The Role of Pharmacists in Advancing Cell and Gene Therapy Integration at UC Davis Health: Jenny Craven, PharmD, BCPS

At University of California (UC) Davis Health, the integration of cell and gene therapies (CGTs) has required a structured, multidisciplinary strategy that prioritizes proactive planning and pharmacist leadership. Jenny Craven, PharmD, BCPS, senior clinical pharmacist and pharmacy lead for emerging therapies at UC Davis Health, explains that UC Davis’s Emerging Therapies Committee helps to accomplish this task by bringing together stakeholders to evaluate each therapy individually and collectively, applying lessons learned from prior product onboarding.

Craven notes the importance of monitoring the pipeline to align formulary reviews with provider and patient interests, while also identifying and addressing resource gaps in advance. Standardized processes, such as checklists and consistent formulary strategies, have helped UC Davis ensure thorough review and anticipate challenges.

Craven also underscores the need to balance clinical considerations of safety and efficacy with operational and logistical demands, stressing that pharmacists are uniquely positioned to lead these efforts given their expertise across clinical, financial, and logistical domains, as well as their involvement throughout the patient journey in multiple care settings. This integrated approach has streamlined operations, improved collaboration with multidisciplinary teams, and supported efficient, safe access to emerging therapies.

This is the second interview in a 2-part series with Craven.

This transcript was lightly edited; captions were auto-generated.

Transcript

What are some key takeaways from challenges you have addressed successfully in cell and gene therapy implementation?

I think one of the biggest things we can do is we can have an organized approach that considers and reviews a variety of our stakeholder concerns. At UC Davis Health, we have an emerging therapies committee that pulls together a lot of these stakeholders from an operational standpoint, and I think that's been really, really helpful in looking at each of these products, individually, but also collectively as a whole. What can you learn from previous products that we've onboarded in the past, and what challenges are we anticipating with maybe this new product that we're onboarding?

I think also, really tuning into the pipeline and having those insights available and communicated to the team is so important. It helps to align our current requests for formulary reviews, as well as helps us to understand our provider and patient interests that we have at our site.

Then also it will help us with evaluating our current resources [and identifying] where some of those resource gaps might be, and what we can do to just become more efficient in those processes and hopefully close those gaps before we go on to onboard something. We've really taken an approach to be as proactive as possible prior to onboarding, trying to identify some of those hurdles before we get down the road too far. I think it's been really, really helpful for us to just try to anticipate some of those challenges that we've experienced in the past.

Then also, we really tried to design a strategy for our CGT formula program to build in that consistency and standardization. Again, I think that just goes back to having a good, solid, organized approach. We have a checklist of items that we review for every single product so that we don't miss anything and also just to try to bounce through some of those nuanced things that we've encountered for previous reviews.

Then finally, I think it really does require that balance of operational and clinical review for the formulary evaluation, and just really trying to make sure that we're taking into consideration the safety, the efficacy, as well as our logistical and operational challenges that come with each of these products.

I think pharmacists are extremely well positioned to help guide this process. I think we have that clinical strength, that clinical background, as well as financial and the logistical knowledge that's required. I think we pharmacists are well positioned throughout the whole patient journey, all the way from being in the clinic through maybe the infusion center, if that's the type of product that it is, and then in the inpatient setting, if needed, and then again back on the outpatient side. We're with patients the whole way. I think it makes a lot of sense for pharmacists to be highly involved in this process. We are medication and formulary experts. I think that has helped us to stay organized and really lean into that P&T [pharmacy and therapeutics committee] formulary approach.

Then, finally, we're involved in all those stages, again, with the logistics involved in the onboarding process. I think it's really helped us to streamline our efforts with the other multidisciplinary stakeholders that are involved as well.