Robert Lee Hummel, Sr.

Experience

• 

  USAMRIID , US Army Medical Research Institute of Infectious Diseases

  Jan 1984 - Sept 1986

  Medical Research Volunteer Subject (MRVS) and Biomedical Laboratory Technician

  Served as a Medical Research Volunteer Subject while a soldier stationed at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) from January 1984 through September 1986 inclusive. During this time, I was an actual human research subject for numerous clinical protocols for various prophylactic and/or therapeutic drugs and vaccines. I participated in a pharmacokinetic (PK) study for pyridostigmine bromide, an anti-nerve agent drug. This drug, termed the Soman Nerve Agent Pretreatment - Pyridostigmine (SNAPP) has received FDA-approval. I feel immensely proud that I played a first-hand role in the R&D of this product, currently fielded to the U.S. military. Another drug clinical trial that I participated in as a MRVS was for the anti-viral drug, ribavirin, to control a subsequent live-challenge sandfly fever infection. I also participated in prophylactic vaccine clinical trials against Argentine Hemorrhagic Fever and Rift Valley Fever, both undergoing Phase I, first-time-in-humans, clinical trials at USAMRIID, before leaving there to become a commissioned infantry officer in the U.S. Army. This practical, real-world experience gave me a rare perspective regarding the conduct of the clinical trials for these, at the time, investigational drugs and vaccines.Supervisor: SSG Robert Bodroghy, US Army (Deceased) Show less

• 

  US Army

  Nov 1986 - Feb 1987

  US Army Officer Candidate and Infantry Officer (in training)

  Attended US Army Officer Candidate School (OCS), Infantry Officer Basic Course (IOBC), Airborne (Parachuting) School, and Ranger (Infantry Commando) School. Transitioned from the enlisted rank of E-5 (Sergeant) to the officer rank of O-1 (2nd Lieutenant). Trained to lead infantry soldiers as an infantry officer in the U.S. Army. Trained to parachute out of military aircraft (C-130 & C-141) as a means of airborne insertion on to the battlefield. Trained to become a U.S. Army Airborne Ranger to engage eventually in airborne infantry commando operations deeply inserted into enemy territory far from operational lines of resupply. Show less

• 

  US Army

  Oct 1987 - May 1990

  Light Infantry Rifle Platoon Leader

  Junior U.S. Army infantry officer responsible for the training and proficiency of a 34-man light-infantry rifle platoon performing infantry combat operations in a tropical environment. Served as a staff officer on battalion level staff supporting the operations functions (S-3) of the battalion commander, including service as the battalion Nuclear, Biological, and Chemical (NBC) Officer. Served on the Judge Advocate General (JAG) staff of the 25th Infantry Division giving divorce briefings and administrating the online transmission of federal income tax returns.Supervisor: Major Donald Dubia (Telephone Number Unavailable) Show less

• 

  Cambridge Consulting Corporation supporting USAMMDA

  Apr 1998 - Aug 2001

  Program Analyst

  I authored Analyses of Alternatives, (AoAs) Life Cycle Cost Estimates (LCCEs), Independent Government Cost Estimates (IGCE's), and Market Investigations (MIs) as a contract employee of Cambridge Consulting Corporation supporting the U.S. Army Medical Materiel Development Activity (USAMMDA) at Fort Detrick, MD.

• 

  Science Applications International

  Aug 2001 - Sept 2005

  Scientific Program Analyst

  Diversely experienced in the life sciences, business, and FDA-related regulatory affairs. Provided the program management and technical support and analysis within" the Medical Chemical and Biological Defense Research Program (MCBDRP) Research Area Directorate 4 (RAD4) of the U.S. Army Medical Research and Materiel Command (USAMRMC) for the development of medical countermeasures to biological and chemical warfare/terrorism agents. Coordinated multiple projects with timely results, and exercised excellent communication skills. Demonstrated a proven ability to build and maintain constructive professional relationships with all interacted stakeholders between the USAMRMC and other organizations, such as the Defense Threat Reduction Agency (DTRA), the Chemical and Biological Medical Systems (CBMS) Joint Project Management Office (JPMO) of the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD), and others. Provided technical support and analysis assessing the scientific merit, military medical research program relevance, and regulatory compliance (human-use, animal-use, laboratory safety, and enVironmental) of proposed peer-reviewed extramural research supporting the USAMRMC's MCBDRP-RAD4. Tracked and managed the review progress of extramural research proposals and assured that all the documentation needed to process the funding of approved research proposals was properly processed and forwarded to the USAMRMC Comptroller's Office representative within the USAMRMC's MCBDRP. Authored technical and programmatic portions of Descriptive Summaries and Accomplishments/Planned Program for DoD FY Budget Estimates for Research, Development, Test, and Evaluation, Defense-Wide for the Chemical and Biological Defense Program relevant to the Basic Research mission of the USAMRMC's MCBDRP. (Contact Supervisor: Yes, Supervisor's Name: Colonel Harry Slife, Supervisor's Phone: 301-619-7363. Show less

• 

  FDA

  Sept 2005 - Feb 2019

  I have drafted, finalized, and coordinated the implementation of compliance policy for the Human Subject Protection-Bioresearch Monitoring (HSP-BiMo) Program within the Medical Products and Tobacco Policy Branch in the Office of Strategic and Operational Policy in the Office of Regulatory Affairs, for all of FDA’s six Centers (CDER, CBER, CDRH, CVM, CFSAN, and CTP). I also drafted, edited, revised, and commented upon various compliance policy documents related to the HSP-BiMo Program such as Chapter 48 of the FDA’s Compliance Program Guidance Manual, specifically the sections relating to clinical investigators, nonclinical laboratories, in vivo bioequivalence, Institutional Review Boards (IRBs), sponsors, Contract Research Organizations (CROs), and clinical trial monitors. I also replied to queries from clinical investigators, nonclinical laboratories, IRBs, sponsors, CROs, and clinical trial monitors, from government, academia, and industry, regarding the protection of human/animal subjects, and the bioresearch monitoring, within the clinical trials of medical products for human/animal use, as well as the data quality, and data integrity, involved therein. I also helped implement the disqualification, or restriction of clinical investigators convicted of, or admitting to, wrongdoing involving investigational, or marketed, medical products seeking the approval of, or already approved by, the US FDA. Show less Formerly managed the technical and regulatory review of Investigational New Drug applications (INDs), New Drug Applications (NDAs), supplemental NDAs (sNDAs), and Drug Master Files (DMFs) by resident review chemists submitted to the Division of Postmarketing Evaluation (DPE) in the Office of New Drug Quality Assessment (ONDQA) of the Office of Pharmaceutical Science (OPS) of the Center for Drug Evaluation and Research (CDER) of the FDA for drug products seeking marketing approval in the USA. Support Pharmaceutical Assessment Leads (PAls) and Branch Chiefs (BCs) within the DPE/ONDQA/OPS/CDER/FDA regarding matters related to the review of the Chemistry, Manufacturing, and Controls (CMC) sections of sNDAs, including their amendments, as well as the CMC sections of NDA annual reports. Provide project management support for the inprocessing of NDA CMC supplements/amendments/annual reports, the processing of multidisciplinary consultations (e.g. microbiological sterility assurance, pharmacological/toxicological consultations, etc.), the continual tracking of NDA CMC supplement/amendment/annual report reviews by resident DPE/ONDQA/OPS/CDER/FDA CMC reviewers, and the final processing and sending of appropriate correspondence (Action Letters) to regulated industry, or other federal agencies, regarding the final disposition (e.g. approval, approvable, not approvable) of their regulatory submissions prior to the GOi?1 Date established by the Prescription Drug User Fee Act (PDUFA Goal Date). Show less

  • Consumer Safety Officer-Human Subject Protection-Bioresearch Monitoring Compliance Policy Analyst

    Apr 2008 - Feb 2019

  • Regulatory Health Project Manager for Quality

    Sept 2005 - Apr 2008
• 

  US Arny Medical Research and Development Command

  Jan 2022 - Dec 2022

  Policy Analyst

  I will serve on an Institutional Review Board (IRB) in the Office of Research Protections within the US Army Medical Research and Development Command on Fort Detrick, MD, USA beginning on Tuesday, January 18, 2022.