Guest Columns

  1. Increase In Drug Approvals, Priority Reviews Points To Bright Future For CMO Industry

    New drug approvals are on the way up, as the FDA approved 11 percent more innovator therapies in 2018 compared to the previous year, spelling good news for both marketing authorization holders (MAHs) and CMOs. Data also shows that small- and mid-cap pharma companies are increasingly turning to outsourcers to manufacture newly approved drugs.

  2. ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  3. A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility

    The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

  4. Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations

    This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”

  5. Why Aren’t More CDMOs Using Continuous Manufacturing For API Production?

    This is the first of a two-part article exploring the factors creating a demand from innovator biopharmaceutical companies for continuous manufacturing facilities in the U.S. and EU. It also covers the economic and technical challenges facing CDMOs considering building API CM facilities.

  6. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  7. Market Assessment: Transcatheter Aortic Valve Replacement In The U.S. and EU

    It’s an exciting time for TAVR, as the market has experienced exponential growth due to expanding indications of TAVR devices in recent years. So, what are this market’s long- and short-term projections, and what barriers exist to more widespread use?

  8. FDA FY2018 Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  9. Developing Novel Policy Proposals To Support Access To Gene And Cell Therapies

    The decades-long focus on more “personalized” medicines has paved the way for the recent and anticipated advances in gene and cell therapies and progress in many other areas. The first generation of gene and cell therapies has the potential to transform the way we treat some diseases and can bring new hope to patients with many rare and serious conditions.

  10. Comparing U.S. & EU Guidances On Combination Product Approval ProcessES

    New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products. In Part 2 of this series, we cover the EU guideline and show how two diverge.