Qualifications and Background
Duane B. Lakings, Ph.D., Principal, DSE Consulting
Dr. Lakings established DSE Consulting in 1994 to assist pharmaceutical and biotechnology companies in characterizing and developing drug candidates into therapeutic products. He has over 30 years of experience in conducting and reporting results from drug discovery and development experiments and for the past 20 years has been involved in placing research studies with contract research organization (CROs). After receiving a Ph.D. in analytical biochemistry, he spent 2 years at NIH/NCI evaluating the disposition and metabolism of antitumor agents and methylated bases in tRNA. While at MRI (one of two CROs for which he has worked), he was the principal investigator (PI) on a number of research contracts to assess the fate of xenobiotics in animals and the environment. During 9 years at The Upjohn Company, he was responsible for a bioanalytical chemistry (BAC) group that developed and validated BAC methods for the quantification of drug candidates, including peptides and proteins, in biological specimens and for the pharmacokinetics (PK) of these candidates in animal models to support pharmacological, toxicological, and drug delivery evaluations and in human clinical studies. At BMS-PRI, he directed two laboratory groups involved in animal ADME studies and toxicokinetic (TK) support of safety studies and coordinated the rewrite of standard operating procedures (SOPs) to standardize the approach used for ADME studies and to be in compliance with Good Laboratory Practice (GLP) Regulations. At Regeneron, Dr. Lakings was responsible for the drug safety evaluations of protein drug candidates being developed for the treatment of neurological diseases. His accountabilities included establishing and monitoring toxicology and metabolism studies at CROs; establishing and directing groups in biochemical toxicology, drug metabolism and PK (animal and human), and drug delivery; and preparing documents for submission to regulatory agencies. During his career, he has collaborated with nonclinical and clinical researchers in CNS, cardiovascular, cancer, virology (AIDS), metabolic diseases (diabetes), infectious diseases, and dermatology therapeutic areas. At each of the pharmaceutical company positions, he was involved in selecting and monitoring CROs who then conducted designed studies to assist in a drug development program. While at SoRI, he managed 17 scientists who supported contract research pharmacology and toxicology studies with BAC and analytical chemistry method development and implementation, PK and TK evaluations, drug metabolism and ADME studies, and drug delivery and formulation stability evaluations.
Dr. Lakings has authored over 40 publications, 11 commissioned reports, 9 book chapters, and over 150 company-specific technical reports (selected references listed below) and has provided major parts to nonclincial and clinical trial protocols, Investigator’s Brochures (IB), the nonclinical sections of INDs and NDAs (both in recommended Common Technical Document [CTD] format). Thus, he has experience in the various types of research studies, whether conducted in-house or at CROs, needed for optimization and selection of discovery leads, for the characterization and development of drug candidates, and in preparation of scientific documents to support regulatory agency submissions. Recent DSE Consulting clients have included both pharmaceutical companies and biotechnology firms where assistance has been provided in designing experiments and evaluating results from studies on both small organic molecules and protein and polypeptide macromolecules.
Selected Publications, Reviews, and Book Chapters
D.B. Lakings, J.M. Friis, R.J. Brown, and H.R. Allen. Pharmacokinetics of Cefpimizole in Normal Humans after Single- and Multiple-Dose Intravenous Infusions. Antimicro._Agents Chemother., 26:802-806, 1984.
E. Novak, D.B. Lakings, and L.M. Paxton. Tolerance and Disposition of Cefpimizole in Normal Human Volunteers after Intramuscular Administration. Antimicro. Agents and Chemother., 31:1706-1710, 1987.
D.B. Lakings, J.M. Friis, C.M. Lunan, et al.. Pharmacokinetics of Furegrelate, a Thromboxane Synthetase Inhibitor, in Man after Oral Administration. Pharmaceutical Research, 6:53-57, 1989.
J.S. Mohrland, J.T. VanderLugt, D.B. Lakings, et al. Thromboxane Synthetase Activity and Platelet Function after Furegrelate Administration in Man. Clin. Pharmacol. and Therap., 29:53-58, 1989.
J.M. Cedarbaum, C. Chapman, D.B. Lakings, et al. The Safety and Tolerability of rHCNTF in Patients with Amyotrophic Lateral Sclerosis. Clin. Neuropharmacol., 18(6):515-532, 1995.
