Tuesday, April 26

Venture Investors Shifting Away From Biotech

"Venture capitalists are investing less in biotechnology and more in Internet companies, according to initial data for the first quarter this year.

While there are no signs that venture capitalists have picked up or slowed down their overall investment pace, they appear to have pulled back from biotech, the hottest sector of the past two years, according to a survey to be released today by VentureOne and Ernst & Young. However, measuring quarterly trends is tricky because venture capitalists like to keep their bets secret. It takes weeks, sometimes months or years, for some investments to be reported."

Read more in this MercuryNews.com article.

Wednesday, April 20

EU Universities Weigh Spin-offs versus Licensing in Tech Transfer

"With regional development and high-tech employment near the top of the agenda in many countries of the EU, a flurry of conferences will be discussing the best way to put the fruits of academic research, including biotechnology, to economical use.

Lessons learned in the UK, one of the European countries most advanced in exploiting its homegrown knowledge, could prevent other countries from making the same mistakes when developing their biotech sector. In particular, the high number of companies spun out of UK universities is spurring debate over whether the country should start shifting priorities from creating spin-offs to licensing inventions to outside companies.

Read more in this news @ nature.com article.

Sunday, April 10

Open Source Biotechnology Project

"'Open Source Biotechnology' refers to the possibility of extending the principles of commerce-friendly, commons-based peer production exemplified by Open Source software development to the development of research tools in biomedical and agricultural biotechnology.

The Open Source Biotechnology Project examines the feasibility of Open Source Biotechnology in the current industry environment. In particular, it explores:

1. Whether it would be possible to run a viable biotechnology business on Open Source principles, and

2. What such a business might look like, including the application of specific Open Source-style licences to particular classes of biotechnology research tools."

Saturday, April 9

FDA Issues Final Guidance on Risk Management of Drugs and Biologics

"The U.S. Food and Drug Administration (FDA) recently issued three final guidances based on draft guidances published in May 2004. The final guidances are directed at improving the assessment and monitoring of risks associated with drugs and biological products in clinical development and general use.

The first of the final guidances relates to premarket risk assessment and focuses on considerations for the stages of clinical development of products. It builds on a number of existing FDA and ICH guidances related to preapproval safety assessments.

The second guidance deals with the development and use of risk minimization action plans. It includes a call for broader input from patients, health care professionals and the public when recommendations are made on whether to initiate, revise or end risk minimization interventions.

The third final guidance, addressing heightened postmarketing vigilance, recommends reporting and analytical practices for monitoring the safety concerns and risk of medical products in general use."

For more information, please see this Pharmacapsules @ Gowlings report.

Monday, April 4

No Research, Development Only Business Model

"New business models are emerging in the biotechnology industry that are geared to reducing investor risk in order to attract funding from investors who are not willing to expose themselves to the level of risk normally associated with biotechnology firms...

Hence the emergence of the NRDO model. NRDO stands for No Research, Development Only, and refers to companies that attempt to reduce the high risk of failure and long periods of unprofitability typically associated with biotechnology start-ups by eschewing drug discovery. Instead they concentrate on shepherding existing but as-yet-unapproved drugs through the clinical trial pipeline and hopefully toward FDA approval...

Theoretically, the NRDO model has the potential of being beneficial to all involved parties.

By increasing the efficiency of the market, it allows biotechnology firms that are adept at drug discovery to concentrate on what they do best, while at the same time allowing big pharmaceutical firms to profit from licensing out technology that would otherwise have sat on a shelf without producing returns, and it obviously benefits the drug development companies that are following the NRDO model.

Consumers benefit from the availability of treatments that wouldnt otherwise have reached the market, and investors benefit because they will have more varied and lower-risk investment options...

In practice, however, it is unclear whether, or to what extent, the NRDO model actually reduces risk. The drug development process still has a high failure rate, and it is not yet known whether firms following the NRDO model will be more successful at getting drugs to the market than traditional biotechnology firms..."

From this Genetic Engineering News article via this post from About.com.