Genentech woman at a slide

Genentech is advancing inclusive research to save lives and empower communities

01/26/2024
By Yanting “Raven” Luo and Cassandra Sedler

Clinical trials and other research studies have historically collected data that comes mostly from people of European ancestry. This has contributed to biased results and inequities in health care. To address these disparities, pharmaceutical companies have been consciously working to mirror real-world demographics. They anticipate that this inclusive approach will lead to a better understanding of disease biology and help ensure that the right medicines get to each patient.

Genentech, who pioneered the biotech industry, is at the forefront of this movement. By seeking genetic and clinical data from a broader population, including underrepresented minority groups, the company aims to develop more targeted and personalized treatments.

Katy Armstrong, Therapeutic Area Head of Oncology, Clinical Operations, Genentech Research and Early Development (gRED)
Katy Armstrong, Therapeutic Area Head of Oncology, Clinical Operations, Genentech Research and Early Development (gRED)

In 2017, Genentech launched an initiative called Advancing Inclusive Research after Quita Highsmith, Chief Diversity Officer, and Nicole Richie, Global Head of Health Equity and Population Science, recognized the crucial need to address underrepresentation in clinical research studies. According to Katy Armstrong, Therapeutic Area Head of Oncology, Clinical Operations, Genentech Research and Early Development (gRED), “At its core, this initiative is intended to deliver more equitable outcomes for each and every patient.” Armstrong and her colleagues believe that their push for inclusive research, specifically at the clinical trial level, will give those patients in need earlier access to new innovative therapies.

Genentech also founded an External Council in 2021 focused on health equity and reducing barriers to participation in clinical trials for traditionally underrepresented groups. A team of physician thoughtleaders, academic research experts, and patient advocates across the industry make up the Council, and their goal is to push for a more equitable and inclusive health-care system. Council members meet twice per year with an aim to help evaluate the company’s clinical trials. Their recommendations prompt Genentech to make ongoing changes to the trials to ensure that they remain patient-centered and inclusive of underrepresented groups.

“Our inclusive research efforts aim to remediate the underrepresentation of diverse communities in clinical research by not only taking into account the specific needs and characteristics of people of all backgrounds, but also by rebuilding trust within these communities,” Armstrong says. “To help improve the recruitment and retention of underserved populations, we have worked to design our studies to be more inclusive. Examples include simplifying and translating consent forms, expanding eligibility criteria, and ensuring our trials are located in areas with diverse populations as part of our overall health equity strategy.”

It Starts with Basic Research

Genentech encourages basic researchers to be curious about the biology of health and disease. They provide resources for their scientists to collect diverse data, taking into account biological sex, ancestry, lifestyle, and so on, and consider the complexity of each individual, rather than relying on simplistic categories. By understanding how individuals differ in their biological make-up, Genentech’s researchers can learn how those diff erences infl uence the risk of disease, its progression, and their response to a medicine.

“Patients and health care systems will increasingly expect us to know how the efficacy and safety of medicines are influenced by individual genetic and non-genetic factors, so that we can tailor the choice and dosage of medicines accordingly,” said Mark McCarthy, Principal Fellow and Executive Director of Human Genetics, Genentech Research and Early Development. “We can’t expect that the knowledge we gather in Europe and North America will apply to those living in Africa and Asia, with their own patterns of genetic variation and experiencing very different environments. We have to study people from all parts of the world to ensure that our medicines are as safe and effective in patients from Harare and Hanoi as they are in Hamburg and Houston.”

In the past, researchers working to understand the biology behind disease and health may have chosen the cell lines that they use in the lab without attention to questions of diversity. Genentech is encouraging its scientists to pay more attention to the origin of the cell lines they use, and to consider questions of diversity, by genotyping the cell lines, and making available to researchers information on their sex and ancestry. The company monitors whether or not this information will lead more researchers to include cell lines from both men and women, as well as those from people of diverse ancestries.

Mark McCarthy, Principal Fellow and Executive Director of Human Genetics, Genentech Research and Early Development
Mark McCarthy, Principal Fellow and Executive Director of Human Genetics, Genentech Research and Early Development

When collecting data from humans outside the lab, Genentech integrates a variety of resources. The company draws insights from UK Biobank (500,000 participants from the U.K.) and FinnGen a similar number of Finnish people for example, but again these powerful resources are dominated by individuals of European descent. To build more diverse cohorts, Genentech is working with colleagues in pharma, and with African scientists to establish a consortium to sequence the genomes of 50,000 people across the African continent.

