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.

Brian Schwartz, MD, has deep experience as a drug development expert in the pharmaceutical and biotechnology industries. Dr. Schwartz most recently served as Chief Medical Officer and head of Research and Development of ArQule, Inc. where he served as a key member of the management team and spearheaded a number of preclinical and clinical drug development programs in oncology and rare diseases. Prior to joining ArQule in 2008, Dr. Schwartz served as Chief Medical Officer and Senior Vice President, Clinical and Regulatory Affairs, at Ziopharm Oncology, Inc., where he built and led clinical, regulatory, and quality assurance departments responsible for the development of new cancer drugs. Earlier in his career, Dr. Schwartz held positions of increasing responsibility at Bayer Healthcare and Leo Laboratories. Dr. Schwartz received his medical degree from the University of Pretoria, South Africa, practiced medicine, and worked at the University of Toronto prior to his career in the biopharmaceutical industry. Dr Schwartz currently serves as an advisor to the California Institute of Regenerative Medicine and as a board member of several biotech companies.

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.