Pharmaceutical drug development is an expensive and complex process, thus it, requires coordinated efforts of diverse disciplines, including nonclinical, clinical, regulatory and commercial experts. On the path to market, pharmaceutical and biotechnology companies face many obstacles and potential pitfalls, which can cause costly delays or stop progress entirely.
Drug regulations can be complicated, and often vary among countries/regions. Regulatory agency perspectives on development topics can evolve, significantly affecting how a new program should be designed and executed. A detailed understanding of regulatory requirements and health authority viewpoints is central to planning a drug development program.
Instead of focusing on a single study, it is critical to consider how that study complements prior data and influences future decisions in a program. A carefully planned set of clinical trials, progressing from first-in-human Phase I to Phase II “proof of concept” and pivotal Phase III trials for registration is a central part of a comprehensive development plan. Clinical trials are often the most expensive and rate-limiting part of a program, so considerable effort goes into designing trials that are both necessary and sufficient for regulatory approval and market success.
PharaPRO’s expert team approaches strategic advice for your program based on therapeutic class characteristics, individual aspects of the asset (formulation, route of administration, etc.), current FDA expectations, target patient population, and disease indication.
We build in steps to increase the valuation of your asset, de-risk certain characteristics of the asset based on your exit strategy, or address known therapeutic class or indication-specific issues to enhance your negotiation position with investors, partners, board members, and FDA/EMA.
Our pharmacokinetic and clinical pharmacology consultants provide a breadth of experience and depth of drug development knowledge that you won’t find anywhere else. PharmaPRO can provide a wide range of strategic planning services.
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