Tag Archive: efficacy

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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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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May 12

Conference Recap – Biomarker World Congress 2011

  Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients.  Specifically, personalized medicine is dedicated to the concept hat the right drug is administered to the right patient at the right dose at the right time.  To get …

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Oct 25

FDA Pediatric Study Information

The FDA’s Pediatric Drug Development page is a great place to find information on pediatric studies.  FDA just posted the most recent metrics for studies performed between September 27, 2007 and September 30, 2010 related to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).  During that period, 305 studies including …

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Oct 07

Improving Assessment Data Consistency in Multi-Center Studies

Ensuring assessments are conducted, analyzed, and reported consistently across sites is a challenge facing managers of multi-center clinical studies.   While identification and quantification of between site variation is typically part of the statistical analysis, collecting more consistent data from the outset leads to cleaner results.  Although an issue for all clinical studies, the impact is …

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Sep 09

Statistics and Statisticians in Clinical Trials – Beginning with the End in Mind

Cover of The 7 Habits of Highly Effective People Begin with the end in mind … is imagination–the ability to envision in your mind what you cannot at present see with your eyes. It is based on the principle that all things are created twice. There is a mental (first) creation, and a physical (second) creation. …

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Aug 11

Accelerated Approval

Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics:  What is accelerated approval and how does it work? The process is defined in 21 …

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Jul 07

505(b)(2) Marketing Applications – Bridging the Gaps

There is no doubt that the drug development business is very expensive and development can take many years before a viable, money-generating product can be marketed. A strategy some of our clients implement to more quickly and more inexpensively develop a novel therapeutic product is to develop a drug that can rely on studies from …

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Jun 16

New Draft Guidance on Noninferiority Trials

In March 2010, the FDA issued a draft guidance on the use of noninferiority (NI) trials.  While not in final form, this guidance should help sponsors understand the issues the FDA considers when reviewing NI trials. In contrast to statements over the last 8 years on the matter, this guidance shows the kinds of arguments …

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