J.M. Cedarbaum, C. Chapman, D.B. Lakings, et.al. The Pharmacokinetics of Subcutaneous Administered rHCNTF in Patients with Amyotrophic Lateral Sclerosis. Clin. Neuropharmacol., 18(6):500-514, 1995.
D.B. Lakings. Biological Stages of Drug Discovery and Development: How Outside Experts Can Help. BioPharm, 9(3):24-33, March 1996.
D.B. Lakings. Scientific Evaluation and Current Opinion of L-659877 (Jan 1998); SDZ-EAA-494 (Jan 1998); Ceronapril (Mar 1998); CS-560 (Apr 1998); Gadobenic Acid (Jun 1998); Atiprimod (Dec 1999); Hemolink (Feb 2000); CPC-211 (May 2000). Current Drugs IDdb Reports.
D.B. Lakings. Discovery Lead Optimization Using Rapid Screening Techniques. Spectrum, Decision Resources, Inc. Feb 1999.
D.B. Lakings. Recent Advances in Renin Inhibitors for the Treatment of Cardiovascular Diseases. IDrugs, Current Drugs Ltd. Feb 1999.
D.B. Lakings. Biological CROs: Enhancing the Opportunity for a Successful Drug Discovery and Development Program. D&MD Reports, Drug and Market Development. Aug 1999.
D.B. Lakings. Nonclinical Recommendations for Successful Characterization and Development of Combination Drug Products. In Development and Approval of Combination Products: A Regulatory Perspective (Evan B. Siegel, editor). To be published by John Wiley & Sons, Hoboken, NJ, 2007.
D.B. Lakings. Biological and Chemistry Assays Available During Drug Discovery and Developability Assessment. In Drug Discovery Handbook, (Shayne Cox Gad, editor). WileyInterscience, John Wiley & Sons, Inc., Hoboken, NJ, 2005, pp.457-482.
D.B. Lakings. Drug Development Project Teams. In New Drug Approval Process, Third Edition, The Global Challenge, (Richard Guarino, editor). Marcel Dekker, Inc., New York, NY, 2000, pp. 1-17 and in New Drug Approval Process, Fourth Edition, Accelerating Global Registrations, (Richard Guarino, editor). Marcel Dekker, Inc., New York, NY, 2004, pp. 118.
D.B. Lakings. Nonclinical Drug Development: Pharmacology, Drug Metabolism, Toxicology. In New Drug Approval Process, Third Edition, The Global Challenge, (Richard Guarino, editor). Marcel Dekker, Inc., New York, NY, 2000, pp. 17-54 and in New Drug Approval Process, Fourth Edition, Accelerating Global Registrations, (Richard Guarino, editor). Marcel Dekker, Inc., New York, NY, 2004, pp. 1962.
D.B. Lakings and A.D.J. Mancini. Working with a CRO. In New Drug Approval Process, Third Edition, The Global Challenge, (Richard Guarino, editor). Marcel Dekker, Inc., New York, NY, 2000, pp. 439-454 and in New Drug Approval Process, Fourth Edition, Accelerating Global Registrations, (Richard Guarino, editor). Marcel Dekker, Inc., New York, NY, 2004, pp. 571588.
D.B. Lakings. Outsourcing of Pharmaceuticals. In Encyclopedia of Pharmaceutical Technology. Accepted for publication, 2000.
D.B. Lakings. The Common Technical Document for the Registration of Pharmaceuticals for Human Use. in New Drug Approval Process, Fourth Edition, Accelerating Global Registrations, (Richard Guarino, editor). Marcel Dekker, Inc., New York, NY, 2004, pp. 441488.
D.B.Lakings. Biological and Chemistry Assays Available During Drug Discovery and Developability Assessment. In Drug Discovery Handbook, (Shayne Cox Gad, editor), John Wiley & Sons, Inc. Hoboken, NJ, 2005, pp.457482.
D.B. Lakings. Safety Pharmacology. In Strategic, Technical, and Regulatory Requirements for First in Human Drug Submissions (Mitchell N Cayen, editor). To be published by John Wiley & Sons, Hoboken, NJ, 2008.
