Contributing Editors

1. Regulatory Implications Of The CARES Act On Over The Counter Drugs 8/3/2020

   The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed in response to the COVID-19 pandemic, reforms how OTC drugs are regulated in the U.S. In announcing the legislation, the FDA called the changes a “landmark step that will have an impact lasting long after the current public health emergency.”

2. 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.

3. 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.

4. 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.

5. 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.

6. 5 Operational Priorities For Pharma Companies In The Wake Of COVID-19 7/20/2020

   Consider Gilead’s ramp-up of remdesivir manufacture under FDA Emergency Use Authorization, or the efforts of many companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, demonstrating safety and efficacy at speeds rarely seen in the past. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!

7. 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.

8. Canaries In A Coal Mine: Can Better Data Integrity Thwart A Looming Deepfake Threat? 7/15/2020

   If you think deepfake security risks are purely science fiction, think again. Not only does the technology exist and the content is readily available to facilitate such activities, but incentives to carry them out are multiplied in the current economic, social, and political environment.

9. System Risk Structures: A New Framework For Avoiding Disaster 7/13/2020

   Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.

10. How To Drive Powerful CAPAs With Lean Six Sigma 7/10/2020

    Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.