S Phase Bio Club的动态

I'm excited to announce that the former?Vanderbilt University Advanced Degree Consulting Club (VUADCC)?will be merging with?S Phase BioClub?to create a comprehensive platform for graduate students interested in consulting. The newly restructured?S Phase BioClub?will host seminars featuring industry consultants, organize case practice sessions, and provide opportunities for pro bono consulting projects. Stay tuned for more updates!

Join me and the wonderful Marta Ciechonska, co-founder of Salient Bio on 22nd January for an informative webinar on the oral microbiome, its importance for dental and systemic health and learn all about their oral microbiome test. Not to be missed! Details on how to register in the post. #oralmicrobiome

? 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

Last week, Holger Senn presented at the PTC European Life Science Exchange event, discussing "AI in Variant and Configuration Lifecycle Management (CLM) of Medical Devices," with a focus on mastering complexity related to regulations and compliance. Holger presented the benefits medical device manufacturers can achieve using a CLM approach, including: - Standardizing processes - Capturing knowledge - One consistent data model Learn more about the benefits of a CLM approach by visiting https://lnkd.in/e8kzsktY #medicaldevice #manufacturing #complexitymanagement ?

Join me with Paul Hinchliffe and Darren Matthews for a webinar discussing how Quotient Sciences and Charles River Laboratories integrated drug development programs can streamline your molecule's path through development.

Thank you Our Longevity for inviting me to this wonderful webinar where we unpacked the need for evidence based longevity medicine in the GCC and discussed current trends in the region. I believe longevity medicine is precision and P4 medicine at its core. Clinical practice and interventions should be rooted predominantly in lifestyle medicine with regenerative medicine and functional medicine, AI-enabled diagnostics, predictive algorithms, omics, biotechnologies, therapeutics and IOMT including longevity-friendly EHRs integrated with wearables and other technologies for data tracking and monitoring. We discussed the need for research & development and longitudinal cohort studies to drive local big data. Governance, regulatory frameworks, policies and private public partnerships create a milieu conducive to innovation, ethical clinical practice and public awareness with adoption. #purehealth #ourlongevity #longevitymedicine #healthspan #lifespan #biotechnology #uae #omics #precisionmedicine #p4medicine

?? 12 Days of Grove-mas ?? We’re almost halfway through our celebration of exceptional partnerships with leading SMOs, CROs, and sponsors! Today, we’re excited to share another impressive achievement driven by Grace, the world’s most advanced AI-powered clinical research agent from Grove AI. Grace increased lead-to-site visit conversions by an incredible 580%! ?? Day 5 Highlights: - Instant follow-ups with potential participants to keep engagement. - Seamless scheduling and prescreening workflows that eliminate delays. - Personalized engagement to ensure participants are informed and motivated to take the next step. ?? Why It Matters: Lead-to-site drop-off is one of the biggest challenges in clinical trials, with many participants losing interest or momentum before their first visit. Grace tackled this head-on, keeping participants engaged and informed, and dramatically reducing drop-off rates.

Leveling up is the name of the game at Bio Biz Bash. Level up your clinic, level up the service you provide client, level up your network, level up yourself. Here's how you can join us and level up: https://biobizbash.com/ #AlternativeMedicineClinic #BiohackingClinic #ClinicOwners #ScaleYourClinic

One2Treat Founder Marc Buyse is speaking today at the Cancérop?le Grand Sud-Ouest Club SMAC event in Bordeaux. ? During this 1.5-day workshop, participants will address statistical concepts for sample size estimation in clinical research, in the context of innovative trial designs and non-standard primary endpoints. ? Marc’s presentation highlights the ?????? ?????????????????? ?????????????? estimator, a powerful approach that can reduce sample sizes by incorporating multiple prioritized patient-relevant outcomes into a single endpoint. ? We’re proud to contribute to this important conversation about advancing clinical research methodologies.? ? Merci to Carine Bellera and Virginie Rondeau for the organization ??

Really inspired by the latest post from one of our PhD students, Birte Hell reminded us that science isn't always about showcasing polished results - sometimes it's about facing the challenges head-on. Presenting on *qPCR troubleshooting* might not sound glamorous, but it's exactly these moments of grappling with setbacks that often lead to real breakthroughs. To all our PhD students: remember, research isn't just about the final outcome; it's about the process - the persistence, the problem-solving, and the learning along the way. Sharing challenges isn't a sign of weakness, but a strength that drives collaboration and innovation. So, if your experiments aren't delivering the perfect data, or you feel stuck in the "trial and error" phase, keep pushing forward. Every hurdle you overcome is a step closer to success, and every problem solved is another building block in your journey. Your perseverance is what fuels progress. Let's embrace the setbacks as part of the story we're writing together. Science is about collaboration, curiosity, and constant learning. Keep going, team - the breakthroughs will come! ???? #PhDLife #ResilienceInResearch #GrowthThroughChallenges #ALLPreT #TeamScience #Collaboration #HorizonEurope #InnovationInProgress #MSCA #H2021 #Foodallergy