DENVER--(BUSINESS WIRE)--The Colorado BioScience Association (CBSA) worked with Senator Michael Bennet's office in assembling a group of more than 35 bioscience industry CEOs from its membership to dialogue with the Senator and Margaret Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration (FDA) today. Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health, and Dr. Vicki Seyfert-Margolis, Senior Science Advisor to the FDA’s Chief Scientist, accompanied Commissioner Hamburg here.
The announcement is made by Holli Riebel (formerly Baumunk), CBSA President & CEO, who says "Senator Bennet invited Commissioner Hamburg and her colleagues to Colorado for the CEO Roundtable. The session today is a positive next step to work CBSA has already contributed to Senator Bennet's Coloradoans For An Innovation Economy (CFAIE), and speaks strongly to the work the Senator is doing on our industry's behalf. We appreciate the opportunity to host Commissioner Hamburg in our state for the first time and share our industry's specific and unique needs for bringing innovative drugs and devices to market under current, often constraining, market conditions."
According to Lilly Marks, VP for Health Affairs and Executive Vice Chancellor, Anschutz Medical Campus, the Roundtable session took place on the Anschutz Medical Campus in Aurora where the FDA delegation also toured research and clinical trial facilities before departing the city.
Last week, Sen. Bennet sent a letter to Commissioner Hamburg addressing his thoughts for how the FDA should proceed in fostering innovation: “At a time when our nation’s drug, biotechnology, and medical device startup companies are struggling to access capital, we must strive to provide them with regulatory clarity and predictability in a way that is safe for patients but also meets their expectations regarding innovation,” Sen. Bennet wrote in the letter.
Further in his letter to Commissioner Hamburg, Sen. Bennet asked how the agency plans to address the following areas as it strives to modernize its regulatory system to adapt to the 21st century:
- Regulatory reform and transparency that will simplify manufacturing processes, rather than add complexity to business operations
- Incorporation of modern scientific tools, standards, and approaches to advance innovation
- Recognition of innovative approaches taken by other global regulatory systems to enhance certainty and predictability
- Incorporation of private-public approaches to ease investment in innovation
"Patients in this country are demanding that we lead in innovation and timely access to breakthrough therapies and cures. At a time when our nation’s drug, biotechnology, and medical device startup companies are struggling to access capital, we must strive to provide them with regulatory clarity and predictability in a way that is safe for patients but also meets their expectations regarding innovation. I believe we have an opportunity to do good things for patients and a critical sector of the U.S. economy. I look forward to partnering with you to ensure the FDA fosters innovation and promotes economic growth." Sen. Bennet said.
David Perez, Chairman, Blood Management Business, Terumo Corporation, and President and CEO, Caridian BCT and Terumo Transfusion, agrees with Sen. Bennet that "access to capital and speed to market of new innovations is more critical now than ever." In addition to the CBSA Board of Directors, Mr. Perez also serves the Advanced Medical Technology Association (AdvaMed) as a member of the board of directors and its Strategic Planning Committee, vice chair of the Technology and Regulatory Affairs Committee, and as the chair of the Blood Products and Technology Sector.
According to CBSA Board Chair Steve Orndorff, CEO of Ariel Pharmaceuticals and also a member of the CFAIE, the FDA recently announced a “Strategic Plan for Regulatory Science,” which aims to foster innovation through better science. "Like Sen. Bennet, our Association applauds those efforts, but we urge the FDA to do more to promote economic growth, American competitiveness and innovation," Orndorff said.
The following CBSA companies participated in the Roundtable Discussion with Senator Bennet, Commissioner Hamburg and the Commissioner's colleagues from Washington:
Array BioPharma, Inc.
Colorado Institute for Drug, Device and Diagnostic Development
Venture Capital Groups:
High Country Ventures
Anschutz Medical Campus
Colorado Bioscience Association
Colorado Clinical and Translational Sciences Institute
Colorado Center for Drug Discovery (C2D2)
Fitzimons Redevelopment Authority
University of Colorado, AMC
University of Colorado Technology Transfer Office
Regulus Pharmaceutical Consulting
About Colorado BioScience Association
The CBSA is a not-for-profit corporation providing services and support for Colorado's growing biosciences industry. With more than 350 members, CBSA actively works to promote the growth of the industry by working for a better business environment, grow the state's biotech workforce, fight for policies that support a strong bioscience industry in the state and speak with a single voice on behalf of the industry. For more information, visit http://www.cobioscience.com.