Briefs
The “molecular optimizer” archetype is a strategy utilized by first-launch companies to optimize existing molecules when developing their first product. Companies using this approach tend to be small and emerging biotech firms that are seeking a foothold to enter the market.
The primary benefit of this approach is that the method offers a higher probability of regulatory approval and streamlines the manufacturer’s path to commercialization. With these benefits come some challenges related to access and pricing of a new product…
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Webinars
Available On Demand
Did you know 62% of products launched between September 2019 and December 2021 underperformed expectations in the first year of launch?
What is going wrong, and how can we get it right? Join Trinity Life Sciences for a thought-provoking webinar to dive into the first white paper in our Industry Impact Series, Picking Winners: Portfolio Management for a New Era.
Hear from Trinity’s Leslie Orne, President & CEO, Herman Sanchez, Chief Business Officer and Chad Faulkner, Partner, as they explore the challenges…
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White Papers
The biopharmaceutical industry is known for its promise of life-changing innovations, but many companies continue to advance the wrong therapies into the clinic, resulting in underperformance and wasted resources. This white paper explores the concentration of activity on well-trodden ground, and the lack of focus on true innovation. With increasing global pricing pressures and policy changes, it is more important than ever to be selective about the drugs that are advanced into the market. This white paper offers insights and…
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Webinars
Available On Demand
Whether you are an emerging, mid-tier or large-tier company preparing for launch, this webinar is a must-watch.
Join us for an informative webinar as our experts dive into Trinity Life Sciences’ latest white paper, the Trinity Annual Drug Index—an evaluation of commercial performance over three years of 58 novel drugs approved in 2020.
Hear from Blair Miller, Krista Perry, Hanson Koota and Smit Mahida from our Strategic Advisory practice as they discuss the impacts of COVID on the 2020 launch…
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White Papers
Trinity Life Sciences has been tracking and analyzing the challenges of commercialization and new product launches in the Biopharma industry for years (see our 2022 white paper, Empowering the Next-Generation Launch Model). One method we have leveraged to track the challenges in commercialization is new product launch performance, comparing first calendar year actual sales with consensus Wall Street analyst forecast estimates at time of launch for novel product (New Molecular Entities) launches within the U.S.
In this white paper, we…
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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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