Formulation Development Featured Articles
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4 Tips To Leverage Your Ingredient Supplier For Faster Formulation
8/3/2023
Speed to formulation plays a critical role in recouping the investment for a new drug. Many ingredient suppliers have an experienced analytical group and material scientist group, and drug developers should reach out and leverage that expertise with these four strategies.
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5 Promising Applications Of RNA Therapeutics
7/28/2023
Ribonucleic acid (RNA), once considered a mere messenger molecule, has now emerged as a versatile tool in the development of novel therapies. In this article, we will delve into the world of RNA therapeutics, exploring their potential and five applications that could impact the future of medicine.
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Targeting RNA With Small Molecules
7/25/2023
Beyond mRNA's dogmatic role as the intermediate in gene expression, non-coding RNA play essential roles in transcription regulation, maturation, and translation. This article explores the potential of RNA as a clinically validated avenue for drug development, methods for design and discovery, and implications for the future of medicine.
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Preparing A Framework For Artificial Intelligence And Machine Learning Validation: A 3-Step Approach
7/20/2023
Experts say it would be foolish to ignore the impending AI/ML revolution. There's official guidance out there now on how to prepare, but waiting for a full framework from regulators would be a mistake. This article lays out some strategies for building a foundation to implement AI/ML into your processes.
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FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity
7/18/2023
The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.
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Using AI In Drug Discovery Isn’t The Golden Solution You Think It Is — Yet.
7/17/2023
Before we realize the true potential of advanced artificial intelligence (AI) and machine learning (ML) technologies to treat disease, we need to start by developing technologies that can generate the massive amounts of reliable, high-quality biological data that make up the fundamentals of any AI/ML approach.
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How Is The Future Of Nuclear Medicine Evolving?
7/13/2023
Nuclear medicine, with its fusion of medical imaging and therapeutic techniques, is reshaping the way diseases are diagnosed, treated, and managed. Let’s look at key market drivers, market restraints, and emerging trends and technologies.
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Protein Degraders: Progress, Limitations, & Future Directions
7/12/2023
There is great excitement surrounding the development of small molecules that trigger the degradation of proteins. This article will highlight proteolysis targeting chimeras (PROTACs), their current limitations, and the emerging strategies to address those limitations, resulting in a bright future for targeted protein degradation.
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Patenting Functionally Claimed Biological Compounds After Amgen V. Sanofi
7/10/2023
Snell & Wilmer attorneys discuss the recent SCOTUS decision to uphold the Federal Circuit's holding that Amgen’s patent claims for functionally claimed antibodies were invalid for failing to meet the enablement requirement. The attorneys share what this means for the industry going forward.
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Targeting SORT1 To Drive Peptide–Drug Conjugates In Oncology
7/3/2023
Peptide-drug conjugates — therapies that generally employ a cleavable or non-cleavable linker to attach a receptor-targeting peptide to a drug payload — have emerged as a potentially viable modality for targeted cancer treatment. How do they work? And how is the glycoprotein SORT1 one of the most promising targets?