Guest Columns

1. Model-based Control In Continuous Manufacturing Of Biotherapeutics: The Role Of Process Integration 11/24/2021

   In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved and uniform product quality, lower capital cost, and easy scale-ups. The primary focus, thereby, lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address the dynamically changing conditions.

2. Can Real-World Evidence Transform Healthcare? FDA Activities Indicate 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.

3. 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.

4. 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.

5. Marks Took On FDA Vaccine Leadership Position – What Happens Now? 11/2/2021

   Center for Biologics Evaluation and Research Director Dr. Peter Marks decided to temporarily take on the leadership of the Office of Vaccine Research and Review after both its director, Marion Gruber, and deputy director, Philip Krause, unexpectedly announced in late August their decisions to exit the FDA.

6. Calculating The Process Capabilities Of Cleaning Processes: A Primer 11/1/2021

   The industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Process capability has become an important measure for demonstrating acceptable cleaning processe performance. Explore process capability, techniques used for its calculation, and how it's applied to cleaning processes. 

7. Benefit Design In Medicare Exacerbates Vaccine Access Inequity 10/27/2021

   Vaccines are widely regarded as the most cost-beneficial intervention in healthcare. Unfortunately, and counterintuitively, current cost-sharing policies discourage our most vulnerable population – seniors – from accessing vaccines.

8. The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials 10/25/2021

   While an influx of new companies and technologies is spurring innovation in the industry, these startups are increasingly in competition for talent and capital. Although a fairly new area with respect to the use of AI, the drug design and development process is ripe for the application of machine learning and deep learning techniques. 

9. Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications 10/22/2021

   While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.

10. Updated Orange Book/Biologic Patent Study: Key Learnings 10/20/2021

    Recently in 2021, the United States Patent and Trademark Office published an update to its 2019 Orange Book patent/biologic patent study report, analyzing America Invents Act post-grant proceeding outcomes for biologic patents and Orange Book‑listed patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.