Why Early, Big-Picture Planning Is Key to Execution Across the CGT Lifecycle

Cell and gene therapies (CGTs) hold tremendous promise for patients. But bringing them to market requires manufacturers to navigate regulatory, operational, and market access challenges that begin long before commercialization.

More than many other therapies, CGTs require a cross-functional approach early in development. Manufacturers that make these decisions in silos may create barriers that become difficult to overcome. This article explores connections across the CGT product lifecycle and the variety of functions and stakeholders that are integral to a therapy’s success.

Section 1: Development Phase – Early Decisions That Impact Commercialization

Many of the challenges that emerge during commercialization can be traced back to decisions made during development. Early decisions related to regulatory engagement, manufacturing, and supply chain can influence approval, reimbursement, and operational readiness years later.

Starting the Regulatory Journey to Commercialization Early

During development, manufacturers are often focused on clinical outcomes. But delaying regulatory engagement can create challenges later in the approval process.

In both the U.S. and Europe, early engagement with regulators can help manufacturers understand market-specific requirements, align development plans accordingly, and build productive relationships with health authorities. This is particularly important because approval by one regulator does not guarantee approval in another market.

Regulatory authorities offer several pathways early in development to help manufacturers determine the best approach, including:

• In the US: Fast Track designation, Breakthrough Therapy designation, and Regenerative Medicine Advanced Therapy (RMAT) designation¹
• In Europe: Priority Medicines (PRIME) designation²
• In the UK: the Innovative Licensing and Access Pathway (ILAP)³

These programs can provide valuable guidance during development while helping manufacturers build credibility and alignment with regulators.

Evidence Generation for Commercialization Success

Regulatory bodies are only one kind of audience for clinical evidence. The same data may also influence whether payers decide to cover a therapy and under what conditions.

That means manufacturers should consider generating the type of evidence payers would prioritize in coverage decisions. This may include patient-reported outcomes, health economics and outcomes research, and other evidence that helps demonstrate clinical and economic value.

To align evidence generation and future commercial needs, manufacturers should ask questions such as:

• Is the comparator consistent with relevant standard of care and are the therapy’s clinical differentiators clearly defined?
• Has the therapy’s full value story been clearly defined and shared?
• Are the study endpoints compelling for different stakeholders, including regulators, patients, physicians, and payers?

Other study design decisions can also directly affect future patient access. Inclusion and exclusion criteria may influence product labeling, which can shape the patient population eligible for treatment. Payers may then apply prior authorization requirements that are even more restrictive. A recent Cencora survey found that payers include prior authorization criteria for CGTs that are more restrictive than the label (74%) as well as criteria aligned with the label (58%).⁴

To better understand payer expectations for evidence, manufacturers should engage payers early and conduct market assessments that can inform decisions around target product profile, trial design, endpoint selection, evidence generation, and value proposition development.

Building a Strategic Approach to Manufacturing Scale-Up

One of the most significant regulatory challenges for CGTs is managing Chemistry, Manufacturing, and Control (CMC) changes as manufacturing processes evolve and scale. Manufacturing processes often change as CGTs move from development toward commercialization. Those changes can raise comparability questions from regulators later in the approval process.

CGT manufacturers can reduce comparability risk by documenting product and process changes as they occur throughout development, rather than trying to reconstruct the rationale later. For each meaningful change, manufacturers should consider what analytical, process, and — where appropriate — nonclinical or clinical evidence may be needed to demonstrate comparability. This allows the comparability strategy to evolve alongside the product instead of requiring teams to justify years of accumulated changes at a later stage.

Section 2: Commercialization – Collaborations for Organizational and Commercial Readiness

As CGT manufacturers prepare for launch, they focus on the complex logistics required to deliver these therapies. While important, logistics are only one part of commercial readiness. Other considerations involving multiple stakeholders include data sharing, site engagement, and EU-specific needs.

