Contributing Editors
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Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
5/5/2021
With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.
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FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
5/3/2021
On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.
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How To Use DMF Content To Support Your Application To The FDA
4/30/2021
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?
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No, Biologics Are Not Natural Monopolies
4/28/2021
Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.
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Are You Approaching LIMS Validation Correctly?
4/26/2021
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
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Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs
4/23/2021
The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits.
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An Analysis Of The Gene Therapy Viral Vector Landscape
4/21/2021
Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.
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Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm
4/19/2021
Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.
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Making Sense Of Antibody Epitope Claims
4/16/2021
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
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How to Ensure Your Quality Culture Assures Data Integrity
4/14/2021
One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.