Reuse Patient Trial Data to Mitigate Go/No-Go Product Development Decision Risks
In our upcoming, 45-minute Feb. 28 webinar, hear from special guest speaker Reinhard Von Roemeling, Board Certified Oncologist and former SVP of Global Oncology at Merck KGaA, who will draw on his extensive history in Oncology Therapy Research and share perspective on the industry's opportunities & challenges for:
- Better scientific validity and much higher decision confidence on whether to advance the compound to the next phase or not
- Reducing the number of failed trials ever started, and advancement of likely/successful compounds that otherwise would have passed over
- Leveraging historical clinical trial data to enhance understanding of diseases and effects of classes of drugs, examine prognosis within patient subgroups, and understand correlation between short-term endpoints and long term responses to design more efficient clinical development programs
Also, hear from former FDA Deputy Director and current Medidata Director of Data Science, Ruthie Davi, phD, sharing how Medidata is operationalizing historical clinical trials data to help trial leaders make ‘go/no-go’ decisions after early-phase trials--and much more.
Date: February 28, 2018
Time: 12:00PM EST
Reinhard von Roemeling, MD
SVP of Global Clinical Development – Oncology and Immunooncology, EMD-Serono Inc.
Reinhard von Roemeling, MD, is an innovative leader of clinical research and global drug development. He received his medical degree from the JWv Goethe University Medical School in Frankfurt am Main – Germany. He completed his specialty training and obtained board certifications in internal medicine, hematology and oncology in Germany and in the USA, with clinical practice as faculty of leading academic institutions including Univ of MN School of Medicine in Minneapolis, Albany Medical College, NY, and Fox Chase Comprehensive Cancer Center, Philadelphia, PA. Author of peer-reviewed 98 scientific publications and 167 abstracts; invited speaker. Professional memberships include ASCO, ESMO, AACR, and ASH.
He has successfully directed global drug development programs of phases I-IV in positions of increasing responsibility at both pharmaceutical and biotech companies for more than 20 years, supporting multiple regulatory small molecule and biologic drug/device approvals.
Recent positions as SVP of Global Clinical Development – Oncology and Immunooncology at EMD-Serono/Merck KGaA and VP Global Clin. Dev. Hem/Onc. at Daiichi-Sankyo, Inc. Previous positions at Schering AG, Boehringer-Ingelheim, and Sanofi.
History of innovation leadership and creative problem solving, focus on efficient trial designs with higher speed and better success probability. Special interest in clinical pharmacology, translational medicine, and biomarker-driven precision medicine in oncology.
His core motivation as physician and researcher is bringing transformational treatments and cures to patients with life-threatening diseases.
Ruthie Davi, PhD
Director, Data Science, Medidata Solutions
Ruthie Davi has worked in the area of pharmaceutical product development, and specifically the FDA, over 20 years. In her current position as a Director in Data Science at Medidata Solutions, she is part of a team focused on providing centralized systematic monitoring and other novel clinical trial tools. Ruthie has held numerous positions within the FDA, including Statistical Reviewer, Team Leader, and Deputy Director, where she implemented innovative statistical methods and made recommendations for clinical trial designs tailored to the regulatory setting. She has conducted the statistical review, represented the Agency at Advisory Committee meetings, and provided recommendations regarding FDA marketing approval for numerous New Drug and Biologic Licensing Applications. With a particular interest in pediatric clinical trials, she was an active member of FDA's Pediatric Review Committee. Ruthie holds a Ph.D. in biostatistics from George Washington University.