BIO From The Editor and Guest Columns

1. EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications 4/3/2020

   While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

2. Inside FDA’s AI-Based Established Conditions Pilot 4/1/2020

   FDA-CDER’s Geok Yan Loo gave us an inside look at CDER’s application of artificial intelligence to inform and improve pharmaceutical quality systems. The pilot offers good reason to consider how machine learning can improve bioprocessing quality and ease your regulatory burden.

3. Implementing Data Quality By Design For Improved Data Integrity 4/1/2020

   We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.

4. Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies 3/31/2020

   One of the most frequent statements made in the biopharmaceutical industry is the need to “control a product’s critical quality attributes (CQAs) by controlling the process’ critical process parameters (CPPs).” While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.

5. Which Biosimilar Companies Will Thrive In 2025? 3/31/2020

   Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.

6. Biosimilar Pipeline Experiencing 12% Annual Growth: A Progress Update 3/26/2020

   This article compares aspects of the biosimilar development pipeline and related market evolution over the past seven years, since 2013, including what has and hasn’t changed.

7. COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain 3/26/2020

   To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.

8. Remote Auditing Best Practices For GMP Compliance 3/25/2020

   Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

9. How To Stop Fighting Quality Fires Using Quality Risk Management 3/23/2020

   Do you like fighting quality fires? Do you enjoy generating meaningless metric reports that no one acts upon? Do you get the most from your quality risk management (QRM) program? This article provides three practical steps for integrating QRM into your quality system to ensure your organization stays on course.

10. Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time) 3/20/2020

    Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.