SomaLogic

Jessica S. Williams

In an interview, Jessica S. Williams, director of licensing and analytical services at SomaLogic, shares her views on the latest trends affecting the pharma industry and the growing problem of NASH.

What are some of the major challenges and trends that have been impacting the Pharma Industry lately?

Perhaps more a constant than a trend, time and money spent on drug development is hugely impactful to Pharma. As an example, drug development for the treatment of nonalcoholic steatohepatitis (NASH) is still relatively nascent – which means it has only been happening in earnest for about a decade – and we have seen many Pharma companies make a big push, only to abandon their programs later.

Why NASH?

Non-alcoholic fatty liver disease (NAFLD) affects approximately 100 million Americans, with about 20 percent of them progressing to nonalcoholic steatohepatitis (NASH), and Europe is catching up. Some of these patients are destined to progress to cirrhosis or liver cancer, with enormous morbidity, mortality, and cost burdens. NASH is a rapidly growing health challenge throughout the developed world and is soon expected to overtake hepatitis C as the leading cause of liver transplant. Faced with this enormous unmet need, Pharma turned its focus to finding the answer.

What happened?

 The current gold standard in NASH diagnosis is liver biopsy-based observation of the presence of histological abnormalities: steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis. Liver biopsies are costly, unpleasant, somewhat risky, and quite subjective. The lack of reproducible interpretation is problematic in the setting of clinical trials, where biopsy is required for screening prior to entering the trial and again to assess the progression of disease or response to therapeutic intervention. Furthermore, the loss in follow-up is high when invasive procedures are required in trial design. Even at enrollment, companies were challenged with high screen failure rates. Facing mounting costs and lacking the tools that could help to demonstrate benefit, many Pharma companies abandoned their NASH programs.

 How can we fix this?

Drug development productivity (not to mention clinical care) would greatly benefit from noninvasive diagnostic and prognostic tools to characterize NASH, predict the rate of disease progression, and monitor the progression or resolution of the disease. SomaLogic has developed SomaSignal™ tests for each histological component of NASH, which, along with 7,000 simultaneous protein measurements provided by the SomaScan® Platform, it can provide from a single blood sample. With noninvasive tools like these, Pharma can get a holistic picture of a disease or the impact of treatment faster, more reliably, less invasively, and more cost-effectively.

What keeps you up at night when it comes to some of the major predicaments in the Pharma Industry?

Every minute of every day, people fantasize about the discovery of a cure for their loved ones' illnesses, and Pharma companies are expending efforts to help make some of those fantasies a reality. I spend a lot of time thinking about what information will be the key to unlocking the lifechanging – or even life-saving – potential. The Mystery of the Aging Brain No, this is not a ‘Nancy Drew’ novel. The more we learn about the brain, the less we seem to know. Alzheimer's disease is characterized by changes in the brain like plaques and tangles and is thought to be caused by some combination of factors like age-related changes to the brain, genetics, lifestyle, environment, and the influence of other conditions – each of which has varying impacts across individuals. New research seems to beget new questions, and as we age, each of us wonders, “Will it happen to me – or to someone I love?”

 This lack of understanding presents a major hurdle for the Pharma Industry, with a lack of clarity around which targets to focus on for the greatest impact. Even the successful drug approvals have been fraught with controversy, with claims of lack of sufficient evidence of efficacy, narrow applicability, side effects, as well as public outcry over pricing. As I lie awake at night, I think about the information that could enable the identification of the best drug targets, monitoring of response to treatment or off-target effects – and whether speed to information could reduce the cost and duration of trials, increase the trust of the public, and ultimately provide greater benefit to people who need treatment.Since about 95 percent of drug targets are proteins, proteomics may be a direct avenue for obtaining the deeper level of information needed. By performing large-scale discovery studies, Pharma can cast a wide net with its research to find cures. 

For example, using SomaLogic’s SomaScan Assay to measure 7,000 proteins simultaneously could not only help with identifying proteins associated with a disease that can be targeted but also throughout the drug development lifecycle to gain real-time information about how the drug is working and what other changes are occurring in an individual's proteome over time. With a multi-faceted condition like Alzheimer's, the more information, the better.

Can you tell us about the latest project that you have been working on and what are some of the technological and process elements that you leveraged to make the project successful?

At SomaLogic, our mission is to empower the scientific community at every stage of their research with our comprehensive proteomic products and services. We previously announced our relationship with Novo Nordisk, a global innovator, for expanded use of our SomaScan Platform and SomaSignal tests in their drug development efforts, including in NASH, cardiovascular disease, and diabetes. In addition, Novo Nordisk provided SomaLogic with proteins that will help to increase the SomaScan Platform content beyond the 7,000 proteins we measure today. We work with Novo Nordisk and our other Pharma customers to better understand their needs and continuously innovate to ensure our offerings support those needs.

One of the most exciting parts of my job is learning from our customers and adapting to their needs to drive new solutions together. SomaLogic continues to offer the only proteomic technology capable of simultaneously measuring proteins rapidly (high throughput), broadly (thousands of proteins simultaneously), deeply (high-and low-abundance proteins), and reproducibly (low coefficients of variability) with small sample volumes enabling customers to conduct faster, more precise drug discovery and biological investigation.

We offer this platform solution as a service from our own lab and also enable customers to bring it in-house as an authorized site. Our SomaSignal tests (SSTs) are mathematical models we developed against endpoints or outcomes of interest, like the nature or severity of a health condition, which provide customers with unique insights across the entire research continuum, enabling a holistic picture of health as well as the ability to enrich trials, conduct safety assessments, and monitor response, potentially saving time and money during drug development. These tests are calculated on the back of our SomaScan Assay data, which means they can be applied to data from the same single sample run for broader discovery. We also offer a range of analytical services; for example, we offer a model development service that capitalizes on our deep data knowledge, honed development discipline, and streamlined processes which enable us to go efficiently and quickly from idea through finalization of models to address unique research questions. In addition, each SOMAmer reagent that measures one of the proteins included in the 7,000-plex SomaScan assay can be used individually in follow-up research where a customer wants to drill down on an application of their discovery. Though I have been at the company for almost a decade, I continue to learn from our customers and am always eager to see where the next idea leads.

What are some of the technological trends which excite you for the future of the Pharma Industry?

 2023: An AI Odyssey Though Hollywood had me believing this would happen a lot sooner, it seems we have finally arrived in the age of Artificial Intelligence (AI). The potential of AI to accelerate and enhance Pharma’s research and drug development is massive. Many companies already apply machine learning to big data to speed discoveries and develop models, but unlocking the full potential of AI requires a colossal amount of data and the right inputs. One of my greatest fears is that it will be misinformed and misapplied – second only to it turning against us; thanks again, Hollywood. There are many examples of the new AI language processing tools providing incorrect answers, and what else would you expect from AI scraping and unsupervised learning from differentially reliable internet data? Everybody knows you can’t believe what you read on the internet (except, of course, this article). The key to AI-based innovation will be the reliability of the information fed into the machine and how you teach it to use the information, e.g., to distinguish the causal from the correlative. A person’s proteome is an unbiased source of truth about their real-time health state and trajectory in the face of their genetics, lifestyle, and environment, and, with enough data, has great potential as the substrate for AI-driven learnings to advance the Pharma Industry. AI may even be able to make sense of the intertwined patterns of complex conditions like Alzheimer’s that have long eluded us, or potentially enable completely personalized forms of treatment and monitoring, or even outcome simulation enabling a virtual ‘try’ of various treatments. I look forward to collaborating with Pharma and others as the use of AI expands and taking care of what we feed into the machine – you are what you eat.