Interview: An interview with Lawrence Lesko for Personalized Medicine.

Area of Science:

• Pharmacology and Pharmaceutics
• Personalized Medicine
• Genomics in Drug Development

Background:

• Lawrence Lesko's extensive career includes 16 years at the US FDA.
• He directed the Office of Clinical Pharmacology within the Center for Drug Evaluation and Research.
• His leadership focused on advancing personalized medicine and pharmacometrics.

Purpose of the Study:

• To highlight key contributions to personalized medicine.
• To detail advancements in drug labeling with genetic information.
• To showcase the development of the Voluntary Genomic Data Submission Program.

Main Methods:

• Led initiatives to update drug labels with pharmacogenetic data.
• Developed programs for voluntary submission of genomic data.
• Published over 200 peer-reviewed manuscripts in clinical pharmacology.

Main Results:

• Significant progress in integrating genetic information into drug labels.
• Establishment of a framework for genomic data submission.
• Recognition through multiple awards for achievements in clinical pharmacology.

Conclusions:

• Lawrence Lesko's work has been pivotal in advancing personalized medicine.
• His contributions have shaped the integration of genomics in drug development and regulatory science.
• He continues to be a leading figure in pharmacometrics and systems pharmacology.