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Imaging biomarkers, molecular imaging in oncology clinical trials

Leveraging Imaging Biomarkers to Improve Drug Development

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  • 02 Jun

Molecular Imaging – Valuable Drug Development Tools

Clinicians need ways to better predict patient responses

The estimated cost for developing a drug is approaching upwards of $5 Billion dollars with a process spanning well over a decade. Coupled with high failure rates in late phase clinical trials and increased complexities in acquiring and analyzing clinical trial data, traditional approaches based on the premise of "one size fits all" are becoming less cost effective and suboptimal.

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Strong Clinical Operations for Enhancing Oncology Trials: Benefits of an Imaging Core Lab

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  • 28 Aug

The landscape of oncology drug development continues to evolve with shortened clinical trials, expedited drug development processes and the use of combined clinical and medical imaging data for patient management.  Advances in imaging and other technologies enable real time assessment of clinical data, providing sponsors with a tool for making rapid go/no go decisions regarding their compounds. Implementing and optimizing these advances can be challenging.

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Applying Tumor Response Criteria for Skin Cancer Trials

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  • 18 Apr

Skin cancer is the most common cancer type, affecting more than 2 million people annually in the US alone. Given the rising incidence of skin cancer, mostly attributable to UV exposure, there are a large number of clinical trials in this area designed to test the efficacy of new drugs emerging from pharmaceutical pipelines.

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Evolving Response Criteria for Tumor Evaluation in Oncology Clinical Trials

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  • 03 Mar

Rapid advances in imaging and cancer biomarkers are helping to shift treatments from cytotoxic to molecularly targeted therapies, necessitating modifications to conventional anatomical response criteria. Newer response criteria take into account parameters such as tumor metabolism, proliferation, lipid turnover, hypoxia and other characteristics of specific cancer types, providing clinicians with enhanced tools for the proper categorization of tumor responses.

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Watson computer

Big Data Analytics for Improved Cancer Treatments

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  • 15 Jan

The White House recently hosted a "Big Data" event to recognize new partnerships aimed at advancing our understanding and develop tools for big data analytics. One of these partnerships, between the Center for Dynamic Data Analytics (CDDA) and BioClinica is developing scalable algorithms for automated measurements of imaging data from clinical trials.

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QCT endpoints in diabetes

Monitoring Skeletal Integrity for Safer Diabetes Therapies

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  • 24 Oct

Last week, I attended the Phacilitate Leaders conference in Boston, which brought together scientific leaders, innovators, executives and regulators in the fields of Oncology, Inflammation and Autoimmunity, and Metabolic Disease. During the Metabolic Disease forum, I gave a talk focused on clinical safety endpoints for assessing skeletal integrity for novel anti-diabetes therapies.

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BioClinica Oncology Symposium 2013

BioClinica Oncology Symposium - May 14th 2013

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  • 10 May

On Tuesday May 14th, BioClinica will be hosting an all-day complimentary oncology symposium as part of their annual User Conference. The symposium will take place at the Hyatt Regency at Penn’s Landing in Philadelphia and will feature presentations from Key Opinion Leaders on the subjects of medical imaging and cardiac safety in cancer drug development. I am pleased to have the opportunity to co-chair this symposium with my new colleague, Dr.

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Moby Dick

3 Principles of Tumor Behavior and Biology

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  • 04 Oct
So just how did James Bond, Moby Dick and the London Natural History Museum teach me about oncology in clinical trials and tumor behavior? Here’s my story. As a child I loved wandering through the London Natural History Museum (NHM). It was fascinating to experience the natural world through its exhibits which was made all the more exciting, knowing these corridors had housed the research and development department of covert operations of the SOE (Special Operations Executive) during the Second World War. Legend has it that the real life director of the department was the inspiration for the character “Q” in Ian Fleming’s James Bond series.
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Innovations in Medical Imaging Software offer New Trial Capabilities

Innovations in Medical Imaging Software offer New Trial Capabilities

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  • 02 Aug
One of the driving forces in medical imaging is the innovation that is taking place in medical imaging software. I previously wrote about this from the 2010 Radiological Society of North America (RSNA) meeting.
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Clinical Data Collection in Oncology Studies - Most Common Challenges

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  • 08 Sep
Creating a clinical data collection strategy for oncology studies within tight timelines can be extremely challenging. Clinical data managers often face particular issues with interpreting the complexities of the study and implementing the data flow as represented in the protocol.
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Imaging Biomarkers in Oncology Clinical Trials

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  • 15 Jul

Following on in my series of blog posts about imaging biomarkers and the recent BioClinica symposium, I wanted to share some insights provided by Ali Guermazi, MD (a consultant to BioClinica, who was also a co-author on the Cheson Criteria) from Boston University School of Medicine who spoke on “Imaging Biomarkers in Oncology from RECIST to beyond.”

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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