Planning for successful cell and gene therapy commercialization

When bringing cell and gene therapies (CGTs) to market, developers must successfully navigate various obstacles, including the technical aspects of clinical trials, scaling manufacturing capabilities, ensuring market access and optimizing product launches.

By considering several key themes, CGT developers can confidently navigate their commercialization challenges and successfully deliver therapies to the patients who need them.

Adding flexibility to team and data infrastructure pre-launch

As most CGT developers have never worked on CGTs before, product commercialization has been likened to building a plane while flying it. Integrating all teams and external partners early in development adds the flexibility required to quickly pivot and respond to new challenges.

Changes in product launch, such as a new target demographic, affect all teams within a company. A strong governance framework ensures manufacturing, market access, sales, external partners and other teams speak the same language to quickly and smoothly overcome challenges.

Mapping the entire technology ecosystem and ensuring flexible data infrastructure is another important pre-launch investment. Individual processes are likely to change, but adaptability and communication between different systems will help lead to a future-proof data infrastructure.

Prioritizing the audience

From patients to healthcare providers (HCPs) to investors, different marketing materials provide different benefits as CGT development progresses. Considering the target audience and competition within the market ensures that marketing materials have the most impact. The technical details of the product, along with clinical data, are insightful to HCPs and investors but may overwhelm the patient audience.

Choosing branded or unbranded materials depends on competition within the market. Unbranded marketing materials are useful if there is no competition as they can raise awareness of a disease and illustrate how CGTs can help. Unbranded educational materials can also be patient-friendly, providing more general information about CGTs. In contrast, branded materials increase brand recognition in competitive markets and are useful for highlighting unique CGT processes or mechanisms.

Consulting with patient organizations at every stage of development is also key to optimizing marketing materials and seeing the most patient benefit.

Maintaining strong partnerships with treatment centers

The size of the treatment center and available budget will determine the role the center will play in CGT development. Every organization is unique but there are some general approaches to maintaining strong partnerships with treatment centers:

• Be flexible with patient onboarding: Treatment centers have a deep knowledge of patients, which CGT developers can take advantage of by being flexible with their patient onboarding process.
• Provide branded and unbranded marketing: Treatment centers can use unbranded materials to explain CGT processes to patients, whereas branded materials are useful for communicating the expectations of the product.
• Integrate patient intake portals: Bespoke patient intake portals require specific training and time-consuming processes. Integrated solutions can be applied to multiple CGTs and improve scalability.
• Plan for post-treatment follow-up: Before launch, create a long-term plan for post-treatment follow-up. Consider patient and treatment center opt-in/opt-out, methods of data collection and budget allocation.

Building trusted and valuable relationships with patients

The patient is paramount throughout the CGT development process. Thinking about patient relationships early influences the other stages in planning and development. Internal patient services teams and external partners (or a combination of both) can provide support to add value to the patient relationship.

Education about a disease and its treatment is important but patient relationships are also opportunities to start impactful conversations. Patients can ask questions that the CGT developer may not have considered, which can challenge what is possible for patient care. By communicating the therapeutic potential of CGTs, developers can also restore hope to patients who may have suffered through past experiences.

Extending patient relationships beyond treatment enhances trust, particularly in the case of rare diseases, which are often chronic. Providing resources to patients who aren’t eligible for clinical trials or treatments maintains relationships even when individuals are no longer part of CGT development. Continued support post-treatment can also be beneficial to patients who have lived with a disease for a long time and are now adapting to life without the disease following a successful outcome.

To learn more about planning for cell and gene therapy commercialization, including the key themes covered in this article, watch the recent panel discussion with:

• Matt Booth, SVP Global Therapy Lead, ApotheCom, an Inizio Company
• Ben Beckley, President, Evoke Mind + Matter, an Inizio Company
• Dean McAlister, EVP, Inizio Biotech
• Greg Christianson, Principal, Nuvera, an Inizio Company
• Rita Johnson-Greene, COO, Alliance for Regenerative Medicine (ARM)