Frédéric Girard

How to save a critical medicine? At Delbert Pharma we follow 3 main steps: ✅ UPDATE the marketing authorization file to meet the requirements of the health authorities 🏭 RELAUNCH production by identifying the right supplier in France or Europe and aligning manufacturing processes with GMP 🤝 COLLABORATE closely at each stage of the project with health authorities, our mission translates into a long-term commitment, sometimes over several years, and it is at this cost that we take up the challenge of preserving pharmaceutical heritage. #DelbertPharma #MissionDrivenCompany #PatientsFirst

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🚀 The challenging journey of Digital Therapeutics. Despite the slow adoption and skepticism of regulators, DTx could enhance patients’ journey and strengthen clinical outcomes 🚀 At the recent digital therapeutics (DTx) France event, Murray Aitken, Executive Director of IQVIA Institute, shed light on the challenges facing DTx in the U.S. Despite its reputation as a digital health haven, the U.S. market remains fragmented and slow to grow compared to countries like Germany. Key Takeaways: 🧩 Fragmented Market -Multiple reimbursement pathways and cautious post-pandemic investments have slowed U.S. growth. -Companies like Pear Therapeutics have struggled, while others like Biofourmis have downsized despite significant funding. 🔬 Potential in Clinical Trials -Digital biomarkers in clinical trials can enhance the credibility of DTx applications. -This integration could help overcome the skepticism of regulators and clinicians. 💸 Diverse Reimbursement Models -The U.S. offers several reimbursement pathways: direct-to-consumer, employer negotiations, and insurance collaborations. -Programs like Medicare and integrated health systems, such as Kaiser Permanente, are adopting DTx solutions. For example, Kaiser Permanente has over 150,000 patients in remote monitoring programs for diabetes and hypertension. 🌟🚧 Success Stories and Challenges -In France, companies like Luna and Poppins are successfully navigating mixed reimbursement models. -Lucine’s Endocare, although sold, was a scientific success, showing the potential even amidst commercial challenges. 📈 Growing Acceptance -Digital tools and biomarkers are gaining traction in clinical trials, improving acceptance among clinicians and regulators. -Progress is notable in areas like oncology, multiple sclerosis, diabetes, autism, and depression. The path for DTx in the U.S. is challenging, but integrating digital health tools into clinical practice and research holds promise for the future. 🚀 Antoine Bassel Amer

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Very happy that our first vaccine trial is a success 😊: ✅ First subject included in EMEA ✅ First subject randomized 1 day after activation ✅ All allowed recruitment slots filled (incl. allowed age ranges) ✅ 0 protocol deviations so far (confirmed by the CRA last Friday) ✅ 0 screenfailures so far (thanks to an extensive pre-screening) ✅ Compliments about the nice source and organization Very ready to continue tis momentum! 🚀 #clinicaltrials #vaccinetrials #vaccines #firstsubject #FPI #siteactivation #momentum

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#Phispers Week 20 - Weekly Pharma News Recap Sponsored by SPI Pharma Bonjour, - France draws US$ 2.25 bn investment from Sanofi, Pfizer, AstraZeneca, GSK. - Sanofi bails out Novavax, pays US$ 1.2 bn to commercialize, develop Covid jabs. - AbbVie, Gilgamesh Pharmaceuticals ink deal to develop psychedelic drugs for psychiatric conditions. - FDA expands use of Bristol Myers Squibb’s Breyanzi to treat follicular lymphoma. #Phispers in a minute - PharmaCompass.com's Weekly News Recap #healthcare #pharmaceuticals #pharmanews #pharmaceuticalindustry #innovation #management #digitalmarketing #technology #startups #marketing #sales #strategy #networking #pharma #biotechnology #pharmacompass

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Leveraging RADAR, CRA’s orphan drug data repository, our #CRALifeSciences practices delves into pricing and market access trends of rare disease treatments in France. Several innovative pharmaceutical products have navigated the complex landscape of reimbursement over extended periods, exceeding five years for some due to prolonged time to clinical trial outcomes. Orphacol stands out as a remarkable achievement, being the sole product to achieve ASMR 1 status since 2013, granted within an impressive 160 days of EMA approval on its first submission. Additionally, Strensiq, Luxturna, Givlaari, and Kaftrio have attained ASMR 2, with early access through ATU preceding reimbursement, except for Strensiq. Furthermore, 32 products, averaging three per year, have secured ASMR 3, with five falling into mixed ASMR categories, including nine with reimbursement restrictions, reflecting the dynamic landscape of pharmaceutical reimbursement and access. For more information, click here: https://lnkd.in/gVEh-zps

