You need to hit your key milestones as fast as you can - but you don’t want your first milestone to be your last. To avoid this, the best practice is to establish a foundation with scalable and robust processes from an early stage in your program. This includes using a platform process that will facilitate regulatory approval and leveraging manufacturing techniques that maximizes your chances to succeed.
Another consideration is to engage a team with experts who can help you seamlessly take your project from cell line development and clinical trials to commercial approval. By doing this, you’ll accelerate your path to market while simultaneously positioning your candidate for future milestones.
When you factor in the future also in your early-stage decisions, then you’ll maximize the chances to hit important inflection points on time. This enables you to preserve all of your options, whether that is selling, partnering, or commercializing your drug.
Ibex™ Design is a pioneering gene to vial package delivering drug product for your clinical trials within 12 months. Also included is manufacturing slot reserved for your clinical resupply needs.