Remap Consulting’s Post

#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.

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

🧑🔬 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.

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

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

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.

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

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

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.

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