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    LAWRENCE J. LESKO, PH.D., F.C.P.

    9011 Furrow Avenue Ellicott City, Maryland 21042

    (410) 750-0335

    EMPLOYMENT 1995 - Present Director, Office of Clinical Pharmacology (OCP)

    Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, Maryland

    • Responsible for directing the overall development and management of

    the review, policy and research components of the clinical pharmacology and biopharmaceutics program in CDER-FDA

    • Provide office level oversight of scientific review packages for selected IND’s and all original NDA’s

    • Provide overall direction and management of CDER’s Interdisciplinary Pharmacogenomics Review Team and Pharmacogenomics Program

    • Provide initiation and direction for critical path programs in clinical pharmacology including model-based drug development, biomarker qualification, EOP2A meetings and individualization of therapy

    • Responsible for Leadership Training and Development in OCP as part of the OCP “Good to Great” initiative from 2003 to 2010

    • Responsible for the recruitment of high quality scientists and retention of scientific staff; building leadership throughout the organization through structured skill set programming

    • Responsible for innovations in regulatory review such as the Question Based Review, NDA regulatory briefings and Scoping Meetings for new NDAs to pinpoint major review issues for industry and drug development

    • Responsible for Clinical Pharmacology Advisory Committee and leading of label changes to include pharmacogenetic information

    • Organize annual PhRMA (BIO)-FDA-OCP meetings to discuss contemporary topics in drug development and regulatory science

    • Lead the development of guidances in clinical pharmacogenomics, special populations (renal and hepatic impairment), pediatrics, population PK and exposure-response relationships that define a framework for contemporary drug development

    • Member of CDER’s Drug Safety Oversight Board responsible for oversight of CDER safety and policy decisions

    • Chair of FDA’s Pharmacogenomics Working Group responsible for guidance development, policy development and overall leadership of

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    the intercenter genomics initiative • Chair of CDER’s Medical Policy Coordinating Committee- Clinical

    Pharmacology Section responsible for the development and implementation of clinical pharmacology guidances for industry

    • Represented FDA on the ICH Common Technical Document Working Group from 2000-2003 (M4)

    • Lead representative from FDA on the ICH Pharmacogenomics Working Group (E15) from 2006-2008

    • Consultant to the American College of Medical Genetics on the pharmacogenetics of warfarin guidelines (2007)

    • Represented FDA on the OECD initiative on Pharmacogenomic (2006)

    1992 - 1995 Associate Director of Research, Office of Generic Drugs (OGD),

    CDER, FDA, Rockville, Maryland

    • CDER’s Project Officer for all extramural research contracts including those in formulations and biopharmaceutics research that formed the basis for the SUPAC-IR and SUPAC-MR guidances for industry, and the solubility/permeability research that underpinned the Biopharmaceutics Classification System and food effects guidances for industry.

    • Supervise and manage short-term review-related regulatory research in the Generic Drug Research Laboratory

    • Office-level secondary assessment of bioequivalence study reviews in all ANDAs prior to approval

    • Consultant to various offices in CDER on complex formulation and biopharmaceutical issues arising from new and generic drug development

    • Organize and manage agendas, speakers and Generic Drug Advisory Committee meetings dealing with biopharmaceutics issues

    • Development of general and drug-specific bioequivalence guidances for industry

    1988 - 1992 Chief Scientific Officer and Vice-President Analytical Laboratory Services Division

    PharmaKinetics Laboratories Baltimore, Maryland • Top-level review of all analytical, pharmacokinetic and clinical study

    designs, data analysis and final study reports • Development and validation of new bioanalytical methods. • Implementation of an a new in vitro dissolution service • Strategic planning and business plan development • New business development in pharmaceutical industry

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    1981 - 1988 Associate Professor of Pharmaceutics and Director, Clinical

    Pharmacokinetics Laboratory, University of Maryland at Baltimore (UMAB), School of Pharmacy, Baltimore, Maryland

    • Responsible for the clinical pharmacology and biopharmaceutics

    graduate research program, and extramural contracts with pharmaceutical sponsors

    • Director of a therapeutic drug monitoring service at the UMAB Medical Center, including pharmacokinetic interpretation of results

