Carl Peck, M.D.
Professor of Biopharmaceutical Sciences

Contact Information:
carl_peck@compuserve.com
Tel: (202) 785-5450
Center for Drug Development Science
1608 Rhode Island Ave., NW
Washington, DC. 20036

Links:
Center for Drug Development Science

Publications

 

CDDS Makes a Difference

The Center for Drug Development Science (CDDS), established in late 1994 at Georgetown University and with the UCSF School of Pharmacy since October, 2004, seeks to advance the science, strategic planning, and management processes of drug development and to establish clinical drug development science as a rigorous academic discipline through four programs:

Research
Investigating contemporary drug development practices and evaluating and developing novel scientific methodologies.

Education
Contributing to the education of practitioners of drug and regulatory science.

Public Policy
Providing for a discussion of drug development science and regulatory policies.

Technical Assistance
Providing in-real-time assessment and guidance of drug development projects.

During the past seven years the center has:

• Established an understanding of contemporary drug development practices.

• Pioneered modeling and simulation of clinical trials.

• Trained over 15 scientists who now work at organizations including the FDA, the Ministry of Health and Welfare (MHW), and various pharmaceutical and bioscience companies.

• Influenced the FDA Modernization Act of 1997.

• Sponsored more than 15 conferences, workshops, and testimonies.

• Advised over 80 firms on a total of over 200 Investigational New Drug (IND) applications to the Food & Drug Administration (FDA).

Selected Publications:
Biomarkers Definitions Working Group. "Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework." Clin Pharm Ther 69 (3): 89-95, 2001.

Cross J, H Lee, A Westelinck, J Nelson, C Grudzinskas, and C Peck. "Post-marketing drug dosage changes of 499 FDA-approved NMEs," 1980-1999 ( Pharmacoepidemiology and Drug Safety , August 2002)

Galluppi GR, MC Rogge, LK Roskos, LJ Lesko, MD Green, DW Feigal, and CC Peck. "Integration of pharmacokinetics and pharmacodynamics studies in the discovery, development and review of protein therapeutic agents: a conference report." Clin Pharm Ther , 2001.

Holford NHG, DR Mould and C Peck. "Disease Progression Models" in Principles of Clinical Pharmacology , Editor: A. Atkinson Academic Press New York NY, 2001.

Holford NHG, JPR Monteleone, HC Kimko, and CC Peck. "Simulation of Clinical Trials" in Annual Rev Pharmacol Toxicol . Vol. 40: 209-234, 2000.

Jang IJ, HC Kimko, H Schaefer, NHG. Holford, and CC Peck. "Population Pharmacokinetic and Pharmacodynamic based Simulation of an anti-hypertensive drug in a confirmatory Phase 3 clinical trial — Blinded, prospective prediction of trial outcomes." Clin Pharm Ther (submitted, 2000)

Kimko HC, J Cross, and D Abernethy. "Pharmacokinetics and pharmacodynamics of methylphenidate." Clin Pharmacokinet 37 (6):457-470, 1999

Kimko HC, SSB Reele, NHG Holford, and CC Peck. "Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumerate; Seroquel) by simulation employing a population pharmacokinetic model." Clin Pharm Ther 68 (5): 568-577, 2000.

Krall RL, KH Engleman, HC Ko, and CC Peck. "Clinical Trial Modeling and Simulation — Warner KE, Peck CC, Work in Progress." Drug Info J , 32: 971-976, 1998.

Mould DR. "Defining Covariate Distribution Models for Clinical Trial Simulation" in Simulation for Defining Clinical Trials , Editors: H. Kimko and S Duffell Marcel Dekker, New York, NY, 2001.

Mould DR "Population Pharmacokinetic Analysis: Industrial Applications and Perspectives" Editor: P. Bonate Marcel Dekker, New York, NY 2002

Mould DR, NHG Holford, JHM Schellens, JH Beijnen, PR Hutson, H Rosing, WW ten Bokkel Huinink, EK Rowinsky, JH Schiller, M Russo, and G Dane MBChB "Pooled Pharmacokinetic and Adverse Event Analysis of Topotecan in Patients with Solid Tumors" Clin Pharm Ther . Submitted September 2001.

Peck CC. "Drug development: Improving the process." Food and Drug Law J . 52 (2):163-167, 1997.

Reigner BG, PEO Williams, IH Patel, J-L Steimer, CC Peck, and P van Brummelen. "An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development." Clin Pharmacokinet , 33(2): 142-52, 1997.

Staschen C-M, RR Bies, NHG Holford, CC Peck and M Eldon. "Regression analysis of a physiologically based pharmacokinetic model (PBPK) for a1-Protease-Inhibitor (API) after IV-infusion." Clin Pharm Ther 69 (2): 87, 2001