Photo By Samuel Mensah | Dr. Chandar Thakur, chief of the Medical Devices and Diagnostics Branch at Defense...... read more read more
FORT DETRICK, Md. – Dr. Chandar Thakur, chief of the Medical Devices and Diagnostics Branch at the Defense Health Agency Research and Development-Medical Research and Development Command’s Office of Regulated Activities, received the 2024 Employee of the Year award for his exemplary regulatory support for the command’s advanced development programs that contribute to Warfighter survivability, force health protection, and readiness.
In announcing the award, DHA R&D-MRDC Director Maj. Gen. Paula Lodi noted that thanks in large part to his leadership, five medical products attained marketing approval by the U.S. Food and Drug Administration last year – believed to be a record number for the organization.
Each of the products meets an urgent military medical requirement to provide Warfighters with cutting-edge solutions that ensure greater resilience, adaptability, and lethality. Thakur’s efforts to field these products, therefore, directly contribute to DHA R&D-MRDC’s success in improving combat casualty care and enhancing human performance.
“It's a great honor to be named as DHA R&D-MRDC Employee of the Year,” says Thakur. “It elevates my confidence level and my motivation to continue striving for the levels of performance that we accomplished last year and continue even further.”
Thakur praised the members of the two teams he leads for their scientific and regulatory affairs management excellence in seeing the five products through the regulatory process to completion last year, along with shepherding many other projects that are currently progressing through the regulatory review process.
Four of the products – the i-STAT Traumatic Brain Injury Whole Blood test, the MEQU Portable Blood and IV Fluid Warmer System, the Automated Processing of the Physiological Registry for Assessment of Injury Severity Hemorrhage Risk Index, and the Infrascanner Model 2500 – received FDA clearances, allowing the devices to be marketed in the United States. The fifth product, the Humacyte acellular tissue engineered vessel, received biologics license application approval from the FDA. These milestones represent the culmination of more than 15 years of development activities and ORA regulatory support to the project management offices for those products.
ORA contributes to DHA R&D-MRDC’s multifaceted effort to integrate medical research and development with Warfighter requirements in a unique way. Its multidisciplinary team of regulatory affairs, compliance and clinical support professionals specialize in guiding regulated medical products through the FDA’s rigorous review process. By identifying and mitigating risks early in the development life cycle, ORA accelerates the delivery of lifesaving drugs, biologics, medical devices, and combination products to the Warfighter. ORA provides its services to partners across DOD. Thakur’s Medical Devices and Diagnostics branch, one of three regulatory branches in ORA, focuses on expeditionary medicine and treatment, brain health protection, and acute care.
“Chandar has been the solid source of regulatory intelligence who makes sure we're getting the most up-to-date understanding of the FDA's thinking and guidance for specific products,” says Lt. Col. Stuart Hobbs, ORA’s deputy director. “He provides constant and steady guidance to ensure his teams get through the development pathway in the shortest and most cost-effective way. It's great to see that steady effort recognized.”
Lisa Borek, ORA’s director and senior regulatory and clinical services manager, who has worked with Thakur since 2015, says the award is a recognition of his strong and unwavering dedication to helping DHA R&D-MRDC develop life-saving treatments, trauma care solutions, and medical devices that harness cutting-edge technologies like artificial intelligence, telemedicine, and human performance optimization.
“When presented with a regulatory obstacle, Chandar views it as a workable challenge,” says Borek. “He has built solid relationships with our FDA partners that serve us well when we need answers to keep a development moving along the regulatory pathway to approval.”
“He cares deeply about the DHA mission and is focused on getting products through the FDA and available to our Service Members,” adds Borek. “He is a tremendous asset to the ORA team.”
Thakur joined ORA in 2013 as a contractor and transitioned to civilian status in 2017. In that time, he’s seen many advances in military medical technologies, but the fundamentals have remained the same; the key, he says, is to stay on top of the latest developments wherever they happen.
“The regulatory environment is always dynamic, always changing,” says Thakur. “It's important to keep up with the current thinking from the FDA. It’s rewarding to support all these product development efforts across MRDC to get them to their finish line, and to put safe and effective medical products into the hands of our Warfighters.”
| Date Taken: | 04.04.2025 |
| Date Posted: | 04.04.2025 13:51 |
| Story ID: | 494596 |
| Location: | FORT DETRICK, MARYLAND, US |
| Web Views: | 89 |
| Downloads: | 1 |
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