Robert Lee Hummel, Sr. Email and Phone Number

With a career dedicated to safeguarding the safety and well-being of human subjects who volunteer for clinical trials, my role as a Senior Human Subjects Protection Scientist at the US Army Medical Research and Development Command (USAMRDC) underscores my commitment to the ethical conduct of clinical research practices. Particularly regarding the conduct of human clinical trials of prophylactic and therapeutic ethical drugs, biologics, such as immunoprophylactic and immunotherapeutic vaccines, and medical devices, such as cardiac pacemakers, magnetic resonance imaging (MRI) scanners, and computerized tomography (CT) scanners intended for human use.During my tenure at the US Food and Drug Administration (FDAj, as a compliance policy analyst my contributions have helped shaped the implementation of critical compliance policies, pertinent to the regulations promulgated by the FDA, across multiple FDA centers, such as the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation Research (CBER), and the Center for Devices and Radiological Health (CDRH). My expertise in regulatory affairs is not just a profession, it's a mission to protect and advance public health, guided by a my rigorous Regulatory Affairs Certification and a history of fostering collaborative success in high-stakes environments dedicated to the FDA approval of drugs, licensing of biologics, and clearance of human medical devices. My ongoing continual mastery in FDA-related regulatory affairs and compliance policies has been a cornerstone for me, ensuring the integrity of FDA’s Human Subjects Protection (HSP) program, which is dedicated to the protection of humans who volunteer to participate in the clinical trials of drugs, biologics, and medical devices intended for human use. I was also involved in FDA’s Bioresearch Monitoring (BiMo) program, which involved monitoring the ethical conduct of clinical trials to ensure that they were compliant with Good Laboratory Practice (GLP), for the conduct of non clinical laboratory studies, Good Manufacturing Practice (GMP), for the manufacture of drugs, biologics, and medical devices intended for human use, and Good Clinical Practice (GCP) for the ethical conduct of the clinical trials of drugs, biologics, and medical devices intended for human use.As an active-duty soldier in the US Army, I was an Army medic who participanted in numerous Phase I clinical trials (First Time in Humans) of numerous human drugs, such as the antiviral drug, Ribavirin, and vaccines such as one to treat Rift Valley Fever.