Dr Herbert Brinkman, based in Denver, Colorado, has over 30 years of experience in the pharmaceutical industry. Dr. Brinkman has prepared over 25 Chemistry Manufacturing and Control (CMC) sections and updates for multiple lnvestigational New Drug (IND), New Drug Application (NDA), supplementary NDA (sNDA), lnvestigational Medicinal Product Dossier (IMPDJ, and Abbreviated NDA <ANDA) filings for United States Food and Drug Administration (FDA) and European regulatory agencies.
Dr Brinkman has filed and commercially launched nine products encompassing oncology, metabolic, dermatology, and endocrinology therapeutic areas and contributed to filing 21ANDAs for various semi-solid and parenteral products. He is also an inventor on 14 patents. His expertise includes current Good Manufacturing Practice (cGMP) systems applied to API manufacture/ Drug Product manufacture and addressing regulatory issues. Dr Brinkman’s previous position was Executive Director of Product Development at NASDAQ-listed company Arcutis Biotherapeutics, Inc. (NASDAQ: AROT), where he was responsible for the successful commercial launch of ZORYVE (roflumilast).
