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Dr. Guttendorf joins Aclairo® with over 20 years of experience directing preclinical and clinical programs, particularly in the DMPK areas. He has directed PK, ADME, and pharmacology programs from discovery through NDA across a wide range of therapeutic areas. He has overseen numerous nonclinical pharm-tox and clinical pharmacology programs, and a host of IND and NDA submissions. His expertise extends to regulatory interactions with FDA on clinical and nonclinical DMPK issues. Dr. Guttendorf has held leadership positions in small biotech and large pharmaceutical companies, including Director of Discovery and Preclinical Development at Pfizer Global R&D and Parke-Davis Pharmaceutical Research, Scientific Strategy Advisor at Pfizer, Vice President of Pharmacology and Biopharmaceutics at Advancis (now Middlebrook) Pharmaceutical Co., and Vice President of Pharmacology and Experimental Therapeutics at Sequoia Pharmaceuticals. Dr. Guttendorf also was actively involved in small pharma business development and funding aspects while at Advancis and Sequoia. At Parke-Davis/Pfizer, Dr. Guttendorf 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 and development. |
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