Immunologix Laboratories

We are excited to announce that Dr. Lisette M. Fred Lucena, will be presenting at the American Association of Pharmaceutical Scientists (AAPS) | @aapscomms Pharm Sci 360 on a key topic in the bioanalytical industry: Immunogenicity Testing Strategies. In her talk, Dr. Lucena will share practical approaches to optimizing immunogenicity testing protocols and mitigating assay interferences. We invite you to attend her engaging presentation and visit us at Booth #1530 to discuss your challenges with immunogenicity assays and explore solutions to overcome assay interferences. #AAPS2024, #PharmSci360, #Immunogenicity, #AssayDevelopment, #Immunologixlabs

We are thrilled to announce our own Dr. Lisette M. Fred Lucena as a speaker at AAPS 2024 PharmSci 360 for her presentation: 📢 "Multiple Strategies for Mitigating Immunogenicity Assay Interferences" 📅 Tuesday, October 22, 2024 ⏰ 9:00-9:30 AM MT Dr. Fred Lucena's presentation will cover practical approaches to optimize immunogenicity testing protocols. Her experience in assay development will provide real-world strategies to mitigate immunogenicity assay interferences. 🤝 After the presentation, Dr. Fred Lucena will be available to discuss applying these strategies to specific immunogenicity challenges. Reach out to us and schedule your meeting now. https://lnkd.in/eYM6GGMZ to arrange a personalized discussion on optimizing your drug development program. We're looking forward to talking with you more. See you in Salt Lake City! #AAPS2024 #PharmSci360 #Immunogenicity #AssayDevelopment #BioanalyticalScience #ImmunologixLabs

Reminder: The 16th Annual Immunogenicity & Bioassay Summit is just around the corner! We can't wait to see you in DC next week! As we prepare for this exciting event, we wanted to remind you of our key contributions and opportunities to connect: 📅 Oct 15-18, 2024   📍 Washington, D.C.   🏢 Find us at Booth #14 Don't miss our featured sessions: Podium Presentation: "Rational ≠ Radical: A Scientific Perspective on Immunogenicity Risk and Assessment"   📆 Oct 16, 9:30 AM   Join Dr. Lauren Stevenson for insights on innovative approaches to immunogenicity risk assessment and testing strategies. Interactive Discussion: "When one size does not fit all: Reevaluating immunogenicity risk assessments and the 3-tiered testing paradigm."   📆 Oct 16, 2:20 - 3:10 PM   Engage with Dr. Lauren Stevenson in a dynamic conversation about tailoring immunogenicity strategies for diverse biotherapeutics. Additional opportunities to connect:  Booth visits: Drop by Booth #14 anytime during the summit for impromptu discussions and insights. Haven't scheduled a meeting yet? There's still time! Reach out to us and schedule your meeting now. https://lnkd.in/eYM6GGMZ to arrange a personalized discussion on optimizing your drug development program. We look forward to engaging in discussions, innovative ideas, and potential collaborations. See you soon in Washington, D.C.! #ImmunogenicitySummit2024 #CRO #Immunogenicity #Bioanalytical #DrugDevelopment #ImmunologixLabs 