    • Course Director for graduate level courses in Fundamental Pharmacokinetics, Advanced Pharmacokinetics and Clinical Pharmacokinetics respectively

    • Responsible for undergraduate teaching in Applied Pharmacokinetics, and serving as a student advisor

    1981 - 1988 Visiting Pharmacokinetic Expert (30% of time), Laboratory of

    Neurosciences and Pharmacy Development Service, National Institute on Aging and Pharmacy Department, National Institute of Health (NIH), Bethesda, Maryland • Conduct collaborative research on the pharmacokinetics and

    pharmacodynamics of drugs in the elderly with special emphasis on patients with Alzheimer’s disease

    • Provide expert input into the in vitro and clinical research projects being conducted in the Pharmacy Department Research Laboratory

    • Provide expert input into the clinical pharmacokinetic consult service for patients at the Clinical Center of NIH

    • In-service education for clinical staff in the Department of Pharmacy

    1979 - 1981 Director, Drug Concentration Laboratory and Adjunct Associate Professor of Pharmacology University of Massachusetts Medical Center Worcester, Massachusetts

    • Director of the a Clinical Pharmacology Consult Service provided by the Department of Pharmacy, including oversight of all bioanalytical methods and pharmacokinetics interpretation of plasma drug levels

    • Development of new bioanalytical methods to support federal and privately funded pharmacokinetic and pharmacodynamic research related to patient care

    • Teaching clinical pharmacology to students in the University of Massachusetts Medical School

    • Initiation and management of a regional toxicology service to measure drug and chemical exposure in patients admitting to the emergency

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    room, and from consulting physicians • Mentor for clinical pharmacy students rotating through the Medical

    Center from the Massachusetts College of Pharmacy 1973 - 1979 Director, Pfeiffer Clinical Pharmacokinetics Research Laboratory And Associate Professor of Pharmacy, Massachusetts College of

    Pharmacy, Boston, Massachusetts • Project Director for industry grants and contracts for in vitro and in

    vivo studies in biopharmaceutics and pharmacokinetics • Course Director for all undergraduate and graduate courses in

    dispensing pharmacy, biopharmaceutics and pharmacokinetics • Taught laboratory courses in Dispensing Pharmacy • Major advisor for 5 Ph.D. students and 2 M.S. students.

    1971 - 1973 Assistant Professor of Pharmacy, Texas Southern University School of Pharmacy, Houston, Texas

    • Course Director for undergraduate offerings in biopharmaceutics and

    dispensing pharmacy • Director of undergraduate research program

    EDUCATION 2001 Selected for Advanced Executive Training at the Federal Executive Institute in

    Charlottesville, Virginia 1971 Doctor of Philosophy (Ph.D.) in Pharmaceutics, Temple University Health

    Science Center, School of Pharmacy, Philadelphia, Pennsylvania, 1967 Bachelor of Science (B.S.) in Pharmacy Temple University Health Science

    Center, School of Pharmacy, Philadelphia, Pennsylvania

    BOARD ACCREDITATION AND LICENSES 2009 Fellow, Japanese Society for the Study of Xenobiotics 2001 Fellow, American Association of Pharmaceutical Scientists 2000 Fellow, American College of Clinical Pharmacology 1992 Board Certification in Clinical Pharmacology and Diplomate, Applied

    Pharmacology, by American Board of Clinical Pharmacology 1988 Registered Pharmacist, State of Maryland

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    1971 Registered Pharmacist, State of Texas 1967 Registered Pharmacist, State of Pennsylvania PUBLICATIONS Book Chapters

    C.I. Haffajee and L.J. Lesko, Amiodarone in "Drug Treatment of Cardiac Arrhythmias", Futura Press, Mt. Kisco, NY, 1984.

    L.J. Lesko, Nonlinear Kinetics of Theophylline Elimination, in "Pharmacokinetic Basis of Drug Treatment", L.Z. Benet, ed., Raven Press, New York, NY, 1984.

    L.J. Lesko, High Pressure Liquid Chromatography of Amiodarone in Biological Fluids, in "Methodology in Analytical Chemistry", I. Sunshine, ed., CRC Press, Boca Raton, FL,1985.

    L.J. Lesko, Dose-dependent