Industry News

SOSV Announces Launch of IndieBio New York

01/08/2020

A fantastic opportunity for life science startups in the New York area! “We’re doubling down on life sciences,” said Sean O’Sullivan, Managing General Partner of SOSV. “We are looking to bring what IndieBio has created for the California life science industry to the East Coast. New York is a great hub for life sciences research and financing, and will be…

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Google Shows AI Can Spot Breast Cancer Better Than Doctors

01/06/2020

According to new research from Google Health, AI can more accurately detect breast cancer than physicians. “The technology’s reading of mammograms reduced both false positives, where healthy patients are mistakenly diagnosed with the disease, and false negatives, where the cancer is missed, the Alphabet Inc. unit said in a blog post on Wednesday. The system reduced false positives by…

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New radiotracer offers opportunities for earlier intervention after heart attack

01/06/2020

“ Reston, VA–Insights into how the heart recovers after myocardial infarction (heart attack) can be obtained with a new radiotracer that targets fibroblast activity prior to it causing permanent damage. According to research published in the December issue of The Journal of Nuclear Medicine, 68Ga-FAPI-04 positron emission tomography (PET) can effectively image fibroblast activation after myocardial…

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Good Example of Integrating Wearable Devices (cameras) with Machine Learning Into Patient Care – The Potential For Use In Clinical Trials

08/31/2019

In a News Release on Eureka Alert, comes a fascinating example of how cameras were used in patient care combined with machine learning to better identify and improve lifestyle strategies for heart failure patients. The article titled “Tiny wearable cameras may improve quality of life in heart failure patients” and is an outstanding example of…

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Meet with Christopher Kata in Tampa, Florida August 19th – 21st.

08/18/2019

Meet with Christopher Kata, Director of Sales & Marketing on August 19th – 21st, 2019 in Tampa, Florida! Christopher Kata, Director of Sales & Marketing905 [email protected] When: August 19th to 21st 2019Where: Tampa, Florida Christopher Kata is in Tampa for meetings all three days and has some availability for additional meetings. If you’re interested in…

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What Is Taking So Long For Meaningful Interoperability In Clinical Research?

08/16/2019

From Clinical Leader comes a very timely article on the state of interoperability within clinical research Clinical Trials today can benefit tremendously as a result of the value produced from integration with EMR systems, leveraging Real World Data and Real World Evidence, and the adoption of eSource! “Three decades ago when I entered the profession…

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WideTrial Partners With Oncotelic to Bring Expanded Access Platform to Cancer

06/14/2019

WideTrial , one of TrialStat’s strategic partners has partnered with Oncotelic to bring the Expanded Access Platform to Cancer. June 03, 2019 (ACCESSWIRE via COMTEX) — SAN FRANCISCO, CA / ACCESSWIRE / June 3, 2019 / WideTrial Inc., a third-party sponsor of Expanded Access programs, has begun a partnership with Oncotelic Inc., a wholly owned subsidiary…

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FDA to Launch Expanded Access Pilot ‘Project Facilitate’

06/02/2019

The goal of Project Facilitate is to make it easier for oncologists or healthcare providers without the regulatory experience or resources to navigate the single patient IND process. “Access to clinical trials and access to novel therapeutics for patients is still a problem. We know that not all oncologists or healthcare providers have the regulatory…

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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

05/26/2019

In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations. A few interesting statements worth highlighting in the statement: “Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more…

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The Proposed New FDA Rule Brings Changes To Informed Consent for Clinical Studies

11/23/2018

The Diagnostic and Interventional Cardiology website posted an important article about recent proposed changes by the FDA which may allow Institutional Review Boards (IRB) to waive or alter informed consent requirements for clinical studies that pose minimal risk to human participants. The conditions under which an IRB could do this are limited and detailed in the…

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