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🎤 Today, Pierre Eftekhari gave a talk entitled "Optimizing Treatments - The Power, Challenges and Downsides of Patient-Centric Drug Development" at the congress organised by BioPharma Nexus Conference At Inoviem Scientific, we believe it's essential to adopt a patient-centric approach by bringing the clinical reality into drug discovery. That's why we've been working hard for over a decade to build a streamlined platform for patient-centric drug discovery and development. 💪 Here's why we stand out: 👉 𝗔𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗜𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: access to any disease and human material for ex-vivo pharmacology. 👉 𝗘𝗻𝗱-𝘁𝗼-𝗘𝗻𝗱 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀: covering the entire journey from early discovery to clinical phases. 👉 𝗘𝗻𝗮𝗯𝗹𝗶𝗻𝗴 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀: Proprietary technologies that empowering drug development. 🤝 Join us in reshaping the medicine, where innovation and causality go hand in hand. 📧 Reach out to Alessandro Bona - a.bona@inoviem.com #inoviem #drugdevelopment #drugdiscovery #clinicalphases #patientcentric #technology #innovations #healthcarefuture #personalizedmedicine

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[STRENGTHENING FRANCE'S POSITION IN PHARMACEUTICAL PRODUCTION]   🌟 France, historically a pharmaceutical leader, faces the challenge of competitiveness. With only 48 out of 508 drugs produced in Europe between 2017 and 2022 (Leem), our position is considered at risk. To ensure French sovereignty and competitiveness, securing the sourcing of raw materials (API and excipients) will be essential.   As a French pharmaceutical lactose producer, we will contribute to securing the supply chain, ensuring consistent access to raw materials for French drug manufacturers. 💊   #securityofsupply #pharmaceuticallactose #distribution https://lnkd.in/eVUVZDSe

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TLDR Biotech for June 28 - July 1 𝐓𝐡𝐞 𝐆𝐨𝐨𝐝 ✅ 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥𝐬: Pierre Fabre's Obgemsa (viberon) passes EMA vibe check, approved for overactive bladder syndrome 💊 + 2 more stories 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Eli Lilly signs $140M radiopharma deal with Radionetics ☢️ + 3 more stories 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬: Boehringer Ingelheim, Gubra begin Ph1 for novel "first-in-class" obesity treatment 🧪 + 3 more stories 𝐅𝐮𝐧𝐝𝐫𝐚𝐢𝐬𝐞𝐬: Freeflow Ventures closes $90M early-stage venture fund 💰 + 2 more stories 𝐈𝐧𝐯𝐞𝐬𝐭𝐦𝐞𝐧𝐭𝐬: Veranova invests $30M into ADC manufacturing facility 🏭 + 1 more story 𝐈𝐏𝐎𝐬: Artiva Biotherapeutics rides cell therapy autoimmune wave to an IPO (this time for real?) 📈 𝐋𝐚𝐰𝐬𝐮𝐢𝐭𝐬: GSK settles another Zantac suit ⚖️ 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩𝐬: Merck & Co. and Orion expand drug discovery partnership 🤝 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐀𝐜𝐜𝐞𝐬𝐬: FDA announces cisplatin no longer in short supply 🏥 𝐓𝐡𝐞 𝐁𝐚𝐝 ❌ 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬: TRACON Pharmaceuticals drops sarcoma asset after Ph2 miss 📉 𝐋𝐚𝐲𝐨𝐟𝐟𝐬: Dexcom lays off 535 staffers in San Diego 😢 + 3 more stories 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩: Bristol Myers Squibb ends $650M ADC partnership with Eisai 💔 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐀𝐜𝐜𝐞𝐬𝐬: Walgreens’ plan to close stores may impact underprivileged communities 🏪 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲: FDA urged to be more transparent about CRLs after recent spate of related rejections 🔍 𝐓𝐡𝐞 𝐔𝐠𝐥𝐲 👹 𝐂𝐫𝐢𝐦𝐢𝐧𝐚𝐥 𝐀𝐜𝐭𝐬: Cassava Sciences drama continues with internal investigation 🕵️ 𝐋𝐚𝐰𝐬𝐮𝐢𝐭𝐬: J&J talc subsidiary bankruptcy plan continues despite restraining order attempt ⚖️ 𝐏𝐨𝐥𝐢𝐭𝐢𝐜𝐬 & 𝐏𝐨𝐥𝐢𝐜𝐲: FTC targets multiple "bogus" Teva Pharmaceutical patents 🎯 𝐖𝐢𝐭𝐡𝐝𝐫𝐚𝐰𝐚𝐥𝐬 & 𝐑𝐞𝐜𝐚𝐥𝐥𝐬: FDA issues Class 1 recalls for multiple ventilator manufacturers 🚨 Read the full newsletter here: https://lnkd.in/gfKrb24F Or subscribe to get it straight to your inbox: https://lnkd.in/gecXctqM #tldrbiotech #pharmanews #biotechnews

