S2: E2 AI in Clinical Research: Decoding Regulatory Expectations

On this episode, Susan McCune, MD (VP, Pediatrics & Clinical Pharmacology, The PPD Clinical Research Business of Thermo Fisher Scientific) and Jacqui Whiteway, PhD (Senior Director & Pediatric Strategy Liaison, Center for Pediatric Clinical Development, ICON plc) join the podcast to discuss what makes pediatric clinical trials unique and how industry can make participation easier for pediatric patients and their families.They dive deeper into the role that compassion plays in designing successful trials, the importance of including pediatric patients and families in trial protocol design, and creative tools to boost patient engagement 

On the latest episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to talk about ACRO’s collaboration with TransCelerate BioPharma, Inc. and to discuss impact that ICH E6(R3) will have on Good Clinical Practice and implications for innovation.They dive deeper into the benefits of a risk-based approach, regulator’s thoughts making clinical research more agile, and the potential to help industry bring medicines to patients more efficiently.

On this episode, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research.They dive deeper into the FDA’s evidentiary standards for AI, what organizations should consider about methodological transparency in submissions, and AI’s potential as a tool that can help bring medicines to market more efficiently.For more information on ACRO's AI/ML Principles Statement, visit ACRO's website: https://www.acrohealth.org/initiatives-hub/ai-ml-in-drug-development/

ACRO’s Good Clinical Podcast is back! This week, Stacy Hurt, Chief Patient Officer at Parexel, and Alicia Staley, Vice President, Patient Engagement at Medidata joined the podcast to discuss how we can turn patient centricity from “buzz words” to action. They discuss how their own experiences as patients have informed their approach to clinical research and the important role that an upstream patient voice plays in reducing the burden on patients.

ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard (ACRO Site Resource Grants Program Manager) and Kristin Surdam (ACRO D&I Steering Committee Member) to discuss ACRO’s new D&I Site Resource Grants Program. They provide background on the goals of the program and what sites need to know when applying for grants.

On this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Cyndi Verst (President, R&DS Design & Delivery Innovation, IQVIA) and Peyton Howell (Chief Operating & Growth Officer, Parexel). Peyton and Cyndi sat down to discuss the changes they have seen in the representation of women in clinical research throughout their careers, from trial participation to the board room. They dive deeper into how the clinical research industry can make trials more accessible for women and the role that many women play as healthcare decisionmakers in their families. 

On this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod sat down with Kimberly Richardson (Patient Advocate & Founder, Black Cancer Collaborative) to talk about what is still missing from conversations about diversity, equity, and inclusion in drug development. Kimberly shares her own experiences as a patient and a patient advocate, and how that has impacted her approach to diversity in clinical research. 

On this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Lisa Moneymaker (Chief Technology Officer & Chief Product Officer, Saama Technologies) and Stephen Pyke (Chief Digital & Data Officer, EVP Clinical Data & Digital Services, Parexel). Lisa and Stephen dive into how AI and ML are currently being used in the clinical research industry and opportunities for further utilization in the future. They discuss misconceptions about AI and how regulators and policymakers are responding to its potential use in drug development.

On this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Lord James O’Shaughnessy (Co-Founder & Senior Partner, Newmarket Strategy), Alistair MacDonald (Operating Partner, GHO Capital Partners), and Leona Fitzgerald (Executive Director, Regulatory Affairs, PPD, part of Thermo Fisher Scientific). Building off Lord O’Shaughnessy’s Report on Clinical Trials in the UK, listen to their discussion about approval timelines, implementation, governmental response, and where we must go from here. 

On this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod of ACRO is joined by Jackie Kent (Executive Industry Advisor) and Catherine Gregor (Chief Clinical Trial Officer, Florence Healthcare). They sat down to discuss their own experiences as women working in the clinical research industry and areas in which the industry needs to continue to grow to better promote representation. Catherine and Jackie dive into what the industry must do to make participating in clinical trials more accessible for all women.