Drug development in psychiatry faces a number of challenges, a particular concern being the slow pace of research and innovation to address the growing need for better mental health treatments.
In this webinar, introduced by Kevin Craig MD, Senior Medical Director at Covance, leading industry experts share their insights and experiences gathered in the design and execution of novel trial designs in psychiatry – designs that can reduce the number of subjects exposed to ineffective therapies, speed availability of effective treatment to patients and allow for more efficient use of trial budgets.
Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants, will discuss how adaptive designs reduce length and increase flexibility in exploratory trials. Prospective subgroup analysis and wider dose ranges can be studied without increasing sample size. Sanjeev Pathak, MD, Senior Medical Director at Alkermes Inc., will review how state-of-the-art methodologies reduce the impact of clinically meaningful placebo response in mid to late phase development. Dr. Craig of Covance will close out the Webinar and moderate questions received from the audience.
Don’t miss out on this opportunity to explore about how better trial design can significantly reduce redundancy, expense, and time in conducting psychiatry trials. Register today!
Scott Berry, PhD,
President and Senior Statistical Scientist, Berry Consultants
Scott M. Berry, PhD, is President and Senior Statistical Scientist at Berry Consultants. He has led Berry Consultants to be widely regarded as the premier Bayesian consulting company in the world. Since 2000, he has been involved in hundreds of Bayesian adaptive clinical trials of pharmaceuticals and medical devices.
Sanjeev Pathak, MD,
Senior Medical Director, Alkermes Inc.
Sanjeev Pathak, MD, is a pediatric and adult psychiatrist, clinical researcher and drug developer. He is the global clinical lead and Senior Medical Director for ALKS-5461(phase III) and ALKS-3831(phase II) programs. The ALKS-5461 FORWARD program is the first phase 3 program to implement sequential parallel comparison designs in pivotal trials.
Kevin Craig, MD, MRCPsych,
Senior Medical Director, Neuroscience Medical and Scientific Services, Covance Inc.
Kevin Craig, MD, is a qualified psychiatrist. He has expertise in early phase, full development and translational medicine trial design and execution. Kevin joined Covance in 2011 and has responsibility for global drug development programs, predominantly for late phase CNS indications. He and has on ongoing interest in methods to reduce trial time and improve success rates in drug development.
- Explore how adaptive designs can improve drug development in psychiatry
- Discuss examples of adaptive design regulatory issues and hurdles and how to overcome them
- Review implementation of novel design methodologies to improve assay sensitivity in pivotal trials
- Understand how improved assay sensitivity reduces the need for placebo control
- Drug Development
- Scientists
- Physicians
- Project Managers
- Operations
- Research and Development
- Regulatory
- Data Managers
- Procurement
- Clinical Safety
- Pharmacovigilance
