Lawrence J Lesko

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Personalized medicine: elusive dream or imminent reality?
    L J Lesko
    Office of Clinical Pharmacology, FDA, Silver Spring, MD, USA
    Clin Pharmacol Ther 81:807-16. 2007
  2. doi request reprint DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA
    Lawrence J Lesko
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, HFD 850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Pharmacogenomics 11:507-12. 2010
  3. ncbi request reprint Paving the critical path: how can clinical pharmacology help achieve the vision?
    L J Lesko
    Food and Drug Administration, Office of Clinical Pharmacology and Biopharmaceutics, Rockville Pike, Rockville, Maryland, USA
    Clin Pharmacol Ther 81:170-7. 2007
  4. doi request reprint The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics
    L J Lesko
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 84:301-3. 2008
  5. doi request reprint Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Clin Pharmacol 52:79S-90S. 2012
  6. doi request reprint Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice
    Joseph A Grillo
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, MD, USA
    Biopharm Drug Dispos 33:99-110. 2012
  7. doi request reprint A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunity
    Myong Jin Kim
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Rm 3188, Bldg 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
    J Clin Pharmacol 49:138-46. 2009
  8. ncbi request reprint Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective
    Lawrence J Lesko
    Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Nat Rev Drug Discov 3:763-9. 2004
  9. doi request reprint Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use
    Felix W Frueh
    Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration FDA, Silver Spring, MD 20993, USA
    Pharmacotherapy 28:992-8. 2008
  10. doi request reprint New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process
    Shiew Mei Huang
    Office of Clinical Pharmacology, CDER, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Clin Pharmacol 48:662-70. 2008

