Development Considerations and Approaches Towards Optimizing Peptide Molecules for Stable Clinical Formulations
Erika Walsh
Associate Principal Scientist, Merck
Peptides as therapeutic tools are highly attractive candidates due to their specificity and potency; however limitations on physical and chemical stability provide unique challenges different from what is experienced in small molecule and biologics development. Despite the potential developmental hurdles, the growth in this field continues to increase. Pharmaceutical scientists are developing new characterization and formulation technologies to work with these complex molecules and help assess liabilities and risk. This presentation will focus on those tools developed to characterize peptide structure, chemical and physical stability, and early formulation development. At this stage of a program, the drug candidate is yet to be selected and the final candidates are under consideration. To enable the selection of a candidate, a key focus will be on balancing material requirements, throughput, and scientific quality. Case studies will be reviewed and discussed to explore the Pharmaceutical Scientist’s approach to candidate selection and transition into Early Development.
Erika Walsh is currently an Associate Principal Scientist in the Sterile and Specialty Products group at Merck with 8 years of experience in preclinical, clinical, and commercial product development. Her experience includes parenteral small molecule programs, peptides and large molecule therapeutics. Erika graduated from the University of North Carolina at Charlotte with a Bachelor’s degree in Chemistry in 2008, and Cornell University with a PhD in Chemistry in 2013. During her tenure, Erika has influenced numerous programs spanning from target identification and candidate selection through clinical and commercial development. In addition to her professional responsibilities at Merck, Erika has been an active member of AAPS since 2013 and recently joined the Biophorum Consortium in 2020. In her free time, she enjoys cooking and traveling with her husband, Paul, and playing with her twin toddlers.