CNS drug development continues to evolve with changing regulations, particularly in light of prescription drug abuse and risk/benefit optimization. Furthermore, the uncertainty with regulations around emerging therapeutics, including cannabinoids, adds to the confusion. Navigating a successful regulatory and commercial pathway for CNS drugs can pose challenges and delays when requirements are not met. In addition to NDA-enabling Phase I studies, specialty studies may be required to further evaluate your risk/benefit profile and support a drug-scheduling recommendation. Such studies may include abuse potential, physical dependence potential and driving simulation assessments.
Understanding when and if these studies are required for your program aids in appropriate planning and budgeting. Strategically including select endpoints in early clinical trials may help streamline or waive certain clinical requirements. Furthermore, a favorable risk/benefit profile or targeting an unmet medical need may position you for expedited regulatory reviews. This webinar will present a comprehensive overview of early phase CNS drug development and will help you navigate the regulatory requirements to a successful submission.
During this session you will:
- Learn about the regulatory requirements for CNS drug development
- Understand what preclinical studies may be needed to support your application
- Understand the clinical studies that may be needed to support your regulatory submission
- Discover the specialty studies that are used to strategically evaluate your risk/benefit profile
Who may this interest?
Preclinical, clinical, regulatory, medical affairs and other specialties who are developing any type of CNS active compound (new chemical entities, 505[b]) for a targeted indication, including new applications for cannabinoids and pharmaceuticals.
Dr Setnik joined Altasciences in 2019 as Chief Scientific Officer. In her previous roles as Vice President of Scientific & Medical Affairs at INC Research/Syneos Health (Early Phase), Senior Director, Clinical Sciences (King Pharmaceuticals and Pfizer, Inc), and Research Scientist (formerly Ventana/Decisionline Clinical Research), she has accumulated impressive experience in early phase clinical trials, regulatory filing, lifecycle management and strategic initiatives in business development and clinical drug development. Dr Setnik is also an Adjunct Professor at the University of Toronto, Department of Pharmacology and Toxicology and the Managing Director of the Cross Company Abuse Liability Council and Chair of the Clinical Pharmacology Community of the Drug Information Association (DIA). She is an active member and speaker at various congresses including the College on Problems of Drug Dependence; and is actively engaged in many aspects of abuse potential assessment, including development of patient-reported outcome instruments and contributing to post-marketing surveillance studies. Dr Setnik has a PhD in Pharmacology and the Collaborative Program in Neuroscience.
In association with:
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept.
For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.
Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics and data management, which are all customizable to specific sponsor requirements. Altasciences help sponsors get better drugs to the people who need them, faster.