Newsletter | May 22, 2024

05.22.24 -- Drug Discovery Powered By Physician Intelligence


Biotech Submits NDA After Risk-Based Mock Inspection

An emerging biotech company recently took a preventative approach to mitigate risks, identify potential concerns before an FDA inspection, and submit their NDA. See how these proactive measures accurately addressed gaps within its application and led to a successful submission.


Drug Discovery And Development, Powered By Physician Intelligence

For Nuvalent CEO James Porter, physician intelligence is more important than artificial intelligence in discovering and developing new therapies that tackle key unmet needs among cancer patients.


The Vital Role Of Community Pharmacies In Clinical Trial Enrollment

Clinical trial enrollment poses significant challenges for researchers. Leveraging pharmacies offers a solution due to their accessibility and established patient trust.

Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying

A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.

Top 10 Most Cited QSR Clauses In FDA FY2023 Medical Device Inspections

By proactively addressing recurring deficiencies in design controls and risk management, manufacturers can ensure FDA compliance and prioritize patient safety and device effectiveness.

Roles And Responsibilities Of Specialized Clinical Supply Experts

Explore the important roles of the Project Manager, Clinical Supply Manager, and Financial Project Analyst, whose responsibilities contribute to clinical supply expertise and study success.

Fundamentals For Bispecific Antibody-Based Cell Line Development

BsAbs’ dual specificity opens a wide range of applications. Understand why consistent production of structurally complex molecules that exhibit high yield and purity requires keen expertise and experience.

Quality By Design: Better Data Using Participant Insights

While clinical trials will always encounter challenges in driving quality experiences and data, there exists one approach that’s backed by regulatory agencies and proven to lead to better outcomes.


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