Molecular Diagnostics
Table 2: Properties and characteristics of different Companion Diagnostic business models. Adapted from Stephen Little17 STAND-ALONE Costs – CD company Revenues Marketing Exclusivity Risk Regulatory Geography Examples High High Independent IP driven High LDT or 510K Company dependent Genomic health PARTNERSHIP Revenue generation Medium Pharma support Clinical Trial or IP Low IVD-PMA Global Qiagen & Dako ONE-STOP SHOP High Very low Partnership Clinical Trial or IP High IVD-PMA Global Roche Low Independent None or IP Medium LDT USA Caris SHORT CUT Medium
ii What is the potential for follow-on products with partner? iii Expertise in development and commercialisation of drug and CD products are essential. iv How will decisions be made regarding test for- mat, scoring, methods, validation, complete con- trol of clinical results and commercialisation strat- egy including co-ordination of activities? v Will the CD company business model/risk shar- ing strategies fit with potential partner?
In addition, Ferrara18 has noted that CD com- panies are very cognisant of the importance of pharmaceutical companies and are deploying two different, time-dependent business approaches that impact clinical development and market risk. The long-term opportunity is in the co-development of the CD and the therapeutic drug with a subsequent co-launch of the two products. This approach affords the opportunity of an optimal outcome since the clinical trials for drug and CD can be co- designed in tandem at the outset, and this is the ‘partnership’ model delineated in Table 2. The problem with this model for the CD companies is that the drug may not ultimately clear clinical tri- als and thus the CD would not make it to market. A more near-term, less risky approach is the devel- opment of a CD linked to a currently used drug therapy. Such a CD would identify for example, optimal responders to the drug, and could be reim- bursed by the payor. However, such an approach would necessitate adequate clinical data in the form of validation and an efficient commercialisa- tion plan. In either model there is still significant risk and cost associated with the development and
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use of the CD even when considering the needs of the pharmaceutical company.
Pharmaceutical company CD business models There are numerous factors that individual phar- maceutical companies must make when consider- ing the incorporation of a CD into the develop- ment and launch of a therapeutic drug. A primary factor is defining the role of the CD in the drug development and post launch surveillance, for such matters as patient stratification, identify respon- der/non-responder and develop new indications for therapeutic agents. In addition the CD must not add a prohibitive cost to the payor such that it becomes a barrier to the actual therapeutic drug use. Also, the CD test needs to be readily available, analytically and clinically validated and approved in all global drug markets. Such stringent require- ments by pharmaceutical companies must also be weighed against the risks, benefits, priorities, development costs, business terms, regulatory and market considerations of the CD itself9. In the ideal situation for the pharmaceutical company, the CD is tied to the development of the drug indication. In such a case Lauber has laid out the generic considerations that each pharmaceuti- cal company must ponder in the development of an appropriate business model9, and these include:
i Internal CD development or partner: this necessi- tates consideration of CD discovery and assay development; CD analytical and clinical valida- tion; manufacturing scale-up; registration strategy and plan; reimbursement strategy; legal/IP due dili- gence and marketing strategy and plan.
Drug Discovery World Summer 2010
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