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505(b)(2) – Part 2: The Assessment: CMC Development Plan

CMC Development Plan

All too often we see plans that don’t integrate the clinical trial materials with the clinical development plan.  This is usually because the people and organizations responsible for each area don’t interact well and there is a lack of overall project management.  Most often, the focus of the company is the clinical plan and teh assumption is that the drug will be available as needed (analogy is the car and the gasoline, those who take a trip off the beaten track plan for gas stops).

Camargo views the CMC and clinical development as one big plan (actually, as you see from our process, medical communication and regulatory are also in this plan too).  The following is an example plan that comes from an assessment of proposed project to develop a topical formulation of an approved oral tablet.

In this plan you can see where the drug product formulation steps are taken in relation to the pre-clinical and clinical studies.  Both the proposed product formulation and packaging are examined for each clinical study, based on the study design (placebo-control, doses needed, quantity of product, labeling, etc.).  Obstacles are identified and solutions offered where possible. The timeline for product development, including procurement of API and excipients, and costs are estimated.

During the Assessment stage, if the client has not conducted a thorough patent search, we may contract with Camargo’s patent attorneys to conduct a search of relevant patents.  The first cut is to determine if another company has patents that cover the proposed idea.  Second is to determine if the proposed idea may be patentable.  We’ll cover more on patents in later postings on this blog.