About Bio-IT World

• When: April 2-4
• Where: Omni Boston Hotel at the Seaport
• Visit us at Booth #816

The Bio-IT World Conference & Expo is the premier global event showcasing technologies and analytic approaches that solve problems, accelerate science, and drive the future of precision medicine. By uniting a community of 2,800+ leaders in life sciences, pharmaceuticals, clinical research, healthcare, informatics, and technology, the event pushes the boundaries of biomedical research, drug discovery and development, and patient outcomes. The program features inspiring plenary keynotes, 200+ educational and technical presentations, interactive panels, hands-on symposia, technical workshops, unparalleled networking opportunities, and an exhibit hall showcasing cutting-edge technologies and solutions. Attendees are invited to engage in transformative conversations on the latest advancements in digital and data transformations; AI; generative AI; machine learning (ML); real-world data strategies; pilot programs; new product results; and biotech investment trends.

About the Astrix Presentation

Pharmaceutical R&D Informatics Track | April 4^th at 12:40 pm

Topic: The Next Wave of CMC Digitalization: Challenges and Opportunities

Presenters: Dave Dorsett, Chief Digital Officer, Astrix & Mohit Agnihotri, Senior Director Development, Sciences Data & Digital Strategy, Abbvie Bioresearch Center

What will be discussed

This talk will focus on applications of digital transformation beyond the “first wave” of laboratory process effectiveness and efficiency, including applying scientific and data architectures developed over the past years of Digital Transformation to:

• Improving the quality and efficiency of internal processes for assembly and review of CMC submission documents
• Supporting ICH Manufacturing Quality Guidelines
• Preparing for the FDA PQ/CMC use of FHIR for electronic filings of CMC Section
• Impacting the lead-in to Development through candidate nomination decisions, and the output of Development by shortening tech-transfer to manufacturing and commercialization
• Developing predictive models from the increasing amount of harmonized CMC data

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.