Newsletter | August 21, 2025

08.21.25 -- Heart-In-A-Jar Organ Model Earns Regulatory Respect After 25 Years In The Making

REGULATORY & COMPLIANCE

Heart-In-A-Jar Organ Model Earns Regulatory Respect After 25 Years In The Making

Aligned with new FDA support for new approach methodologies (NAMs), Ronald Li, Ph.D, and Kevin Costa, Ph.D., share their story of creating Novoheart's mini heart organ model and discuss its current use in clinical trials.

Mitigating Risk With Ex-U.S. Clinical Trials

Gain insight into why certain regions offer strategic advantages, from regulatory flexibility to faster enrollment, and how to effectively integrate them into your development strategy.

Project Optimus: Shifting Away From Maximum Tolerated Dose

Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

Conflict Of Interest: Implications For Clinical Research Sites

Amid scrutiny of the financial conflicts of interest in biomedical research, new federal rules aim to improve transparency and preserve the integrity of publicly funded research.

OUTSOURCING MODELS

A New Barometer For Clinical Outsourcing Performance

Interested in how some of the top publicly traded clinical development outsourcing companies are doing in the market? Andrew Schafer may be able to help with his Schafer Clinical Development Index (SCDI).

Making The Lives Of Patients And Research Sites Easier

Most clinical trials overlook one crucial factor: giving sites and patients a voice in how studies are run. That’s starting to change—and the impact is significant.

Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

CDMO Support: Success In Early-Phase Drug Product Development

As sponsors strive to deliver therapies with increasing efficiency, CDMOs are poised to remain vital, offering specialized expertise, accelerated timelines, cost efficiency, and risk mitigation.

Your Global CRO Partner In Neuroscience

Leveraging over 140 completed neuroscience studies and specialized knowledge in neurodegenerative diseases, TFS delivers substantial expertise and a demonstrated history of successful trials.

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  • Clinical Trial Technology (Tuesday)
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