Scientific Publications
OBJECTIVES: Endogenous Cushing’s syndrome (CS) is a rare endocrine disorder characterized by chronic cortisol overproduction. Our objective was to summarize the economic and health-related (HR) quality of life (QoL) burden of CS and evaluate post-treatment burden.
METHODS: A systematic literature review (SLR) using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was conducted to identify peer-reviewed manuscripts and conference abstracts published in English from 2015 to December 4th, 2020, in PubMed, MEDLINE, and Embase.
RESULTS: Forty-five publications were included. Data…
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White Papers
The U.S. health economics and outcomes research (HEOR) field has seen many changes over the last decade, including significant growth driven by payers, regulators and clinicians who are increasingly looking to Real-World Evidence (RWE) as a valuable source for patient-level data. To understand the implications of this growth, the Trinity Life Sciences Evidence Strategy team sought to gain a multi-disciplinary view on where and how HEOR experts see the field evolving and to better understand how HEOR capabilities can be…
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Briefs
Learning and Development leaders within life sciences have led and managed change like never before. The global pandemic brought live customer engagements to a halt and an intense focus on using time for enhanced development. To deliver, Learning and Development (L&D) teams had to identify resources to meet the expectations of stakeholders while redesigning and virtually-delivering to learners. In most scenarios, L&D teams were learning at the same time as their audiences.
This study assesses the current landscape of L&D,…
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Blog
Published April 8, 2022
The Assessment Process of Innovativeness of a New Medicine in Italy
In April 2017, AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) released an upgraded algorithm to assess and evaluate the level of innovativeness of new drugs seeking reimbursement from the EUR one billion innovative medicine fund made available by the Italian MoH (Ministero della Salute, Ministry of Health).
The algorithm introduced in 2017 provides a multi-dimensional approach: innovativeness will be judged by AIFA’s CTS (Commissione Tecnico-Scientifica, Technical and Scientific…
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Webinars
Available On Demand
Join Trinity Life Sciences for a webinar that explores the findings from our TGaS report entitled, ‘Commercial and Medical Affairs Leaders Landscape 2022’. The study is based on the responses of 35 Commercial leaders and 24 Medical Affairs leaders representing 56 separate biopharmaceutical companies.
Commercial and Medical Affairs teams continue to play an important role in healthcare innovation and the value of having cross-functional collaboration is more critical than ever.
Join us for a dynamic discussion as we cover the…
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Blog
Published March 29, 2022
Executive Summary
French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement immediately after the evaluation by the Transparency Committee (TC)
In these cases, price negotiations will start while the new therapies are already on the market
This new reform started in January 2022 as part of a two-year pilot project and is expected to significantly reduce the average time…
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White Papers
The Example of ASH 2021
Medical conferences are designed to bring bright minds together and pique interest and curiosity. The American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), European Society for Medical Oncology (ESMO), Gene Therapy for Rare Disorders, and other medical conferences play an important role in disseminating clinical and scientific information. Attendees range from physicians to investors, and the conferences provide a forum for peer-to-peer interactions, exposure to current research, innovative trends and an environment…
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Blog
Published March 18, 2022
Key Takeaways
An analysis was conducted of all the orphan therapies registered by the FDA and ANVISA before and after 2018 to effectively evaluate approval times once the RDC 205 pathway was implemented. The main takeaways from the analysis can be found below:
The difference between FDA and ANVISA time to approval for orphan drugs is four times shorter after the implementation of the RDC 205 / 2017 pathway
The RDC 2015 pathway regulated the deadlines for the regulatory and…
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Webinars
Available On Demand
Life science companies are often faced with situations that require quick decisions—from triage and/or pre-diligence phases through full due diligence. Trinity’s expert team routinely provides time-sensitive business development support, delivering robust insights and evidence-based answers in days. Come join us for a dynamic discussion on evaluating Business Development opportunities in life sciences.
Key Webinar Topics
What are the best approaches, data and tools to meet your business needs within your time horizon?
How can you leverage rapid access to Real-World…
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Webinars
Available On Demand
Companies frequently contract with various government channels as part of their contracting strategies. Each channel requires statutory price reporting, which drives manufacturer rebate calculations and/or provider reimbursement. With significant penalties for non-compliance and real financial impact on the bottom line, there is no room for error with government pricing calculations. Dynamic regulations add to the complexity.
Join TGaS’ pricing and contracting experts for an exclusive webinar for pre-commercial and emerging life science companies. We will discuss common challenges that companies…
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