Mark your calendars for an insightful keynote at AAPS 2024 PharmSci 360! Our CSO, Dr. Lauren Stevenson, examines current practices in drug development: 📢 Keynote: "Effective Drug Development Requires Rationales, Not Rules – Rethinking Guidance for Industry"   📅 Wednesday, October 23   ⏰ 1:30-2:30 PM MT Dr. Stevenson advocates reconsidering our approach to drug development guidance as therapeutics evolve. Here's what you'll explore: 🔬 New Modalities, Old Rules: Why existing guidance, designed for simpler therapeutics, may not fully address today's complex landscape. 🤔 Beyond Analogy: How relying on reasoning by analogy has influenced approaches in drug development and bioanalysis. 💡 First Principles Thinking: The value of approaching challenges (both new and old) from first principles – embracing scientific thinking. 💰 Real-world Impact: How specific approaches affect time, money, and resources, potentially impacting the delivery of therapies to patients. 📊 Data-Driven Insights: Lessons from two decades of industry data, illustrating the importance of rationales in crafting industry guidance.  Dr. Stevenson will discuss shifting from traditional practices to those grounded in scientific rationale. This talk aims to offer fresh perspectives on navigating the complexities of modern drug development. 🤝 Continue the Conversation: We'd love to chat at Booth #1530 after the keynote. Our team is ready to discuss how these insights might apply to your drug development and bioanalysis work. Let's explore how this approach could enhance your strategies! Reach out to us and schedule your meeting now. https://lnkd.in/eYM6GGMZ to arrange a personalized discussion on optimizing your drug development program. We're looking forward to talking with you more. See you at AAPS 2024 in Salt Lake City! #AAPS2024 #PharmSci360 #CRO #DrugDevelopment #Bioanalytical #RegulatoryScience #ImmunologixLabs 

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 

We're thrilled to invite you to collaborate with us at the 16th Annual Immunogenicity & Bioassay Summit! 📅 Oct 15-18, 2024   📍 Washington, D.C.   🏢 Meet our experts at Booth #14 Don't miss this opportunity to engage with groundbreaking approaches in immunogenicity assessment, bioassay optimization, and regulatory science.  We're proud to present the following key scientific contribution from Dr. Lauren Stevenson:  Interactive Discussion:  📆 Oct 16, 2:20 - 3:10 PM   "When one size does not fit all: Reevaluating immunogenicity risk assessments and the 3-tiered testing paradigm."  Key Topics:  * Revising our thinking on risk assessments - incidence without impact and the myth of the medium risk molecule  *  Lessons learned from over 20 years of data generation - perspectives on benefits and challenges with the current testing paradigm  * Mining all the data from the screening tier - how S/N analysis can help fill in the blanks and turn confusion into clarity  * Immunogenicity is a biomarker - Understanding the context of use ensures we don't try to put square pegs in round holes and fail to measure what matters  * Rethinking the Nab testing tier—if Nab is important to understand, why wait? Differentiating what may be scientifically interesting from what affects patient safety and efficacy. Our team is eager to share insights, answer your questions, and explore potential collaborations. Your next breakthrough could start with a conversation at the summit! #ImmunogenicitySummit2024 #Immunogenicity #Bioanalytical #Bioanalysis #DrugDevelopment #BeAScientist #CRO #LaboratoryServices #Immunologixlabs

We're thrilled to invite you to collaborate with us at the 16th Annual Immunogenicity & Bioassay Summit! 📅 Oct 15-18, 2024   📍 Washington, D.C.   🏢 Meet our experts at Booth #14 Don't miss this opportunity to engage with groundbreaking approaches in immunogenicity assessment, bioassay optimization, and regulatory science.   We're proud to present the following key scientific contribution: Podium Presentation: Dr. Lauren Stevenson  📆 Oct 16, 9:30 AM   "Rational ≠ Radical: A Scientific Perspective on Immunogenicity Risk and Assessment"  Abstract: This presentation critically examines the evolution of immunogenicity risk assessment and the 3-tiered testing paradigm. Dr. Stevenson will propose a novel framework recontextualizing immunogenicity as a biomarker, exploring its impact on:   a) Risk assessment refinement focusing on the likelihood of clinically meaningful immunogenicity   b) Using the totality of immunogenicity data to build complete subject profiles  c)  Enhanced data representation to facilitate interpretation and regulatory review Join us in advancing the field of immunogenicity! We invite you to attend Dr. Stevenson's presentation and visit us at Booth #14 to learn more about these innovative concepts. Let's explore how these new approaches can enhance your bioanalytical strategies and accelerate your drug development programs. Your insights and questions are valuable – let's push the boundaries of science together at the Immunogenicity Summit!    #ImmunogenicitySummit2024 #Immunogenicity #Bioanalytical #Bioanalysis #DrugDevelopment #BeAScientist #CRO #LaboratoryServices #Immunologixlabs 

