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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Webinars
Available On Demand
This session will discuss trends in the HTA/Reimbursement environment in Latin America and the drivers for value-based health care (VBHC) implementation within the region. The potential benefits of VBHC, stakeholders’ roles in VBHC, contextual barriers and facilitators for VBHC implementation, and potential future impact of VBHC to healthcare in the region will be discussed by a panel of speakers.
Note: The webinar will be presented in Spanish and Portuguese with PowerPoint Slides shown in English.Dr. Hector Castro will moderate the session and…
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White Papers
Providing optimal care to all patients is an imperative that unites the various, interconnected parts of the medical field, from primary care to the pharmaceutical industry to the work of large academic medical centers. Over the past 30 years, there have been exceptional advances in care, treatment, diagnostics, and early identification of disease. Unfortunately, even with these many technological advances, addressing the importance of diversity has been lagging. Since the advent of clinical trials, recruitment has been largely centered on…
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Blog
Published February 18, 2022
Executive Summary
A new pan-European Health Technology Assessment (HTA) regulation that will redefine the processes for the evaluation of new medicines in the EU entered into force in January 2022
Although it will not become fully active until 2025, the new regulation will require EU member states to give “due consideration” to joint clinical assessment (JCA) reports and provide feedback to the European Commission
These new JCAs will only focus on the clinical domain of HTAs and thus they will…
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Briefs
What is keeping commercial data leaders in emerging life sciences companies up at night as they bring their technology to life in preparation for launch? What are the biggest concerns when considering changes to an existing infrastructure? Trinity Life Sciences has partnered with many first launch and emerging companies for decades to find solutions to their biggest technology challenges.
In this Advisory Brief, we pause to reflect upon some of the common missteps we’ve seen companies take when deploying their…
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Webinars
Available On Demand
Life science Competitive Intelligence (CI) is growing in importance and impact. From innovation in technology to the number of products launching to the more connected global marketplace, CI teams are wrestling with the needs of an evolving function. With more data coming at CI teams faster, organizations need to adapt and optimize or be left behind. Pulling from the initial findings of a recent study, Trinity’s team of CI-focused experts share insights and commentary on the opportunities and challenges facing…
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Blog
Published February 2, 2022
The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide earlier and more equitable access to treatments as well as display increased flexibility in the evaluation of new health technologies. As part of NICE’s plan to modernize healthcare, the changes will apply to both digital therapeutics as well as…
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