Blog
Published June 20, 2025
Reflecting on the first half of 2025 including data from AACR, ASCO and EHA, we see several notable trends continuing to shape the oncology landscape. While development follows momentum observed the last few years, these learnings provide a clearer understanding into the next wave of innovation.
Immunotherapy Moves Earlier in the Journey
One of the most notable themes is the continued momentum of PD-L1 therapies moving into earlier lines of treatment. New data supporting neoadjuvant use in solid tumors suggests…
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Blog
Published June 13, 2025
March 2025 marked a pivotal moment for pharmaceutical and biotech companies operating in the European Union (EU) as the first two molecules began to proceed through the Joint Clinical Assessment (JCA) process. At a recent seminar hosted by Trinity Life Sciences, stakeholders gathered to explore the implications of this new regulatory framework and how to prepare for it.
What is the JCA?
The JCA is a centralized EU initiative designed to harmonize the clinical assessment component of Health Technology Assessments…
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Webinars
White Paper & On-demand Webinar:
This report, the seventh in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. We provide a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2021, scoring each on its commercial performance, therapeutic value and R&D investment.
2021 saw 40 unique drug and biologic approvals, of which ~33% (13/40) were Oncology, followed by…
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Blog
Published January 24, 2025
On January 20, 2025, CMS announced the set of fifteen drugs targeted for the second round of Maximum Fair Price (MFP) “negotiations” under IRA. With the outcomes of the first price “negotiations” announced only last August, the IRA MFP process is still in its early development and there remains uncertainty over how it will evolve – particularly in terms of the extent to which CMS will aim for true drug cost reductions vs. generating political capital via nominal “savings” on…
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Blog
Published January 29, 2024
Introduction
In the summer of 2023, many oncologists and cancer patients faced an impossible choice. Amidst many challenging treatment decisions, they had to determine how to proceed without two mainstays among oncology therapeutics: cisplatin and carboplatin. While it can sometimes be expected that there may be delays for the newest and most innovative treatments to reach patients, both cisplatin and carboplatin have been available for over twenty years, are used frequently in oncology regimens and are not considered particularly expensive.…
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Blog
Published January 12, 2024
Introduction
The Trinity Life Sciences’ team recently attended the 65th ASH Annual Meeting and Exposition from December 9-12, 2023, in San Diego, California. The conference brought together physicians, scientists and industry experts to share and collaborate on advances in understanding and treating blood cancers and blood disorders. Below are a few of the key insights that the Trinity team observed during the conference:
Advances in CAR-T Therapy: Expansion into New Targets and Therapeutic Areas
Numerous groups across the industry are…
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White Papers
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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Blog
Published November 7, 2022
Executive Summary
The Oncology Care Model (OCM) was designed to test whether financial incentives can improve care and lower Medicare (U.S. federal health insurance program) spending, emphasizing value-based care within oncology treatment. This model supported a wide range of services such as high-cost emergency room visits, 24/7 access to clinicians and specialized, patient-specific coordinated care plans.
The Enhancing Oncology Model (EOM) builds on the structure of OCM with an increased focus on managing provider risk, promoting patient-centric care and addressing…
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Scientific Publications
Cremophor EL (CrEL) is a solubilizer used in paclitaxel and is associated with side effects (i.e., hypersensitivity reactions, peripheral neuropathy). Current CrEL-containing therapies require long infusion times (2-4 hours) and pre-medication with steroids to manage these side-effects. However, the holistic burden of CrEL on patients is not well studied. This study aimed to characterize the burden associated with CrEL-paclitaxel treatment on patients with ovarian cancer, including clinical, safety, and quality of life (QoL) implications.
Authors
Diana Brixner, Anke-Peggy Holtorf, Ayesha…
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Blog
Published September 27, 2021
Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program is intended to be used as an adjunct tool to the review of digital scanner slide images from prostate biopsies.
The program was reviewed through the De Novo pathway, a regulatory pathway for low-to-moderate risk novel devices. The FDA authorization is based…
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