Emily Jerry Foundation’s Post

Did you know? Jarosław Kasprowicz, PhD, MBA, Head of Clinical Operations at Clinmark, who will be representing us at the upcoming Bio Convention in San Diego, boasts over 12 years of extensive expertise in clinical trials setup, monitoring, and management across diverse therapeutic fields. With his wealth of experience, he's ready to explore collaborations and discuss how Clinmark can elevate your research. Don't miss this opportunity to connect and schedule a meeting with him! #Clinmark #BioConvention #SanDiego #ClinicalResearch #CebioForum #PolishTradeandInvestmentAgncy

▪ It was great to catch up with old friends and colleagues, seeing them now in these positions of influence, hugely successful careers, taking ownership, protecting our two-legged and four-legged public. ▪ It was great to connect with FDA in this relaxed setting - instead of during an inspection or regulatory meeting! 😉 ▪ It was also great to meet folks for the first time! The networking opportunities were great, though I did miss quite a few of you! A few take-aways: 🔹 Basic, fundamental GMP issues continue to be seen by FDA across the industry, despite the tools, technology, resources, policy, guidance documents, history of observations, warning letters and enforcement, training, industry groups. 🔹 Bare feet in an ISO-classified suite?!?! 🔹 FDA’s Top Ten Issues cited in 483s have not really changed over 20+ years; rankings have shifted up or down, but it is still the same things 🔹 Similarly, DI (data integrity) is not a new concept. As Dr. Cavazonni said, “Get away from paper.” 🔹 “Reading an SOP is not training” – Alonza Cruse 🔹 “The battle is won and lost at the Supervisor level” – Kevin O’Donnell, (HPRA) 🔹 Have we forgotten about the patient? Have we forgotten who the patient is? Do we not realize we are The Patient? 🔹 “Cost of Quality” Why do we use this term? Why don’t we ever speak of the Cost of HR? The Cost of Supply Chain? of Technical Services? 🔹 Leadership sets the tone: it is the determiner of success. 🔹 Leadership is responsible for issues – whether they know it, or not. 🔹 Training, training, training. Real, intentional, training. Designing your org to be effective over the product life cycle should be your goal, not just for the next quarter’s results. Isn’t there a company out there that can help with this? 🔷 Eliquent – from thought to finish 🔷 Christie Bielinski; Karin Baer; Ileana Barreto-Pettit; Linda Evans O'connor;William (Al) Kentrup; Gerard (Jerry) Greco; Donald Ashley; Grace McNally ; Barbara Clendenen; Carmen C. Araujo; Elaine Shannon; Magaly Aham, MSc, RAC-US; Christina M. Mazzella; Domenic Veneziano; Sumaiya Reza; Zhenzhen Liu; Arlene Wolny; Arie Menachem; Saundrea Munroe; Jerome Chal; Maria McCaffrey; Cathy Burgess; Beth Weinman; Greg Levine ; Darrin Schellin; Brendan Carroll; Ben Wolf; Anthony Fanucci, PharmD, JD; Quality & Regulatory Network; Alonza Cruse; Michelle Toro, ASQ CQA, CSQP; Judy Zdanowicz; ELIQUENT Life Sciences; Eliquent Japan, Inc; Eli Shani; Ori Landau; Kimberly Garko; Jenna McCarthy

🎉Happy #RNADay! To celebrate, we're inviting you to share your favorite #RNA jokes or memes in the comments below. Whichever joke gets the most LinkedIn reactions will win a pair of Vernal branded socks.* 🧦 ___________________________________________________________ Example joke to get you started: Why did the RNA go to school? Because it wanted to be a #messengerRNA (#mRNA) & deliver some knowledge! ___________________________________________________________ The fine print: *No purchase required. The winner will be selected on Monday, August 5, 2024. The estimated value of the socks is $8.00 USD. By submitting a promotional item request, you warrant that you are not prohibited by employment, contract, or law from receiving a promotional item from Vernal Biosciences. Offer void where prohibited, licensed, or restricted by federal, state, provincial, or local laws or regulation or agency/institutional policy. Other restrictions may apply.

