Co-sponsored with the FDA
Complex Innovative Trial Designs (CID) have the potential to increase the efficiency and lower the cost of drug development which will accelerate patient access to life-altering therapies. The 21st Century Cures Act (Cures Act) and the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) recognize the need for CID and include provisions to advance their use to enhance medical product development. One such provision within PDUFA VI is the launch and implementation of the FDA CID Pilot Meeting Program which aims to foster discussions and education of the use and value of CID within drug development programs.
In an effort to promote CID, the unique conference will provide a platform for extensive scientific exchange among the FDA, other global health authorities including EMA, PMDA, and CFDA, patient advocates, and drug development innovators on CID topics such as master protocols, complex adaptive design, and Bayesian techniques, highlighting also the potential of alternative data sources.
Each session will begin with an introductory presentation by an FDA representative to set the stage followed by presentations and perspectives from a diverse group of expert speakers and panelists. The suitability of each CID topic and the proposed innovations from a US and global regulatory perspective, their usefulness from a patient perspective, and how challenges in the designs can be overcome, will be explored.
This conference is designed for key drug development decision-makers including clinicians, regulatory scientists and reviewers, and other key stakeholders, in addition to statistical specialists. Join us in this unique forum that will catalyze progress in advancing innovation in drug development.
The program is developed in collaboration with BIO, PhRMA and FDA.
The program has been released! Preview all session descriptions, speakers, and more all in one place!
Who should attend?
Professionals involved in:
- Biostatistics, including Adaptive Design and Bayesian Statistics
- Clinical Research
- Research and Development
- Trial Design
- Clinical Operations
- Therapeutic Area Development, Management, and Operationist
- Rare disease, oncology, immunology, Alzheimer’s disease
- Medical Affairs
- Medical Science Liaisons
- Medical Writing
- Regulatory Affairs
- Explain how complex innovative clinical trial designs (CIDs) contribute to increased efficiency and other enhancements of medical product research in order to ultimately accelerate patient access to innovative therapies
- Describe the purpose, anticipated outcomes, and progress to date of the FDA CID Pilot Program
- Discuss the views of global regulatory authorities (e.g., FDA, EMA, PMDA, and NMPA) on CIDs and their suitability/applicability for clinical research in their respective regions
- Explore aspects and further opportunities for alignment among global regulatory agencies in regard to CID adoption
- Examine several examples of CIDs, including master protocol designs, complex adaptive designs, and designs using Bayesian techniques, and discuss their regulatory suitability, potential challenges, and benefits for patients and medical product developers
Robert A. Beckman, MD • Professor of Oncology, Bioinformatics, and Biomathematics
Georgetown University Medical Center, United States
Fanni Natanegara, PhD • Senior Director - Statistics
Eli Lilly and Company, United States
Zoran Antonijevic, MSc • Vice President, Statistical Consulting
Abond CRO Inc., United States
Cristiana Mayer, DrSc, PhD • Head of Biostatistics
Johnson & Johnson Vision, United States
Dionne Price, PhD • Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States
Karen Lynn Price, PhD • Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States
Pritibha Singh, MBA, MSc • Global Program Associate Director, Oncology Hematology Development
Novartis AG, Switzerland
Rui (Sammi) Tang • Vice President, Global Head of Biometrics
Servier Pharmaceuticals, United States
Amy Xia, PhD • Vice President, Center for Design and Analysis
Amgen Inc., United States
Maria Apostolaros, JD, PharmD, MS, RPh •
PhRMA, United States
Yi Liu, PhD • Executive Director Biostatistics
Nektar Therapeutics, United States
On Demand Content Preview Webinar
Recent Regulatory Efforts on Complex Innovative Clinical Trial Design