LONDON, August 24, 2012 /PRNewswire/ --
Pharma IQ has just produced the Drug Recalls Industry Outline, where it analyses the challenges and implications of the late stage development failures. Pharma IQ had a quick look back over the last few years to see a timeline of drug failures and recalls at the late stages of development.
'Some of the key time saving strategies and information sources to make these decisions are trial design approaches, imaging techniques, biomarkers, strategic outsourcing and patient recruitment' says Nicola Ambler, Senior Conference Director, Pharma IQ, who is directing the upcoming Innovation in Phase 1 Clinical Development in Milan this September.
The outline analyses the drug withdrawals in the latter stages. In August 2012, Pfizer and J&J announced they were going to stop the development of the Alzheimer's drug, Bapineuzumab. In March 2012 AstraZeneca and Targacept announced that their partnered depression drug - TC-5214 - failed at Phase III. The last two of four late-stage studies failed to meet their primary endpoints, eliminating plans for a comeback after the first two Phase III studies also ended in failure. In March 2011 Sanofi-Aventis' lung cancer drug aflibercept failed to meet its primary endpoint in a phase III trial.
The Drug Recalls Industry Outline can be accessed at http://www.phase1clinicaldevelopment.com/news
The Industry Outline was created as a part of the pre-conference preparation for the 3th Innovation in Phase I Clinical Development Forum taking place 17-19 September, 2012 in Milan. The agenda and final speaker line-up feature JW McBlane, Pharmaceutical Assessor, MHRA that will lead the session Early Clinical Studies - A Regulator's Expectations for Complex Protocols and Complex Productsand Corina Dota, ECG Centre Director, Co-chair Cardiac QT/Arrhythmia Safety Knowledge Group from AstraZeneca presenting the case study Designing and Integrating a Robust Cardiac Safety Strategy.
Other important topics that will be discussed at the event include:
- Biomarker development and early strategies for patients selection (case study from Roche);
- Overcoming the internal and external challenges of developing the right biomarker at the right time (open discussion with Lundbeck);
- Potential impact of ICH guidelines (M3, S9 and S6) on the scientific based non clinical assessment to achieve faster regulatory decisions on anticancer Phase One Clinical Trials (Italian Health Ministry)
To access the full Overview or to find out more about Phase I Clinical Development Forum 2012 please visit http://www.phase1clinicaldevelopment.com/news, email [email protected] or call +44(0)2073689421.
Press are invited to attend this important industry forum, if you would like to a complimentary press pass please email Joanna Checinska ([email protected])
Media contact: Joanna, +44(0)20-7368-9421, [email protected] - Please contact for more information or images.
SOURCE Pharma IQ