Michael LoPresti
With over 20 years of experience in Japan’s healthcare industry, Michael
LoPresti is a leading expert in clinical and reimbursement evidence generation
for medical devices and regenerative medicines in Japan. As President of
GinePro LLC (https://www.gineprogo.com), and throughout his career, he has
spearheaded more than 400+ reimbursement strategy studies, including over
50+ focused on medical devices, and supported multinational companies and
startups in navigating Japan’s complex regulatory and market access
landscape. His work emphasizes robust HEOR evidence and generation of real-
world evidence (RWE) that contributes to optimal regulatory and reimbursement
approvals in Japan.
Michael is also recognized for his contributions to medical writing, having
authored or co-authored numerous peer-reviewed publications, including key
studies on cost-effectiveness and value-based reimbursement for medical
devices in Japan – and other related topics such as epidemiology studies,
systematic literature reviews, the development of treatment burden scales, and
more.
A passionate advocate for the valued-based assessments of medical devices,
Michael has led teams of professionals in designing and executing HEOR and
RWE studies tailored to Japan’s unique healthcare system. He is also a
member of the Medical Devices and Diagnostics Special Interest Group of
ISPOR and collaborates with other members of that group to advance value-
based evidence for medical devices and IVDs. Fluent in Japanese, Michael
bridges cultural and technical divides to drive innovation in clinical evidence
generation in Japan.
A passionate advocate for the valued-based assessments of medical devices,
Michael has led teams of professionals in designing and executing HEOR and
RWE studies tailored to Japan’s unique healthcare system. He is also a
member of the Medical Devices and Diagnostics Special Interest Group of
ISPOR and collaborates with other members of that group to advance value-
based evidence for medical devices and IVDs. Fluent in Japanese, Michael
bridges cultural and technical divides to drive innovation in clinical evidence
generation in Japan.