Cannabadiol (CBD) products have been in news a lot recently, but what does it take to bring a CBD product to market for an unmet medical need? This webinar will discuss development considerations for CBD and other cannabis-derived products from a clinical, preclinical (pharmacology/toxicology), CMC, and regulatory perspective.  The webinar will also review challenges and lessons learned from the development and approval of Epidiolex of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Featured Speakers

Catherine Maher, Ph.D.

Vice President, Regulatory Affairs and Quality Assurance 
Evofem

Catherine Maher, PhD, joined Evofem Biosciences as Vice President, Regulatory Affairs and Quality Assurance in early 2019. Catherine earned her PhD in 2000 from Wake Forest University Bowman Gray School of Medicine and has been developing drugs since then. Most of Catherine’s experience has been in regulatory strategy at small companies focused on populations with significant unmet medical needs.

David Shoemaker, Ph.D.

Senior Vice President, R&D
Rho

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas, including hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and anti-bioterrorism agents. 

Jack Modell, M.D.

Vice President and Senior Medical Officer
Rho

Dr. Modell is a board-certified psychiatrist with over 35 years of experience in clinical research, including 20 years in academia teaching, providing patient care, and conducting clinical trials, as well as 18 additional years of experience in clinical drug development, medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management within the pharmaceutical and CRO industries. Dr. Modell’s specialties and expertise include neuroscience, pharmacology, drug development, clinical research, medical governance, and clinical diagnosis and treatment.

Dana Minnick, Ph.D.

Senior Research Scientist
Rho

Dana Minnick, PhD, DABT, RAC, is a toxicologist and general regulatory affairs professional with more than 20 years' experience in the pharmaceutical industry supporting drug and biologics programs throughout the development lifecycle in both the pharmaceutical and CRO industry. She has demonstrated capability in identifying gaps and defining drug development strategies with specific expertise in nonclinical safety assessment and regulatory affairs to support proposed clinical trials and enable successful regulatory filings.  

Scott Burian, Ph.D.

Senior Research Scientist
Rho

Scott Burian, Senior Regulatory Scientist, is a broadly-experienced regulatory affairs professional specializing in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC).  Dr. Burian has more than 15 years of experience in the pharmaceutical industry and has contributed to the development of a diverse range of small molecule, biologic, and nanoparticle-based gene therapy products. 

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