The Highs and Lows of Cannabinoid Research: Exploring the Regulatory, Clinical, and Bioanalytical Requirements in US and Canada

Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Wednesday, July 11, 2018 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Interest in the medical use of cannabis and cannabinoids continues to grow as patients and caregivers consider this option for treatment of unmet medical needs. Ever growing efforts to legalize cannabinoids in the US and Canada are creating an increased need to evaluate safe and effective use. Individual cannabinoids have been approved for use as appetite stimulants and anti-emetics in the US, and as an adjunct treatment for the relief of spasticity in patients with multiple sclerosis in Canada.

Recently, a cannabidiol oral solution, for the adjunctive treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, underwent a successful FDA Advisory Committee review. Cannabis plant material has been cited as potentially useful in various other conditions including glaucoma, AIDs wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders. Many indications have currently not been presented with formal studies for the review and approval of the FDA and Health Canada, and more research is needed to support the given indications. Regulatory agencies are expressing the need for adequate safety, efficacy, and abuse potential evaluation of cannabinoids and related products.

The webinar will provide you with an overview and strategies to navigate the development of cannabinoid-based therapies in complex regulatory environments.

  • Learn about the required clinical studies and challenges to testing the efficacy and safety profile of cannabis and cannabinoids to obtain regulatory approval for targeted indications
  • Understand various aspects of clinical trial design relevant to cannabinoids, including route of administration, dosing, subject selection, relevant pharmacodynamic endpoints and safety monitoring
  • Review appropriate bioanalytical methods to monitor plasma levels
  • Learn strategies to navigate the complex US and Canadian regulations around drug scheduling and access to cannabinoid-based investigational drugs for clinical research purposes

Speakers

Talar Hopyan, PhD, CPsych, Associate Director, Scientific Affairs-Neuropsychology, Early Phase, Syneos Health

Talar Hopyan is the Associate Director, Scientific Affairs – Neuropsychology at Syneos Health™ Early Phase. Dr. Hopyan earned her doctorate degree in Psychology, Biology and Behavior, from the University of Toronto, Canada in 2008 and received her clinical designation as a Neuropsychologist from the College of Psychologists of Ontario in 2009. As a Neuropsychologist, Dr. Hopyan provides expertise in CNS assessments and provides strategic planning for the evaluation and development of pharmacodynamic measures in Early Phase trials. She oversees the dedicated pharmacodynamics team as well as Data Entry. Dr. Hopyan is also responsible for the oversight of Syneos Health™ proprietary neurocognitive assessment software, PsychometRx®.

Message Presenter

Beatrice Setnik, PhD, VP Scientific & Clinical Strategy, Early Phase, Syneos Health

Dr. Setnik has been working in the area of clinical drug development and CNS research for over 13 years and is a leading expert in the area of abuse and dependence evaluation. Dr. Setnik is currently the Vice President of Scientific and Clinical Strategy at Syneos Health (Early Phase) and an Adjunct Professor at the University of Toronto (Department of Pharmacology and Toxicology). Dr. Setnik earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto in 2005.

Message Presenter

Sylvain Lachance, Associate Director Bioanalysis, Early Phase, Syneos Health

Sylvain Lachance has been the Associate Director, Bioanalysis at Syneos Health Inc. since 2015. He managed a group of 25 dedicated Scientists responsible for bioanalytical method development and validation at the Quebec City laboratory. He has been working for the company since 1998 as a Research Scientist, Chromatography Specialist, Expert Scientist and now Associate Director. Sylvain has spent the last 20 years in the bioanalytical division developing assays for small molecules, peptides and hormones by LCMSMS and has been involved in more than 100 presentations and publications.

Message Presenter

Who Should Attend?

Companies with current cannabinoid products or active pipeline. Relevant job roles include:

  • Preclinical Development
  • Toxicology
  • Clinical Pharmacology
  • Clinical Operations
  • Data Management
  • Regulatory Affairs

What You Will Learn

  • Learn about the required clinical studies and challenges to testing the efficacy and safety profile of cannabis and cannabinoids to obtain regulatory approval for targeted indications
  • Understand various aspects of clinical trial design relevant to cannabinoids, including route of administration, dosing, subject selection, relevant pharmacodynamic endpoints and safety monitoring
  • Review appropriate bioanalytical methods to monitor plasma levels
  • Learn strategies to navigate the complex US and Canadian regulations around drug scheduling and access to cannabinoid-based investigational drugs for clinical research purposes

Xtalks Partner

Syneos Health™

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

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