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Thursday, January 11, 2018 5:04:28 PM
A strategic reason to structure the phase III Sunrise in order to place the 1st interim look-in where the long tail separation in curve would not be separated enough as of yet, especially since new FDA SOC was recently approved and the non Bavi patients that were in the control arm .....became skewed, abnormally peeking to unseen levels before in the history of Docetaxel arms....
The thing is both Woodcock and Gottlieb made public statements in how the system is broken and this would be one way how the FDA system is broken.
Did then CEO Steve King realize this ? Well he specifically states the drug Bavituximab in Sunrise performed as expected and IF any other Docetaxel arm was used....such as on the FDA approval of Opdivo, Sunrise would have been approved
One must gather all the facts, being aware that Dr Wolchok, Dr Birge, Dr Lyerly....and many others have been validating PS Targeting.
Within my last 10 posts or so, it is explained how Novartis, Dana Farber and others have PS Targeting related patents recently filed ...also shows the research of increasing responders as TOXICITIES are limited like never before seen.
It is a fact that Peregrine was collaborating with Epiontis and Precision For Medicine ....so ask yourself what is strategically being planned? Likely since March 2014 when there were the trading day indications
Precision for Medicine Expands Services in Europe, Announces Next Generation Biomarker Data Management and Translational Informatics Platform
ADDITION OF GENEVA-BASED TEAM COMPLEMENTS U.S. EXPERTS;
QuartzBio? RELEASE ACCELERATES BIOMARKER DATA MANAGEMENT
AND TRANSLATIONAL INFORMATICS CAPABILITIES
Bethesda, MD and Geneva, Switzerland – January 9, 2018 – Precision for Medicine, part of Precision Medicine Group, today announced it is expanding its biomarker data management and translational informatics services into Europe. The addition of a Geneva, Switzerland–based team of experts complements Precision’s US offerings to provide clients with truly global translational research services. The Geneva team also gives Precision another European operational base, continuing Precision’s active international expansion.
At the forefront of precision medicine, biomarker research has become critical to the development of innovative treatments, including predicting relevant clinical outcomes across a variety of treatments and populations. However, researchers continue to struggle to organize and interrogate these highly dense and expansive data sets.
Precision’s new Geneva team is a unique and diverse group of experienced data scientists, computational biologists, computational immunologists, and translational informaticians. These computational and data science experts join Precision’s existing translational informatics team to provide unrivaled biomarker data management and translational informatics services to facilitate translational research for innovative pharma and biotech clients, both in Europe and the United States. Dr. Jerome Wojcik was named Senior Vice President, Translational Informatics and Biometrics, Europe, and will lead the new team in Switzerland.
The Geneva office, along with established offices in Berlin, Paris, and Edinburgh, strategically expands Precision’s growing European footprint and further positions the company as a scientific frontrunner in the rapidly expanding precision medicine space.
Precision is also pleased to announce the release of QuartzBioSM, the next generation of its proprietary technology platform designed to accelerate translational research. Initially launched in 2014, this latest iteration represents a significant advancement in the support of biomarker data management and translational informatics and actively supports a diverse client base of biopharmaceutical customers.
QuartzBioSM assimilates all biomarker data with extreme speed including high-content to high-throughput data, such as immunosequencing, flow cytometry, and profiling of the transcriptome, and is capable of harmonizing more than 10 million data points. The first-in-class interactive platform is 21 CFR Part 11 and CDISC compliant to enable support of regulatory submissions and offers advanced visualization and reporting capabilities, ultimately saving clients valuable time and effort. For more in-depth information on QuartzBioSM, visit www.quartz.bio
Commenting on Precision’s expanded European capabilities and release of QuartzBioSM, Chad Clark, president of Precision for Medicine, said: “We are very excited to be expanding our translational research offering into Europe with the addition of our Geneva office. The unique diversity and scientific expertise of the team is tremendously valuable for our clients. Our global teams together with our technology platform, QuartzBioSM, create a distinctly comprehensive, industry-leading biomarker data management and translational informatics offering for international pharmaceutical innovators who are grappling every day with how best to harmonize and assess highly complex biomarker information.”
...
https://www.precisionmedicinegrp.com/article/precision-medicine-expands-services-europe-announces-next-generation-biomarker-data-management-translational-informatics-platform/
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