Life is a Journey..how to make the best of it!

BayBiotech.NET International efforts to complete the human genome project and HapMap (Haplotype mapping of human genome) projects channelized the development of Division of Personalized Nutrition and Medicine (DPNM). Data generated from these projects made us to think in the direction of personalized medicine emphasizing that even though humans are genetically similar, each retains a unique genetic constitution that contributes to the wide array of biochemical, physiological, and morphological phenotypes in human populations. The unique identity is mostly shaped by nutrients and environment in which an individual lives. DPNM is geared to develop and implement research strategies that account for genetic, environmental, and cultural diversity that influence expression of genetic makeup and produce knowledge for improving personal and public health. Within DPNM, there are two active divisions—Biometry and Biology. While, Biometry branch works to develop biometrical methods for all asp

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M