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Small enterprises without drug approval or commercialization experience should outsource or partner on preclinical investigations and strategies.
FREMONT, CA: Today, the biopharmaceutical industry tends to initiate crucial drug development tasks early in the drug development lifecycle. In several instances, clinical and commercial manufacturing conversations commence during the preclinical period. Biologic drug development timelines and outcomes can be expedited and enhanced using preclinical methodologies. Obtaining competence in preclinical investigations is essential for maximizing a biologic's commercial potential.
Preclinical investigations must plan drug development programs with clinical trials in mind on a fundamental basis. Preclinical research intends to guide trial design and satisfy regulatory requirements for regulatory submissions, such as an investigational new drug or clinical trial application. Preclinical trials must inform candidate selection to ensure that only the strongest program enters clinical trials. The data should also create documentation for a full safety profile, including reliable toxicity data, and offer sufficient pharmacokinetic and pharmacodynamic data to determine the best dosage in terms of potency and timing.
Preclinical data must also prepare the selected drug development program for clinical manufacture with information regarding chemistry, manufacturing, and controls. In the modern drug discovery and development era, robust preclinical studies offer programs the greatest chance of success by identifying and defining programs with the greatest potential benefit for patients or by identifying patients most likely to benefit from a particular candidate.
It can be advantageous to begin strategizing clinical and commercial development tasks early on. The strategy is prevalent in cell and gene therapy (CGT). The key reason for this early planning in CGT is the shorter timeline to the clinic and the potential for a shortened commercialization timeline compared to traditional therapies. The ability to scale up a therapeutic's manufacturing process from one suitable for preclinical study to one that can operate in an environment compliant with current good manufacturing practices is crucial. It is complemented by the definition of a strong, consistent manufacturing process and analytical tests to ensure a seamless transition from preclinical to clinical to commercial.