Guest Columns

1. A Functional History Of Process Validation, Part 1 – A Weak Foundation 8/7/2020

   This article is the first of a two-part series that describes the origins of process validation to explain the underlying concepts necessary to control the advanced bioprocess manufacturing technologies required to make the next generations of biopharmaceutical therapies.

2. COVID-19’s Impact On Bioprocessing: Insights From Industry Leaders 8/5/2020

   We interviewed 26 biopharma senior executives regarding how they are handling the crisis and its long-term impact on their operations. We found the pandemic has begun to catalyze and accelerate a number of significant changes, including many preexisting trends.

3. 3 Healthcare Changes Biosimilar Companies Must Prepare For 8/4/2020

   There are several changes I have been observing in the broader healthcare space that biosimilar companies must be prepared to consider to promote greater uptake of biosimilars and, in turn, greater cost savings.

4. Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering 7/30/2020

   Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.

5. The Case For Optimism In The U.S. Biosimilar Market 7/28/2020

   In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S. 

6. Critical Thinking In Root Cause Investigations: Are You Asking The Right Questions? 7/27/2020

   As we write or review a root cause investigation, it is up to each of us to challenge the information we are given and see if it stands up to having a critical light shined on it.

7. Lessons Learned From An Outsourced Validation Project That Came Off The Rails 7/24/2020

   I was recently hired by a sponsor company to support initiatives related to computer system, information technology validation, and automation system validation. This article discusses my experiences and perspectives on this engagement, including best practices and lessons learned that other life sciences sponsor companies can apply in their interactions with their consultants.

8. 4 Skills An Exceptional Project Manager Can’t Survive Without 7/22/2020

   Project manager can mean many different things to many people. To some it means passing a PMI-accredited test and being knighted into project management. To others it means running cross-functional meetings, issuing and following up on minutes and action items, and managing GANTT charts. And to others it means meeting key project milestones and budgets.

9. 5 Operational Priorities For Pharmas In The Wake Of COVID-19 7/20/2020

   Consider Gilead’s ramp-up of remdesivir under FDA Emergency Use Authorization, or the efforts of companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, safety and efficacy trials at speeds not seen before. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!

10. What Can The Antibiotic Shortage Teach Us About Weathering API Supply Disruptions? 7/17/2020

    The COVID-19 pandemic has highlighted the need to reevaluate API manufacturing partners, and we may see companies shift to a more regionally diverse supply chain, including an appropriate mix of localized and global capabilities to meet specific market needs.