BioData Solutions

Join Us for an Open Scientific Discussion! The American Association of Pharmaceutical Scientists (AAPS) | @aapscomms Gene and Cell Therapy Products (GCTP), Bioanalytical, and Regulatory Science Communities invites you to a thought-provoking discussion on proposed #FDA guidance on the use of #AI in #drugdiscovery and #drugdevelopment. What to Expect: ✅ Explore key provisions of the FDA's draft guidance on AI in regulatory decision-making ✅ Discuss implementation challenges and practical applications ✅ Gain insights from AAPS community members and ongoing AI initiatives What: FDA's Draft Guidance on AI in Regulatory Decision-Making for Drug & Biological Products When: March 10, 2023, 12 PM – 1 PM EDT Who: Stephanie Pasas Farmer, PhD – President & Founder, BioData Solutions Robert Dodge, PhD – Bioanalytical & Immunogenicity Consultant Where: Please join the meeting from your computer, tablet or smartphone. https://lnkd.in/g3TgH5qq You can also dial in using your phone. Access Code: 505-947-717 United States: +1 (646) 749-3122 Join from a video-conferencing room or system. Meeting ID: 505-947-717 Dial in or type: 67.217.95.2 or inroomlink.goto.com Or dial directly: 505947717@67.217.95.2 or 67.217.95.2##505947717 A big shout out to the organizers, Stephanie Pasas Farmer, PhD (BioData Solutions) & Allison Radwick (US Pharmacopeia), for putting this Scientific Discussion together. Don’t miss this engaging discussion—see you there!

We look forward to seeing you at the 19th #WRIB. Please join us at our booth to learn more about our #offerings and exciting #updates. What: Booth #37 at 19th WRIB When: April 7 - 11, 2025 Where: Hilton New Orleans Riverside, New Orleans, LA, USA

Please join Stephanie Pasas Farmer, PhD at CYTO 2025 on June 1, 2025 as she highlights #artificialintelligence #innovations on medical imaging for #drugdevelopment.

We're #hiring a new Compliance Manager – Software Development. Apply today or share this post with your network.

Exciting Breakthrough in RSV Prevention! Discover how RSM01, a novel monoclonal antibody, is paving the way for affordable #RSV prevention in low- and middle-income countries. The latest Phase 1 trial by the Bill & Melinda Gates Foundation shows that dried blood samples are just as effective as serum in measuring virus-neutralizing antibodies and pharmacokinetics. This #innovative approach could significantly reduce patient burden, especially for infants. BioData Solutions team feels proud to have collaborated with Bill and Melinda Gates Foundation on this innovation! Read more about this promising development and its potential impact on #globalhealth in "Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candidate respiratory syncytial virus neutralising monoclonal antibody"! https://lnkd.in/g28xDRTu

We at BioData Solutions are immensely #grateful for the unwavering support and collaboration of our #stakeholders. Your dedication and commitment have been instrumental in our journey towards #innovation and excellence in #bioanalysis. Together, we have made significant strides in advancing the field, and we look forward to achieving even greater milestones together. Here's to continued success and shared accomplishments! 🙌

We are deeply grateful to PBSS International for the opportunity to present at last week's #workshop, "Current State of Bioanalysis for Biologics and Cell/Gene Therapy Products: Refining Established Approaches for New Complex Therapies." Our heartfelt thanks also go to all the attendees. Should you have any further questions, please do not hesitate to reach out to us. #bioanalysis #biologics #cellandgenetherapies

Join us at #EBF Open Symposium for a study on whether ultra-low cut points for your #immunogenicity assays should be concerning.

Don't forget to join us today for an informative #webinar where we explore the transformative role of #AI in #bioanalysis and #biomarkers. We will present data-supported applications and explore how AI, integrated with genomic, proteomic, and metabolomic analyses, can forecast #immunotherapy effectiveness early in the drug development process. What: Revolutionizing Bioanalysis: Harnessing AI for Enhanced Precision, Insights, and Efficiency When: November 13, 2024, 11:00 am ET Who: Corinne Ramos, Aliri Bioanalysis, and Stephanie Pasas Farmer, PhD, BioData Solutions Where: Register at https://lnkd.in/eWMdqEUU

Are you struggling with the expanded scope, increased oversight, and other challenges stemming from In Vitro Diagnostic Medical Devices Regulation (IVDR). Learn from industry experts in this PBSS International #webinar. What: "Current State of Bioanalysis for Biologics and Cell/Gene Therapy Products: Refining Established Approaches for New Complex Therapies" When: November 15, 8:45 am - 5:20 pm PT Who: Sebastian Guelman, Genentech; Jintang He, Genentech; Stephanie Pasas Farmer, PhD, BioData Solutions; Kelly Colletti, Beam Therapeutics; Surinder Kaur, Ph.D., Genentech; Bob Liu, Genentech Where: In-person at Crowne Plaza Foster City, CA or virtually via a webcast Register at: https://lnkd.in/gYbXcnVJ #bioanalysis #biologics #cellandgenetherapies