The Alignment Program is a standardized yet highly adaptable consulting program appropriate for pharmaceutical asset development teams in early Phase II and later stages who have determined that a companion or other diagnostic test will be required to obtain approval for their therapy or to fully realize and leverage their therapy market.
The Alignment Program is designed as a mirror aligned process to the asset team’s drug development work and is organized around the same functional frameworks with which every pharmaceutical asset development team is familiar. This approach – road tested and proven on over 25 personalized medicine programs across multiple therapy areas – significantly reduces the learning curve to optimal personalized medicine planning, thus saving valuable time and resources.
The Alignment Program delivers true competitive and financial advantage by ensuring asset teams take a comprehensive approach to personalized medicine planning -
Assist the asset development team to understand the universe of commercial challenges and develop a strategic plan and route map to successfully commercialize an assay to support therapy goals.
Provide expert reference points on how the companion or other diagnostic can be used to enhance the assets overall value proposition while avoiding common pitfalls that destroy value.
Frame decisions through personalized medicine specific worktools on the roughly 250 required workstreams and align resources around a joint strategic product plan to be cost effective.
Help identify potential partners to develop the companion or other diagnostic for commercialization and assist in constructing agreements to guide and incentivize partners to achieve asset goals.
To learn more about the timing, specific organization and deliverables of the Alignment Program, click here.
The Alignment Program is delivered through Diaceutics Fusion™, a proprietary, personalized medicine specific software application designed to allow asset development teams to visualize and easily navigate the 11 functional frameworks in which they need to make and operationalize the key decisions in personalized medicine planning. To learn more about Diaceutics Fusion™ click here.