Translational Assessment of Pressor Effects of Drugs

emka TECHNOLOGIES hosted a SPS hosted session on Assessment of Pressor Effects of Drugs on September 13th, 2022 in Montréal.

The effect of a drug on blood pressure is an important consideration in drug risk assessment and product labeling. Yet, in some cases the IND-enabling studies don’t include measurements of blood pressure according to regulatory guidelines, or don’t measure blood pressure adequately.

This scientific panel highlighted different perspectives, from a Contract Research Organization (CRO), from a pharmaceutical company, and from a regulator/clinical specialist to discuss best practices surrounding preclinical ICH S7A studies and premarketing assessment of a drug’s effect on blood pressure.

Dr.Christine Garnett (FDA), Dr.Todd Wisialowski (Pfizer) and Dr.Brian Roche (Charles River) presented their research interests and discussed:

Guideline requirements and deviations from the guideline
Preclinical vs. Clinical Blood pressure considerations (rodents, large animals, humans)
Improvements to controls and sensitivity
Considerations for drug class, target indication, patient population, magnitude of change, etc.
BP assessment in vitro, ex vivo, in vivo

Learn more about our speakers

DR. CHRISTINE GARNETT – FDA

Christine Garnett is Clinical Reviewer in the Division of Cardiology and Nephrology. She leads CDER’s interdisciplinary review team for cardiac safety studies. Since 2008, Dr. Garnett has represented the FDA in the International Council for Harmonisation for the E14 guideline, and currently serves as FDA’s Topic Leader. For her work on the ICH E14 guideline and the scientific white paper on concentration-QTc modeling, she received ASCPT’s Gary Neil prize for innovation in drug development in 2019. Dr. Garnett has published over 40 manuscripts in peer-reviewed journals in the area of cardiac safety, and received both Critical Path and Office of Women’s Health grants.

DR. TODD WISIALOWSKI – PFIZER

Todd Wisialowski has worked at Pfizer for 22 years and his current role is Director of In Vivo Safety Pharmacology. He is responsible for In Vivo Safety Pharmacology activities supporting various programs/projects across multiple therapeutic areas and drug modalities to deliver Pfizer’s portfolio, strategic direction, innovation and productivity goals of nonclinical drug safety and research/development. This includes review and approval of all aspects of In Vivo Safety Pharmacology work including study design, data interpretation, report writing, study finalization, and responses to regulatory and team inquiries.

He is also co-chair of an internal cardiovascular safety council which provides comprehensive support and leadership in the areas of strategic planning, project team advice, and educational development including internal guidance documents.

He is President of the Safety Pharmacology Society and also supports additional external collaborations and consortia including HESI and the ICH E14/S7B Industry Work Group.

DR. BRIAN ROCHE – CHARLES RIVER LABORATORIES

Brian Roche is a dual-boarded toxicologist (DABT) and safety pharmacologist (DSP), and the Executive Director of global safety pharmacology at Charles River. Dr. Roche has responsibility for CRL’s global safety pharmacology portfolio, which includes aligning best practices across sites and providing the highest level of scientific support to CRL partners.

Dr. Roche has focused on mechanistic follow-up studies to ICH S7A core battery to de-risk drugs in development, as well as supplemental studies to include renal, gastrointestinal, and autonomic nervous systems. His research has included toxicological and pharmacological evaluations of compounds from early in vivo discovery/lead optimization through IND enabling studies.