Therapeutic drug monitoring (TDM) of biologics is emerging in recent years as a valuable tool for clinical decision making. While the benefits for patients are clear and the analytical performances of the commercial TDM kits established, their adoption strategy as well as the implementation of a best TDM practice into the clinic is still under debate. This and other similar topics were discussed during the event "TDM and personalization of therapy in the context of new anti-infective and biological molecules: Update of the last 6 years" held in Turin back on the 13th and 14th March, under the scientific supervision of Prof. D'Avolio and sponsored by A.Menarini Diagnostics S.r.l. and other top market leaders. One of the most relevant outcomes of the meeting was the general agreement, among the experts, that rapid testing and easy sampling will be key to the implementation of such a practice into the various clinical settings. A.Menarini Diagnostics S.r.l., with its long-time history of being a flexible and trustworthy partner of the medical community, can assist public and private institutions in the implementation of TDM practices by offering a wide range of AFIAS kits and analysers specifically conceived for the rapid use at the point of need. AFIAS systems are cartridge base platforms that offer fast turn-around-time (12-15 min), easy to use and reliable analysis of various laboratory parameters. These single test based solutions prevent waste - ideal for small to mid-volume routines. #pointofcare #menarini #innovation #technology #healthcare
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We are excited to attend the 18th WRIB at St. Antonio, TX from May 6 - 8, 2024. Drop by booth #35 and meet our team to discuss how Syngene can help accelerate your clinical development programs. To book a meeting, visit the link in the comment section. We are a full-service CRO and CDMO offering integrated discovery, development, and manufacturing services across small molecules and biologics. We provide full-service solutions to the following clinical development solutions: ⦿ Bioequivalence studies (BABE)/ comparative bioavailability studies in healthy volunteers for generic drugs. ⦿ Phase-1 studies in healthy volunteers for biosimilars or vaccines. ⦿ Phase I-IV trials in patient populations ⦿ Regulated bioanalytical support for small and large molecule development programs. Here are some advantages of outsourcing clinical requirements to India: ⦿ Access to a larger pool of volunteers/patients for quicker recruitment. ⦿ Efficient regulatory processes ensure timely approvals and study conduct. ⦿ Timely project execution with experienced teams and facilities. #18thWRIB #ClinicalDevelopment #CDMO
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Citeline's influential clinical development success rate analyses have been foundational for supporting investment decisions in biopharma R&D. Our landmark paper in 2014 established the commonly cited 10% benchmark. However, this has steadily fallen over the last decade. This drop is both a concern and inevitable as competition intensifies and the barriers to market entry become higher. Click to read about why clinical development success rates are falling on the Norstella blog: https://ow.ly/E12a50RIPZF. #ClinicalDevelopment #DrugDevelopment #Biopharma #BiopharmaceuticalCompanies #BiopharmaTrends
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Citeline’s influential clinical development success rate analyses have been foundational for supporting investment decisions in biopharma R&D. Our landmark paper in 2014 established the commonly cited 10% benchmark. However, this has steadily fallen over the last decade. This drop is both a concern and inevitable as competition intensifies and the barriers to market entry become higher. Click to read about why clinical development success rates are falling on the Norstella blog: https://ow.ly/4fh250RIMpu. #ClinicalDevelopment #DrugDevelopment #Biopharma #BiopharmaceuticalCompanies #BiopharmaTrends
Why are clinical development success rates falling? | Norstella
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Soft Tissue Sarcoma Pipeline Analysis Covering Clinical Trials, Emerging Therapies, FDA, EMA, and PMDA Approvals, Competitive Landscape | Philogen, Epizyme, CytRx, Incyte, Karyopharm, AstraZeneca #Finance #FinancialMarket #MarketingSales #PharmaceuticalsBiotech
Soft Tissue Sarcoma Pipeline Analysis Covering Clinical Trials, Emerging Therapies, FDA, EMA, and PMDA Approvals, Competitive Landscape | Philogen, Epizyme, CytRx, Incyte, Karyopharm, AstraZeneca | ABNewswire
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We’re proud to announce, we have received the FDA grant for the "Evaluation of Oral Modified Release Dosage Forms to Support the Approval of Additional Strengths" 💊 , in collaboration with Northeastern University and SimulationsPlus. The research objectives are to determine critical quality attributes for oral controlled release drug products. For that, mechanistic models, parameterized with in vitro dissolution data from our dynamic in vitro gastrointestinal model, tiny-TIMsg, will be developed. “The research efforts of our team and Dr. Shen have the potential to accelerate the availability of critical treatments to patients across the world, with minimized need for clinical trials,” said Susann Bellmann, Chief Technology Officer at The TIM Company. “We are proud to support those efforts and this collaboration through the use of our dynamic in vitro gastrointestinal model, tiny-TIMsg.” The combination of in vitro and in silico studies will support the identification of critical quality attributes and help to build a model to identify key variables affecting drug release mechanisms for formulation design strategies. The overall objective is to advance the development of oral generic controlled release drug products. To achieve this award was not possible without the initiative and collaborative effort of Jie Shen from Northeastern University, Maxime Le Merdy, Viera Lukacova from Simulations Plus, Inc. and Susann Bellmann from The TIM Company. We also extend our gratitude to everyone involved in this collaborative effort, Franc Overmars, PhD, Anita Gashi, Lieke van den Elsen, PhD, Saleh Allababidi and Yang Lin. We are confident our partnership will yield valuable insights for the pharmaceutical industry and healthcare! #fda #pharmaceuticalresearch #collaboration #innovation #Healthcareadvancement
