In April, Aetion, the Real World Evidence Platform®, partnered with HealthVerity to launch a real-time treatment tracker for COVID-19, allowing doctors and researchers to assess outcomes and how treatments are evolving. A month later, Aetion partnered with the FDA to use real-world evidence to analyze potential treatment plans. Now, Aetion is actively being used by vaccine makers in the race to find a solution to the pandemic. The healthcare systems’ eager adoption of Aetion is a result of the platform’s ability to ingest real-word data sets and generate reliable and replicable real-world evidence, which allows the healthcare industry to make critical decisions about treatments and drug development from a high-level and detailed perspective.  Real World Evidence leads to informed decision-making and Aetion, founded by two former Harvard Medical School faculty members, enables this with a focus on technology and big data.

AlleyWatch caught up with CEO Carolyn Magill to learn more about how the company powers regulators, biopharma, payers, and health technology assessment (HTA) bodies, the company’s future plans, and  Aetion’s Series B, which brings the total round size to $82B extension. Aetion has now raised a total of $93.6M across five rounds.

Who were your investors and how much did you raise?

Our newest investors are Johnson & Johnson Innovation, EDBI, and Greenspring Associates. They join our existing global community of investors, including Amgen, Sanofi, UCB, McKesson, and Horizon Blue Cross Blue Shield of New Jersey and of course our lead investors, Flare Capital Ventures and NEA.

This $19M extension completes the Series B round at $82M.

Tell us about the product or service that Aetion offers.

Our technology, the Aetion Evidence Platform®, ingests real-world data sets and transforms those data into transparent, reliable, and replicable real-world evidence to assess the safety, effectiveness, and value of treatments. Our platform is used by global biopharma, regulators, payers, and health technology assessment bodies to help answer some of the most critical decisions in health care — which interventions work best, for whom, and what we should pay for them.

What inspired the start of Aetion?

Our founders, Drs. Jeremy Rassen and Sebastian Schneeweiss, had been assessing the safety and effectiveness of clinical treatments through their work as faculty members of Harvard Medical School. Research studies required writing thousands of lines of code. Often, researchers with the same data set and same questions would come up with different results – and it was difficult to decipher why.

Drawing on Jeremy’s experience in big data and technology, they built the Aetion Evidence Platform specifically for the purpose of transforming real-world data into regulatory-grade, real-world evidence at scale. Their commitment to scientific rigor led to an unprecedented level of transparency in methodology and assumptions supporting each analysis.

As we’ve developed the technology, we’ve seen an incredible uptick in the demand for evidence that can help inform patients, caregivers, and clinicians as they navigate treatment decisions. Never has the urgency to generate scientifically validated RWE at scale been more apparent than now, especially as we grapple with the devastating impact of COVID-19.

How is Aetion different?

What sets the Aetion Evidence Platform® apart is the deep scientific expertise that has informed the technology along every step of the way. The technology is specifically built to engender trust and alignment across stakeholders, bringing biopharma 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 a given research question.

We also have relationships with key regulatory agencies around the world, including the U.S. Food and Drug Administration (FDA), which recently selected Aetion for a research collaboration to inform the agency and support its pandemic response.

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, the FDA, the Institute for Clinical and Economic Review (ICER), and other major international regulatory bodies. We see tremendous market potential, especially as global regulatory bodies, including the FDA, prepare to issue formal guidance on when and how they’ll incorporate real-world evidence in their decision-making.

What’s your business model?

We license the Aetion Evidence Platform® and provide expert guidance on transforming RWD to RWE at scale, and how to integrate RWE into the most critical business decisions. Our technology enables biopharma manufacturers, payers and regulators to conduct studies using data they have in-house, license through other parties, or access through one of our data partners.

How has COVID-19 impacted the business?

COVID-19 has accelerated the need for RWE that is transparent and scalable as biopharma and regulators look to understand which interventions work, and for which patients. We’re seeing RWD provide a valuable complement to traditional clinical trial studies, as we learn about the disease and look to answer urgent treatment questions.

As mentioned above, the FDA recently announced a research collaboration agreement with Aetion, to support their pandemic response. We’re using the Aetion Evidence Platform® to understand the natural history of the disease, understand patient populations and their medication use, identify risk factors for related complications, and contribute to the scientific evaluation of potential interventions.

We are also honored to engage in the important work of the COVID-19 Evidence Accelerator, an initiative launched by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. The collaboration is aimed at discovery and learning among many different entities joined in advancing COVID-19 research.

“The FDA recently announced a research collaboration agreement with Aetion, to support their pandemic response. We’re using the Aetion Evidence Platform to understand the natural history of the disease, understand patient populations and their medication use, identify risk factors for related complications, and contribute to the scientific evaluation of potential interventions… we are also honored to engage in the important work of the COVID-19 Evidence Accelerator, an initiative launched by the Reafan-Udall Foundations for the FDA in collaboration with Friends of Cancer Research.” Carolyn Magill, Aetion

What was the funding process like?

The funding process was relatively straightforward and efficient. This new infusion of capital was an extension to our B-round and our new investors were already familiar with Aetion.

What are the biggest challenges that you faced while raising capital?

The biggest challenges we faced related to raising capital in the era of COVID-19. We did not have the benefit of in-person meetings or welcoming our investors to our offices.

What factors about your business led your investors to write the check?

Our investors recognize that Aetion is the market leader in technology and services to transform Real-World Data into regulatory-grade Real-World Evidence, at scale. Customers offered attestations about why they chose Aetion, and how they see their collaboration with Aetion expanding in the years ahead. Further, investors recognized that Aetion has the culture and team to achieve our growth potential.

What are the milestones you plan to achieve in the next six months?

In the next six months, we’re looking to further build on our existing momentum. Our focus will be on expanding our global footprint as we build our customer, data partner, and regulatory relationships and work to help advance real-world evidence standards worldwide.

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 are always seeking to expand our customer relationships and to partner with new customers as they adopt RWE. We are also continuously expanding our partnerships with regulators and policymakers who are eager to advance the integration of data and technology into their decision-making. In addition to the recently announced research collaboration with the FDA to advance understanding of COVID-19, we are collaborating with government agencies and thought leaders in Europe and, increasingly, in Asia.

“In addition to the recently announced research collaboration with the FDA to advance understanding of COVID-19, we are collaborating with government agencies and thought leaders in Europe and, increasingly, in Asia.”

https://www.alleywatch.com/2020/09/aetion-drug-development-data-real-wo…