Our Team

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Samuel Pollard

Representative Director, General Manager

Samuel has over a decade of experience and expertise in biomedical research and the regulatory/clinical space with an extensive background in developing and implementing path-to-market strategies, regulatory submissions, and clinical programs for a wide array of therapeutic technologies in the US, EU, and Japan.  As General Manager of Vorpal Technologies, Samuel is passionate about helping companies navigate the complexities of the Japanese regulatory, clinical, reimbursement, and commercialization landscape.

Previously Samuel served as Director of Regulatory Affairs at MCRA, where he focused on the development of regulatory submissions, design and implementation of clinical trials, and assessment of pre-clinical and clinical data in a wide array of therapeutic areas including orthopedics, cardiovascular, and wound care. 

Since joining MCRA in 2013, Samuel has developed and reviewed hundreds of regulatory submissions for medical devices including 510(k)s, PMAs, De Novos, and IDEs.  In addition, he has developed and reviewed submissions for CDER and CBER products, as well as combination products including IND and pre-IND submissions. He also has many years of international regulatory experience, authoring and reviewing numerous CERs and Technical Files, and assisting with PMDA submissions. Prior to joining MCRA, Samuel worked as a research associate in tissue engineering at the Medical University of South Carolina in Charleston, SC and Clemson University, conducting research in bioprinting and stem cell technology. Samuel received his Bachelor of Science in Bioengineering at Clemson University. Samuel is RAC-certified and is an active member of the Regulatory Affairs Professional Society.
 

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Shinichi Tsugawa

Vice President
Regulatory & Clinical Affairs 

Shinichi Tsugawa has over 20 years of experience in the regulatory, reimbursement, clinical, and quality sector. As Director of the Regulatory and Clinical Affairs team at Vorpal, Shinichi oversees the development and implementation of regulatory, reimbursement, and clinical strategies to navigate the PMDA and MHLW processes and Japanese market entry. Shinichi leverages his broad experience to work closely with others on the Vorpal team to develop and execute creative strategies to bring medical products to the Japanese market. His thorough understanding of the PMDA process allows him to ensure the Vorpal team anticipates potential PMDA questions and hurdles and meets these challenges with pragmatic solutions.
 
Shinichi has over 20 years of experience in domestic and overseas Regulatory Affairs and Quality Assurance in various medical device companies. Prior to joining Vorpal, he managed the Regulatory Affairs and Quality Assurance Department at a global medical device company’s Japanese subsidiary for nearly a decade. He led the establishment of a new functional classification in the national health insurance system for a variety of products with a focus in the Urology field. Shinichi has led a multitude of projects spanning a wide array of therapeutic and product areas including vascular & interventional access, surgical, anesthesia, respiratory, urology inc. interventional urology, hemodialysis, and blood donation set.  

Shinichi holds a master’s degree at Kumamoto University Graduate School in Applied Science.
 

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Hiroshi Ichinose

Director
Regulatory Affairs

Hiroshi Ichinose has 18 years' experience in R&D at a Japanese pharmaceutical company, including clinical trial design, KOL engagement and development of R&D-related systems. He then joined the founding team of a US medical device company's Japanese subsidiary and created the SOPs for a good clinical practice (GCP) clinical trial in advanced wound care. As part of this work, he led the conduct of a GCP clinical trial in Japan. Following regulatory approval, he designed and ran the post-marketing surveillance (PMS) study, established the safety management system, and became the company's safety manager. Since then, Hiroshi has managed regulatory submissions at foreign-affiliated medical and dental device manufacturers. He has a broad range of experience over his 30-year career and has performed safety manager, quality manager and overall responsible person roles. In his free time, Hiroshi enjoys gardening, scuba diving and other marine sports. 

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Hidetoshi Yamamura

Pharmacist, Director
DMAH Manager (So Seki)

Hidetoshi Yamamura is a pharmacist by training with nearly 30 years of experience in the pharmaceutical industry. Hidetoshi Yamamura began his career in clinical trial management and regulatory submissions for 8 years in a Japanese pharmaceutical company followed by 20 years in two foreign-capital pharmaceutical companies where he was responsible for medical device and drug development programs. Since 2019, he has managed Vorpal's Clinical Affairs team, overseeing the clinical portions of PMDA submissions, good clinical practice (GCP) audits and post-marketing surveillance (PMS) studies. Hidetoshi serves as Vorpal’s So Seki where he oversees the overall DMAH process with an emphasis on regulatory and clinical considerations.

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Mari Teshirogi

 Director
DMAH QA manager  (Hin Seki)

After graduating from university and working across a variety of Japanese companies, Mari Teshirogi started her quality management career in a foreign-affiliated medical device manufacturer where she supported external partnerships with key clients and contributed to oversight quality activities including supplier qualification and audits. Next, she moved to Fresenius Kabi Japan where she gained pharmaceutical and medical device quality management experience, serving as Quality Manager to develop and oversee quality strategy to ensure inspection readiness for assigned projects in collaboration with global team members. Mari joined Vorpal in 2017 and leads the quality team, overseeing foreign manufacturing site registrations (FMR), quality management system (QMS) applications and ongoing quality management for approved products for which Vorpal is designated marketing authorization holder (DMAH). Mari serves as Vorpal's quality manager (i.e., Hin Seki), a role she has served in for over five years.

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Hiroshi Torikai

Director
DMAH SA Director (An Seki)

After graduating from university and working across a variety of Japanese companies, Mari Teshirogi started her quality management career in a foreign-affiliated medical device manufacturer where she supported external partnerships with key clients and contributed to oversight quality activities including supplier qualification and audits. Next, she moved to Fresenius Kabi Japan where she gained pharmaceutical and medical device quality management experience, serving as Quality Manager to develop and oversee quality strategy to ensure inspection readiness for assigned projects in collaboration with global team members. Mari joined Vorpal in 2017 and leads the quality team, overseeing foreign manufacturing site registrations (FMR), quality management system (QMS) applications and ongoing quality management for approved products for which Vorpal is designated marketing authorization holder (DMAH). Mari serves as Vorpal's quality manager (i.e., Hin Seki), a role she has served in for over five years.

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Robert E. Claar

Founder, Advisor

Rob Claar co-founded Vorpal Technologies in 2013 to help create solutions for Japan’s device lag and become the premier pathway into Japan for innovative MedTech solutions.

 

-Vorpal is a full-service virtual subsidiary, enabling overseas medtech innovators to enter Japan on their own terms with transparency, confidence and optionality. Vorpal delivers expert solutions in clinical development, regulatory affairs, reimbursement, quality and safety management, logistics and market development.

-Prior to Vorpal, Rob founded Junicon K.K., a healthcare market research and strategy consulting firm. Junicon now has a global reach with offices in the US and Europe and strong affiliations in all major markets.

-Rob has nearly three decades of experience in healthcare innovation management, opportunity assessment, strategy development and implementation. He is passionate about developing innovative solutions for access to Japan’s healthcare market.