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Avoiding CGT commercialization pitfalls

By Lung-I Cheng

Focus on these five areas for a successful launch
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5-minute read
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Through novel mechanisms, cell and gene therapies (CGTs) expand treatment options for patients with debilitating diseases. Developing complex CGTs requires meticulous precision to provide patients the care they deserve. Similarly, the commercialization strategies for CGTs also necessitate a keen attention to detail. In this highly competitive field, biopharma companies face distinct obstacles when it comes to bringing their treatments to market. 

Strategic planning plays a crucial role in helping organizations overcome challenges and navigate the complexities of the commercialization process. In this discussion, we will explore when to initiate planning efforts, highlight five key areas that require careful consideration during planning, and offer tips for achieving a successful launch.
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Unique challenges for CGTs

CGT commercialization differs from the commercialization of other biologics due to several factors. Firstly, CGTs are a relatively new addition to the market, introducing complexity regarding approval, reimbursement, and patient access. Furthermore, navigating import and export rules for international logistics poses additional challenges.  

Another hurdle is the need for more standardization across procurement platforms, which can complicate the process of ordering CGTs. In addition, facilities and equipment required for cryogenic transportation and storage, crucial for maintaining the safety and efficacy of CGTs, are not widely available. 

Unlike traditional transitions from clinical to commercial production and distribution, CGTs often require the continued involvement of clinical trial sites at commercial launch, at least initially. As Cencora’s Vice President and Head of Cell and Gene Therapy, Lung-I Cheng, PhD, explains: "What's unique, especially for cell therapy, is that your clinical trial logistics and supply chain is most likely your commercial distribution plan. So if you don't plan for your commercial distribution while still designing your pivotal trial, you often see delays and other challenges and issues at product launch." 

Five areas to focus on when commercializing CGTs 

To achieve successful commercialization of CGTs, it is crucial to prioritize five key areas during the planning stages: regulatory affairs, logistics, distribution, patient support, and market access. By paying attention to these areas early in the planning process, companies can lay a solid foundation for the overall success of their commercialization strategy. 

1. Engage with regulatory agencies early and often 

It is essential to involve regulatory bodies in the early planning stages. By incorporating their perspective, companies can gain valuable insights and guidance that will contribute to a smoother approval process. These regulatory insights also allow the market access team to have informed discussions with payers early.  
Seeking early advice from health authorities is highly recommended. The FDA's Center for Biologics Evaluation and Research (CBER) is committed to collaborating with biopharma companies to facilitate drug development. Similarly, in Europe, several initiatives support biopharma companies. Engaging with the European Medicines Agency for scientific advice has been shown to significantly increase success rate during the approval process.  

2. Understand how the product is handled at site of care 

Efficiently addressing the unique challenges related to storage and transport of CGTs requires careful planning. When cells cannot be transported fresh, cryogenic storage at temperatures below -150°C becomes essential to maintain their viability. It is crucial to consider strategies for ensuring the prompt delivery of CGTs to patients, maintaining optimal storage conditions during transportation, and effectively tracking the movement of these products. Establishing a robust chain of custody is particularly important to ensure that the correct therapy reaches the intended patient in a timely manner. 

Since 2005, World Courier, a part of Cencora, has supported biopharma companies by delivering numerous shipments annually to clinical sites across the globe. To accommodate the diverse transportation requirements associated with CGTs, continuous innovation is key. For instance, some treatment centers need help with handling liquid nitrogen for cryogenic storage or have concerns about managing dry vapor shippers.  

3. Refining distribution strategies 

Planning for commercial distribution of CGTs is a crucial aspect that biopharma companies must consider early on. This is particularly important for cell therapy, where clinical trial logistics may also serve as a blueprint for commercial distribution. It is essential to incorporate commercial distribution considerations into the design of the pivotal trial and collaborate with a partner that can assist in future-proofing the distribution strategy. 

One key factor to consider is leveraging established distribution networks with the necessary infrastructure to safeguard CGTs and established connections with healthcare systems. Cencora, for instance, has made significant investments in infrastructure to support CGT distribution and has successfully distributed several approved CGTs across the United States. Additionally, factors such as easy access to customer support during time-sensitive processes, expertise in navigating federal drug pricing programs, and streamlined financial transaction processes should be considered when selecting a distribution partner. 

4. Prioritizing patient support and services 

Prioritizing seamless service at critical touchpoints is crucial in CGT, as patients are at the heart of this therapeutic approach. It is essential to ensure that patients and their caregivers have access to treatments, timely updates on the process, comprehensive education about CGTs, and support from healthcare providers, nurses, and payers. According to Lung-I Cheng, “Coordination is important because, ultimately, this is about the patients. Cell and gene therapy is an area where patient-centricity is at the core of what we do." 

An illustration of a patient-centric service that also benefits providers and other stakeholders is Cencora’s CGT Integration Hub. This hub seamlessly integrates with existing platforms and expedites the benefits verification process. It provides real-time visibility for providers regarding therapy manufacturing and transportation, enabling them to coordinate patient scheduling effectively so that patients feel supported throughout their journey. Since CGTs are often administered during critical moments or after multiple lines of therapy, offering holistic service and support becomes paramount in ensuring optimal patient care. 

5. Market access, market access, market access 

In an era where payers face competing priorities and budget constraints, biopharma companies must be able to demonstrate value alongside efficacy and safety for their products. By involving payers early on and leveraging their insights, companies can effectively guide their planning process and mitigate potential pricing and reimbursement challenges. Cheng says, “From a provider's perspective, you have to be better than your competitors. Otherwise, why would they onboard your product if there are other choices? For regulators and payers, companies demonstrating value is going to be even more important." The importance of communicating the value proposition of CGTs to gain traction among providers, regulators, and payers cannot be overstated.

Our CGT distribution footprint 

  • ~100 % health system connectivity across the US with established accounts for specialty distribution
  • $65M+ invested in storage infrastructure 
  • 1,150+ sites served and ~ 30,000 shipments completed in 2022 
  • Dedicated 24/7/365 customer service support 
  • Proven expertise to help navigate the complexities of 340B 
  • Streamlined order-to-cash process with proprietary order portal

Connect with our team

Getting started early with the right partner is key to avoiding common pitfalls. To learn more, contact us and download the comprehensive guide to CGT commercialization.


This article may contain marketing statements.  Cencora, Inc. strongly encourages readers to review all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions for CGT commercialization.  

About The Author

Lung-I Cheng
Vice President, Cell and Gene Therapy
Biopharma Services
View Bio