Dr. Gralinski is an internationally recognized authority and advisor in cardiovascular pharmacology. He has founded multiple contract research and consulting companies and is also currently the Chief Executive Officer of CorDynamics, a position he has held since 2002. He has more than 30 years of experience in pharmaceutical research and development with deep expertise in cardiovascular pharmacology and toxicology experimental design, data analysis, and interpretation for more than 600 biopharmaceutical clients.
Prior to CorDynamics, Mike garnered extensive management experience working for several pharmaceutical organizations including Warner-Lambert/Parke-Davis, G. D. Searle, Pharmacia, and Pfizer. His past responsibilities included directing product safety and toxicology operations, leading resolution efforts for cardiovascular issues involving discovery and development, and marketed compounds including Rezulin, Celebrex, and other COX-2 inhibitors as well as cultivating relationships with international colleagues throughout small and large biopharma. He was involved in the genesis of the Safety Pharmacology Society and was elected to multiple positions on its Board of Directors including Treasurer, Vice-President, and President.
Dr. Gralinski earned a Bachelor of Science in Pharmacology and Toxicology from the University of Wisconsin-Madison and a Doctor of Philosophy in Cardiovascular Pharmacology from the University of Michigan.
Dr. Sager is an internationally recognized cardiologist and senior healthcare executive with global leadership experience in both large pharmaceutical and privately held development stage companies with special expertise in the CV safety of drugs and CV/Metabolic drug development. He is the past Chair of the FDA Cardiovascular and Renal Drugs Advisory Committee, Consulting Professor of Medicine at Stanford Univ., chairs the Scientific Programs Committee of the Cardiac Safety Research Consortium, is a member of the ICH E14 Discussion Group and was the PhARMA Topic Leader.
At Sager Consulting Experts, Philip is globally distinguished for his deep experience and expertise in assessing and mitigating CV Safety issues (QT, arrhythmias, cardio-toxicity, BP, etc.) in all phases of drug development across the entire therapeutic spectrum. He is also an expert in designing and executing innovative methodologies to develop drugs in the CV and metabolic arenas.
Dr. Crumb is a world-renowned expert in ion channel research with CRO experience since 1996, having founded Zenas Technologies, later to become NOVA Research Laboratories. Dr. Crumb provided the hERG data for the ISLI/HESI study which became the foundation for the S7B guidelines. In addition, starting in 2014, Dr. Crumb was contracted by the FDA to provide manual ion channel screening in support of the CiPA initiative, the update to the S7B guidelines.
Endpoint Preclinical reimagines how life sciences studies are run, placing a career’s worth of experience on your team, without the typical overhead, onboarding time and challenges of hiring a skilled candidate from a decreasing candidate pool. While the scope of our Services expand each day to meet evolving industry needs, we describe them in the following 4 areas: Surgical, Data Collection & Analysis, Report Generation, and Training.
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