Developing Optimized Cannabinoid Medicines for FDA and EMA Approval
Schedule 1 Therapeutics is developing cannabinoid medicines for FDA and EMA approval in large, poorly managed pain and neurological conditions.
Funded by the Migraine Research Foundation and the U.S. National Institutes of Health, we’re engaged in R&D partnerships with leading universities in the U.S. and Europe. We operate in strict compliance with all national and international laws and regulations for pharmaceutical products, and are re-imagining how controlled substances are developed and applied in a clinical setting as approved medicines in national health systems around the world.
Team
Founder, CEO
George Pappas
George has over 20 years' experience in the use of cannabinoids for medical purposes. He began in patient advocacy in 2001, working with some of the earliest researchers and public policy leaders bringing awareness of cannabis self-medication into the public domain for the first time. He led numerous local, state, and federal policy and regulatory initiatives, including as Field Director at Americans for Safe Access, then the nation's leading medical cannabis patient advocacy group. In 2009, he was recruited as the 1st hire at the international wing of Bedrocan BV, the sole supplier of research-quality cannabis raw material to the Dutch Government and the world’s 1st cannabis producer to be ISO 9000 and cGMP certified. The renowned medical program of the Dutch Health Ministry was for years the only source of cannabis available in government-sponsored “special access” programs and for clinical research throughout Europe. At Bedrocan, George led projects in regulatory and market analyses, strategic planning, IP management, brand development, and more. He was involved in multidisciplinary research initiatives and in the emergence of numerous medicinal cannabis special access programs around the world. In 2016, he began to focus exclusively on developing cannabinoid medicines for FDA / EMA approval to treat large pain disorders, and in 2018 he formed Schedule 1 Therapeutics.
Regulatory VP
Terry Ocheltree, PhD
Terry is a former Division Director at the U.S. Food and Drug Administration. Among many other initiatives, he led the drafting of FDA’s Guidance for Industry on the Development of Botanical Drugs. Terry is a champion of and industry leader in the international harmonization of pharmaceutical manufacturing (Chemistry Manufacturing Controls, or CMC). He has held senior and VP positions at AbbVie and large regulatory consulting firms.
Operations VP
Dominique Kendrick, RPh, MBA, RAC
Dominique has over 25 years of biopharmaceutical leadership ranging from publicly traded Fortune 500 corporations to start-ups. She led quality, regulatory, medical, and technical operations at Abbott (Abbott/Abbvie), Melinta, Sagent, and West Therapeutic Development, and has also been involved in over 80 new product approvals and launches in the US, Europe, and Latin America. She is an expert in developing regulatory strategies, diligence for asset evaluations, FDA negotiations, and implementing global regulatory and quality systems.
Scientific Lead
Greg Dussor, PhD
Greg is the Chair of the Neuroscience Department at the University of Texas at Dallas. His research focuses on the mechanisms of migraine and new drug development. Greg is on the Advisory Board of the Migraine Research Foundation and associate editor of the journals Headache, PAIN, PAIN Reports, and Molecular Pain. He is also co-founder of 2 pain product companies: Ted’s Brain Science Products, an over the counter pain cream company, and CerSci Therapeutics, developing a novel FDA-approved pain treatment, which was acquired in 2020. In 2009, he was recruited as the 1st hire at the international wing of Bedrocan BV, the sole supplier of research-quality cannabis to the Dutch Government and the world’s 1st cannabis producer to be ISO 9000 and cGMP certified. The renowned medical program of the Dutch Health Ministry was for years the only source of cannabis for government-sponsored “special access” programs and clinical research throughout Europe. George led projects in regulatory and market analyses, strategic planning, IP management, and brand development, and was involved in the emergence of numerous medicinal cannabis programs around the world. Since 2016, he has focused exclusively on developing cannabinoid medicines for FDA / EMA approval. In 2018, he formed Schedule 1 Therapeutics.
Clinical Lead
Alan Rapoport, MD
Alan is Past-President of the International Headache Society, founder and Director-Emeritus of The New England Center for Headache, and co-founder of BonTriage, an app supporting migraine clinical trials and patient care. He is clinical professor of neurology at The David Geffen School of Medicine at UCLA and has extensive experience in migraine clinical trials. Board-certified in neurology and headache medicine, he has co-authored more than 350 articles, chapters, and posters on headache. Alan is an editor of Headache, CNS Drugs, and Editor-in-Chief of Neurology Reviews. He reviews for many peer-reviewed journals including Cephalalgia, Neurology, and the New England Journal of Medicine.
Selected Advisors
Gary Winer
Former CEO, AbbVie Japan
Messoud Ashina, MD, PhD
Past President, International Headache Society; Lundbeck Foundation Professor
Steve Kuemmerle, PhD
Former head, Abbot Ventures
Rob Schickel, PhD
Founder and Managing Director, The CorStar Group; NUAgo Therapeutics
Steven Wright, MD
Former Chief Medical Officer, GW Pharmaceuticals
Paul Burton, JD
Managing Partner, 2Flo Ventures
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