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🌟 From Biologics To Biobetters: A Leap For Better Patient Outcomes🌟 In the ever-evolving landscape of biotechnology, the term "biobetter" is gaining momentum, and for good reason. A recent report by Celltrion Healthcare France has shed light on the significant advantages biobetters hold over biosimilars and biologics. 🔬 What Are Biobetters? Biobetters are enhanced versions of existing biologics, engineered to improve various attributes such as delivery routes, efficacy, safety, and patient tolerance. Unlike biosimilars, which are merely equivalent to their reference biologics, “biobetters” introduce tangible improvements. These can include better glycosylation profiles, modified Fc fragments, extended half-lives, and reduced immunogenicity. 💡 Why Biobetters Excel ·        Improved Efficacy and Safety: Clinical results often show enhanced effectiveness and a safer profile. ·        Better Patient Experience: Enhanced pharmacokinetics, improved formulations, and more convenient administration methods. ·        Innovation and Patent Benefits: While the development of biobetters can be costly and time-consuming, they offer the possibility of new patents, ensuring extended market exclusivity and innovation incentives. 📈 The Future is Biobetters As we look towards the future of medicine, biobetters represent a significant leap forward. They hold the potential to provide better therapeutic outcomes and a higher quality of life for patients. At Plantibodies, we're at the forefront of this revolution. Our mission is to convert blockbuster IV biologics into oral capsules, maintaining efficacy while reducing toxicity. This not only extends the therapeutic window but also rejuvenates the drug's patent life, ensuring continued innovation and accessibility. Join us on this journey to transform and improve healthcare! #Biotechnology #Biobetters #HealthcareInnovation #Plantibodies #Sorbonne #SorbonneVentures Interested to learn more about Biobetters? Read the following Celltrion article: https://lnkd.in/ekmNryW4

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Among familial lipid conditions we advocate for, there’s #HoFH and #FCS, which are rare and severe. With the people living with those #rarediseases in mind, we have signed the #ActRare2024 pledge led by EURORDIS-Rare Diseases Europe ! To date, the 30 million Europeans living with a rare disease in Europe still have high unmet needs in a wide range of areas, including accessing early and appropriate diagnosis, treatment and health and social care. Rare diseases are an area where EU action can have exceptional added value, as knowledge and data are scattered and scarce, and national action is limited. This is YOUR opportunity to use your vote and help prioritise public health in the EU! Sign the #ActRare2024 pledge and become a rare disease champion! https://lnkd.in/eKNWtTJZ #VoteHealth2024

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#PancreaticCancer poses a significant challenge to public health in 🇪🇺! Our Position Paper, co-developed with Pancreatic Cancer Europe, Cancer Patients Europe - CPE, epc european pancreatic club, and UEG - United European Gastroenterology, delves into the facts surrounding pancreatic cancer, outlining the current challenges and proposing actionable solutions in the next five years. Read the full paper ➡ https://lnkd.in/enhN8cSk #PancreaticCancer #EUElections #EUElection2024 #EU4Health #HealthUnion #EUCancerPlan #DigestiveCancers EU Health and Food Safety EU Science, Research and Innovation European Health and Digital Executive Agency (HaDEA) European Parliament European Commission EU Health Coalition WHO Regional Office for Europe IARC - International Agency for Research on Cancer / World Health Organization

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🚀 💯 🌏 Last week, our CEO Sofie Piepers embarked on a "Tour de France" for several interactive training sessions on #selective #treatment of #clinical #mastitis with BINET Frédéric, Alizée Deriviere, Christine Monchy, and Stephanie D'ESQUERMES of Vetoquinol France. The approach focused on elucidating, through 10 practical examples, all factors influencing the success or failure of mastitis #treatment and thus our treatment decisions. 🐄 What is selective treatment of clinical mastitis? 🐄 How can selective treatment of clinical mastitis help us towards a more responsible and lower use of #antibiotics? 🐄 What do we need to implement selective treatment of clinical mastitis in practice? 🐄 What are the #opportunities for farm vets? 🐄 Are there any precautions and prerequisites to take into consideration? 🔍 Expectations and conclusions: ✅ 25 to 40% lower use of antibiotics. ✅ No negative effects on clinical or bacteriological cure or any other future performances of the cow. ✅ Significant less days milk out of tank. 💡 ❗ ❗ ❗ ❗ 🙄 😯 Look at the example below (Case 10...). An example straight from a farm that is immediately treating every cow with clinical mastitis according to a strict protocol. What a waste of antibiotics (31.000 mg ❗), milk (at least 154 kg ❗) and money... This can be avoided by switching to selective treatment of non-severe cases of clinical mastitis.

