Youssef Lazrak

🔍 𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝘁𝗵𝗲 𝗣𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵𝗧𝗲𝗰𝗵 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰𝘀 𝘄𝗶𝘁𝗵 𝗠𝗘𝗗𝗞𝗔𝗣 We’re excited to share insights from Frank Desiere - PhD MBA in our latest article on the 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰𝘀 𝗠𝗮𝗿𝗸𝗲𝘁! Discover why 𝗶𝗻𝘃𝗲𝘀𝘁𝗶𝗻𝗴 𝗶𝗻 𝗛𝗲𝗮𝗹𝘁𝗵𝗧𝗲𝗰𝗵 is not only a strategic financial decision but also a way to drive transformative healthcare solutions. From early disease detection to personalized treatments, diagnostics are shaping the future of medicine. 𝗪𝗵𝗮𝘁 𝘄𝗲 𝗰𝗼𝘃𝗲𝗿: - The market’s growth, projected to reach $109 billion by 2028. - Trends transforming diagnostics, like 𝗽𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲 and 𝗔𝗜 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗼𝗻. - Cutting-edge advancements, such as 𝗹𝗶𝗾𝘂𝗶𝗱 𝗯𝗶𝗼𝗽𝘀𝗶𝗲𝘀 and 𝘄𝗲𝗮𝗿𝗮𝗯𝗹𝗲 𝗵𝗲𝗮𝗹𝘁𝗵 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝘀. - The opportunities and challenges awaiting investors in this dynamic sector. Explore the full article below and see how MEDKAP, through Dr. Frank Desiere's insights, is highlighting the revolutionary impact of diagnostics in healthcare!

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#News: French drugmaker Sanofi is nearing a decision to invest between 1.3 billion euros and 1.5 billion euros ($1.4-$1.6 billion) at a major production site in Frankfurt, Germany, where it makes #insulin brand #Lantus, newspaper Handelsblatt reported on Monday. The paper cited German government sources as saying Sanofi changed course after initial considerations to transfer Lantus production to France and the company is now close to committing to an upgrade of the German site in Frankfurt's Hoechst district. Sanofi did not immediately respond to a request for comment. Among recent wins by Germany's ruling coalition to attract healthcare investments, Daiichi Sankyo Europe GmbH (4568.T), said in February it would spend about 1 billion euros to boost its work on precision cancer drugs near Munich. U.S. drugmaker Eli Lilly and Company (LLY.N), in November last year pledged to invest 2.3 billion euros to make #obesity and #diabetes #drugs in Germany. Read more from Reuters 👇🏽 https://lnkd.in/eqUbmUuK

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Early access in France will use a new means of real-world data (RWD) collection in a 12-month trial project. The National Health Authority (HAS) will extract data from the système national des données de santé (SNDS; national health data system), a repository of pseudonymised administrative health data collected by public bodies.   A key objective of the 2021 reform of early access in #France was the collection of RWD to support assessment for routine reimbursement. Details of the data required are defined in a protocole d’utilisation thérapeutique et de recueil des données (PUT-RD; protocol for therapeutic use and data collection). For drugs available early before marketing authorisation, the PUT-RD should enable the collection of data on patient characteristics, conditions of use, efficacy (including quality of life) and safety.   The HAS notes that “in practice, and despite the compensation mechanisms that have been put in place, this data collection is complex to implement. It relies mainly on hospital healthcare professionals, whose time is limited and who have little information about these drugs and the effective use of the data collected in return.” The use of SNDS data could complement previous actions to streamline data collection.   The agency already has access to the SNDS, which contains data on patients treated as part of early access programmes because these drugs are billed to the health insurance scheme. In the trial project, the HAS will extract data on the number of patients treated and the context of use of an early-access drug (in particular, patient age, sex, presence of comorbidities, category of prescribing establishment).   An automated programme will extract the data, which will complement data collected via the PUT-RD in assessing early access renewal applications or applications for routine reimbursement. In the future, the automated programme might be upgraded to include the calculation of complex variables, such as an estimate of the dosage or duration of treatment, for specific projects (subject to feedback from a public consultation).   This method of data extraction could be especially relevant for early access after marketing authorisation, which accounted for 58% of early access cases in 2023. Other methods of #RWD collection could thereby focus on drugs approved for early access prior to marketing authorisation—lightening the administrative burden for all parties.   The evaluation of the results from the pilot project will establish whether the SNDS data extraction meets the HAS’s requirements for its assessments (in terms of content and time of availability compared with summary reports), whether it is possible to identify criteria for selecting cases for which producing an SNDS report is relevant and whether the organisational conditions for data extraction are appropriate. The HAS will then decide whether to replace the data requested in the PUT-RD of post-MA #earlyaccess protocols with SNDS data extraction.

