Next Generation Analytical Methods | August 12-13, 2026

Next-Generation Analytical Methods

New Technologies to Support the Characterization of Complex Biologics

8/12/2026 - August 13, 2026 ALL TIMES EDT

For 2026, the Next-Generation Methods track explores the forefront of analytical innovation for biologics, highlighting strategies to streamline workflows and enhance data-driven decision-making. Sessions will focus on advances in automation, from miniaturized, flexible systems to end-to-end solutions that increase throughput and enable parallel analysis. Attendees will examine emerging technologies, including expanded MAM workflows, single-cell analysis, molecular dynamics simulations, and real-time monitoring of protein interactions. The track will also cover mass spectrometry innovations, such as ion mobility, proteoform-resolved approaches, and single-particle analysis, alongside structureâ€“function studies that leverage AI/ML, cryo-EM, and advanced microscopy to guide CQA identification, method development, and risk assessment for novel and complex modalities.

Preliminary Agenda

Session Block

PLENARY SESSION

PLENARY KEYNOTE PRESENTATION:
The Correct Way to Bring Digital and AI into Biopharmaceutical Quality

Photo of Anthony R. Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences , SVP , Global Quality , Gilead Sciences — Anthony R. Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences , SVP , Global Quality , Gilead Sciences

Digitalizing quality systems and the advent of artificial intelligence has the potential to revolutionize the way we work in quality. However, it needs careful planning and execution to gain the maximum benefits to the business. Appropriate use cases, change management, training, and streamlining processes before you digitalize is essentialâ€”putting complexity in just results in digital complexity. In addition, the implementation of AI must follow GxP principles in what is currently a vague regulatory framework.

Panel Moderator:

FIRESIDE CHAT: Bringing Digital and AI into Biopharmaceutical Quality and Manufacturing

Photo of Susan Hynes, Global Head of Quality, GSK , SVP, GSK Global Quality , GSK — Susan Hynes, Global Head of Quality, GSK , SVP, GSK Global Quality , GSK

Panelists:

Photo of Lynn Bottone, Senior Vice President, Quality Operations, Environment Health & Safety, Pfizer Inc. , Senior Vice President Quality, Safety & Environmental Operations , Quality Operations, Environment Health & Safety , Pfizer Inc — Lynn Bottone, Senior Vice President, Quality Operations, Environment Health & Safety, Pfizer Inc. , Senior Vice President Quality, Safety & Environmental Operations , Quality Operations, Environment Health & Safety , Pfizer Inc

CHALLENGES AND GAPS FOR NOVEL BIOTHERAPEUTICS

Integrative Biophysical Characterization for Advanced Modalities in Biotherapeutic Discovery

Photo of David Boggs, PhD, Senior Scientist, AbbVie , Senior Scientist , AbbVie — David Boggs, PhD, Senior Scientist, AbbVie , Senior Scientist , AbbVie

An increasingly complex landscape of antigen targets and therapeutic modalities demands the coordinated use of advanced tools for robust characterization. We present an integrated toolkit for biophysical characterization to support the discovery and development of novel biotherapeutics and genetic medicines. By combining light-scattering techniques with single-particle analysis, we deliver deep insights and drive innovation across antibody-antigen, lipid nanoparticle, and virus-like particle platforms.

Single-Particle and Single-Cell Microscopy to Increase the Sensitivity of Characterizing Multivalent Cargo Nanoparticles

Photo of Sabrina Leslie, PhD, Associate Professor, Physics, The University of British Columbia , Associate Professor , Department of Physics , The University of British Columbia — Sabrina Leslie, PhD, Associate Professor, Physics, The University of British Columbia , Associate Professor , Department of Physics , The University of British Columbia

Identification of HMW Artifacts Induced by Reducing Agents in CE-SDS Analysis and Their Removal via Post-Reduction Alkylation

Yannan Lin, PhD, Senior Scientist, Merck , Senior Scientist , Merck

Bridging across Analytical Methods for Novel Modalities

Photo of Diane McCarthy, PhD, Vice President, Global Biologics, US Pharmacopeia , Vice President , Global Biologics , USP — Diane McCarthy, PhD, Vice President, Global Biologics, US Pharmacopeia , Vice President , Global Biologics , USP

Buoyant Mass Reveals Distinct T Cell States Predictive of Checkpoint Response

Photo of Jiaquan Yu, PhD, Research Scientist, Massachusetts Institute of Technology , Research Scientist , MIT - KI — Jiaquan Yu, PhD, Research Scientist, Massachusetts Institute of Technology , Research Scientist , MIT - KI

EXPANDING AND OPTIMIZING MS ANALYTICS

Photo of Chris M. Chumsae, PhD, Director, Analytical Development, Bristol-Myers Squibb , Associate Director , Analytical Development , Bristol-Myers Squibb — Chris M. Chumsae, PhD, Director, Analytical Development, Bristol-Myers Squibb , Associate Director , Analytical Development , Bristol-Myers Squibb

HTP MS Chemical Liability Screen

Photo of Xiaohua Liu, PhD, Principal Scientist, Sanofi , Principal Scientist , Sanofi Grp — Xiaohua Liu, PhD, Principal Scientist, Sanofi , Principal Scientist , Sanofi Grp

Early identification of chemical liabilities is essential for advancing developable biologic candidates without delaying timelines. We present a high-throughput MS screening platform that overcomes peptide mapping bottlenecks through an innovative acquisition strategy and automated data processing, delivering a 100-fold increase in throughput. This workflow enables early, comprehensive PTM characterization and generates high-density datasets to support ML/AI-driven antibody engineering.