Tech-clusion, Gilead, AstraZeneca + Merck + Myriad, DNAnexus

Technology for inclusion, layoffs, oncology approvals, and $200M for a tech platform.

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Story References
Gilead
AstraZeneca + Merck + Myriad
DNAnexus


About the Show
Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.

Transcript

Introduction

Welcome to Life Science Today, your source for stories, insights, and trends across the life science industry. I’m your host, Dr. Noah Goodson. This week, technology for inclusion, layoffs, oncology approvals, and $200M for a tech platform.

Disclaimer

The views expressed on Life Science Today are those of the host and guests. They do not necessarily reflect the opinions of any organizations with which they are affiliated. 

Getting Past 4% - What Tech Does and what Tech Doesn’t

In the United States, clinical trial enrollment remains perennially low in certain populations. Challenges in recruiting participants exist for many reasons, including access to information and proximity to major research centers. These forces tend to impact the rural, poor, and historically marginalized communities in a disproportionate fashion. Many estimates suggest that only 4-5% of all trial participants in US studies are Black, compared to 13.4% of the US population. While these are not the same across all indications, many of the studies that are very successful in recruiting Black participants are for specific indications like sickle cell disease, or other areas of research like psychiatry. So how do we increase enrollment of these, and other historically marginalized communities? 

Some  organizations claim that moving to digital solutions can make a major impact. And emerging data from various studies shows that adding a more digitally connected clinical trial designs can have a meaningful impact on who enrolls in a study. For example, researchers from Duke University completed a study with almost 8000 participants. In one group they utilized video during the informed consenting process, while the other group had only traditional paper consenting. The results showed a statistically significant increase in rural, non-white, and elderly participants when video consent was used. Additionally, there was  a 39-day shortening of first patient enrollment. Past consenting, evidence suggests that replacing some study visits with telehealth and completing assessments on smartphones are just a few practical innovations that decrease barriers to research.

All of this can lead companies to make claims that seem to suggest technology is going to solve inclusiveness issues. However, I think it’s important to acknowledge that many of the resistors to clinical trial enrollment, particularly among historically marginalized communities in the United States are deeply rooted in long-standing inequities. Just last week, data again surfaced of a major pharmaceutical company funding studies in which Black participants who were prisoners were injected with the known carcinogen Asbestos for $10 and this was in 1971. The company in question did follow all standards at the time for consenting. But I doubt any of us would argue that makes this study ethical.  

My point is that low enrollment from a population may often have complex reasons beyond even the current delivery of healthcare. Indeed, there are tons of papers on how social structures impact clinical care and interested in research. Technology that makes consenting, clinical trials activities, and engagement better can take us a long way. So can listening to participants and actually implementing their feedback into study design. But even after we do all that, participation in clinical research may be a huge request for any participant, who tries an experimental medication or medical device. And it might be helpful to take a look in the mirror and realize that perhaps there is good reason some populations distrust our industry. 

It's obvious that leveraging technology will meaningfully improve the way we collect data in studies. But let’s not imagine that technical implementation alone is sufficient to override meaningful objections grounded in all-to-present history of social inequity and abuse of power. 

Gilead Layoffs from Acquisition

Gilead has announced they are laying off 114 employees at their Morris Plains facility which was acquired in 2020 with the $21B acquisition of Immunomedics. The company was acquired on big hopes for the anti-TROP-2 oncology antibody Trodelvy. In 2021, the drug brought in just $380M but there is continued uptake as global launch proceeds. It’s not clear if this move is really related to Trodelvy’s poor performance, or a larger plan to just cut some bottom line. In many ways this is par-for-the-course for large company acquisitions. Acquire, integrate, lay off or sell off, and redirect assets into highest value. This may not be comforting to those laid off, but I don’t currently see this as an indicator of big challenges at Gilead, more a normal acquisition cycle. 

AstraZeneca and Merck Share Cancer Win + Companion Diagnostic for Myriad Genetics

AstraZeneca and Merck have earned approval for their collaboration on the Breast Cancer drug to be sold as LYNPARZA. The targeted adjuvant therapy has been approved for a specific subpopulation of oncology patients with HER2-negative early breast cancer. The high-risk population saw a 32% reduction in death compared to control in a phase III trial. If you’re not familiar with oncology language, adjuvant therapies are given after the removal of a tumor or other tissue to treat cancer to treat prevent the spread and hopefully destroy and cancerous tissue that remained. They also tend to have significant side effects, and LYNPARZA is no exception here. 

The germline BCRA mutation that lead to this form of early and aggressive cancer must be detected via genetic test. Thus, the FDA simultaneously approved Myriad Genetics BRACAnalysis CDx test. The test can be used to distinguish between germline BRCA1 and BRCA2 and can lead to early recognition of risk as well as provide a gateway for treatment with LYNPARZA. 

All told, taking LYNPARZA is unlikely to be pleasant. But, it does provide hope of extended life.  

DNAnexus Raises $200M

In its third significant funding round since 2019, DNAnexus has raised $200M from Blackstone. The data analytics software company is building a platform centered around AI driven genomics analysis and insight. Although genomics was their core business, the platform spans a wide range of services that may need tech-enablement and integration in the Life Science industry, including genomics analysis for pipelines, multi-omics and mixed datasets, and Regulatory GxP support. Now, with $68M in 2019, $100M in 2020, and this latest infusion they are primarily focused on increased commercial rollout, drive their product roadmap, and increase cross-functional integrations.  

Companies, like DNAnexus, with data and analytics solutions that are broad enough to meet pharma and biotech developmental needs continue to see major success. As we see financial setbacks and there is a need to refresh pipelines, organizations that promise to use data to accelerate discovery and speed go/no-go decisions often have a leg up. While we are certainly developing more technically advanced medications, it’s not yet clear to me if we have accelerated the process from bench to bedside. 

Closing Credits

Thanks for joining me for Life Science Today, your source for stories, insights, and trends across the life science industry. Learn more at LifeScienceTodayPodcast.com. If you like what you hear, please tell a friend. Once again, I’m Dr. Noah Goodson, I’ll see you next week.