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Europe to establish regulatory guidance on psychedelics in 2024 

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Europe to establish regulatory guidance on psychedelics in 2024 

The European Medicines Agency (EMA) is set to hold a multi-stakeholder workshop on medical psychedelics in April 2024 to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe.

In what marks an important next step for psychedelics in Europe, the workshop – Towards an EU regulatory framework – will bring together patients, healthcare professionals, academia, regulators and industry.

The meeting is being held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics.

See also  PAREA launches psychedelics manifesto for mental health in Europe

The MEPs wrote to the European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organisations need to play a more active role in the advancement of psychedelic medicines in Europe.

The letter states the EMA recognises that mental health conditions and substance use disorders are one of the highest public health challenges in Europe, and that the organisation is closely following the developments in the field of psychedelic-assisted therapies.

Signatories of the letter included MEPs Alex Agius Saliba, Robert Biedroń and Sara Cerdas of S&D, Jarosław Duda of the EPP, Tilly Metz of the Greens and European Free Alliance, and Frédérique Ries of Renew Europe.

The EMA previously responded to the MEP’s letters confirming the organisation will cooperate with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) on psychedelic substances.

The workshop will discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health across Europe.

The EMA has stated that the workshop will cover research methodology, regulatory processes and requirements and the relevance of real-world data, and aims to:

  • Hear the views of stakeholders and experts on the therapeutic potential of psychedelics;
  • Provide further clarity on defining the safe and effective use of psychedelics;
  • Inform on regulatory challenges associated with the development and evaluation of psychedelic medicines;
  • Define areas for which further regulatory guidance is required.

The meeting will be held from 16 to 17 April.

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Beckley Psytech receives $50 million investment from atai Life Sciences

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Beckley Psytech receives $50 million investment from atai Life Sciences

Beckley Psytech has confirmed it has received a strategic investment of USD$50 million from atai Life Sciences to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates.

The candidates, BPL-003 and ELE-101, will be advanced by their inclusion in atai’s mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT also known as Mebufotenin), and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin. 

atai Founder and Chairman, Christian Angermayer stated: “This transaction underscores our conviction in the potential of psychedelics as groundbreaking treatments for people living with mental health disorders. Short-duration psychedelics have the potential to offer similar clinical benefit to longer-acting psychedelics, in a more efficient and scalable way, which could lead to increased patient access. 

See also  Beckley Psytech to study DMT for treatment-resistant depression

“By including BPL-003 and ELE-101 in the atai platform, we are building the largest portfolio of psychedelic compounds with prior clinical evidence.”

Beckley Psytech’s CEO, Cosmo Feilding Mellen added: “Beckley Psytech and atai Life Sciences share a vision for the future of mental health treatment, and we are excited to join forces on the journey to develop effective, accessible, rapid-acting psychedelic medicines for people in need. 

“Alongside the financial investment, we are optimistic about the numerous possible synergies of this collaboration, especially in developing digital tools to optimize patient support and planning for future commercialization. 

“We look forward to exploring these in the coming months.” 

BPL-003 is currently in development for Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD), with three clinical trials underway. 

The first trial is a global, multi-site, double-blind, randomized Phase IIb study in people living with TRD, evaluating the effects of a medium and high dose of BPL-003 against an active placebo comparator in 225 patients with moderate-to-severe TRD. 

Medium and high dosages were found to reliably induce profound psychedelic experiences in a completed Phase I trial, with a rapid onset of psychedelic effects within minutes and the resolution of all perceptual effects within 60-90 minutes. 

In addition to the Phase IIb study in TRD that is anticipated to read out in the second half of 2024, BPL-003 is also being investigated in two small Phase IIa open-label studies in TRD and AUD, with data expected in the first half of 2024 and mid-2024 respectively. 

Beckley Psytech’s second candidate ELE-101 is being developed for the treatment of Major Depressive Disorder (MDD). This compound has the potential to offer the therapeutic benefits of psilocybin, which has demonstrated significant antidepressant effects in multiple clinical studies, in a more consistent, controllable, and shorter treatment paradigm of less than two hours. Initial results from the current ELE-01 Phase I/IIa study are anticipated in the first half of 2024. 

atai Co-founder and Chief Executive Officer Florian Brand added: “When it comes to mental health, there is no one-size-fits-all solution, and the diverse pharmacology of our drug candidates acknowledges the heterogeneity of neuropsychiatric patient populations. Looking ahead to the next 12 months, adding to our already strong pipeline of potential catalysts, we anticipate this investment will lead to several additional meaningful clinical readouts, including topline results from the BPL-003 Phase 2b study, expected in the second half of 2024.”

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Vital report explores employment in the psychedelics industry

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Vital report explores employment in the psychedelic industry

Psychedelics Today recently surveyed students and graduates of its 12-month intensive professional psychedelic certification programme, Vital, publishing its findings in The Emerging Psychedelic Workforce report.

