Editors' Desk

1. 10 Ways To Strengthen U.S. API: Part II 9/4/2025

   We continue the API supply chain conversation, jumping into KSM sourcing and substitution, utilizing idle space and connecting the dots. The road to strengthening the U.S. pharmaceutical supply chain won’t be easy, but it is manageable.

2. 10 Ways To Strengthen U.S. API: Part I 8/29/2025

   Bringing the API supply chain closer to home not only strengthens the supply chain for U.S. drug makers, but it also strengthens the U.S. reserve of critical medicines.

3. Reimagining Psychedelics: Mental Wellness Without the Roadblocks 8/19/2025

   The rising incidence of mental health disorders brought the mental health benefits of psychedelics back into the spotlight, and we are currently at a watershed moment.

4. Gedatolisib Shatters Phase 3 Goals and Scales For Breast Cancer Breakthrough 8/11/2025

   After unprecedented phase 3 clinical trails of gedatolisib, Celcuity is working feverishly with its partners to get the drug ready to offer a new standard of care to those that suffer from advanced breast cancer.

5. The Rise Of NAMs 7/31/2025

   New Approach Methods (NAMs) are rapidly being accepted as replacements for preclinical animal tests long considered to be the gold standard. NAMs include systems of organoids, organs-on-chips, AI-based prediction models, and non-mammalian species.

6. The 3 Big Barriers To AMT Implementation 7/18/2025

   Advanced manufacturing technologies (AMTs) can not only lower costs but also improve the quality and consistency of both API and final dosage manufacturing in pharmaceuticals, so why are they not more widely implemented?

7. Can AMTs Make U.S. Pharmaceuticals Faster, Better, Stronger? 7/11/2025

   As the pharmaceutical industry prepares for impending tariffs and invests in domestic manufacturing, advanced manufacturing technologies present a viable opportunity to modernize systems for improved efficiency, consistent quality and potentially lower costs.

8. How Modular Facility Design Can Accelerate GMP Facility Construction 5/20/2025

   Autolus Therapeutics' COO talks about the accelerated construction of the company's cell therapy manufacturing facility, The Nucleus.

9. A Facilities Expert Answers Audience Questions On Construction And Validation 5/5/2025

   Bioprocessing facility expert Herman Bozenhardt responds to some unanswered audience questions from a Pharmaceutical Online Live event on facility design and validation.

10. Experts' Advice On Facility Design And Construction 4/24/2025

    This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.