Brian M.

Consulting to build a regulatory writing function and to explore the use of artificial intelligence (AI) in creating regulatory documents.

Consultant: Regulatory Affairs: IND, NDA, BLA, MAA, Meeting Packages, Clinical Development

RPI acquired by Premier Research and rebranded as an independent division, Premier Consulting. Manage and grow a regulatory (submissions)/medical writing service for a Regulatory Affairs consultancy. Hire and manage a team of FTE and contract regulatory writers, write and review CTD submission modules (M1, M2, M4 and M5) for INDs, BLAs, NDAs and MAAs, regulatory meeting packages, an assortment of other regulatory documents (IBs, iPSPs, PIPs, CSRs, CSPs, etc.) as well as medical communication services. Provide advice and strategy for nonclinical and clinical development (study design and presentation of results), and for regulatory submissions. Oversee the production of all CTD documents and accessory regulatory documents for small molecule (505b1 and 505b2), biologics, cell (CAR-T, NK, stem cell) and gene (iRNA, AAV, addition, editing) therapy products and devices across a very wide spectrum of therapeutic areas (Oncology, Immunology and Rheumatology, Analgesics, Dermatology, Opthalmalogy, Neurology and Mood Disorders, Gastroenterology and Metabolism, Cardiology, Women's Health, Emergency Medicine, Transplantation, Blood Disorders, Rare Disease, as well as others). Build infrastructure for efficient preparation of submission documents, set budgets, created quality controls, mentored other writers and company staff. Senior management within company structure.

A continuation of Director role. Created a regulatory (submissions)/medical writing service for a Regulatory Affairs consultancy. Hired and managed a team of FTE and contract regulatory writers, wrote and reviewed CTD submission modules (M1, M2, M4 and M5) for INDs, BLAs, NDAs and MAAs, regulatory meeting packages, an assortment of other regulatory documents (IBs, iPSPs, PIPs, CSRs, CSPs, etc.). Provided advice and strategy for nonclinical and clinical development (study design and presentation of results), and for regulatory submissions. Oversaw the production of all CTD documents and accessory regulatory documents for small molecule (505b1 and 505b2), biologics, cell and gene therapy products and devices across a very wide spectrum of therapeutic areas (Oncology, Immunology and Rheumatology, Analgesics, Dermatology, Opthalmalogy, Neurology and Mood Disorders, Gastroenterology and Metabolism, Cardiology, Women's Health, Emergency Medicine, Transplantation, Blood Disorders, Rare Disease, as well as others). Built infrastructure for efficient preparation of submission documents, set budgets, created quality controls, mentored other writers and company staff. Senior management with company.

Preparation of clinical developments, regulatory and safety deliverables including: Common Technical Document (CTD and eCTD) – Submission documents: Clinical Overviews (Module 2.5) and Clinical Summaries (Module 2.7), Clinical Study Reports (Phase I to IV), Clinical Protocols, Investigator Brochures, Clinical Narratives, Drug and Periodic Safety Update Reports (DSUR/ PBRER), Risk Management Plans, Quality Assurance, proficient GCP, ICH, FDA and EMA guidance relevant to clinical and safety data. Therapeutic areas: Oncology, Neurology/Psychiatry, Vaccines, Hematology, Immunology, Cardiovascular, others. Contract assignments, completed with minimum oversight, early or on time, consistently. Manage multiple assignments simultaneously, and work in cross-functional, multicultural and international clinical trial teams. Mentor to more junior colleagues. Excellent verbal, written and presentation skills (English/Biomedical/Clinical).

Medical communications. Planned, created, edited and published biomedical, clinical, technical and educational documents. Devised medical/biomedical communication strategies. Identified and liaised with key opinion leaders, internal and external stakeholders, and influencers.

Medical School Professor and Medical Research Scientist