About CSRC
(Cardiovascular Sciences Research Consortium)
Who We Are
Independent. Objective. Trusted.
The CSRC is dedicated to advancing cardiovascular health through regulatory science: the appropriate application of cutting-edge research to accelerate the bench-to-bedside delivery of novel therapies. We achieve this by facilitating structured interactions among regulators, industry, and academia to address cardiovascular challenges in the development of drugs, devices, and diagnostics.
Academic Advisory Board
Michael Lincoff
Cleveland Clinic
Marc Bonaca
CPC Med
Renato Lopes
Duke University
Norman Stockbridge
Retired, FDA
C. Michael Gibson
Harvard, BAIM
Christopher Roy deFilippi
Harvard University
Giulio Stefanini
Humanitas University, Italy
Kazuhiro Sase
Juntendo University
Eri Kato
Kyoto University
Roxana Mehran
Mount Sinai
Carolyn Lam
National Heart Center, Singapore
Sanjeev Bhavnani
Scripps Clinic
Kenneth Mahaffey
Stanford University
Krishna Pundi
Stanford University
Brian Bergmark
TIMI, Brigham and Women's Hospital
Nicholas Marston
TIMI, Brigham and Women's Hospital
Sanket Dhruva
UCSF
Patrick Lawler
UHN, Canada
Mark Petrie
University of Glasgow
Executive Leadership
Jonathan Seltzer
Executive Director
Lakshmi Sundar
Head, Stakeholder Engagement
Why CSRC?
Problem: No singular platform empowers stakeholders with direct visibility into regulatory science challenges and provides guidance
Impact: Reduce delays in getting the right medicines to the right patients at the right time.
Drug and device companies have ideas for incorporating new designs, questions, and technologies, into drug development.
Regulatory agencies have minimal exposure to these ideas and face redundant questions from multiple companies.
Academic thought leaders have deep experience and insights that can accelerate these ideas to reality.
Clear need for a collaboration platform to ease bottlenecks and challenges.
Partner with CSRC
Often, there is ambiguity introduced in the development of new therapies due to the development of new scientific discoveries, the implementation of new technologies, or novel regulatory approaches. These “pain points” are often felt among stakeholders.
The CSRC is dedicated to resolving these pain points, through a relatively simple process:
- Contact the CSRC and alert us to the issue. The issue must be primarily a scientific one, not a commercial one.
- The CSRC will discuss with the FDA and other stakeholders.
- If approved, the CSRC will most likely authorize a publicly available think tank that guarantees participation from experts in the FDA, private sector, academia, and potentially other regulatory agencies. The CSRC may choose to authorize a research project, with similar participants.
- The conclusions of the think tank or research project will be shared publicly with the publication of a peer-reviewed manuscript.