Richard Bergstrom, Ph.D.

Summary:

PK/PD Scientist with extensive experience in Clinical Pharmacology particularly with a focus on the pharmacokinetics and pharmacodynamics of drugs for projects ranging from preclinical to Phase 1, 2, 3, or 4 clinical development as well as throughout the discovery, development, registration and commercialization phases of a product’s life cycle.
Biopharmaceutics experience including in vitro and in vivo evaluation for the development of alternative or new dosage forms and bioavailability/bioequivalence.
Expertise in the design, execution, analysis, interpretation, and reporting of preclinical or clinical PK/PD studies.
WinNonlin noncompartmental data analysis, PK/PD study result interpretation, and writing or reviewing PK/PD study reports for all types of clinical studies conducted as a part of drug development.

Core Competencies:

Biopharmaceutics
Clinical pharmacology
Pharmacokinetics
Pharmacodynamics
Pharmacogenomics
Drug metabolism
Drug-drug interaction
Special populations such as pediatric, elderly, renal, hepatic, and ethnicity studies
Bioavailability/Bioequivalence
Dosage Form Design and Line Extensions
Biopharmaceutics Drug Development Strategies and Planning
PK/PD Analyses such as Population PK Strategies and Noncompartmental Analyses
Preclinical Toxicokinetic or ADME Study Report Authorship or Review
Clinical Study Report Authorship or Review
CTD and Submission Document Authorship or Review
Regulatory Agency Interaction Strategies and Response Documents
Regulatory Briefing Documents Authorship or Review
Regulatory Advisory Committee Meeting Experience, Strategies, and Planning
Phase 1-4 Regulatory Meetings United States, Canada, Europe, Japan
Noncompartmental Analysis (WinNonlin)
Compartmental Modeling (WinNonlin)
Graphical Analysis and Result Illustration (Sigma Plot)
Statistical Descriptive Analysis and Assessment (SAS, JMP)
Simulation and Predictions (Excel, WinNonlin)
Population Pharmacokinetics (NONMEM strategy and consulting, nontechnical)

Degrees & Certifications:

Doctor of Philosophy (1980) The University of Michigan, College of Pharmacy, Major Professor: Dr. John G. Wagner
Master of Science (1977) Butler University, College of Pharmacy
Bachelor of Science in Pharmacy (1973) Suma Cum Laude, University of Pittsburgh, School of Pharmacy and Taylor University (1967 – 1970) Major: Chemistry

Experience:

PK/PD Scientist at Eli Lilly and Company, Indianapolis, IN including Axid, Prozac, Zyprexa, Cymbalta, and many project teams (33 years)
Professor of Pharmaceutical Sciences, Butler University College of Pharmacy and Science, Indianapolis, IN (part time 2 years, current appointment)
Adjunct Professor of Medicine and Adjunct Associate Professor of Pharmacology and Toxicology, Indiana University Medical School, Indianapolis, IN (part time 25 years, current appointment)

Association memberships: