Individualized Drug Therapy for Patients

Roger Jelliffe MD, FCP, FAAPS, an adult cardiologist, developed the first software, for individualizing digitalis dosage, in 1967. He founded the USC Laboratory of Applied Pharmacokinetics and directed it until he retired and had recruited Dr. Michael Neely, who became director in 2013. The laboratory has developed what is now the USC Pmetrics software for population modeling and the Bestdose clinical software for individualizing drug dosage regimens specifically with maximum precision, including several different Bayesian methods for managing individual patients in various clinical situations. The laboratory has contributed significantly to optimize therapy for cardiovascular, bacterial and fungal diseases, transplants, and for acutely ill and unstable patients in the ICU. Dr. Neely is an Associate Professor of Pediatrics and a Clinical Scholar at the University of Southern California (USC) in Los Angeles, CA. He is a board-certified pediatric infectious diseases physician with an active clinical practice at the Children’s Hospital of Los Angeles (CHLA). His research interests are in pediatric clinical pharmacometrics, including population pharmacokinetic and pharmacodynamic modeling, pharmacogenomics, simulation, and most importantly, use of models to optimize therapy for individual patients. He is currently the Director of the Laboratory of Applied Pharmacokinetics and Bioinformatics at the CHLA Saban Research Institute. LAPKB is a multidisciplinary team of physicians, mathematicians, statisticians, engineers, and information technologists, who are leading experts in non-parametric population modeling and multiple-model Bayesian adaptive control of therapeutic drug regimens in individual patients. LAPKB maintains the freely available Pmetrics pharmacometric package for R, and the BestDose software for individualized dosing. LAPKB has numerous local, national and international collaborators. Dr. Neely has a Master’s of Science Degree in Clinical and Biomedical Investigations at USC, is a Fellow and Regent in the American College of Clinical Pharmacology, a member of the Society for Pediatric Research, and he consults on the United States Food and Drug Administration Anti-infective Drug Advisory Committee. He is currently the principle investigator on two NIH-sponsored clinical projects involving the developmental aspects of voriconazole pharmacokinetics, as well as creating software tools to optimally dose voriconazole, vancomycin, and other therapeutic drugs. He mentors numerous trainees and visiting scholars, is an invited speaker worldwide, and is the author of over 80 peer-reviewed papers.

• Section I: Basic Techniques for Individualized Therapy1. Basic Pharmacokinetics and Dynamics for Clinicians2. Describing Drug Behavior in Groups of Patients3. Developing Maximally Precise Dosage Regimens for Patients - Multiple Model (MM) Dosage Design4. Optimizing Laboratory Assay Methods for Individualized Therapy5. Evaluation of Renal FunctionSection II: The Clinical Software6. Using the BestDose Clinical Software - Examples With Aminoglycosides7. Monitoring the Patient: Four Different Bayesian Methods to Make Individual Patient Drug Models8. Monitoring Each Patient Optimally: When to Obtain the Best Samples for Therapeutic Drug Monitoring9. Optimizing Individualized Drug Therapy in the ICU10. Quantitative Modeling of Diffusion Into Endocardial Vegetations, the Postantibiotic Effect, and Bacterial Growth and Kill11. Individualizing Digoxin TherapySection III: Clinical Applications of Individualized Therapy12. Optimizing Single-Drug Antibacterial and Antifungal Therapy13. Combination Chemotherapy With Anti-Infective Agents14. Controlling Antiretroviral Therapy in Children and Adolescents with HIV Infection15. Individualizing Tuberculosis Therapy16. Individualizing Transplant Therapy17. Individualizing Dosage Regimens of Antineoplastic Agents18. Controlling Busulfan Therapy in Children19. Individualizing Antiepileptic Therapy for Patients20. Individualizing Drug Therapy in the Elderly21. The Present and Future State of Individualized Therapy