The basics first- The high costs of drug development (for both successful and unsuccessful candidates) results in exorbitant drug prices, leading to high healthcare expenditure. The only solution to reduce this burden is open communication between all science streams involved during the complete cycle, better alignment on “regulatory requirement” and “right experimental design,” along with transparency in sharing result and interpretation. This helps to reduce costs associated with drug development at each milestone, including the preclinical stage. It is clear that preclinical is a turning point for any drug, and involves millions of dollars. Selection of optimal experimental design, study protocol, assay, cell lines, and animal model with significant translation value have a tremendous impact on the completion of the preclinical phase with desired results. A significant amount of research is needed in generating sophisticated preclinical models to understand and evaluate the effects of disease-related factors, cellular microenvironments, and therapy-related (drug + device) parameters. Although 3D bioprinting, in silico are showing some promise, but still the question is whether these techniques are reducing— long experiments—to get better results or they are just generating more information in the pool of existing data. Databases can certainly help, but questions about data protection, safety, company policy, and openness to share all information remain unanswered. Importantly, outsourcing preclinical studies to Contract Research Organizations (CROs) can support companies and speed up preclinical development to a significant extent. Optimal, cost-effective, and timely collaborative research is the way forward to reduce health expenditure.
Preclinical testing—Understanding
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