Biofidelity’s Post

Join the 𝗽𝗿𝗲-𝗰𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝘄𝗼𝗿𝗸𝘀𝗵𝗼𝗽 𝗱𝗶𝘀𝗰𝘂𝘀𝘀𝗶𝗼𝗻𝘀 at the 3rd ALS Drug Development Summit: 💡 Join Fen Huang, Philip Wong and Robert P. Bowser, Ph.D. to deepen understanding of TDP-43 function and discover new clinically relevant biomarker opportunities 💡 Navigate anticipated trial complications stemming from an evolving standard of care, while optimizing the potential of combination therapies with Shiran Zimri, Machelle Manuel and Fred Grossman D.O., FAPA 💡 Collaborate with Angela Genge, MD, FRCP(C), eMBA, Christopher Ocampo, Stacy Lindborg and Marjan Sepassi to evaluate the potential of novel surrogate biomarkers extending beyond ALSFRS-R and debate the most meaningful endpoints based on regulatory requirements Full details can be found here: https://ter.li/3dn781

Future biomarker research should evolve to consider not just the disease-target relationship but also the characteristics of the modality. This approach is essential because individual mechanisms can vary even within the same modality, particularly in the case of drug conjugates. https://lnkd.in/gknSDb5f

We're excited to see you at AAPS 2024 PharmSci 360 in a few weeks!  📅 October 20-23, 2024   📍 Salt Lake City, UT   🏢 Say hello at Booth #1530 This year's Bioanalytics Track is packed with insights:  * Lab Innovations: AI in assay design, predictive outcomes, cut-point analysis  * Current Challenges: Multi-domain therapeutics, nontraditional matrices, patient-centric sampling  * Regulatory Implications: Guideline harmonization, biomarker validation, rare disease considerations   We're proud to have our CSO, Dr. Lauren Stevenson, sharing her expertise: 🔎Hot Topic: "FDA Laboratory Developed Test Proposed Rule and Biomarker Testing" Monday, October 21 | 10:00-11:00 AM MT Moderator: Dr. Lauren Stevenson Joined by: Dr. Steven P. Piccoli, Dr. Patrice Hugo, Dr. Mark Ma Learning Objectives:    * Describe changes in FDA regulations pertaining to LDTs used in clinical trials.  * Demonstrate familiarity with the technical requirements for future LDT assay development and validation.  * Conduct, oversee, and submit successful patient results using LDTs to the FDA.    📅 Would you like to discuss your biomarker and bioanalytical challenges further? We're available for personalized meetings throughout the conference. Visit https://lnkd.in/eYM6GGMZ to schedule a time that works for you. We look forward to discussing how to optimize your drug development program. 📍 Stop by Booth #1530: Our team would love to chat about how these insights apply to your work. Whether you're tackling a specific challenge or exploring new opportunities, we're here to brainstorm with you. Looking forward to great conversations and connections. See you in Salt Lake City! #AAPS2024 #PharmSci360 ##CRO #DrugDevelopment #Bioanalytical #ImmunologixLabs 

Check out the ISSX Virtual Workshop hosted by the Transporters Focus Group on February 28 - March 1! View Session 1 Program details at https://lnkd.in/gJXiJ6F9 Session 1 Spotlight: 10:00am - 10:15am: Welcome and Overview on Transporter Biomarkers 10:15am - 10:45am: Practical Consideration on Designing Clinical Studies to Incorporate Endogenous Biomarkers to Evaluate Transporter DDI and Drive the Decision Making  10:45am - 11:2am: Update from IQ OATP1B Biomarker Working Group 11:25am - 11:50am: Break 11:50am - 12:40pm: Case Studies: Applying Transporter Biomarker Data to Support Mechanistic Understanding of DDIs and Drive DDI Strategy and Decision-Making in Drug Development: 4 Short Presentations 12:40pm - 1:15pm: Regulatory Perspectives on Transporter Biomarkers 1:1pm - 1:55pm: Roundtable Discussion with Speakers and Dr. Ryota Kikuchi (AbbVie) 1:55pm - 2:00pm: Session Closing Remarks

