Uwe Trinks

As part of AstraZeneca’s focus on sustainable science, we have set ourselves the ambitious goal to introduce electronic product information (ePI) across all medicines, while ensuring flexibility for patients to access product information through alternative ways if needed. The introduction of ePI brings with it a host of benefits for the planet, patients, and healthcare systems, including: 🌍 Improved accessibility to the most up-to-date information on medicines, available in multiple different languages. 💊 More efficient and wider availability of medicines through digitalisation of labels and quick implementation of label changes. 🍃 Lower environmental impact. If ePI was introduced across all AstraZeneca products, it could potentially save an average of 500,000 trees and 1.6bn litres of water each year. Learn more: https://lnkd.in/gJC-fwtd #WhatScienceCanDo

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Discover the latest enhancements to Labcorp Global Trial Connect, designed to streamline site workflows and boost clinical trial efficiency. These updates, driven by insights from collaboration with sponsors and sites, aim to empower investigator sites to focus more on what truly matters, patient care. Your commitment to patient care is why we’re committed to redefining clinical trial delivery. Learn more: https://lnkd.in/eavYncMz #ClinicalTrials #GlobalTrialConnect

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After nearly 14 years of draft guidance, the #FDA published the final guidance for industry on Pharmacokinetics in Patients with Impaired Renal Function 📝 ❗ In this edition of the New Medicines, Novel Insights newsletter, Parexel regulatory experts discuss the history and evolution of the FDA's approach in this field and provide five specific areas to consider in the assessment of draft to final guidance. Bring innovative therapies to patients more efficiently and effectively. Read the article below and subscribe to receive the latest #NovelInsights weekly! #Pharmacokinetics #Regulatory #RegulatoryAffairs #WithHeart

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What better PODD: Partnership Opportunities in Drug Delivery Community News #PODD2024 grand finale – than a discussion on #OralPeptides #OralBiologics with experts Andy Lewis, Suman Luthra, Lipa Shah? We covered #design, #drugdelivery and #formulation aspects of this aspirational #research and #development aim. Key take home messages include 1) Barriers are monumental – degradation by peptidases and permeability needs to be overcome by design but delivery can also help with permeability, 2) design strategies includes non-natural amino acids, conjugation, cyclization, stapling, prodrugs – important here to also consider the clinical substance supplies as the more elaborate designs increase complexity, 3) thinking outside the small intestine important – buccal, gastric and colonic delivery have shown success, 4) physicochemical and biophysical property elucidation really important for a preclinical and clinical formulation strategy that includes excipient selection such as permeation enhancers, 5) #biopharmaceutics knowledge extremely valuable – know where you want your peptide to be absorbed and design the product accordingly, 6) in terms of clinical POC, preclinical to clinical translation can be achieved if you know your biopharmaceutics well and tweak the formulation accordingly, 6) blue sky is the ingestible injectables devices, designing novel permeation enhancers and targeting transporters (although the latter has been attempted for a while wo being hugely successful) Thanks to the organizers and PODD staff for an awesome conference!

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Project Optimus is revolutionizing early oncology trials, aiming to ensure more effective and safer cancer drugs and improve patients' quality of life. Parexel experts have identified three strategies to help sponsors overcome challenges in achieving dose-optimization requirements. Here’s what we know works: 1️⃣ Design an integrated first-in-human study 2️⃣ Reach agreement with FDA at each step 3️⃣ Challenge guidelines with a compelling rationale Let me know your thoughts below and read more in our New Medicines, Novel Insights report! https://lnkd.in/dmYADu-n #ProjectOptimus #Oncology #NovelInsights

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The mRNA technology platform holds immense potential to revolutionize the process of drug and vaccine development. On June 19th, join Parexel experts Sinan Sarac, Cecil Nick, and Christiane Niederlaender for a free live webinar on navigating regulatory challenges and conducting clinical research for mRNA therapies, accelerating your product development, approval, and improving patient outcomes. Webinar agenda: >  Section 1 - Accelerating Approval for Oncology Drug Development >  Section 2 - Optimizing the Path to Regulatory Approval for Novel Vaccine >  Section 3 - Overview of mRNA Product Manufacturing Challenges >  Q+A session and discussion Gain valuable insights to optimize your mRNA study. Details and registration information here: #mRNA #oncology #vaccine #regulatory

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In #NeurodegenerativeDisease news, specifically on an experimental treatment for #ALS, with this new #strategic partnership is penned between Dewpoint Therapeutics and Mitsubishi Tanabe Pharma America. ⚛️ The asset is the former's drug, designed "to address the accumulation of a protein into toxic structures that lead to neuronal dysfunction in people with ALS." 🤝 The alliance would grant MTP exclusive rights to license, upon achieving certain developmental milestones. ⚕️ This would add to MTP's existing US-marketed ALS treatment, #Radicava https://lnkd.in/evayrVv4' #Dewpoint #Mitsubishi #Pharma #Biopharma #Healthcare

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Understand the implications of ILD toxicity monitoring in Antibody Drug Conjugate (#ADC\) trials and how to meet worldwide #regulatory expectations in this on-demand webinar. https://lnkd.in/euEtKVE6 #MedicalImaging #Oncology #ChooseCalyx

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For those interested in Physiologically Based Biopharmaceutics Modeling (PBBM) please check out our recently published article from the 2023 PBBM workshop. It proposes best practices for measuring solubility, dissolution, precipitation and permeability for parameterizing PBBMs, summarizes breakout sessions, and shares PBBM case studies. https://lnkd.in/gda_HH4F

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The importance of patient insights in developing better clinical trials. Parexel experts outline a proven 4-part approach to understanding and integrating the patient perspective and how it can guide study design and improve outcomes. #patientsinsights #patientvoice #OncologyResearch #PatientPerspective #ClinicalTrials #ParexelBiotech

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Let’s hope this is a big step forward by anticipating and addressing potential regulatory backlog given the inflection of #cellandgene therapy and #AI approaches. The logic being that a standardized framework for development platforms could take less assessment time and offer #biotech swifter approvals and reduced development costs. #innovation #medicine #pharmaceutical #

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Discover strategies for overcoming the specific obstacles associated with launching your cell and gene therapies (CGTs) into the marketplace. Dive into our newest blog post! https://gag.gl/NJNQ1Q and make sure to explore the accompanying white paper that you can find linked within our blog. #cellandgenetherepy #CGT #CMC #biopharma #drugdevelopment #regulatoryaffairs #pharma

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In this interview with Triangle Business Journal, CEO Peyton Howell shares her vision for how Parexel will tackle global challenges and leverage cutting-edge technology to reach more patients where they are. Read it: https://lnkd.in/gqS-FRmJ #PatientsFirst

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Looking forward to joining fellow industry leaders at this year’s IDDST-International Drug Discovery Sciences & Technology Congress in Budapest! I am particularly excited to discuss how drug development in women’s health can uniquely leverage female biology to customize delivery methods and durations for optimized outcomes. If you are attending or will be in the area, let’s connect and talk all things #womenshealth!

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