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

Introducing the new Rapidox 7100

When dealing with volatile applications such as those within chemical and combustion processes, you need a high specification instrument you can trust; the Rapidox 7100 Multigas Analyser is that instrument
More info >>

White Papers

ECCRT

ECCRT

The European Centre for Clinical Research Training (ECCRT) is a professional clinical research training provider focusing on the transfer of implementable knowledge for the day-to-day activities of our participants whether being new to the industry, starters on the job, or seasoned professionals. Our mission is to facilitate Clinical Research professionals to excel in their job for the benefit of patients. We aim to achieve this by providing clinical research professionals with competencies to develop new therapies for patients quicker & more efficiently, without jeopardizing quality and safety.
More info >>

 
Industry Events

World Vaccine Congress Europe

28-31 October 2019, Barcelona, Spain

The 20th annual World Vaccine Congress Europe is taking place 28-31 Oct in Barcelona. It’s the biggest and most established European vaccine event with over 250 speakers, 700+ senior vaccine attendees, hundreds of networking hours. It cover key topics across the complete vaccine value chain bringing together: • Government • big pharma • big biotech • SME Biotech • academia and the wider service provider community and their partners to discuss scientific, clinical and strategic advances and opportunities. The event has already confirmed over 200 speakers from Human Vaccine Project, OECD, CEPI, European Commission, FDA, WHO, OECD, NIH, GSK and many more… There is a Super Early Bird offer available – Find Out More www.terrapinn.com/WVCEU/EBR
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement