Michael Husband, Pmp Email & Phone Number

United States

Leads the development of regulatory strategy for medical devices, digital health products, combination products, in-vitro diagnostics, and companion diagnostics.

Provides regulatory strategy for medical devices, digital health products, combination products, in-vitro diagnostics, and companion diagnostics. Assists industry partners in interactions with the federal government.

Fort Detrick, Maryland

Lead team of 85 employees and oversee 40 ongoing product development projects and 130+ clinical trials within the USAMRMC. Oversee regulatory and clinical support for all FDA-regulated product development and clinical research within USAMRMC. Took on director role and stood up the ORA as an independent organization when it split from US Army Medical Development Activity (USAMMDA) group in 12/2017. ☑FDA Regulatory Compliance: Ensure all FDA sponsorship responsibilities are met under CFR 312 Subpart D for clinical studies and marketing applications submitted by USAMRC and the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) and sponsored by the Surgeon General (TSG).☑ Regulatory Strategy: Supervise and oversee all regulatory scientists and clinical trial managers; create and implement quality and regulatory compliance plans for products to include infectious disease portfolio (vaccines and drug treatments), combat casualty care (lifesaving blood products, forward surgical solutions and traumatic brain injury (TBI) treatment and diagnosis), regenerative medicine (vascular grafts, tissue and skin regeneration, and burn treatment) and military operational medicine (PTSD diagnosis and treatment).☑Clinical Monitoring and Data Management: Supervise all data managers, clinical trial monitors and biostatisticians. Oversee clinical trial agreements statistical analysis plans for all TSG-sponsored trials Monitor metrics and data such as bio statistics, manufacturing and safety KPIs, clinical trial results, regulatory affairs and medical writing and publishing.☑Safety and Manufacturing: Supervise and oversee safety surveillance, pharmacovigilance and the delivery of investigational product to principal investigators for all TSG-sponsored studies. Ensure manufacturing facilities are in compliance with quality system regulations and supervises all input and output of the USAMRMC Electronic Document Control system and Safety Database.

Managed cost, schedule and performance for all projects in the Neurotrauma and Psychological Health Portfolio. Provided strategic support for a suite of projects in the Neurotrauma and Psychological Health Project Management Office. Worked and supervised cross-functional team to establish project scope, define team’s roles and responsibilities, optimize efficient allocation of resources and resolve operational problems to keep projects on-track.☑ Project Oversight: Guided projects through the entire lifecycle from concept and research through clinical trials, manufacturing, testing and approval. Kept projects on schedule and within budget parameters. ☑ Project Scope Clarification: Effectively translated medical concepts from early research phase through manufacturing, testing and FDA approval. Bridged communication gap between scientists and stakeholders.☑ Planning and Execution: Directed planning and execution of diverse project portfolio with budgets up to $100M each. Oversaw Program Objective Memorandum (POM) planning to include Army and Defense Health Program Research Development Test and Evaluation (RDT&E) funding.PROJECT HIGHLIGHTS:➟Directed development of computational Pharmacokinetic/Pharmacodynamics (PK/PD) modeling of drug treatments for Traumatic Brain Injury (TBI) and Post Traumatic Stress Disorder (PTSD).➟Served as Planning and Lifecycle Review Committee (PLRC) chair for laboratory assay for TBI, drug treatment for TBI and drug treatment for PTSD. ➟Selected as the Advanced Development representative and portfolio manager for Combat Casualty Care Research Program and Military Operational Medicine Research Program.➟Served as the Acting Director for Hyperbaric Oxygen Treatment Project Management Office (PMO) from 1/2015 until 10/2015 while maintaining Project Manager duties.➟Served as the PM of primary contractor/developer (Banyan Biomarkers) that created field test for TBI detection in lieu of a CT scan; first FDA clearance received 2/2018.

Managed advanced development efforts and executed project resources for development of medical devices and diagnosis and treatment assays with project budgets up to $100M. Provided solutions and regulatory strategies and oversaw decision gate and development activities for laboratory assay for traumatic brain injury, non-invasive neurodiagnostics, compartment syndrome diagnosis and treatment, field anesthesia, en route medical care, coagulation and hemorrhage control. PM and Contracting Officer Representative (COR) for development contracts, service contracts, grants and Small Business Innovation Research (SBIR) applications. USAMMA’s Office of Research and Technology Applications (ORTA) rep.☑ Project Management: Highlights included predictive mathematical modeling and development of devices for compartment syndrome, hemorrhagic shock and TBI Diagnosis. ☑ Product Management: Assisted with FDA clearance and commercialization of X-Stat device, a hemorrhage control device with non-absorbable, hemostatic sponge that controls severe, life-threatening bleeding wounds in 12/2015.☑ Product Management: Assisted with FDA clearance and commercialization of the initial Brain Scope Ahead 200: electrodes that assess brain function with an EEG brain function index in 5/2015.

Department of Biology instructor for BMS 549: Regulation of Medical Devices course that included an overview of the historical development as well as the current status of the laws, regulations and guidelines governing medical devices. Presented key aspects of gaining regulatory approval for all classes of medical devices using various submission processes including the 510(k) Premarket Notification, the Premarket Approval Application and the Product Development Protocol.

Oversaw advanced development projects for medical devices specializing in non-pharmaceutical respiratory counter-measures as well as pharmaceutical and vaccine delivery devices and diagnostic systems. Worked with and managed interagency agreements with other branches of government to conduct research. Managed procurement efforts for Health and Human Services (HHS) as the Contracting Officer Technical Representative (COTR).☑ Special Program Management: Developed policy for drug/vaccine delivery and respiratory countermeasures for the novel H1N1 pandemic and other all hazards events. Member of International Vaccine Group to develop policy for vaccine acceptance, transfer of custody and distribution to the rest of the world.☑ Technical Expertise: Provided technical guidance for advanced development and testing of portable ventilators and more functional surgical respirators (N95) for mass casualty events and innovative drug and vaccine delivery systems.

Rockville, Md

Served as the Branch Chief of Anesthesiology and Respiratory Devices (ARDB) in the Office of Device Evaluation (ODE) from 9/2007 to 9/2008 and as a reviewer in ARDB 1/2004 to 9/2007. Supervised a team of reviewers and reviewed 510(k)s PMAs, IDEs, pre-IDEs, HDE’s, Risk Determinations, Requests for Designation and 513(g)s throughout CDRH. Provided consult for combination products to the Center for Drugs and Center for Biologics. ☑ Product Development: Worked closely with CDER on several combination products involving aerosolized drugs and developing new policy and guidance for the regulation of these drug/device combinations.☑ Regulatory Compliance: Organized and chaired expert panel meetings to discuss complex regulatory issues and briefed senior Office and Center management on regulatory procedures. ☑ Standards Representation: Served as FDA standards representative for ASTM, IEC and ISO for standards development in the areas of closed loop medical devices, ventilators, anesthesia machines and nebulizers.

Master Of Science - Ms, Applied Biomedical Engineering

Bachelor'S Degree, Biomedical And Chemical Engineering