Extended Team

Denise Krawitz, PhD is Principal Consultant at CMC Paradigms LLC. Dr. Krawitz has 20 years of experience in chemistry, manufacturing and controls (CMC) biologics development and manufacturing, with an emphasis in analytical development and impurity analysis. Prior to becoming a consultant, Dr. Krawitz held positions of increasing responsibility at Genentech, BioMarin, and Ambrx. At Genentech, she led all research and developed strategies related to host cell proteins (HCPs). Dr. Krawitz has authored several peer-reviewed publications in the HCP field, has been invited to give presentations at multiple international conferences and serves on the Board at BEBPA (BioPharmaceutical Emerging Best Practices Association). She received her PhD in Molecular and Cell Biology from the University of California, Berkeley. Additionally, Dr. Krawitz received a Fulbright fellowship to study protein folding in Regensburg, Germany.

Michelle Higgin, PhD is Managing Principal at PharmaDirections. Dr. Higgin has over 20 years of experience in pharmaceutical research and development and is an expert in development and regulatory operations. She has supported the virtual biotech model for the past 15 years and has conducted numerous health authority meetings (including pre-IND meetings) and successfully opened 40+ INDs/IMPDs/CTAs/NDAs in the United States, Europe, and Australia in many therapeutic areas (neuroscience, psychiatry, oncology, GI and cell/gene therapies). Dr. Higgin has held fractional leadership roles at Complexa Inc., Cavion, Inc. (acquired by Jazz Pharmaceuticals), and Cortendo AB (now Strongbridge Biopharma), among others. She received her PhD in Biochemistry from the University of Wisconsin-Madison.