Newsletter | June 25, 2025

06.25.25 -- Psychedelics For Mental Health Disorders

SPONSOR

Webinar: Fixing the Monitoring Model: How a Flexible Resource Supports Trial Success

As clinical trials grow increasingly complex, traditional monitoring models are showing their cracks. Overextended CRAs, inconsistent site engagement, and reactive oversight can lead to delays, data quality issues, and strained site relationships. Join clinical operations experts for a candid conversation about what's not working in today’s trial monitoring—and what could.

FEATURED PODCAST

Psychedelics For Mental Health Disorders With Srinivas Rao, M.D., Ph.D.

On this Business of Biotech episode, Dr. Srinivas Rao, co-founder and CEO at atai Life Sciences, explains how his engineering background led him to the development of psychedelic compounds for treating depression, anxiety, and other mental health disorders. Internal drug development efforts at atai are focused on short-duration psychedelics that can work within existing healthcare infrastructure, with the potential to transform the treatment of mental health disorders.

INDUSTRY INSIGHTS

Key Criteria For Choosing The Right Phase 1 CRO

What steps can you take to select the best CRO partner for your Phase 1 clinical trial? Evaluate several factors, such as therapeutic area expertise, experience with trial complexity, and cost transparency.

How Cloud ERP Overcomes Hidden Costs And Customization Constraints

Explore how cloud ERP systems provide businesses with the flexibility to scale and adapt quickly to market changes, as well as benefit from seamless updates without extensive customization.

The Streetlight Effect

Examine the shortcomings of existing clinical trial finders, particularly regarding the accessibility of eligibility criteria for patients seeking treatment options.

Advancing Immunotherapy In Head And Neck Cancer: The IT-MATTERS Study

A randomized controlled pivotal Phase 3 study evaluated the efficacy and safety of neoadjuvant complex biologic administered for three consecutive weeks pre-surgery.

Successful Regulatory Submission Via The Trifecta Of Awesomeness

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

FUJIFILM Diosynth Biotechnologies Signs $3B Deal With Regeneron

Fujifilm has signed a $3 billion, 10-year deal with Regeneron to manufacture biologics in North Carolina, reinforcing U.S. supply chains and expanding domestic biopharma capabilities.

Nanomedicine Modalities Find Path To Clinic Through Analytics

Lipid nanoparticles have revolutionized drug delivery, ushering in a new era of nanomedicine. Discover how advanced analytical tools are accelerating next-generation LNP therapeutics.