Completion of the Alignment Program provides pharmaceutical asset development teams with a comprehensive Companion Diagnostic Co-Development and Commercialization Strategy plan, including a full project management plan that clearly identifies and maps out the specific steps and initial activities that the asset team will need to undertake to successfully commercialize their companion or other diagnostic.
Asset teams must implement the commercial plan on numerous, simultaneous fronts, requiring consistent and ongoing consideration of personalized medicine specific activities and incentives in order to fully realize optimum value for the therapy. Successful launch of the targeted therapy requires close attention to ensure that all of the activities are successfully devised, executed and timed and that the extended stakeholders – including diagnostic partners and laboratories – are working congruently to optimize the therapy goals.
Asset teams who do not have sufficient resources to manage all of these moving parts, or who are seeking additional expertise in these areas, may continue working with Diaceutics in an Implementation Program in order to achieve a variety of deliverables, such as:
Propose and agree on the proper architecture of the commercial agreement that ensures goal congruence among external partners;
Derive financial business models with which to approach partners with the financial opportunity and risk profile of the project;
Propose and agree specific two–way responsibilities and resources to deliver seamless global access to the companion or other diagnostic;
Propose and agree on milestone payments designed to ensure the partner or partners are properly incentivized to meet therapeutic goals;
Support of appropriate project management of required companion or other diagnostic activities fully integrated into ongoing therapy development and launch;
Support legal team in negotiating and converting the partners’ understanding into specific contractual terms designed to advance and support a continued and on-going partnership;
Participate at joint commercial committee meetings with partners to ensure team technical and commercial needs continue to be met;
Map anticipated companion or other diagnostic demand in launch markets to determine appropriate lab coverage required;
Based on prior map, target and align necessary labs and lab networks including establishing best test adoption practices; Identify and brief outside marketing groups on personalized medicine specific concepts as required to optimize launch of the companion or other diagnostic to further therapy goals;
Identify and brief outside companion or other diagnostic standards groups who may be required to support the introduction of multiple testing options over time in a way which avoids downstream test variability;
Identify and engage with expanded personalized medicine enabled key opinion leaders and others to support necessary guideline changes and physician awareness of companion or other diagnostic protocol, including novel trial strategies to drive test adoption;
Assist in implementing necessary health economic studies to support relevant payer requests for coverage and reimbursement of test(s).
