Tag: drug development

Q&A: Alex Zhavoronkov on Cognitive Enhancement, Anti-Aging, and AI Drug Development

The Petrie-Flom Center Staff Leave a comment

Interviewed by William Leonard Pickard

Alex Zhavoronkov, PhD, is Founder and CEO of Insilico Medicine, a leading clinical stage biotechnology company developing next-generation artificial intelligence and robotics platforms for drug discovery, with headquarters in Cambridge, MA and facilities around the world. He has invented critical technologies for the creation of novel molecular structures, and pioneered the prediction of human biological aging.

Q: Tell us about Insilico’s work

AZ: Insilico has two main focus areas: developing software and discovering and developing novel drugs for aging-related diseases (thus enhancement in neurodegenerative states and in healthy adults). When it comes to software, most of our platforms are commercially available for startups and academics with free trial access, and for some specific projects we can provide software for free in the form of a collaboration. When it comes to drug discovery, academics and startups can contact us to test our drugs in a variety of experimental models.

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Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

FDA Solicits Feedback on the Use of AI and Machine Learning in Drug Development

Matthew Chun Leave a comment

By Matthew Chun

The U.S. Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. On May 10, FDA published a discussion paper on this topic and requested feedback “to enhance mutual learning and to establish a dialogue with FDA stakeholders” and to “help inform the regulatory landscape in this area.” In this blog post, I will summarize the main themes of the discussion paper, highlighting areas where FDA seems particularly concerned, and detailing how interested parties can engage with the agency on these issues.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

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By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

The Petrie-Flom Center Staff Leave a comment

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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Pregnant woman sitting across desk from doctor wearing scrubs and holding a pen

Excluding Pregnant People From Clinical Trials Reduces Patient Safety and Autonomy

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By Jenna Becker

The exclusion of pregnant people from clinical trials has led to inequities in health care during pregnancy. Without clinical data, pregnant patients lack the drug safety evidence available to most other patients. Further, denying access to clinical trials denies pregnant people autonomy in medical decision-making.

Pregnant people still require pharmaceutical interventions after becoming pregnant. Until maternal health and autonomy is prioritized, pregnant people will be left to make medical decisions without real guidance.

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Washington, DC – October 16, 2020: One of the many official ballot boxes placed around the city for early voters to place their completed ballots to avoid lines due to the ongoing Covid-19 pandemic.

Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws

The Petrie-Flom Center Staff Leave a comment

By Melissa Lavasani

In December 2019, I proposed a ballot measure, now known as Initiative 81, which would effectively decriminalize natural psychedelics – including psilocybin and ayahuasca, which had helped me overcome postpartum depression – in the District of Columbia.

This would help ensure that other D.C. residents benefiting from natural psychedelics are not targeted by law enforcement. After tumultuous months of hard work including collecting more than 25,400 signatures from voters, Initiative 81 is on the November ballot.

I am not the usual protagonist you’d imagine as an advocate for psychedelics: I am a married mother of two with two graduate degrees and an established career working for the District of Columbia government. But I had a psychedelic experience that changed my life. In 2018, I had taken psychedelics – first psilocybin mushrooms, and then ayahuasca and San Pedro cacti – because I was desperate to overcome severe postpartum depression that came to dominate my life.

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man lying on couch.

Psychedelics and America: A Digital Symposium

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By Mason Marks

In 2020, the psychedelics research and policy reform renaissance is in full swing. Prohibited by federal law since the 1970s, psychedelic substances can alter how people see themselves, the world, and those around them. Clinical trials suggest they may help people overcome ingrained thought patterns associated with depression, anxiety, and addiction.

Acknowledging their spiritual and therapeutic potential, universities have established new psychedelics research programs. The Food and Drug Administration (FDA) has deemed them breakthrough therapies for depression and post-traumatic stress disorder. This designation means they could be significant improvements over traditional treatments such as selective serotonin reuptake inhibitors (SSRIs). Accordingly, the FDA has put some psychedelics on an accelerated course toward approval. Eventually, they could help millions who have not benefitted from existing therapies.

However, despite their breakthrough status, psychedelics will not become FDA approved for several years. Meanwhile, the COVID-19 pandemic is making the country’s mental health crisis worse. According to the Centers for Disease Control and Prevention, rates of depression, anxiety, substance use, and suicidal thoughts have risen in the past nine months.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

As Cities Decriminalize Psychedelics, Law Enforcement Should Step Back

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By Mason Marks

Amid rising rates of depression, suicide, and substance use disorders, drug makers have scaled back investment in mental health research. Psychedelics may fill the growing need for innovative psychiatric drugs, but federal prohibition prevents people from accessing their benefits. Nevertheless, some cities, dissatisfied with the U.S. war on drugs, are decriminalizing psychedelics.

In 2019, Denver became the first U.S. city to decriminalize mushrooms containing psilocybin, a psychedelic the FDA considers a breakthrough therapy for major depressive disorder (MDD) and treatment-resistant depression.

In a historic vote, Denver residents approved Ordinance 301, which made prosecuting adults who possess psilocybin-containing mushrooms for personal use the city’s “lowest law enforcement priority.” Since then, in Oakland and Santa Cruz, California, voters approved their own decriminalization measures.

As a Schedule I controlled substance, psilocybin remains illegal under federal law, and despite ongoing clinical trials, it is unlikely to become FDA approved for several years. Social distancing requirements due to COVID-19 are disrupting medical research causing further delays. But as the November election approaches, other U.S. cities prepare to vote on psychedelics.

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