Detail Information

Publications31

  1. ncbi request reprint Personalized medicine: elusive dream or imminent reality?
    L J Lesko
    Office of Clinical Pharmacology, FDA, Silver Spring, MD, USA
    Clin Pharmacol Ther 81:807-16. 2007
    ..They are well equipped to provide timely genetic education to others and to interpret genetic data so that actionable decisions, especially about drug dosing in individual patients, can be implemented in clinical practice...
  2. doi request reprint DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA
    Lawrence J Lesko
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, HFD 850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Pharmacogenomics 11:507-12. 2010
    ....
  3. ncbi request reprint Paving the critical path: how can clinical pharmacology help achieve the vision?
    L J Lesko
    Food and Drug Administration, Office of Clinical Pharmacology and Biopharmaceutics, Rockville Pike, Rockville, Maryland, USA
    Clin Pharmacol Ther 81:170-7. 2007
    ....
  4. doi request reprint The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics
    L J Lesko
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 84:301-3. 2008
  5. doi request reprint Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Clin Pharmacol 52:79S-90S. 2012
    ..The objective of this article is to discuss the FDA's current recommendations and provide examples that illustrate the importance of and challenges in studying effect of renal impairment during drug development...
  6. doi request reprint Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice
    Joseph A Grillo
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, MD, USA
    Biopharm Drug Dispos 33:99-110. 2012
    ....
  7. doi request reprint A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunity
    Myong Jin Kim
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Rm 3188, Bldg 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
    J Clin Pharmacol 49:138-46. 2009
    ..Therefore, the purpose of this report is to review the current recommendations for warfarin therapy that involve genetic testing...
  8. ncbi request reprint Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective
    Lawrence J Lesko
    Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Nat Rev Drug Discov 3:763-9. 2004
    ..Here, we consider this challenge from a regulatory perspective, highlighting recent initiatives from the FDA that aim to facilitate the integration of pharmacogenetics and pharmacogenomics into drug development and clinical practice...
  9. doi request reprint Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use
    Felix W Frueh
    Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration FDA, Silver Spring, MD 20993, USA
    Pharmacotherapy 28:992-8. 2008
    ....
  10. doi request reprint New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process
    Shiew Mei Huang
    Office of Clinical Pharmacology, CDER, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Clin Pharmacol 48:662-70. 2008
    ....
  11. doi request reprint Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006
    Yaning Wang
    Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    J Clin Pharmacol 48:146-56. 2008
    ..A draft Guidance is being developed to be issued in 2008, and we hope this initiative will be resourced by then...
  12. doi request reprint Quantitative disease, drug, and trial models
    Jogarao V S Gobburu
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 0002, USA
    Annu Rev Pharmacol Toxicol 49:291-301. 2009
    ..It requires a consorted effort by industry, academic, and regulatory scientists. We also describe the strategic goals of the FDA Pharmacometrics group...
  13. doi request reprint Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008
    Joo Yeon Lee
    Division of Pharmacometrics, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA
    Clin Pharmacokinet 50:627-35. 2011
    ..Case studies are presented to better illustrate the role of pharmacometric analyses in regulatory decision making...
  14. ncbi request reprint Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop
    Lawrence J Lesko
    Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, USA
    J Clin Pharmacol 43:342-58. 2003
    ....
  15. doi request reprint Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation
    Ping Zhao
    Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Pharmacol 52:91S-108S. 2012
    ..The simulations demonstrate the utility and challenges of the PBPK approach in evaluating the pharmacokinetics of nonrenally cleared drugs in subjects with RI...
  16. ncbi request reprint Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective
    Shashi Amur
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
    Biomark Med 2:305-11. 2008
    ..g., biomarkers for drug safety). In addition, the FDA has initiated the creation of various consortia that are working towards the identification and characterization of exploratory biomarkers in order to qualify them for a specific use...
  17. doi request reprint Clinical pharmacology as a cornerstone of orphan drug development
    Edward D Bashaw
    Office of Translational Sciences, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Nat Rev Drug Discov 10:795-6. 2011
    ..A recent US Food and Drug Administration (FDA) advisory committee meeting highlighted the potential of clinical pharmacology to overcome challenges in orphan drug development...
  18. ncbi request reprint Microarray data--the US FDA, industry and academia
    Joseph L Hackett
    Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, Maryland 20850, USA
    Nat Biotechnol 21:742-3. 2003
  19. ncbi request reprint Drug-drug, drug-dietary supplement, and drug-citrus fruit and other food interactions: what have we learned?
    Shiew Mei Huang
    Office of Clinical Pharmacology and Biopharmaceutics, HFD 850, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, PKLN 6A 19, Rockville, MD 20850, USA
    J Clin Pharmacol 44:559-69. 2004
    ..issues to consider in the interpretation of study results, and (3). recent labeling examples to illustrate the translation of study results to information useful for patients and health care providers...
  20. doi request reprint Understanding the genetic basis for adverse drug effects: the calcineurin inhibitors
    Jane P F Bai
    Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA
    Pharmacotherapy 30:195-209. 2010
    ..The disease-associated genes provide candidate genes for exploring ADEs and may provide genomic biomarkers for assessing the risk for developing severe calcineurin inhibitor-related ADEs as well as for developing preventive strategies...
  21. ncbi request reprint Scientific perspectives on drug transporters and their role in drug interactions
    Lei Zhang
    Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Mol Pharm 3:62-9. 2006
    ....
  22. doi request reprint Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels
    Yang Chang
    School of Pharmacy, University of Maryland, Baltimore, MD 21201, USA
    J Clin Pharmacol 53:962-6. 2013
    ..Updating the FDA guidance on PK studies in patients with impaired hepatic function could provide a standardized approach to improve the clinical usefulness of this dosing information for practitioners. ..
  23. ncbi request reprint Medical applications of microarray technologies: a regulatory science perspective
    Emanuel F Petricoin
    Division of Therapeutic Products, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA
    Nat Genet 32:474-9. 2002
    ....
  24. ncbi request reprint Biopharmaceutics classification system: the scientific basis for biowaiver extensions
    Lawrence X Yu
    Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Rockville, Maryland 20857, USA
    Pharm Res 19:921-5. 2002
    ..3. Use the intrinsic dissolution method for solubility classification. 4. Define an intermediate solubility class for BCS Class II drugs. 5. Include surfactants in in vitro dissolution testing...
  25. ncbi request reprint Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006
    V A Bhattaram
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 81:213-21. 2007
    ..PM analyses were ranked as important in regulatory decision making in over 85% of the 31 NDAs. Case studies are presented to demonstrate the applications of PM analysis...
  26. ncbi request reprint Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop
    R A Salerno
    Worldwide Regulatory Affairs, Pharma and Translational Medicine, Wyeth Research, Collegeville, PA 19454, USA
    Pharmacogenomics J 6:78-81. 2006
  27. ncbi request reprint Drug interaction studies: study design, data analysis, and implications for dosing and labeling
    S M Huang
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 81:298-304. 2007
    ..In the past 10 years, clinical pharmacology guidances covering important areas have been issued, including pharmacokinetic data in patients with renal and hepatic impairment, dose-response studies, and drug-drug interactions...
  28. ncbi request reprint The need for education in pharmacogenomics: a regulatory perspective
    F W Frueh
    Pharmacogenomics J 5:218-20. 2005
  29. ncbi request reprint Pharmacogenomic-guided drug development: regulatory perspective
    L J Lesko
    Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Pharmacogenomics J 2:20-4. 2002
  30. ncbi request reprint Individual bioequivalence revisited
    M L Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Pharmacokinet 40:701-6. 2001
    ..Collection and analysis of bioequivalence data from replicate study designs may permit further assessment and resolution of these questions...
  31. ncbi request reprint The effects of St John's wort (Hypericum perforatum) on human cytochrome P450 activity
    Z Wang
    Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN 46202, USA
    Clin Pharmacol Ther 70:317-26. 2001
    ..St John's wort did not alter the CYP2C9, CYP1A2, or CYP2D6 activities. Reduced therapeutic efficacy of drugs metabolized by CYP3A should be anticipated during long-term administration of St John's wort...