April 13-14, 2010 – Biocompatibility of Medical Devices Certification Course

Biocompatibility of Medical Devices:
Two Day Certification Course

February 16 & 17 ~ San Diego, CA
April 13 & 14 ~ New Orleans, LA

This course is geared toward those who need to have a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan. Participants also learn how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on. Participants who attend and complete all exercises will be certified as a biological safety specialist.

Who Should Attend?
-  Regulatory Affairs and Quality Assurance Professionals
-  Research, Design and Manufacturing Engineers
-  Product Managers
-  Laboratory Managers
-  Process Development and System Engineers
-  Biological Safety Analysts
-  Anyone interested in learning more about meeting the test requirements of regulatory bodies in
world markets
-  Those needing continuing education for RAPS Certification

San Diego, CA Session: Register by January 15 and receive a $200 discount! Attend this 2-day course for only $900. After January 15 the registration price will be $1100. Space is limited.

New Orleans, LA Session: Register by March 12 and receive a $200 discount! Attend this 2-day course for only $900. After March 12 the registration price will be $1100. Space is limited. Register today!

Register 3 or more attendees at the same company during early registration to receive a further discount. Each registrant will receive an additional $100 off for a total registration fee of $800.00 per person.

Contact Anne Urfer at 419.662.4498 or email events@namsa.com.

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February 16-17, 2010 – Biocompatibility of Medical Devices Certification Course

Biocompatibility of Medical Devices:
Two Day Certification Course

February 16 & 17 ~ San Diego, CA
April 13 & 14 ~ New Orleans, LA

This course is geared toward those who need to have a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan. Participants also learn how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on. Participants who attend and complete all exercises will be certified as a biological safety specialist.

Who Should Attend?
-  Regulatory Affairs and Quality Assurance Professionals
-  Research, Design and Manufacturing Engineers
-  Product Managers
-  Laboratory Managers
-  Process Development and System Engineers
-  Biological Safety Analysts
-  Anyone interested in learning more about meeting the test requirements of regulatory bodies in
world markets
-  Those needing continuing education for RAPS Certification

San Diego, CA Session: Register by January 15 and receive a $200 discount! Attend this 2-day course for only $900. After January 15 the registration price will be $1100. Space is limited.

New Orleans, LA Session: Register by March 12 and receive a $200 discount! Attend this 2-day course for only $900. After March 12 the registration price will be $1100. Space is limited. Register today!

Register 3 or more attendees at the same company during early registration to receive a further discount. Each registrant will receive an additional $100 off for a total registration fee of $800.00 per person.

Contact Anne Urfer at 419.662.4498 or email events@namsa.com.

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Where Is Medical Innovation Happening In The U.S.?

In a recent Inc. magazine article “The New and Improved You” by Adam Bluestein, several innovative medical products were highlighted, from head to toe:

Take the time to read the article and visit the company websites. Truly amazing technologies and products are being developed by these innovators!

What I found extremely interesting while reading the article was the repetition of a particular geographic area. Look at the list again. Did you notice?

MASSACHUSETTS. Specifically, the greater Boston area. The article also cited many of these technologies come from MIT and the name Robert Langer was mentioned for a few of the technologies.

I don’t know if the author conducted exclusive research throughout the country, whether he has MIT and/or Massachusetts ties, or if Boston, MA is the place for medical innovation. Regardless, there is a formula for biomedical success that continues to work in the Boston area.

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What Does All The Lilly News Mean For Indiana & Life Sciences?

Indianapolis based pharmaceutical company Eli Lilly has been in the news quite a bit recently. Maybe I just hear more about Lilly because I’m in Indiana. It’s clear to many in Indiana’s life science community that Lilly is one of a few foundational companies supporting Indiana’s life science presence. Here are some recent news postings regarding Lilly:

August 7, 2008: Lilly Sells R&D Facility to Covance – The commentary I heard about this deal was it would be very positive for both Lilly and Covance. This is supposed to help Lilly be more nimble regarding drug discovery.

July 22, 2009: Lilly Will House ImClone In New York Tech Park – The Lilly / ImClone news is evidence that New York is positioning itself to become a hub for biopharmaceutical research.

September 14, 2009: Lilly Unveils Blueprint for Speeding Innovative Medicines to Patients – Lilly unveiled a new operating model and announced a series of changes to speed medicines from its pipeline to patients. The interesting thing about this news that the local media picked up on was Lilly would be laying off 5,500 employees, many of which would be from Indy. The press release from Lilly doesn’t mention this explicitly.

October 14, 2009: Lilly Sells Tippecanoe Manufacturing Site To Evonik Industries – Instead of shutting the facility down, Lilly sold the site to Evonik, one of the world’s largest chemical companies. The employees of this facility will be offered employment with Evonik.

October 29, 2009: Lilly Opens Eco-Friendly Biotech Center in San Dieg0 – “We are moving full speed ahead toward building a biotechnology powerhouse,” said John Lechleiter, Ph.D., Lilly chairman and chief executive officer. “The science, technology and talent at our new center in San Diego will help bring novel biotech medicines to patients faster and more efficiently . . .” The biotechnology center is in close proximity to life science activity and research near the University of California and other prominent biomedical research institutes, which is consistent with Lilly’s FIPNet (fully integrated pharmaceutical network) strategy to leverage external resources and knowledge to advance its pipeline. The primary driver is biotech innovation.

October 30, 2009: Lilly CEO Calls for Repair of ‘Engine of Biopharma Innovation’ – Lechleiter offered a vision to San Diego officials for biopharmaceutical companies to “reinvent innovation” to make the most of today’s wealth of scientific knowledge to benefit patients and address unmet medical needs.

Here are some of my speculations about all the Lilly news:

  • Lilly is quickly moving more into the biotech sector. (Maybe most of big pharma is?) Lilly claims to be the 5th largest biotech in the world.
  • Lilly realizes Indiana is NOT a hub for biotech innovation.
  • Lilly will likely reduce its R&D presence significantly in Indianapolis. Indy will be primarily focused on manufacturing.

Life science leaders in Indiana need to figure out how to be successful in a world without a strong Indiana presence from Lilly.

September 22, 2009 – San Diego Biotechnology Network

The September San Diego Biotechnology Network (SDBN) event will feature Intellikine, a leader in the development of innovative, small molecule drugs for the treatment of cancer, inflammation and autoimmune diseases, and recently in the news for raising $51M in VC funding. Troy Wilson, Ph.D., CEO, will give a short presentation, and as always there will be plenty of time to ask questions and interact with representatives from Intellikine.

Sign up today to reserve a spot, and we’ll see you soon!

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