Tag Archive: biotech

Oct 09

Top Five Mistakes in Clinical Protocol Design

By Lisa R. Sanders, Ph.D., R.A.C., Sr. Clinical Scientist II at Cato Research Almost a Holy Grail for the pharma/biotech world, the perfect clinical study protocol requires no amendments, collects only the data needed for the planned analysis, is fully feasible, and is enrolled on time. The reality is that the average clinical trial protocol …

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Apr 11

AMP’d Up Search for Biomarkers

By Kathy A. Grako, Ph.D., PMP, CCRP, Senior Clinical Strategy Scientist In February the United States government announced a unique triad brought together to “accelerate the development of life saving drugs and to help identify new treatments and cures for diseases” under the Accelerated Medicine Partnership (AMP).  FDA and NIH have teamed up with 10 …

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Jun 13

The ILSI-BioMed Israel Conference Continues to Grow

ILSI-BioMed

The 11th annual ILSI-BioMed 2012 Conference, also known as National Life Science and Technology Week, was held in Tel Aviv, Israel on 21-23 May 2012. Throughout the many years of attendance, we’ve seen exciting growth in diverse fields of technology at this conference. The ILSI-BioMed conference attracts as many as 6,000 industry players, engineers, and …

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Jun 06

New FDA Guidances Released in May 2012

Here’s a list of the  guidances released by FDA in April 2012, compiled by Cato Research Scientist Elinore Mercer, Ph.D. Pediatric Information for X-ray Imaging Device Premarket Notifications (Draft) S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (Draft) …

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May 02

Cato Research Canada Celebrates Two Decades of Success in the Drug Development Industry

Over the past 5 years, the life sciences industry throughout Canada, and especially in Québec, has been extensively challenged. Capitalizing on strong relationships built over years with clients and partners has helped Cato Research continue to provide excellent services and weather the industry’s roller coaster ride. On 03 May 2012, Cato Research Canada will celebrate its 20th anniversary with a celebratory wine tasting. You are invited to join us and other industry representatives to talk about the changing climate for pharmaceutical and biotechnology companies in Canada.

Mar 20

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

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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Nov 29

Fifth China Medicinal Biotech Forum – Conference Recap

I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011.  The purpose of this conference was to update graduate students in China on the latest trends in biotechnology.  This forum also allowed scientists from Europe, Australia, Japan, US, and South America to collaborate with Chinese colleagues at …

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Nov 02

Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to lag behind and often do not recognize that project management is not too complex or …

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Jun 28

Biotech Funding: Still Playing Hard-to-Get

After a few lean years, biotechs raised $25 billion in 2010.  For the majority of small companies however, funding remains difficult to find.  Ernst & Young’s annual report on the biotechnology industry, Beyond Borders, was recently released and it paints a less rosy picture than the $25 billion number would appear to. It turns out …

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