PAREXEL MassBio Lunch & Learn
May 22, 2018
Optimizing Clinical Drug Development Through Pharmacogenomics (PGx), PK Modeling and Ethnobridging Studies
For more than two decades in clinical drug development, many regulatory guidelines have been published regarding PGx, PK modeling and Ethnopharmacology. “Clinical PGx: Premarket Evaluation in Early-Phase Clinical Studies” (2013, FDA), “Population PK(1999, FDA)” and “Ethnic Factors in the Acceptability of Foreign Clinical Data”(1998, EMA) to name a few.
This session will explore how drug developers are using genomic information, PK Modeling techniques and Ethnobridiging ( with emphasis on Japan) to reduce the unnecessary burden of conducting inefficient and not-so-well designed clinical studies in all phases/aspects of clinical drug development. Each speaker has more than a decade of experience in initiating/applying/conducting Pharmacogenomics (PGx), PK Modeling and Ethnobridging studies and will share their experience with case studies.
Topics for discussion include:
· Applying pharmacogenetics in global drug development
· Application of PK/PD modeling and simulation in clinical drug development
· Ethnobridging for accelerated global drug development
Anita Nelsen, Sr. Director and Head, Genomic Medicine, PAREXEL International
Stan Jhee, Corporate Vice President, Scientific Affairs, PAREXEL International
Joseph Kim, Sr. Director, Quantitative Clinical Development, PAREXEL International