing clinical trials in different regions, collaborating with high-level stakeholders, and strong relationship with pharmaceutical companies.
Ms. Miyauchi joined Ascent in 2021 as a Director in Clinical Development – Japan.
John Winebarger
APAC Clinical and Strategic Advisor
Mr. Winebarger has lived and worked in Asia since 1984 with a Japan base and focus. He has focused his career on assisting pharmaceutical companies in integrating Japan and Asia into global regulatory and development strategies for investigational new drugs and devices.
Mr. Winebarger first worked for Otsuka Pharmaceutical Co., Ltd. in Japan and the US from 1988 to 1996, where he assisted in establishing and managing Otsuka’s expanding global clinical development operations. In 1997, Mr. Winebarger joined PPD and initially served as Executive Director of Pan-Asian Business Development. In this position, he was instrumental in building PPD’s product development business which focused on Japanese, Korean and Taiwanese companies seeking entry into the US market. Mr. Winebarger then drove the formation of PPD’s Asian presence both establishing PPD Japan and led a partnering and acquisition strategy that culminated in PPD having a presence in Japan, Korea and 5 Southeast Asian countries.
Mr. Winebarger left PPD in 2004 to establish Integrated Development Associates Co., Ltd. (IDA), where he worked to develop a unique model for enabling US and European companies to integrate Japan and Asia into their global drug development strategies. Through his leadership of IDA, Mr. Winebarger assisted more than 60 companies without a base of Japanese operations in understanding the Japanese medical, regulatory and development landscape, and helping them gain consensus and endorsement from KOLs and PMDA regarding clinical development programs to gain Japanese regulatory approvals. Under Mr. Winebarger’s leadership, IDA also established a Clinical Trial In-Country Caretaker (“CT-ICC”) and MAH infrastructure to operationalize the integration of Japan into global clinical trials and for product registration including for Orphan Drugs and drugs designated by MHLW with particularly high unmet medical needs.In 2018, Mr. Winebarger founded Ascent Development Services to assist companies with establishing Pan Asian development strategies that integrate regulatory pathways to approval in Asia’s major pharmaceutical markets particularly, Japan (PMDA) and China (NMPA). Moreover, Ascent supports companies in leveraging all Asian in order to support the most efficient implementation of clinical trials in the region.
Noboru Sato, PhD
Executive Director, Scientific Affairs (Non-Clinical)
Dr. Sato brings over 30 years of experience in the Pharmaceutical Industry covering a broad range of areas including basic research and drug discovery, clinical research, regulatory affairs and GCP Auditing which enables him to provide a unique and comprehensive perspective to Ascent clients.
After earning his Doctorate Degree in Hokkaido University Post Graduate School, Dr. Sato began his career as an Assistant Professor at the Biochemistry Department of the National Defense Medical College, while simultaneously working as a Research Associate at Harvard Medical School and Visiting Assistant Professor at Brown Medical School.
In 1991, he transferred to GlaxoSmithKline and spent 10 years in positions of increasing responsibility in the fields of basic research for drug discovery and project management for clinical studies and GCP training. In 2003 Dr. Sato became Director of the Regulatory Affairs Consulting Division of CMIC Co., Ltd. From 2006 until 2009 he served as Director of Regulatory Affairs for CSL Behring KK and then as a Principal Consultant at PAREXEL Consulting from 2010-2012. In 2013 he returned to CMIC where he served again for more than 5 years as the head of Consulting Division and RA Consulting Department.
Dr. Sato brings a full range of experience in consulting services on regulatory affairs and drug development strategy including drug development planning & data gap analysis, Clinical Trial Notification (CTN), PMDA Consultation Meeting, New Drug Application (NDA), Orphan Drug Designation (ODD), Foreign Manufacturer’s Accreditation (FMA), Business Licenses (Marketing Business License, Manufacturing Business License).
Dr. Sato joins Ascent as Executive Director of Scientific Affairs managing both regulatory strategy and regulatory operations including Ascent’s In-Country Caretaker function.
Ryosei Kawai, PhD
Senior Consultant, Scientific Affairs (Clinical Pharmacology, DMPK)
Dr. Kawai has 27 years of experience in the pharmaceutical industry as an international scientist and expert in translational drug research and development.
His contribution to multiple global R&D sites in Switzerland, the US, and Japan as a member of the senior leadership team include focusing on Drug Metabolism and Pharmacokinetics (DMPK), clinical pharmacology, modeling & simulation, and translational medicine in global scope, as well as development strategy for regulatory approval in Japan.
He was also a member of the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics, an Associate Editor for Drug Metabolism and Pharmacokinetics, a Council Member in the Japanese Society for the Study of Xenobiotics, and was recipient of the JSSX Fellow in 2008, the Kitagawa Memorial Award in 2010.
He joined the Ascent team in mid-2022 as the Senior Consultant in Clinical Pharmacology.
Tomohito Shibata, PhD
Senior Regulatory Scientist (CMC)
Dr. Shibata offers almost 10 years of experience in clinical research, with therapeutic area in epidermal bullosa, brain tumors, and polycystic kidney disease, etc.
He started his career working as a Project Manager under the Clinical Research Operation Division at the Translational Research Center, Hokkaido University (currently integrated into the department of Hokkaido University Hospital). He then continued to enhance his proficiency in drug development as a CMC expert in the Office of New Drug II of Pharmaceuticals and Medical Devices Agency in Tokyo, being involved in PMDA consultations and CTN/ J-NDA (CTD) reviews.
Before joining Ascent, he also worked as a manager for the policy recommendation development team at the Health and Global Policy Institute. His expertise includes drug analysis (JP, EP, USP general test methods) including analytical instruments, genetic engineering methods (cloning, PCR, etc.), cell biology method (analysis of intracellular expression system of target protein). He has the unique experience of being in the applicant side and also the reviewer side of drug development.
Dr. Shibata joined Ascent in February 2022 and has successfully managed the CMC aspects of Japan development programs on behalf of Ascent clients as a Senior Regulatory Scientist under the Regulatory Affairs Department.