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.
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.
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.
Dr. Kanmuri has over 20 years of extensive clinical development expertise covering indications for cardiovascular diseases, renal diseases, hepatic diseases, and obesity, in addition to various rare disease applications including gene therapies 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 since 2007 in positions of increasing responsibility in the field of clinical research focusing primarily on products indicated for cardiovascular metabolic illnesses 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 organizations, 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 chairperson of program committee for DIA Japan Symposium focused AI and digital technology in 2019.
Executive Director, Scientific Affairs
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 Director of Regulatory Affairs managing both regulatory strategy and regulatory operations including Ascent’s In-Country Caretaker function.
Dr. Okamoto brings in more than 30 years of expertise in Chemistry, Manufacturing and Controls (CMC) across a wide range of areas which include Regulatory CMC, CMC Project Management and GMP control (QA and QC), outsourcing and technology transfers for biologics (vaccines, antibodies, cytokines), regenerative medicines and RNAi therapeutics.
Dr. Okamoto started his career as a Researcher for Key Technology Laboratories before being part of Kirin Pharma for 12 years as a Senior Researcher and a Project Manager for the CMC Laboratory where he was involved in the development of various analytical methods and production/CMC platforms for biologics such as pharmaceutical antibodies. While working at Kirin, he also earned his PhD in Agricultural Chemistry (current Applied Bioscience) from University of Osaka Prefecture. Dr. Okamoto later joined UMN Pharma as the Vice-president and General Manager for Production and Development Division where he became a significant contributor in the design of the facility for recombinant vaccines and the successful tech-transfer of vaccine productions from US to Japan.
He further expanded his career in Regulatory Affairs when he joined Novartis Pharma as a Regulatory CMC Manager and later on at Cellseed as a Senior Director for Regulatory Affairs where he led development programs for regenerative medicines as well as successful vaccine registrations in Japan. Dr. Okamoto also has extensive GMP expertise with his experience in leading numerous PMDA/MHLW inspections and in conducting audits and quality control of contract manufacturing sites and laboratories. He also spearheaded construction of GMP organizations while at UMN Pharma and NapaJen.
Ms. Kurai has spent nearly 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 suppliers while establishing and maintaining good business relationship.
Ms. Kurai left the company to enrich her English skills and earned 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 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 Director, Project Management to take care of strategy/regulatory management, project management and business/corporate management.
Ms. Tsutsui has over 11 years of clinical research and project management experience across a wide array of therapeutic areas under academic, clinical, and commercial settings.
Following her high school graduation in Japan, Ms. Tsutsui moved to the United Kingdom and received her Bachelors of Science in Physiology from the University of Manchester. After spending a year working as a Research Assistant in the university’s neural developmental biology laboratory, Ms. Tsutsui worked for Hammersmith Medicines Research in London as a research associate and quality coordinator to support and establish the Japanese “ethnic bridging” study team.
In 2010 Ms. Tsutsui became a Clinical Research Practitioner at the Royal Free Hospital in London, where she spent 3 years managing Phase 2 through 4 oncology studies. After gaining clinical experience at the hospital, Ms. Tsutsui moved into project management roles at King’s College London and Queen Mary University of London, where she was responsible for the oversight and delivery of multi-national European studies in kidney transplantation and rheumatoid arthritis, respectively. In 2015, Ms. Tsutsui joined Chiltern UK as a Project Manager where she was responsible for the delivery of global phase 2 and 3 studies in the areas of respiratory and rare disease. From 2016, Ms. Tsutsui was given the additional role in Business Development, with a focus on expanding relationships and generating new business opportunities for Chiltern’s Japanese client base.
Following Covance’s acquisitions of Chiltern and IDA in 2017, Ms. Tsutsui moved back to Japan to join IDA as an Associate Director of Program Management where she was responsible for managing programs on behalf of foreign clients across regulatory strategy and clinical trial implementation phases, as well as supporting business and corporate development objectives.
Ms. Tsutsui joined Ascent in 2020 as a Director of Strategic Development to lead Strategic and Business Development activities.
Ms. Kikuchi serves as Manager, Clinical Development. 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 both Japanese and Korean clinical operations support organizational development of Ascent’s clinical operations team.