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Cell and Gene Therapy Landscape: Challenges and Opportunities for Biotech and Investors

Published October 19, 2021

Executive Summary The American Society of Cell & Gene Therapy (ASCGT) wrapped up their 2021 conference earlier this year, which covered a range of topics, from new scientific advances to the evolving pricing and market access dynamics surrounding cell and gene therapies (CGT). Trinity had the opportunity to attend the conference, which brought together stakeholders from across the CGT landscape to discuss some of the challenges and opportunities within the space today. In this post we will cover the most…

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Blog

Assessing the Value of Non-Curative Cell and Gene Therapies

Published October 6, 2021

Executive Summary Given the majority of cell and gene therapies to date have offered the potential of a cure, pricing and access considerations are likely to differ for non-curative agents that are entering this space Although non-curative cell and gene therapies have demonstrated clinical efficacy (e.g., for multiple myeloma and wet age-related macular degeneration), manufacturers will need to communicate additional value offerings of these therapies to payers in order to avoid pushback and enhance access potential, such as: Robust evidence…

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Case Studies

Global Value Messaging and P&MA Strategy for a CAR-T Cell Therapy

Trinity completed an engagement to support the successful launch of a CAR-T cell therapy with distinct clinical profile in a competitive landscape. Geographic Scope: Client Situation The client asked Trinity to develop and externally validate global payer value messages and the associated evidence set for their CAR T cell therapy. They also required support with developing a robust global pricing and market access strategy for their asset. Trinity’s Solution Trinity conducted focus groups and In-Depth-Interviews (IDIs) with key payer and provider stakeholders in scope markets to understand…

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The Future of Cell Therapy: What’s Next?

Published November 3, 2020

Executive Summary Cell-based therapies are emerging as a promising strategy for cancer and are generating a lot of interest both academically and industrially To date, cell therapies have been approved in the US by the Food and Drug Administration (FDA) with them showing a lot of promise in a limited number of solid tumors although they have not yet progressed to FDA approval There have been multiple challenges involved when trying to successfully commercialize the products, but the landscape looks…

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Case Studies

P&MA Assessment to Support BD&L Decision-Making

Trinity completed a P&MA assessment for a gene therapy in Leber hereditary optic neuropathy (LHON) to support BD&L decision-making. Geographic Scope: Client Situation The client wanted to understand the current and future market landscape and the resulting pricing and access potential for a gene therapy asset in Leber hereditary optic neuropathy to support their BD&L decision-making. Trinity’s Solution Trinity conducted in-depth interview (IDI) discussions with payers and key opinion leaders (KOLs) to evaluate current treatment practices and price thresholds for LHON, and understand likely payer restrictions as a function of price.…

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White Papers

Commercializing Cell and Gene Therapies: Overcoming the Barriers to Commercial Success

Cell and Gene Therapy (CGT) is an exciting new frontier in the biopharmaceutical industry. The novelty of the technology and market introduces many complexities for companies commercializing CGTs. This white paper analyzes the challenges faced and outlines six key questions to consider for reducing complexity and supporting commercial success: Are we confident in the supply chain right up until administration of the treatment to the patient? Do we have the right pricing, reimbursement, and evidence model in place, not just…

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White Papers

Exploring the Truth of Reimbursement Challenges for Cell and Gene Therapies

Trinity has worked with over a third of companies with cell and gene therapies (CGTs) on market or in Phase 3 clinical trials. Our work has supported business development, launch planning, evidence generation (HEOR, etc.), market access, pricing, and other critical commercial activities to support the development and launch of these therapies. As such, we have seen CGTs morph from a small niche into possibly the most exciting market in pharma. 2019 is poised to be an inflection point for…

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