Stefano Bolletta’s Post

Exciting update! 🌟 1. Addressing Challenges with COMBINE Project: The COMBINE initiative tackles hurdles in joint studies involving medicinal products, medical devices, and in vitro diagnostics in Europe. It's all about harmonizing regulatory frameworks to foster innovation, safety, and efficiency in clinical research across the EU. 2. MDCG Endorsed Documents and Guidance: Dive into our latest documents and guidance endorsed by MDCG! These materials provide preliminary reassessment review for MD and IVD regulations within the EU. Essential reading for industries and manufacturers across all EU nations. 3. Recently, the Regional Consultation of the Americas on Human Genomics and Health was held in Brazil, in collaboration with PAHO. This event, which was part of the scientific agenda of the Secretariat of Science, Technology, and Innovation, aimed to promote the widespread use of genomics for both individual and public health. Stay informed, with Pure Global! 🚀 Contact us: https://lnkd.in/ei5BRcgN #MedTech #IVDR #MDR #PureGlobal #Genomics #Regulations #EU #Innovation

Join Sharmeen Roy, PharmD, BCPS Roy on September 18 alongside a great line up speakers for the Technology Networks event **Advances in Drug Discovery & Development 2024** Full agenda here: https://lnkd.in/eDWdkQbH Sharmeen will dive into accelerating precision medicine through precision dosing. Great topic as hospitals and pharmacists are seeing the impact of personalized health to address every patient's unique needs and characteristics. #futureofmedicine #pharmacist #precisiondosing 

What do top regulators, data scientists, and biomedical innovators say we can do to improve #ClinicalTrials for #RareDiseases? Here are multiple ideas we heard from leaders of FDA CDER, National Center for Advancing Translational Sciences (NCATS), Jazz Pharmaceuticals and the National Bleeding Disorders Foundation: - Consider patients as "lived experience experts" and involve them in the process of identifying research gaps, from the very beginning. - Go out of your way to bring diversity to your clinical trials as a requirement; don't leave anyone out. - Incorporate as much "fit for purpose" patient data as possible; not just clinical data, but experiential data. (i.e. What is it like to grow up day to day with a certain #RareDisease?) - Speed up the process of clinical trials delivering results by defining the efficacy of products in multiple ways, with multiple #endpoints. And make sure these endpoints will have a true beneficial impact for patients, otherwise the #ClinicalTrial may not be worth the time. Ask patients first! - Make enrollment easier, rather than requiring significant travel and time. New digital tools can help with this.

Breaking news: Molecular Culture receives FDA Breakthrough Device Designation! We are honored to announce that we have received the FDA's Breakthrough Device Designation for our Molecular Culture ID technology! This designation will greatly help us to bring our diagnostic test to the U.S. market. This exceptional designation is awarded to medical devices that offer significant advantages over existing options, to speed-up clinical implementation of critical innovations in the U.S. It not only accelerates the regulatory review process but also facilitates more efficient reimbursement pathways. Our Molecular Culture ID test can rapidly detect and identify over 200 bacterial species in clinical samples, providing same-day, highly accurate diagnoses. This will lead to quicker, more precise patient treatment, saving lives, and improving patient outcomes. We're grateful for the support from our partners, the European Innovation Council (EIC), and our dedicated team. Together, we're making significant strides in the global fight against antimicrobial resistance. Read more about this exciting milestone and what it means for the future of healthcare in our press release: https://lnkd.in/eRnMSGNW #Inbiome #BreakthroughDevice #MolecularCultureID #Healthcare #InfectiousDiseases #Diagnostics #AMR

Next week's highlight: AGAH e. V. Applied Course on Basic Principles of Clinical #Pharmacokinetics 🎤 SocraTec R&D Speaker: Dr. Ralph-Steven Wedemeyer on the interplay between #biopharmaceutics and absorption in human pharmacokinetic studies 💠Our SocraMetrics colleague Dr. Jan Rüger will be part of the #workshop 🔄 It's all about Pharmacokinetics – the prerequisite and door opener for understanding #pharmacology! ⏩ #ClinicalResearch #ClinicalTrials #ShareKnowledge

