Women in STEM: Fixing Manufacturing and Administrative Bottlenecks in Advanced Therapies (Part 2)

*Full transcript available below

Cell and gene therapies are transforming treatment for serious and rare diseases, but persistent manufacturing and administrative hurdles threaten to slow patient access to these life-changing innovations, says Anna Catalanotto, director, Advanced Therapy Commercial Strategy, Cardinal Health. In the second part of an interview with BioPharm International® for its Women in STEM coverage, Catalanotto explains that manufacturing challenges can delay or even derail care, from patient cell collection through to product delivery. Unpredictable timelines may cause patients to abandon treatment altogether, undermining both clinical outcomes and commercial success.

Each advanced therapy follows a unique, highly complex path to the patient, Catalanotto emphasizes. This complexity makes clear, proactive communication essential. For instance, treatment sites and patients must understand the end-to-end manufacturing journey, expected timelines, and potential delays. Without that transparency, providers struggle to plan resources, and patients face uncertainty in an already stressful treatment experience.

"That really upfront collaboration between manufacturers, treatment sites, and payers really is so critical to making sure that the process for getting these patients access to therapies is as smooth and as expedited as possible and that there is…a process in place to get patients access to these therapies and that all stakeholders…have all the resources and education that they need to navigate these processes that, again, are much more complex in the cell and gene therapy space compared to other therapy types," Catalanotto says.

How do manufacturing and administrative barriers shape patient access?

Beyond manufacturing, high upfront prices create payer hesitation, especially when durability data are limited, trial sizes are small, or endpoints are unfamiliar, Catalanotto notes. She stresses that manufacturers must be ready with robust evidence, clear endpoint rationale, and tailored education for payers.

Treatment sites face additional operational and administrative burdens, such as specialized training, workflow redesign, storage requirements, benefits verification, prior authorization, and one-off single-case agreements with payers. When sites are unfamiliar with a given health plan, securing coverage can take even longer, further delaying time to treatment.

Solving these multi-layered challenges demands early, structured collaboration across manufacturers, payers, and treatment sites, supported by practical tools, standardized workflows, and targeted education to safeguard timely patient access, Catalanotto explains.

Click here for part one 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

The manufacturing challenges can really have a significant impact to patient access to these therapies, whether that's from perspective of the patient cell collection or whether that's from the manufacturing timeline, it can really delay patient access or create unpredictable patient access, or potentially even create a situation where you know the patient, the patient you know, decides to no longer seek treatment, because it's been so unpredictable. So I think these challenges around commercial is around the manufacturing, excuse me, of the products really can have a really strong impact on the patient's both ability to get access to the product, but then also can create challenges in the distribution strategy, in the delivery of these products, given that Potential unpredictability and so, you know, I think the communicating what that manufacturing process is going to look like, and making sure that the treatment sites and patients are really well well aware of what that process will look like is really important for the commercial success of these therapies, so that the the sites and the providers and The patients you know, know what to expect in their treatment journey, and given again, that each of these products can have such a different process, a different path to the patient, making sure that they are that they know what to expect and that they are prepared for the potential challenges or delays or changes to the to their timeline.

Patient access to these cell and Gene and advanced therapies is really so crucial for manufacturers to solve for. And, you know, I think the you know, one of the most obvious pieces is that these therapies can come with really high upfront prices, kind of across the ecosystem. So this high upfront price, you know, from a payer perspective, I think can create some hesitation, given that there might not be readily available durability data, there might be other potential evidence gaps, questions about the trial size, or the trial design, maybe even just a lack of familiarity with the indication and the end, the endpoint selected for that, for that given indication. So I think there's a lot of you know potential questions that manufacturers need to come prepared to educate payers on and the you know, from the treatment site perspective as well, there can be a number of of challenges. I mean, there's, of course, the operational challenges, things like the trainings and the workflows and the storage requirements for treatment sites. But there's also the kind of administrative burden and challenges there for treatment sites in navigating the patient's health plan and do completing the benefits verification, completing the prior authorization, oftentimes they're conducting one off, single case agreements for these therapies, for coverage and payment with the payer. So I think, you know, those that administrative burden associated with with the coverage of these products can also really impact patient access. If a treatment site hasn't worked with a health system before, it can take even longer to secure that, that single case agreement and that coverage for that patient, which then, you know, goes on to delay that patient's time to treatment. So again, that really upfront collaboration between manufacturers, treatment sites and payers, I think, really is so critical to making sure that the the process for starting getting these patients access to therapies is as smooth and as expedited as possible, and and that, you know, there is kind of a process in place to get patients access to these, these therapies, and that all stakeholders have involved, have all the resources and education that they need to to navigate these processes that, again, are much more complex in the cell and gene therapy space compared to other therapy types.