Connect with us

Markets & Industry

A drug developer’s guide to navigating psychedelic trials



A drug developer’s guide to navigating psychedelic trials
Photo by Ashley Batz on Unsplash

As their 300-gram MDMA shipment got to the border, PharmAla Biotech found themselves in a sticky situation. The export and import permits were in place, but the dispatch of the shipment was left by their shipper to the last possible day.

When the shipment was finally sent out, a worker at the airport put the properly prepared and labelled box into another box, resulting in its rejection by the airline. Meanwhile, both the import and export permits expired and the shipment was stuck for an agonising three months, because of a mere box.

Amid the frustration and setbacks, stakeholders navigate the convoluted landscape of permits and regulations, delivering clinical trials successfully. The lessons learnt during these frustrating times are invaluable, and worth sharing for the advancement of the sector. 

See also  Clerkenwell Health: Developing a gold standard for psychedelic care

The discussion led by Clerkenwell Health at PSYCH Symposium: London 2023 brought together a panel to do just that. Here are some of the key takeaways. 

Stay abreast of regulatory changes

Psychedelics exist within a highly regulated subset of an already highly regulated space.  On top of that, regulatory requirements change constantly. As George McBride, Co-founder and CCO of Clerkenwell Health puts it, “It’s an evolving beast causing uncertainty, hurdles and delays. You might conceive of a trial now, but by the time you’re delivering, it might be in a different environment with different regulations.”

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

“Compounds that are not controlled today may become controlled tomorrow due to changes in the regulatory framework and following increased activity or awareness on the compound,” adds Peter Mollison, CEO of Eramol, a clinical trial manufacturing organisation. “So, keeping abreast and horizon scanning of the upcoming changes that will impact your study design and drug supply is key.”

Help develop robust frameworks for psychedelic clinical trials

Until very recently, there was no guidance showing what a psychedelic clinical trial should look like. Drug developers have been engaging regulators at a very early stage and working with them as they request information in real-time, further increasing the timelines.

While FDA’s recent guidance is a good starting point for the sector, the nuances between jurisdictions still exist. “It’s challenging to navigate exactly what these nuances might look like and how you might address those in terms of your trial applications and designs,” says Clare Knight, Senior Clinical Trial Manager at Clerkenwell Health. 

See also  PSYCH Symposium: shifting perceptions, in conversation with Robin Carhart-Harris 

There is a need to develop more robust guidelines for each jurisdiction as well as an understanding of key principles that work across areas. This will be essential to make trials more approvable and streamline the whole process.

Plan carefully for drug import and export, and returns

While planning for an early phase single territory trial isn’t too complicated, the minute you start thinking about Phase 2 and 3 trials, you’re looking at multi-site multi-country trials. It’s then no longer feasible to have a drug manufacturer in every territory and you’ll have to move the compounds around. That’s when the delays and unknowns come in. 

Peter from Eramol says that “One of the biggest mistakes is to think that you can just ship a product back without any permits.” For example, an underperforming site might want to return the product but struggle to return it quickly enough. The product then goes out of date and leads to waste.

See also  PSYCH Symposium: solutions for police and society

Panellists noted that drug import and export in the US, UK and Australia are relatively easy; however, Australia uses a paper-based system which slows down timelines. Moreover, although the EU is a single market, import/export permits still exist, and the regulations vary depending on the country.

Work with sites that understand what is required to deliver a protocol

One of the main pain points for drug developers is the lack of highly experienced delivery infrastructure. There is a real shortage of sites that are able to deliver psychedelic clinical trials. 

Knight adds: “I’ve worked in psychiatry research most of my career. In psychiatry. There’s a whole set of considerations that don’t exist in other areas of medicine. We’re just adding another layer on top of that when we work with vulnerable populations and substances that may cause a change in their perception.”

Have early and open communication with your vendors

In other more well-established areas of clinical research, vendors work in silos and you can assume that the different parts will run fairly to plan and join together in the end. On the other hand, the constantly evolving psychedelics sector rely on communicating with each other.

Dr Guy Higgins, CSO of Transpharmation, a preclinical CRO, shares: “We work very closely with Mindset and always have an open dialogue such as how the animal data can translate and help guide the early clinical programme.” Engaging your collaborators at the earliest stage, before working on a protocol, is also crucial to understand each other’s timelines and interdependencies and mitigate these in trial designs.

Improve collaboration in the sector

A $3 million grant to research psilocybin was recently announced by the Canadian government. That was a direct result of the lobbying work carried out by PsyCan, a trade association in Canada. The member companies were organised and went to the government together to engage in sectoral issues.

PharmAla’s Nick is the board chair of PsyCan and he says, “If you want government to stop hindering your progress, you have to tell them so. If you tell them so by yourself, they’re probably not going to listen, but if you act as a group, you might have some success.”

Psychedelics is still a nascent sector where everyone is finding their feet. We need to work together, particularly in this challenging economic climate, to build a supportive network that propels psychedelic research to new heights.

Watch the full panel

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Markets & Industry

Psychedelic therapy programmes launch to address heartbreak, burnout and more



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.”