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#France's #Sanofi could become the latest #bigpharma company to exit the #consumerhealthcare #business. It is in talks to sell a 50% #controllingstake in its #consumer #health unit #Opella, which employs over 11,000 people and has operations in 100 countries. Sanofi’s move follows similar divestments by other #pharmaceutical #companies such as #GSK and #JNJ. Consumer healthcare will remain a key segment, given strong #demand for #everydayproducts like #vitamins, #skincare and #cosmetics. Then why are these #pharma companies exiting consumer health? Will others follow suit? Read my take here: https://lnkd.in/gRsTRatW

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#Phispers Week 15 - Weekly Pharma News Recap Bonjour, - Vertex Pharmaceuticals bolsters its pipeline for autoimmune diseases with US$ 4.9 bn Alpine Immune Sciences, Inc. acquisition. - FDA approves Carvykti, Abecma as earlier lines of blood cancer treatment. - Bristol Myers Squibb’s schizophrenia drug reduces symptoms without weight gain in phase 3 trial. #Phispers this week - PharmaCompass.com's Weekly News Recap #healthcare #pharmaceuticals #pharmanews #pharmaceuticalindustry #innovation #management #digitalmarketing #technology #startups #marketing #sales #strategy #networking #pharma #biotechnology #pharmacompass https://lnkd.in/gUk2PCCW

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Pierre Fenaux presents LUSPARA trial, sponsored by EuroBloodNet association: Phase II clinical trial evaluating Luspatercept in patients affected with rare inherited anemias. 45 patients are expected to be enrolled in 3 different centers (FR, ES, IT). #ERNeu #ERNs #HealthUnion #EU4Health #ShareCareCure #haematology #European CommissionEuropeanHealthandDigitalExecutiveAgency (HaDEA) #EBNMeeting2024

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#pharma have been doing patient support for a long time. But a new generation of patient support services is emerging, creating significant impact on patient outcomes and experiences with treatments. With my colleagues Glen McCracken and Sharon Yau, we have distilled recent learnings into this article. All based on REAL experiences and evidence!

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With several high-profile manufacturing outlays already in the books in Europe this year, Sanofi is returning to the bloc in a bid to boost production for a long-approved transplant treatment and a relatively new Type 1 diabetes drug. Read more below: https://lnkd.in/eRekbPMj #drugproduction #drugmanufacturing #biomanufacturing

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France: The Pharma-Place-to-Be in 2024! 🌟 Exciting developments are happening in the pharmaceutical world, and France is at the forefront of it all. According to Fierce Pharma, major investments are pouring into R&D and manufacturing in the EU, with France taking a leading role. Sanofi is investing $1.1B in treatments for COPD, Asthma, MS, and T1D, along with over $100M to boost Dupixent and an additional $10M+ for TZIELD. AstraZeneca is committing nearly $400M to its initiatives. Pfizer plans to spend over $500M on R&D in the next five years. These are just a few examples, with other significant investments coming from AbbVie, Novartis, Kenvue, and Chiesi Group. What's particularly intriguing is the dynamic shift we're witnessing: while the EU, particularly France, is becoming a hub for R&D and manufacturing, US companies are focusing on direct-to-patient initiatives. This includes direct contracts with pharmacies, diagnostics, and telehealth providers. 🔄 Produce and Innovate in Europe, Sell in the US 🔄 The future of pharma looks promising with this transatlantic synergy! For more insights, check out the full article from Fierce Pharma: https://lnkd.in/dQ9rB6ks

