[ON-DEMAND WEBINAR]

Starting with Endpoints – Developing a Clinical Scale Protein Biomarker Assay for Fibrosis

Presenters
Ben Gonzales, Senior Vice President, Commercial
Ernestas Sirka, Chief Scientific Officer

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Abstract

Join us for a rapid-fire, 30-minute Fibrosis Flash Webinar, where we’ll explore the latest advancements in fibrosis biomarker development using mid-plex workflows. From FDA considerations on surrogate markers to validation guidance for multiplex assays, we’ll provide insights into how Inoviv is leading the way in biomarker development and clinical assay validation.

About the Webinar

This webinar is designed for therapeutic developers and clinical researchers looking to understand the evolving role of protein biomarkers in fibrosis-related drug development. We’ll cover how mid-plex workflows, such as those developed with the FibroKey™ assay, provide a robust and efficient platform for tracking disease progression and therapeutic impact. Our experts will also outline regulatory considerations and practical applications, helping you stay ahead in biomarker discovery and validation.


During this webinar, our Proteomics Experts will discuss the following:

FDA’s Approach to Biomarkers as Surrogate Endpoints 
Understand the increasing importance of multi-marker studies and the role of biomarkers in drug development.

FibroKey™ Assay Overview
Discover how our mid-plex workflow supports the development and validation of fibrosis biomarkers, ensuring regulatory readiness.

Grant Program Announcement
Learn how you can take advantage of pre-validated work through the FibroKey™ Grant Program, designed to streamline your drug development efforts.

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Speakers

Ben Gonzales, Senior Vice President, Commercial

Ben Gonzales, SVP Commercial at Inoviv, spearheads business development, marketing, and product strategy for the company’s fully validated, multiplexed, mass spectrometry-based proteomics assays. With over 20 years of leadership in biotech and pharma, Ben specializes in proteomics, having successfully developed and commercialized innovative technologies in diagnostics and R&D. Previously, he served as General Manager at Biognosys Inc., expanding US operations in support of mass spectrometry-based proteomics. Ben’s career also includes pivotal roles, such as Product Manager at SomaLogic, where he contributed to the commercialization of cutting-edge technologies. His expertise drives Inoviv’s growth and leadership in proteomics solutions.

Ernestas Sirka, Chief Scientific Officer

Ernestas Sirka is a seasoned biochemistry expert and life sciences leader with extensive experience in clinical test development, distinguished by roles at Pfizer and UCL. Notably, he has pioneered the development of a unique targeted proteomics platform and multiple patent-pending biomarker tests for drug development applications across several therapeutic areas. Ernestas’ pursuit of novel mass spectrometry applications has resulted in multiple academic accolades, including peer-reviewed publications in Nature Medicine and the Lancet group of journals. As Chief Scientific Officer at Inoviv, Ernestas leads initiatives that push the boundaries of medical science, driving growth at Inoviv and innovation in the field to shape the future of drug development

Learn more about FibroKey™

about the assay
Read our case study