When beginning with a concept drug candidate, the first important step in an efficient drug development path is to determine its feasibility. For 505(b)(2) drug pathway candidates, a strategic assessment is especially important.
Done right, a strategic assessment determines the key components of the drug development plan, like a roadmap for a trip. Without a roadmap, it is possible to reach a desired destination. But with an informed roadmap, it is possible to reach a desired destination by planning for efficiency from the beginning, spending the least amount of time and money to get there.
At Camargo, we believe a strategic assessment is the first key to a drug candidate’s success via 505(b)(2), making go/no-go informed decisions at the beginning, and evaluating and planning for the scientific, medical, regulatory, and commercial aspects of a product’s development.
Does the science make sense? For instance, is the formulation stable and readily prepared? Is manufacturing scalable? Are active and inactive ingredients available and affordable?
Does the product have a clear niche in the medical specialty? Is it effective for solving a unique problem or solving a problem in a unique way? Does it present an acceptable risk/benefit? Is there evidence the product would be appealing to the proposed patient population?
What clinical trials or other data will be required to gain approval? Can development be expedited? Would exclusive marketing rights (“exclusivity”) be available? What distinguishing information can be presented on the labeling for eventual promotional activity?
Is there a viable market for the product? What is the potential for future competition or substitution? What is needed to ensure reimbursement? What is the optimal pricing?
Camargo offers the strategic assessment, scalable to fit each program’s needs.
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