Brooke Helfer

Leader within the product development team at BlueSphere Bio Brings together clinical, scientific, and technical disciplines to ensure high-quality protocol development, trial design, protocol authoring, study execution, and data interpretation Selects, establishes and maintains relationships with contract manufacturers and contract testing organizations Performs CMC regulatory writing of INDs Works with process development to establish critical process parameters, process improvements, and critical quality attributes Serves on internal product teams for product development Mentors a team of direct reports

Guided and performed studies to assess the safety and potency of gene edited cell products Transferred manufacturing of engineered T cell product to contract manufacturing organization Led the implementation of LabGuru electronic lab notebooks within Product Development Standardized protocols, processes, and document control practices Part of the study execution team, coordinating clinical trial operations Authored, edited, and reviewed technical reports for regulatory submissions Contributed to IND assembly and authorship Collected and evaluated outsourcing proposals

Led the translation of new products and their adoption Led CMC strategy for two clinical products Developed grants and data packages for Celsense, clients, and the FDA Maintained drug master files with the FDA and Health Canada Planned IND enabling studies with cell therapy developers Generated data for IND submissions with the FDA Authored sections of IND submissions for the inclusion of cellular imaging Contract work with ATMP (cell therapy) developers Experience with engineered and non-engineered T-cells, NK cells, DC therapies, SVF preparations, and multiple MSC products Reviewed funding and reagent grants submitted to Celsense Created Standard Operating Procedures and other technical documents Represented Celsense at conferences, in client interactions, and in FDA interactions Trained clients in the use of Celsense reagents

Developed assays for the safety assessment of Celsense reagents Generated preclinical data for the establishment of a drug master file with the FDA Generated preclinical data for and aid in the submission of INDs with the FDA Evaluated cellular cultures/ cellular therapeutics for compatibility with fluorine (19F) labeling Organized collaborative studies using Celsense reagents Trained in coursework on GLP methods for preclinical studies Trained in GMP methods for clinical studies Prepared clinical study protocols for Investigational New Drug Applications Business development Worked to build relationships with clients, including key thought leaders in academia and industry Represents the Company at national and international scientific meetings including invited oral presentations

Performed original research, in the laboratory of Dr Steven Frisch, toward the completion of my doctorate degree. Studied the non-apoptotic roles of caspase-8 and caspase-2 Trained incoming graduate students Specialized in molecular and cellular biology techniques

Optimized 2D electrophoresis conditions for the separation of proteins in an insulin sensitive cell line Located two putative autoantigens for Type 1 diabetes.

Viral and Rickettsial Zoonoses Branch - student researcher Howard Hughes Medical Institute grant supported Performed DNA extraction, quantitation, and sequencing sample preparation Examined Ixodes scapularis ticks for the HGE pathogen