Liz is the Managing Partner and Regulatory Affairs lead of The Bracken Group. Her vast expertise in early IND submission strategies through NDA preparations including the FDA NDA review has helped many companies with their development programs. ​

With a particular expertise in FDA communications and meeting preparations Liz leads and/or prepares companies for FDA interactions, notably with milestone meetings as part of the preparations of early IND through late-stage NDA preparations including labelling negotiations. ​

Liz has experience in a wide range of indications including development programs that are under the jurisdiction of the FDA, CDER, Office of Specialty Medicine - Division of Imaging and Radiation Medicine (DIRM). Liz is also adept at orphan drug submissions, handling US Agent support for global clients and regulatory intelligence questions to further assist in the overall development strategies.

Chanelle recently earned her Ph.D. in Biomedical Sciences from the University of Alabama at Birmingham (UAB), where she focused on PET imaging techniques for monitoring immune responses in oncology and tuberculosis. Her groundbreaking work on chemokine receptor-targeted PET imaging probes earned her the prestigious 1st Place Presentation Award at the STEMNoire Research Conference in 2023. Chanelle’s doctoral research, under the guidance of Dr. Benjamin Larimer, involved developing novel imaging agents to enhance personalized medicine. 

Chanelle also holds a B.S. in Biomedical Sciences from the University of Central Florida, where she was recognized with the Women’s Executive Council Scholarship and conducted independent research across multiple institutions, contributing to nine research presentations and receiving two travel awards. 

Chanelle’s expertise and dedication to advancing research outcomes drive innovative solutions and impactful discoveries in the field, solidifying her reputation as a leading contributor to pharmaceutical sciences. 

Chelsea is a Senior Regulatory consultant primarily focused on coordinating, compiling, submitting, and maintaining submissions, including INDs, NDAs, and BLAs for the FDA, and other global regulatory authorities. Her expertise extends to preparing, submitting, and negotiating product submissions with the EPA and Health Canada. She has led and supported the submission and maintenance of multiple INDs across a wide range of therapeutic areas.

Marilyn is a Senior Regulatory Consultant experienced in CMC development strategy and authoring of INDs, IMPDs, and CTAs for small and large molecule products. She recently served as Director Regulatory Affairs CMC-Biologics Early Development at BeiGene. She has vast expertise in both pre- and post-approval drug lifecycle management, including comparability protocols (commercial products)/comparability amendments (development products) and FDA formal meetings/EMA scientific advice meetings.​