SciPro’s Post

Vir eyes expansion beyond infectious diseases and into oncology, neurology with new leadership >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #pharma #healthcare #biotech

In "How RWE is Impacting Regulatory Decision-Making" Volumes 1 and 2, we discussed how real-world evidence has impacted drug approvals and label expansions. Volume 3 presents ten more cases of successful RWE use in submissions to regulatory agencies. The booklet includes regulatory guidance on RWE, drug background info, RWE impact on decisions, and approval's effect on future decisions. Download: https://ow.ly/Kcvt50PwmPx.

𝐉𝐨𝐢𝐧 𝐨𝐮𝐫 𝐥𝐢𝐯𝐞 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 - The use of generics, biosimilars and NBCDs for Multiple Sclerosis ⤵︎ Because MS usually has an onset in early adulthood and is a progressive disease, the economic burden is substantial, and disease-modifying treatments (DMTs) constitute a large proportion of healthcare costs. The use of generic versions (of synthetic drugs), biosimilars (for biologics) or follow-on versions of non-biologic complex drugs (NBCDs) can reduce the overall cost of MS care and improve patient access. In Europe, there are robust regulatory processes and effective oversight for generic, biosimilar and follow-on NBCDs of DMTs so that these agents can be considered interchangeable with the originator product. Physicians caring for patients with MS need to familiarise themselves with the evidence so that they can have informed conversations with their patients about the potential use of these agents. Register now to gain insights from experts and ultimately optimize MS treatment strategies and improve patient outcomes: https://lnkd.in/eNNtH9bZ #paradigmsfoundation #multiplesclerosis #patiencare #msresearch #MS #livewebinar #neurologist #neurology

In "How RWE is Impacting Regulatory Decision-Making" Volumes 1 and 2, we discussed how real-world evidence has impacted drug approvals and label expansions. Volume 3 presents ten more cases of successful RWE use in submissions to regulatory agencies. The booklet includes regulatory guidance on RWE, drug background info, RWE impact on decisions, and approval's effect on future decisions. Download: https://ow.ly/Kcvt50PwmPx.

In "How RWE is Impacting Regulatory Decision-Making" Volumes 1 and 2, we discussed how real-world evidence has impacted drug approvals and label expansions. Volume 3 presents ten more cases of successful RWE use in submissions to regulatory agencies. The booklet includes regulatory guidance on RWE, drug background info, RWE impact on decisions, and approval's effect on future decisions. Download: https://ow.ly/Kcvt50PwmPx.

Recently we shared a fresh case study with you in the field of lower back pain treatment. We’d like to point out that this was not our only experience in the area of neurology therapy. Some time ago we partnered with Dr Reddy’s Laboratories, a leading Indian pharmaceutical manufacturer, to conduct a multicenter, prospective, double-blind, randomized, parallel-group comparative study. Despite pandemic-related challenges, OCT Clinical achieved an impressive enrollment milestone two weeks ahead of schedule in a multicenter, double-blind study. Curious about the key milestones of this collaboration? Watch the video to find out more about our achievements! #neurologyresearch #clinicaltrials #octclinical #expertise

Biosimilars can improve access to potentially life-changing treatments in areas such as oncology, neurology, ophthalmology and immunology. In France, the percentage of Rheumatoid Arthritis patients starting biologic treatment increased from 10% to 80% in 4 years due to biosimilars gain sharing models. Learn more about the many ways biosimilars are delivering value ⬇ #Biosimilars #PatientAccess #WithPatientsInMind

🌟 Exciting News in Eye Disorder Research! Aviceda Therapeutics hits a huge milestone, as dosing begins for the second part of their Phase 2/3 SIGLEC Clinical Trial for Geographic Atrophy (GA)! Their therapy AVD-104 is a sialic acid-coated glycoimmune therapeutic, which binds activated macrophages and causes regulatory changes in cellular/ humoral innate immunity. The primary endpoint for part two is the difference in GA area growth rate, with additional measures assessing visual function and anatomy. 🚀 The Chief Medical Officer, Dr. David Callanan, emphasized the positive safety profile and BCVA improvements already observed in part 1. 👩⚕️ Aviceda Therapeutics' CEO Dr. Mohamed Genead envisions a paradigm shift in GA treatment with AVD-104's dual-mechanism approach. #EyeDisorderResearch #ClinicalTrials #AvicedaTherapeutics #AMD #InnovationInHealthcare #ElixirAssociates #clinical #pharmaceuticals #Geographicatrophy #innateimmunity #science #ophthalmology

Simplify your #drugdevelopment challenges with the help of our experts who will guide you through the changing regulatory terrain with personalised, flexible, and responsive support. https://okt.to/7jwkqF #biotech #therapeutics #drugdiscovery #oncology #immunology #neuroscience #antibody #ophthalmology #cardiovascular #respiratory #inflammation #pharmaceuticals #chemistry #biology #CharlesRiver #Lifesciences #startups

Check out Allucent’s most recent case study, where our clinical pharmacology A-Team details how they implemented modeling and simulation to determine the feasibility and design of a First-in-Human (FIH) study for their client’s program. This case study has been developed as a follow-up to the Novel Neurotherapeutics Risk Assessment Webinar hosted in December and developed by Allucent A-Team experts Devin Welty, Rachel (Tyson) Rozakis, PharmD, Marcus Delatte, PhD, and Alison Wakeford. The client's challenge lay in determining if their pharmacodynamic (PD) objective was achievable given preclinical toxicities linked to maximum observed concentration (Cmax) and conflicting in vitro brain penetration data. Read how Allucent's Clinical Pharmacology experts were able to determine how much of the drug should be given to achieve the clinical PD objective, while simultaneously ensuring participant safety. https://lnkd.in/g2CtS6yP #Allucent #BringNewTherapiesToLight #pharmacology #modelingandsimulation #neurology