Partnerships 2010: Let’s Make a Deal: Breaking Out of Organizational Silos – Bridging the Gap from Clinical Development to Commercialization

Moderator:
John Doyle, DrPH, SVP, Quintiles Consulting

Panelists:
Deirdre BeVard, Vice President, Clinical Operations and Data Management, Endo Pharmaceuticals
Alan Butcher, Vice President Business Development, Endo Pharmaceuticals
Peter DiBiaso, Senior Director, Clinical Planning and Performance, Vertex Pharmaceuticals
Karen Gallagher, Director, Clinical Programs and Due Diligence, Shire Pharmaceuticals

The topic is the convergence of clinical and commercialization. The panelists come from backgrounds that emphasize partnering as a way to mitigate capacity or capability constraints, clinical operations, and new compound and acquisition assessment that would seem well suited to addressing the topic.

The integration of clinical and commercial strategy is not a new goal. The roots of the modern iteration can be traced back to the 1980’s when the ‘hand-off’ or ‘throw-the-baby-over-the-wall’ method from clinical to commercial was deemed insufficient in terms of more, better, and faster. Bridging those silos mitigates risk by supporting enhanced due diligence both within an organizations infrastructure and, in the case of corporate partnerships, acquisitions or mergers, externally.

The empirical evidence of clinical efficacy has become the buy-in. The accurate valuation of the product over the entire lifecycle is necessary to produce the high value product desired. Health economics must be considered early in the process and continually reassessed throughout the development and marketing process.

Especially in today’s uncertain healthcare environment a collaborative approach is necessary so that the data and information collected all along the R&D continuum is ‘captured’ for data mining and decision-making throughout the organization and not ‘captive’ within any one part or division of the organization.

This supports the currently refocused interest in predicting what ‘comparative outcomes research’ will be performed, comparing what products, and how will this affect the product portfolio decisions internally and early on in the decision-making process. Anticipated comparator studies are, or should be, becoming more ‘baked in’ to the clinical development plan early in the process. Since there is not unlimited resource for performing ‘dueling’ comparisons in attempts to regain market share, initial studies can be shaped to address potential downstream comparator studies.

How does this play out in evaluating a pre-market product and/or a post-market product with regards to partnering or acquisition or even de-novo development? Clearly the take home for a biotech wanting to work a partnership with their product is that the products value is enhanced if R&D is encouraged to develop this ‘commercial’ mindset.

The summary here is all around the mitigation of uncertainty to increase confidence in valuation. In this uncertain climate with health care payer reform, insurance reform, and health care delivery reform the message from Senator Daschle, uncertainty is not likely to be calmed quickly.