Blog
Published November 9, 2021
In 2020, Trinity assessed three applications developed to treat Opioid Use Disorders (OUD) (e.g., reSET-O, Connections, DynamiCare) through the lens of ICER conducting a cost-effectiveness evaluation. Only a year later, several more health tech startups have adopted a preventative outlook and seek to address chronic pain with digital health tools (e.g., phone applications). A key focal point is the current public health issue faced by the US with ~2.1 million Americans diagnosed with OUD.
These applications, including Clearing, Curable, Remedee Labs, Swing Therapeutics…
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Webinars
Available On Demand
Whether you are preparing to deploy your commercial data environment or considering changes to your existing infrastructure, don’t be left wondering. There is a lot to consider from both a strategy and day-to-day operational perspective to ensure you are making optimal decisions.Trinity Life Sciences invites you to join us for a webinar created specifically for emerging and pre-commercial life sciences companies. After working with many companies in your shoes, we have compiled the most important “Did You Knows.” Come learn…
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Blog
Published November 2, 2021
Executive Summary
In March 2020, the FDA amended its classification of add-on insulin products, changing the approval pathway from that of a chemical drug follow-on to a biosimilar and more closely aligning with the EMA’s longstanding biosimilar insulin approval pathway
The FDA approved the Semglee Pen (insulin glargine) as the first product through the new biosimilar insulin approval pathway in July 2021; the Semglee was priced as almost three times less costly in the USA than the previously approved biosimilar…
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Blog
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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Webinars
Available On Demand
October 28, 2021 | 1:00-1:45 pm ET
Trinity MedTech, a part of Trinity Life Sciences, invites you to our webinar, MedTech in the Post-COVID World: Where Do We Go From Here? We will share data from our real-world evidence team on key sectors within the broader MedTech industry to show the impact of COVID on different MedTech lines of business. We will also explore what the implications are moving forward for companies/brands. In particular, what are best practice companies/brands doing…
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White Papers
The Example of ASCO 2021
While people were expecting to return to in-person conferences soon, the emergence of the Delta variant and the possibility of future unknown variants, combined with uneven vaccination rates, has created significant uncertainty about how soon that can happen. Trinity Life Sciences wanted to understand what perceptions medical conference attendees had of the new virtual conference world, what advantages and disadvantages they saw in it, and how manufacturers performed at engaging their audiences. We performed a…
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Blog
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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Webinars
Available On Demand
December 1st, 2021 | 1:00 pm EST
In today’s highly competitive market, innovation and creativity are critical to create a strong Brand Strategy that supports meaningful differentiation. A key challenge for life sciences companies in 2022 will be to identify the clearest strategies to address brand performance and assessing brand health for their unique context. Whether your brand is on-market already or is preparing for launch, leveraging a nuanced, evidence-based view of performance drivers – from prescriber adoption, to payer…
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Blog
Published September 30, 2021
Written by Caspar Kengeter and Manon Ricard…
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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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