Greg and Matias interview Tim Marjenin, a regulatory consultant at MCRA with 16 years of experience at the FDA, to discuss the regulatory landscape for neurotechnology devices.

Tim provides insights into the FDA approval process for neurotech devices, drawing from his extensive experience on the FDA's Neurostimulation-Neurology Devices Team. The episode explores the evolving field of neurotechnology and its regulatory challenges.

In this episode, we discuss:

• Different regulatory pathways for neurological devices (510(k), De Novo, PMA)
• FDA's approach to novel neurotechnologies like brain-computer interfaces (BCIs)
• Considerations for invasive vs. non-invasive neurotech devices
• The importance of cybersecurity in neurotechnology
• Common mistakes companies make in the regulatory process and how to avoid them
• The potential future of neurotechnology, including human augmentation and telepathy
  
  

Created by Greg Kubin and Matias Serebrinsky
Host: Matias Serebrinsky & Greg Kubin
Produced by Jonathan A. Davis, Nico V. Rey & Caitlin Ner

Find us at businesstrip.fm and psymed.ventures
Follow us on Instagram and Twitter!
Theme music by Dorian Love
Additional Music: Distant Daze by Zack Frank and Krotoa by Makropulos

Greg and Matias interview Gurdane Bhutani, an investor at MBX Ventures, to discuss the impact of environmental toxins on health and the field of exposomics.

Gurdane is an expert in environmental health, with a background in Epidemiology and Environmental Health Sciences. He provided insights into the pervasive nature of environmental toxins and their implications for public health. This episode also has a guest appearance from Bruce Blumberg, a Professor of Developmental and Cell Biology at UC Davis.

In this episode, we discuss:

• The widespread presence of environmental toxins and their link to diseases like Parkinson's and autism
• The field of exposomics and lifetime environmental exposures
• Obesogens (chemicals whose exposure makes you fat)
• Startups building solutions for better diagnostics, green chemistry, and water treatment
• Practical lifestyle changes to reduce exposure to harmful chemicals and improve health

Credits:

Created by Greg Kubin and Matias Serebrinsky
Host: Matias Serebrinsky & Greg Kubin
Produced by Jonathan A. Davis, Nico V. Rey & Caitlin Ner

Find us at businesstrip.fm and psymed.ventures
Follow us on Instagram and Twitter!
Theme music by Dorian Love
Additional Music: Distant Daze by Zack Frank and Temperance by Eltham House

Greg and Matias interview Josh Hardman, founder and editor of Psychedelic Alpha, to discuss the recent FDA advisory committee meeting on Lykos Therapeutics’ MDMA-assisted therapy for PTSD.

Josh is a leading writer covering the intersection of psychedelics and business. He provided live reporting and analysis of the AdComm meeting.

In this episode, we discuss:

• The FDA advisory committee process and its implications for drug approvals
• Functional unblinding and expectancy effects in psychedelic clinical trials
• Potential impacts on the broader psychedelic medicine industry
• The future of psychedelic-assisted psychotherapy protocols
• Neuroplastogen development and non-hallucinogenic approaches
• Challenges around therapy, safety, and regulatory pathways for psychedelic medicines

Credits:

Created by Greg Kubin and Matias Serebrinsky
Host: Matias Serebrinsky & Greg Kubin
Produced by Jonathan A. Davis, Nico V. Rey & Caitlin Ner

Find us at businesstrip.fm and psymed.ventures
Follow us on Instagram and Twitter!
Theme music by Dorian Love
Additional Music: Distant Daze by Zack Frank