At the recent German Network for Personalised Medicine (DNPM) congress, Josef Hecken, chairman of the Federal Joint Committee (G-BA), shared key shared innovative approaches to evidence generation and patient care, signalling a shift from traditional drug trials. This could mean easier access to personalised therapies, benefiting both patients and manufacturers. 🏥 Dive into the details and implications of this transformative change in our latest insider insight ➡ 🔗 https://lnkd.in/evj6naTn #MarketAccess #PatientAccess #PersonalisedMedicine #HealthcareInnovation #DrugTrials #Pharma #Biotech #PatientCare * 𝒘𝒓𝒊𝒕𝒕𝒆𝒏 𝒃𝒚 Manahill Baig
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#RealWorldData can be your prescription for commercial drug success! How❓ Really enjoyed sharing a panel discussion at LSX - partnering for Life Science eXecutives event with Anders Borglykke (Novo Nordisk), Nicole Mather (IBM) and Marc Jones (Altoida, Inc.) where we shared examples how #RWD can accelerate drug development but also support your launch and commercial success. 👉insillico drug development, which algorithms should used large amounts of objective quality RWD 👉external clinical trial control arms such as historic controls or synthetic, again using large amount of health data 👉#digitalbiomarkers using sensors to capture data At Ypsomed AG we integrate connected injection devices with therapy management solutions to support patients for #selfcare, but also generating robust and objective data to support Pharma commercial success.
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Join our COO, Chris Schoonmaker and me at the Spring MIT Forum (June 17, 2024) for an exciting panel discussion on regulatory approvals and many other discussions. The conference brings together leaders in our field for a productive 2-day in-person dialogue on several key topics. Approvals are the grand finale of the work we do and I wake up every day with renewed energy to support yet another drug/biologic/therapeutic option for patients globally. At #OneMMS, this is our passion and expertise, working with regulators and sponsors to enhance efficiencies one submission at a time while maintaining our data-focused efforts. #dataCRO #biometrics #submissions
We are thrilled to announce that our CEO, Uma Sharma, will be moderating an insightful session on “Getting to Regulatory Approval” at the Longwood Healthcare Leaders Spring MIT Forum, June 17, 2024. With over 8-10 successful submissions each year over the past 17 years, MMS is the leading data and regulatory-focused CRO, with the know-how, technology, and track record of success guiding sponsors through their data services and clinical trial submission goals. Don’t miss the interactive panel discussion with the top minds in pharma, biotech, government, academia, and healthcare, where we will discuss biomedical innovations and the advancement of life-changing therapies to positively improve lives worldwide. Connect with Uma Sharma and Chris Schoonmaker (COO, MMS Holdings) at this event to explore how MMS can support your clinical data and regulatory submission needs from INDs to NDAs/BLAs. #Pharma #Biotech #OneMMS #HealthcareInnovation
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🧑🔬 Pharma should not compete on (digital) endpoints. 🔍 We require industry collaborations in order to usher in a new era of medicine. 🤝 Our latest report, in collaboration with Biofourmis, outlines why we need to create a more cohesive and collaborative industry to unlock the full potential of digital measures in clinical trials and how to get there. Download your copy now ➡️ https://lnkd.in/egUvJkvC #pharma #digitalmeasures #drugdevelopment Maulik Majmudar, M.D., Ariel Dowling, Paul Strijbos, Alf Scotland, Erwin De beuckelaer.
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The world needs your big idea! I guide underrepresented life science founders and investors who want to make a difference.
