Michelle Devine

All clinical trials ongoing after 30 Jan 2025 must be transitioned to CTIS and follow the current legal requirements. See the quick guide!

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Patients can’t benefit from what they don’t understand. Don’t let poor communication keep your solution from reaching the right patients. 🩺 Rheumatology innovators Patiently’s engagement solution ensures your innovative treatment connects with the patients who need it most. 💡 Drop the name of your solution and the disease you’re solving in the comments, and let’s make sure the right patients find your breakthrough. 🚀 #Rheumatology #HealthTech #PatientEngagement #RightPatientRightCare #InnovativeHealthcare #MedTech #DigitalHealth #HealthcareInnovation #Patiently

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Pharma Contract Manufacturing 2025 is dedicated exclusively to enhancing CMO selection and partnerships. We understand the vital role pharma-CMO collaborations play in driving success for both organisations and patient outcomes. https://lnkd.in/eAnAHWXB    This year’s event (26th-27th March, 2025) has been re-designed for interactive learning, featuring thought-provoking opinion pieces, engaging roundtable discussions, expert-led panel sessions, and lots of networking opportunities. Attendees will explore the latest challenges in areas such as pricing, contract negotiation, sustainability, digital transformation, and evolving regulations. Read more about our sessions here: https://lnkd.in/eAnAHWXB    Welcome to our fantastic thought leaders sharing their insights this year, including:   Philip Coetzee, Mohamed Fayez Monir, Maik Talarczyk, Maria Palha, PharmD, Olaf Peter Birkenmeier, Matthias Horn, Bhavin Makwana, Olusegun Adetunji, Dr. Ulrich Rümenapp, George Ntortas, Kyriakos Kansos, Marta F., Laure Bovet, Marco Badiali, Sam B., Eduardo da Fonseca, Carlo Capobianco, Matthew Harris MBA CPIM, Yasir Hassan, Gil Roth, Patrick Frey, Ingrid Lux, Maria Palha, PharmD, Nicolas Puljic, Tero Virtanen, Nicolò Orbello, Roeland Vandebrouck   We hope to see you all in March!

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Meet the Accellacare experts at #WVCEU this 28 - 31 October, booth #47. Discover how we manage to support #VaccineDevelopment for biotech, pharma, government, and NGOs more than 30+ years now. https://ow.ly/Hcz650TFna6 #VaccineInnovation #HealthcareInnovation #Vaccines

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🌶️ 𝐇𝐎𝐓 𝐏𝐎𝐒𝐈𝐓𝐈𝐎𝐍𝐒 𝐀𝐋𝐄𝐑𝐓! We're kicking off the new month with an exciting mix of opportunities. Whether you’re looking for a short-term project or a long-term role, we have something for you. 😎 Dive in and apply today! ⤵️ #headcountag #lifesciences #clinical #engineers #toxicology

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PDC*line Pharma reports promising Phase I/II clinical results for its therapeutic lung cancer vaccine, recently presented at ESMO - European Society for Medical Oncology in Geneva. Its PDC*lung01 cancer vaccine, in combination with pembrolizumab, demonstrates the potential to provide meaningful clinical benefit compared to pembrolizumab alone in stage IV Non-Small Cell Lung Cancer patients with PD-L1 ≥ 50% and is associated with mild safety profile. 👉 Read the full news (FR): https://lnkd.in/e86fGxKc 👉 See the release: https://lnkd.in/etwb26jE

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Fantastic first day at the Targeted Radiopharmaceuticals Summit - Europe here in Amsterdam! Our very own Ashley Mishoe, PharmD presented today on the crucial need for a strong quality system and expertise in effective sponsor and CDMO partnerships. Titled “Quality, Collaboration, and CMC: Aligning for Drug Development Excellence”, Dr. Mishoe highlighted the importance of alignment between drug sponsors and #CDMOs for successful regulatory filing and commercialization efforts. #TRPEurope #TakeTheLead

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There is increasing pressure on biotech companies to optimize R&D spend in an effort to quickly deliver robust scientific evidence. In our latest webinar, our experts guide you through the compelling journey where scientific ambition intertwines with the ever-evolving landscape of clinical research. Register now and discover how to leverage strategic partnerships to achieve remarkable outcomes. https://bit.ly/3JuqEgM #regulatory #biotech

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What’s new in SUN PHARMA's pipeline? Here’s a dosage of their recent milestones: 💊 Consolidated topline grew by 10.4% in FY24, with the US market leading the growth. 💊 The company's EBITDA for the year increased by 11.8%, reaching a margin of 26.9%. 💊 Revenue from API business was ₹19,187 million, with a 5% share of revenues. 💊 Aims to enhance its share of specialty/branded business, focus on complex generics, and high entry barrier segments. Stay updated with the latest market insights and analysis from Needl.ai. Check out the AI-generated summary of the BSE annual report: https://lnkd.in/gPdTVwBg For the full report, click here: https://lnkd.in/g34HCwsf #Needlai #SunPharma #FinancialHealth #Innovation #Growth #Income #Revenue #EBITDA #API #FinancialAnalysis #AIAnalytics #AnnualReports #BSE #StockMarket #AIsummarization #FY24

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Advanced Therapy Medicinal Products (ATMPs) which include CAR T-cell therapies, will be some of the first products to undergo assessment through the new EU HTA Regulation process from January 2025. Understanding the evidence requirements and implications on decision outcomes is imperative for future reimbursement success in Europe. Discover additional insights on CAR T-cell reimbursement in the US, UK and EU4 in our whitepaper: https://buff.ly/4dHJ2ke #LumanityPerspectives #HEOR #Oncology #Reimbursement #EUHTARegulation

