BioSpace’s Post

During #DIA2024, I was honored to sit down with Dr. Peter Marks and get his thoughts on how the industry is fairing 2024, as well as his vision for the future. ➡️ Watch the Full Interview: https://lnkd.in/ga_z9spj #regulatory #clinicaltrials #rarediseases #AI #FDA #globalcollaboration .

Less than one week to go until #EUCROF24 takes place! Team Archer is happy to attend this inspiring event that brings together pharma, biotech, medical device companies, CROs and other service providers, technology providers, regulators, patients, and academia, to discuss the current challenges, and future direction of Clinical Research across Europe. Let’s catch up in Prague! 💬   More info 🔗 https://lnkd.in/eQP39Kx3 #clinicalresearch #medicaldevices #cro #gcp #archerresearch 

In March, the Medical Device Coordination Group (MDCG) published its new document: “Guidance on the Content of the Clinical Investigation Plan for Clinical Investigations of Medical Devices” 📋📊 The MDCG 2024-3 guidance aids sponsors in crafting their CIP by providing detailed descriptions of the information expected in each CIP section. This preemptively addresses potential inquiries from competent authorities during the assessment of clinical investigation applications. 🔍 You can access the complete guidance document here 👇 https://lnkd.in/dedMGjT3 #ClinicalResearch #Innovation #HealthcareSolutions #BiTrial #clinicaltrial #medicalsupport #clinicalmonitoring #fullservicecro #cro #pharma #biotech #hungariancro #crohungary #mdcgguidance #medicalguidance #clinicalinvestigation

Introducing BioPass - the ultimate drug delivery solution that will revolutionize CNS disease drugs. With a breakthrough patent, BioPass streamlines the medicine effect process, the effectiveness, and the response. Imagine the medicine getting into the brain and bypassing the BBB in less than 5 minutes, with a fifth less medicine. The best part? BioPass is fully compatible with the regulatory pathway of the FDA, under section 505(b)(2), which means less time to market! With BioPass, invest in the future and make the smart choice for the world. So why wait? Meet the future today and ask us about this exciting innovation. #biopass #drugdelivery #CNSdiseasedrugs #innovation

Great insights into the future of #weightloss #drugs #ozempic and GLP-1 with more competition from Eli Lilly and other manufacturers we can expect greater #access and #evidencegeneration demonstrating the long term #outcomes and #clinical benefits of these new medications that have taken the market by storm. Great insights from Scott Gottlieb below 👇#rwe #rwd

Don't miss out! Learn about Scilligence's RegMol during Amjad Nasir's presentation on Tuesday, February 27th. Talk Abstract: The pharmaceutical industry is transitioning from traditional Small Molecule therapeutics to Biologics-based therapeutics (antibodies, proteins, oligonucleotides and peptides, etc.). At Scilligence, our goal is to provide the scientist with a unified informatics platform that embraces multi-modal entities - RegMol is a Registration and Assay Management system that enables scientists to do just that. Users can register antibody-drug conjugates, peptides, oligonucleotides, and LNPs, to name a few. RegMol also automatically tracks the relationships between all of these registered entities - this enables the User to have a comprehensive overview of how Entities are linked to each other. RegMol's architecture enables Users to configure registration forms to suit their workflows and thereby evolve to meet their scientific needs in a single system without the need for any custom code.   #entityregistration #scienceandtechnology #freeevent https://lnkd.in/esJGBbrc

Hey Discovery Scientists, come hear what Amjad Nasir has to say about Scientific Entity Registration! #researchanddevelopment #scientificinformatics #chemistry #biology

Alas, there is no "A" or "I" in EUCROF" so we are missing AI in the list. I am sure we will be setting up a couple of sessions on the subject. So, if you want to tell the world how AI is changing clinical research, please send us your abstract.

On Friday, the FDA published "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," which represents the FDA's coordinated approach to #ai. This paper is intended to complement their "AI/ML SaMD Action Plan" and represents a commitment between the FDA's Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP), to drive alignment and share learnings applicable to AI in medical products more broadly. To support uses of AI across the medical product life cycle, #FDA intends to: ☑️Foster Collaboration to Safeguard Public Health ☑️Advance the Development of Regulatory Approaches That Support Innovation ☑️Promote the Development of Standards, Guidelines, Best Practices, and Tools for the Medical Product Life Cycle ☑️Support Research Related to the Evaluation and Monitoring of AI Performance #aiinmedicine #drugdevelopment #medicaldeviceregulation #productmanagement #academicresearch #clinicalresearch

PurMinds is at the forefront of clinical innovation with our IP-protected approaches for ground-breaking combinatorial therapies. We're combining the power of psychoplastogens with proven technologies. Here's what's on the horizon: Multiple programs are in pre-clinical stages gearing up for IND filings starting in the first half of 2024. As part of our intelligent drug development strategy, we're eyeing potentials for FDA "Breakthrough Designation," the 505(b)(2) pathway, and fast-tracking to Phase II/III. Find out more at Purminds.com #NeuroPharma #FutureofMedicine #ClinicalInnovation