Certis Oncology Solutions is a life science technology company committed to realizing the promise of precision oncology. Pulse 2.0 interviewed Certis Oncology Solutions President and CEO Peter Ellman to learn more about the company’s work in closing the translation gap in cancer therapeutics development.
Peter Ellman’s Background
Could you tell me more about your background and what attracted you to Certis? Ellman said:
“Anything science has always been incredibly interesting to me. My path to Certis started at the Bronx High School of Science, which led me to study Chemistry and Biology in college. As a young graduate, it didn’t take me long to discover that I was better suited to business than laboratory work, so I began my career in sales. I was the first sales executive for Interplak, an electronic consumer products company that was acquired by Bausch and Lomb in 1988. I then moved to a company called Thermoscan, where I helped take the world’s first infrared ear thermometer to market. Having enjoyed the thrill of launching a new product, my interest turned to start-ups. When you build a business from scratch, you chart new territory, and there is something deeply compelling about that.”
“Before joining Certis, I was involved in several early-stage tech companies, including ParadoxDx, a pharmacogenomics business, and Nextec Applications, an advanced materials technology company. I love being at the intersection of science and business. When Certis’ founders approached me to lead the company, it was a no-brainer. This role has afforded me the opportunity to do what I love while pursuing a noble mission: improving the lives of cancer patients by advancing precision medicine.”
Focus For This Year
What is the company’s focus heading into 2025? Ellman shared:
“This is an exciting time for the company and for cancer research in general, as recent advances in artificial intelligence and machine learning have given us powerful tools for accelerating progress. In 2024 we launched two AI-enabled technologies. One, CertisAIä, correlates drug response with a tumor’s unique gene expression signature—enabling drug efficacy predictions that benefit both patients and companies working to develop the next generation of cancer therapies. The other, CertisOI Assistantä, leverages ChatGPT’s large language model to dramatically accelerate scientific workflows, by allowing researchers to easily analyze vast datasets of clinical, genomic, and drug response information.”
“We also continue our work developing more clinically relevant biological models, which are used in preclinical cancer research and as a validation platform for AI predictions. As drug targets and mechanisms of action become more complex, so does the need for animal models that more closely mimic cancer in humans. The company’s foundational expertise in orthotopic PDX model development has never been more in demand. Going into 2025, we had more than 500 highly characterized patient-derived xenograft (PDX) models in our library, with another 200 in development that will be ready for commercial use by year’s end.”
CertisAI And The CertisOIAssistant
Can you discuss CertisAI and the CertisOI Assistant and what value they bring to cancer research? Ellman explained:
“CertisAI is a patented artificial intelligence/machine learning (AI/ML) platform that predicts therapeutic efficacy by identifying complex biomarker signatures that correlate with drug response. To build the platform, our data science team employed neural networks and other computational algorithms to map the molecular structures of all FDA-approved drugs to drug response data for thousands of research tumor models, resulting in a platform that can quickly identify the gene expression signatures predictive of drug response and/or resistance. This can bring greater speed and precision to oncology drug development by informing biomarker strategy, optimizing model selection, and generally improving preclinical decision-making. The platform can also help guide personalized treatment decisions by predicting drug response from the whole transcriptome RNA sequence of an individual’s tumor.”
“CertisOI Assistant actually sits on top of CertisAI. It is a generative AI ‘chatbot’ tool designed to enhance the efficiency and effectiveness of cancer research. It leverages the predictive power of CertisAI and OpenAI’s ChatGPT language model to quickly provide researchers with insights into oncology models and drug response, bringing greater precision to early drug development decisions. What really sets this tool apart is its ability to conduct sophisticated real-time analysis through an integrated coding environment, and its ability to present insights through visualizations, interactive charts, tables, and downloadable datasets.”
Patent For CertisAI Platform
Certis was recently awarded a U.S. patent for its CertisAI platform—can you share more about what this patent covers and why it’s significant for the company and the broader oncology drug development space? Ellman noted:
“The patent broadly protects our predictive AI/ML platform that integrates multiple data sets, including drug features, gene expression biomarkers, and drug response, and the use of patient-derived xenografts (PDX) for model validation. This is a major milestone for Certis, reinforcing the uniqueness of our proprietary approach to predicting drug response. Beyond the patent itself, this represents a step toward democratizing access to AI/ML technologies in oncology drug development. CertisAI is commercially available as a service, making these advanced predictive tools broadly accessible to biopharma companies that may lack the internal resources to develop their own AI-driven workflows. By leveling the playing field, we’re helping more companies make smarter, data-driven decisions earlier in development, reducing failure rates and ultimately accelerating better patient treatments.”
Challenges Faced
Have you faced any challenges recently, and how did you overcome them? Ellman acknowledged:
“Challenges are constant in oncology, but I’d have to say the most significant business challenge over the last year or so has been the widespread prioritization of later-stage clinical candidates by our pharmaceutical clients. When drug developers reprioritize R&D investment, it causes uncertainty around the funding of early-stage oncology programs, leading to slower decision-making and less predictable near-term demand for translational services.”
