Presented By: Center for the Discovery of New Medicines - CDNM
Drug Discovery Lecture Series: "Early Clinical Research Takes Patients”
J. Fred Pritchard, Ph.D. Vice President, Global Drug Development, Celerion
Learn about the key factors involved in running successful clinical proof-of-concept studies.
Strategies for studying new drug candidates in early clinical testing have changed dramatically over the last few years as the industry and regulators respond to increasing public expectations for access to more effective and safer medicines.
For drug developers, establishing Clinical Proof-of-Concept (CPoC) has become critically important in determining whether or not to make further investments of time and effort into a new drug therapy. This in turn drives the need for earlier access to patients and robust clinical biomarkers of effect, safety and patient selection.
This presentation will focus on strategies and challenges in working with patients to establish CPoC with examples of success.
About the speaker
As Vice President of Global Drug Development, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, project management professionals and alliance managers that work actively with clients to bring their drug products efficiently through early clinical testing.
Dr. Pritchard brings 30 years of drug development experience to his work, including pre-registration work on five currently marketed pharmaceuticals and several that are currently in clinical development. Leveraging his experience in leading international teams of scientists at large pharmaceutical companies, Dr. Pritchard founded and led a group of consultants and program directors within a full service CRO that collectively worked on nearly 40 integrated drug development programs, bringing several of these through IND into phase I and II clinical trials.
Dr. Pritchard has given numerous invited lectures at scientific meetings and academic institutions and is an author on over 120 scientific publications and abstracts. He is the 2000 Alumni Fellow of the Penn State College of Medicine, and named one of nine “Notable People in Pharmaceutical R&D” by R&D Directions magazine in 2009. He currently serves on the Therapy Acceleration Program Committee for the Leukemia and Lymphoma Society (LLS), the LLS North Carolina Chapter Board of Trustees and the Executive Committee of the Research Triangle Park Drug Metabolism Discussion Group where he has been past Chair and Treasurer.
Strategies for studying new drug candidates in early clinical testing have changed dramatically over the last few years as the industry and regulators respond to increasing public expectations for access to more effective and safer medicines.
For drug developers, establishing Clinical Proof-of-Concept (CPoC) has become critically important in determining whether or not to make further investments of time and effort into a new drug therapy. This in turn drives the need for earlier access to patients and robust clinical biomarkers of effect, safety and patient selection.
This presentation will focus on strategies and challenges in working with patients to establish CPoC with examples of success.
About the speaker
As Vice President of Global Drug Development, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, project management professionals and alliance managers that work actively with clients to bring their drug products efficiently through early clinical testing.
Dr. Pritchard brings 30 years of drug development experience to his work, including pre-registration work on five currently marketed pharmaceuticals and several that are currently in clinical development. Leveraging his experience in leading international teams of scientists at large pharmaceutical companies, Dr. Pritchard founded and led a group of consultants and program directors within a full service CRO that collectively worked on nearly 40 integrated drug development programs, bringing several of these through IND into phase I and II clinical trials.
Dr. Pritchard has given numerous invited lectures at scientific meetings and academic institutions and is an author on over 120 scientific publications and abstracts. He is the 2000 Alumni Fellow of the Penn State College of Medicine, and named one of nine “Notable People in Pharmaceutical R&D” by R&D Directions magazine in 2009. He currently serves on the Therapy Acceleration Program Committee for the Leukemia and Lymphoma Society (LLS), the LLS North Carolina Chapter Board of Trustees and the Executive Committee of the Research Triangle Park Drug Metabolism Discussion Group where he has been past Chair and Treasurer.
Explore Similar Events
-
Loading Similar Events...
