Tag Archive: clinical development

Jul 20 2020

Are you ready for the new European clinical trial regulation?

29 June 2020 – Cleo François MSc, Regulatory Affairs Manager The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is …

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Mar 20 2012

Senator Hagan’s TREAT for Small Biotech

Image via www.dog-paw-print.com Beginning with the Pure Food and Drugs Act of 1906, legislation proposed by Congress has constructed and continues to modify the FDA.  By extension this legislation represents the rulebook that biotech plays by in its pursuit of advancing drugs to market.  Longtime biotech advocate, Senator Kay Hagan (D-NC) has proposed the TREAT …

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Feb 23 2012

The CED Life Science Conference and Biotech’s Yellow Brick Road

The 21st annual CED Life Science Conference achieved its mission of cementing the Research Triangle Park as a hotbed for innovation and opportunity in biotech.  The 2012 CED LSC showcased local leaders like Victor Dzau, President and CEO of Duke University Health Systems, and former four-term North Carolina governor James B. Hunt, as well as …

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Jul 28 2011

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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May 11 2011

Conference Recap – BayBio 2011

The BayBio Annual Conference 2011 was held on 20-21 April 2011 in Burlingame, CA.  The event was attended by more than 1,000 San Francisco Bay Area biotech and life sciences professionals from over 400 companies. This year’s conference focused on funding trends and emerging markets in the life sciences industry.  In keeping with BayBio’s spirit …

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Jun 18 2010

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

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May 12 2010

Approval of Therapeutic Cancer Vaccines

Last month, Dendreon was granted approval for Provenge®, the first cell based cancer vaccine for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.  Provenge is the first cancer treatment that utilizes the strength of the patient’s own immune system to fight tumors.  This approval could mark the beginning of a …

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