Re-Thinking Clinical Trials in Oncology
 Assessing the landscape of novel trial design for cancer therapies to improve data collection, enhance patient access, and drive clinical outcomes for breakthrough therapies

October 28, 2020 | Live Virtual Forum (EST)

Caroline Germa

Vice President, Head Clinical Development, Early Portfolio, Oncology R&D AstraZeneca

In my role at AstraZeneca, I oversee the clinical development of the Early Oncology portfolio. I lead a global cross-functional team of more than 160 people, comprised of physicians, scientists, and clinical operations experts dedicated to advancing in the clinical stage our extensive pipeline of immuno-oncology, tumor drivers and resistance, DNA damage response and antibody drug conjugates compounds. The key to our approach is our focus on innovative clinical trial designs, from first time in human to Phase 2, grounded on the most cutting-edge science. We are aiming at reinventing conventional early clinical development, by employing adaptive designs, using biomarker-rich multidrug platforms, targeting early disease or integrating innovative translational approaches. Everyday, I’m inspired by our colleagues and research partners who are passionate about pushing the boundaries of science. Together, we are driven by improving the efficiency and speed at which we develop and deliver the next generation of oncology therapies, in order to shift the paradigm in the lives of people affected by cancer. I’ve led development programmes exploring compounds in numerous solid tumours, including breast cancer and thoracic cancer. Prior to joining AstraZeneca, my most recent roles included positions at Bristol Myers Squibb and Novartis where I led multifunctional teams for immuno-oncology, antibodies and small-molecule inhibitor programmes. Board-certified in medical oncology, I earned my medical degree at Lille II University in Lille, France and have authored more than 40 cancer studies. I have earned multiple awards during my career, including several Vision Awards, and President Awards at Novartis.

WEDNESDAY, OCTOBER 28

1:15 PM Designing Trials in the Age of Rapidly Developing Innovation

We have adaptive design, but what else can be considered in diverse approaches to treat cancer? What have we learned about what else might be considered to augment with real world evidence and other data sets that could be valuable to understand the safety and effectiveness of a new molecule? How can industry be “better” at designing trials to utilize resources in the best way possible?