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The potential of personalized medicine to marshal the body’s own defenses is changing the therapeutic landscape for patients, providers, and the industry. But creating these “disruptive” and highly individualized therapies requires a new approach to commercialization.

In anticipation of its first commercial launch, Legend devised a three-pronged, strategic approach to commercializing a CAR-T therapy. Steve Gavel, vice president of global commercial development at Legend Biotech, details how the young company created the infrastructure to bring the cell therapy to market at an accelerated pace.

Q: Tell us about Legend’s commercial development strategy and what must be considered to ensure commercial success?

A: When developing a commercial strategy for cell therapy, one must first understand the clinical, operational, and economic profiles of the new therapy.

A superior clinical profile is always the goal, but it’s a requirement when you are competing in a market saturated with options. Health technology assessments weigh the incremental benefits of products against their costs, and payors follow suit. High clinical differentiation is the only way to ensure that the value of the drug to a patient population is undeniable before and after approval.

Once the clinical differentiation is understood and the risk-benefit profile is established, the commercial strategy can start to reflect the treatment’s external operational requirements. For example, does the clinical profile constrain us to certain treatment centers? Can patient monitoring be performed remotely or does monitoring need to be performed within a hospital environment?

That’s what I refer to as the operational profile. The operational profile for any new therapy can significantly influence the product’s economic and reimbursement profile. If site of care is not factored in early on, healthcare providers may be unable to obtain adequate reimbursement from third-party issuers, which would force hospital administrators to restrict access for a new therapy.

In addition to reimbursement, manufacturers also need to consider tightening resources in our hospital systems. Hospital administrators may need to create alternative sites of care to manage the ever-increasing patient demand for cell therapies. This is especially true in more prevalent diseases. The historical model of in-patient cell therapy administration and monitoring must change over time to accommodate increased demand.

Speaking of accommodating patient demand, it’s also critical to understand both the manufacturing and operational scale requirements as early as possible in the clinical development process. An early understanding of scale helps account for the long lead times required to build capacity in manufacturing and operations. Without consideration of scale and operating requirements early on, ground-breaking therapies may not achieve their full potential.

The last critical consideration for effective commercialization is cell therapy expertise. Personnel with cell therapy expertise in the sales, nursing support, marketing and CAR-T operating areas can help you scale with speed. When it comes to delivering CAR-T therapy, the commercial team is not just a sales organization; it’s the main line of communication that providers, patients, and healthcare personnel rely on to navigate the complexities of individualized medicine. The autologous CAR-T process entails multiple steps that begin and end with the patient, moving from cell collection to cryopreservation and manufacturing along the way. A robust commercial infrastructure allows all parties to effectively coordinate products and services throughout the patient treatment journey and ultimately achieve a seamless experience for all.

Q: Is Legend’s strategic planning approach a reliable blueprint for future cell therapy launches?

A: The short answer is yes. Our approach is intended to mitigate major commercial risks and identify future market requirements and opportunities. When executed properly, a three-pronged approach should create more access for patients.

Q: What factors have the biggest impact on how biotechs bring cell therapies to market today? How can they keep up with the changing dynamics?

A: Today, most cellular therapies are administered in the in-patient hospital setting. This approach is acceptable in a clinical environment but can be problematic in a commercial environment. Generally, most hospitals are resource-constrained; have limited physical space; and in-patient reimbursement is often not favorable. Covid-19 is also straining hospital resources and is creating an environment in which health care practitioners are reluctant to administer to and admit high-risk, immunocompromised cell therapy patients.

In the near term, the U.S. healthcare system will experience a surge in new cell therapies, so paying close attention to the operational profiles of these therapies is critical. Stated simply, the global hospital ecosystem cannot effectively treat all eligible patients in a hospital setting; there is simply not enough infrastructure to accommodate market demand. In response to this infrastructure challenge, drug developers must work with healthcare providers and administrators to create more flexibility in the administration of cell therapies and the management of patients. This is achieved by developing a comprehensive understanding of a product’s safety profile and developing portable patient monitoring devices to manage safety requirements.

As cell therapies become more widely utilized, drug developers need to consider how site of care administration tactics can be implemented to improve patient throughput.

Lastly, generating both inpatient and outpatient data during the clinical development stage is instrumental to ensuring market adoption in the real-world setting.

Q: What safeguards should biotechs have in place when handling sensitive patient data?

A: Cell therapy products are manufactured individually, patient by patient. Because of this, confidential patient-level data must be carefully managed during the product fulfillment process. To ensure the integrity of patient-level data, drug developers must build and implement sophisticated IT data management platforms in preparation for commercial launch.

In addition to safeguarding data, data management platforms must also serve as the communication hub connecting hospitals, physicians, drug manufacturers, support services, and patients.

Q: Given everything we’ve discussed, what’s one piece of commercialization advice for your colleagues in the industry?

A: When commercializing cell therapies, start commercial planning early and think cross-functionally. I recommend starting the commercial development process at the same time as the clinical plan is under development. Clinical development teams need to understand commercial launch requirements to ensure they are incorporated into clinical trial designs. Once manufacturing and medical are brought into the mix, cross-functional working groups will be indispensable to creating the target product profiles and identifying the optimal performance metrics to measure success. I firmly believe that implementing a three-pronged strategic approach to cell therapies will provide an excellent foundation for success.

Steve Gavel has served as vice president of global commercial development at Legend Biotech since July 2018. He brings over 28 years of commercial experience in biotech start-ups, leading pharmaceutical and medical device organizations.

Most recently, Gavel worked at Celgene Corporation, where he led US CAR-T commercial development activities for their bb2121 program. In this role, he led commercial launch strategy and execution planning in the United States. Prior to Celgene, Gavel led VELCADE marketing strategy and execution at Takeda Oncology, where he served as Senior Marketing Director.

Prior to Takeda Oncology, Gavel held multiple sales, marketing, and market access leadership positions in companies such as Syntex, Immunex, Johnson & Johnson, and IMS Health.

Gavel earned his Bachelor of Science degree in finance and business administration from Millersville University in Millersville, Pennsylvania, USA.