Blog
Published January 10, 2025
Cell and gene therapies (CGTs) have ushered in a new era of medicine, offering patients transformative, even potentially curative solutions, with a single treatment. Despite the clinical promise, barriers to patient access remain given administration complexity, gaps in patient outcome evidence and high costs. As cell and gene therapies become available in new indications beyond oncology and rare pediatric diseases, developers of innovative therapies need to develop strategies targeting patients, providers and payers to overcome these challenges and promote access…
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Trinity Life Sciences is pleased to release our highly anticipated white paper, the Annual State of Global Market Access. This year’s white paper focuses on six key global market access trends and provides payer perspectives on these trends. We explore the consequences of new therapeutic advances and policies aiming to control costs globally and the impacts for pharma manufacturers.
Register for this webinar for a deeper dive into a few trends in the white paper. Join experts from our Evidence,…
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White Papers
In 2023, the life sciences industry saw key therapeutic advances in sickle cell disease, obesity/weight management, and Duchenne muscular dystrophy, among others, and the continued approvals of therapies with cutting edge mechanisms, including the first CRISPR therapy. While 2022 was characterized by accelerated development processes and the rapid evolution of therapeutic standards, 2023 featured increased implementation of cost-effectiveness policies and the emergence of the consequences of these pricing controls and cost-effectiveness measures, including the Inflation Reduction Act (IRA) and Germany’s…
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Blog
Published February 15, 2024
2023 was a busy year for cell and gene therapies (C>). There were regulatory approvals in the U.S. and EU, including both in rare pediatric conditions with no current effective options (e.g., Duchenne muscular dystrophy (DMD)), as well as in indications where competition is better established (e.g., hemophilia A and B).
Towards the end of the year, the FDA approved not one, but two sickle cell gene therapies on the same day, creating instant competition between them. One of these…
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Cell therapies are becoming increasingly incorporated as late-line standards of care across relapsed/refractory oncology indications, with an expanding ability to improve outcomes for a diverse set of tumors and patient subgroups. As the next frontier of personalized and precision medicine continues to grow, Natural Killer (NK) cell therapies offer the potential to penetrate untapped needs across a variety of cancers. However, enthusiasm surrounding the opportunity offered by NK-based technologies has fluctuated over recent years. Several large pharma leaders have made…
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How can companies maximize their potential when launching a gene therapy product?
Gene therapy commercialization is in its infancy. Limited commercial precedent creates significant difficulty in modeling gene therapy revenue and uptake. The single administration nature of the products also presents a unique challenge for companies as the eligible patient population decreases over time.
In this webinar, Trinity Life Sciences’ cell and gene therapy experts evaluate the factors that are unique to forecasting gene therapy markets and share what companies…
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Gene therapies’ single administration nature presents a unique commercial challenge for biopharmaceutical companies; unlike traditional small molecule or biologic therapies that can be dosed chronically or repeatedly on an “as needed” basis, the one-time per patient administration of a gene therapy means that as time passes, the eligible population decreases in size.
In this white paper, Trinity Life Sciences’ cell and gene therapy experts explore the unique opportunities that life sciences executives can utilize to unlock eligible patient populations and…
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Secure success in bringing your novel therapies to market with Trinity’s innovative, holistic approach to valuing early-stage assets.
Biopharma companies have been experiencing record levels of growth in recent years through M&A, co-developments, joint ventures, licensing agreements and other partnership deals. It is unlikely that this accelerated growth would have been sustained using traditional methodologies that are less able to generate realistic valuations for complex innovative therapies. Using traditional valuation methods, we likely would not have seen the commercialization of…
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Blog
Published August 9, 2022
It’s been 10 years since the first pediatric patient was treated with chimeric antigen receptor T-cell (CAR-T) therapy for her acute lymphoblastic leukemia. At the time, the approach to engineer immune cells was a novel, ground-breaking concept. In the subsequent decade, research into this space had continued to advance. Equally importantly, the patient has remained cancer-free, serving as one of the most visible examples of the impact this type of therapeutic may have for patients with complex or difficult to…
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In 2018, Trinity Life Sciences published a white paper titled, How to Approach Asset Valuation in Pharma & Biotech: Putting a price tag on emerging therapies. At the time, pharma and biotech firms were seeing venture investment growth of ~20% per year. This trend has only accelerated alongside the value of co-developments, partnerships, joint ventures, licensing agreements and other deals nearly doubling from 2019 to 2020. Quantifying the value of underlying assets throughout the clinical development process remains vital to…
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