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Dealers licence for psychedelic medicines received by Psygen Labs

Psygen hits a major milestone with the receipt of a dealer’s licence from Health Canada.

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Dealers licence for psychedelic medicines received by Psygen Labs

Psychedelics manufacturer Psygen has received the dealer’s license for LSD, MDMA, psilocybin, psilocin, DMT, 2C-B and mescaline.

Receipt of the Health Canada dealers licence opens the doors to the commercial production of psychedelics at Psygen’s Good Manufacturing Practices (GMP) facility.

The licence will enable, Psygen Labs, a wholly-owned subsidiary of Psygen, to manufacture, sell, import, export and otherwise deal with the above-listed controlled substances. The company In also manufactures high-potential unscheduled substances such as 5-MeO-DMT, ibogaine and others.

CEO of Psygen, Danny Motyka, commented: “Psygen’s dealer’s licence is a major milestone that opens the doors to commercial production of GMP psilocybin and other psychedelics at our facility. 

“Our dealer’s licence issued following a perfect inspection, meaning we had zero observations from the inspector, which is indicative of the diligence and skill that Psygen brings to our work.”

The licence will enable a global reach for Psygen’s facility, which is Canada’s only dedicated manufacturer of synthetic psychedelics based in Calgary, Alberta. Upon completion of the facility Psygen will begin onsite manufacturing of synthetic psychedelics for use in clinical and scientific research.

CSO, Peter van der Heyden, commented: “A primary application for psychedelics is to support psychotherapy for treatment of mental health conditions. 

“After two years of a global pandemic, mental health conditions are a more urgent need than ever. We are excited to supply material for use in clinical trials and the SAP to further validate the utility of psychedelic medicines.”

The company has also announced it will be providing GMP psilocybin for use in patients through Canada’s Special Access Program, following recent amendments that were made to allow access to restricted drugs such as psilocybin and MDMA through the SAP.

See also  Canada's amendment allowing patients access to psychedelics welcomed

GMP psilocybin previously manufactured by Psygen personnel in collaboration with a licensed dealer using Psygen’s methods has already been used in clinical trials for development of therapeutic products. 

The company also has over twenty supply agreements in place for psilocybin, DMT, ibogaine, 5-MeO-DMT, MDMA and LSD to be fulfilled globally.

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Top UK and European academics join Clerkenwell Health advisory board

Renowned academics in the field of psychedelics from leading European universities will be joining clinical research organisation Clerkenwell Health.

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Top UK and European academics join Clerkenwell Health advisory board

Clerkenwell Health is expanding its pan-European advisory board with the addition of Dr David Erritzoe, Dr Dea Siggaard Stenbæk, Dr Kim Kuypers and Dr James Stone from Danish, Dutch and British universities.

With psychedelic research flourishing in Europe, Clerkenwell Health says it is building connections between commercial research organisations and academic institutions. 

The expansion of its advisory board will give the company access to knowledge and networks from some of the most prestigious European universities – working to fulfil the company’s mission to create a more vibrant psychedelic clinical trial ecosystem and foster wider sharing of best practices across Europe.

Discover how Clerkenwell Health is developing a gold standard for psychedelic care

Chaired by Dr Henry Fisher, the Clerkenwell Health CSO, the board will focus on clinical research and therapy, with its new members bringing expertise in areas of psychotherapy, psychopharmacology, mental health, experimental medicine and psychedelics.

Speaking to Psychedelic Health, CEO of Clerkenwell Health, Tom McDonald, said: “The UK is an attractive location to undertake psychedelic drug development as the government are opening up innovation pathways and championing clinical research.

“We are excited to be joined in our work exploring psychedelics-assisted therapy here in the UK with leading experts from prestigious European universities. Their involvement ensures we have a variety of expert opinions to shape innovative trial designs whilst preparing a platform for European expansion in the coming years.”

See also  Clerkenwell Health is launching a free UK psychedelic therapist training programme

With an aim to support the commercial research ecosystem in the UK and Europe, the new board additions place Clerkenwell Health as an ideal partner to support drug developers wishing to conduct trials in European countries.

CSO of Clerkenwell Health, Dr Henry Fisher, stated: “I am delighted to be able to bring together such high calibre advisors into the Clerkenwell Health scientific advisory board. These researchers are leaders in their respective fields in Europe and are shaping the direction of clinical and fundamental research with psychedelics. 

“This gives us access to the knowledge and network built in some of the most prestigious universities from Copenhagen to Maastricht and London, and it is a privilege to be able to consult with these figures on our own research.”

Meet the advisory board

Dr David Erritzoe is clinical director and deputy head of the Centre for Psychedelic Research at Imperial College London.

Erritzoe is currently investigating brain mechanisms and therapeutic potential of MDMA, ketamine and classic psychedelics, and is clinical senior lecturer in general psychiatry in Centres for Neuropsychopharmacology and Psychedelic Research at Imperial, as well as consultant psychiatrist at St Charles Hospital, CNWL Mental Health NHS Foundation Trust. Erritzoe also heads a NHS-based research clinic at St Charles Hospital, the CIPPRes Clinic.

Dr Dea Siggaard Stenbæk is an associate professor at University of Copenhagen and Copenhagen University Hospital. 

Stenbæk’s research mainly focuses on neuropsychopharmacological effects of the 5-HT2A receptor agonist psilocybin. She collaborates with the Centre for Psychedelic Research at Imperial College London and is currently an honorary clinical research fellow in this group. As the clinical lead, she works on a study of psilocybin as a treatment for obsessive compulsive disorder.

Dr Kim Kuypers is an associate professor at Maastricht University. Her PhD focused on memory and risk-taking during MDMA intoxication. 

Kuypers’ main goal is to understand the neurobiology underlying flexible cognition, empathy and wellbeing. To accomplish this she uses a psychopharmacological model, studying the (sub)acute and longer-lasting effects of psychedelics on these behaviours and their underlying biology.

Dr James Stone worked as a clinical senior lecturer at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, with a focus on experimental medicine and clinical trials. 

During his time there, Stone set up the ketamine clinic at the Maudsley Hospital for patients with treatment-resistant depression. He also worked at Imperial College London as a senior lecturer, working as co-director of the intercalated BSc in neuroscience as well as continuing research into the role of glutamatergic abnormalities in psychosis.

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Beckley Psytech strengthens leadership team as it progresses clinical pipeline

Dr Laura Trespidi has been appointed as chief development officer (CDO).

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Beckley Psytech strengthens leadership team as it progresses clinical pipeline

Dr Laura Trespidi is joining the Beckley Psytech leadership team as CDO, bringing more than 30 years’ experience in global pharmaceutical and biotechnology companies.

Trespidi will bring world-class leadership and technical expertise to the Beckley Psytech team, having worked across clinical product development and manufacturing, from pre-clinical research through to market approvals and global product launches. 

Trespidi will support the progression and development of Beckley Psytech’s investigational assets, including the proprietary formulations of intranasal 5-MeO-DMT, currently in Phase 1 studies.

See also  Beckley Psytech collaboration to develop next-gen psychedelic medicines

CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “Dr Trespidi joins us as our chief development officer at an exciting time, with our lead drug candidates in Phase 1 clinical studies. Laura’s impressive track record and expertise across clinical development and manufacturing will be invaluable, as Beckley Psytech continues to grow and progress its clinical pipeline in this groundbreaking area of medicine.”

Trespidi’s former roles were placed at Summit Therapeutics and other leading companies such as Mundipharma, Shire Pharmaceuticals and GlaxoSmithKline. Most recently Trespidi worked as senior vice president of chemistry, manufacturing and controls (CMC), supply chain and technical operations at Summit Therapeutics, successfully leading global CMC and external manufacturing teams through the development and market preparedness of investigational medicines, including end-to-end supply chain and manufacturing readiness and expansion.

Trespidi’s expertise extends further to formulation development, technology transfers, outsourcing and offshoring, with additional experience developing and executing change management strategies. 

Throughout her career, Dr Trespidi has played a pivotal role in over 40 first-in-human clinical trials and pre-clinical trials, as well as contributing to four New Drug Applications (NDA) and market approvals, and over 40 Investigational New Drug (IND) applications.

Trespidi said: “I am thrilled to be joining Beckley Psytech at such a transformative time for the Company and for psychedelic medicines. 

“Beckley Psytech’s innovative pipeline has real potential to offer meaningful improvement to patients’ lives, and I am looking forward to working alongside a world-class team to turn this vision into a reality.”

Trespidi received her PhD in Pharmaceutical Science from the University of Milan, Italy; an MSc in Medicinal Chemistry and Biochemistry from the University of North Carolina, US; and in 2008 she received an M.B.A from the Open University Business School, UK. She has also authored a number of papers published in peer-reviewed journals and is a member of several scientific societies and associations.

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DEA grants approval for the manufacture of psychedelic compounds

Compounds that have been approved include psilocybin, MDMA, 5-MeO DMT and DMT.

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DEA grants approval for the manufacture of psychedelic compounds

Drug developer Benuvia has received approval from the DEA to manufacture psychedelic Active Pharmaceutical Ingredients (APIs).

Benuvia will manufacture the APIs in its 83,000 square foot manufacturing facility that is permitted by the US DEA for Schedule I to III Controlled Substances. The facility is FDA registered and a cGMP facility.

Primarily specialising in cannabinoids, with the approval, Benuvia has begun focusing on four primary psychedelic ingredients: psilocybin, 5-MeO DMT, DMT, and MDMA.

Benuvia CCO, Joe Shupp, commented: “We are excited to announce our approval by the DEA to manufacture Psilocybin, MDMA and DMT for emerging providers of psychedelic-based drugs focused on neural and mental illness indications.

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“As pharmaceutical companies become more aware of the positive effects of cannabinoids and psychedelic compounds for therapeutic use, the demand for APIs is expected to grow. Our diversified portfolio of APIs and entry into the development of novel psychedelic compounds aims to strengthen Benuvia’s position as a drug developer and provider of APIs focused on cannabinoids and psychedelics.”

With this approval, Benuvia is now able to offer the APIs to drug developers and research organisations under the CSA, and it will also enable the company to advance its life cycle management services to drug developers for their psychedelic development programmes. 

The company has stated that it intends to develop novel intellectual property formulations of these psychedelic compounds, and will provide full toxicology, chemistry, manufacturing and controls, or CMC, and full data analysis. 

See also  Mind Medicine Australia to host summit on psychedelic therapies

Through its partners, Benuvia also intends to manage all research and development, manufacturing, analytical methods, intellectual property capture, placebo manufacture, randomisation and assistance with clinical trials, which will enable it to create custom technologies that allow rapid and cost-effective scale up of commercial operations for production in anticipation of research success.

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