Home | ePD-LLC pharmacometrics systems pharmacology CRO in Buffalo

Enhanced Pharmacodynamics

ABOUT US

Enhanced Pharmacodynamics, LLC (ePD) is a privately-owned service provider which combines academic innovation and industry experience to assist clients with the design and implementation of model-informed drug development strategies across various therapeutic areas. ePD leverages the knowledge derived from the application of advanced pharmacometric and cutting-edge systems pharmacology techniques to guide dose selection and provide timely decision-making results that have a fundamental impact on drug development programs.

Since being founded in 2015, ePD has worked with government agencies such as the National Institutes for Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), and other not-for-profit organizations. ePD has also had a successful track record of working with over 60+ venture-start-ups, mid-size biotech companies and large pharma in all stages of drug development.

ePD is strategically located in the New York State Center of Excellence in Bioinformatics and Life Sciences (CBLS), which is a hub for life sciences innovation and technology-based economic development driving scientific discovery and helping to facilitate collaboration among academia, industry and the public sector. ePD was also awarded funding from UBCAT and the Buffalo Institute for Genomics & Data Analytics (BIG) to utilize the cluster-computing environment at the Center for Computational Research (CCR). This enables ePD to conduct complex pharmacometric and systems pharmacology analyses using parallel computing software programs such as NONMEM, NLMIXR, R and other machine-learning applications in a high-throughput and validated computing environment.

About

ePD Team

ePD Leadership

Donald E. Mager, Pharm.D., Ph.D.

President and CEO

Email: dmager@ePD-LLC.com

Dr. Donald E. Mager, President and Chief Executive Officer (CEO), is responsible for new business development, client relations, and oversight of all scientific and business activities at ePD.

Don received a Pharm.D. and Ph.D. degree in Pharmaceutical Sciences from the State University of New York (SUNY) at Buffalo. Don has accumulated 15+ years of experience in partnering with pharmaceutical companies, the FDA, and research institutes on applications of pharmacometric and systems modeling in drug development and pharmacotherapy. Don has contributed to over 140 peer-reviewed publications and brings a unique and global perspective to developing pharmacometric and systems-based strategies in drug development and understanding sources of individual and population-level variability in drug responses.

Don is a Professor of Pharmaceutical Sciences at SUNY at Buffalo and has served as a Visiting Professor at the University Paris Descartes. He served on the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee to the FDA and is an expert member of the Board of Pharmaceutical Sciences at FIP. Don also serves as an Associate Editor at CPT:Pharmacometrics & Systems Pharmacology (CPT:PSP). Don is a Fellow and Past-President of the International Society of Pharmacometrics (ISoP) and is a Fellow and President-Elect of the American College of Clinical Pharmacology (ACCP). Don is also a Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the American Association for the Advancement of Science (AAAS).

Scott A. Van Wart, M.S., Ph.D.

Founder, Vice President and CSO

Email: svanwart@ePD-LLC.com

Dr. Scott A. Van Wart, Vice President and Chief Scientific Officer (CSO). He is primarily responsible for all operational aspects, as well as the execution and supervision of all scientific activities at ePD.

Scott received an M.S. and a Ph.D. degree in Pharmaceutical Sciences at the State University of New York (SUNY) at Buffalo. Scott has consulted for over 20 years with many pharmaceutical companies to plan and implement modeling and simulation strategies to support drug development and commercialization programs. Scott’s broad range of pharmacometric expertise includes statistical analysis, population PK-PD analysis, physiologic- and mechanism-based systems modeling, optimal study design, and clinical trial simulation. Scott is the author or co-author of over 50 peer-reviewed scientific publications, primarily involving population PK and PK-PD applications.

Scott has also served as an Adjunct Professor teaching biometry in the School of Pharmacy Practice at SUNY-Buffalo.

Meet the Other ePD Team Members

Announcements

DONALD MAGER ELECTED PRESIDENT OF AMERICAN COLLEGE OF CLINICAL PHARMACOLOGY

PUBLICATIONS, PRESENTATIONS &

PRESS RELEASES

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Services

Enhanced Pharmacodynamics, LLC (ePD) provides a comprehensive range of services:

In vitro and in vivo pre-clinical study design, pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) data analysis, and expert interpretation of results.

Clinical pharmacology consulting regarding the design and conduct of studies in all phases of clinical development, PK analysis (both noncompartmental and model-based analyses), and expert interpretation of results.

State-of-the-art pharmacometric services such as population PK analysis, development of mechanism-based PK-PD and disease models, exposure-response analyses for safety and efficacy endpoints to identify therapeutic windows and support dose selection, derivation of clinically useful sparse PK sampling strategies and clinical trial simulation (CTS).

Quantitative systems pharmacology (QSP) and disease modeling analytical services for a number of therapeutic areas including immunology and oncology, with the ability to spearhead collaboration with multi-disciplinary teams within your organization and experts in the field, provide expert interpretation of results, and to provide key decision support during drug discovery and development.