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White Paper - May 10, 2011 - pdf
By: Scott A. Shell, PhD; Robert L. Wappel, BS; J. Rick Turner, PhD; Sarah S. Bacus, PhD
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Prospective identification and potential amelioration of cardiotoxicity is a critical component of contemporary drug development. Accordingly, the Quintiles CardioCheck Program has been created to provide rapid insight into potential cardiotoxic influences of pharmaceutical compounds. While screening a library of compounds in the early phases of development to choose the appropriate candidate for clinical development is extremely useful, the CardioCheck Program can also be utilized for compounds that are farther down the clinical development path to identify and potentially ameliorate negative influences the drug may have on the heart.
Additionally, the program can identify pharmaceutical drugs that demonstrate cardio-protective effects with regard to mitochondrial health and energy homeostasis. The myriad of tests performed in the CardioCheck program enable the pharmaceutical companies to make quick and informative decisions on drugs that may cause potential cardiotoxicity. In addition, it enables the pharmaceutical companies to understand the cause of the cardiac myocyte toxicities of the drug and find ways to mitigate it.
About the Authors:
Scott A. Shell, PhD
Director, Translational R&D – Oncology, Quintiles
Dr Scott Shell is the Director for the Translational R&D – Oncology group within Quintiles Innovation. He directs and manages both the sponsored and internal pre-clinical R&D projects that result in identification and validation of biomarkers best suited for specific oncology drug development programs. He has had the responsibility for bringing the CardioCheck program into operation and is involved in the continued enhancement of the components and deliverables of the program.
Robert L. Wappel, BS
Senior Research Associate, Translational R&D – Oncology, Quintiles
Robert Wappel is the main technical expert for the CardioCheck program. His responsibilities include the end-to-end operations of CardioCheck, data analysis, and result reporting. His additional functions include new reagent, assay, and platform evaluation for newer iterations of CardioCheck.
J. Rick Turner, PhD
Senior Scientific Director, Cardiac Safety Services, Quintiles
Dr Rick Turner is the Senior Scientific Director for Cardiac Safety Services. He leads our Interdisciplinary Cardiac Safety Services Team, which provides consultation and guidance for Sponsors on study design issues, operational efficiencies, and regulatory submissions. His business travel schedule enables him to meet and keep close contacts with members of regulatory agencies worldwide. He is a regular presenter at international cardiac & cardiovascular safety meetings. He writes a “Cardiovascular Safety Watch” column for the Journal for Clinical Studies and publishes regularly in peer-reviewed journals.
Sarah S. Bacus, PhD
Senior Vice President and Chief Scientific Officer, Translational R&D – Oncology, Quintiles
Sarah Bacus is Sr. VP and Chief Scientific Officer of the Translational R&D Oncology group within Quintiles Innovation. She is responsible for overseeing all of the preclinical R&D projects in understanding new targeted therapy mechanism of action and proof of concept. Using genomic and proteomic biomarkers, her group can help pharmaceutical companies identify the right indication for their drugs through understanding mechanism of response or resistance. In addition, by understanding mechanism of action, her group can test for cardiotoxicity. She also oversees the choice and validation of biomarkers associated with clinical development programs. She originated the CardioCheck program through a paper in PNAS and currently has a pending patent regarding that program.