Ep. 1 – Operational Innovation - September 1, 2022

Our understanding of human biology and disease is progressing at an unprecedented pace, and clinical trial development and execution needs to evolve just as quickly to deliver potentially lifesaving medicines to patients who can't wait. We also need to recruit underrepresented patients into trials, which requires us to think differently about how we identify and recruit patients. In this episode, we talk to Cynthia Verst, president of Design and Delivery Innovation for Research & Development Solutions at IQVIA, a global provider of advanced analytics, technology solutions, and clinical research services. We discuss the drivers for applying innovation in the trial execution space and how the clinical trials model is evolving across the industry thanks to modern innovations.

Speaker
Cynthia Verst, PharmD
President
Design and Delivery Innovation
Research & Development Solutions
IQVIA

 

Ep. 2 – Real World Data in Drug Development - September 8, 2022

Randomized clinical trials are the gold standard for evaluating the efficacy and safety of medicines, but they come with many drawbacks including high monetary and time costs, a lack of representation compared to the general public, and ethical limitations. Historically, these trials were the main mechanism to understand the effects of a medicine. But more recently, real world data from sources such as electronic health records, insurance claims and billing activities, disease registries, and wearable devices, is having a greater effect on understanding a medicine’s usage and effects. Although this information is collected outside of clinical trials, clinical researchers incorporate it during the earliest phases of clinical development to gain additional information and speed up the drug development process. In this episode, we talk to Brian Bradbury, vice president of the Center for Observational Research at Amgen, about the increased utilization of real world data and its potential to revolutionize every stage of clinical research, from trial design to regulatory requirements and outcomes measurement.

Speaker
Brian Bradbury, PhD
Vice President
Center for Observational Research
Amgen

 

Ep. 3 – The Right Patients - September 15, 2022

With advances in genetics and other human data, researchers and doctors will one day be able to practice precision medicine. However, predicting how a patient will respond to a medicine is challenging in under-represented patients who are often not included in clinical trials. This is due in part to systemic issues that deter people from participating in research, especially those who have been historically excluded due to factors such as race, ethnicity, sex, and age. In this episode, we talk to Ponda Motsepe-Ditshego, vice president and Global Medical Therapeutic Area head in General Medicine at Amgen, about the recognized differences in disease incidence among racial and ethnic groups and new approaches to increase representation in clinical trials.

Speaker
Ponda Motsepe-Ditshego, MD
Vice President
Global Medicine Therapeutic Area Head
General Medicine
Amgen

 

Ep. 4 – Real-World Clinical Trial Design and Execution in Oncology - September 22, 2022

Cancer is one therapeutic area where patients cannot wait the conventional 10 or 12 years for a new therapy. For these patients, time is of the essence, and improved access to faster clinical trials can be the difference between receiving a new life-saving medicine and it being too late. In this episode, we talk to David Raben, vice president of Global Development Oncology at Amgen, about the next generation of oncology trial design and execution.

Speaker
David Raben, MD
Vice President
Global Development Oncology
Amgen