BEGIN:VCALENDAR VERSION:2.0 PRODID:-//CiviCRM//NONSGML CiviEvent iCal//EN X-WR-TIMEZONE:Europe/London METHOD:PUBLISH BEGIN:VTIMEZONE TZID:Europe/London BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0100 TZNAME:BST DTSTART:20260428T083000 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:CiviCRM_EventID_1958_e86a4f28f24ec85011f2b11344e0bb4c@onenucleus.com SUMMARY:Recent Advancements and Hot Topics in Regulated Bi oanalysis X-ALT-DESC;FMTTYPE=text/html:

Regulat ed bioanalysis continues to evolve alongside incre asingly complex therapeutic modalities and the nee d to accelerate drug development without compromis ing data quality. Recent years have seen a shift t oward more streamlined\, fit-for-purpose bioanalyt ical strategies\, prompting a re-evaluation of lon g-standing conventions while remaining firmly grou nded in science.

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This seminar will hi ghlight current hot topics in pharmacokinetic (PK) \, immunogenicity (ADA/NAb)\, and biomarker bioana lysis\, with a focus on the practical application of scientific and regulatory principles in drug de velopment programs. Presentations will explore how context-of-use\, risk-based decision-making\, and thoughtful assay design can be applied in practic e\, with case studies providing practical examples of bioanalytical approaches that support efficien t and accelerated drug development.

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< strong>Event sponsored by...

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Agenda:
\n 08:30 Arrival\, Registration & Breakfast (45 mi nutes)
\n 09:15 Welcome from One N ucleus (5 minutes)
\n 09:20 BioAgilytix introduction & updates (5 minutes)
\n Valeria Ventura\, Senior Director Business Development\, BioAgilytix
\n 09:25 Hot Topics in Regulated Bioanalysis (20 minutes)
\n Rob Nelson\, PhD\, Sci entific Officer\, BioAgilytix
\n 09: 45 Playing Catch-up: A Case Study on Maximising CRO-Pharma Interactions (20 minutes)
\n Gareth Satchell\, Associate Director\, Biomar kers and Bioanalytical Platforms\, GSK
\n 10:05 Developing an Ultra-Sensitive PK As say: Pushing Analytical Limits Within a Traditiona l
\n Immunoassay Framework (20 minu tes)
\n Matthias Reichel\, Scientific Operati ons\, BioAgilytix
\n 10:25 Q&A (20 minutes)
\n 10:45 Networ king (45 minutes)
\n 11:30 End of One Nucleus Networking Morning Seminar

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Moderator
\n Valer ia Ventura\, PhD\, Senior Directory Business Devel opment\, BioAgilytix
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Speakers
\n Rob Nelson\, PhD\, Scientific Officer\, BioAgilytix
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Gareth Satchell\, Associate Director\, Bi omarkers and Bioanalytical Platforms\, GSK
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Matthias Reichel\, Scientific Operations\, BioAgi lytix
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Att endance: This event is free of charge.
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For more detai ls and to register\, take a look here.
DESCRIPTION:Regulated bioanalysis continues to evolve alongsid e increasingly complex therapeutic modalities and the need to accelerate drug development without co mpromising data quality. Recent years have seen a shift toward more streamlined\, fit-for-purpose bi oanalytical strategies\, prompting a re-evaluation of long-standing conventions while remaining firm ly grounded in science. \n \n \n \n This seminar w ill highlight current hot topics in pharmacokineti c (PK)\, immunogenicity (ADA/NAb)\, and biomarker bioanalysis\, with a focus on the practical applic ation of scientific and regulatory principles in d rug development programs. Presentations will explo re how context-of-use\, risk-based decision-making \, and thoughtful assay design can be applied in p ractice\, with case studies providing practical ex amples of bioanalytical approaches that support ef ficient and accelerated drug development. \n \n \n \n Event sponsored by...\n \n \n \n \n \n \n \n A genda:\n \n 08:30 Arrival\, Registration & Brea kfast (45 minutes)\n \n 09:15 Welcome from One Nucleus (5 minutes)\n \n 09:20 BioAgilytix intr oduction & updates (5 minutes)\n \n Valeria Ventur a\, Senior Director Business Development\, BioAgil ytix \n \n 09:25 Hot Topics in Regulated Bioana lysis (20 minutes)\n \n Rob Nelson\, PhD\, Scienti fic Officer\, BioAgilytix \n \n 09:45 Playing C atch-up: A Case Study on Maximising CRO-Pharma Int eractions (20 minutes)\n \n Gareth Satchell\, Asso ciate Director\, Biomarkers and Bioanalytical Plat forms\, GSK \n \n 10:05 Developing an Ultra-Sen sitive PK Assay: Pushing Analytical Limits Within a Traditional \n \n Immunoassay Framework (20 minu tes)\n \n Matthias Reichel\, Scientific Operations \, BioAgilytix \n \n 10:25 Q&A (20 minutes)\n \ n 10:45 Networking (45 minutes)\n \n 11:30 En d of One Nucleus Networking Morning Seminar\n \n \ n \n Moderator\n \n Valeria Ventura\, PhD\, Senior Directory Business Development\, BioAgilytix \n \ n \n \n \n \n Speakers\n \n Rob Nelson\, PhD\, Sci entific Officer\, BioAgilytix \n \n \n \n \n \n G areth Satchell\, Associate Director\, Biomarkers a nd Bioanalytical Platforms\, GSK\n \n \n \n \n \n Matthias Reichel\, Scientific Operations\, BioAgil ytix\n \n \n \n \n \n Attendance: This event is fr ee of charge. \n \n \n \n For more details and to register\, take a look here.\n \n CATEGORIES:Events CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/London:20260428T083000 DTSTART;TZID=Europe/London:20260428T083000 DTEND;TZID=Europe/London:20260428T113000 LOCATION:Kings Hedges Room\n The Babraham Research Campus\n Babraham\n Cambridge\, CB22 3AT\n United Kingdom\ n URL:https://onenucleus.com/civicrm/event/info?reset=1&id=1958 END:VEVENT END:VCALENDAR