Michael Stamatis, Pharm.D.

Immuno-oncology

• Offer regulatory strategy support for multiple in-development molecules in Immuno-Oncology, Neuroscience, and Infectious Disease therapeutic areas. • Supported cross-functional clinical filing team in developing original immuno-oncology BLA dossier, including: reviewing summary documents and clinical study reports, leading compilation of documents to meet OSI requirements, leading components of Module 1. •Led subteam to draft USPI for original BLA submission, incorporating FDA guidance and competitive precedence. • Supported cross-functional teams in multiple FDA interactions by supporting or leading drafting of briefing documents and team rehearsal sessions. Interactions included: Type B Pre-Phase 3 and Pre-BLA meetings, Controlled Substance Staff consult, and FDA Office of Policy meeting. • Led the compilation and submission of an IND for a small molecule for pain to FDA's Division of Anesthesia, Analgesia, and Addition Products to successfully initiate Phase 1 trial. • Led the compilation of a CTA for an anti-infective large molecule for submission to Health Canada to successfully initiate Phase 1 trial. • Supported internal working group addressing regulatory challenges associated with the co-development of investigational drugs for combination use. • Contributed to and coordinated submission of routine IND submissions, including: Development Safety Update Reports, Investigator packages (Form FDA 1572 and CVs), and protocol amendments • Maintained internal regulatory strategy documents.

- Completed UConn Honors Thesis based on HSPA6 characterization research. - Investigated the downstream effects of nuclear receptor regulation on heat shock protein expression in association with cell survival and maintenance. - Worked with a graduate student to design, conduct, and troubleshoot experiments. - Analyzed and interpret experimental results.

- Assess and process prescription orders to ensure accuracy. - Perform patient drug utilization review and drug interventions to improve safety. - Counsel patients on effective use of medications and potential adverse reactions. - Interact with doctors’ offices and insurance companies on behalf of the customer in order to provide appropriate service in a retail setting.

• Supported a Drug Information team handling company pharmaceutical products. • Drafted standard drug information letters with a focus on diabetes, anti-coagulation, and anti-hypertensive products. • Reviewed promotional materials for diabetes product launch.

• Supported a Global Regulatory Sciences team with a focus on development strategy for a novel oncology molecule in pre-Phase II development. • Developed competitive analysis spreadsheets on specific oncology molecular targets and supported Phase II protocol planning.