Quoting CBSA's Pres/CEO perspective from the Northern Colorado Business Report article by Josh Zaffos covering Inviragen, Senator Bennet/FDA Commissioner Hamburg CEO Roundtable and the RMLIPC:"Bringing a drug or device to market has its challenges, said Holli Riebel, president of the Colorado BioScience Association: 'What makes it difficult right now is the regulatory market.'...
'There's a really large concern we're hurting (biotechnology) innovation in this country by not getting to market' within a reasonable timeframe, Riebel said...
Riebel said the FDA has struggled to keep up with developing technologies, while also suffering through the ubiquitous federal-agency problems of understaffing and restricted budgets. The agency is currently hiring new reviewers, but bringing inexperienced staff up to speed is a concern...
Riebel said one of the major interests from biotech boosters is for a fast-track process for regulatory approval of certain products. Officials have also pushed for reviewers to get training and certification in certain areas to speed along processing in some cases.
'How can we develop more predictability and consistency?' Riebel said. 'How do you start putting benefits into the analysis and not just look at what is the risk.'...
Much of the funding for biotech ventures is based on the East and West coasts, so the investor conference enables regional bioscience firms to make connections and prove they're equal to competitors from around the country, Riebel said.
The time is particularly ripe for such opportunities, she added, since many big pharmaceutical corporations have trimmed down in-house research and development in recent years, partly because of the costs and the regulatory environment. Companies are more willing to invest in small biotech firms that can focus on developing a few product lines from research programs to marketable drugs and devices.
Inviragen is a prime example, Riebel said, having developed vaccines that originated from the local labs of the U.S. Centers for Disease Control and Prevention and CSU and now targeting them for populations in developing countries.
'We're feeling better about some of the financial opportunities,' Riebel said, 'because we're turning out fantastic companies.'"
Link to the complete article
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