Drug Development

Increasing innovation in medical products is a policy priority. A first step to understanding changes in the level of innovation is to determine how to measure the baseline of innovation. Existing research employs a variety of measurement methods–scientific, therapeutic, and economic measures–to study trends in medical product (e.g., drugs, biologics, devices) innovation.

Patient advocacy organizations (PAOs) play a key role in medical product development. Many PAOs raise money to fund medical product development activities – such as basic science research, preclinical research, and clinical trials - for their condition of focus, whereas others fund or develop resources such as biobanks or patient registries to support the research community.

March-in authority allows the federal government to grant licenses on privately owned patents for inventions developed with federal funding provided certain statutory requirements are met. It was designed to ensure that the benefits of the American taxpayers’ investment in research and development are reasonably accessible to the public.

The pipeline and commercial market for novel antimicrobial drugs is insufficient to address current and future patient needs or mitigate the loss of effective treatments as antimicrobial resistance spreads. The U.S. Government implements a range of efforts to ensure sustainable availability of antimicrobial treatments, supporting research, product development, and appropriate use.

Rare cancer clinical trials appear to enroll less diverse participants than clinical trials more broadly and therefore may require additional considerations or unique solutions to diversify participant recruitment. These differences persisted within both NIH and non-NIH funded trials.

The cost of bringing a medical product to the U.S. market has been increasing and clinical trials constitute a large portion of these costs. In drug development, the clinical phase lasts an average of around 95 months compared to 31 months for the non-clinical phase and accounts for 69 percent of overall R&D costs (DiMasi, et al., 2016).

This landing page presents the abstract of a paper published in Health Affairs. The full text of the article is available at: https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2023.00837.

We report findings of a study that described the emerging nonprofit pharmaceutical industry and its commercialization activities to enhance access to affordable and essential drugs, or resiliency in the supply chains of medical products.

This landing page represents the abstract of a paper published in JAMA. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820562.Abstract

Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.