Interview: ValveXchange's Larry Blankenship and Dr. Ivan Vesely

w3w3's Larry Nelson:

"We're talking with Larry Blankenship, Chairman of the Board and CEO of ValveXchange and Ivan Vesely, Founder and Chief Science Officer. Dr. Vesely is a PhD. Bio Physicist who founded the company and invented this heart valve technology." Link to the w3w3.com interview

ValveXchange recently announced its successful First in Man procedures. Link to the related Business Wire release.

Award-Winning Fashion Photograher Rick Guidotti To Keynote 2011 Colorado BioScience Awards Celebration

The Colorado BioScience Association (CBSA) Annual Awards Dinner is slated for Thursday, December 8, at the Embassy Suites in Downtown Denver. The event, celebrating the success of the bioscience industry in Colorado and its 2011 standout companies and individuals, will feature a keynote presentation by Rick Guidotti of Positive Exposure in New York. The announcement is made by Holli Riebel, CBSA President and CEO, who says: “CBSA is honored to partner with Positive Exposure in sharing Rick’s important message about genetic difference and dynamic images with our industry community.”

“CBSA is honored to partner with Positive Exposure in sharing Rick’s important message about genetic difference and dynamic images with our industry community.”

While in Denver on December 7th, Guidotti will photograph a select group of children in partnership with the Linda Crnic Institute for Down Syndrome, Mile High Down Syndrome Association, Global Down Syndrome Foundation, and Colorado Children’s Hospital. An exhibit reception will also be held at VSA Colorado/Access Gallery, an inclusive nonprofit organization that engages people with disabilities to access and experience the arts, located at 909 Santa Fe Drive, in the Santa Fe Arts District. The Exhibition will be on display from November 18 – December 16, 2011.

Link to the Business Wire Release

Link to the Pitch Engine Social Media Release

Genetic Engineering & Biotechnology News: 'Can the FDA Be a Catalyst for Innovation?'

Quoting Colorado's Dr. Tim Rodell (GlobeImmune) and Holli Riebel (CBSA) from the October 15 GEN:

"The products the FDA regulates represent 20% to 25% of every consumer dollar spent in the U.S., Dr. Hamburg pointed out. 'That’s a gigantic percent of the country’s gross domestic product,' Tim Rodell, M.D., CEO of GlobeImmune (www.globeimmune.com) and a member of the BIO board of directors, said. 'Given the FDA’s importance, it warrants being a cabinet-level agency.'

...Although FDA reviewers typically are trained in scientific research, applying that experience to the regulatory environment is learned on the job. 'That’s a significant deficit for the agency,' Dr. Rodell said. 'There’s no process to train the kinds of people the FDA needs.' Consequently, 'it takes one to two years for new reviewers to get up and running.'

Meanwhile, the FDA, in its determination to do no harm, risks being so cautious that it withholds live-saving therapies. Admittedly, it’s a delicate balance. 'Innovation occurs so quickly that FDA staff can’t keep up with new technology,' observed Holli Riebel, president and CEO of Colorado BioScience.

'Patients are waiting and—sometimes—dying, while amazing drugs aren’t released because of fears about potentially adverse reactions. Science isn’t perfect. We can’t push forward without some risks.'

...BIO also supports a progressive approval pathway so that even before final trials are completed, promising therapeutics could be released and monitored. Dr. Rodell suggested that could be accomplished safely and effectively by designing electronic medical records systems to accommodate retrospective, anonymous analysis of drug safety in real time. Therefore, drug developers could track adverse events associated with the commercial release of particular therapies more accurately than under the current system, which depends upon harried physicians taking the time to voluntarily report adverse events. Dr. Rodell added that the FDA is exploring this already with its pilot Sentinel initiative.

Link to the article at the GEN website

DBJ: 'Shortage of investors hurts biotechs'

Quoting from the article by Greg Avery:

"The No. 1 reason venture capitalists shy away from domestic biotech startups and are increasingly investing overseas is the unpredictability of the U.S. Food and Drug Administration approval process, according to a recent survey...

'New novel treatments are dying on the vine because they can’t get approval quick enough,' said Holli Riebel, CEO of the Colorado BioScience Association. 'If we’re going to develop cures to major diseases, we’re going to have to finance new drugs and major devices.'"

