ABSTRACT
This article summarizes the broad messages from pharmaceutical and diagnostic companies on the collaborations required to support companion diagnostics. Since the groundbreaking herceptin HER2 diagnostic model in 1998, it has taken until 2011 for the US FDA to issue a draft guidance document, which was then immediately followed with approvals for two new drugs and their companion diagnostics. This conference summarized the current state of thinking in new projects and innovative technologies in pharmaceutical and diagnostic codevelopment. Attitudes are slowly changing and collaborations are rapidly ensuing, although the alignment between pharmaceutical and diagnostic understanding of value, timelines, outcomes and impact is difficult and remains a contentious area. The value of this conference has been to address these issues.
Subject(s)
Diagnostic Techniques and Procedures/standards , Drug Industry , Diagnostic Techniques and Procedures/trends , Humans , Industry , Technology/legislation & jurisprudence , Technology/methods , Technology/standardsABSTRACT
By 2012 the pharmaceutical industry has generally recognized the value proposition offered through 'personalized medicine': shorter regulatory reviews and higher prices as a tradeoff for a more specific patient market. Examples of companion diagnostics (Cdx) exist not only in oncology, but across therapeutic areas that allow us to define treatment benefit and identify the 'best patients' for a given treatment approach or combination thereof. In the 13 years since the co-approval of trastuzumab (Herceptin(®)) from Genentech and the HercepTest(®) from Dako, the regulatory and commercial environments have yet to adopt a standard methodology for co-development and co-approval. Furthermore, a one-size-fits-all approach is unlikely to emerge despite attempts by various stakeholders to create an environment of conformity for approval and reimbursement issues. What has emerged, however, is the experience of clinical developers and commercial teams in bringing these products to market. In this article, we focus on the many factors that should be considered to successfully develop and market a companion diagnostic, based on lessons learned from recent case studies. A proposed framework of questions to be addressed at the various stages of developing highly effective companion diagnostic products is also presented.
Subject(s)
Drug Discovery/economics , Marketing , Molecular Diagnostic Techniques/economics , Molecular Diagnostic Techniques/methods , Translational Research, Biomedical/economics , Drug Approval/legislation & jurisprudence , Humans , Reagent Kits, Diagnostic , Translational Research, Biomedical/legislation & jurisprudenceABSTRACT
The twin forces of payors seeking fair pricing and the rising costs of developing new medicines has driven a closer relationship between pharmaceutical companies and diagnostics companies, because stratified medicines, guided by companion diagnostics, offer better commercial, as well as clinical, outcomes. Stratified medicines have created clinical success and provided rapid product approvals, particularly in oncology, and indeed have changed the dynamic between drug and diagnostic developers. The commercial payback for such partnerships offered by stratified medicines has been less well articulated, but this has shifted as the benefits in risk management, pricing and value creation for all stakeholders become clearer. In this larger healthcare setting, stratified medicine provides both physicians and patients with greater insight on the disease and provides rationale for providers to understand cost-effectiveness of treatment. This article considers how the economic value of stratified medicine relationships can be recognized and translated into better outcomes for all healthcare stakeholders.
