DECEMBER 12, 2022
Newly created role will expand support for growing number of complex clinical development programs involving medical devices, combination products and diagnostics
CARY, N.C., December 12, 2022 – Global biopharmaceutical services leader, Allucent, announced today the appointment of Sugato De, M.S., as vice president of regulatory strategy and head of medical technology. In this newly created role, Sugato will head the team supporting Allucent’s growing number of clients with complex regulatory and clinical development needs for medical devices, combination products and diagnostics across a broad range of therapeutic areas and modalities. In addition, Sugato will oversee Allucent’s clinical strategy team responsible for clinical study design, evaluation and optimization.
“We’re thrilled to be adding this critical role, and to welcome Sugato as the right expert to fill it,” said Leslie DeVos, president of Allucent’s Regulatory & Drug Development Consulting Business Unit. “Sugato brings the specialized expertise our biotech partners need to navigate complex regulatory and clinical challenges involved in progressing medical technologies and combination products. His expert guidance will bring immense value in helping our clients bring innovative new therapies to market for patients in need in the most effective and efficient way possible.”
Sugato brings extensive and wide-ranging experience in the development and regulation of medical devices and combination products, and in the creation and implementation of clinical development plans. Highlights of his career to date include:
- More than 11 years with the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA), with specialized expertise in drug-device combination products, digital health technology, precision medicine, and critical care medical devices.
- 6+ years in the clinical research and development space as a vice president with Parexel, where he led the Medical Technology practice and served in a senior leadership role for the consulting business unit.
- Provided expert guidance on regulatory strategies, clinical development plans and submissions to support clearances and/or approvals of over 50 medical devices, drugs and biologics, including groundbreaking therapies for oncology, type 1 diabetes and Parkinson’s disease.
- Leading role in both FDA and industry in shaping policy around combination product regulatory policy, including submission requirements, digital health considerations and human factors testing.
“Small and mid-sized biotech companies are the tip of the spear in advancing groundbreaking innovations across oncology, neurology, rare diseases and other indications with the potential to address significant unmet medical needs,” said Sugato. “These companies often face unique regulatory and clinical development challenges that require tailored solutions, and I am honored to join Allucent to apply my expertise to advance breakthrough therapies that will directly impact patients around the world.”
Sugato earned his M.S. in Biomedical Engineering from Johns Hopkins University in 2009 and his B.S. in Biomedical Engineering and Electrical Engineering from Rensselaer Polytechnic Institute in 2007.
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients. Visit Allucent.com for more information.
Patty Collinsworth, Allucent