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.

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
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"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:
Pharma/Biotech:
Amgen
Apopologic
ARCA Biopharma
Ariel Pharmaceuticals
Array BioPharma, Inc.
Colorado Institute for Drug, Device and Diagnostic Development
Clovis Oncology
GlobeImmune
Inviragen
Merck
N30 Pharma
Nextgen Pharma
Tolmar
Med Device/Diagnostics:
AlloSource
Baxa Corporation
Biodesix
Caridian BCT
Clarmedix
Covidien
Gambro
Labs Inc.
Medivance
Medtronic Navigation
Sharklet
SomaLogic
ValveXchange
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AgBio
Invitria
Venture Capital Groups:
Boulder Ventures
High Country Ventures
Universities/Associations:
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
Regulatory:
Reglera Corp
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.
# # #
Contacts:
Mae Desaire, Director of Marketing, Colorado BioScience Association ‐ http://www.cobioscience.com – 720‐382‐5918,
mdesaire@cobioscience.com
Maggie Chamberlin Holben, APR, Absolutely Public Relations ‐ http://www.absolutelypr.com – 303‐984‐9801,
maggie@absolutelypr.com