The Colorado BioScience Association (CBSA) brought more than 35 industry CEOs together last week to dialogue with Senator Michael Bennet and U.S. FDA Commissioner Margaret Hamburg at the Anschutz Medical Campus in Aurora. At Senator Bennet's request, CBSA designed the session to share the bioscience industry's specific and unique needs in bringing innovative drugs and devices to market under current, often constraining, market conditions.
Colorado BioScience Association Assembles CEO Rountable for Senator Michael Bennet and FDA Commissioner Margaret Hamburg
1. Colorado Senator Michael Bennet
Colorado BioScience Association Serves as Catalyst in Assembling CEO Rountable Discussion
for Senator Michael Bennet and FDA Commissioner Margaret Hamburg
at the Anschutz Medical Campus in Aurora
The Colorado BioScience Association (CBSA) brought more than 35 industry CEOs together today to dialogue with
Senator Michael Bennet and U.S. FDA Commissioner Margaret Hamburg at the Anschutz Medical Campus in Aurora.
At Senator Bennet's request, CBSA designed today's session to share the bioscience industry's specific and unique
needs in bringing innovative drugs and devices to market under current, often constraining, market conditions.
Denver, CO, August 22, 2011, 3 p.m. Eastern ‐ 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
‐More‐