Launching your iPS cell-based therapy? Lindville Bio (www.lindvillebio.com) is here to help. From lab to clinic, the journey of developing cell-based therapies is challenging, but with Lindville Bio by your side, we make it possible. We provide expert advice for: 1️⃣ iPS cell sourcing and quality control 2️⃣ iPS cell expansion and scale-up 3️⃣ Preclinical efficacy and safety testing 4️⃣ Navigating complex regulatory pathways 5️⃣ Manufacturing and process development 6️⃣ Designing and executing clinical trials 7️⃣ Intellectual property and competitive analysis 8️⃣ Ensuring reproducibility and consistency 9️⃣ Long-term safety monitoring 🔟 Securing funding and investment 1️⃣1️⃣ Tackling regulatory and legal hurdles 1️⃣2️⃣ Market access and commercialization Let's bring your therapy to life together. Arrange an initial discussion today at www.lindvillebio.com #iPSC #CellTherapy #Biotech #LindvilleBio #BiopharmaSolutions #HealthcareInnovation

Our Executive Director of Clinical Operations, Brendan Doran, PharmD, offered insights into #clinicaltrial trends the #biopharma industry can expect in 2024 as part of Citeline’s #ScripAsks series. Explore Brendan’s perspectives on the importance of flexibility in clinical trials and the adoption of adaptive study designs: https://bit.ly/42uY7Ae

🚨 Only 1 day to go until our webinar on the latest advancements in ADCs! Novel drug conjugates are emerging as a transformative force in the ADC space so don't miss this chance to dive deep into emerging trends and cutting-edge insights with our expert speakers, Yu-Shin Hsu and Callum Angus. ⏳ Last chance to register: 🔗 https://ter.li/rzae33 Whether you're in drug development or clinical research, this is the event to stay ahead! #ADCs #noveldrugconjugates #ADCinnovation #ADCclinicalsuccess #emergingADCs Hanson Wade Intelligence

The FDA’s medical product Centers have joined forces to release a groundbreaking paper on Artificial Intelligence and Medical Products. This collaborative effort aims to foster transparency, encourage ethical innovation, and safeguard public health. Let’s dive into the details: 📝 Document Highlights: Entities Involved: The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) are all working in harmony. Shared Goal: Their mission? To ensure that medical products benefit society while adhering to responsible regulation. Clear Framework: By providing a clear framework for collaboration, the FDA demonstrates its commitment to advancing medical technology. 🚀 Key Takeaways: Transparency: The joint paper promotes transparency, allowing stakeholders to understand the intersection of AI and medical products. Ethical Innovation: Innovation is essential, but it must be ethical. The FDA’s commitment ensures that cutting-edge solutions prioritize patient safety. Public Health: With this collaboration, public health remains at the forefront, ensuring that advancements benefit everyone. 👏 Let’s applaud this remarkable initiative! Share your thoughts below. 👇 #ArtificialIntelligence #MedicalProducts #PublicHealth #Innovation #FDA #CBER #CDER #CDRH #OCP #QBDgroup #Medtech

The mechanistic translation of nonclinical pharmacokinetic data to humans can make or break the success of your clinical plan. It’s critical to understand how to get the insight you need to determine…  · What the clinical starting dose should be based on your nonclinical data  · What doses will be included in your first-in-human (FIH) study  · If you will achieve safety cover in nonclinical species  · If your drug product will benefit from micronization  · Whether you need to consider drug-drug interaction (DDI) studies  · Other challenges that may need to be addressed in clinical development  Join us for our webinar on March 20, where Becky Graves, Director of Simulation Studies at Simulations Plus, will explain how to leverage the FIH Simulator to gain these insights and more. She’ll walk through physiologically based pharmacokinetic (PBPK) best practices, and how you can build PBPK models to translate nonclinical data to accurately design your FIH clinical trial and beyond.  Save your seat: https://lnkd.in/gAjrHtWK