Overcoming the Challenges in Bringing Cell & Gene Therapies to Market – Part 4

As cell and gene therapies (CGTs) continue to enter the market, treatment centers have become the primary gatekeepers to patient access. Capacity limitations, operational burden, financial exposure, and increasing competition—both from other approved therapies and ongoing clinical trials—are forcing centers to be increasingly selective in what they adopt and sustain.

In this four-part blog series, we will address four major challenge areas manufacturers face in bringing cell and gene therapies to market, and the best practices to follow in overcoming them. Challenges and solutions discussed include:

1. Treatment Center Capacity Constraints
2. Operational Complexity and Workflow Burden
3. Financial Concerns and Reimbursement Exposure
4. Market Competition in Clinical Trials and Commercial Applications

Challenge 4: Market Competition in Clinical Trials and Commercial Applications

When considering the challenges in the CGT space, the brutal competition for securing treatment centers in this increasingly crowded market is impossible to ignore.

Factors attributing to treatment center competition

Competition for treatment centers for both clinical trials and commercial applications is being driven by limited site capacity at any given time. The centers of excellence and/or more established treatment centers are often running multiple clinical trial and commercial product therapies at any given time, utilizing all the staffing and infrastructure that is available. They may also be drawing from the same patients you would hope to treat in your program limiting your possible patient pool.

On the other hand, working with a new treatment center offers more challenges in that it requires significant time and resources for both you and the center to reach the necessary certification for therapy implementation. Working on this approach would need to start very early in your clinical trial or commercial launch plan.

The very nature of your product – clinical trial or commercial – can also drive competition for these centers. Treatment centers can perceive advantages in taking on a clinical trial over a commercial product. They may view clinical trials more favorably since they are less cost-inhibitive with procedure and staff costs covered by the manufacturer. They may have academic and/or research interests and priorities that may favor clinical trial participation over commercial program adoptions, and/or they may delay or decline commercial therapies while they are awaiting clinical trial outcomes.

Recognizing the number of clinical trials occurring and in the immediate offing should inform your plan for securing treatment centers. The sheer number of clinical trials occurring at any given time, and those immediately forthcoming, does add a layer of complexity to securing treatment centers. This complexity may be impossible to ignore but is not insurmountable as discussed below.

What you can do to address the competitive threat

There are ways you can address competition for treatment centers to make your clinical trial and/or commercial program attractive to your targeted treatment center(s).

1. You need to clearly articulate the value you are offering beyond the clinical differentiation of your product. To do so, you should establish protocols and workflow processes that can easily co-exist within the center’s current procedures, or provide a strong rationale for deviation while maintaining overall operational ease. Share with the treatment center your workflow plan. Demonstrate how consistent your therapy administration will be, and how the treatment center can handle the increased patient load as the program scales.

   Such efforts are particularly helpful in securing sites for your clinical trials. Since treatment centers bear no cost burden in holding clinical trials, by demonstrating the value of your process and implementation relative to others, you are establishing a strong case for implementing administration of your therapy.

2. Engage trial sites early. In so doing, you are fostering a relationship that builds over time and will pave the way for seamless trial-to-commercial transitions. Although you may just be looking for sites to conduct your clinical trial now, you should look for treatment centers that can grow with you from clinical trial to commercial product. Then by securing these centers early, and building a productive relationship, you are in a better position to ensure the continuity of your therapy administration.

   A good place to start is to identify the breadth of stakeholders involved across the therapy administration and develop a plan mapping for their roles and functions. Be sure to identify those who will play a role in both your clinical trial and commercial treatment setting, so you can preserve continuity in workflows, training, and staffing when transitioning from trial to commercial product.

   By building into your plan this understanding of the treatment center’s staff roles and processes, you are demonstrating how you will work in true partnership to deliver value to the patient.

3. Be a readily accessible resource for treatment centers as therapy volume and trial activity continue to evolve. Your ability to demonstrate proactive support throughout your partnership with a treatment center will influence the treatment centers willingness to take on your therapy. You should equip centers with patient centric resources that can ease burdens on staff and help address patient needs. This should span from patient eligibility identification to product ordering and monitoring throughout the program’s evolution. By being laser-focused on the stakeholders involved and providing appropriate support we can ensure they deliver a seamless treatment experience, without disturbing the center’s workflows or impeding the center’s relationship with the patient.
4. Demonstrate long-term partnership across a portfolio, not a single product. You have a distinct competitive advantage when you can demonstrate pipeline depth that could also come to the treatment center. Treatment centers dealing with a single manufacturer across a portfolio of products are able to develop efficiencies in engagement based on established manufacturer protocols across the range of products. This allows them to more effectively utilize staff and resources than they would when dealing with the discrete requirements of one-off products and manufacturers.

The demand for treatment center sites is growing with each passing day as new cell and gene therapies reach clinical trial and commercialization. At the same time, treatment centers are becoming more selective with whom they partner. Recognize these capacity limitations early in your planning process so you can develop a strategy to successfully win these critical partnerships.

Want guidance with your upcoming CGT project?

Contact our team at Nuvera to leverage our deep treatment experience capabilities with allogenic and autologous therapies.

See our Case Example on CGT Therapy: Designing an End-to-End Therapy Order Management Process – Nuvera