(Listen to Professor Fred Ledley discuss his testimony before Congress on Bloomberg's Taking Stock radio program.)

As the U.S. Congress embarks on a first-of-its-kind initiative to help accelerate the pace of medical cures in America, Bentley professor Fred Ledley joined a panel of experts who testified at a congressional hearing in Washington, DC, on incentives for pharmaceutical and device development.

The comprehensive evaluation — from discovery to development to delivery — is aimed at helping determine how to leverage advances in science and technology for medical innovation. Ledley, professor and director of the Center for Integration of Science and Industry at Bentley, recommended a shift toward policies and incentives that accelerate the process of developing new medicines to help the pharmaceutical industry transition from what he calls a reliance on old science.

“The role of incentives should be to promote 21^st-century cures based on 21^st-century science,” he said in a presentation to the House of Representatives Subcommittee on Health of the Committee on Energy and Commerce. “This requires sustained support for translational science, from the early stages of basic research, through drug discovery and drug development.”

Among Ledley’s points:

• Patent rights are essential for this innovation. Patents transform scientific discoveries into economic capital that can be monetized through technology transfer, capital investments, licensing fees, or royalties. Innovation can be incentivized by efficient and timely patenting of scientific discoveries.

• Statutory exclusivity for existing products — particularly those in dormant or late in their life cycle — may block innovation by making companies less likely to commit resources to the risky business of translational science. In some cases where market forces do not provide sufficient incentive, exclusivity can promote science. Examples include exclusivity for testing products in children or new medicines for rare diseases.

• Incentives to engage stakeholder could include accounting standards that assign value to R&D spending; valuation models that consider the intermediate products of innovation; or differential tax rates and shareholder rights that favor long-term investments. 

Citing research by Bentley colleague Laura McNamee, Ledley noted that a majority of the 100 new medicines approved by the FDA since 2010 arose from basic science that was, on average, 40 years old. “Thus, in the second decade of the 21^st-century, the pharmaceutical pipeline is not providing 21^st-century cures, but rather cures based on 20^th-century science.”

Ledley urged committee members to focus on incentives that will help move the industry forward, away from the products based on the science of an earlier age. “The reason we are here today is that the treatments and cures that were developed from 20^th-century science are not good enough. There are critical unmet needs in incurable diseases and the ever-increasing cost of healthcare. Incremental improvements or new indications for the products of old science will not meet these needs.”

Fred Ledley is director of the Center for Integration of Science and Industry at Bentley University, and professor of natural and applied sciences and management. His research focuses on accelerating the translation of scientific discoveries to create public value. He served as an investigator at the Howard Hughes Medical Institute, as scientific founder of one of the first gene therapy companies (GeneMedicine), and as president and CEO of Variagenics, an early start-up in the field of personalized medicine. He is also the inventor on 10 U.S. patents.