Client

Major US-based Pharmaceutical Company

Year

2019

Services

Drug Development - Clinical, Drug Development - CMC, Drug Development - Commercial, Drug Development- Preclinical, Drug Development - Regulatory, Drug Development - Start-up,

Field

Pharmaceuticals

Challenge

To provide clinical translation expertise that is fine-tuned to a specific clinical program and situational needs, increasing efficiency and reducing risk.

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From a concept to clinical trials and results in less than 12 months

The Novateur team was engaged in January of 2019 by a major US based pharmaceutical  company with an idea and aggressive timeline for a clinical program in the area of CNS/cognition but they were lacking the internal resources and expertise required for clinical translation.

We rapidly mobilized our experts in the areas of preclinical, CMC, regulatory and clinical development to work with the client on the development of an ideal Target Product Profile (TPP) and a realistic project plan that would support their objectives while generating meaningful results within the internal timelines.  In a strategic review, the team identified several problematic areas in the initial study plans that were likely to result in delayed timelines and suggested alternative solutions and risk-mitigation strategies to streamline the project and set it up for success. Several geographies were studied to conduct the trials including North America, Europe, Asia and Australia. Working in partnership with the client, a new plan was generated, and activities and timelines were mapped out for execution which would bring the product into the clinic by year-end.

Our preclinical team went to work researching the most appropriate model to support the client’s hypothesis and we designed and executed the study in conjunction with a contract research partner generating data for inclusion into our draft of the Investigator’s Brochure. To advance the clinical trial, the Novateur team led the vendor selection process choosing the highest quality clinical contract research organization with the experience to support our partner’s objectives and generate the required data within the prescribed budget and timeframe. We are flexible and versatile, integrating seamlessly with the client’s current clinical operations team, managing the review of all study-related documentation, providing support for bioanalytical method development and validation, guiding regulatory document submission and delivering strategic direction on endpoint analysis. At each step of the development journey, our goal is to work closely with the client as an extension of their team, mitigating risk and managing timelines to generate successful outcomes. For this project, our total timeline from project inception to the first patient dose in the clinic was under one year and our client will be able to use the data from this program to guide future product decisions.

If your company is resource limited and you need the flexibility and versatility of a tailored team to get your product from the idea-stage into clinical development, contact us to see how we can help.

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