BIO From The Editor and Guest Columns
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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.
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Developability: Making Better Bets On Biologic Winners
10/25/2021
Developability assessments are objective analyses of a molecule’s therapeutic potential, but their execution is as much art as it is science. AltruBio VP of Technical Development Gene Lee, Ph.D. shares his insight into when, why, and how to go about assessing CMC developability.
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Recent Explosion Of Start-Ups Underline Business Need For AI/ML In Drug Discovery, Development & Clinical Trials
10/25/2021
While this 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. Discovering potential defects and indications of efficacy at such an early stage can dramatically decrease development costs and timelines.
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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.
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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 Bookâlisted patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.
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25 Years Of VST Therapies: The Journey Behind The Technology And Innovation
10/19/2021
This article explains the major stepping stones to preventing and treating serious viral infections in high-risk populations with T cell deficiencies.
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Computerized Systems Validation And Audit Trail Requirements
10/18/2021
A plug-and-play approach can significantly impact how we design, build, and operate biopharma facilities. Yet, innovative developments create industry adoption challenges. This article summarizes two recently released BioPhorum standards: Plug-And-Play Computerized Systems Validation Strategy and Plug-And-Play Audit Trail Requirements.
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The Essential Components Of A Sterility Assurance Program
10/15/2021
The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components for a holistic sterility assurance program needed for an aseptic manufactured product.
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Challenges In Analytical Development And Testing For Gene Therapies
10/13/2021
Given the rapid emergence of gene therapies based on recombinant adeno-associated virus (rAAV), there is a great need for appropriate analytical tools to support every lifecycle stage of these products.
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Technology Transfers: Critical To Medicine Mobilization, Success & Sustainability
10/13/2021
When an innovative device or drug product has shown promise in the research and discovery phase, the process needs to be further developed for clinical, then commercial, production. Often, this means the process must be transferred to a new site that can accommodate further development and scale-up. When executed properly, this transition can be successful.