An Update to Real Innovation - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
An Update to Real Innovation The Innovative Medicines Initative has launched several projects to improve quality of life.

Source: Applied Clinical Trials



Peter O’Donnell
There is a risk that the currency of terms like "innovation" will be devalued by over use in Europe. Hardly a week goes by without some new claim to have harnessed innovation to Europe's economic recovery, or to solving the problems of demographic change, or to building sustainable health systems.

Amid so much hype and loose rhetoric, one organization at least has come a little closer to matching words with deeds. The grandly-titled Innovative Medicines Initiative (IMI) last month provided an overview of some of its achievements—and some of them merit recognition.

This $2.4 billion program claims to be already generating "tangible results that will improve Europeans' quality of life," notably through better and safer medical treatment. It has been linking industry, academic teams, regulators, and patients' organizations in joint research and training projects.

One of the consortia has created a tool to help understand diabetes and to test potential new drugs in laboratory conditions—an achievement recognized by the scientific community as a breakthrough in diabetes research. This IMIDIA consortium has generated cell lines that continue to live in the laboratory in test tubes and that closely resemble the beta-cells that malfunction in the human pancreas of patients with diabetes. The cell lines represent an invaluable new tool that was so far missing in diabetes research, allowing studies that otherwise would have to be done on fresh cells extracted from the human body. The current lack of understanding of the mechanisms of the failing insulin production and the death of the beta-cells in diabetes hampers the development of better treatments, and the new cell lines will be used to test potential new drugs against diabetes and to further unravel the causative mechanisms.

Unsurprisingly, given the growing incidence of diabetes, there is more than one project studying the condition and its impacts. The SUMMIT consortium is developing methods to identify patients with a high risk of developing complications of diabetes, such as stroke or problems with the heart, kidneys, and eyes—complications that account for more than 10% of healthcare costs in Europe. Following extensive literature searches to identify changes in the body that predict such complications, researchers have identified a strategy for a new computer model to assist in prediction. They have also started studies with patients aiming to identify non-invasive markers of complications in the blood vessels.

Another consortium has contributed to a better understanding of the mechanisms of chronic pain. The EUROPAIN project has revealed similarity between pain caused by chemotherapy and cold hypersensitivity. Scans have identified changes in the brain activity of patients with low back pain that can be used to predict pain intensity. Researchers have also identified several molecules in the body that could be potential new targets for the treatment of pain.

Companies have pooled data to create the largest known database of studies on schizophrenia, including information on more than 23,000 patients from 67 studies in more than 25 countries, offering industry and academics unique opportunities for the development of tools and models that will help find targeted treatments for schizophrenia. This consortium has also assembled a database with data on 2,500 patients with major depression, which they are scanning for new clues to treat the disease in patients that do not respond to existing therapies and for predicting the response in those who do. Genetic analysis of DNA-samples of these patients has already identified targets for predicting the response to treatment and the limits of current predictions.

Because more than seven million Europeans suffer from Alzheimer's disease and other forms of dementia, the PHARMA-COG consortium is developing methods to identify the most promising candidate drugs earlier in the development process. The researchers have proven that sleep deprivation induces cognitive impairment similar to that of patients with Alzheimer's disease in human volunteers, and have shown that commercially available drugs for Alzheimer's disease can reverse this cognitive impairment. This suggests that sleep deprivation could be used as a model of cognitive impairment to test the effectiveness of new candidate drugs.


ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
87%
Borrow lightly from EMA's pathway program?
6%
Create entirely its own pathway program?
8%
View Results
Untitled Document
Source: Applied Clinical Trials,
Click here