📢 Exciting news from our CEO, Simon Chandler! In a recent blog by RNID in partnership with BIA, Simon delves into the dynamic landscape of commercialising hearing research.   The journey to developing hearing therapies is filled with potential, driven by advanced insights into hearing biology, partnerships with clinical communities, and a supportive regulatory environment. However, the path is not without its challenges. Transforming scientific discoveries into clinical therapeutics demands innovative solutions.   At Rinri Therapeutics, we are at the forefront of addressing these obstacles. By pioneering new delivery methods, designing novel clinical trial frameworks, and enhancing manufacturing processes, we aim to broaden the impact of our ground-breaking treatments. Our flagship product, Rincell-1, exemplifies our swift preclinical progress, and we are on track to begin clinical trials in the UK within the next 18 months. Our goal: to be the first to offer a comprehensive therapeutic solution for the hearing loss community.   This is a pivotal moment to tackle hearing loss. We urge researchers, pharmaceutical firms, and investors to join us in advancing innovative therapeutics that promise to transform the lives of millions.   🔗 Read the latest blog here: https://lnkd.in/eWf7jmid #HearingLoss #RegenerativeMedicine #Innovation #Healthcare #Celltherapy #cellandgenetherapy #atmps #atmp #yorkshirebusiness #ukbusiness

ELIQUENT Life Sciences is pleased to announce that Brian M. has joined our team of regulatory experts. A recognized regulatory policy leader, Brian brings more than two decades of experience to ELIQUENT's expanded Regulatory Policy Solutions. Learn more about Brian and how ELIQUENT's Regulatory Policy Solutions empower life science innovators facing complex regulatory policy challenges: https://lnkd.in/e6dcpNE6

🌏 Have you considered Australia for your next trial? Here is why Australia is a Top Destination for Medical Device Clinical Studies #Australia presents an attractive and efficient option for MedTech innovators looking to streamline clinical development. Whether you're a start-up or an established player, the benefits of running trials there can give your device a head start on the path to commercialization. Here’s why: ✅ Fast Regulatory Pathway: The TGA’s Clinical Trial Notification (CTN) scheme allows trials to begin without formal pre-approval, significantly reducing startup timelines. ✅ Cost-Effective R&D Incentives: Companies can claim up to 43.5% cashback on eligible expenses through Australia’s R&D tax rebate, maximizing budgets. ✅ Global Data Recognition: Clinical data from Australian trials is accepted by regulators like the FDA and EMA, enabling seamless market progression. ✅ Diverse Patient Recruitment: Australia’s multicultural population ensures robust, generalizable trial data. ✅ World-Class Research Infrastructure: With cutting-edge facilities and renowned investigators, Australian trials maintain high scientific standards. You can catch up with Deborah Bell this week at AusBiotech or set up a consultation at a more convenient time to explore how Australia can support your clinical development goals. #MedTech #ClinicalTrials #MedicalDevices #Australia #ClinicalResearch #Innovation

Learn how to track and trace your samples at the Emerald Scientific booth!

When a new product lands on your doorstep 🤩 Perks of being an INTEGRA Biosciences rep, buuuut you all have to wait until April 30th to see! Entertain me with guesses 🤐 #INTEGRABiosciences #newproduct #whatsinthebox #laboratoryequiptment #liquidhandling #nospoilers #lablife #researchanddevelopment #laboratorylife #academiaresearch #academia #pipette

Join the webinar to get more insights and understanding about the first FSSAI approved Postbiotic - Epicor. New studies published

Honoring our past and building our future. Happy Independence Day. #sarianhealthcare #pharmadistributor #pharmaexports #pharmadistributornetwork #globalpharma #internationalhealthcare #pharmaexportbusiness #pharmamanufacturing #nutramanufacturing #cosmeticmanufacturing #contractmanufacturing #harmonalproduct