Former Johnson & Johnson, Bristol Myers Squibb executive to lead COTA

COTA, an oncology-centered real-world data (RWD) and analytics company, has promoted Miruna Sasu to president and CEO. In her new role, Sasu (who previously served at Johnson & Johnson and Bristol Myers Squibb) reportedly will lead COTA’s efforts to encourage broader adoption of RWD in order to accelerate development and reduce the cost of life-saving cancer drugs.

To learn more about the company, its mission, and her career, Outsourcing-Pharma recently connected with Sasu.

OSP: Could you please share some of the reasons why COTA appealed to you enough as a company that you wanted to join?​

MS: I was first introduced to COTA when I was at Bristol Myers Squibb. As head of the digital innovation team, I was responsible for getting to know the real-world data landscape and incubating some of the pioneers in the industry. At that time, COTA was still very provider focused but even then, I was impressed by their medical expertise and deep understanding of oncology patient care.

COTA remained very much on my radar with my move to Johnson & Johnson, especially as they began to focus on life sciences and various drug development use cases.

And then when I started to consider ways that I could influence the real-world data industry from the data production side, COTA was at the top of my list because of its focus on oncology and improving the lives of cancer patients and their families. Like many others, the fight against cancer is personal for me.

OSP: Why did you say ‘yes’ to taking the helm as CEO?​

MS: I joined COTA as chief strategy officer about a year ago and it’s been amazing to work at an organization where the people around me share the same vision and drive to improve the lives of people affected by cancer.

I’m humbled to be a part of a team with such an unparalleled wealth of knowledge, empathy, and experience. I believe this team can move mountains by working together. We have an opportunity to change the way cancer is studied and treated, and I am honored to be part of this effort.

OSP: You’ve had quite a career for a number of notable companies. Could you talk about some of the most notable developments you’ve been part of and paid witness to over the course of your career?​

MS: I have been in the life sciences the majority of my career and I was brought into COTA for this reason. I’ve had the privilege of understanding the drug development pipeline all the way from the lab to commercialization. Having worked across almost every department within pharmaceutical companies and biopharma, I have a deep understanding of the problems that can be solved with real-world data.

One endeavor where I’ve had a true front row seat is the development and evolution of real-world data and its utility to accelerate clinical trials. I am really proud to say that I think my team and I were one of the first to help companies craft how to develop and analyze real-world data for external control arms at scale.

For many years, I also incubated and developed strategies for most of the players in the real-world data industry (~18-20 companies). I know the ins and outs of why these companies thrive and why some of them fail - and I am now helping COTA avoid pitfalls and seize promising opportunities based on my experience.

Another one that typically doesn’t get discussed a lot but provides a true competitive edge is company innovation pipelines that actually change the way the company performs everyday functions. One example that ties in with this is how my prior team developed a smart, custom technology platform targeted toward data scientists that ingested real-world data and centralized the way all data scientists performed their work. 

I have seen a lot of companies work on different pieces of the puzzle. For example, analytics, data, or tech platforms. With this understanding of the holistic picture and how it all fits together—the RWD ecosystem if you will—COTA will be prioritizing flexibility and agility in its products and services to bring the most value to our pharma and provider partners.

OSP: Specifically, could you talk about some of the digital innovations that have arisen, especially in recent years, and why such advances mean good news for drug developers and patients?​

MS: The pandemic shed light on the power and potential of real-world data to drive efficiencies in clinical trials and overall vaccine development and as a result - the FDA released much-needed guidance on real-world data. This provided clarity in some areas and drove questions in others.

I expect more guidance from the FDA on RWD – likely in relation to how the most important high-quality RWD can best be captured starting at the point of care. This guidance will, over time, help ensure the most accurate and comprehensive data is collected from patients and then shared in a secure and private way with both providers and life sciences companies that are looking to personalize and optimize patient treatments and outcomes.

Also, the types of RWD that are accepted by the FDA for submission will undoubtedly broaden, including biomarker data, genomic data, patient-reported outcomes data, and even more consumer-focused data elements like financial data.

