Drug Discovery Featured Articles & Applications

1. A Checklist For Mechanism-Based Potency Testing In Cell Therapy 4/25/2025

   New research concludes that potency cannot be decoupled from a product's mechanism of action because surrogate markers fail to capture functional relevance.

2. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

   Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

3. Promising Clinical Trial Updates Shared At The American Academy Of Neurology Conference 4/24/2025

   The 2025 American Academy of Neurology (AAN) conference in early April saw some promising clinical trial updates treating Guillain-Barre Syndrome and Huntington’s Disease, CIDP, and ALS.

4. How To Approach Tech Transfers And Sponsored Life Sciences Research In An AI Age 3/27/2025

   Two IP attorneys examine the patentability of AI-conceived inventions and share tips for technology transfers and sponsored research in pharma/biotech.

5. Applying AI To Identify Synergistic Drug Combinations For Cancer Treatment 3/14/2025

   By combining drugs/therapies with different mechanisms of action, different pathways in cancer cells can be targeted, potentially leading to improved patient outcomes. Using AI is hastening this research.

6. Mesenchymal Stem Cells Hold The Key To Treating Degenerative Conditions 3/7/2025

   Mesenchymal stem cells offer a promising path forward in managing complex conditions that are often age-related. What makes MSCs unique and how do they compare to iPSCs?

7. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

   The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

8. Drug Design At The Speed Of Quantum 2/28/2025

   Using quantum computing to optimize drug design can identify the most effective molecular structures, and new therapeutic pathways could open the door to more personalized drugs.

9. EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety 2/28/2025

   There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments. The public comment period ends April 30.

10. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

    AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.