トップファーマによる75以上のプレゼンテーション
（トップファーマ15社の代表者を含む）

2026年のプレゼンテーション

業界のビジョナリー、ソートリーダー、パイオニアによるプレゼンテーションでは、進歩を促し、イノベーションを推進する独自の視点が提供されます。

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Applied Automation and Mechanistic Modeling for Purification Development of Challenging Molecules under Accelerated Timelines
Scott H. Altern, PhD, Senior Scientist I, AbbVie Inc.

Integrative Biophysical Characterization for Advanced Modalities in Biotherapeutic Discovery
David Boggs, PhD, Senior Scientist, AbbVie

Increasing Cell Culture Process Robustness through Raw Material and Metabolic Understanding
Delia Lyons, Principal Scientist, Process Sciences, AbbVie Inc.

Low Molecular Weight (LMW) Species Control in Bispecific Antibody Purification Process
Lingling Xia, PhD, Principal Research Scientist I, Purification Process Development-ADC, PDS&T-BDL, AbbVie Inc.

KEYNOTE PRESENTATION: Next-Generation Cation Exchange Chromatography Platform Process Development for Biologics Purification
Lihua Yang, PhD, Senior Principal Research Scientist, BioProcess Purification Development, AbbVie, Inc.

KEYNOTE PRESENTATION: Perfusion Cell Culture in Large Scale Manufacturing
Glen R. Bolton, PhD, Executive Director, Late Stage Bioprocess Development, Amgen, Inc.

Characterizing Cellular Responses to Diverse Feeding Strategies in High-Intensity Dynamic Perfusion Bioprocesses
Peter Amaya, PhD, Associate Director, AstraZeneca

Scaling Up TFF for Upstream Continuous Processing: Applications of Mechanistic Modeling
Ashna Dhingra, Bioprocess Technologies & Engineering, Senior Scientist, AstraZeneca

Talk Title to be Announced
Jerry Eriksson, MSc, Senior Research Scientist, AstraZeneca R&D

Drug Product and Delivery of Cell Therapies
Vidyashankara Iyer, PhD, Director, AstraZeneca

PANEL DISCUSSION: Latest Challenges in Cell Therapy Analytics
Panelist: Jigesha Dholakia, Director, CMC Analytical Strategy, DA01 Analytical Workstream Lead, Bayer US LLC

Fully Automated and Closed Stem-Cell Expansion and Differentiation at a Commercial Scale
Wonjong Si, Director, Cell Therapy Process Development, Bayer US LLC

Challenges and Strategies of 2’-NMA Chemistry in Oligonucleotide-Synthesis Process Development
David Cho, Scientist I, ASO Process Development, Biogen

Hydrophobic Interaction Chromatography (HIC) as an Innovative Platform for High Purity and Yield ASO Manufacturing
Juan P. Cueva, Scientist, Purification Process Development, Biogen

Development of a Raman Model for Continuous Monitoring of Detergent Viral Inactivation
Kurtis Denny, Engineer I, Cell Culture Development, Biogen

Enhancing Control of Endotoxins during Oligonucleotide Purification
Sanjeev Jeyabalan, Engineer II, Technical Development, Biogen

KEYNOTE PRESENTATION: Converting Low-Seed Processes to Intensified Fed-Batch Processes through Smart Media Design and PAT Controls
Sarwat Khattak, PhD, Head of Cell Culture and Cell Line Development, Biogen

KEYNOTE PRESENTATION: Concept and Execution for an Enhanced Analytical Control Strategy Development and Execution for Autologous Cell Therapies
Stephan O. Krause, PhD, Executive Director Analytical Quality, BMS Cell Therapies

Accelerating Biologics Development with Predictive Stability Modeling
Dan (Cassie) Liu, Principal Statistician, Bristol Myers Squibb

Utilizing Advanced Modeling Techniques for Investigating and Optimizing Buffer Exchange in Ultrafiltration/Diafiltration (UF/DF) Processes
Chadakarn Sirasitthichoke, PhD, Senior Process Engineer, MS&T Systems and Engineering, Bristol Myers Squibb Co.

Structured Approach to Develop and Deploy AI/ML Predictive Models for Commercial Biologics Manufacturing
Sivashankar Sivakollundu, PhD, Associate Director, Robustness and Digital Strategies, Bristol Myers Squibb

How to Transform Bioprocess Analytics in Digital and Autonomous Landscapes-Steering for Success
Dhanuka Wasalathanthri, PhD, Associate Director, Biologics Development, Bristol Myers Squibb

Peptide-Peptide Interaction Studies in Co-Formulations
Yingmei Gu, Advisor, Eli Lilly and Company

Quantum Cascade Laser-MidIR (QCL-MIDIR) for Real-Time Monitoring of Capsid Concentration and Empty/Non-Empty Percentage of Adeno-Associated Viral Particles
Juan Carlos Rosario, MSChE, Senior Principal Scientist, Purification & Virology Development, Eli Lilly & Company

Enhancing Sanitization for AVB Sepharose Resin in AAV Vector Purification
Albert Kao, Senior Scientist, Purification Development, Genentech, Inc.

Optimization of the Harvest Process for AAV-Based Gene Therapy Manufacturing
Yixuan Ming, PhD, Downstream Process Development Scientist, Technology Development, Genentech Inc.

Plasmid Engineering for AAV Production and Increased Safety
Azadeh Sarfallah, PhD, Senior Scientist, Applied Viral Sciences, Genentech Inc.