OSP: Your role apparently will include heading efforts to increase real-world data adoption—could you please share your perspective on why this is a worthy pursuit and what kinds of progress it could lead to?​

MS: With 83% of oncologists stating real-world data is critical to accelerating cancer research and treatment, we expect more providers and life sciences companies to invest in creating teams that will own real-world data strategy and innovation – helping to push patient care, clinical trials, and R&D into a new era of value-driven, preventive medicine.

RWD will become the foundation for other technologies and analytical capabilities to develop, so the trend we have seen around developing predictive algorithms and technology to interrogate the data for continuous insights will definitely continue. We already see several companies adding capabilities through mergers and acquisitions that are pointing the industry in that direction. Now, drug developers and the FDA will need to start utilizing those capabilities so that patients actually benefit from big data and analytics.

OSP: Could you please share your perspective of your personal experience with cancer—namely, your grandfather’s lung cancer journey, your family’s experience, and the clinical trial he contributed to?​

MS: After immigrating from Romania as a child, my grandfather helped to raise me in America. Soon after, he was diagnosed with advanced metastatic lung cancer and given only three months to live. At the time, we didn’t have the resources for conventional treatment. But there was a clinical trial that offered experimental care we could afford.

Instead of living for three months, he went into remission and got to spend another thirty years with our family. He got to see me grow up, graduate with advanced degrees, and launch my career as a scientist so I could help other people just like him.

We were lucky to have access to this transformational clinical trial. If we hadn’t learned about the program, or if we didn’t live close enough to the trial site for regular visits, our lives would have been very different. Now, my goal is to ensure that all patients have similar opportunities, no matter what their background or resources.

OSP: Could you please talk about your contributions to helping advance diversity, equity, and inclusion in care and trial access, and how your philosophy aligns with COTA’s?​

MS: It’s extraordinarily difficult to find enough patients to fill the vast majority of proposed clinical trials, and many trials fail to get off the ground due to recruitment. Despite the FDA’s clear endorsement of diversity in clinical trials, most trials do not meet acceptable thresholds of representative participants. Evidenced by the fact that in 2020, 75% of clinical trial participants were white.

What are the implications of this? Multiple myeloma is the second most common hematologic malignancy, with an estimated 35,000 new cases and 12,000 deaths expected to occur in the US in 2021. Research has shown that the incidence rate of myeloma in black Americans is two to three times higher than in other populations — and the death rates are higher as well. However, in the clinical trials to develop new treatments for multiple myeloma, Black Americans are often underrepresented.

It is critical that we understand optimal treatment pathways and risk prognostication in black populations - something COTA has researched extensively using RWD.

In addition to lowering recruitment thresholds with data-driven external control arms (replacing the human placebo group with data), real-world data allows researchers to accurately assemble or isolate racially and ethnically representative data sets. By representing patients’ treatments as they occurred, real-world data allows learning from real-world experiences, turning otherwise abstract health disparities into tangible patient stories, pathways, and outcomes.

COTA is committed to educating researchers about the ways RWD can make their work more inclusive and representative. We are also working with providers – like the University of Chicago Medicine and UT Southwestern - to support their use of real-world data to uncover unwanted disparities in care based on race, ethnicity, gender, and geography.

OSP: What’s next for COTA—any noteworthy partnerships or initiatives in the works you can tell us about?​

MS: As an RWD company with trusted relationships across the clinical and life sciences communities, COTA is uniquely positioned to form the critical bridge between stakeholders. We are extremely proud to be bringing stakeholders together, and we take our responsibility preparing real-world data for research very seriously.

We are excited to continue educating, supporting, and connecting all members of the clinical and life sciences communities. With real-world data at the center of our efforts, we will forge even stronger, more collaborative relationships to ensure patients have access to the best possible therapies for their needs.

In the short term, COTA will continue to expand its best-in-class, premier oncology, RWD, and evidence services to the life science industry. You will also see an expansion in our data, analytics, and services - geographically and across additional cancer types.

Additionally, our provider partnerships are growing rapidly and we are preparing for several announcements in the coming months.

OSP: Do you have anything to add?​

MS: A lot of our audience wants to know about our competitors and how we will differentiate ourselves. The reality is that while we are competitors, and we do believe COTA has the deepest and most usable oncology real-world data, we are also all in partnership against cancer.

Each player in this industry has a piece of the puzzle that is crucially important, and we honor and respect the work we are doing to help patients and end cancer.