Other Capabilities

Provide detailed and technical expertise with regard to both marketing and manufacturing capabilities of potential diagnostic partners, including review of development plan to move from prototype test to manufacturing, technical processes, supply chain, cost of goods, quality assurance and regulatory approach, identifying and highlighting areas of concern that might impede future availability of test on market.

Provide day-to-day management of diagnostic partner selection process, setting lines of open communication and working with shortlisted candidates to obtain full responses to personalized medicine specific RFI’s, and reviewing responses to rate/recommend optimal partners. Shift of resource from client to Diaceutics reduced average time to partner selection process by half.

Strategic analysis of potential PM in-licensing opportunities, providing a complete analysis of the competitive landscape in the disease area and the financial opportunity of the potential asset, along with outline of a companion diagnostic strategy to fully leverage the asset.

Strategic analysis of development of potential companion diagnostics for a variety of assets across lifecycle, including extension of lifecycle with late stage indication for asset already on market.

Review and audit of post-launch commercial strategies, identifying gaps in best practices to optimize adoption of companion diagnostics, potential points of resource losses and recommendations for more cost effective strategies designed to better drive test adoption.

Develop and lead multi-functional collaboration between client, International Federation of Clinical Chemistry, disease area association and key academic groups to research, in order to agree upon and implement standardized measurement of primary biomarker necessary to support client’s therapy. Shift of resource from client to Diaceutics reduced average time of standardization process from 36 to 11 months.

Comprehensive expertise in the development of PM specific software tools, as well as review, customization and re-engineering of client developed tools created in non-scalable formats, to improve user interface and augment with additional data and metrics to better drive and support decision outcome.

Comprehensive expertise in content and structure development of novel, physician targeted e-learning sites. Diaceutics have reviewed and augmented a sponsored test information website and expanded the content with novel physician targeted e-learning, accessible online. By working with Key Opinion Leaders in the field, Diaceutics developed the content to provide physicians, relevant to a therapy Dx strategy, with meaningful and easily accessible information about testing (in the specific field) and relevant topics.

Comprehensive expertise in executing physician targeted online-surveys and subsequent analysis of the results. Diaceutics recruited specialists in 11 countries and successfully completed a survey covering testing challenges and needs in a specific field. Key results were analyzed, compiled and presented with further recommendations. The results helped the client to answer physician needs with specifically targeted messaging and education.

Comprehensive expertise in creating Key Opinion Leader forums in multiple disease areas in order to reach consensus on disease diagnosis, drawing together a broad perspective across both therapy and test areas.