Business of Biotech Shorts
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Ep. 257, Chapter 6: Research Funding, Cuts, And Lessons Learned With Thomas Levenson
7/28/2025
Levenson states that curiosity-driven basic science often seeds unexpected, beneficial technological developments. He cautions that relying on individual philanthropists is not a sustainable solution because private funding can be sporadic. So, for science on the scale required by modern society, social-level funding is essential and should not be subject to the whims of changing political administrations.
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Ep. 257, Chapter 5: The Challenges Of Microbiomes And Antibiotic Resistance With Thomas Levenson
7/28/2025
Levenson acknowledges the microbiome as a potential new frontier for germ theory, acknowledging its immense complexity since traditional germ theory focuses on individual microbes with clear cause-and-effect relationships, while the microbiome is an intricate ecosystem within our bodies. Past clinical failures in developing microbiome-targeted drugs highlight how much more there is to learn.
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Ep. 257, Chapter 4: Unseen Biases In Modern Science With Thomas Levenson
7/28/2025
Levenson states that it is inherently difficult to identify current scientific and medical biases, drawing parallels to historical assumptions like miasma theory. He highlights that societal willingness dictates scientific research — for example, how political decisions in the US have shifted NIH and NSF focus from infectious diseases to chronic conditions.
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Ep. 257, Chapter 3: Early Germ Theory Insights From Unlikely Sources With Thomas Levenson
7/28/2025
Several lesser-acknowledged individuals contributed significantly to understanding of germ theory, including Cotton Mather, often remembered as a Puritan "hellfire and brimstone" figure. Mather compiled an extensive, though unpublished in his lifetime, encyclopedia of medical knowledge called “The Angel of Bethesda,” and became a pioneer in smallpox inoculation, learning the practice from his enslaved servant, who had been inoculated in Africa.
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Ep. 257, Chapter 2: Miasma Theory's Stubborn Grip With Thomas Levenson
7/28/2025
Historical misconceptions, particularly the concept of miasmas, hindered the acceptance of germ theory. Traditional ideas to explain the spread of disease centered on keeping the body's humors (or, later, chemical imbalances) in balance, Levenson explains. These ideas were metaphorically useful for describing disease, but they offered no specific treatments. Still, miasma theory’s enduring power lay in its descriptive utility. Observing a disease spreading, the idea of invisible "seeds" carried on the wind seemed like a plausible explanation, even if it didn't reveal the actual mechanism.
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Ep. 257, Chapter 1: Unpacking The Germ Theory Revolution With Thomas Levenson
7/28/2025
Life Science Leader Chief Editor Ben Comer and science writer Thomas Levenson discuss the latter’s latest book, "So Very Small: How Humans Discovered the Microcosmos, Defeated Germs, and May Still Lose the War Against Infectious Diseases.” The book focuses on the 19th-century "germ theory revolution," particularly Robert Koch's 1876-1877 discovery of the anthrax bacillus as the pathogen causing anthrax.
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Ep. 256, Chapter 6: Biomarkers, Endpoints, And The Future of Psychedelic Therapies With Srinivas Rao
7/18/2025
Dr. Srinivas Rao notes that validated biomarkers and regulatory endpoints for mental health conditions like depression would be transformative, however despite promising signs from psychedelic research, they have not yet been verified. He also discusses whether the hallucinatory aspect of psychedelics, i.e., the trip, is necessary, noting that the experience most likely plays a role in disrupting entrenched neural patterns and promoting neuroplasticity. Ultimately, he believes psychedelic therapies, especially short-duration ones, have the potential to reshape mental health treatment by offering rapid, effective relief.
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Ep. 256, Chapter 5: The atai Life Sciences Approach With Srinivas Rao
7/18/2025
atai began with a broad hub-and-spoke model, combining internal drug development with strategic investments in Beckley Psytech and Recognify Life Sciences to diversify its pipeline and address unmet needs in mental health. After disappointing clinical results with their PCN-101 (R-ketamine) therapy, atai streamlined its operations to focus on fewer assets with high potential, particularly short-duration psychedelics that align with existing clinical infrastructure. Over the next year, the company anticipates four key Phase 2 readouts which will be critical in shaping its next phase of growth.
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Ep. 256, Chapter 4: Unique Challenges Of Psychedelic Development With Srinivas Rao
7/18/2025
While Dr. Srinivas Rao views psychedelics as simply another class of pharmacological compounds, they carry cultural baggage that can complicate drug development. He acknowledges the stigma around substances like psilocybin and MDMA among some physicians and patients, especially those wary of their histories as illicit drugs. To address this, atai focuses on rigorous science, novel compounds with shorter durations to reduce patient anxiety, and physician education to shift perceptions over time.
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Ep. 256, Chapter 3: Successes And Failures In The Psychedelic Therapy Space With Srinivas Rao
7/18/2025
Reflecting on his experience at other drug companies, Dr. Srinivas Rao emphasizes the importance of prioritizing patient-reported outcomes and starting with the end in mind. atai designed its VLS-01 compound to fit existing healthcare infrastructure and gained significant insight from the Spravato® path to market. Rao also discusses the Multidisciplinary Association for Psychedelic Studies’ (MAPS) failed attempt to gain FDA approval for its MDMA-assisted therapy due to non-standardized therapy protocols, unblinded trial designs, and inadequate trial size.