We can provide individual functional experts to complement existing skill sets, or build a full product development team, working independently to provide solutions that meet the specific needs of an asset. Adnovate’s services span all stages of company and product development, from the creation of asset strategy, through to strategy operationalization and clinical trial oversight.
Adnovate utilizes its wealth of experience in drug development to create comprehensive cross-functional strategies for products across their development lifecycle from scientific conception to market access and commercialization.
Adnovate provides industry-leading expertise to help life science companies successfully operationalize their strategy and advance their assets through pre-clinical and clinical development, and regulatory interactions.
Adnovate’s clinical operations experts manage and oversee vendors through the set-up and execution of clinical studies at all stages of development, including first-in-human and proof-of-concept studies.
Indication Prioritization is the process of identifying, evaluating, comparing, and contrasting 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 achievement of corporate objectives. Adnovate utilizes its evidence-based indication scoring system and its breadth of expertise in all phases of clinical development, regulatory affairs, target engagement and product positioning to identify a lead indication with the greatest potential for clinical and commercial success.
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 successful Clinical Development Plans.
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.
Adnovate works with clients of all sizes, stages of development, geographical locations, staffing models and experience. We have strong expertise in asset development from early-stage though to market access and commercialization. Drawing on our deep expertise across a broad range of therapeutic platforms and technologies, and across many therapeutic areas, Adnovate has helped clients from privately-owned Biotech startups to established publicly traded Biopharma organizations.
From asset strategy and clinical development to interim executive leadership and support, Adnovate can provide industry-leading expertise to help your organization meet its goals and ambitions.
Early Stage Biotech
Early-stage biotech companies that do not have a formal medical/clinical function. Our service helps these smaller companies to develop drugs in a capital-efficient way and without the need to dilute management shareholdings, whilst maintaining the highest standards of development.
Pharma / Biotech Organizations of all sizes
Companies that have assets not being developed due to lack of alignment with corporate strategy. By using our services, these companies can continue to create value in non-core areas and advance their pipeline without the need to distract internal teams and expertise from strategically important areas of focus.
Expanding Businesses
Companies that lack regional expertise in developing drugs internationally. Our services help by eliminating the need to hire dedicated regional development teams outside of their home territory.
Working as an extension of our team, Adnovate supported not only the clinical study execution, but strategic planning of the product, and additions to the QMS. GEXVal, Adnovate, and partners in Australia formed an excellent team, sharing the same goal to deliver innovative medicines to patients and families who live with rare diseases.
Juran KatoCEO, GexVal Inc
We partnered with Adnovate to leverage their strong scientific and strategic support. Their highly qualified and organized team helped us understand the treatment and competitive landscape which refined our clinical development plan and clinical trial designs.
Sudha ParasuramanCMO, Ribon Therapeutics
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 the process of identifying, evaluating, comparing, and contrasting 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 achievement of corporate objectives. Adnovate utilizes its evidence-based indication scoring system and its breadth of expertise in all phases of clinical development, regulatory affairs, target engagement and product positioning to identify a lead indication with the greatest potential for clinical and commercial success.
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.
