External Partnering, Chief Diversity Office Genentech, Inc. South San Francisco, California
There are well characterized disparities in clinical research. Disease pattern, clinical presentation, and therapeutic response can vary dramatically by race/ethnicity
and ancestral background. Racial/Ethnic differences in drug response has been demonstrated across disease areas and can be attributed to CYP enzyme polymorphisms and HLA variations. ~ 20% (35/167) of NME’s approved between 2008-2013 reported racial/ethnic differences in PK, safety, efficacy in the label
16% NMEs required PMC due to this.
The healthcare industry has the opportunity to shine a spotlight on disparities and address barriers to clinical access, particularly for underrepresented racial and ethnic minorities. Roche/Genentech believes that data representative of real world patient populations is required to improve clinical outcomes for patients. Advancing Inclusive Research is a corporate initiative at Genentech/Roche focused on broadening inclusion of historically underrepresented groups in clinical research and ensuring personalized healthcare tools are designed for all patients.
Advancing Inclusive Research Priorities:
Clinical Development Strategies
• Deliver a framework to clinical development teams to mitigate barriers, enable teams and support teams
• Produce scientific insights and advance thought leadership through medical congress publication on analysis of outcomes in specific disease areas
• Build Genentech clinical trial policy and coverage options
• Educate diverse communities about clinical research (so they’re not left behind)
• Leverage coalitions to increase awareness of genomics and personalized healthcare for all
By partnering with stakeholders, we can combine scientific advances, new technologies and real-world data to drive scientific innovation and create new standards for inclusive clinical research.
❑Recognize the importance of representative data in clinical research databases
❑Identify approaches to ensure all eligible patients have access to clinical research and the benefits of personalized healthcare
Understand strategies to better understand the impact of ethnicity on PK/PD, safety and efficacy during drug development