Cell & Gene Therapy Strategy - Center of Excellence

Turning Cell & Gene Therapy Barriers into Breakthroughs

Driving Cell & Gene Therapy Success with Proven Strategic Expertise

Launching cell and gene therapies (CGTs) requires precision, innovation, and deep expertise to navigate complex manufacturing, market access, and reimbursement hurdles. The Dedham Group stands as the trusted partner for CGT pharmaceutical companies and biotechs, offering unparalleled strategic insights and a proven track record in driving success. From pipeline planning to lifecycle optimization, we deliver comprehensive strategies that integrate customized payer and provider site engagement plans and data-driven decision support tools.

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Learn more about the Dedham Group’s Expertise in Cell & Gene Therapy

Our Tailored Strategies for Cell and Gene Therapy Success:

Enhanced Provider Support

Greater stakeholder collaboration, resource allocation, and cross-department coordination

Provider site selection (e.g., capacity, experience, economic sensitivity, access)
Patient identification and referral support (e.g., genetic testing, cost support)
Provider site certification contracting (e.g., trade agreement terms)
Provider site staff training (e.g., clinical, operational, billing / coding)

Elevated Payer Engagement

Increasing payer cell and gene therapy expertise, management sophistication, and cost containment priorities

Differentiated payer education (e.g., unique discussion materials for sophisticated payers with CGT-specific review team on clinical value)
Risk-sharing opportunities (e.g., innovative payment models)
Novel engagement focus areas (e.g., patient journey, cost per step, certified provider site list)

Novel Distribution & Support Models

New supply chain infrastructure, vertically integrated solutions, and expanded access support

Novel distribution models (e.g., drop-ship, specialty pharmacy “drive-by”)
Novel patient support models (e.g., travel / lodging for government patients)
Vendor involvement in innovative payment model flows (e.g., outcomes-based agreement)
Customer access support with brand.com coverage look-up tool

Coordinated Commercial Operations

Increased infrastructure, cross-functional roles, points of communication, training, and resource needs

Novel order fulfillment model (e.g., internal vs. external roles, manufacturing slot scheduling, patient enrollment platforms)
Relevant policy monitoring & commenting (e.g., DRG, 340B, carve-outs)
Novel field team roles & responsibilities (e.g., cell procurement managers, vein-to-vein planner)

C+G Resources

Thought Leadership

How Healthcare Systems Can Support Cell and Gene Therapy Growth

With the rapid increase in approvals for cell and gene therapy (CGT) products, a critical question emerges: does our healthcare system have the capacity to meet the growing patient demand? The CGT pipeline is continually expanding, with nearly 3,000 assets in development from preclinical through pre-registration phases, according to a report from ASGCT and our sister company, Citeline.

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Broadening Access to CAR-T Through the Community – What is Holding Us Back and What is Needed?

Although CAR-T therapy access has historically been confined to large academic centers and sophisticated community health systems with inpatient capabilities, a growing opportunity exists for broader adoption within community practices.

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Overcoming Barriers:
How Manufacturers Can Tackle Reimbursement Challenges for Cell & Gene Therapies

Cell and gene therapies (CGT) are revolutionary medical treatments that offer potential cures for previously untreatable diseases. Here are some of the biggest challenges to cell and gene therapy reimbursement, and how manufacturers can address them.

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The Clinical Trials Connection:
How Cell & Gene Therapy Clinical Trial Design Impacts Commercial Access

In high-cost categories, clinical trial design has increasing implications on commercial access. Here’s how clinical trial design impacts market access and why pharma needs to develop clinical trial criteria with access and outcomes-based research in mind before clinical trials start.

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5 Barriers to Access for Sickle Cell Disease Gene Therapies

Accessing appropriate medical care for rare conditions is often a long and complex journey. As such, gene therapy developers often begin commercial model design and launch planning 4-5 years pre-launch. The first step is understanding what a therapy is up against and how access barriers have or could be addressed.

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Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng.

The Dedham Group's Jennifer Klarer, M.Sc.Eng., Partner and Head of Cell & Gene Therapy, joins Erin Harris on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Klarer shares a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability.

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Bridging the Gap: What have we learned from an ever-evolving cell and gene therapy field?

Scientific innovation and market reality are almost like an unstoppable force colliding with an immovable object. Research has progressed at a rapid rate, but are we prepared to deal with the challenges of manufacturing and accessibility? Providing that the industry rises to the task, Jennifer Klarer suggests the future could be bright.

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