Expert Content & Resources

Nina Bauer

Why NAMs Took Decades to Arrive – and Why iPSCs are Making Them Possible

When US and European regulators acted in recent years to support the use of animal model alternatives for drug development, reactions were mixed. There is broad acknowledgement regarding the limitations of animal-based disease models and their inability to fully recapitulate human biological complexity, contributing to a high clinical failure rate, and so there was true excitement for the possibilities.

FDA QSMR Image

Navigating FDA QMSR in 2026 

How medical device manufacturers can move beyond checklist compliance and build inspection-ready quality systems 
For years, many medical device manufacturers approached FDA inspections through a familiar lens: prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework.

Avoiding Recalls: How to Ensure Sterility in Ophthalmic Products

In the wake of several high-profile eye drop recalls, we look at the challenges of achieving sterility in ophthalmic products, the consequences of failing to do so, and how AbbVie Contract Manufacturing ensures product sterility and safety.

Executive Interview: Advancing Regenerative Medicine for Chronic Disease

Lance Alstodt, CEO of BioRestorative Therapies, discusses the development of its lead cell therapy candidate BRTX-100, the evolving regulatory and manufacturing landscape for autologous therapies, and how regenerative platforms could reshape treatment paradigms for chronic conditions.

How Can a Stage-Based Program to Determine HME Applicability Benefit Your API?

Low bioavailability due to poor API solubility is one of the major challenges to be overcome when developing oral dosage form drug products. An effective way of addressing this problem is to transform low solubility APIs into amorphous solid dispersions (ASDs) and can often be achieved via hot melt extrusion (HME).

Single B Cell Antibody Discovery: Improving Therapeutic Candidate Selection in Drug Development

Changchun Zha says as therapeutic pipelines become more complex, technologies that combine biological relevance with molecular accuracy are shifting from helpful additions to essential capabilities. Single B cell antibody discovery supports this transition by capturing naturally occurring antibodies, preserving native chain pairing, and producing sequence-defined candidates from the beginning.

Enabling a Breakthrough in Ophthalmology: A Case Study in Collaboration Between a Biotech & Device Manufacturer on a Novel Drug Delivery System

Ashwin Agarwal, CFO of Azura Ophthalmics and John Merhige, Co-CEO of Credence MedSystems, share an inside look at how two partners are aligning technical and regulatory strategies, integrating complementary expertise, and collaborating effectively to deliver an innovative ophthalmic combination product and inform future biotech–device partnerships.