Guest Columns

  1. Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?

    These are formative days for biosimilar developers in the U.S. courts. Last month, the biosimilar market witnessed its first legal settlement, between Mylan and Genentech for trastuzumab, and further settlements are sure to follow. On April 26, the Supreme Court began hearing the case between Amgen and Sandoz regarding the infamous “patent dance.” The Court’s ruling (expected in July) will have significant ramifications on how quickly new biosimilars reach the market.

  2. Brexit & The Biopharma Industry: What Happens Next?

    Last year, after the fateful June 2016 Brexit referendum that ended in a shocking win for the “Leave” camp, I wrote an article discussing the options going forward and the uncertainty that faced the biopharmaceutical industry. Now, almost a year later and after the official triggering of Article 50 — through a letter delivered by Eurostar, no less — have we actually learned anything new?

  3. Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies

    President Trump promised to take action to streamline the federal government. Within just a few days of taking office, he launched his deregulatory agenda, and he has now issued several executive orders that build on each other. How the concept will be implemented and by whom will continue to evolve with the addition of key staff.

  4. How To Optimize Your Stability Program At Each Phase Of Drug Development [Checklists Included!]

    A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.

  5. FDA's Quality Metrics Guidance: Reading Between The Lines

    A previous article covered several key things the FDA's Revised Quality Metrics Guidance document did communicate to industry, Lou Angelucci, currently a project management consultant to Johnson & Johnson, focuses more on what the guidance document failed to say and do … and the implications of those omissions.

  6. 4 Key Considerations When Engaging A New GMP Contract Service Provider

    This article explores what is important when establishing an effective relationship with a CSP as the program moves from product and process design to commercial manufacturing. 

  7. Are You (Inadvertently) Teaching Your Personnel To NOT Think?

    We control our processes through our SOPs, as we should. But where many of us have gone wrong is that we teach people to blindly follow the SOP — and if the SOP doesn’t say it, they shouldn’t do it. 

  8. Integrating Risk Management In The Quality Management System — A Primer

    This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.

  9. Interacting With The FDA — Best Practices For Drug Development Success

    When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?

  10. Measuring The Impact Of Recent Regulatory Guidances On Quality Systems

    This article summarizes opinions on how well specific regulations have impacted operations and looks at the general health of some key quality management system (QMS) elements that are described and proposed in these regulations.