While the growth of big data and analytics help businesses understand their customers, serve better ads, and sell more, in healthcare, these same methodologies and technologies have a real enduring, profound societal impact. Real-world data (RW) and real-world evidence (RWE), made possible by technology, are being used by pharmaceutical companies and the healthcare ecosystem to develop, evaluate, implement, and optimize new treatment approaches. Aetion is the RWD and RWE platform that enables the healthcare system to harness the power of data to shape the future of medicine. The platform is designed to accelerate the time to market without compromising scientific rigor. For example, the company partnered with the FDA to develop real-world analytics related to COVID and vaccines.
AlleyWatch caught up with CEO Carolyn Magill to learn more about Aetion’s approach to RWD is enabling the healthcare system to make informed decisions, the company’s strategic, plans, latest round of funding, and much, much more.
Who were your investors and how much did you raise?
We raised $110 million with our Series C, bringing total funds raised to date to $212 million. The round is led by Warburg Pincus, a leading global growth equity firm, with additional investments from B Capital and Foresite Capital, and from our existing backers NEA and Flare Capital Partners.
Tell us about the product or service that Aetion offers.
Our technology, the Aetion Evidence Platform®, ingests real-world data (RWD) generated by the health care system and transforms those data into real-world evidence (RWE) to inform decisions on the safety, effectiveness, and value of medical treatments and technologies. Our platform is used by global biopharma organizations, medical device, and diagnostics companies, regulators, payers, and health technology assessment (HTA) bodies to help answer some of the most critical questions in health care—which interventions work best, for whom, and what should we pay for them?
What inspired the start of Aetion?
Our cofounders, Drs. Jeremy Rassen and Sebastian Schneeweiss, developed the Aetion Evidence Platform specifically for the purpose of transforming RWD into high quality, transparent, and replicable evidence at scale.
Since our founding, we’ve seen RWE continue to gain traction as a tool to support decision-making across the product lifecycle. Especially in the past year, COVID-19 has highlighted the important role of rapid, reliable evidence, cementing the need to continue to use these insights to inform health care decisions.
How is Aetion different?
What sets Aetion apart is the deep scientific expertise that has informed our technology throughout our journey. The platform is specifically built to support trust and alignment across stakeholders, bringing manufacturers together with regulatory agencies, payers, and HTA bodies. The platform provides transparent reporting, audit trails, and the ability for a reviewer to rerun analyses and test assumptions.
Further, the Aetion Evidence Platform is fluent across global sources of data, meaning that our technology can support customers in using data fit for the specific purpose of answering a research question.
We also have relationships with key decision-making bodies around the world. Last year, Aetion established a COVID-19 research collaboration with the FDA, using RWD to advance the understanding of and response to the disease. In addition, ICER selected Aetion as its preferred RWE partner and platform to generate evidence for value assessments and reassessments.
Finally, we are able to use our technology to tie the safety and effectiveness of medical products to value, which enables us to serve as the bridge between manufacturers and payers on the path to value-based contracting.
What market does Aetion target and how big is it?
The Aetion Evidence Platform is used by the majority of top global biopharma, leading payers, as well as regulatory and HTA bodies, such as FDA and ICER. We see tremendous market potential, especially as we await formal RWE guidance from the FDA and other global regulators.
What’s your business model?
We license the Aetion Evidence Platform and provide scientific and regulatory expertise to support our customers in generating evidence to inform their most critical decisions. Our technology is data fluent, meaning that manufacturers, payers, and regulators can conduct studies using data they have in-house or data they license through third parties.
How has the business changed since we last spoke in the fall?
We’ve continued to see RWE drive value globally and help bring necessary interventions to patients. Through our relationships with standard-setting agencies, we’ve engaged in research to deepen our collective understanding of how RWE can inform high-stakes decisions.
For example, we collaborated with the National Cancer Institute and others on a study that used RWD to evaluate the risk of COVID-19 reinfection. Aetion also co-authored a study in Science which provides a novel example of how RWE can accelerate the clinical research process by assessing lab-generated hypotheses to identify drug repurposing candidates for COVID-19.
In addition, as part of our work with the COVID-19 Evidence Accelerator, led by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, Aetion scientists co-authored the first published manuscript from the project. This work helped lay the methodological and logistical groundwork for future collaborations using different RWD sources to generate rapid insights on COVID-19.
We’ve also seen important updates from some of our existing partnerships and initiatives. We recently announced that we will work with ICER to generate RWE to inform its value reassessments of three treatments for hereditary angioedema. We’ve also seen interim results released from RCT DUPLICATE, an FDA demonstration project led by Brigham and Women’s Hospital using Aetion’s platform. This work will inform the agency’s forthcoming guidance on RWE, and will help shape the use of RWE for regulatory decision-making going forward.
What was the funding process like?
The funding process was a gratifying, and demanding journey. Our experience demonstrated the momentum we’ve achieved over the past few years, and investor belief in the potential for RWE to have a transformative impact on health care globally.
What are the biggest challenges that you faced while raising capital?
Raising capital is a time-intensive endeavor; we of course continued to prioritize our commitments to customers and prospects to keep pace with increasing demand for our Aetion Evidence Platform and thought leadership. Balancing time between those commitments with spending time with investors was our biggest challenge.
What factors about your business led your investors to write the check?
Our investors believe that Aetion is best positioned to set global standards for transforming data into regulatory-grade evidence, at scale. They share our long-term objectives—to improve patient outcomes by helping our customers make better decisions on how treatments are developed, accessed, and paid for. And they believe our team is uniquely qualified to achieve our ambitious mission.
Our investors believe that Aetion is best positioned to set global standards for transforming data into regulatory-grade evidence, at scale. They share our long-term objectives—to improve patient outcomes by helping our customers make better decisions on how treatments are developed, accessed, and paid for. And they believe our team is uniquely qualified to achieve our ambitious mission.
What are the milestones you plan to achieve in the next six months?
We plan to use the new funds to extend the capabilities of the Aetion Evidence Platform, expand our European and Asian-Pacific footprint, and grow our team to serve the demand from biopharma, payer, and medical device and diagnostics customers.
What advice can you offer companies in New York that do not have a fresh injection of capital in the bank?
Focus on understanding the most critical business needs of your customers. Demonstrate to them that you have the team and products to deliver superior value.
Where do you see the company going now over the near term?
We’re committed to continuing to improve the capabilities of the Aetion Evidence Platform so that it can better serve the growing demand from biopharma, payer, and medical device/diagnostics customers. Aetion will also continue working closely with regulators and HTAs around the globe to advance the use of RWE as part of their approval processes, and we will collaborate across stakeholders to ensure harmonization in research and methodological standards. We plan to expand our team in the European and Asian markets to support this effort, as well as grow our presence in those markets.
What’s your favorite outdoor dining restaurant in NYC?
Red Hook Tavern, in Brooklyn.