We're thrilled to invite you to the forefront of immunogenicity analysis and interpretation at the 16th Annual Immunogenicity & Bioassay Summit! 📅 Oct 15-18, 2024   📍 Washington, D.C.   🏢 Meet our experts at Booth #14 Don't miss this opportunity to engage with cutting-edge approaches in immunogenicity assessment, bioassay optimization, and regulatory science. We're proud to contribute to the scientific discourse through two key sessions: Podium Presentation: Dr. Lauren Stevenson 📆 Oct 16, 9:30 AM    Immunogenicity Assessment & Clinical Relevance "Rational ≠ Radical: A Scientific Perspective on Immunogenicity Risk and Assessment"   Dr. Stevenson will explore innovative approaches to immunogenicity risk assessment, challenging current paradigms and proposing new strategies for evaluating clinically meaningful immunogenicity in biotherapeutics. Roundtable Discussion: Immunogenicity Risk Assessment Paradigms   📆 Oct 16, 2:20 - 3:10 PM   "When one size does not fit all: Reevaluating immunogenicity risk assessments and the 3-tiered testing paradigm."   Join us for an engaging discussion on tailoring immunogenicity risk assessments and testing strategies to meet the evolving needs of diverse biotherapeutic modalities. We look forward to collaborating with fellow scientists to advance our understanding of immunogenicity and its implications for drug development and patient outcomes. #ImmunogenicitySummit2024 #Immunogenicity #Bioanalytical #Bioanalysis #DrugDevelopment #BeAScientist #CRO #LaboratoryServices #Immunologixlabs 

Join us at two key biopharma R&D events this October: 16th Annual Immunogenicity & Bioassay Summit   📅 Oct 15-18, 2024    📍 Washington, D.C.   🏢 Booth #14  Focus: Advanced immunogenicity testing, bioassay optimization, and regulatory insights. Highlights: ADA/NAb assay development, bioanalytical techniques for complex biologics. AAPS 2024 PharmSci 360   📅 Oct 20-23, 2024   📍 Salt Lake City, UT   🏢 Booth #1530  Bioanalytics track emphasis:   • Lab Innovations: assay design, predictive outcomes, cut-point analysis, development, validation, and analysis for non-standard therapeutics, solutions for GLP and GCP lab documentation using AI technologies  • Current Challenges: multi-domain therapeutics, nontraditional samples in matrices such as whole blood, tissues, PMBC, cerebrospinal fluid, etc., patient-centric sampling, and bioanalytical challenges and approaches for personalized medicine  • Regulatory Implications: Guideline harmonization, biomarker validation, cut point for rare diseases, outsourcing, study design and implementation  Connect with our team of immunogenicity experts: • Visit us at our booths for an in-depth discussion on your specific bioanalytical challenges. • Schedule a one-on-one meeting with our team during the sessions to explore how our innovative approaches can enhance your drug development programs. • Reach out to us before the event to set up a personalized consultation during the meetings: https://lnkd.in/eYM6GGMZ    #ImmunogenicitySummit2024 #AAPS2024 #PharmSci360 #Bioanalytics #Bioanalysis #Immunogenicity #DrugDevelopment #CRO #LaboratoryServices 

What a wonderful turnout we had yesterday for our first annual Bioanalysis Symposium in Boston! It was wonderful to engage with so many of you for an afternoon of conversations on navigating the complex landscape of biomarkers. A special thank you to our esteemed speakers and panelists for sharing your knowledge and real-world perspectives regarding the context of use and clinical relevance of biomarkers, from discovery to clinical applications. Pictured below: A group of brilliant and inquisitive scientists and thought leaders. Left to right - Dr. Lauren Stevenson, Dr. Devangi Mehta, Dr. Dania Rabah, Dr. Donald McLaren, Dr. Seema K., Maurine Braun MS, DABT, Dr. Steven Piccoli, Dr. Robert Neely, Dr. John Canfield, PhD, and Dr. Raj Rajagovindan. #beascientist #biomarkers #contextofuse #clinicalrelevance #bioanalysissymposium #immunologixlabs