spacer
home > ebr > summer 2017 > teething problems
PUBLICATIONS
European Biopharmaceutical Review

Teething Problems

One of the most significant developments in the progress of new therapies is when the asset comes out of the laboratory and into the clinic. While the final goal – to market a new therapy with proven effect – is someway off from this event, progression or lack thereof has many more consequences than are seen prior to this milestone, including a significant increase in costs, which is coupled with amplified potential for attracting investment. The visibility of the asset is heightened, as are the risks. The scientific endeavour becomes more complex both operationally and technically.

This requires that the assessment, management and mitigation of the risks is more critical than previously, partly due to the developing trend in the type of organisations embarking on clinical trials with new potential therapies. More and more biotechnology companies, some of which are almost virtual in size, are involved in drug discovery and development. A common trend is that it is only the Phase 1 and possibly 2a studies being completed by the biotech firms alone. The expectation is that these assets are then subsequently co-developed or sold on to the large pharma organisations to take through full development and to market.

The attrition rate in clinical development is that less than 10% of compounds entering trials achieve approval. Overall, the attrition rate also appears to be increasing at each key stage, but the biggest impacts remain in late stage failure. Thus, the ‘biotech model’ is changing, sometimes quite subtly, regarding how this early phase development is run, resourced and funded.

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
Richard Hucker is Director for Regulatory Bioanalysis for A4P Consulting and was one of the four co-founders of the company in 2011. Originally trained as a biochemist, he began his career in bioanalysis over 30 years ago and has worked in organisations in both the public and private sectors. Richard has published and presented on numerous bioanalytical topics and is currently interested in the interface between regulatory demands and the practice of bioanalysis.

Ian James is the Director, Chief Executive Officer and co-founder of A4P Consulting and holds a PhD on the study of novel bone biomarkers. Originally a Pharmacodynamic Assay Advisor at Pfizer, Ian moved into the support of global companion diagnostics working in HIV tropism diagnostic development for Maraviroc and supporting additional HIV/hepatitis C virus, oncology and various near patient platform developments.

Scott Vincent is Logistics Director and co-founder of A4P Consulting. He graduated in management science from the University of Manchester Institute of Science and Technology, UK, and is a member of the Chartered Institute of Logistics and Transport. Scott is an industry acknowledged expert in providing inventive logistical solutions for time and condition critical shipments, bespoke packaging solutions and best value approaches for provider management and selection.

Carl Watson is a Director and co-founder of A4P Consulting. He has held various roles in the field of biomarker analysis in CROs and is a subject matter expert in various bioanalytical technologies, including flow cytometry and ligand binding analysis.
spacer
Richard Hucker
spacer
spacer
spacer
Ian James
spacer
spacer
spacer
Scott Vincent
spacer
spacer
spacer
Carl Watson
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Top Research University Enjoys Easy-to-Use Software to Support Enterprise-wide Temperature Monitoring, Alarming and Reporting


More info >>

White Papers

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

United BioSource Corporation (UBC)

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
More info >>

 
Industry Events

6th Annual Cancer Vaccines Conference

27-28 September 2017, Copthorne Tara Hotel, London UK

Cancer Vaccines 2017: Overcoming hurdles to cancer immune response: Cell therapies, vaccine development and combination therapies. SMi Group is thrilled to present the 6th annual Cancer Vaccines conference, taking place on 27th & 28th September 2017 in Central London, UK. Overcoming hurdles to cancer immune response: Cell therapies, vaccine development and combination therapies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement