Robert Lee Hummel, Sr. Email & Phone Number

Fort Detrick, Md, Usa

I have served in the Institutional Review Board Office (IRBO) in the Office of Human and Animal Research Oversight (OHARO) within the US Army Medical Research and Development Command on Fort Detrick, MD, USA.

10903 New Hampshire Avenue, Silver Spring, Md 20993-0002

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.

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).

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.

Fort Detrick, Md

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.

25Th Infantry Division (Light), Schofield Barracks, Hi 96786

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)

Fort Benning, Georgia, United States

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.

Fort Detrick, Md, Usa

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)

Dba, Business Administration

Studied for and completed a Doctor of Business Administration degree.

Graduate Certificate, (Fda) Regulatory Compliance, 3.3 Cum. Gpa

Awarded a 15-credit-hour graduate-level Certificate in Regulatory Compliance from the Graduate Regulatory Compliance Program, directed.

Mba, Business Administration

Bachelor Of Science (Bs), Pre-Medicine/Pre-Medical Studies

Management, Cumulative Grade Points Average (Gpa) 2.43

Activities and Societies: USAF Academy Honor Guard Fancy Rifle Drill TeamAttended seven out of eight semesters as an Air Force Cadet.

High School Diploma, Academic Curriculum, 3.0 Cumulative Gpa

Activities and Societies: Electronics Club, Marching Band, Vocational Industrial Clubs of America (VICA)Attended a local area High School.