Brandon Macisaac Email & Phone Number

San Francisco Bay Area

San Francisco Bay Area

San Francisco Bay Area

• Assist with FDA submission strategy, program management and submission of Pre-Market Tobacco Applications (PMTA)• Well-versed in e-cigarette/ENDS regulatory guidances (FDA/CTP, PMTA (ENDS), TPSAC, Health Canada)• Provide regulatory guidance regarding FDA PMTA and Center for Tobacco Products (CTP) for cross-functional groups within the company (Product development, Engineering, Marketing, Underage Use and Access Control Integration, Net Population Health Impact, Clinical, Non-Clinical, Marketing & Consumer Insights)• Management of 13 Clinical Study Report (CSR) reviews and writing from shell creation to CSR sign-off and finalization.

San Francisco Bay Area

•Electronic Nicotine Delivery System (ENDS)/e-cigarette clinical trials (Pharmacokinetic, Biomarkers of Exposure, Topography, Environmental, Intellectual Property)•CRO management and deliverable tracking•On-site vendor training, oversight and supervision of clinical conduct for clinical trials•Clinical Standard Operating Procedure development•Study start-up, conduct and closeout activities•Clinical Study Report review management•New hire on boarding and training•Investigational property management•eTMF audit readiness

Foster City

Clinical Contracts and Finance• Quality check and remediate phase I-IV clinical and vendor contracts for Medicines and Healthcare products Regulatory Agency (MHRA) company audit.• Assist in the successful start-up of a novel functional area (Document Management) within Clinical Contracts and Finance Department to be utilized corporately.• Collaborate closely with all functions in Gilead Clinical Contracts and Finance (Payments, Document Management, Vendor Outsourcing, Site Contracts, IT, Regulatory Compliance) to ensure all company clinical studies are in a state of audit-readiness.• Various simultaneous Project Management relating to document management and eTMF with often fluid or shortening deadlines.• Compose and execute process guidance’s and project proposals for independent, and large team document management projects.

Stanford, Ca

Department of Anesthesia, Perioperative and Pain Medicine• Lead coordinator for National Institutes of Health funded K23 grant and team member of large P01 center grant.• Manage patient treatment administration for two clinical studies across nine sites in San Francisco Bay Area.• Audit and approve treatment payments for multiple providers• Optimize and maintain patient recruitment through traditional and online means.• Schedule, screen (physical, psychological) and conduct Quantitative Sensory Testing on patients.• Create, maintain and perform quality control on Electronic Data Capture platforms for clinical studies.• Prepare Data Safety Monitoring Board documentation and upkeep regulatory binders.• Communicate concepts of pain research, alternative medicine therapy and quantitative sensory testing to patients.Notable projects include: Stanford Center for Back Pain - backpainstudy.stanford.edu Predicting Analgesic Response to Acupuncture - https://med.stanford.edu/pain/snapl/current-studies/acupuncture.html

Stanford, Ca

Department of Medicine• Independently developed protocols to be used in T regulatory cell proliferation assays and immunoassays.• Acquired, stored (physically, electronically) and experimented with human primary samples (blood, urine, stool, saliva).• Presented research findings to mentors and collaborators linking heavy metal exposure to asthma development• Lab supply procurement for moderately sized research group (15-20 members)Notable projects include:Effects of second-hand smoke exposure and air pollutants on peripheral blood immune cell populationsExposure to Cadmium alters T lymphocyte populations in infant cord blood http://med.stanford.edu/allergyandasthma.html

Edmonton, Ab

Department of Medical Microbiology and Immunology• Performed experiments using human blood and tissue biopsies to research the development of a functional crossmatch using Natural Killer cell-mediated cytotoxicity assays for organ transplants.• Presented research at year-end group presentations for panel of mentors and peers.http://www.mmi.med.ualberta.ca/

Courtenay, Bc