Miri Halperin Wernli | President, MindMed

Can you tell us about your background in biotechnology and pharmaceuticals?

My basic training is in Genetics and Experimental Psychology complemented with many years of hospital clinical practice in hospital settings in Switzerland and Canada specializing in Infant Psychiatry and adult infertility and sexology.

After many years of hospital clinical work, I joined the pharma industry and spent over 25 years in Pharma in Switzerland and the US in various executive functions in R&D and Marketing, leading large global organizations and international departments covering multiple therapeutic areas.

I have over 25 years of strategic and operational leadership experience in the biopharmaceutical industry and a deep understanding of drug and product development in heavy regulated environments.

I worked for 10 years in Roche, 3 years in Merck Sharp & Dohme (MSD), and 15 years in Actelion Pharmaceuticals.
I held worldwide senior leadership positions in product development, R&D and Strategic Marketing throughout Switzerland and in the US.

My pharmaceutical industry and biomed research and development experience covers the full spectrum of areas and activities from Preclinical to Clinical Development and Strategy, to Drug Registration and Launch, across several therapeutic areas.

I am an experienced Pharmaceutical leader with skills and broad expertise in Drug Development, Regulatory Affairs, Project & Portfolio Management, Development Finance & Controlling, and Corporate Strategy and Governance.

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What got you excited about psychedelic medicines?


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I spent many years in clinical settings in Hospitals in Canada and Switzerland in Adult and Infant Psychiatry and was confronted to the unsatisfactory solutions to most mental health conditions.
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There have not been significant advancements (which would achieve a significant reduction of psychiatric morbidity and its related burden on society) in psychiatric treatments for many years, nor in the field of psychopharmacology nor in the field of psychotherapy.
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Yet, in most psychiatric conditions, the guidelines usually agree that the combined approach (psychopharmacology and psychotherapy) is the most efficacious. But effect sizes of treatments, even when combined, remain until that day low and often disappointing. I think that the psychedelic approach is trying to move all the field away from a purely mechanistical view of psychopharmacology, thus changing the usual paradigm and making place for much greater improvements, and probably for durable ones that are not merely symptomatic reduction.

How do you see the psychedelic derived medicine opportunity and what impact could that potentially have on the world?

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Psychedelic inspired medicine has the potential to offer new treatment paradigms to many mental health conditions.

Many mental health disorders appear to be interconnected. In fact, there is no consensus on the validity of psychiatric diagnosis separation into clusters. Of course, psychiatrists, as all other medical doctors, absolutely need a structure, a framework, which will help them communicate between them and with patients, which will allow clearer drug development and which is certainly necessary for reimbursement policies. That does not mean it reflects the complex reality of the mind (psyche).
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The common features of anxiety, depressive and obsessive-compulsive disorders may be based on a shared genetic, neural circuits anomalies and biological foundation that is linked to the normal dimensions of experience we can summarize as distress and negative affectivity. It is important to remember that these disorders are highly comorbid and that their symptoms are frequently not separable.
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Also, as an example, 50% of ADHD patients also suffer from anxiety disorders and the vast majority of patients with General Anxiety Disorder also have symptoms of another mental health problem, such as depression or substance abuse. Given such data, we see a large opportunity to create novel treatment platforms that incorporate both experiential psychedelic-assisted therapy and non-hallucinogenic take-home medicines.
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Regarding the treatment paradigms, if we take depression for example, there is a clear difference between these new treatment and conventional antidepressants: the psychedelics don’t by themselves address the underlying biological, psychological or social causes of depression. The psychedelic therapy takes advantage of a therapeutic window opened up by the brain through the effects of the drugs to facilitate insight and emotional release and, with psychotherapeutic support, a subsequent revision of health.
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Psychological means of defense (such as repression, denial, displacement), as Freud and its followers found and described, are the way our mind copes with anxiety, which is rooted in our psychological development since very young. In other words, our mind has learned how to cope with existential anxiety by working around them. While psychotherapy usually addresses these, psychopharmacology in reality encourages these mechanisms (the aim is symptom reduction).
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What psychedelic medicine allows to do, I think, is to help patients open their eyes, in a safe and professional environment, on their wounds and deep conflicts, process them, and create new meanings (between them and their wounds, between them and the world, between their ego and their soul) which in turn alleviate pain and suffering and improve functioning in its wide meaning.


Could you talk about what it was about MindMed that made you want to get deeply involved?


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MindMed is for me the leading neuro pharmaceutical company working to develop psychedelics inspired medicines to address significant unmet medical needs within the trans-diagnostic applicability to the field of mental health.

Psychedelics may not only hold hope for treating various mental disorders, they provide an opportunity to discover the basic neuroscience of how these drugs really affect brain activity and the worldview.

Psychiatry and our society find itself faced with greater challenges than ever before. Suicide and addictions are major challenges our society is facing. The last major advance in the treatment of depression was over 30 years ago with the clinical approval of the first SSRIs and there is a clear need for substantial improvement in that field.

Psychiatry is in desperate need of fundamental mechanistic advances and MindMed with a platform of projects across the field of Mental Health will be in the best position to bring the change needed.

Psychedelics are showing promise for distinct and wide-ranging psychiatric disorders, including depression, anxiety, and addictions across a variety of drugs.

MindMed and our programs to evaluate and test a variety of treatment paradigms will mark the return of psychedelics to psychiatry, meaning the return of psychiatry to its roots, before the focus on biology and the brain took center stage, with a psychological understanding focused on the sense of self as it interfaces with personal history and the environment, as in the psychodynamic models which once predominated.

