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The Target Product Profile (TPP) is a living document that outlines the desired characteristics of a product, and provides a strategic framework for an asset to reach its full therapeutic and commercial potential. The TPP is the cornerstone of successful clinical development and is vital for trial designs and future decision-making. Adnovate utilizes its breadth and depth of expertise in clinical development, regulatory affairs, and product positioning within the competitive landscape to develop future-proofed TPPs that will guide Clinical Development Plans to achieve success.

The Clinical Development Plan (CDP) is a blueprint of an asset’s full clinical research strategy for a given indication. It outlines the design of each phase of development, including clinical endpoints and other assessments, go/no-go decision points, timelines, and budgetary estimates.

Yes. Adnovate supports life science organizations of all sizes, including startups, adapting flexibly to meet fast-evolving company and asset development needs. We can build full product development teams that work independently to provide solutions to successfully operationalize company strategy, and advance assets through pre-clinical and clinical development, and regulatory interactions. We can also provide individual functional experts (including interim CMOs, COOs, and CEOs) to complement the skill sets of an existing team of drug developers.

Indication Prioritization is a process to identify, evaluate, compare, and contrast different potential indications for a specific drug to enable strategic selection of those indication(s) that have the greatest potential for success, value creation, and to achieve corporate objectives.

The Oncology Center of Excellence (OCE) Project Optimus is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. See https://www.fda.gov/ for more details.