GUEST COLUMNISTS

• Model-Based Control In Continuous Biomanufacturing

  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

  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

  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

  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

  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

  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

  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.

• Opportunities For Implantable Drug Delivery To Modernize Drug Therapy

  The implantable drug delivery system allows targeted and localized drug delivery for achieving an optimum therapeutic effect. This article examines the clinical significance of implantable drug delivery systems as well as opportunities that can be leveraged by drug therapy developers in meeting global health needs, particularly in the areas of women's health, cancer treatment, and ocular disease treatment.