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Aspiring MBA Graduate | Specializing in Pharmaceutical Management | Student council Core | Core committee member SPTM | Public relations E-Cell | Graphic designing TWH | NMMUN RND
**Exciting Breakthrough in Pharma! 🌟** The pharmaceutical landscape is buzzing with innovation as Vertex Pharmaceuticals recently announced a game-changing development! Vertex's groundbreaking new therapy for cystic fibrosis has received FDA approval, marking a significant leap forward in treating this debilitating disease. This new treatment, Trikafta, targets the root cause of cystic fibrosis and promises to enhance the quality of life for thousands of patients. But that's not all! The industry is also witnessing a surge in AI-driven drug discovery, with companies like Insilico Medicine leading the charge. By leveraging cutting-edge artificial intelligence, Insilico has accelerated the drug development process, bringing new hope to patients with unmet medical needs. These advancements highlight the transformative potential of technology and innovation in healthcare. It's an inspiring time to be in the pharma industry, where every new discovery brings us closer to a healthier future. Let's celebrate these milestones and continue pushing the boundaries of what's possible in medicine! 💊🔬 Vinod K Sharma,Ph.D #PharmaNews #Innovation #Healthcare #CysticFibrosis #AI #DrugDiscovery #VertexPharmaceuticals #InsilicoMedicine #FDAApproval
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TNO has launched Peregrion to enhance the market impact of its accelerated biomedical mass spectrometry (AMS) technology, aiming to accelerate medicine development. Peregrion, the 41st spin-off since TNO's Tech Transfer inception, focuses on aiding pharmaceutical companies in expediting their early clinical development programs. This spin-off builds on TNO's decade-long development of AMS technology, which has gained regulatory acceptance and a proven track record. Peregrion will leverage TNO's expertise in generating early human microtracer data and optimizing processes for drug development. The company aims to support pharmaceutical firms in advancing their medicine development initiatives by utilizing AMS technology for microtracer studies, optimizing drug development and reducing risks. The co-founders of Peregrion, Wouter Vaes and Steven Erpelinck, emphasize the significance of the microtracer approach in advancing drug metabolism data collection. They highlight the industry's growing acceptance of this innovative method, positioning it as a promising trajectory for animal-free innovation in pharmaceutical research. Moreover, Peregrion is poised to broaden the application field of AMS technology, focusing on biomarkers, efficacy research, and data enrichment studies for various drug types. https://lnkd.in/epCFR7ds Join Practical Patient Care for Daily Healthcare News Updates and Weekly Newsletter Subscription! #practicalpatientcare #BiomedicalInnovation #AcceleratedMedicineDevelopment #PharmaTechAdvancement #DrugDevelopmentRevolution
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Running Strategic Feasibility in #ClinicalResearch for an upcoming trial is often a slow and inaccurate process... Highlighted by the simple facts that: 1. Sponsors are only 58% confident in feasibility assessments. 2. 91% of feasibility assessments "have short turn-around times" and 3. 78% of feasibility assessment have poor data collection mechanisms to power their forecasts. Sound familiar? With the Launch of Spectrum, Lokavant's #AI optimized Feasibility solution, these challenges may be a thing of the past. Case-in-point Recently, a top-10 Pharmaceutical Sponsor leveraged Spectrum to achieve their goal of identifying the most suitable sites for a critical phase III Obstructive Hypertrophic Cardiomyopathy(oHCM) #clinicaltrial; ensuring their plan remained on target 🎯 . 🔍 Discover how Spectrum is transforming clinical trials by reading our case study below and here: https://lnkd.in/dwM3E7tY cc Rohit Nambisan Aaron Mackey
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Soft Tissue Sarcoma Pipeline Analysis Covering Clinical Trials, Emerging Therapies, FDA, EMA, and PMDA Approvals, Competitive Landscape | Philogen, Epizyme, CytRx, Incyte, Karyopharm, AstraZeneca #Finance #FinancialMarket #MarketingSales #PharmaceuticalsBiotech
Soft Tissue Sarcoma Pipeline Analysis Covering Clinical Trials, Emerging Therapies, FDA, EMA, and PMDA Approvals, Competitive Landscape | Philogen, Epizyme, CytRx, Incyte, Karyopharm, AstraZeneca | ABNewswire
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We are excited to attend CPHI Japan from April 17-19, 2024. Drop by booth #4W-33 and meet our team to discuss how Syngene can help accelerate your clinical development programs. To book a meeting, write to us at bdc@syngeneintl.com We are a full-service CRO and CDMO offering integrated discovery, development, and manufacturing services across small molecules and biologics. We provide full-service solutions to the following clinical development solutions: ⦿ Bioequivalence studies (BABE)/ comparative bioavailability studies in healthy volunteers for generic drugs. ⦿ Phase-1 studies in healthy volunteers for biosimilars or vaccines. ⦿ Phase I-IV trials in patient populations ⦿ Regulated bioanalytical support for small and large molecule development programs. Here are some advantages of outsourcing clinical requirements to India: ⦿ Access to a larger pool of volunteers/patients for quicker recruitment. ⦿ Efficient regulatory processes ensure timely approvals and study conduct. ⦿ Timely project execution with experienced teams and facilities. Yogesh Joshi #ClinicalDevelopment #Biopharma #CDMO
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