“This dynamic is not unique to Certis—it has prompted layoffs across many preclinical services companies we compete with. But this is a temporary issue that we believe will stabilize once the policies of the new administration become clear. The necessity to do better for cancer patients persists, and so does the financial imperative for developers to maintain a robust early-stage pipeline.”
“At Certis, we’re meeting this challenge by doubling down on efforts to be the very best at what we do.”
Evolution Of The Company’s Technology
How has Certis evolved since its launch? Ellman pointed out:
“Certis has evolved dramatically over the nine years since it was founded, but the decisions that brought us here have been directed by the same goal: applying the best science and technology possible to advance precision oncology. Being at the forefront of ‘what’s next’ is central to the Certis mission and deeply engrained in our company culture.”
“From its founding in 2016 until late 2020, Certis’ primary business model involved serving patients and their oncologists directly, by performing in vivo functional testing. This type of testing involves developing personalized patient-derived xenograft (PDX) models, sometimes referred to as mouse “avatars,” from an individual’s tumor tissue, then testing response to various drugs and/or drug combinations simultaneously to evaluate which is mostly likely to be effective for that individual. Research institutions have been utilizing in vivo functional testing for decades, but the approach wasn’t—and still isn’t—widely available, largely because it is costly and difficult to scale. Certis continues to offer this service to patients today, as it is critical to our mission. But we also wanted to increase the impact we could have on patient’s lives, which led us to launch a pharmaceutical services division in late 2020.”
“The preclinical contract research organization (CRO) space is a relatively mature industry, but it is dominated by a handful of companies that have been slow to adopt new technology. Most mouse models traditionally used in cancer research consist of tumor tissues derived from mouse tumors (syngeneic models), are genetically modified (GEMMs) or are developed by implanting human cancer cells just below the skin in the animal’s flank (subcutaneous PDX models). At Certis, we had always specialized in orthotopic patient-derived xenograft (O-PDX) models, which are developed by surgically engrafting tumor tissue in the same location from which it occurred in its human counterpart. A significant body of research shows that O-PDX models more accurately model human cancer kinetics and retain the tumor microenvironment, which is critically important to tumor growth, metastasis and druggability. We were determined to be the very best at developing the world’s most clinically relevant. Today, we offer a broad suite of in vitro and in vivo pharmacology assays, but many of our customers seek us out because of our expertise in orthotopic PDX and humanized orthotopic PDX development.”
“Since the 2021 launch of our pharma services division, our bank of PDX models has grown significantly, and so has our need to manage the related genomic, clinical, and other characterization data related to each model. We needed to find ways to more efficiently retrieve and analyze that data. As many great innovations go, CertisAIä was originally borne out of an internal business need to work smarter. The Certis bioinformatics team seized on the growing availability of open-source algorithms and built an elegant, one-of-a-kind AI/ML solution we knew would further differentiate Certis from its preclinical peers. In May 2024, we began offering CertisAIä predictions commercially, and the CertisOI Assistantä launch followed in December. Today, being “AI-enabled” is central to who we are and how we operate.”
Success Stories
Can you share any specific success stories? Ellman highlighted:
“Our greatest success as a company is our strong company culture, characterized by scientific excellence and a deeply collaborative spirit. Each of us ‘Certisians’ is mission-driven, responsive to those we serve, and accountable to each other. It’s a real joy to be a part of that.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Ellman assessed:
“Most agree it is difficult to quantify market size for preclinical oncology CROs, but with the services Certis offers and the growing demand for more advanced cancer models, we estimate our TAM for pharmaceutical services at about $1 billion and growing faster than the market in general (7% to 8%). The AI in oncology market is substantial and rapidly expanding; analysts expect it to approach $20 billion by 2030.”
Differentiation From The Competition
What differentiates Certis from its competition? Ellman concluded:
“Several things differentiate Certis as a translational oncology partner:
— Our AI-enabled approach to preclinical development – Offering AI-driven insights to guide model selection, candidate prioritization, biomarker strategy, and other strategically important decisions deepens collaboration and strengthens our client relationships. It can also reduce the need for early screening studies and improve overall efficiencies.
— Our expertise in orthotopic PDX model development – While most preclinical CROs now offer O-PDX studies as part of their mix, Certis has always focused on orthotopic modeling, so we’ve been optimizing the microsurgical techniques required for successful orthotopic engraftment for years. Because tumor microenvironment is critical to evaluating next-generation ADCs and other highly targeted therapies, cancer researchers need orthotopic models for pivotal studies.
— Advanced imaging capabilities – One often-cited “drawback” of orthotopic models is they require in situ imaging. Early in our journey, Certis invested in murine-scale MRI, which provides far greater detail than what is available via ultrasound. Over the years, we’ve curated an arsenal of high-definition imaging technologies that provide an efficient way to non-invasively localize tumors, quantify tumor growth and metastasis, monitor tumor response over time, and provide greater insight into deep tissue structures.
— The quality of our PDX collection – All our 550+ patient-derived cancer models are subjected to rigorous quality controls. They are low-passaged, well-characterized, and originated from North America over the past 1-10 years. Many PDX models currently circulating in the market are 25 or more years old (not exposed to current standard-of-care therapies) and have been passaged dozens of times, which negatively impacts model accuracy.”