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/ FUND RAISING /   Société de Bourse Gilbert Dupont is delighted to announce that MaaT Pharma, a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer, has successfully closed a fund raising for a total aggregate amount of €19.2m in the context of the (a) Primary Offering through (i) a reserved offering for the benefit of specific categories of investors for c.€17.3m and (ii) a public offering, via the PrimaryBid platform for c.€0.9m and (b) the sale of 125,000 existing ordinary shares for €1m.   The net proceeds from the Primary Offering, which are estimated to be approximately €17.3m, will be used to fund the company’s R&D activities, covering completion of the Phase 3 trial for MaaT013 in Europe, including top-line results/primary endpoint in mid Q4 2024, continuing the pipeline development, including the initiation of Phase 3 trial activities for MaaT013 in the US and the broadening of the Phase 2b trial with MaaT033 across Europe and for working capital and other general corporate purposes, including repayment of current debts.   Société de Bourse Gilbert Dupont acted as Joint Bookrunner. We thank Herve Affagard, MBA, Eng., Sian Crouzet, Guilhaume Debroas, Ph.D. and all the MaaT Pharma team for their trust.  👉 Link to the press release : https://lnkd.in/eX6iG4Hz   MaaT Pharma #Healthcare #ECM #finance #Bourse #Smallandmidcap #Markets

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WEBINAR | Listen to our expert speakers Yves Buelens, Jean-Christophe Moreau and Christophe Schwoehrer explain blow-fill-seal (BFS) technology and the unique benefits of unidose BFS for ophthalmics, biologics and other sterile drug products. Webinar learning objectives: 1. What is BFS technology and the unique benefits of unidose BFS 2. What are the advantages of BFS unidose format in comparison to ocular multidose or glass vial format? 3. How can a CDMO support pharma companies in switching to unidose BFS Watch on demand here : https://lnkd.in/d9TRp6ZV

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🩺 Are you looking to improve your understanding and ability to start a #biologic treatment, follow up with the #patient, and evaluate the success of treatment? EUFOREA hosted its first edition of the European Biologics Training Course on 1 March 2024 at the Académie royale de Médecine de Belgique in #brussels with more than 250 attendees worldwide. A hybrid training course designed to increase engagement and understanding of #biologics among healthcare professionals (ENT specialists, pulmonologists, and allergologists) treating patients with uncontrolled type 2 diseases including #asthma, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Atopic Dermatitis (AD). Watch the European Biologics Training Course now and earn your #CME accreditation! 🔗 https://lnkd.in/ejmBkbn4 #eubiologics24 #health #healthcare #healthprofessionals #patients #patientcare #airwaydiseases #chronicdiseases #physicians #trainingcourse #trainingprogram #events2024 #nasalpolyps #asthmaawareness #treatment #ent #nonprofit #euforea #belgium #clinicians #pulmonologist #allergologist #atopicdermatitis #cmecredits

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𝗝𝗼𝗶𝗻𝘁 𝗥&𝗗 𝗲𝗳𝗳𝗼𝗿𝘁𝘀 𝘄𝗶𝘁𝗵 𝗿𝗲𝗴𝗮𝗿𝗱𝘀 𝘁𝗼 𝗰𝗼-𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀 are considered „crucial“ for (European) SME Pharma and Biopharma companies’ future success, claims Telma Costa 🇪🇺 … to make a few steps in the right direction Europharm smc and Alain Verrijdt foster relationships through their annual business meeting (this year in #zagreb)… and collaboration proposals like from maurienne will from Will Pharma reiterate the need/demand for that from CEOs. 💡💡💡 But there is more, that is on the CEOs minds. And therefore, in Zagreb 🇭🇷 theses three (Manfred Stadler, Telma Costa, Alain Verrijdt) advocate for more transparency concerning strategic topics in Pharma and Biopharma SMEs as an input, inspiration and as a decision making basis have promoted our CEO survey. 𝗪𝗵𝗲𝗿𝗲 𝘁𝗼 𝗽𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝘁𝗲? The annual CEO survey is again online: https://lnkd.in/gj97_VRa #europharm #healthcarestrategy #ceoreport #vinc

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