January 2025 Newsletter
Truliant Consulting
Objectivity, skill, and holistic support to deliver against objectives. Right first time, every time.
We survived January ?? – but it wouldn’t be right to write this newsletter without wishing you all a very happy new year!? We hope you all were able to relax, recharge and spend time with family, friends and loved ones and came back to work refreshed.?
We can’t wait to see what unfolds in 2025 and you can be sure we will share our accomplishments, all the latest news within the world of PV and across the industry, with you through these monthly newsletters, so let’s get started…….?
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Digitalizing Product Information in Europe?
The EFPIA, AESGP, and Medicines for Europe have proposed a four-year phased rollout of electronic product information and patient leaflets to replace traditional paper-based inserts. Currently, pharmaceutical companies produce 100 billion paper product information leaflets annually. Electronic product information would provide continuous access to medicinal information via secure digital platforms, improving layout and readability to encourage safe medicine use and enhance health promotion among prescribers and patients. A pilot sponsored by EMA and several national authorities tested electronic product information, resulting in recommendations for its introduction in the EU. With around 90% of EU citizens accessing the internet daily, the adoption of electronic product information not only seems feasible but moreover it seems the most logical next step. For industry, this adoption will translate into cost reductions and potentially improve medicine availability in smaller EU markets. At the same time though, we need to ensure that accessibility of consistent information is guaranteed for the entire population. Although the internet has increasingly become the main source of information for many, there are some minorities for whom this is not the case.? Health authorities should therefore protect these groups and propose alternative solutions to make sure medicinal product information is current and accessible to everyone.?
You can read more here: https://pharmaphorum.com/news/eu-pharma-calls-speedy-shift-digital-package-inserts?
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Artificial Intelligence (AI) Generated Promising Small Molecule Drug??
As we embark on a new year and return to the office, it's clear that AI remains a pivotal force in the pharmaceutical industry. The first drug to reach a Phase IIa trial, fully conceptualized using AI, has emerged. INS018_055 is a small molecule candidate and was identified by AI models as a promising treatment for Idiopathic Pulmonary Fibrosis (IPF), a debilitating disease with a median survival of just 3 to 4 years. This breakthrough comes from Insilico, a Hong Kong-based biotech company that has built its entire business around AI. Remarkably, not only was INS018_055 developed through advanced AI models, but its novel therapeutic target was also discovered using a different in-house AI technology. The challenges of developing a successful drug are well-known, and the role of AI in this achievement highlights the potential advancements we can expect in 2025 from similar technologies.??
To learn more about the candidate molecule visit this link?
At Truliant, we continuously reflect on the implications of AI in the pharmaceutical sector. Last year we collaborated with numerous clients to integrate AI into their processes effectively. Our recent White Paper on AI delves into these advancements and showcases our commitment to leveraging AI for transformative outcomes in the industry.?? You can read our White Paper that was released last year here: https://www.truliantconsulting.com/whitepaperai2024?
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The Windsor Framework?
Agreed upon by the UK and the EU in February 2023, it introduces significant changes to the pharmaceutical industry, particularly concerning the supply of medicines in Northern Ireland.? These changes took effect from?1st?January 2025?enforcing the new rules in the UK around product licensing, labelling and the EU Falsified Medicines Directive (FMD). It ensures that:?
You can find more information about the Windsor Framework here:?MHRA Windsor Framework hub - GOV.UK?
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New Regulation on Health Technology Assessment?
A Health Technology Assessment helps the EU Member States make informed decisions on the use, price and reimbursement of a new medicine or medical device based on its effectiveness, safety and value for patients and society, whilst also considering its impact on sustainability within the healthcare system.??
A new Health Technology Assessment regulation became applicable on?12th?January 2025.? The European Commission states that the Regulation on Health Technology Assessment (HTA) will bring a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. This will help national authorities to make more timely and informed decisions on the pricing and reimbursement of health technologies and streamline the procedure for health technology developers. This will contribute to?faster and wider access to new and more effective innovative products for patients.?
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You can read more about the HTA Regulation here:??New EU rules on Health Technology Assessment?
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Upcoming Events from Truliant?
Webinar News?
We were delighted to bring you the insight of industry leaders and immerse you in topical debates and discussions over the course of last year by way of our webinars.???
Don’t worry if you missed any of them, all of our webinars are available to be downloaded at your leisure here;??
Listen to five industry experts [Richard Wolf, Santosh Cheruvupalli, Nicole Baker and Emma Brookes] guide us through the world of Pharmacovigilance Process and Change Management here: https://www.dhirubhai.net/events/futurevigilance-process-changem7196813803487907840/theater/?lipi=urn%3Ali%3Apage%3Ad_flagship3_pulse_draft_preview%3BsXuqigkeRs2xHXVM0LZmMA%3D%3D???
Join Abhishek Kumar and industry experts Griselda Saldana, Sanjeev Srivastav, Suzanne Foncin and Bruno Ohana to discuss the real-world impact of Artificial Intelligence (AI) and help us to uncover the detail behind the noise here: https://www.dhirubhai.net/events/futurevigilance2-artificialinte7227243712433582080/theater/?lipi=urn%3Ali%3Apage%3Ad_flagship3_pulse_read%3BpQ1EDoPOSPyFhdgLQGn28Q%3D%3D?
Furthermore, you can also catch up on our first webinar discussing digital transformation and putting the patient first on either of these platforms:?
Podcast News?
At the end of last year we concluded our third season of podcasts discussing relevant industry topics with industry experts.???
You can catch up on all three seasons of our “Innovation and the Future of Pharmacovigilance” podcasts from any of these platforms;? ?
?? Apple: https://lnkd.in/epCStTmJ? ?
?? Spotify: https://lnkd.in/esHKmjvT? ?
?? YouTube Podcasts: https://lnkd.in/esZKjJig?
?Future Events??
We are excited to participate and attend conferences in 2025.? Representatives from Truliant will be available to meet at the Bio US in Boston, USA from April 2-4. If you’d like to arrange a meeting please don’t hesitate to reach out to us on [email protected]??
Newsletter Content?
If you are interested in our view/insight into a topic we will endeavour to do our best to cover it in a future newsletter.? Please reach out to Alberto Bertolini ([email protected]) with the details.?