spacer
home > ict > autumn 2020 > a smart approach to ai
PUBLICATIONS
International Clinical Trials

A Smart Approach to AI

Medical imaging, due to its ability to decrease drug development costs and accelerate regulatory approvals, is playing an increasingly influential role in the development of life science products. The FDA has, in part, spurred this trend through positions outlined in the 1997 Food and Drug Administration Modernization Act, the 2004 Critical Path Initiative, and the 2011 draft guidance: Clinical Trial Imaging Endpoint Process Standards (1-3).

The expanding use of medical imaging in clinical trials has also been propelled by the numerous benefits it offers the drug development process, including:

  • A non-invasive means to analyse tissues that are difficult to biopsy, such as brain lesion counts in MS patients
  • Enabling clinical researchers to better understand the safety, efficacy, and mechanism of action of therapeutics in early phase clinical trials, leading to earlier identification of responders vs non-responders (precision medicine), and the ability to better screen/stratify patients in subsequent trials
  • Increasingly being used as surrogate endpoints (e.g., hippocampus/ entorhinal-cortex volumes and structural connectivity in Alzheimer’s disease), therefore, leading to reduced trial length and smaller study populations (4)

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Vesna Prchkovska PhD is the Co-Founder and Chief Operating Officer (COO) of QMENTA. Vesna graduated summa cum laude in electrical engineering at Saints Cyril and Methodius University, Macedonia. After obtaining her PhD in neuroimaging, she was awarded the prestigious Marie Curie postdoctoral fellowship at Harvard Medical School, US. As part of this grant, Vesna also joined the department of radiology at Massachusetts General Hospital, US. In her role as COO, Vesna leads the implementation of the company’s strategy and the R&D programme. Vesna brings a wealth of knowledge on neurodegenerative diseases, medical image processing, and computer vision to the company, its partners, and clients.

Paulo Rodrigues, PhD, graduated summa cum laude from the Software Engineering Department at the University of Minho, Portugal, and obtained his PhD in Neuroimaging from the Eindhoven University of Technology, Netherlands. Paulo is now a Co-Founder and Chief Technology Officer at QMENTA, where he uses his expertise in medical image processing, cloud computing, and artificial intelligence to lead technological and scientific innovations for the company. Paulo has published numerous scientific papers and patents, and has presented in a variety of industry and entrepreneurial events including TEDx 2016 and ‘Pharma & Health Shapers Debate’ of the Digital Enterprise Show 2018. In 2013, he was elected as Innovators Under 35 by the MIT Technology Review.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Charles River Laboratories Acquires Distributed Bio

– Establishes a Premier, Integrated, Large Molecule Discovery Platform – – Advances Exclusive Partnership Initiated in 2018 –
More info >>

White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement