Product Strategy Case Studies

//Product Strategy Case Studies
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Market Opportunity Assessment for the Treatment of Refractory Allergies

Management Challenge

Our client, Nuvo Research, had achieved positive results in their Phase 2 proof-of-concept study and wanted to confirm the scale of the US market opportunity for their asset and any challenges to overcome with physicians, patients and payers.

Engagement

Please see the study summary, published by Nuvo, for further details.

Benefits and Outcomes

Please see the study summary, published by Nuvo, for further details.

Preparation for Out-Licensing Discussions

Management Challenge

Our client, a technology-based specialty pharmaceutical company with no ex-US experience or operations, was planning to out-license (for RoW) their leading Ph IIb asset while retaining US commercialization rights. In preparation for discussions with major pharmaceutical companies, they engaged Psscion to brief them on key aspects of new product commercialization in RoW, with a focus on the EU, Japan, and BRIC (Brazil, Russia, India, and China) markets.

Engagement

Psscion reviewed the main similarities and differences in pharmaceutical new product commercialization in major EU markets, Japan and BRIC markets compared with the US, including:

  • Approaches to pre-launch market conditioning including KOL development, guidelines, and publications strategy
  • Regulatory approval process/requirements
  • Pricing, Reimbursement & Access considerations (including NICE etc. guidance, comparative effectiveness, launch sequencing to optimize pricing etc.)
  • Marketing launch strategy, promotional levers/tactics and regulations

Additionally, Psscion identified specific considerations and key parameters pertaining to the commercialization of new products in the specific disease area in EU, Japan and BRIC markets. Finally, we also suggested key questions to ask the potential licensee company to validate their competences and commitment to maximizing the value of the asset to be out-licensed.

Benefits and Outcomes

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.

Integrating Asset Development and Commercialization

Management Challenge

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.

Engagement

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

Benefits and Outcomes

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.

Developing a Core Communications Strategy

Management Challenge

A small US biotech company wanted to maximize the immediate shareholder value of early and highly promising clinical data on its leading key asset without causing ’prior publication’ issues which could be prejudicial to subsequent publication in a prestigious peer-review journal. They needed short-term help to craft a press release and key messages for an upcoming symposium presentation. Longer term, they needed support to define the core communications strategy that would maximize asset value. Psscion was engaged to help deliver short and long-term solutions.

Engagement

Psscion worked with the client company to urgently address the short-term needs. The longer-term core communications strategy was also developed in close collaboration with the client. We recommended the establishment of a Core Communications Team to flesh out the strategy and develop the tactical publications plan and facilitated the creation, remit and ongoing operations of that team. The approach included these steps to prepare for a receptive environment at launch:

  1. Build the Scientific Rationale – providing the scientific reason to believe
  2. Establish Proof of Concept – key messages based on pre-clinical and Phase I/II data
  3. Deliver the Clinical Promise – key messages based on Phase III data when available
  4. Confirm the Clinical Value – key messages based on Phase III/IIIb data when available

Benefits and Outcomes

The press-release and symposium presentation were substantially revised to avoid prior publication and pre-approval promotion concerns, while enhancing key message delivery. The company was highly satisfied with the coverage they received, the positive impact on share price, and the guidance we delivered regarding target specialist/primary care journals and back-ups.

Longer-term, the core communications strategy has been agreed in alignment with the overall asset strategy, and is in the process of being implemented (currently at Steps 1 and 2 above).