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.
Ariel “Ari” Weber recently joined Ascent Therapeutics as Associate Director, Regulatory Affairs. Prior to joining Ascent, Ari was a full-time staffer at PMDA in multiple roles, and has broad and in-depth experience working with the staff of departments throughout the agency. Ari also regularly participated in MHLW lawmaking project teams tasked with developing amendments to Japan’s controlling Pharmaceutical and Medical Devices Act, as well as policy-based responses to issues identified. Ari became PMDA’s first non-Japanese staff member in July 2016.
Prior to joining PMDA in Tokyo, Ari worked while attending law and graduate school. He was most recently a Policy Analyst at FDA in its Division of International Drug Quality for two years, leaving FDA temporarily for three months to work as a Summer Associate attorney in the Boston and Tokyo offices of Jones Day, an international law firm. Before joining FDA, Ari worked for the U.S. Securities and Exchange Commission’s Division of Corporation Finance reviewing the technical content of biopharmaceutical industry investor disclosures as an interagency liaison with FDA. Outside of government service, Ari also frequently provides advice to drug and device companies regarding entrance to the Japanese market and navigating the regulatory landscape. Notable independent projects include providing regulatory advice and translation/interpretation services to Gilead Sciences’ then newly-established Japanese entity. Ari’s work supported the company’s 2015 marketing approval for its curative anti-hepatitis C combination drug Harvoni in Japan. Ari is bilingual in Japanese and English and literate in Mandarin Chinese. He earned B.A. degrees in Neuroscience and Japanese from Dartmouth College in 2009, a M.S. in Pharmacology from The Ohio State University College of Medicine in 2016, and a J.D. from The American University Washington College of Law in 2016. Ari is admitted to practice law in New Jersey, USA.
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 planned 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.
While she was spending a year in Singapore providing translating services for medical firms, Ms. Kurai remotely joined Ascent as a project manager to take care of strategy/regulatory management, project management and business/corporate management. She relocated to Tokyo in July 2018.
Maricris has been with the Clinical research industry for over 12 years. She has handled various phases of Clinical Trials and a wide range of therapeutic areas. She has experience in Clinical Trial Management, Quality Management and Training, Business Development and Line Management. Maricris has a degree of Public Health from the University of the Philippines Manila and is a licensed medical technologist.
Maricris first worked in GlaxoSmithKline Philippines as a Clinical Trial Assistant then promoted to a Clinical Research Associate in 2007 where she has handled several Phase II-IV Vaccine Trials and Epidemiological Studies. Maricris joined IQVIA (Formerly Quintiles) in 2009 as a Clinical Research Associate II handling also several Phase II-III Vaccine Clinical Trials where she also served as a Lead CRA. In 2011, Maricris joined Covance Asia Pacific as a Senior Clinical Research Associate where she experienced several Phase II-III and Registry Trials in Infectious Diseases, Endocrinology (Diabetes and CKD), Psychiatry/ CNS (Schizophrenia, Bipolar 1 and Major Depressive Disorder), Cardiology, Oncology and Hematology Studies. She has also been a Clinical Team Lead for studies in Asia Pacific including Philippines and South Korea. She is also a certified Clinical Quality Control Assessor conducting Quality Visits for Asia Pacific.
In 2015, Maricris joined ICON Clinical Research as a Clinical Trial Manager where she handled several studies for Phase III-Phase IV Rheumatology and Endocrinology in Asia Pacific including Philippines, South Korea, Malaysia, Hong Kong, China, Thailand, Taiwan, Australia and New Zealand. In 2016, Maricris left ICON and joined Integrated Development Associates (IDA) as a Supervisor for Quality Assurance, Training and Process Development. In this position, she was able to ensure that all IDA’s Procedural Documents are aligned with the current laws and regulations including ICH-GCP. She has also conducted several trainings for CRAs and ensured that IDA’s training is up to date. She was then promoted to Manager for Program Management where she has handled Phase III Trials on Rheumatology, Pulmonology and Hematology in several Asia Pacific Countries including Philippines, South Korea and Australia. Maricris is also immersed with Business Development in IDA and also act as the head of operations in the Philippines.
Maricris joined Ascent Therapeutics in 2019 as a Manager for Clinical Operations where she will take lead on different Clinical Trials for Asia Pacific and head the Operations in the Philippines.
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. Miki 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. Miki 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, Miki 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. Miki provided guidance in developing the skills of internal staff as well as managing external CRO staff and contractors. Miki’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, Miki leads both Japanese and Korean clinical operations supports organizational development of Ascent’s clinical operations team.