Link to the Denver Business Journal

NCBR: 'Rocky Mountain Innosphere at capacity'

Quoting from the article by Josh Zaffos:

"Less than a year after its grand opening, the Rocky Mountain Innosphere is at capacity.

Envisioned as a hub for innovation and tech companies, the three-story Innosphere was half-empty at the beginning of the years but has since leased all of its office space...

...Looking ahead, Speir said the Innosphere has teamed with the Colorado BioScience Association and National Renewable Energy Laboratory, among others, to host events aimed at showcasing its tenants and drawing investors. Speir said Innosphere staff also plans to foster better connections to businesses on the east side of I-25 in Weld County, as well as the Upstate Colorado Economic Development Corp. and University of Northern Colorado."

Link to the Northern Colorado Business Report

CBSA Pres/CEO Holli Riebel: Denver Business Journal 2011 Power Book Finalist, Technology Division

CBSA Pres/CEO Holli Riebel is a Finalist in the Denver Business Journal's 2011 Power Book/Newsmakers Awards Program.

Riebel was nominated in the Technology & Telecommunications Division. Quoting from the DBJ website: "The Colorado BioScience Association has managed to keep the state’s biotech drug and medical-device industries in the minds of public policy makers and national investors at a time of tight funding. CEO and President Holli Riebel (formerly Holli Baumunk) has maintained support for the industry during her first year leading the organization. CBSA organizes a regional conference that each year attracts investors from biotech hubs on the East and West Coasts, and it’s worked to keep state tax incentives and other support largely intact at a time when state funding has been cut for many other programs."

Learn more at the DBJ website.

Coming This Week: BioBeers Boulder, October 12

BioBeers Boulder

October 12th - 6PM

Twisted Pine Brewery
3201 Walnut Street Boulder, CO

Register at www.biobeers.com

DBJ: 'A rare biotech IPO: Clovis hopes for $149.5M'

Quoting from the 9/23 posting by DBJ reporter Greg Avery:

"The Colorado biotech industry hasn’t had a company go public since 2008, when Arca BioPharma went public through a reverse merger.

A Colorado biotech holding an IPO helps raise the profile of the state’s industry at a time when funding for it is scarce nationwide, said Holli Riebel (formerly Baumunk), CEO of the Colorado BioScience Association.

'It’s good for Colorado to be able to show there are deals going on, and there are things always going forward here,' she said.

And the kinds of drugs Clovis is developing — treating pancreatic and lung cancer — could have a lot of promise for patients, she said."

Link to the Denver Business Journal website

FDA Week: 'Colorado Bioscience Firms Lobby FDA, Bennet On Innovation, Consistency'

Quoting from FDA Week article by Nanci Bompey - August 26, 2011:

"The Colorado bioscience industry this week urged top FDA officials and a key Democratic lawmaker engaged in the drafting of major medical product legislation to enhance predictability and consistency among agency reviewers, improve the device 510(k) process, and streamline product approvals to foster innovation and competitiveness...

Colorado BioScience Association President Holli Riebel said firms expressed reservations about the agency's consideration of risks alongside benefit and ex-pressed their desire to align the agency's approval process with European policies.'It seems that they are trying to change some of the culture and structure within the agency and we hope that they follow through on that,' Riebel said.

'I know some of our companies had suggested some different solutions for some of the things they could do and hopefully they will take a look at that.'"

Link to access to the article (fee required)

Genetic Engineering News: Online Industry Updates About Colorado BioScience Association

■ Innovative Thought Leaders Address the 2011 Rocky Mountain Life ...
The announcement is made by Holli Riebel (formerly Baumunk), President and CEO of
the Colorado BioScience Association (CBSA), who says: "The conference will be ...
9-19-2011 - Link to Read

■ 2011 Rocky Mountain Life Science Investor and Partnering ...
The announcement is made by Holli Riebel (formerly Baumunk), President and CEO of
the Colorado BioScience Association (CBSA) who says, 'Leading biotech ...
9-7-2011 - Link to Read

■ Colorado BioScience Association Serves as Catalyst in Assembling ...
... The announcement is made by Holli Riebel (formerly Baumunk), CBSA President & CEO, who says "Senator Bennet invited Commissioner Hamburg and her colleagues to ...
8-22-2011 - Link to Read

■ Colorado BioScience Association Showcases Colorado's Bioscience ...
CBSA President and CEO, Holli Riebel (formerly Baumunk) recently stated,
'Colorado is the next frontier in life sciences. Everyday ...
6-27-2011 - Link to Read

PoliticalNews: 'Bennet Applauds FDA Commitment to Modernize, Foster Innovation, Drive Global Economy'

Quoting from Senator Bennet's release:

"Washington, DC – Colorado U.S. Senator Michael Bennet applauded the release of the U.S. Food and Drug Administration’s new report 'Driving Biomedical Innovation: Initiatives to Improve Products for Patients,' which outlines initial efforts the FDA is undertaking to modernize its regulations and foster innovation in the bioscience industry, which accounts for 20,000 jobs in Colorado, according to the Colorado Bioscience Association...

In August, Bennet sent a letter to FDA Commissioner Margaret Hamburg pushing for reformed FDA regulations that foster innovation and competitiveness and position the FDA to serve as a driver of the global economy. Following the letter, Hamburg joined Bennet to hear about innovation and advances in the bioscience industry in Colorado while touring the Colorado Science and Technology Park at Anschutz Medical Campus."

Link to politicalnews.me

Denver's ValveXchange® Performs First In Man Surgeries of New Heart Valve

Quoting from this morning's news release:

"ValveXchange, Inc., has performed successful First In Man (FIM) surgeries demonstrating the practicality and advantages of its novel Vitality™ two-part heart valve system.

The surgeries were performed by two highly renowned US cardiac surgeons, Lars Svensson, MD, PhD of The Cleveland Clinic and W. Randolph Chitwood, MD of The East Carolina Heart Institute, working with Adrian Ebner, MD at his facilities in Asuncion, Paraguay. The surgeries took place Sept. 26 and 27, 2011. Three men aged 49, 62 and 72 received the Vitality™ heart valves. All have been discharged and are recovering normally.

The mission of ValveXchange® is to bring the full, active lifestyle advantages of tissue heart valves to patients of all ages. Currently, tissue valves are recommended only for older patients because the leaflet sets wear out every 10-15 years, requiring repeated open-heart surgeries. Younger patients today receive mechanical heart valves that do not wear out, but require lifelong high doses of anticoagulation drugs that force a sedentary lifestyle with serious side effects."

ValveXchange is a former CBSA Venture Showcase winning company. Further, ValveXchange CEO Larry Blakenship is a CBSA board member, chair of its legislative committee and member of the executive committee.

Link to the Business Wire release

Opinion by Dr. Scott Gottlieb: 'How the FDA Could Cost You Your Life'

Quoting from an opinion piece by Dr. Scott Gottlieb in this morning's WSJ:

"When the U.S. Congress crafted the modern device-review process, it envisioned an approval path structured much differently than drug reviews. The Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee are working on comprehensive legislation that would reinforce the FDA's mandate to be "least burdensome" when it comes to new devices. The measure would also prevent the FDA from jamming companies with draft 'guidance' documents that change the rules on innovators midstream, without advance notice or chance for comment. The bill will tell the FDA, with unusually explicit direction, how to use its existing rules to improve post-market monitoring to ensure patient safety. The FDA was recently upbraided by the Government Accountability Office for not effectively using its current recall tools even while asking for new post-market authority.

These ideas have broad bipartisan support. Congressional Democrats and Republicans have expressed concerns that the FDA's regulatory slide could be harming innovation, job creation and patient care. Sen. Michael Bennet (D., Colo.) recently brought FDA Commissioner Margaret Hamburg to Colorado for a public meeting with local entrepreneurs and health leaders to address these concerns. 'At a time when our nation's drug, biotechnology and medical device startup companies are struggling to access capital,' he said, 'we must strive to provide them with regulatory clarity and predictability.'"

The meeting in Colorado was arranged at Senator Bennet's request by the Colorado BioScience Association.

Link to wsj.com

Dr. Gottlieb, the deputy commissioner of the FDA from 2005-2007, is a practicing physician and a resident fellow at the American Enterprise Institute. He invests in medical-device companies.