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Anti Nerve Growth Factor

Monitoring the Joint Safety of Anti-Nerve Growth Factor Drugs

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  • 25 Jul

The March 12, 2012 meeting of the Arthritis Advisory Committee (AAC) of the Food and Drug Administration (FDA) focused on the safety of the anti-nerve growth factor (anti-NGF) drug class. Anti-NGF agents are being developed primarily for the treatment of chronic pain associated with osteoarthritis (OA).

There are three anti-nerve growth factor monoclonal antibodies in clinical development including:

  • Tanezumab (Pfizer) in phase III
  • Fulranumab (Janssen) in phase II
  • REGN475 (Regeneron) in phase II
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Osteoarthritis Imaging Abstract Presented at EULAR 2012

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  • 09 Jul
I recently attended the 2012 European League Against Rheumatism (EULAR) Annual Congress of Rheumatology in Berlin where a lot of novel clinical research on osteoarthritis, arthritis, and rheumatism was presented. Dr. Harris Ahmad, my colleague at BioClinica, and I co-authored two posters with Desiree van der Heijde and her team.
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ASMBR and OARSI Meetings Part 1 on Osteoathritis Imaging

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  • 28 Sep
This blog is being written on a flight back from San Diego where I have just attended the OARSI (Osteoarthritis Research Society International) meeting and the ASBMR (American Society of Bone and Mineral Research) conference. While it was great that they were co-located in the same city, it was a very tough time trying to go between the two meetings, which both had some great science and debates on imaging in osteoarthritis and bone.
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Clinical Trial Analogy for Real-World US Airways Flight Scenario

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  • 23 Aug
This is a second follow-up to my recent blog post on what happened flying back from the Osteoarthritis Imaging Conference. Aside from a variety of clarifying questions, I've found that the topic has consistently turned to one regarding compensation and specifically: "Did the airline give you a free flight in return for saving them a huge expense?" Upfront disclaimer: US Airways did give me compensation: A $350 coupon for US Airways travel for me and since my wife was flying on a frequent flyer ticket, they gave me back 25,000 air miles. The ticket for my wife was in excess of 100,000 air miles. Was this fair compensation? I was underwhelmed, but I would value other opinions.
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What Happened Flying Back from the Osteoarthritis Imaging Conference

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  • 26 Jun
How would you react if you were given this statement at 38,000 feet above the Atlantic Ocean? Most of us hope we would never be in this position, but unfortunately that is where I found myself two weeks ago flying back from Munich after attending the Osteoarthritis Imaging Conference. My wife, a trained nurse who was traveling with me, was given this information by a passenger we were working on who had taken illicit drugs just before boarding the plane (the passenger was high in more ways than one!). My wife whispered the words to me and I then relayed them to the head stewardess on the flight and we and 2 other physicians worked through the problem. We tried to ensure very few people knew the issues and so very little was made of this, although it was a tough 7.5 hours. We eventually had the passenger handcuffed and strapped very securely to a seat where one of three of us guarded him for the rest of the flight until we landed in Philadelphia and prevented the plane from being diverted to Shannon or Rechyakic. For those of you who may be questioning the validity of this story on my way back home from the Osteoarthritis Imaging Conference, there was a very limited press release on it that can be found here.
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Osteoarthritis Imaging in Clinical Trials Challenges

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  • 17 Jun
The last few blogs I posted have been about the Alzheimer's Disease NeuroImaging Initiative. However, there is a second public/private partnership that has been going on longer – the Osteoarthritis Initiative (OAI). Last week there was a major release of new 4 year data from nearly 4,000 osteoarthritis clinical trial participants. Furthermore this coincided with the 5th Annual Osteoarthritis Imaging Conference, which this year was held in Salzburg, under the chairmanship of Prof Felix Eckstein. As usual, this was an excellent workshop with some great dialogue on osteoarthritis imaging in clinical trials.
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The Latest Developments in Osteoarthritis Imaging

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  • 20 Sep
I will be at the 2010 World Congress on Osteoarthritis in Brussels later this week. This conference, organized by the Osteoarthritis Research Society International (OARSI), runs from September 23 to September 29 and is a great opportunity to identify some of the new osteoarthritis imaging work that is going on in the field. Osteoarthritis (OA) is a common degenerative disease of the joints that is characterized by cartilage breakdown. It affects about 10% of adults in Western countries. Interestingly last year a work force put together by the FDA to further characterize OA defined it as a disease of the whole joint and not just focused on the cartilage.
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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

What's next from Bioclinica? Hear if first during #PCTrials Europe next week in Amsterdam!
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Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme…
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Another CRO seeing big gains in the sites payments process! Access the Case Study here
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Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials.
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Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will give a…
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Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will giv…
bioclinica (Yesterday)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices