Idrugs
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Backed by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.
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The importance of biomarker technology and biomarker strategies in pharmaceutical development is still in its infancy, but the impact of biomarkers is already proving to be significant in this field. Strategies for incorporating biomarkers form the basis for translational medicine and also for the industry/regulatory focus on reducing the high attrition rate of drugs often encountered at phase II clinical research. The depth and breadth of knowledge required to successfully implement biomarkers into drug development are generating many collaborative efforts within the pharmaceutical industry, as well as encouraging the involvement of professionals who traditionally have not been part of the drug-development process.
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Sepsis continues to intrigue and challenge drug developers because of the high unmet need for this illness. The large market potential for sepsis is counterbalanced by the historical failure of multiple drug candidates for this indication that have not demonstrated clinical benefit. ⋯ This article reviews several treatment approaches for sepsis that are in clinical development to highlight the scope of research in this field. Although a near-term clinical breakthrough for sepsis is not imminent, current research provides a substantial amount of hope for the field.