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A relaxation of evidentiary requirements for HTA in France in some circumstances is highlighted in the latest annual report of the Commission de la Transparence (CT; Transparency Committee). The proposed new approach “seeks to strike a balance between accelerated clinical development and level of uncertainty for the benefit of patients.”   The CT notes that, “while the gold standard remains the randomised controlled trial (the safest design for patients), the Committee now accepts, under certain justified conditions, a reduction in the level of evidence required for reimbursement of health products, by valuing indirect comparisons subject to their methodological quality.”   Specifically, “the results of a study without a comparator arm may now be accepted, subject to 3 essential conditions: ● Duly justified impossibility of evaluating the new drug in a comparative trial; ● Choice of external comparator decided upstream during the drafting of the study protocol provided and not adapted and determined on the basis of the results of the single-arm trial; ● Rigorous matching.   Thus, indirect comparison data of good methodological quality or data from control groups are now acceptable, provided that they are explained and justified upstream by the manufacturer.   Under the new policy, the CT evaluated a drug based on data from an indirect comparison and awarded an ASMR of IV.   The annual report also discloses that the CT will use nuances in ASMR ratings to reflect uncertainties and thus better inform public decision makers: “When it comes to recommending the reimbursement of a new treatment, the Committee will continue to demand a rigorous methodology so that its opinions can always be qualified as scientific, indicating when it considers that the data are not sufficient to provide a complete picture. With this in mind, the new doctrine recognises that ASMR Vs may correspond to several types of situation, in particular, those where the absence of added value is proven and those where a development plan, with a timetable given to the manufacturer, could enable the uncertainty to be resolved.” #France #HTA #indirectcomparison

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In case you missed it, Emmanuel Walckenaer, CEO of Yseop, discussed the importance of accuracy, security and intuitiveness in generative AI applications for medical writing in a recent interview with Euronews. The interview also highlighted Yseop's recent partnership with Amazon Web Services (AWS). Read the full article: https://bit.ly/4c8wTTD #AI #GenAI #GenerativeAI #Clinicaltrial #Pharma #Automation #Euronews #AWS

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Think patient experience does not have an impact? Think again. ''The perception of the pharma industry’s reputation among respondent US patient groups declined in 2023, with 57% rating the industry’s reputation as “Excellent” or “Good”, compared with 65% saying the same in 2022.'' ...sharp declines were reported by respondent US patient groups for: • the quality of pharma’s patient-group relations; • its provision of patient information; and • its ability to improve access to medicines. I would put this in a large bucket called 'Experience'. Magnus Franzén-Rossi would welcome your thoughts as you have spent a lot of time in this space; improving organisational ability to deliver improved patient experience, and quantifying impact. https://lnkd.in/ekZvtp_U

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Very interesting to visualize the revenue evolution of #pharma companies over the many years. They are also a reflection of the innovation brought by #science to the lives of millions of #patients. If you pay attention to the #COVID outbreak years you can see it very clearly.

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Capgemini Life Sciences and Healthcare we have built a practice within #connectedhealth to help #medtech define how to use existing data to shape, deliver and grow new value models and revenue streams. In our latest paper, we dive into the steps MedTech companies need to take to build effective subscription value offerings. From crafting the right product strategies to adapting organizational structures, we explore how these transformations can usher in a new era of value. Discover how subscription-driven models are shaping the future of MedTech— and how your organization can stay ahead: https://lnkd.in/eWpnMTcJ Capgemini Invent Prakash Kadirvelu Wali Hosein Ananya Das Satya Patloori Benjamin Latusek Thorsten Alexander Rall

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One critical factor shaping the future of pharma: science-based transparency 😉 Florent Edouard, an expert in pharma sales and marketing, shared insightful perspectives with us: “Right now, because the patients and the HCPs will have access to neutral AI models, that will give them briefings on the products, on the disease, on the symptoms, on absolutely everything. If you are not transparent, if you are not honest, you will not be heard". ✨ This is just a snippet of our talk show “Pharma Insights”. Watch all full episodes on our website!  https://lnkd.in/dZTWQ-eq    #WebinarSnippet #PharmaInsights #PharmaIndustry #Healthcare

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An “Inclisiran First” Strategy vs Usual Care in Patients With ASCVD! https://lnkd.in/d6862xCQ Full article in the first comment!

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