Biomedical Innovation and Evidence Development

Scientific advances in basic disease and systems biology, genomics, proteomics, metabolomics, and immunology are driving a robust drug and therapeutic development pipeline that increasingly includes targeted, more effective and even curative specialty therapies, as well as more advanced medical devices. At the same time, biomedical Innovation is challenged by many of the same forces driving the need to reassess delivery and payment models, including the high prices of many new therapies.

Many chronic diseases and acute conditions lack adequate therapies and cures, forcing policy makers to grapple with practical approaches for encouraging innovation and development while facilitating access to leading-edge medical technologies in ways that maximize value and outcomes. Better approaches are needed for encouraging investment in areas of unmet need, reducing the time and cost of medical product development, and supporting high value evidence-based uses of drugs, devices, and other technologies.

Our Approach

Duke-Margolis is focused on increasing the value of biomedical innovation to patients – including both better health outcomes and lower overall health care costs. Policy solutions are needed to gain ground in implementing drug development tools such as biomarkers and clinical outcome assessments, and to adopt methods incorporating the voice of the patient in both drug development and regulatory decision-making. development and evaluation of new payment models and contracting approaches related to innovative biomedical projects that support better outcomes and higher value care to patients.

Current Focus Areas

Our Projects

8th Annual Sentinel Initiative Public Workshop

Supporting the Planning Board for the National Evaluation System for Health Technology (NEST)

Supporting Innovative Sources of Real-World Data (RWD) for Medical Devices

Standardizing and Integrating REMS into the Healthcare System

Economic Incentives for Antimicrobial Innovation

Mapping Global Health Research & Development

Second Panel on Cost-Effectiveness in Health and Medicine

Value-Based Payment for Medical Products