spacer
home > ebr > summer 2019 > the next frontier
PUBLICATIONS
European Biopharmaceutical Review

The Next Frontier

Drug development is an arduous process punctuated by go/no-go decisions related to the efficacy and safety of drug candidates. When a new preclinical drug candidate with a reasonable profile of efficacy and safety is identified, it is still uncertain whether this new therapeutic agent will ultimately make its way to the patient and advance human health. In fact, ~90% of all compounds entering clinical trials fail, largely due to safety issues in clinical phases or drug efficacy issues in patients (1).

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.

spacer
Judi Wardwell is a Senior Application Scientist at InSphero, with more than 25 years of experience working in the pharma industry. Prior to joining InSphero, she was the Manager of a functional genomic group at Bristol-Myers Squibb, where she developed physiologically relevant cell models and conducted phenotypic screens to identify new drug targets in developing integrated approaches to target identification. Judi has also held scientific research positions at Wyeth and Hoffmann-La Roche.

Dr Radina Kostadinova is Lead Product Manager for InSphero 3D InSight™ Liver Toxicology and Disease Platforms. She has more than 17 years of research experience in industry and academic settings, working in the fields of molecular and cellular biology and preclinical mechanistic toxicology. At InSphero, her focus is to develop and establish liver tissue models for detection of drug toxicity, as well as 3D liver disease models for the study of fibrosis, inflammation, diabetes, and obesity.

Professor Armin Wolf is Chief Scientific Officer at InSphero and Professor of Toxicology at the Technical University of Kaiserslautern, Germany. An accomplished pharma R&D executive and board-certified toxicologist with more than 30 years’ cumulative experience at Janssen and Novartis, Armin offers a first-hand perspective on the challenges facing the pharma industry and the need for more physiologically relevant human models to improve efficiency in drug discovery and safety testing.
spacer
Judi Wardwell
spacer
spacer
spacer
Judi Wardwell
spacer
spacer
spacer
Professor Armin Wolf
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Pistoia Alliance Publishes Free Guide to Accelerate the Implementation of FAIR Principles in Clinical Data

Boston, 25 January 2023, The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D today launched its freely accessible FAIR4Clin guide. The guide will help clinical regulators, biopharmaceutical and healthcare organizations to implement the FAIR principles (Findable, Accessible, Interoperable, Reusable) in clinical datasets. The diversity of data types, standards, and regulatory and privacy requirements, combined with the huge volume of clinical datasets, has presented a particular problem in life sciences R&D. The guide emphasizes the value of FAIR to the clinical space, including making data machine-readable to support AI, innovating in clinical trial design, and enabling the transfer of data between sponsors, CROs, and regulatory agencies. FAIR4Clin was co-authored by the Pistoia Alliance and leading experts in the field, including from AstraZeneca, Bayer, Roche, Genentech, Galapagos, The Hyve, Elixir, The University of Manchester and Oxford University.
More info >>

White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement