2026 Summer Scientific Forum Program Themes
Bioanalytical Track
Theme 1: From Signals to Impact: Translating Bioanalytical Data to Clinical Meaning
Keywords: predictive modeling, PK/PD, biomarkers, immunogenicity, standardization, cellular assays, ELISpot, longitudinal risk, multi-omics, integrative analytics, systems biology, high parameter assays, bioanalytical/biomarker assay strategies, ultra-sensitive assays and assay life cycle management.
Case studies and workshops illustrating the coalescence of bioanalytical work streams to provide meaningful study impact as well as utilizing modelling tools and information to guide advanced strategies are sought. Emphasis is placed on orthogonal evidence and model-informed analyses to accelerate regulatory and clinical translation. Examples that integrate biomarkers, PK/PD, and immunogenicity to map exposure–response, optimize dosing, and enhance safety for fit-for-decision development are encouraged. Themes advance from detection to mechanistic insight and clinical risk assessment and could include cellular immunity and innate/adaptive cross talk.
Theme 2: Beyond Platforms: New Bioanalytical Challenges and Opportunities
Keywords: LC-HRMS, LBA, NGS/ddPCR, spectral flow, CyTOF, ICH M10, patient-centric sampling & logistics, digital monitoring, AI-driven assay design, cloud-based bioanalysis, automated analytical pipelines, data integrity, mRNA vaccines, CRISPR-based therapies, exosome analytics, synthetic biology products, nanocarriers, immune-effector cell therapies, in vivo CAR-T and conjugated technologies
This theme seeks to showcase efforts to reimagine the role of bioanalytical platforms within the newer technological advancements of drug delivery approaches, decentralized trials and AI integration. Discussions should include emerging and legacy assay platforms while addressing validation, comparability, and operational readiness across complex modalities and decentralized studies. Examples are sought highlighting orthogonal strategies, cross‑lab and cross-method bridging as well as traceable data packages and lifecycle‑ready documentation from exploratory to regulated use.
Pharmaceutical Analysis Track
Theme 1: Analytical Tools, Technologies, and Approaches for Driving Efficiency and Innovation
Keywords: analytical technology, instrumentation, automation, experimental design, artificial intelligence, stability, modeling, method development, design of experiment, peptides, oligonucleotides, proteins, complex generics, mAbs, ADCs, data trending, orthogonal technologies, software, compliance, regulatory, standardization, data integrity tools, emerging platform technologies
Advancements in analytical approaches play a critical role in enabling teams to meet varied challenges associated with the increasing size and complexity of the pharmaceutical pipeline. This theme explores the diverse innovations applied to increase efficiency, navigate complexity, and drive scientific insight across various modalities, with examples including emerging platform technologies, lab automation, method development strategies, and experimental design approaches.
This theme also includes software tools, modeling approaches, and applications of artificial intelligence. By using these tools, scientists in the pharmaceutical analysis space can build rigorous fundamental understanding and efficiently deliver timely data and conclusions to drive product and process development.
Theme 2: Risk-Informed Analytical Control Strategies: Advancing Drug Development, Lifecycle Management and Manufacturing Excellence
Keywords: Analytical Target Profile (ATP), critical quality attributes (CQAs), analytical control strategy, QbD, lifecycle management, standardized reference materials, risk assessment frameworks, heterogeneity, immunogenicity, Process Analytical Technology (PAT), AI/ML, ICH Q2(R2), ICH Q14, ICH Q3E, ICH Q1, regulatory compliance and harmonization, QC readiness, quality risk management, multi-attribute monitoring (MAM)
The complexity of modern drug development—from clinical batches to commercial manufacturing—demands a seamless integration of Chemistry, Manufacturing, and Controls (CMC) with robust analytical control strategies. Long-existing challenges such as variability, method lifecycle gaps, and fragmented global systems highlight the need for an approach that combines analytical sciences, risk-based principles, and predictive technologies.
This theme invites innovative solutions that transform CMC development into a dynamic, knowledge-driven process, creating audit-ready analytical control strategies that improve drug development efficiency and product robustness. Key areas of focus will include examples to enhance CMC decision-making, improve comparability, and accelerate readiness for regulatory filings which may leverage predictive modeling, AI/ML, or PAT. Other topics will include real-time trending, early detection of failure modes, and adaptive control strategies in modern manufacturing environments. Additionally, case studies on integrating analytical sciences into manufacturing, such as ATP-driven strategies to proactively manage CQAs will be presented.
Bioanalytical and Pharmaceutical Analysis Thursday Joint Session
Scientific Programming Committee
Scientific Programming Committee
Landon Greene, Ph.D., Vertex Pharmaceuticals (Chair)
Mark Wissel, Ph.D., Eurofins Viracor BioPharma Services (Vice-Chair)
Bioanalytical Track
Indiwari Gopallawa, Ph.D., AstraZeneca (Chair)
Liang Zhu, Ph.D., Moderna (Vice-Chair)
Clarinda Islam, Somru BioScience, Inc.
Dominic Warrino, Dsc., KCAS Bio
Jennifer Vance, Ph.D., Recursion Pharmaceuticals
Yue Du, Ph.D., AstraZeneca
Pharmaceutical Analysis Track
Xiuli Li, Ph.D., Eli Lilly and Company (Chair)
Sanghati Bhattacharya, Ph.D., Stira Pharmaceuticals
Nathan Contrella, Ph.D., Merck & Co., Inc.
Phanikumar Reddy Satti, Msc., Veranova
Prasanna Yakkala, Ph.D., The Ohio State University