Brendan B. Email & Phone Number

Washington, Dc, Us

• Global Regulatory Affairs Lead representing the organization before Health Authorities • Quarterbacking, Leading multiple winning Health Authority interactions• Shaving months off the FDA approval timeline • FDA Office of Orthopaedic Devices sponsor consulting• FDA Division of Gene Therapy sponsor consulting • Medical writing

Westborough, Ma, Us

• Regulatory Affairs, institutional review board (IRB), FDA, clinical trials, & GCP auditing lead subject matter expert• GCP auditing of cancer clinical trials• Develop and conduct employee regulatory training• New drug applications (NDAs)• Adeno-associated virus-based therapeutics• in vitro diagnostic (IVD) biomarkers• Human cells, tissues, and cellular and tissue-based products (HCT/Ps) (i.e. "361 tissue products") • Therapeutic areas: AAV, CAR-T, Immunooncology, Oncology, Orthopaedics, Neurology, Sports Medicine, rare diseases• FDA BIMO inspection readiness training for GMP, GLP• Medical writing

Richmond, Va, Us

• Served as Regulatory Affairs subject matter expert (SME) for a Level I trauma center, NCI comprehensive cancer center, Level IV NICU• Authored, e-filed winning appeal before FDA, Division of Diabetes, Lipid Disorders & Obesity (DDLO) to Office of New Drugs (OND) — Policy clearing the path for destination medicine• Scratch-built a clinical trial monitoring/GCP auditing business unit• Meetings with health authorities• Designed, built and beta tested systems supporting continuous improvement• Managed dozens of INDs across a constellation of therapeutic areas• Regulatory Affairs support for $27 million Neurology clinical research portfolio• Regulatory Affairs support for $25 million opioid Addiction/Psychiatry clinical research portfolio• Therapeutic areas: Addiction, CAR-T, Diabetes, Lipid Disorders, and Obesity, Gastroenterology, Hematology / Oncology, Hepatology, Infectious Disease, Transplant surgery, Neurology, Neurosurgery, Orthopaedics, Pediatrics, Psychiatry• Medical writing

Richmond, Va, Us

• Grateful for the opportunity to have built destination medicine while leading a team to 350% yoy $ growth during a pandemic• Increased patient access to research trials close to home• Built international partnerships to expand treatment options for our suffering patients• Provided physicians with enhanced care options• Delivered superior clinical research enrollment metrics• Consented a teaching case study patient in support of an investigator’s Orthopedics Phase 1 first in human (FIH) study • Consented the 1st patient in the city to receive an experimental orthobiologic treatment by the Principal Investigator• Privileged to consent the 2nd patient in the world to receive an experimental, first in human orthobiologic adjunct plus arthroscopic double-row rotator cuff repair by the Principal Investigator• Designed, evangelized, & implemented a business model that disrupted “household name” medical institutions• Scratch-built a tier 1, phases I-IV Orthopaedics clinical trials business unit across multiple sites• Occasionally out-recruiting all other sites combined, the highest recruiting site, the 1st or second site to activate, randomize, and/or close• Trained, led, followed, and managed principal investigators, staff, and senior leaders on Good Clinical Practice (GCP), FDA & IRB compliance• Oversaw & provided operational leadership to study teams • Drove business development to geometric portfolio growth 3 years on• 300% increase in PI bench depth • Orthobiologics, robots, injectables, gene therapy, regenerative medicine, devices, small molecules, & combo products• Accountable for operational excellence, P&L, trial metrics, communication platforms, and other process improvement initiatives• Functional representative during on-site regulatory inspections• Built strong relationships with physicians, leadership, sponsors, & management • ISO 13485:2016, ISO 14971:2019, 21CFR §820, §312, §314, §50, §56• Physician recruiting• Medical writing

Richmond, Va, Us

• Drafted winning patent appeal brief for Maternal-Fetal Medicine (MFM) patent application to US patent office appeals board resulting in examiner capitulation• Medical device Regulatory Affairs consultant• FDA submissions, Office of Health Technol. 6 • DeviceCo board Regulatory consultant• Medical writing• Worldwide Regulatory strategy• Drafting medical device 510(K) submissions • Drafting, filing QSub/PreStar meeting requests• Regulatory Affairs Certification – US (RAC US)

Silver Spring, Md, Us

• Managed, led, coached, influenced, and mentored cross disciplinary (matrix) teams of medical officers, Engineering, Nonclinical/Pharmacology-Toxicology, Statistics, Chemistry Manufacturing and Control (CMC) and Regulatory Affairs subject matter experts• Championed continuous improvement recommendation implemented across three FDA divisions within the Oncology Center of Excellence (OCE)• Managed the regulatory project development of over a 100 Investigational New Drug (IND) pre-Phase I, Phase I/II/III applications directed to biologics, small molecules, biosimilars, botanicals, companion diagnostics, and a variety of drug/biologic device combinations• Communicated remove clinical hold letter 16 days before the PDUFA VI deadline• Communicated meeting minutes 8-30 days before the BSUFA II or PDUFA VI deadlines• Managed and facilitated face-to-face and teleconference meetings with biopharmaceutical industry sponsors• Extensive regulatory experience within the biopharmaceutical/device industry and a health authority• Thorough knowledge of drug development• Assertive project management skills• Excellent communication, writing, interpersonal, public speaking, and computer skills• Provided regulatory expertise on procedural and documentation requirements as defined by FDA• Triaged submissions for adequacy, completeness, and regulatory compliance• Triaged and elevated SUSARs for clinical team lead /medical officer consideration of risk / benefit to clinical trial patients• Flagged submission deficiencies for cross-disciplinary team members• Monitored applications and managed and tracked submission and maintenance processes to ensure regulatory compliance• Proven passion for continuous improvement• Public trust security clearance