Project plan development

• Leadership and management of drug discovery and early development projects are among of our core capabilities.
• We apply our expertise to formulate an attractive product vision and create a fit-for-purpose project plan towards it, having in mind three key imperatives:

Deliver Proof-of-Concept

Demonstrate developability

Display differentiation

• Defining the PoC as early as possible is critical for efficient project planning as it allows for timely definition and implementation of appropriate translational strategy and recognition of a minimum data set which should be delivered to enable PoC trial.
• Timely identification and remediation of possible developability issues is of outmost importance, since developability is critical for product viability.
• Early recognition of differentiation potential and building-up the supporting evidence is vital for product attractiveness, reimbursability and overall commercial value.
• Finally, realistic estimation of project timelines and budget provides insurance that the project could be delivered against the approved plan.

Virtual drug development

The cornerstones of each R&D project are:

• Good idea,
• An investor willing to fund its development, and
• A capable project leader who is able to understand the idea, formulate a clear vision of the product, and set-up a right core project team.

Starting from above, everything else needed for successful execution of the project does not represent the core capability and, therefore, may be outsourced.

Evolution of business-driven mindset within academia, along with maturation and diversification of the CRO industry, have created a suitable environment for complete virtualization of R&D, even from the earliest stages of the project.

There are at least three major benefits of virtualisation.

• R&D projects can be succesfully run by virtual companies, minimizing the fixed costs of the business; instead of investing into labs, equipment and other amenities, the funds are solely dedicated to project progression and anticipated benefits.
• There are no internal barriers to seek worldwide expertise; individual studies or parts of the project are run by the companies that are specialists in particular field, with good insight into both state-of-the-art and standard practice.
• There is high level of flexibility, which allows for a fit-for-purpose mix of collaborators. While the overall objective is to run the project as fast as possible at minimum cost, depending on the current project needs and challenges, the particular studies may be outsourced to the world leading scientific centres, or to cost competitve routine service providers, as appropriate.

Based on our expertise in pharmaceutical R&D, proven project management skills, long-standing experience in out-sourcing a variety of R&D services, and a trusted network of experts with industrial background across key R&D disciplines, we are well positioned to take over the management of drug discovery/early development projects and deliver these for the Client using virtual R&D operations.