Drug Discovery Featured Articles & Applications
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How To Mitigate The Risks Posed By "High-Risk" Host Cell Proteins
11/3/2021
Host cell proteins are process‐related impurities that may copurify with biopharma drug products. Some of these can be considered high-risk, including those that are immunogenic, biologically active, or enzymatically active with the potential to degrade molecules or excipients used in formulation. Here's how to mitigate those risks.
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AION Labs’ Challenge To AI Drug Development Innovators
11/1/2021
AstraZeneca, Merck, Pfizer, The Israel Biotech Fund, BioMed X Institute, Teva Pharmaceuticals, and Amazon Web Services are teaming up to support the AION Labs mission to inspire innovation in AI-enabled drug discovery and development. Here’s how the consortium created collaboration among fierce competitors.
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Inside Canavan Disease With BridgeBio’s Dr. Eric David
10/29/2021
Canavan disease is rare genetic neurological disorder characterized by the spongy degeneration of the white matter in the brain. Affected infants may appear normal at birth, but usually develop symptoms between 3-6 months of age. According to National Organization for Rare Diseases (NORD), most affected children develop life-threatening complications by 10 years of age. Canavan disease occurs because of mutations in the aspartoacylase (ASPA) gene that affects the breakdown (metabolism) of the N-acetylaspartic acid (NNA). It is inherited as an autosomal recessive condition.
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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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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.
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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 Book‑listed patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.
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Gene Therapy & AADC Deficiency
10/18/2021
In AADC deficiency, dopamine is not produced in the part of the brain called the putamen, which is, therefore, a prime target for gene therapy.
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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.
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Is A SPAC The Right Option For Your Emerging Biotech?
10/1/2021
As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.
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Cell And Gene Therapies: Solving Six Challenges
9/20/2021
This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.