NEW YORK & PARIS--(BUSINESS WIRE)--

Bionest Partners, a premier strategy and management consulting firm for the life science industries, and a recognized leader in personalized medicine (PM) strategy consulting, announces the publication of an article in a recent issue of Nature Reviews Drug Discovery (NRDD).

This article, a result of the FDA Personalized Medicine Initiative a consortium effort across the FDA, industry and academia analyzes the key value drivers of PM development and commercialization strategies, elucidates a comprehensive approach for evaluating these strategies, and employs various modeling tools to support decision-making.

The publication of this article is timely, given the significant and increasing commitment to PM by pharmaceutical companies, highlighted by recent PM launches such as Xalkori and Zelboraf, and notable PM candidates in the pipeline including T-DM1 (Roche/Genentech, for Her2 positive breast cancer), Dabrafenib (GSK, for BRAF V600E positive melanoma), and Afatinib (BI, for EGFR mutation positive NSCLC).

Dr. Sean X. Hu, Head of Bionest USA and Managing Partner, North America, a co-lead author of the article, and the only representative from the management consulting industry serving in the FDA PM Initiative consortium, points out that the key to successful decision-making around whether and how best to incorporate biomarkers into drug development and commercialization depends on an in-depth understanding of multiple disciplines: the underlying science, clinical trial design and development paths, regulatory requirements, partnership and coordination between drug and diagnostic partners, drug and diagnostic commercialization, pricing and market access, and decision-making in the context of many uncertainties. This article identifies key value drivers and risk factors associated with PM drug and diagnostic development and commercialization. In addition, it presents a coherent approach to tie these factors together, and describes the use of financial modeling tools to arrive at such metrics as risk-adjusted net present value (NPV) and return on investment (ROI) metrics that companies often use to make key investment decisions for their products.

Dr. Federico Goodsaid, who co-authored the article while at the FDA and is currently VP of Strategic Regulatory Intelligence at Vertex Pharmaceuticals, adds: This consortium, with the participation of FDA, academic institutions and many pharmaceutical companies, was a unique opportunity to advance the field of PM by tackling one of the bottlenecks in optimizing decision-making on PM development and commercialization strategies how to quantify the commercial value of a potential biomarker-based strategy. Sean and his team made this work possible with their knowledge about PM, advanced modeling tools, and rigor in the application of decision-analysis methods to assess the value of PM strategic options and to account for their corresponding risks and uncertainties.

Bionest is attending the upcoming ASCO 2012 Annual Meeting in Chicago, June 1 5, 2012. For further discussions with Dr. Hu and his Bionest team on PM strategies, either at ASCO 2012 or another occasion, please contact Dr. Rachel Laing (rlaing@bionest.com).

Bionest is a powerhouse in PM strategy consulting, experienced in a broad spectrum of project types, from corporate level PM business models, commercialization capability building, R&D and commercialization business processes, and organizational structure, to development and commercialization strategies for individual drug assets and companion diagnostics.

In addition, Bionest has been driving thought leadership on PM, with many articles published or in development on the strategic, commercial and technical aspects of PM, including a recent article in collaboration with the Personalized Medicine Coalition (PMC) in the December 2011 supplement issue of Science which describes the approaches for optimization of PM decision-making.

For more details, please visit http://www.bionest.com, and navigate to section Strategic/Practices/Personalized Medicine Strategy.

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Bionest Publishes Landmark Article on Quantitative Financial Analysis of Personalized Medicine Strategies

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