|
|
|
European Biopharmaceutical Review
|
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 |
| | | | | |
|
|
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.
|
|
|
Judi Wardwell |
|
|
|
|
Judi Wardwell |
|
|
|
|
|
|
|
 |
News and Press Releases |
 |
Injection vials for vaccines for protection against Covid-19
Düsseldorf, July 02, 2020 The vaccines under development to protect
against Covid-19 are, like many other drugs, filled in so-called
injection or vials made of type 1 borosilicate glass, also known as
vials. The large worldwide demand for vials is met by the Gerresheimer
Group's plants in Europe, America and Asia, where they are manufactured
to high quality standards for customers in the pharmaceutical industry.
The Company has already received initial orders for vials for drugs and
vaccines against Covid-19.
More info >> |
|
 |
White Papers |
 |
|
Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
DrugDev
With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
More info >> |
|
 |
Industry Events |
 |
CPhI Festival of Pharma
5-16 October 2020, Virtual
A virtual gathering for the pharmaceutical industry, the CPhI
Festival of Pharma has been created to fill the gap left by in-person events at
a time when travel and gatherings are off the cards.
More info >> |
|
|
.jpg)
