DRUG DISCOVERY & DEVELOPMENT 39
Moving forward, pharmaceutical businesses are aiming to capitalise on the potential of ethnobridging.
Knowing this vital information can add value to the compound being considered and might potentially even lead to co- development and licensing opportunities.
Others factors that will influence future successes include:
l Establishing a broad ethnic base of data and creating studies that can bridge data between
countries and regions l Performing PK, PD and other Phase I testing with multiple populations as early as possible to reduce ethnicity-based safety
risks l Working with Asian regulators to ensure study designs, protocols, analytical methods and bridging strategies meet their
individual requirements l Ensuring all participating nations and institutions conduct trials under Good Clinical
Practices regulations as defined by ICH.
The future
Te Asian pharmaceutical industry is growing and changing rapidly. As the regulatory environment also evolves, the broader industry will find itself challenged to find and employ the right resources and best practices.
While coping with this, sponsors must also consider the differences that continue to characterise the different drug approval process in each region.
Taking the right approach, it is possible for global pharmaceutical companies to gather a percentage of clinical
data from ethnic-Asians living outside of their native homelands, and, in doing so, speed up drug development.
Pharmaceutical businesses that make the most of ethnobridging practices will not only save time and money, but will also maximise the value of their products thereby gaining competitive advantage.
Parexel International provides comprehensive drug development capabilities and its regulatory expertise, Phase I-IV clinical research services, integrated eClinical technologies, and advanced commercialisation services to biopharmaceutical and medical device companies worldwide.
Stanford Jhee is vice president of Scientific Affairs, Early Phase, at Parexel International.
www.parexel.com
www.scientistlive.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92