Women in STEM: How Real-World Outcomes Will Drive Future CGT Adoption (Part 3)

*Full transcript available below

In the third and final installment of an interview with Anna Catalanotto, director of Advanced Therapy Commercial Strategy, Cardinal Health, as part of BioPharm International®’s Women in STEM coverage, Catalanotto notes how the challenge for the cell and gene therapy (CGT) market has moved beyond just scientific innovation. The challenge now centers around building a healthcare ecosystem capable of scaling, supporting, and sustaining these high-impact treatments.

With a rising number of CGTs targeting broader and more diverse patient populations, these therapies hold the promise of life-changing outcomes, but their success depends on how effectively the system can deliver them in the real world, Catalanotto emphasizes.

A critical requirement is the rigorous development and collection of real-world evidence (RWE). As products mature beyond clinical trials, payers increasingly demand data on durability of response, long-term outcomes, and performance in everyday clinical practice. Robust RWE helps quantify true value, reduce uncertainty, and support informed coverage decisions, she explains.

How can real-world outcomes and innovative contracts scale CGTs?

Today, many CGTs are still concentrated in large academic medical centers, where administrative complexity and patient journey friction can limit access, Catalanotto notes. Expanding into care settings closer to patients, while maintaining safety and quality, will be essential to broaden reach and relieve pressure on major centers.

“As the cell and gene therapy market matures, it will be critical for us to work together to develop alternative reimbursement models that are sustainable for payers, patients, treatment sites, and manufacturers,” she says.

At the same time, payers need sophisticated tools and data packages to anticipate clinical impact, long-term value, and budgetary implications. This is driving cross-industry innovation in payment and contracting, including outcomes-based agreements and other alternative reimbursement models. However, these models introduce operational challenges in tracking outcomes, reconciling payments, and aligning stakeholders, Catalanotto explains.

Click on the following for parts one and two of her interview.

About the speaker

Anna Catalanotto, Director, Advanced Therapy Commercial Strategy, Cardinal Health

Catalanotto drives commercialization strategy and market access initiatives for CGTs at Cardinal Health. She works with biopharmaceutical manufacturers, payers, and health systems to build integrated solutions that accelerate patient access to advanced treatments. Before joining Cardinal Health, Catalanotto worked in life sciences consulting, specializing in CGT and rare disease. She advised leading biopharma companies on go-to-market strategy and market access planning, across patient, provider, and payer engagement strategies. Catalanotto holds a Bachelor of Science in Biology from Davidson College and is passionate about supporting patient access to innovative therapies that have the potential to redefine treatment possibilities.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Speaker 1

I think this is something that we spend a lot of time thinking about at Cardinal, because we know, as we look down the pipeline, there is really an increasing number of cell and gene therapies coming to market. There's also really exciting data and research and clinical trials in new patient populations and in broader patient populations, which you know, has the potential to bring these really life changing therapies to even more patients. And I think as we we think about that, we also think about how the broader healthcare ecosystem is going to be able to kind of scale, support that scale and sustain that scale. And so I think one thing that is really increasingly important is the development, the collection and development of real world evidence and looking at real world outcomes. So, you know, as these products kind of mature on the market, being able to look at and show what that durability of the outcomes looks like, and what the, you know, the outcomes look like in in patients outside of the clinical trial setting. So I think that becomes increasingly important for payers, as they, you know, gain comfortability with the the real kind of impact of these products. And then I think also, from a site perspective, we we think a lot about how these products are expanding into into other settings of care that are closer to the patient. So you know, historically, while the majority of cell and gene therapies are being administered and treated in large health care systems, large academic centers, there are a lot of challenges, kind of administrative challenges and and patient treatment journey challenges that come along with that. And so you know, where appropriate bringing certain services closer to the patient, that that enable, you know, a more seamless or an easier journey for them to gain access to these therapies. So I think you know, again, as more of these products comes to market, making sure that more treatment sites are going to be able to administer them, and that also, you know, from the payer perspective, payers have have increasing data and and information to inform just you know the level of impact of these products and the you know the value to patients, and then also giving them the tools to understand, you know, potentially the impact from a budgetary perspective, or giving them the tools to be able to plan for covering these therapies in the long term. And then the other piece I would also mention is just the the cross industry innovation around payment and contracting. So think while we've seen that there is increasing interest in more innovative contracting models, reimbursement models, I think continuing to to collaborate, to build those out further and to better operationalize them. You know, there's a number of kind of operational challenges that exist with with more innovative contracting models, like outcomes based agreements or the like. And so I think as we continue to kind of grow into this space, and the cell and gene therapy market matures, it'll be important for for us to kind of work together, to to develop those alternative reimbursement models that that kind of are more sustainable for all, all parties involved, from a payer, patient, treatment, site and manufacturer perspective.