Tag Archive: personalized medicine

Jan 30 2014

FDA’s Comprehensive Status Report on Personalized Medicine

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA published a report, prepared by the Office of the Commissioner in the Office of Medical Products and Tobacco, in October 2013 entitled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development” with an enthusiastic forward by …

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May 12 2011

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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Sep 21 2010

Biomarker Qualification and Validation: Where are We Now?

Personalized medicine.  The pinnacle of healthcare where treatment for a patient’s disease is specifically tailored for his or her genetics and disease characteristics.  As the era of blockbuster drugs is drawing to a close, the era of personalized medicines is gushing in to fill the void.  One primary force driving the shift in healthcare and …

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Aug 20 2010

Important Steps Forward for Early Detection and Diagnose of Alzheimer’s Disease

Image via Wikipedia In a recent report by Geert De Meyer of Ghent University in Belgium and colleagues, titled “Diagnosis-Independent Alzheimer Disease Biomarker Signature in Cognitively Normal Elderly People” (Arch Neurol. 2010;67(8):949-956) it was demonstrated that measuring certain proteins in spinal fluid can accurately diagnose Alzheimer’s and predict which patients with memory problems will develop …

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Aug 16 2010

Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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Aug 16 2010

Joint Statistical Meetings 2010 Retrospective: A CRO Statistician's Perspective

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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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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Mar 18 2010

Challenges associated with oncology development within an immunotherapeutic platform

Although cancer immunotherapeutics (intended to treat already existing cancers by strengthening the body’s natural defenses) represent a very active area of development world wide, few cancer immunotherapeutics have been approved to date. Unfortunately, the overall clinical benefit in patients treated with an immunotherapeutic (intended for oncology indication, or otherwise) compared with those treated with placebo …

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