Increased Collaboration and Investment in Science and Regulatory Workforce Necessary to Advance Scientific Discovery

21st Century Cures Initiative Seeks to Accelerate Pace of Cures

06.09.14 | By Dr. William "Bill" Chin, M.D.

A Path to 21st Century Cures logoPhRMA strongly supports the goals of the House Energy and Commerce Committee’s 21st Century Cures initiative that seeks to accelerate the discovery, development and delivery of new treatments and potential cures to patients. We commend the Committee for its active outreach to stakeholders from across the scientific ecosystem.

The Committee’s first white paper, 21st Century Cures: A Call to Action, explained the mission of the initiative and sought feedback on how to ensure that our nation’s regulations and laws keep pace with the rapid advance of science in order to spur even greater innovation. This is the first in a series of blogposts on our feedback on the white paper.

NIH Plays A Critical Role in Basic Research

The dynamic, collaborative research ecosystem that exists in the U.S. among government, academic, and biopharmaceutical companies is one of our greatest strengths in moving medical advances forward.  The National Institutes of Health (NIH) plays a critical role in supporting basic research—curiosity-based investigation—that often can provide new ideas that can transform medicine when translated into novel therapeutics. We support Congress’ commitment to provide robust resources to fund research at the NIH and at the universities, hospitals and other research institutions throughout the country which receive NIH research grants. 

More effective collaborative efforts within NIH institutes and centers, including interactions with the National Center for Advancing Translational Sciences, could ensure that the groundbreaking basic research done at the NIH is shared and translated into practical applications for the ongoing medical research, discovery, and development done in the private sector.

Pre-competitive efforts in the discovery phase could include target validation, predictive animal efficacy models and use of existing regulatory authority to streamline approaches to proof-of-concept in humans as well as novel approaches to develop combinations of medicines, medicines with devices, and medicines with companion diagnostics.

Public-Private Partnerships Harness Collective Strength to Solve Public Health Challenges

More public-private partnerships such as the Accelerating Medicines Partnership could harness the collective strength, resources and creativity of the members to solve significant public health challenges, and PhRMA is actively helping to progress these initiatives.  By working collaboratively across industry, academia, government and non-profit patient advocacy organizations and foundations, we can increase the odds of success in finding new approaches for therapies and diagnostics, while reducing the time and cost associated with their development. 

Investments in a Strong Science and Regulatory Workforce Necessary

The process of translating biomedical discoveries into novel therapies continues to increase in complexity just as science and technology rapidly evolve.  Investment in training is needed so that experts across the ecosystem are able to understand, adopt and apply new scientific tools, standards, and approaches in drug discovery and development. Growing and maintaining a pool of professionals properly trained in regulatory science is also essential and requires collaboration as well as rigorous, forward-thinking education. 

We all have a role to play in this effort.  As we announced in a blogpost earlier this week, PhRMA and Georgetown University recently established a postgraduate Fellowship in Regulatory Science to provide interdisciplinary expert training needed to modernize and improve the way medical products are reviewed and evaluated. This fellowship program demonstrates the biopharmaceutical industry’s commitment to supporting and sustaining training and education in this specialized field.

As the Committee’s white paper noted, the U.S. is the world leader in early discovery due to the combined efforts of industry, academia and the NIH.  We must work together –even more closely- in order to maintain our leadership in biomedical innovation and bring new medicines to patients.


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