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Advanced Therapy Medicinal Products (ATMPs) which include CAR T-cell therapies, will be some of the first products to undergo assessment through the new EU HTA Regulation process from January 2025. Understanding the evidence requirements and implications on decision outcomes is imperative for future reimbursement success in Europe. Discover additional insights on CAR T-cell reimbursement in the US, UK and EU4 in our whitepaper: https://buff.ly/4eFtDkM #LumanityPerspectives #HEOR #Oncology #Reimbursement #EUHTARegulation

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Advanced Therapy Medicinal Products (ATMPs) which include CAR T-cell therapies, will be some of the first products to undergo assessment through the new EU HTA Regulation process from January 2025. Understanding the evidence requirements and implications on decision outcomes is imperative for future reimbursement success in Europe. Discover additional insights on CAR T-cell reimbursement in the US, UK and EU4 in our whitepaper: https://buff.ly/4eBFnDL #LumanityPerspectives #HEOR #Oncology #Reimbursement #EUHTARegulation

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Advanced Therapy Medicinal Products (ATMPs) which include CAR T-cell therapies, will be some of the first products to undergo assessment through the new EU HTA Regulation process from January 2025. Understanding the evidence requirements and implications on decision outcomes is imperative for future reimbursement success in Europe. Discover additional insights on CAR T-cell reimbursement in the US, UK and EU4 in our whitepaper: https://buff.ly/3ZE5FQ7 #LumanityPerspectives #HEOR #Oncology #Reimbursement #EUHTARegulation

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*European Pharma Takes on Antibiotic Resistance: A Bold Incentive Proposal* Antimicrobial resistance (AMR) is a global health crisis, and the European pharmaceutical industry is stepping up with an innovative solution: the Transferable Exclusivity Extension (TEE) voucher system. Modeled after the U.S. Priority Review Voucher (PRV), the TEE aims to incentivize the development of groundbreaking antibiotics by offering financial and market-driven rewards. With pilot programs under consideration, this initiative could redefine antibiotic innovation. 📖 Read more about this transformative approach and its potential to balance financial incentives with public health needs. Let’s discuss how incentives like TEE can drive innovation in critical areas like antibiotics R&D. #Antibiotics #PharmaInnovation #AMR #R&D#PRV#FDA #EMA #Priorityreviewvoucher#CleracsConsulting#KYBORA#ThePRVFundProject

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Obesity market is expected to be >$100B by 2030, according to IQVIA. Source: https://lnkd.in/dCvc7_yv Entera and collaborative partner OPKO are working to develop the first GLP-1/glucagon agonist (Oxyntomodulin) peptide tablets for obesity. Ongoing work is combining Entera's N-Tab™ technology with OPKO’s long-acting Oxyntomodulin (OXM) analogues for potential treatment for obesity and other metabolic diseases.

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⚡ Exciting News: CDMO Live 2025 Comes to Rotterdam! ⚡ 📅 Save the Date: May 7-8, 2025 PharmaSource has chosen Rotterdam as the host city for CDMO Live 2025, following its successful online debut. The exclusive 2 day in-person European event will shine a spotlight on the pivotal role of outsourcing in biopharma, at a time when 9 out 10 biotechs rely on CDMOs to launch and manufacture new products. “We couldn’t be more excited to announce the first in-person edition of CDMO Live at this critical moment for the industry." said Co-Founders Chris Kilbee and Luke Bilton. "Following a sold-out online edition, we cannot wait to bring people together in-person for an experience that the contract development and manufacturing sector deserves.” 🤝 𝐏𝐫𝐨𝐠𝐫𝐞𝐬𝐬 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩𝐬 CDMO Live connects external manufacturing and scientific outsourcing leaders to potential partners and explores the latest trends in contract manufacturing. The 2025 event will see the next phase of development of PartnerMatch, a curated 1-to-1 meeting platform to connect outsourcing leaders with contract service providers who can address their specific requirements. An interactive two day agenda will include inspirational keynotes, in-depth analysis of small molecule and biologics markets, best practice roundtables, live podcast recordings... plus many more experiences to be announced! 🎤 𝐋𝐢𝐯𝐞 𝐟𝐫𝐨𝐦 𝐖𝐨𝐫𝐥𝐝 𝐓𝐫𝐚𝐝𝐞 𝐂𝐞𝐧𝐭𝐞𝐫 𝐑𝐨𝐭𝐭𝐞𝐫𝐝𝐚𝐦 The event will bring the vibrant pharma and biotech ecosystem together in the Postillion World Trade Center, in the heart of the Netherlands. “We are proud to see CDMO Live land in Rotterdam, a city in which we see the life sciences and health industry at all stages of the life cycle: from research to the market, to the continuous cycle of innovation." said Catherine Kalamidas, Business Development Manager, Rotterdam Partners "We look forward to seeing this event grow with the city’s ambitions at our excellent partner venue, Postillion Hotels & Convention Centre – World Trade Center, Rotterdam.” Industry support includes key association partner the PBOA - Pharma & Biopharma Outsourcing Association "As the only trade association in North America & the EU that represents the CMO/CDMO sector, PBOA is glad to support CDMO Live and help foster more conversation and connection in this critical industry." -said Gil Roth, President, PBOA. Outsourcing leaders pledging their support include Philip Coetzee, Director CMO Management at Daichee Sankyo Europe who said: "In an environment where time is money, CDMO Live is the best ever. They created a fantastic platform where information can be shared in a round tables and meet partners to see if there is a synergy. I will be back next time." 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐠𝐞𝐭 𝐢𝐧𝐯𝐨𝐥𝐯𝐞𝐝? If you can contribute to this exciting new event, let us know in the comments 👇 #CDMOLive #CDMO #Rotterdam #Netherlands #contractmanufacturing

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