11.04.26 -- Non-Clinical Supply Needs More Outsourcing Strength

Three factors often decide success or failure in FIH studies: integrating biomarkers and pharmacodynamic endpoints, including patients in the trials, and leveraging manufacturing infrastructure.

Tablets and liquid medicines look simple to the patient, but their reliability depends on formulation choices made early and on technical expertise that continues well after commercial production begins.

Explore innovative solutions for improving the solubility and bioavailability of poorly soluble compounds in solid oral dosage forms to enhance drug delivery and therapeutic effectiveness.

See how Altasciences’ integrated CDMO and nonclinical teams pivoted to capsule dosing to overcome formulation challenges, preserve a GLP study timeline, and avoid costly delays.

Replacing methylene chloride in a slow, labor-intensive API step led to a single-solvent, one-pot process with a shorter reaction time and improved yield and purity.

Coordinating CRO, clinical supply, and central lab activities from the start shaped how a 1,500-site, 35-country cardiovascular outcomes trial moved ahead of plan on activation and enrollment.

Regulatory pressure to study broader dose ranges is reshaping formulation strategy. This executive summary examines how early planning for dose flexibility reduces development risk and clinical delays.

Gain practical perspective on emerging capabilities, common sponsor challenges, and what will matter most as the CDMO landscape continues to evolve.

Discover how innovative and safer synthetic strategies can streamline the manufacture of Upadacitinib while addressing the complexity and safety challenges inherent in its key intermediates.

We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.