I was attracted to MindMed because the focus is on developing new treatments for mental health conditions and register them as medications through the drug approval process.

And the aim is to work to ensure broad patient access.

By diligently proceeding through established clinical and regulatory pathways, we not only ensure that psychedelics will become approved medicines and therefore become integrated into mainstream healthcare, we also ensure that we are producing the pharmacoeconomic data needed to show insurers that for patients for whom existing therapies haven’t worked (the treatment resistant population), it makes financial sense for these treatments to be covered.
We all know that patients with unmanaged mental illnesses overutilize all aspects of the healthcare delivery system (both physical and mental), so it is in the best interest of insurers to support patients in finding meaningful solutions.

MindMed has an approach that is at the same time revolutionary, bold, and courageous - all these are needed to make real meaningful changes.
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But we are also conservatory in that we believe, at MindMed, that this has to be done with a totally controlled medical and regulatory strategy.
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We believe that the combination of these two aspects is the key.

Taking absolutely no risk and maintaining a strictly conventional approach can’t achieve the goals; and doing it in a purely traditional manner (shamanic medicine) would not allow a real breakthrough characterized by proven and safe treatment protocols.

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MindMed currently has trials going on around 18-MC, LSD, and MDMA. Could you share what’s happening in real time with those projects?

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LSD
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We are starting a phase 2a study in LSD microdosing for treating adult ADHD in 2 centres in Europe.
We are preparing to open an IND and conduct a phase 2b study in Anxiety with an experiential treatment paradigm.

We have a number of studies ongoing in collaboration with Dr. Liechti and the Basel Hospital – for examples studies with MDMA and a study with DMT.

For example the DMT study:
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This Phase 1 study aims to experiment with dosing methods to better understand how humans react to DMT, setting stage for future potential Phase 2a proof of concept trials  
There is a growing trend in Western society to use Ayahuasca and DMT to facilitate a healing process for one’s mind.  However, there is very limited safety data and clinical trials evaluating DMT as a potential medicine so we are going to work to understand the therapeutic opportunity and more effective ways to administer DMT in a controlled setting to achieve this healing process.
Through this Phase 1 clinical trial, together with the Liechti Lab we are exploring how DMT can achieve experiential effects similar to Ayahuasca by testing a more controlled intravenous dosing method.
There is non-clinical, anecdotal evidence which suggests DMT and Ayahuasca's experiential effects are powerful healing tools for addiction disorders. The human safety data and associated knowhow gathered in this Phase 1 clinical trial will better enable us to design future potential commercial drug development programs based on DMT sessions.
 
DMT is rapidly metabolized as it enters the body if taken orally and therefore it only has a very short duration of action. In contrast through a continuous intravenous perfusion application the effect is longer but can be stopped rapidly. In order to potentially induce a stable DMT experience lasting 1-2 hours, an intravenous dosing regimen including a starting dose and then a maintenance dose will be evaluated in this Phase 1 clinical trial. This intravenous administration may also allow therapists to induce and to end an experiential state safely and more quickly as required. 
Currently, no study has validly determined the elimination half-life of DMT and other pharmacokinetic parameters and there is limited known data on dosing regimens of pure DMT. This Phase 1 double blind placebo controlled 5-period crossover design study will provide a well controlled study setting to illuminate these shortcomings in the current clinical understanding of DMT and pave the way for future Phase 2a proof of concept efficacy studies in various indications.

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MindMed has a partnership and ongoing collaboration with Liechti Lab. Can you share what is being developed there and what the potential is?

Through the deal with the University Hospital Basel and the Liechti Lab we have acquired exclusive, worldwide data rights to eight completed or ongoing LSD clinical trials conducted for 10 years.
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We have also received the data and worldwide rights to an additional ongoing Phase 2 trial for the LSD assisted therapy treatment of anxiety disorders administered by Dr Matthias Liechti, and the psychedelic therapy expert, Dr Peter Gasser.
We have engaged Dr. Peter Gasser as an advisor to our LSD experiential therapy program which we call Project Lucy.
Dr. Gasser has pioneered the legal, medical use of psychedelics through clinical research and compassionate access in Switzerland and has served as the President of the Swiss Medical Society for Psycholytic Therapy since 1997. Through compassionate access in Switzerland, Dr Gasser holds several individual treatment permissions to treat patients with MDMA and LSD. Dr. Gasser helped pioneer compassionate access for end of life psychedelic assisted therapy in Switzerland.
Our Project Lucy intends to start a Phase 2b human efficacy trial that will focus on experiential doses of LSD to treat anxiety disorders administered by a therapist.

What are the biggest challenges facing MindMed in the foreseeable future? What steps will you be taking to prepare for and overcome them?

The challenges are to go through rigorous development of the different programs.

In other words, taking an unconventional approach and making it suit to the usual rigorous requirements for drug development.
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Another challenge would be for us to help the authorities and the community understand how and why this approach is different, and what this means concretely in terms of clinical research and future treatments.
Merely as an example: the question of blinding in clinical trials. Can we blind the patients and teams while at the same time trying to open their eyes inward? Are we afraid to admit that a potential placebo effect and the effect per se are not distinguishable and that this is OK, because that’s what the mind (and therefore therapy for the mind) is about?


What would success look like for you as President of MindMed? What key metrics and initiatives will you be focusing on?

Driving forward all our clinical and scientific programs in a timely manner and to the highest clinical and regulatory standards.
In societal terms, I would like MindMed’s vision to be visible and understandable to the community, because our deep goal is to bring significant relief to suffering of a huge segment of the society and our deep belief is that it is achievable through psychedelics, at the condition that it is done in a truly scientific and controlled manner, with no compromises.