More than 100 North American and European-based individuals from large and small biopharma, CROs, risk-based monitoring and consulting organizations participated in the 2019 MCC Risk and Performance Management Summit in Philadelphia, PA on September 4-5.
This year, the Summit focused on five themes:
- Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution: Keynote speaker Kenneth Getz, Director of Sponsored Programs and Associate Professor, Tufts University; Founder and Board Chair, CISCRP shared insights about the state of the drug development industry and the need for and impact of patient engagement approaches.
- Metric Program Implementation: Practical approaches and lessons learned from industry veterans
- Risk-based Quality Management: Emerging practices in the adoption of risk-based quality management, including the impact of ICH-E6(R2) updates, risk management for small sponsors, quality tolerance limits, developing and using key risk indicator libraries and the application of artificial intelligence and machine learning.
- Risk-based Vendor Oversight: The impact of ICH E6(R2) on vendor oversight, key considerations to developing healthy sponsor/vendor engagement, and using metrics to manage vendor risk and performance.
- Applying Critical Thinking Skills to Utilize Metrics Effectively: Participants worked in teams to uncover the root cause(s) of issues described in a case study. Each team was provided with a case study packet that included a description of the organization and outsourcing vendors, protocol synopsis, data reports, questions to explore. Teams were able to request additional metric reports and other types of information to help them determine whether there were issues that needed to be addressed.
The Summit format of presentations, panel discussions, audience polling, facilitated breakout group discussions and small group exercises encouraged active participation of all attendees, and fostered the sharing of ideas and collaborative discussions.
“I am pleased that we continue to provide the industry with a safe place for people to learn, meet peers and share ideas. We received very positive feedback from participants confirming that the Summit is a unique experience and the importance of continuing to run the event in the future. Many participants shared that they plan to bring colleagues to the 2020 Summit” stated MCC Executive Director, Linda Sullivan. “We are already exploring the feasibility of starting several new MCC online, interactive groups to provide MCC members with a forum to continue to explore several popular breakout group topics!”.
Risk-based Monitoring Track Chair, Keith Dorricott summarized his experience, “We had some great exchanges of views and ideas amongst real thought leaders in the industry. There was a high level of energy in the room. I found the discussion on use of Artificial Intelligence eye-opening as senior leaders were quoted as expecting critical thinking skills would no longer be in as much need and yet delegates all thought more critical thinking skills will be needed.”
MCC will be hosting the third annual MCC Clinical Trial Risk and Performance Management Summit September 9-10, 2020. Please contact MCC Executive Director Linda Sullivan or MCC Ambassador Keith Dorricott if there are topics you would like to see included and whether you are interested in participating as a presenter of panelist.
Visit the MCC Risk and Performance Management Summit website to sign up for event updates.