samedan logo
 
 
 
spacer
home > ebr > summer 2021 > human fresh tissues vs clinical attrition
PUBLICATIONS
European Biopharmaceutical Review

Human Fresh Tissues vs Clinical Attrition

Despite the ever-increasing number of technologies available to drug developers, attrition rates remain stubbornly high. For novel compounds entering Phase II trials, the rate of success has historically remained around 10-15% (1). Even once Phase III is reached, the current rate of success is only around 55% (2). In addition, the bar for drug approval and commercial success has never been higher. Blockbuster drugs have achieved their success by addressing a large unmet medical need and by outperforming standard of care treatments. As these treatments improve, the quest to develop the next blockbuster becomes more difficult, the number of unmet medical needs becomes less, and the target patient populations becomes smaller.

The advent of precision medicine has provided an opportunity for drug developers to better target these non-responding patient groups (3). The challenge now is to streamline the drug development process to account for these more abundant, but smaller, target patient populations. Clinical phases of development are by far the highest contributors to the overall cost of drug development, therefore, improving translation to the clinic and understanding the target patient populations at the preclinical stage is critical (4). In practice, 100% translation to the clinic is clearly not realistic, but there is, as evidenced above, plenty of room for improvement.

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
Graeme Macluskie is Director of Precision Medicine at REPROCELL. Since 2011, he has been designing and delivering preclinical projects globally. With more than 15 years’ research experience in the pharma and biotech industry, he leads a team responsible for developing tissue-based assays for inflammatory disease such as psoriasis, COPD, and IBD.

Zara Puckrin is Marketing Manager for REPROCELL. Since joining the company in 2017, she has been helping scientists understand the benefits of incorporating human data in their research. A molecular biologist by training, Zara’s mission is to make the world a better place through translational science and pharmacology.
spacer
Graeme Macluskie
spacer
spacer
spacer
Zara Puckrin
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Premier Research Deepens Support for Oncology Sponsors By Expanding Oncology Leadership Team

As the number of next-generation oncology therapies in the clinical trial pipeline surges, Premier Research today announced three new oncology leadership team hires to strengthen the company’s expertise in the fast-growing areas of cell and gene therapies and immuno-oncology.
More info >>

White Papers

Bio/Pharmaceutical Methods: Do your Analytical Methods Hold Up to Regulatory Scrutiny?

Eurofins BioPharma Product Testing

As FDA guidelines evolve and drug products on the market begin to age, bio/pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are even facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe. This exercise requires significant amounts of time and resources, which many manufacturers do not have since they are focused on getting their next products to market. For that reason, some clients have been turning to Eurofins Lancaster Laboratories for support.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement