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How Effective is ANVISA’s Rare Diseases Expedited Approval Pathway [RDC 205]?

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…

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Make Rapid Decisions with Confidence: Trinity’s Approach to Business Development Assessments

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 Evidence…

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Demystifying Government Pricing: A Lens Into Industry Best Practices

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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HTA/Reimbursement Evolution and Priorities for Assessment in a Value-Based Healthcare Environment in Latin America

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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Diversity in Clinical Trials Participation: A Life Sciences Perspective

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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EU Adopts Regulation on Pan-European Health Technology Assessment

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 2022Although 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 CommissionThese new JCAs will only focus on the clinical domain of HTAs and thus they…

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A Playbook for Optimizing Your Commercial Data Environment

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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Competitive Intelligence Complexity in 2022 and Beyond: Making Friends with Volume and Velocity

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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Life Sciences Forecasting: Managing Dynamic Inputs, Calculations and Outputs

Life science forecasters support complex analytical needs, all while grappling with ever-changing assumptions and datastreams. Working in Excel is often one of the few constants, but the comfort of working with a familiar tool frequently becomes a trade-off in functionality as forecasters pursue easy consolidation and communication, greater version control and intuitive scenario planning. Trinity’s forecasting team has focused on life sciences forecasting and modeling projects for 25 years—and that breadth and depth of experience drove the creation of Trinity…

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