Contributing Editors
-
Regulatory Intelligence: It’s More Than Just Compliance
12/3/2021
Every pharmaceutical company is under pressure to monitor the changes that are taking place in the regulated landscape and respond to them accordingly. Regulatory intelligence activities include collecting, evaluating, and analyzing various pieces of information to position your company for success.
-
Using AI In Drug Discovery: The Latest Market Research
12/1/2021
The deployment of AI-driven drug discovery in areas such as oncology, neurology, and cardiology reduces gaps in R&D for improved drug manufacturing processes and further helps in targeted manufacturing of drugs. These technologies are rapidly attracting pharma and biotech companies, CROs, and academics and research institutions.
-
How To Enable Your Quality Risk Management Lifecycle
11/29/2021
The topics covered in this article represent some of the common risk management pain points and mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). This includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.
-
Model-Based Control In Continuous Biomanufacturing
11/24/2021
In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved product quality, lower capital cost, and easy scale-up. The primary focus lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address dynamic conditions.
-
The 2 Emerging Fields Propelling The Use Of AI In Precision Medicine
11/22/2021
Advances in AI-based analysis paradigms have created an unprecedented momentum in computational medical imaging applications, giving rise to new areas of precision medicine research. This article examines how recent medical imaging advances in oncology are bringing about new areas of precision medicine and previews its full potential.
-
Can Real-World Evidence Transform Healthcare? FDA Indicates Yes
11/19/2021
Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.
-
Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry
11/17/2021
More than 10 years after introducing track and trace, the pharmaceutical industry still faces a number of technical challenges and limitations related to regulatory expectations, with many companies still transforming their packaging operations to meet them.
-
Demystifying Blockchain-Supported Smart Contracts
11/15/2021
Promising increased accuracy, transparency, and security, smart contracts and blockchain technology are the next steps in the evolution of secure data transaction. Companies in the pharmaceutical industry, and their supply chains, will be forced to adapt their operations to keep up with these generational changes in order to competitively deliver services and treatments.
-
Juno v. Kite Case Implications For Functionally Claimed Biological Compositions
11/12/2021
The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?
-
Model-Based Control In Continuous Manufacturing of Biotherapeutics
11/10/2021
During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.