2023 Recap: Your Favorite Alira Health Publications
In 2023, our dedicated team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, thought leadership, and expert guidance on the life sciences industry. As we wrap up this year, we’re sharing our top ten most popular publications with you.
The 2023 U.S. MedTech Contract Manufacturing (CDMO) Report
This report makes our top ten list for the second year in a row! The 2023 report investigates the current trends in the US medtech outsourcing industry in the post-COVID era. Despite the scarcity of device components and skilled labor, the industry has not only endured but succeeded. Our analysis includes the competitive advantages that drove growth through these unrelenting challenges, insight into the market trends with a critical view of the opportunities and risks ahead, and more.
Content of Integrated Summaries of Efficacy and Safety (ISE/ISS): A Comprehensive Guide
When sponsors prepare an application for the registration of pharmaceuticals for human use, a common technical document (CTD) must be submitted to the regulatory authorities to facilitate the review process. The CTD includes the ISE/ISS, highly technical documents that require expertise and experience to complete and submit successfully. This guide offers insight into the content of the ISE/ISS and how to submit them.
2023 Biologics & Advanced Therapies Contract Manufacturing Report
In recent years, Biologics and Advanced Therapies have emerged as the primary drivers of innovation within the pharmaceutical industry. For this report, our team investigated industry trends, mergers and acquisitions activity, and projected growth in this area which has produced blockbuster drugs and holds promise for patients with significant unmet needs.
A Playbook for Patient Engagement in MedTech in the U.S.
This playbook was developed by the Patient Engagement Think Tank in MedTech, an unprecedented 18-month collaboration established by Alira Health with MassMEDIC, The Center for Patient Advocacy Leaders (CPALs), and six top-tier medtech industry leaders: 3M, Abiomed, Boston Scientific, Exact Sciences, Insulet, and Smith+Nephew. The playbook delivers actionable insights on how the medtech industry can successfully incorporate patient engagement activities at each stage of the product development lifecycle.
Diabetes Management Devices Market Trends 2023
Increasing incidence of diabetes and high mortality rate result in high unmet needs and clinical/economic burden, driving the continued growth of the diabetes management device market. This report analyzes the growth, advancements, and challenges faced in diabetes management devices, including market trends and dynamics in the US and EU4+UK.
2021-22 Review and 2023 Outlook: Report on European MedTech CDMO Industry
This article explores the return to growth for Europe’s MedTech CDMO industry after significant disruption created by the pandemic and considers the risk companies still face given the increased competitive pressure, logistics disruption, and the rising cost of materials and labor.
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the Medical Device Regulation (MDR) in Europe and the opportunities and challenges it presents to device manufacturers. Our team provides details on the proposed extension of the transition period for MDR compliance and discusses key aspects of the proposal. Manufacturers under pressure to recertify medical devices in accordance with MDR need to understand the nuances of the extension to the transition period.
The EU Pharmaceutical Package: Introduction to Changes
After months of consultation with all stakeholders, the European Commission (EC) finally published the proposed Pharmaceutical Package in April of 2023. In this article, our regulatory experts outline nine key changes introduced in the package, including a revised definition of unmet medical need and changes to regulatory data protection. These changes will have a major impact on how drug companies develop and market drugs and earn revenue in the EU.
The Biotech Industry Today: What Leaders Need to Know
In this interview, we share our expertise in providing biotech companies with 360-degree support from funding to commercialization. The story features an analysis of the current biotech industry, the key trends impacting the industry, and the three fundamental functions that biotech executives must address to overcome the challenges of today’s environment.
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