On-Demand Online Seminar:

"Ethnic Bridging in Drug Development: Science-approach and Practical Experience with Asian Study Participants"

In this complimentary on-demand online seminar Dr. Grit Andersen, Director Clinical Pharmacology of Profil, talks about the importance of bridging studies in clincial science and illustrates different obstacles you should be aware of.

Watch this educational online seminar and benefit by:

• understanding the importance of bridging studies in clinical research
• learning about differences of intrinsic and extrinsic factors between ethincities which can influence the drug metabolism
• learning about factors to consider for authorisation of bridging studies

Online Seminar synopsis

According to van Hoogdalem et al. [1] several characteristics of drugs, such as exposure or safety, are subject to potential differences between human races or ethnicities. In the last decades these differences have been evaluated in clinical trials and even mentioned specifically in drug product label texts. These factors can be of extrinsic or intrinsic nature and are often related to the incidence of a specific genotype for drug metabolizing enzymes or to other risk factors. However, no strict guidance to prescribers resulted from these insights.

In clinical bridging trials at our site in Germany Japanese as well as Chinese healthy volunteers have been included to get first data in these ethnicities. Some of these studies have been discussed with the respective authorities beforehand and received the authorisation for conduct. According to a publication from the Japanese regulatory agency, approval times could be decreased significantly using an ethno-bridging strategy.
Conducting single center bridging studies creates unique challenges such as subject recruitment and provision of adequate medical care in the required languages during the trial. Profil has proven to be one of the few CROs in Europe capabale to conduct these trials successfully.

Meet the presenter

Dr. Grit Andersen has worked as a physician in several medical fields such as surgery, general medicine and neurology in Germany and Costa Rica. She started working in clinical research in 1999 in an international Phase III study, worked for 12 years in early phase studies and joined Profil in 2013. She is a board certified medical specialist in clinical pharmacology and as Director Clinical Pharmacology she runs the specialisation program in clinical pharmacology for medical doctors at Profil. Furthermore, she is one of our experts for first-in-human trials. 

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