From Discovery to Patient: The Journey of a New Drug

The development of a new drug is a long, complicated process involving up to 15 years of research and, in many cases, hundreds of millions of dollars. There are two distinct processes that every drug must go through before reaching the general patient population and treating a specific disease – Drug Discovery and Drug Development.Continue reading

Making Sense of the Medical Device Tax

Estimated at $20B, the Medial Device Tax was included in the Affordable Care Act that was signed into law by President Obama in 2010. The amount is based on a 2.3% excise tax that will be levied on the total revenues of a company, regardless of whether a company generates a profit, starting in 2013.

While many industry groups including AZBio, AdvaMed, and MDMA have been sharing information on why this tax is unwise and have worked to explain the negative effects that it could have on innovation and patient care, there is always the possibility that it will not be repealed before 2013.

Ernst and Young recently published a Tax Note on the Medical Device Tax that gives a comprehensive overview of what it is, who it affects and how they will be affected.  The tax note is provided below as published by E&Y and is shared with permission.Continue reading

Going Global? The USEAC is there to help

Are you ready to take your biotech business global?  The U.S. Export Assistance Council is ready to help with a number of services ranging from counseling and advice to in country introductions with qualified business partners.

The U.S. Commercial Service has a network of export and industry specialists located in more than 100 U.S. cities and over 80 countries worldwide. These trade professionals provide counseling and a variety of products and services to assist small and midsized U.S. businesses export their products and services.

Below is the current Global Healthcare Resource Guide with great information listed country by country to help you expand the global footprint of your business.

 

Want to download the guide?

Click here and download it from AZBio’s resource library on SlideShare.

Report shows global medtech industry emerging from global recession

Pulse of the Industry: Medical technology report 2011

September 2011 via AdvaMed

An overview of the United States, European and Global medical technology industry with performance metrics and analysis of the context within which the industry operates. Demographic, regulatory, macro-economic and expanding non-traditional markets create a need for innovative approaches to developing better medical technologies going forward. Click to download >>  Continue reading

Tips on Writing Powerful Public Comment Letters Regarding Proposed Regulations

By: Michael T. Hull – Managing Director, InVent Life Sciences   mhull@inventls.com  (Former Regional Advocate for the U.S. SBA Office of Advocacy)

The federal government proposes and finalizes approximately 4,000 new rules every year. In general approximately 800-1,000 will directly affect small business. A 2008 study by the U.S. Small Business Administration’s Office of Advocacy estimated that the cost of complying with federal rules and regulations exceeds $1.75 trillion per year with small businesses spending approximately 36% more per employee than their large business counterparts.Continue reading

For Business and Bio there is new opportunity in the cloud

There’s lots of talk of cloud computing these days.  From basic accounting to sales and from marketing/media to HR management companies are leveraging new resources to move forward faster.

But the cloud is not just for administrative applications.  Cloud computing is causing a major shift in how we tackle complex scientific opportunities.  Check out this video from IBM on how researchers from ETH Zurich, IBM and high-performance cloud computing are leading in the bioscience field across the cloud.

 

BioIndustry Resources

Online:

Beaker -Beaker is the online community for life sciences professionals.

OnBioVC – Provides timely coverage and comprehensive analysis of global bioscience venture capital  investment activity.  Bioscience venture capital data and information that can  be sorted by financing round, state and regional geography etc., a unique  feature provided is the ability to also sort by technology and clinical  indication, as well as by therapeutic, diagnostic or medical device company.  Click Here for OnBioVC’s May 2009 Trend Analysis.

LinkedIn – Join AZBio’s online group for discussions and
updates.


Funding:

CLICK HERE to search and access a comprehensive list of current and upcoming federal grant and funding opportunities.
  • CLICK HERE to view NIH Challenge Grants.
  • CLICK HERE to view the Omnibus of Broad Challenge Areas and
    Specific Grants

Arizona Organizations:

AzCI (Arizona Center for Innovation) – AzCI is a business incubator designed to meet the needs of developing technology companies, particularly in the areas of: aerospace, advanced composites and materials, information technology, environmental technology, life sciences and optics/photonics.

Arizona Nano Tech Cluster – The cluster works to share and promote technological advances in the fast-growing field of Nanotechnology.  To view their calendar of events, please CLICK HERE.

ASU Venture Catalysts – Helps to to spur innovation and transform the metro area’s knowledge economy.  CLICK HERE to view their event calendar.

The Flinn Foundation – The Foundation is committed to helping Arizona become a global competitor for research and commercialization in the biosciences and host to  Arizona’s Bioscience Roadmap

NACET (Northern Arizona Center for Emerging Technologies) – NACET is a small-business assistance program founded to help entrepreneurs and startups succeed in northern Arizona.


Training Courses:

DIA (Drug Information Association) – DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes.

MTLI (Medical Technology Learning Institute) – MTLI offers a variety of educational programs including regulatory, technical, and professional training courses covering all facets of the medical technology business lifecycle.

PERI (Pharmaceutical Education & Research Institute) – PERI is a not-for-profit organization that has been serving the pharmaceutical industry since 1989 providing the highest quality training available

RAPS (Regulatory Affairs Professionals Society) – RAPS supports the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources.

I have a trademark and a cybersquatter.

The domain name business remains rough-and-tumble. Little consideration goes into the niceties of paying attention to trademark rights. If you have a federally registered trademark and don’t already have a corresponding domain name, chances are the domain name has already been grabbed. Someone is probably cybersquatting on your domain name right now.  Continue reading