Given the complexity and breath of the project, we suggested a multi-step secondary research approach. Our teams compiled a list of over 200 indications in which transient RNA expression can lead to a therapeutic effect; each indication was then assessed on eligible population, severity and unmet need, and feasibility of clinical proof of concept. We selected the top 25 “gateway” and “value” indications and then further evaluated for feasibility using a set of 9 sub-criteria and competitive intensity. A Target Product Profile (TPP) was created for each final selected indication, comparing the lentiviral product to the most relevant comparator, including development of the most impact value proposition in each instance.

Certara CS Defining path to market strategy

By considering a commercial lens through which to view a choice of indications to pursue, Certara helped our client de-risk the development at this early stage where commercial considerations are usually absent.

By systematically narrowing down a large number of therapeutic areas to a select few through a rigorous assessment, Certara supported the client’s clinical development strategy, providing them with a reliable framework of existing competitive dynamics they would encounter. The client used our selection of gateway and value indications as the foundation in the next phase of their clinical development. With our help, they succeeded in recruiting relevant clinicians whom they engaged in narrowing down the target and bringing the promising technology to market.

Certara CS Analytics Driven Research 2

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