Quotient Prepares for the Japenese Market
News Mar 16, 2016
The Japanese market is one of the leading pharmaceutical markets worldwide, and bridging studies conducted outside of Japan ensure that drugs that are to be marketed in Japan have been thoroughly evaluated in the Japanese population.
This program of work was a first-in-human investigation, performed on behalf of a US sponsor, and comprised an integrated four part clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug candidate targeting an important orphan disease.
The program was delivered using Quotient’s Translational Pharmaceutics® platform, which integrates formulation development, real-time GMP manufacturing and clinical testing, allowing the drug product to be adapted in real-time, based on emerging clinical data. The inclusion of first generation Japanese volunteers into one part of the study accelerated the transition into downstream clinical trials in Japan.
Ian Nisbet, VP Clinical Operations, said “We are delighted to extend our core Translational Pharmaceutics services to now include Japanese volunteers. Recruitment was undertaken in partnership with UK Chiken Services Ltd, an experienced company which specialises in Japanese volunteer recruitment. All cohorts were dosed on time and in full.”
PhoreMost and Plexxikon Collaborate to Identify Novel Drug TargetsNews
PhoreMost, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, today announced it has signed a collaborative agreement with Plexxikon Inc., the small molecule structure-guided R&D centre of Daiichi Sankyo.READ MORE
Anti-Malaria Drugs Delivered With CaffeineNews
Many drug delivery systems, such as capsules and tablets, can be difficult to swallow, especially for children. Making delivery systems out of polymer gels is an attractive option, but usually requires hazardous levels of heavy metals to be used. Now, scientists have found a way to build these gels from caffeine molecules.READ MORE
Lonza Opens World’s Largest Dedicated Cell-and-Gene-Therapy Manufacturing Facility in TexasNews
First-of-its-kind, state-of-the-art manufacturing facility with capacity to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases.READ MORE
Comments | 0 ADD COMMENT
2nd International Conference and Exhibition on Nanomedicine and Drug Delivery
May 21 - May 23, 2018
World Congress on Advanced Biomaterials and Tissue Engineering
Jun 20 - Jun 21, 2018