Aiming to understand more about the emerging workforce, Psychedelics Today spoke to 130 students and graduates of its Vital course about how they are building their psychedelic careers.

With the nascent psychedelics industry seeing rapid progress, the report highlights the need for a knowledgeable workforce of people with a variety of skills — not just doctors and therapists.

To succeed, the industry will need to establish “a racially, economically, and culturally diverse workforce that can service a broad spectrum of communities,” states the report. 

This ecosystem is already on its way to being established, with the report finding that 50.4% of the survey respondents said they are interested in working in areas beyond facilitation and therapy, including media, academia, biotech, cultivation, marketing and finance.

Further key findings from the report include: 47% of students are not switching careers but instead are incorporating psychedelics into their current careers; 87.6% have been influenced to do so by their own positive experiences with psychedelics; and, 98.3% of respondents indicated that making money is not a primary motivation to enter the field.

David Drapkin, Director of Education at Psychedelics Today, discussed the findings, emphasising the growth of the industry and highlighting the significance of personal experience and motivations for entering the field, as well as the importance of education and awareness.

“The report shows that our future workforce is going to have a lot of diversity on multiple levels including racial and ethnic diversity and LGBTQ representation,” said Drapkin.

It also revealed that over half of the current psychedelic workforce – 67% – are women, 2.5% are non-binary and 1.7% are transgender, demonstrating the inclusivity and progressive nature of the industry. 

The report reads: “The psychedelic field’s workforce appears to be breaking some traditional gender norms, with a strong female presence complemented by diverse gender identities. This inclusivity and diversity might shape the field’s progression and outcomes in unique ways, and lead to a richer pool of ideas, methods, and approaches to challenges.”

Further findings include a 66% BIPOC representation in the industry, who say they aim to serve their community, indicating a dedication to addressing racial and ethnic disparities.

“That looks to me like a positive development for those communities and the kinds of communities that are often underrepresented in mental health care,” Drapkin added.

As different countries have different regulations around psychedelics and different requirements around licensure, Drapkin highlighted that there is also a need to open the industry up to both licensed and unlicensed professionals.

“We’re seeing that a lot of the folks entering the psychedelic workforce are mid-career. They’ve had seasoned careers already and half of them are self-employed. Half of them also intend to build psychedelics into their existing career. So, they are already in quite a good place with a career and want to get a depth of education, learning and community to enable them to take the next step,” he said.

“Those are the folks in the real world that are going to be a really big part of the workforce. When you think about that and the number of people that are going to be required for centres, clinics, integration support, and more, there are currently not enough licensed professionals to do that. 

“We simply have to be honest about that. And that’s why Vital is going to be serving all of those people who have to be part of scaling out of the psychedelic ecosystem.”

Drapkin also emphasised that with over 90% of people surveyed saying they had their own personal experience with psychedelics, the workforce “knows how psychedelics feel”, as well as the benefits of psychedelic medicine.

“I think our community is also really aware of the state of affairs that we’re in globally around trauma, depression, anxiety, suicidality, and addictions. We know a lot of students in the workforce know that psychedelics could be a game changer for mental health. 

“Because of those two factors, I believe that folks entering the psychedelic workforce are more motivated to maximise impacts on local communities and to be part of this new paradigm of helping people more effectively than the status quo. 

“That’s something we have really prioritised when interviewing students for the Vital course. We’re looking for those that are working in the community, maybe involved in policy work, and working with marginalised people, because we know that this will maximise health impacts by reducing health inequalities on the ground.

“I’d say people entering the psychedelic workforce are still the pioneers. It still is early days and career opportunities are slowly starting to expand and open up. If and when MDMA gets medicalised and commercialised this could have a huge impact on not just practitioners, but the entire industry when it comes to mental health and wellness – the industry is going to be revolutionised. 

“I think people are aware that getting ready now is best because it’s happening now in places, like Oregon, Colorado and Australia. We’ve got quite a lot of students coming from those places who can do the work right now and are already legally able to work.”

To help improve access to psychedelic education and champion diversity in the industry, Vital has established a diversity fund and scholarship programme which has provided funding of $700,000 over the last two cohorts of its scholarship awards.

To read the full report please visit: https://psychedelicstoday.com/new-report-the-emerging-psychedelic-workforce/ 

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Psychedelic therapy programmes launch to address heartbreak, burnout and more

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Psychedelic therapy programmes launch to address heartbreak, burnout and more

Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges. 

Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.

All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.

See also  Psychedelics for frontline workers, palliative care and eating disorders

The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.

Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.

Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.

“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”

“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.

“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”

Additional Mastermind programmes will be released in the coming months, including: Getting Unstuck, by Dr Elizabeth Lombardo; Beating Burnout, by Dr Shauna Shapiro; and Coping with Cravings, by Dr Jud Brewer

“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.

“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”

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