Continue Reading

Markets & Industry

Mychedelica launches to revolutionise psychedelic medicine



Mychedelica launches to revolutionise psychedelic medicine

A new company specialising in psychedelic medicine – mychedelica – is offering a comprehensive suite of services to support the advancement of this transformative field. 

With a team of experienced medical writers and research support specialists, mychedelica is committed to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in the psychedelic medicine space.

Psychedelic medicine is rapidly gaining recognition for its potential to treat a wide range of mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). However, the field is still in its early stages of development, and there is a critical need for high-quality medical writing and research support services to facilitate its progress.

CEO of mychedelica, Bilal Bham, commented: “We are thrilled to launch mychedelica and contribute to the advancement of psychedelic medicine.

“Our team of experienced professionals is dedicated to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in this groundbreaking field.”

mychedelica provides a comprehensive range of services, including:

Medical writing: Experienced medical writers will craft clinical trial protocols, regulatory submissions, and peer-reviewed publications, ensuring that research findings are communicated clearly and effectively.

Funding research support: Experts in grant writing and fundraising strategies will assist researchers in securing funding for their psychedelic medicine studies.

Regulatory consulting: mychedelica’s team of regulatory experts will navigate the complex regulatory landscape surrounding psychedelic medicine, ensuring that clinical trials and products comply with all applicable laws and regulations.

With its commitment to quality and innovation, mychedelica is poised to play a pivotal role in shaping the future of psychedelic medicine. The company’s services will empower researchers to conduct rigorous clinical trials, clinicians to provide effective treatments, and pharmaceutical companies to develop safe and effective psychedelic medicines.

Continue Reading

Markets & Industry

Short Wave Pharma: innovating eating disorder care with psychedelics



Short Wave Pharma: innovating eating disorder care psychedelics

Psychedelic Health speaks to Short Wave Pharma CEO Rivki Stern about the company’s plans to innovate eating disorder care through psychedelics and its recent acquisition by Psych Capital.

Short Wave Pharma was recently acquired by global investment firm Psych Capital. The companies are on a mission to transform mental health care, focusing on innovative approaches and treatments, including psychedelics, which are increasingly gaining acceptability as clinical research results accumulate.

Short Wave Pharma’s clinical programmes are particularly focused on Anorexia nervosa – a complex mental health condition with one of the highest fatality rates. Despite the condition being associated with high rates of suicide, it is a hugely underserved area of mental health, with no FDA-approved pharmacological drug, and a high rate of chronicity. 

See also  Psych Capital completes acquisition of Short Wave Pharma

The company has developed a novel delivery method and drug combination specifically designed to address the requirements of this vulnerable population. Short Wave focuses on methods of delivery that will be effective for Anorexia, which is a metabolic disease as well as a mental health condition. Its unique buccal film delivery method is intended to affect the brain while bypassing the liver and gut degradation through mucoadhesive absorption.

“Our goal is to alleviate, solve, and treat mental health conditions. It’s a dire need in our global society, and it’s constantly on the rise,” commented Stern. “Eating disorders are a very good example of that and we have seen a very alarming growth since COVID. 

“What drew our attention to psychedelics is that they have the potential to address very complex mental health diseases and have been designated by FDA as breakthrough medicine for life-threatening conditions.

“Because there are no current solutions, we must harness very innovative approaches and potential solutions. That’s why we started working with psychedelics which may be difficult because they are not regulated, but we don’t shy away from challenges.”

The company’s drug is based on psilocybin and another API which together utilise an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain. 

The delivery method is sensitive to the patients’ needs – who may not want to swallow or be injected – and is known for its high bioavailability. 

“By mucosal absorption, we are speeding the onset of the medicine and amplifying the impact which will help tackle the patients’ metabolic challenges and improve acceptance,” says Stern. 

The drug product and delivery method are currently in preparation for Phase 1 clinical studies, and in its current preclinical studies, the company is validating its delivery and expanded mechanisms of action. So far, initial safety results are positive, with a further, more in-depth toxicity study taking place. 

Psych Capital – which is a public investment and awareness platform for mental health, and has a portfolio of innovative companies – has supported Short Wave Pharma’s IP-driven approach to eating disorder care through its recent acquisition of the company.

Short Wave and Psych Capital say they are aligned in their missions to innovate mental healthcare and deliver transformative care in areas of high unmet need.

Stern commented: “We all share a passion for innovation and together have decades of experience in evaluating investments as well as scaling up R&D projects and start-ups in life sciences. 

“We have a shared commitment to alleviate the suffering from mental health. Every one of us has experienced the frustration and challenges of dealing with mental health issues.

“Together, we’re going to put this commitment into action, by bringing forth innovative solutions and developments and getting them through the first stages of development, from discovery through to early phases of clinical study. 

“With psychedelics components, this is extra challenging because of their status as scheduled drugs within a still evolving regulatory framework, which adds uncertainty to the drug development process. 

“Short Wave Pharma has operational expertise in early-stage drug development which will bring extra value to the group’s projects as they develop through our funnel and grow into promising candidates for mental healthcare.  

“We want to identify the gems, guide them through clinical development, and create the right network to attract the right partners for further development and commercialisation.”

Short Wave Pharma is planning to enter its treatment into clinical studies in 2024.

Continue Reading