伴随诊断,2012-6,Biomarker联盟 - 在个体化医学时代加速临床试验进程.pdf

Accelerating Clinical Trials in the Context of Personalized Medicine: A Consortium Case Study Sonia Pearson-White, Ph.D., The Biomarkers Consortium September 28, 2012 Advanced Biomarker Strategies to Accelerate Clinical Development and Achieve Patient Stratification • Incorporating biomarker • Innovations in strategies into an adaptive clinical trial design clinical trial paradigm to accelerate drug and biomarker development • Collaborative clinical trial design using a public- private partnership The PPP Value proposition PPP= Public Private Partnership ■ For NIH: PPPs are a means to accomplish the NIH mission to improve the public health through biomedical research in a better way – faster, more economically, more safely, more effectively – by leveraging public resources with partners’ resources. ■ For regulators: to develop a robust body of regulatory science to underpin regulatory decision-making. ■ For industry: to increase the knowledge base to facilitate the more effective and efficient development of new targets, new interventions, new diagnostics, new devices, etc. ■ For academics: to increase access to resources for training, research and extensions into improvements in the public health. ■ For patients: to gain earlier access to applications and improvements deriving from NIH’s investment in biomedical research – i.e., new, safer and more effective drugs, interventions, and diagnostics Partners for Innovation, Discovery, Health l 3 Putting it together as a public-private partnership Key elements