Integrating Asset Development and Commercialization
Our client, a clinical-stage biopharmaceutical company, had a key asset which had recently completed successful Phase IIb studies. They intended to sign a co-development deal with a ‘big pharma’ partner prior to commencing Phase III studies. Psscion was engaged to help the client prepare for partnership discussions by building and gaining internal alignment around an integrated strategic approach to the optimal development and commercialization of the asset.
Psscion worked collaboratively with the client to develop an integrated strategic approach to the development of the asset. Key steps included:
- Defining the Asset Vision, positioning, market development and LCM strategy
- Defining the Target Label – the key claims desired for competitive differentiation, pricing, reimbursement and patient access were agreed. Key sections of the of the desired product label were fully drafted and laid out in side-by-side comparison with key competitors. From this work, the evidence required from the Phase III development program to deliver the desired label/comparative claims was defined
- Integrated Development Plan – in line with the outputs from above, high level development plan objectives required to deliver the Asset Vision and Target Label were agreed. This required the strategic alignment and integration of all relevant functional area plans
Going into partnership discussions, the client organization had a clear understanding of the value of the asset and the optimal approach to its development and commercialization. Feedback from the client indicates that they felt much better equipped, and more on an ‘equal footing’, with potential partners than in their prior partnering experiences with other assets. Discussions are still ongoing – the client will select the most attractive partner based on a shared vision of how best to optimize patient and corporate value arising from the asset.
Based on the success of this initiative with the company’s key asset, we were engaged to work with their senior R&D and Commercial management to review and prioritize opportunities for development in a new Therapy Area and range of Diseases beyond their core expertise.
Client feedback was extremely positive and indicated that we exceeded their expectations, particularly in light of the broad scope and extremely tight turn around time for this project (5 days). Our briefing provided the context necessary for our client to objectively evaluate the preliminary licensing pitches. Going forward, once the Client has shortlisted the preferred candidates, we have been asked to help them review their detailed bids (including Ph III development/ commercialization plans and forecasts) and recommend which to pursue.