Contributing Editors
-
Slow-walking The Isolator — A Cautionary Tale
12/2/2020
Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.
-
Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: Sizing Up The First Wave
11/30/2020
NASH has remained a relative graveyard of drug development over the past 40 years: no disease-specific approved therapies have made it to market. This article analyzes the first wave of drugs (at Phase 3) poised to change the NASH management paradigm and shape the ambiguous pricing and reimbursement landscape.
-
A Framework For Managing The Quality And cGMP Compliance Capability Of Your CMOs
11/25/2020
When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.
-
Advancing The State Of Aseptic Processing: Let’s Get Serious
11/23/2020
It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.
-
Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics
11/20/2020
All partners in the vaccine supply chain recognize that the supply chain challenges posed by COVID-19 must be assessed and mitigated. Increased monitoring and corrective and preventive actions of supply chain issues and technical support for analytical challenges need to be addressed.
-
System Impact Assessment: A Risk Management Framework For A COVID World
11/18/2020
Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.
-
Moving Beyond Human Error In Biopharma Investigations And CAPA Programs
11/16/2020
Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.
-
Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty
11/13/2020
Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.
-
Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions
11/11/2020
In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.
-
Good Documentation Practices And Data Integrity: The Conjoined Twins Of Compliance And Good Business Practices
11/10/2020
Establishing a policy of required GDP/DI for all employees from the outset is cheap insurance for the future of your projects. Here's why.