Staying on Track from Manufacturer to Patient

For patient-specific and time-sensitive therapies — such as autologous therapies and even matched allogeneic and gene therapies — maintaining visibility throughout the treatment journey is critical. Manufacturers must be able to track products from collection through manufacturing and administration while maintaining chain of identity (CoI) and chain of custody (CoC) — while coordinating patients, care teams, manufacturing schedules, logistics providers, and treatment centers — to ensure therapies reach the right patient at the right time.

Different stakeholders often manage different parts of the process using separate systems. This can create data silos, limit visibility, and make it more difficult to coordinate scheduling and therapy delivery. It can also cause operational delays.

To address these challenges, manufacturers need a connected approach to data sharing across the supply chain. Digital tools that leverage common identifiers, such as a therapy’s unique CoI number, can help provide real-time visibility into product status, location, and timing, making it easier to coordinate activities across stakeholders.

Setting Up Feasible CGT Programs for Health Systems

A US Health Systems program may look effective with its early clinical results, but long-term success depends on whether it can be implemented and scaled in real-world care settings. Processes that work for a small number of patients in a clinical trial may become difficult to manage for larger patient populations. Hospitals and treatment centers need processes that fit within existing workflows while meeting the unique requirements of advanced therapies.

CGT manufacturers can gain valuable insights about meeting site of care requirements by engaging sites participating in clinical trials early. These sites often help identify operational challenges related to delivery, storage, preparation, and administration that may become barriers during commercialization.

If providers lack confidence in the operational feasibility of a program, they may decide not to offer it. Designing programs with site realities in mind can help reduce friction, support adoption, and ultimately help expand patient access.

Managing Commercialization Requirements in Europe

For many CGT manufacturers, Europe is part of the long-term commercialization plan. However, planning for European expansion often begins later than it should. Regulatory requirements, market access timelines, importation rules, and pricing considerations can all affect launch strategy and should be addressed well before commercialization.

Manufacturers should especially be aware of evolving European market access requirements. Legislation will require marketing authorization holders (MAHs) to launch a product within three years of receiving local marketing authorization. Yet access timelines vary significantly across Europe. It takes an average of 578 days between market authorization and patient access, ranging from 128 days in Germany to 840 days in Portugal, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).⁵

Manufacturers should bring together regulatory, market access, supply chain, reimbursement, and commercialization teams to address these wide-ranging challenges. Taking a coordinated approach can help organizations prepare for country-specific requirements before they become barriers to market entry.

Conclusion: Adopting a Cross-Lifecycle, Cross-Functional Approach to CGT Commercialization

CGT success is often constrained not by scientific innovation, but by operational execution, coordination, and scalability across a complex product lifecycle. Ultimately, patient access depends on how effectively manufacturers navigate the interconnected challenges of development, commercialization, and growth.

It takes a closely aligned ecosystem to move advanced therapies from concept to commercialization to care. Positioned at the center of this ecosystem, Cencora connects developers, providers, and patients to foster collaboration throughout the CGT lifecycle. With deep regulatory expertise, strategic consulting capabilities, and specialized logistics and distribution services, we help manufacturers navigate the complexities of development, commercialization, and growth.

Connect with our expert team today to learn how Cencora can support your product’s journey.

References

1. Food and Drug Administration. Fast track, breakthrough therapy, accelerated approval, priority review. Accessed 26 August 2026. Available at: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
2. European Medicines Agency. PRIME: Priority medicines. Accessed 26 August 2026. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
3. Medicines and Healthcare products Regulatory Agency. Innovative Licensing and Access Pathway. Accessed 26 August 2026. Available at: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway
4. Cencora. Evolving landscape of payer coverage for cell and gene therapies (CGTs): Trends and insights. January 2026. Accessed 26 August 2026. Available at: https://www.cencora.com/resources/pharma/evolving-landscape-of-payer-coverage-for-cgt-whitepaper
5. European Federation of Pharmaceutical Industries and Associations. Imagine if all Europeans had faster access to treatments. Accessed 26 August 2026. Available at: https://www.efpia.eu/about-medicines/access-to-medicines/back-innovation-boost-access/