Shaping A Digitally Enabled Commercialization Road Map For Your Cell/Gene Therapy Company

By Anna Ivashko, Clarkston Consulting

The cell and gene therapy (CGT) space is unique in its commercialization requirements. With a typical focus on rare disease, CGT organizations inherently work with small patient and key opinion leader (KOL) populations, and they often receive orphan-drug designations that expedite their approval and can lead to compressed launch readiness timelines. These factors make it critical for commercial, marketing, and digital leaders to understand key business decisions that shape the digital backbone of your commercialization road map. Focusing on CGT companies in the gene therapy and allogeneic cell therapy spaces, this article outlines some of the key questions to ask up front that will enable easier, cross-functional, and strategic decision-making.

Commercial Operations

In preparing for commercial launch, CGT organizations have many decisions to make about the structure of their commercial teams that drive their needs for commercial technology. Aligning strategically on building a commercial field team in-house vs. outsourcing shapes the landscape required for enabling commercial capabilities.

Organizations that choose to outsource focus on technology solutions that support the collection and processing of analytics from their outsourced partner, whereas organizations that build in-house field teams face a delicate balance of establishing foundational capabilities that can scale for the future. Fundamental among these capabilities are:

• commercial customer relationship management (CRM) platforms;
• master data management (MDM) sources;
• data sets required for targeting strategy; and
• tools to support territory alignment and compensation.

Depending on the size of the target KOL and patient populations, some capabilities can remain manual (e.g., on spreadsheets) until scale and complexity necessitate a change.

More advanced analytics capabilities, such as enabling CRM with next best action algorithms, are best implemented once the rush of launch has passed and the organization has achieved steady state; however, keeping these capabilities in mind during initial design will make CRM more scalable to adopt these functionalities in the future.

To develop your commercialization road map, commercial leaders should consider:

• Will the field capabilities be outsourced or built in-house?
  • For in-house field team: What is the strategy for targeting, territory alignment, and compensation?
  • For outsourced partnership models: What are the data feeds for transparency reporting and sales performance analytics that will need to be incorporated in contracting?

Marketing Operations

To enable marketing operations for launch as well as scale, CGT organizations should focus on technology solutions that support marketing materials review and digital asset management. Leaders should focus on establishing not just a platform but also a set of processes that will enable compliant review and management of marketing assets. This means taking volume and more advanced concepts (e.g., modular content) into account when enabling the launch-critical functionality (e.g., medical, legal, and regulatory affairs [MLR] review and 2253 submission workflows). Building with volume in mind will ensure process limitations don’t slow down material review in the future.

To develop your commercialization road map, marketing leaders should consider:

• Will personal and/or non-personal promotion be used to support drug launch or subsequent market entry?
• Will digital assets be developed in-house or outsourced to agency partners?
  • If leveraging agencies, what role will these partners play within the material review and digital asset management process?

Digital

In today’s digital world, a CGT organization’s digital function is its mechanism to unify the in-person experience that healthcare provider (HCPs) have with the virtual touchpoints throughout their journey. The goal is to make the digital experience seamless for the end users and scalable for the organization as it grows. This means that along with foundational websites to support launch, CGT organizations need to focus on developing the infrastructure that connects these digital presences with marketing automation, ensures GDPR compliance, and collects analytics to create a 360-degree view for the physician for the field team.

To develop your commercialization road map, digital leaders should consider:

• What digital landscape is in scope for commercial launch (e.g., disease awareness site, branded site, social media presence)?
  • Which of these have entry points for individuals to sign up for updates?
• Will marketing automation and triggered email capability be enabled for launch?
• What is the level of segmentation data available to enable personalized content suggestions?

Patient Services

Within a rare disease landscape, a CGT organization commonly invests in building patient services capabilities to support the patient throughout their journey from enrollment to adherence. To enable this function, CGT organizations establish a patient enrollment portal and a back-end patient services CRM with relevant call center capabilities and analytics.

Aligning with marketing on the patient engagement strategy¹ will help you design a patient portal that is informed by the disease state (e.g., simple interfaces for patient populations with cognitive symptoms). Launching a solution that will scale to support a multi-product pipeline helps focus design decisions that will eliminate major overhauls down the line.

To develop your commercialization road map, patient services leaders should consider:

• In what markets do we plan to enable a patient services function?
  • Will these be outsourced or built in-house?
• What decisions around site of care and reimbursement are likely to create pinch points in the patient’s journey where they require additional support?
• What patient education do we plan to make available prior to enrollment in therapy?

Positioning Your Commercialization Road Map For Success

Regardless of the answers to the above questions and the decisions you ultimately make, there are two key factors to keep in mind: 1) maintain a minimal viable product mindset to ensure your choices in the present allow you to reach your future vision, and 2) ensure cross-functional decisions are consistent to the patient and physician experience you look to enable.

Maintaining a Minimal Viable Product Mindset

Across the commercial organization, keeping a minimal viable product mindset² ensures you’re not investing in all the bells and whistles but enabling a fit-for-purpose technical solution with scalable processes that won’t prevent the implementation of the more advanced tactics down the line. Limiting up-front investment does not mean thinking small, however. While robust AI capabilities may not be on the table for launch, initial design of core systems can take data requirements into consideration that can support making these a reality in the future. Developing a long-term strategy with short-term goals will help commercial leaders make balanced investments that scale for the future.

Prioritizing Cross-Functional Collaboration Outside of the Commercial Organization

Outside of the commercial organization, considerations around label, safety, and distribution can impact your commercial team.

• Supply Chain: Alignment with supply chain counterparts is, of course, crucial for commercial leads to understand the label implications and supply forecasts.
• Medical Affairs: Partnership with medical ensures physician interactions have a seamless look and feel across the organization and commercial teams have a clear path to facilitate adverse event reporting, complaint handling, and medical inquiry responses.
• Clinical: Lessons learned sharing across the clinical and commercial organizations can provide the commercial team with early signals for typical discontinuation reasons and opportunities to continue to improve the patient journey.

Enabling A Unified Digital Path To Commercialization

Ultimately, it’s keeping a one-team mindset and the patient at the center of your decision-making that enables a unified path to commercialization across the cell and gene therapy organization. Understanding the impact of various people and process decisions allows commercial leaders to make timely technology choices that scale for the future. Further, adopting an enterprise mindset allows commercial leaders to learn from your clinical and medical counterparts how to better serve the patient on their path to treatment.

References

1. Ivashko, A. (2022, April 5). Personalizing the Patient Experience – A Digital Approach for Pharma. Clarkston Consulting. https://clarkstonconsulting.com/insights/digital-approach-for-pharma/
2. Ivashko, A. (2022, February 9). 2023 Life Sciences Sales and Marketing Trends. Clarkston Consulting. https://clarkstonconsulting.com/insights/2023-life-sciences-sales-and-marketing-trends/

About The Author:

Anna Ivashko is a manager at Clarkston Consulting with 13 years of experience in the life sciences industry. Ivashko has supported businesses in both developing digital strategies and managing their implementation. She is experienced in commercialization, digital strategy, patient and physician experience, and digital health technology implementation.