In this webinar brought to you by Merck, learn how a novel immunoassay kit and multiplex platform streamlines biomarker screening, saving researchers time and preserving their precious samples. #AD Register today: https://ow.ly/Rs5F50RETs2

We are thrilled to have been selected as a Fierce 15 Biotech Company! As our President and CEO Nancy Whiting noted: "It truly has been a transformative time for Recludix. We are the first company to successfully drug SH2 domains, exciting targets that are critical in mediating protein-to-protein interactions in many diseases. Our innovative oral small molecule inhibitors are based on our proprietary platform, which integrates custom DNA-encoded libraries, parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. This cutting-edge platform led to a strategic collaboration with Sanofi to advance a novel oral STAT6 inhibitor in multiple immunological and inflammatory indications, which included a total of $125 million in near-term payments and more than $1.2 billion in potential future milestones, while having an option to participate in an equal profit-sharing arrangement in the U.S. Additionally, we have identified highly potent, selective and orally bioavailable STAT3 inhibitors in our wholly-owned STAT3 program. We are excited to advance these molecules towards the clinic, as STAT6 and STAT3 activation is found in multiple disease pathways.” Read about the recognition: https://lnkd.in/eXVdVv4z

PROLIGHT: PoC troponin testing ready for next step With proof-of-performance for its proprietary digital technique for detection of high-sensitive biomarkers even in whole blood, Prolight Diagnostics has taken significant steps forward in the past year. The share however, has experienced extended downwards pressure following the unit issue and subsequent compensation issue for the underwriters. Once the underwriters’ 150m shares have found their way to more sturdy investors, and the company continues to make progress with prototype development and IVDR certification towards launch in 2026, we expect the pressure to ease, and a revaluation that better reflects the long term prospects, where we find support for a fair value of SEK 1.1 – 1.2 per share. Read the full report here: https://lnkd.in/diPZcqzQ #POCtesting #troponin

Streamline your screening projects. Listen to this on-demand webinar with The Scientist to hear from our and Luminex’s expert scientists and learn how combining the new MILLIPLEX® PLEXpedition screening assays with the xMAP® INTELLIFLEX® system can streamline your protein #biomarker screening. Watch now to see how easy it is to measure up to 115 biomarkers at once.

This could be most exciting for 2025! Using Navinci Diagnostics' PLA knowhow and Vector Laboratories, Inc.'s glycobiology knowledge this could be game changing! Do let me know if you are in the UK and interested in spatial location of glycosylated proteins , and I will be sure to reach out to you as soon as we have the realease date! #glycobiology #spatialbiology #glycomics #glycosylation

Massive Bio is introducing our latest innovation, the Drug Utilization Optimizer (#DUO), at the ASCO Annual Meeting 2024 in Chicago! Building on the success of our SYNERGY-AI platform, DUO is set to transform how pharmaceutical commercial teams target and engage physicians. This innovative analytics and real-time notification platform provides unparalleled insights and efficiencies, allowing commercial teams to analyze the competitive landscape with up-to-date and accurate data. DUO connects with the right physicians, identifies relevant patients quickly and efficiently, increases brand revenues, and reduces the cost of sales. Unlike traditional real-world data companies, we improve operational efficiency and facilitate patient access to medicines by providing real-time and detailed insights. We recognize the challenges in cancer clinical trials and continue to work rapidly to bring more hope. Visit our booth at #ASCO24 to learn more about DUO and see a demo and click on the link below. 👉🏻 https://bit.ly/3yL8eGo Booth: #29137 Selin Kurnaz, PhD, Arturo LoAIza-Bonilla MD, Çağatay M. Çulcuoğlu, Toygun Onaran, Oz Huner, Aslan Aslanağı, Eren Caskurlu, Hakki Isik, PMP, Mert Sarı, Ertuğrul T., Toykan Dogan, MCogSc, #MassiveBio #ClinicalTrials #Innovation #Oncology #AIinHealthcare