Bristol Myers Squibb UK & Ireland’s Post

In this feature with Drug Development & Delivery, Andy Lewis, Chief Scientific Officer, speaks on our #TranslationalPharmaceutics® platform and its benefits to accelerating and controlling the full #drugdevelopment value chain, including implementing adaptive clinical trial designs and transforming the traditional model. Read the full article here: https://bit.ly/4bqABaj

“Using adaptive clin­ical trial designs in early development can help rapidly advance a fit-for-phase for­mulation to a POC-ready format, optimize performance of a drug product in re­sponse to emerging clinical data, and gain valuable data to inform the next stage of development.” Read the full article to understand the benefits #TranslationalPharmaceutics could have on your clinical development projects. #QuotientSciences

Discover key strategies for a smooth clinical transition from Phase 2 to Phase 3 in the latest episode of The VirtualPharm 🎧 This is a must-watch for biotech teams looking to drive success in late-stage development. Check it out here

#ICYMI, President and Chief Science Officer of Pharmatech Associates, a USP company, Bikash Chatterjee joined FDA staff, industry leaders, and academia scholars at the 2024 #NIPTE conference last week. As chair of the session on “Barriers and Opportunities for Using Prior Knowledge to Expedite Drug Development and Approval.” 💡 Here’s what we learned from the #FDA presenters: ✅Core Principles behind Platform Designation Guidance & Advanced Manufacturing Designation: Drug sponsors will benefit from defining how prior knowledge fits into your regulatory strategy vs. platform knowledge. ✅ Engage Early: Leverage FDA's interaction avenues to gain clarity and discuss how prior knowledge can streamline development activities. ✅ Modeling Benefits: Industry and FDA agree—modeling is essential for optimizing development and manufacturing processes. ✅ Data Infrastructure: Success requires investing in systems to support and manage development data and models. 📈 Stay ahead by aligning your strategies with FDA guidance! #DrugDevelopment #AdvancedManufacturing #Pharma

🔊 Call for abstracts! 🔊 Is your research focused on exploring novel approaches to advance #DrugRepurposing globally? Then you could be one of the speakers at #RExPO24 💊 💡 Whether you're interested in giving a main talk or presenting a poster, this is your chance to present your work in front of international peers from across the entire #PharmaInnovation landscape — from drug repurposing, formulation and discovery, all the way to patient engagement, patenting, trials and regulatory affairs. Find all the information you need on our website, including a how-to guide for submitting your abstract via ScienceOpen ➡ https://lnkd.in/e2PBnicG ⏰ Deadline closes on the 3rd of May, and we strongly encourage early submissions! Find out more about RExPO24, the 3rd international conference on Systems Medicine and Drug Repurposing 👉 https://repo4.eu/rexpo24/ #CallForAbstracts #DrugResearch #MedicalResearch #MedTech #HealthTechInnovation #MedicalConference #FutureOfMedicine

It was a great experience partnering to write this whitepaper on a topic so many clients have asked about. With approximately 90% of candidates entering clinical trials failing to achieve regulatory approval, understanding the reasons behind these failures is crucial for companies aiming to future-proof their product candidates. Read our latest whitepaper, “Learning the Lessons of Failure: How to improve the economics of Life Sciences R&D” and dive deep into eight real-world case studies that reveal the challenges and invaluable lessons learned from drug development programs. View here: https://ow.ly/mIL530sBS4g #clinicaltrial #drugdevelopment #regulatory

Key takeaways from the USFDA speakers at last week’s NIPTE conference :

Today the FDA launched its new Center for Real-World Evidence Innovation (CCRI) program designed to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making across Center for Drug Evaluation and Research (CDER). Focus areas include: 1. Scientific Review and Policy 2. Outreach and Engagement 3. Regulatory Science Initiatives 4. Knowledge Management For more information visit https://lnkd.in/gsBsfh5j

Amicus is the Latin word for “friend”. This name signifies our collaborative approach to developing technologies and incorporating the patient perspective in every step of drug development. Learn more at http://amicusrx.com #raredisease #AmicusCares

Drug pooling has long been a topic of conversation among clinical supply managers. While use of drug pooling is far less common today than it was over a decade ago, our co-founder and Senior Director of Customer Solutions, Marc Lisi, shares how it can still be helpful in making today's trials more efficient. With clinical trial design getting more and more complex, time pressures to deliver on these trials continually increasing, and sponsors looking to save costs wherever possible, drug pooling can prove to be extremely beneficial in specific situations. Learn more at https://lnkd.in/eGiRswmS #Suvoda #clinicaltrials #clinicalresearch #drugpooling #healthtech