Samantha Holmes Email and Phone Number

- Program management of major regulatory filings (INDs, NDAs, MAAs)- Identify and implement learning and submission strategy across programs - Centralized support of all submission-specific program activities - Oversight and coordination of medical writing activities

• Working with internal stakeholders and direct manager to develop and execute regulatory project plans for assigned projects. • Plan and prepare documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities.• Participate in and represent Regulatory Affairs on assigned project teams.• Support external collaboration as they relate to regulatory deliverables.• Ensure the timely completion of appropriate regulatory filings to global health authorities.• Exercise good judgement in elevating and communicating actual or potential issues.

• Working with internal stakeholders and direct manager to develop and execute regulatory project plans for assigned projects. • Plan and prepare documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities.• Participate in and represent Regulatory Affairs on assigned project teams.• Support external collaboration as they relate to regulatory deliverables.• Ensure the timely completion of appropriate regulatory filings to global health authorities.• Exercise good judgement in elevating and communicating actual or potential issues.

• Responsible for organizing, creating, and managing Microsoft Project timelines and tabulated outlines for the BLU-782 IND submission to the FDA• Utilize OnePager to visually depict the Gantt charts generated from Microsoft Project• Manage and facilitate Regulatory meetings • Assign individuals as authors, reviewers, and approvers for all the document to be submitted to the FDA• Set up and enforce submission dates and deadlines, meetings, agendas, and updates• Maintain communication and direct contact with Directors and Team Members • Know how to communicate with different personality types to ensure overall progress and success • Become familiar with other programs, such as avapritinib, BLU-554 and BLU-667, that are also undergoing regulatory approval

Conducted research surrounding the stem cell basis of skeletal muscle and disease, with particular focus on fibrodysplasia ossificans progressiva (FOP) Utilized the Cre system to experiment with and observe the effects MyoD, Myf5, and knocked out versions have on embryo muscle regeneration as well as conducting studies surrounding Fibrodysplasia Ossificans Progressiva (FOP)Completed various sectioning and histology techniques of post-injury mouse samples

• Successfully cloned and ligated several PDGFRA constructs into desired viral vector backbones using methods of PCR and restriction enzymes, as well as completed Mini preps and Maxi preps to extract the purified DNA• Became very proficient at sending samples to be sequenced, analysis of sequencing results, primer design, and gene synthesis design• Performed transfections into 293T cells and retroviral transfections into Ba/F3 suspension cells, which led to the execution of drug resistance screens and proliferation assays • Additionally completed PCR reactions, PCR purifications, running of gels, gel extractions, RNA extractions, cDNA synthesis, Genomic DNA extractions, western blots, and cell culture

Measured hox gene expression in bryozoans by completing transcription and labeling protocols, in-situ hybridizations, creating specific probes, staining the tissues, and then visualizing under the wide field fluorescent and confocal microscopes

Taught staining protocols for auto-fluorescent slides, coverslips and frozen thick sections, made sure reagents and buffers were fully stocked, and helped with imaging on the confocal microscope.Conducted and graded practical exams, where students had to perform different tasks on the microscope and associated software.Commented and graded students on their final portfolios at the end of each semester.

Member of the MM-310 team working on the following tasks:- Created and evaluated mouse models for various cancer cell lines and PDX models and observed how they respond to specific chemotherapeutic nanoliposomes. - Maintained the cell lines, prepared cultures for inoculation, injected mice via subcutaneous and tail vein, and completed PDX harvesting.- Helped with IFP study and tissue staining as well as observed perfusions - Weighed mice, measured mouse tumors, randomization based on weight, calculated dosages, euthanized mice and removed their tumors- Literature research for new murine models - Worked with different strains of mice for various experiments

Focused on three main projects; process optimization, off-target activity, and AGT ELISAs which all consisted of copious amounts of screenings of various targets and in vitro lab work.

The explore post allowed students, like myself to explore the different departments in the hospital to further our understanding of what goes on in the hospital. We also talked with doctors, nurses, and people specialized in certain topics. We visited the ER, X-Ray, ICU, Maternity, Pathology, Lab, OR, and the morgue.