Driving Product Success: Navigating The Clinical To Commercial Transition For Autologous Therapies
By Andrea Zobel, Melissa Lattanzi and Jason Ramseth
Autologous cell therapies are some of the most innovative products being developed today, offering targeted, life-extending, and potentially curative treatments for patients. Driven by increased investments and new regulatory guidance, officials anticipate a wave of new cell therapies to reach market by 2024. In fact, there are more than 1,300 active cell therapy trials—a number that has grown significantly in recent years due, in part, to a dramatic increase in CAR-T cell clinical trials. Cell therapies — most of which are of autologous origin — offer tremendous promise for patients worldwide, including those who have conditions where there are few treatment options and no cures. However, the potential of these products could remain largely unrealized if innovators and their partners don’t develop a sound commercial strategy — one that accounts for the unique logistics considerations and the end-to-end solutions needed to support providers, payers and patients throughout the product journey.
As the number of cell therapy agents in the global pipeline continues to increase, it’s critical that therapy innovators take the necessary steps, including identifying the right partners, to navigate the challenges of moving from clinical to commercial development. In order to expand patient access and maximize the potential of these therapies, innovators should consider the following strategies as part of their planning for a successful product launch.
Developing a Sound Commercial Strategy
The product journey for autologous therapies is very similar in the clinical phase as it is in the commercial stage, which is unique compared to traditional branded pharmaceutical products. The difference lies in the scale — more patients are being treated and more centers are administering the product in the commercial phase. An additional nuance when moving from clinical to commercial setting requires innovators to leverage partners who deliver a variety of services, from distribution and order-to-cash support to payer coverage, provider reimbursement and patient support programs.
The decisions therapy innovators make in the pre-clinical and clinical trial phases dictate the future success of their products. With that in mind, innovators should engage partners early in the development process so they can build scalable and reliable processes that support patient, provider and payer requirements and drive commercial success. Given the complexity of these therapies and the interconnectivity required, pharmaceutical companies and their partners each should establish a cross-functional team of leaders that have a deep understanding of the nuances of cell therapies and their specific roles. It’s also critical that innovators and their partners develop robust, end-to-end plans that map out the product journey and value streams, outlining how the process will work and accounting for a variety of scenarios. Knowing these therapies are highly unique, innovators should prioritize exception management.
As part of the planning process, innovators need to consider a variety of questions, including which—and how many — sites of care will administer the therapy. For example, an academic medical center will likely have different needs than small community physician practices, which may not have as many resources or staff dedicated to facilitating payer requirements or patient support services. Another key component is provider education. Innovators and their partners need to ensure the broader prescribing physician base understands which patients are eligible for the therapy, how to refer them and how they can support follow-up care. As with any novel product launch plans, access to the right data is critical. In the early stages of drug development, innovators can leverage data and clinical information to address key questions, ranging from market potential and clinical trial design to care coordination. For example, therapy innovators can use data to identify patients who may benefit from their product and the healthcare facilities currently treating them. Innovators must also work with their partners to gather data and real-world evidence that supports their product value story, both pre- and post-launch. Now more than ever before, payers seek access to credible product value information earlier in the development process. With access to the right data, innovators can build a strong value proposition to support long-term coverage.
Building Logistics Platforms for Secure, Reliable Deliveries
Given their unique composition, autologous cell therapies introduce new challenges and considerations to the supply chain. Innovators and their logistics partners must manage two time- and temperature-critical supply chains — first, from the patient to the manufacturer and then from the manufacturer back to the patient. Most products have an extremely limited shelf life — often less than three days — requiring supply chain partners to deliver these products around the world within a narrow timeframe and temperature range. Cryogenic storage (at -196 degrees Celsius) can extend the shelf life of these products, enabling long-distance deliveries. Logistics partners that offer dry shippers as well as a global network of cryogenic charging centers and charging stations can support the secure and reliable distribution of these therapies around the world, helping innovators expand product access.
When building a supply chain strategy, innovators and their partners also need consider country-specific regulatory requirements as well as tracking technology, like monitoring solutions, that can provide increased visibility throughout the supply chain. When transporting cell therapies, traceability is paramount. Innovators, in collaboration with their partners, need to deploy solutions that can track and transmit metrics in real-time, providing proof of shipment stability and enabling teams to mobilize, if needed, to take corrective measures. Ultimately, the shipment of these therapies demands near flawless execution throughout all phases of distribution. Innovators need to establish a logistics strategy even before the first patient in the first clinical trial is treated. The logistics strategy, which will need to be ready for scale up after launch, must involve collaboration among the manufacturer, logistics partner and healthcare providers to ensure products are delivered on time and in the right condition.
Leveraging Technology to Create a Connected Ecosyste
Bringing autologous cell therapies to market requires a high degree of integration among all stakeholders. Because the clinical and commercial phases are very similar, the partnerships and processes are often the same throughout the product journey. As such, it’s critical to establish meaningful partnerships early in the development process and create a connected ecosystem, starting as early as possible including site onboarding and eventually patient engagement. As far as the repeatable processes for every patient, the cycle starts with patient enrollment and coverage research all the way through to treatment and post-treatment patient outcomes follow-up. Technology platforms not only provide real-time tracking capabilities but can also play a vital role in enhancing communication among all stakeholders and creating supply chain efficiencies. Access to the right technology solutions and data is critical to integrating and orchestrating every aspect of a clinical program and commercial product journey, as it enables supply chain partners to establish a comprehensive chain of custody, chain of identity and traceability throughout.
In order to capitalize on this momentum and bring novel cell therapies to market, innovators need to prioritize planning early in the development process. By engaging partners that offer modern, flexible and scalable, end-to-end solutions that have pre-build integrations, innovators can build a strategy to move from clinical to commercial effectively scaling their operations through an interconnected approach to maximize patient access and product success.
Andrea Zobel, Senior Director of Personalized Supply Chain, World Courier (a part of AmerisourceBergen)
Andrea Zobel leads World Courier’s Cell and Gene Therapy and Direct-to-Patient service lines, with a focus on defining strategy, driving growth and solving operational and process challenges which arise from the complexity of these shipments. With a wealth of expertise and experience gained across academia, pharmaceutical services and clinical trials logistics, Andrea has served in a number of senior leadership roles in research and development, clinical trial supply chain as well as product and project management before joining our team in 2021.
In parallel, Andrea is an active member of the ISPE (International Society for Pharmaceutical Engineering), author for the PDA (Parenteral Drug Association), HBA (Healthcare Business Women Association) and the female manager network of the VBU (Verband der Biotechnologieunternehmen).
Melissa Lattanzi, Senior Director of Channel Strategy, AmerisourceBergen
Melissa Lattanzi is Senior Director, Channel Strategy for AmerisourceBergen’s Strategic Global Sourcing team. She is responsible for consulting with brand, specialty and advanced therapy manufacturers on channel considerations in order to enhance product access and commercial success. Melissa engages manufacturers in their commercialization efforts by bringing together solutions from across the AmerisourceBergen enterprise. Additionally, she supports and leads internal efforts to develop AmerisourceBergen’s advanced therapy strategy.
Jason Ramseth, Chief Product Officer, TrakCel
Jason Ramseth is a senior IT and customer experience leader who drives strategy, business processes, and digital solutions to help biopharmaceutical and emerging cell & gene therapy companies bring new therapies to market. He has over 19 years of cross-functional life sciences experience anchored in optimizing customer experience and automation. Previously, Jason has held leadership roles at Juno Therapeutics-BMS, Amgen and Oracle.