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Bentley Professor Advocates Incentives to Leverage 21st-Century Science for Innovative Medical Cures
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(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 21st-century cures based on 21st-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 21st-century, the pharmaceutical pipeline is not providing 21st-century cures, but rather cures based on 20th-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 20th-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.
BENTLEY UNIVERSITY is one of the nation’s leading business schools, dedicated to preparing a new kind of business leader – one with the deep technical skills, broad global perspective, and high ethical standards required to make a difference in an ever-changing world. Our rich, diverse arts and sciences program, combined with an advanced business curriculum, prepares informed professionals who make an impact in their chosen fields. Located on a classic New England campus minutes from Boston, Bentley is a dynamic community of leaders, scholars and creative thinkers. The Graduate School emphasizes the impact of technology on business practice, in offerings that include MBA and Master of Science programs, PhD programs in accountancy and in business, and customized executive education programs. The university enrolls approximately 4,100 full-time undergraduate, 140 adult part-time undergraduate, 1,430 graduate, and 43 doctoral students. Bentley is accredited by the New England Association of Schools and Colleges; AACSB International – The Association to Advance Collegiate Schools of Business; and the European Quality Improvement System, which benchmarks quality in management and business education. For more information, please visit www.bentley.edu.