A Novel Approach to ALS Trial Development

Use of non-human primates (NHPs) continues to be necessary as part of the drug development process for various reasons, including current regulatory requirements and scientific justifications of human relevance, to ensure the safety of new pharmaceuticals in humans.

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Artificial intelligence is changing how pharmaceutical companies operate, how they develop and study new treatments, and even what form those treatments take. Pharma companies are now pairing medicines with software — so-called digiceuticals powered by virtual reality and AI. Most of the world’s largest drug companies now have a technology officer in their C-suites. And AI is now being used to help find new drug targets, model diseases, and make clinical trials more efficient.

After years of innovative research, advanced therapies are dramatically changing the way patients are treated for a wide variety of diseases particularly for patients with rare diseases and orphan indications. New developments in advanced therapy medicinal products (ATMPs) comprising cell and gene therapy products show the potential to modify or even cure severe chronic conditions for which previously no treatment existed. As a consequence, the dynamic market for innovative therapies such as CAR-T, immuno-oncology, and gene and cell-based therapies grows across the globe. Academic institutes and biotech companies are contributing to these developments both in terms of scientific discovery and undertaking clinical trials aiming for regulatory approvals to treat specific patient populations. While we might be in a golden age of medicine due to advancements in ATMPs, innovative clinical research and development remain crucial for getting treatments to patients.