Contributing Editors

  1. Pulling Double Duty: Packaging Considerations For Combination Products 1/2/2020

    Blending formula and function into one neatly packaged item may seem to simplify the drug delivery process for end users, be they healthcare professionals or patients, but a product that pulls double duty comes with its own set of challenges. Combination products require their own precautions and packaging measures that help to ensure quality, safety, and reliability.

  2. They’re Not Mind Readers: Have You Told Your Suppliers What You Want? 12/30/2019

    There are many reasons for issues to crop up in a supply chain. For some, there aren’t realistic, economical work-arounds available to every company to mitigate all consequences.

  3. How “Two People With A Molecule” Can Build A Quality Culture 12/30/2019

    Robert Lutz, Ph.D., is chief science officer of Iksuda Therapeutics, a 20-person start-up developing new antibody drug conjugates (ADCs) to target difficult-to-treat cancers. With an extensive background in ADC development, he believes that building mature quality capabilities is what your company must do every day from day one.

  4. An Analysis Of The FDA’s Drug Shortages Root Cause Report 12/27/2019

    In Oct. 2019, the FDA's Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report's findings and discusses potential next steps the FDA may take.

  5. When Should Formal Quality By Design Documentation Begin? 12/23/2019

    When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?

  6. Rebels Vs. Clones: Constructive Dissent In The Pharma Industry 12/20/2019

    The pharma industry is in the middle of an identity crisis, but not in the way you may think. Rather than a period of uncertainty and confusion typically brought on by a change in role or expectations, this crisis is far more insidious. It’s brought on by a mind-set in which industry leaders believe they know exactly what the industry should be doing.

  7. Pharmacy Compounding Vs. Manufacturing For Clinical Studies: The Regulatory Perspective 12/18/2019

    FDA requirements and compendial standards for pharmacy compounding and outsourcing continue to evolve, and the FDA has different requirements for products prepared through pharmacy compounding practices as compared to those manufactured for use in clinical studies.

  8. Nickels & Dimes: What To Do When Your CDMO Charges You Unexpected Fees 12/17/2019

    In many cases, the business development and sales teams from your organization and the contract service provider work separately. What happens when the invoices have unexpected costs?

  9. A Biopharma Year In Review — And A Look Ahead To 2020 12/16/2019

    The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.

  10. Cats In The Warehouse! 9 Real-Life Blunders To Avoid In Your Pharma Facility 12/13/2019

    Our previous review of humorous and horrifying pharmaceutical facilities blunders Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) revealed our industry is flawed like any other. Here are some examples from the engineering side of the business.