VP, CSO, Principal Consultant Clinical Pharmacology/DMPK
Aclairo Pharmaceutical Development Group, Inc.
Robert J. Guttendorf, R.Ph, Ph.D. is Vice President, Chief Scientific Officer and Principal Consultant in Clinical Pharmacology and DMPK, at Aclairo Pharmaceutical Development Group, Inc. He manages the Clinical Pharmacology/DMPK Group and provides scientific, regulatory, strategic planning, and due diligence advice and support for early and late stage nonclinical and clinical drug research and development programs. Dr. Guttendorf has held various positions of increasing responsibility over 37+ years in the pharmaceutical industry, culminating in leadership positions in small biotech and large pharmaceutical companies, including Director of Discovery/Preclinical Development at Pfizer Global R&D and Parke-Davis Pharmaceutical Research; Scientific Strategy Advisor at Pfizer; VP of Pharmacology and Biopharmaceutics at Advancis Pharmaceutical Co.; and VP of Pharmacology and Experimental Therapeutics at Sequoia Pharmaceuticals. He has in-depth experience managing, overseeing, and contributing to ADME, pharmacology, toxicology, and PK/PD programs and studies in drug discovery and development, through NDA and post-marketing across a variety of therapeutic areas. He has overseen the strategic and scientific planning and drafting of numerous IND and NDA submissions to the FDA, including 14 NDA approvals, 8 in the past five years. At Parke Davis/Pfizer, he helped pioneer the implementation of higher throughput ADME/PK screening approaches in drug discovery and was instrumental in defining best practices for DMPK in drug discovery/development, leading Pfizer’s Global PDM organization in optimizing strategies to enhance the quality and R&D survival of exploratory development candidates. He has presented and published numerous papers on various topics in bioanalysis, PK, PK/PD, drug metabolism, and the strategic use of ADME data to improve drug discovery and development. He received a B.S. (Pharmacy) from West Virginia University and a Ph.D. in Pharmaceutical Sciences from the University of Kentucky. He has adjunct faculty appointments at Duquesne University and the University of Wisconsin Schools of Pharmacy and is a registered pharmacist.