CureLab Oncology CEO Alex Shneider’s lament is a biopharma industry that exhibits little appetite for those discoveries made while coloring outside the lines. We caught up with him for an update on the maverick path of lead candidate Elenagen.

At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, recently published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” indicating their undoubted primacy in the Task Force’s overall assumption as to their influence on drug shortages.

The pace of deal-making in cell and gene therapy is faster and occurring much earlier in the drug development process compared to what has historically been seen for other innovative therapies. To understand how the landscape is evolving, we reviewed more than 30 deals in the sector and compared them to deals that were executed for mAbs between 1999 and 2013.

Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

The FDA issued draft guidance on the qualification process for drug development tools (DDTs) in December 2019. The guidance defines DDTs as methods, materials, or measures that have the potential to facilitate drug development — examples include a biomarker used for clinical trial enrichment, a clinical outcome assessment used to evaluate clinical benefit, or an animal model used for efficacy testing of medical countermeasures.

This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product issued during inspections in 2018 and published in October 2019. Part 1 provided an overview of the 2018 data and identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle. 

There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.