“Magrolimab is a potential, first-in-class investigational monoclonal antibody that binds to CD47. The primary mechanism of action of magrolimab is to block the inhibitory CD47-signal regulatory protein (SIRP?) interaction, enhancing the ability of macrophages and other phagocytes to identify and destroy foreign and malignant cells, with the goal of blocking the “don’t eat me” signal used by cancer cells. Magrolimab is a novel immunotherapy being developed in several hematologic cancers and solid tumor malignancies.” (quoted from Gilead Sciences, Press Release).

My Projects:

CSR pre-data draft process:

1. Created an initial shell document in the RDMS (Regulatory Database Management System).
2. Scheduled meetings with the lead medical writer and subject matter experts.
3. Analyzed model Clinical Study Reports (CSRs) to comprehend formatting and requirements.
4. Participated in timeline update meetings.
5. Reviewed protocols, statistical analysis plans, and data from prior amendments.
6. Initiated drafting the preliminary content pre-data stage using existing and new information.
7. Addressed style and accuracy comments from the lead medical writer.
8. Acquired and reviewed Table, Figures, and Listings (TFLs), and incorporated remaining essential data.
9. Shared the draft with subject matter experts for input.
10. Submitted the report for quality assurance and document processing.

Lean Writing Principle Initiative

Lean writing principles are essential in the medical writing team of a pharmaceutical company to ensure the effective communication of complex scientific and medical information. By focusing on clarity, conciseness, and relevance, lean writing minimizes unnecessary complexity and verbosity, enabling seamless comprehension by various stakeholders such as healthcare professionals, regulatory bodies, and patients. The application of lean writing principles not only enhances the efficiency of communication within the team but also contributes to the success of regulatory submissions, clinical documentation, and medical communication endeavors.

I had the privilege of collaborating with senior medical writing managers and directors on a Lean Writing initiative. Our focus was on enhancing the quality and effectiveness of our documents. We meticulously analyzed internal protocols and clinical study reports, benchmarking them against publicly available reports and protocols submitted to the FDA by other organizations. This comparative analysis aimed to streamline and standardize pertinent document sections, ultimately boosting team efficiency, minimizing errors through enhanced consistency, and elevating accuracy for increased success rates. Through thorough examination of numerous reports and CSRs, I identified noteworthy sample sections and their contributions, which I synthesized into a comprehensive research submission. Moreover, this undertaking lays the groundwork for potential software applications that could automate specific sections, opening doors to further efficiency improvements.