The discovery and development of new medicines can be convoluted. Many founders begin their search for a new therapy without understanding these details. In my experience, most of the public views drug development as “the news reports that scientists show it works in a mouse, so my doctor will be able to write a prescription next week.” Learn more in Part 2 of my New Medicines blog series. https://lnkd.in/gAxJ6c_s #DrugDevelopment #MedicineMaking #KatrinaRogers
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Today we announced several important milestones for Hemab: The first patient has been dosed in the Phase 2 clinical study of HMB-001 for #GlanzmannThrombasthenia (GT). Additionally, the FDA has cleared our IND enabling expansion of our clinical study into the U.S., and granted HMB-001 Fast Track designation, emphasizing the seriousness and high unmet need for prophylactic treatments for GT. These achievements are the result of the dedication and commitment of the entire Hemab team, our partners and investors, and the healthcare providers and people living with GT who are participating in our ongoing clinical study. Read more: https://lnkd.in/gQRmNNHx #IND #FastTrackDesignation #RareDisease #Biotech
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Next Tuesday - join us talking about how experience and collaboration can really influence how successful your software implementation can be. Beyond understanding how your sponsors work, there is a lot to be said about really challenging each other and not being afraid to have a frank conversation about risks, risk mitigation and potential solutions. There is a movement around not annoying the client with questions, but it's only through talking and holding open dialogues that you get to the root of the requirements. My mum always said, "Siobhan, you've got two ears and one mouth. You should listen twice as much as you speak!" She didn't necessarily mean that I was a noisy child - although I probably was - but rather listening to what people say is important and undervalued. Listen to what people say, and what they don't say. Ask open questions that give people the opportunity to share information with you. It'll benefit you in the long run. There is a shorthand that I've seen: "I want a system exactly like Y". But what this doesn't take into account is that the end goal may not be and probably aren't exactly the same. What people assume this means is that they must build an identical system, but instead, what the sponsor means is that they want a similar system for their end users but one that still achieves their goals. Come along, have a listen, ask questions. I think you'll find a few things that will help in your next project, along with a few funny anecdotes along the way.
⏲️ One Week Left to Register ⏲️ Clock's ticking - With just one week remaining, now is the perfect time to secure your spot for our highly anticipated webinar. This exclusive event promises to deliver invaluable knowledge, expert advice, and opportunities to connect with leaders in the industry. From Past to Future: Using Experience to Enhance Clinical Trial Protocols 🗓️ Date: Tuesday, July 09th - 10am EDT / 3pm BST / 4pm CET 📍Location: Online – Join from anywhere! 👉 Register: https://bit.ly/4cpstZ1 📢 Siobhan McKenna-Power 4G Clinical Peter Craig, Novo Nordisk 👩⚖️Libbi Rickenbacher, PhD Moderator 4G Clinical We look forward to seeing you there! #clinicaltrials #xtalks #pharma #biotech #xtalks #RTSM #IRT #4GClinical
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With overall drug development costs exceeding $300 Billion annually, even a mere 10% improvement in the clinical translation success rate represents a multi-billion dollar opportunity for the industry and patients in need. How do we achieve this? Download our new white paper on AtlasGEN Novel Drug Designer to learn more: https://bit.ly/3RoWMqs
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FDA-Approved Drugs: Monthly Edition 💊🌟 Stay informed with the latest breakthroughs in medicine! This month, we're spotlighting the newest FDA-approved drugs revolutionizing healthcare. From innovative treatments to life-changing therapies, these advancements are set to impact patient care significantly. Keep up with the cutting-edge developments and discover how these new approvals can benefit you. . . . . . . #FDAApproved #PharmaceuticalIndustry #HealthcareInnovation #MedicalBreakthroughs #DrugDevelopment #ClinicalResearch #PharmaNews #MedicareAdvancements #HealthUpdates #MedicalScience #HealthcareTechnology #TheLotusBiotech #TLB
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2023 was a big year with lasting impact on the global health landscape – as we witnessed the end of the COVID-19 pandemic emergency, major medical advancements, and are working to meet the challenges of drug shortages to ensure patient access to quality medicines. Looking ahead to 2024, USP is committed to our work to help strengthen resilience working with stakeholders across the medicines supply chain. Read more in my healthcare outlook for 2024 via @DrugChainReview.
“The past year brought major milestones and advancements in the supply of quality medicines. As we enter 2024, we see the biggest areas of focus centering on improved supply chain resilience and biomedical innovation in emerging medical fields.” 💬 Ronald Piervincenzi | US Pharmacopeia CEO As we embark on a new year, our CEO sets the stage for the 2024 health care landscape and how it will shape priorities across the pharmaceutical sciences, medicine, and public health community. Scroll ➡ below for three big takeaways from Ron and read more in his full healthcare outlook via Chain Drug Review: https://ow.ly/HIU550Qqqic. #GlobalHealth #HealthcareOutlook #PharmaIndustry2024 #MedicineSupplyChain
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Medical congresses are valuable but chaotic. Extracting that value requires optimal #congress planning – pre-congress, during the event itself, and post-congress. Here’s how one leading #pharma company used congress monitoring to uncover novel observations and inform their business #strategy: https://hubs.la/Q02JTl620
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