Optimizing Your CGT Commercial Distribution Strategy: Four Priorities for a Successful Launch

Innovative healthcare products are opening new possibilities for patients, driven by the promise of advanced cell and gene therapies (CGTs). Originally focused on targeting rare diseases, these therapies are now expanding to larger patient populations.
However, bringing a CGT to market is a significant undertaking for developers and organizations must implement a strategic and thoughtfully crafted approach to distribution for success.1 As the landscape for advanced therapies continues to evolve, manufacturers must ensure their distribution strategies are robust, adaptable, and, above all, centered on patient needs.
To support a smooth transition from clinical development to commercial distribution, consider these priorities:

• Designing an effective channel strategy.
  
• Broadening access through new care sites.
  
• Reducing administrative burdens for sites of care.
  
• Maintaining the agility to respond to the needs of various stakeholders, given changing market dynamics.

Ultimately, the path to success is paved with a solid strategic plan and the ability to stay flexible when circumstances change.

Every successful launch starts with a strong foundation: a distribution network that efficiently and reliably connects patients to the therapies they need. For CGT products, this means working with partners who not only have both the technical expertise and the reach to serve your targeted patient population but also have direct experience distributing complex therapies.

Administering CGTs presents several significant hurdles, one of which is logistical. Many CGTs require ultra-cold storage, specialized handling, and strict chain of custody, making the logistics challenging for most clinics to manage.

Capacity limits, the need for surgical procedures, and advanced monitoring further complicate delivery, especially in centers already supporting clinical trials. In addition, high upfront costs, coupled with reimbursement complexities, add financial barriers for both patients and providers.

Patients and caregivers may need to travel long distances to receive the treatment, which can pose logistical, personal, and economic barriers. On the provider side, and for community sites in particular, payer restrictions are often a challenge.

Due to the high upfront costs of CGTs, providers typically rely on credit lines from distributors to purchase these products. Even if the site of care has sufficient credit to purchase the therapy, the potential for financial strain and even delays in ordering additional supplies or medications due to slow reimbursement processes are factors that can disincentivize providers and their sites of care from administering CGTs.

Aligning with distribution partners who can help manage these varied challenges and scale alongside your therapy while providing consistent access ensures you can keep the patient at the center of every decision. This approach lays the groundwork for broad patient reach and long-term growth potential.

Once the foundation is set, it’s time to ask: “How can we expand access more broadly?”

As your therapy receives approval for new indications or you plan to enter new markets, expanding the network of care sites becomes essential. However, many providers may be unfamiliar with new therapeutic modalities such as CGTs or lack the capabilities to administer them, limiting patient access and making it harder to plan logistics for distribution and referral pathways from general practitioners to specialized centers.

This underscores the importance of proactive education, such as implementing programs to help potential sites of care understand the benefits, risks, and administration protocols of your treatments, as well as guidelines for patient identification and referral processes.

Partnering with distribution experts who already have trusted relationships across the healthcare landscape can help broaden your reach into eligible sites of care and potential referral networks. This makes it easier to align your priority sites with a distribution partner’s existing network, easing the addition of new locations and expanding patient access.

The operational and financial challenges associated with CGTs are real for treatment centers. High upfront costs, complex ordering processes, and reimbursement delays can quickly strain resources and limit willingness to prescribe.

Supporting providers by streamlining administrative workflows, such as simplifying account setup, managing credit arrangements, and ensuring efficient payment processing, can make a significant difference.

By working with partners who can simplify this complexity by drawing on their experience with the logistical and financial hurdles associated with distributing CGTs can free up healthcare professionals to focus on what matters most: delivering the best care to as many patients as possible.

In the world of CGT products, change is the only constant. Whether it be new regulations, shifting reimbursement models, or evolving patient needs, a flexible channel strategy is table stakes and a distribution partner that can scale with your product to support long-term growth is essential.

The right partner should give you the flexibility to quickly adapt your channel strategy as demand shifts. For instance, quickly shifting from a limited network to a broader one if demand for your therapy suddenly spikes.

Flexibility also enters into play when it comes to provider payment terms, such as allowing site of care customers to defer product costs until reimbursement.