September 13th, 2022 | Montreal
Palais des Congrès de Montréal – Room 518 – 12:00pm-1:00pm EST
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 will highlight 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) will present their research interests and experience.
This will be followed by a panel discussion around the current research practices and challenges in this domain :
- 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
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Learn more about our speakers
DR. CHRISTINE GARNETT – FDA
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.