Clinical Research Collaboration

It takes a village to turn the discoveries gleaned from basic research into medicines that benefi t the public. Genentech espouses the importance of both collaboration and feedback to drive their clinical research, fully harnessing the power of communities.

The company has forged novel partnerships to expand the recruitment and retention of patients for clinical trials. For example, Genentech’s Advancing Inclusive Research (AIR) Site Alliance has built trust in underrepresented populations around several medical centers across the United States since 2021. This initiative combines financial support with education to reach out to patients. Along with other sponsors, they also support the Yale Cancer Consortium to Advance Equity in Early-Phase Clinical Trials, a project led by Dr. Patricia LoRusso to afford underserved patients greater access to new therapeutics through community locations close to where they live and work.

Beyond the United States, Genentech operates “without borders,” no longer placing artificial limits on which sites or countries are appropriate for early drug development, and real-world data is used to inform where they must conduct their trials. As a result, they have followed populations impacted by specific diseases, for example to Kenya and Brazil even though they would not have typically chosen these countries as early-phase research research sites in the past.

The pharmaceutical company’s leaders assert that they value every bit of data that their researchers generate in the clinical setting. They use feedback to fuel what they consider to be a virtuous cycle of research, one that starts with inclusive studies in early clinical development. In the typical clinical trial pipeline for pharmaceutical companies, Phase I focuses on safety and dosage and has a smaller number of participants, while Phase II typically focuses on a drug’s effectiveness in a study of hundreds or thousands patients. In a departure from popular belief—which assumes that inclusiveness is only beneficial from Phase II onward—the company pays attention to preliminary signals of safety, efficacy, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body), in Phase I, even when the number of participants is low.

Genentech scientistsIn addition to genetic analyses, patient insights are fed back into the research. Genentech’s global patientnetwork team embeds perspectives from patients, caregivers, advocacy groups and experts throughout the research and development lifecycle to address the needs of all patients. This feedback loop provides key insights.

From Bench to Bedside

At Genentech, company leaders have an intense focus on meeting the healthcare needs of everyone in the disease areas they treat. “We believe that advancing inclusive research is a moral, social, and business imperative,” says Armstrong. “To have the greatest impact, medical advances must reach everyone. We believe taking a bench to bedside approach leads to better medicines, more rigorous science, and improved health outcomes for all patients. Clinical trials specifi cally have the ability to give earlier access to potentially transformative medicines to those in need.”

Science can never be perfectly objective. Nonetheless, Genentech is working to increase trust within the communities that they serve and to gather clinical and genetic data that is more representative of patients across all demographics. The company hopes to serve as a model for advancing more equitable and individualized health care worldwide. communities that they serve and to gather clinical and genetic data that is more representative of patients across all demographics. The company hopes to serve as a model for advancing more equitable and individualized health care worldwide.

As Armstrong points out, “All these eff orts are the initial steps to fully realize the promise of personalized health care and to provide increased patient benefi ts at less cost to society.”

Yanting “Raven” Luo, PhD Student, Duke UniversityYanting “Raven” Luo is a PhD student in the University Program in Genetics and Genomics at Duke University. She does research in evolutionary genomics and is passionate about science communication.

 

 

Cassandra Sedler, PhD Student, Temple UniversityCassandra Sedler is a PhD student in Chemistry at Temple University. She does research in organic synthesis methodology development. She enjoys reading and writing in her free time and is passionate about outreach to inspire the next generation of scientists.

 

The authors would like to thank Genentech’s Katy Armstrong, Therapeutic Area Head of Oncology, Clinical Operations, and leader of the Genentech Research and Early Development’s (gRED) Inclusive Research and Health Equity Pillar; Dr. Mark McCarthy, Principal Fellow and Executive Director of Human Genetics; Andrew Gordon, Senior Manager of Science Communications; and Dr. Karen Ring, Senior Manager of Science Communications for their contributions to this article.

This article was originally published in AWIS Magazine. Join AWIS to access the full issue of AWIS Magazine and more member benefits.