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Enabling Innovation: Drug Development Through Biomarker Validation and Qualification
Decision Resources, Inc, March 2011, Pages: 22
Biomarkers are becoming integral to drug development processes. Most pharmaceutical companies have initiated biomarker programs alongside drug discovery and development because biomarkers can aid in discovery of drug targets, assess drug safety and efficacy, stratify patients in clinical trials, and facilitate go/no-go decision making.
Biopharmaceutical companies recognize that use of biomarkers in regulatory applications can significantly boost the likelihood that their drug candidate will gain approval. Hoping to capitalize on opportunities that biomarkers can offer, other stakeholders, such as contract research organizations, are also stepping up their efforts to advance innovation in drug development. In their quest to use biomarkers in this way, all parties face the challenges of biomarker validation and qualification and applying the findings to strengthen their development strategies.
Questions answered in this report:
- Compared with unvalidated biomarkers, validated biomarkers offer a greater advantage at all stages of drug development—especially if these markers are qualified for a specific use. What challenges do pharmaceutical companies face in validating biomarkers? Are the opportunities provided by use of validated biomarkers worth the resource-intensive validation and qualification processes?
- Pharmacogenomic biomarker data are only voluntarily submitted to the FDA in drug applications, but there is an unspoken consensus that biomarker data are preferred because they facilitate the assessment of drug safety and efficacy evidence. What type of regulatory support has encouraged the preference for biomarker data? Looking at the 70 drugs whose labels include pharmacogenomic data, in what therapeutic areas is the influence of biomarkers growing?
- Regulators and pharmaceutical companies agree on one thing: the value of biomarkers is undeniable because they create opportunities for drug development. For instance, the partnership between Human Genome Sciences, a company focused on making connections between genes and biological functions, and GlaxoSmithKline led to the recent new drug approval of Benlysta (belimumab) for SLE in 50 years. Other stakeholders, such as contract research organizations (CROs), concur. What are the types of biomarker services that CROs provide to pharmaceutical companies? Of the three CROs we feature in this report, which is the biggest proponent of biomarkers?
Scope of the report:
- Issues in using biomarkers in drug discovery: Biomarkers as clinical end points to evaluate drug efficacy and drug safety, select patient populations, associate drug with clinical outcome, anticipate likelihood of success in market, and use in clinical trials.
- Regulatory support: Critical Path Initiative, FDA Amendments Act, Prescription Drug User Fee Act, Guidance for Industry: Pharmacogenomic Data Submissions, Draft Guidance for Industry: Qualification Process for Drug Development Tool.
- Pharmacogenomic biomarker data: A look at 70 drugs whose pharmacogenomic data the FDA has included in drug labels.
- Clinical trials assessed: A top-level look at 88 clinical trials for biomarker validation by therapeutic area and biomarker discovery technology.
- Nontraditional stakeholders with interest in biomarkers: Examples of the role of advocacy groups and contract service providers/contract research organizations in furthering biomarker research.
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