Allogeneic Cell-Therapy Manufacturing
Sreedhar Thirumala, PhD, Director, Process Development, Genentech

Multimodal ML Framework to Predict Antibody Viscosity
Krishna D. Bharadwaj Anapindi, PhD, Senior Scientist, Biology, Gilead Sciences Inc.

Machine Learning-Assisted Image Analysis of Sub-Visible Particles in Biologics Drug Products: A Comparative Study Using Micro-Flow Imaging (MFI) and FlowCam
Yi Li, Principal Scientist, Gilead Sciences Inc.

PLENARY KEYNOTE: The Correct Way to Bring Digitalization and AI into Biopharmaceutical Quality
Anthony R. Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences

Optimizing TI-CHO Platforms: Process Acceleration and Chromatin-Driven Expression Variability
Derek Smith, PhD, Principal Scientist, Cell Line Development, Gilead Sciences

PLENARY: Fireside Chat with Audience Q&A
PANEL MODERATOR: Susan Hynes, Global Head of Quality, GSK

Realizing the Potential of Transposase-Mediated Integration for CHO-Based Vaccine Antigen Production
John Ruano, PhD, Principal Scientist, GSK

Cell-Therapy Manufacturing Analytics
Prasid Dasgupta, Process Statistical Analytics Lead, Advanced Therapies Supply Chain, Johnson & Johnson Innovative Medicine

Formulation Development Toolbox for Biologics
Can Araman, PhD, Senior Manager, Excipients R&D, Merck

Unlocking the Potential of an ADC Platform through Development of a Continuous Decapping Reaction
Becky Chmielowski, PhD, Principal Scientist, Merck & Co.

Single-Cell RNA Sequencing Identifies Cellular Heterogeneity Impacting Product Formation in CHO Perfusion Culture
Sean Engels, PhD, Senior Scientist, Process Research and Development Enabling Technologies, Merck

Enabling Process Characterization Activities via Mechanistic Modeling of Chromatography for a Protein-A Capture Step
Spyridon Konstantinidis, PhD, Principal Scientist, Merck

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

KEYNOTE PRESENTATION: Novel Expression Systems for Biomanufacturing
Zhen Ma, PhD, Director, Process R&D Enabling Technologies, Novel Expression Systems, Merck

Accelerating Drug-Product Development: Design, Execution, and Analysis of High-Throughput Liquid-Formulation Screening
Hanlin Ouyang, PhD, Associate Principal Scientist, Analytical Enabling Capability, Merck

How “Flexible” Platform Design Paradigm Enables Innovation to Support Highly Intensified Processes
Jonathan K. Romero, PhD, Distinguished Scientist, BioProcess Research & Development, Merck Research Laboratories

Image-Based Toolkit to Track Recombinant HPV VLP in Yeast for Vaccine Upstream Process Development
Nicole Smiddy, PhD, Assoc Principal Scientist, Vaccines Analytical R&D, Merck & Co.

Strong Tunable Synthetic Promoters for Recombinant Protein Expression
Shuang Wei, PhD, Senior Scientist, Merck

Use of Bayesian Optimization for Analytical Method Development
Rose Yin, PhD, Senior Scientist, Merck

Slope Spectroscopy: The Fast Track to Reliable Protein Quantification
Veronika Matoša, Analytical Method Expert, Novartis

PANEL DISCUSSION: Latest Challenges in Cell Therapy Analytics
Panelist: Yu Qian, PhD, Director, Head, Cell Therapy Analytical Development, Novartis

KEYNOTE PRESENTATION: CMC for in vivo CAR T Manufacturing: Opportunities, Challenges, and the Road Ahead
Nripen Singh, PhD, Executive Director and Site Head, Process Development, TRD CGT, Novartis

PLENARY: Fireside Chat with Audience Q&A
Panelist: Lynn Bottone, Senior Vice President, Quality Operations, Environment Health & Safety, Pfizer Inc.

Developing & Scaling-up Intensified Fed-Batch Processes
Jose M. Gomes, Senior Principal Scientist & Manager, Bioprocess R&D, Pfizer Inc.

Mechanistic Modeling Frameworks for Predicting Multispecific Co Culture Dynamics and Enabling Real Time Process Control
Bhanu Chandra Mulukutla, PhD, Senior Principal Scientist, Group Leader, Process Development, Pfizer Inc.

Chromatographic Control of dsRNA Impurities Using a Mixed Mode Method with Platform Potential
Sabeen Nadir, Scientist, Pfizer Inc.

Leveraging Next-Generation Sequencing to Examine saRNA Replication and Host Response
Sage Rohrer, PhD, Postdoctoral Fellow, Analytical R&D, Pfizer

Leveraging SSI CHO for Exogenous PAM Enzyme Co-Expression to Enhance Fusion Peptide Processing
Laura Zielewicz, PhD, Principal Scientist, Pfizer Inc.

Transfection Complex Acid Quenching
Louis Coplan, Process Development Engineer II, Regeneron Pharmaceuticals Inc.

Manufacturing Intensification Of AAV Harvest Processes Using Acid Pretreatment For Combined Removal Of Host Cell Protein And Host Cell DNA Impurities At Pilot And Production Scale
Ana J Garcia, Engineer II, Process Development, Regeneron Pharmaceuticals Inc

Mechanistic Understanding of Metal-Induced Oxidative Instability in Antibody-Drug Products
Emma Ren, Senior Associate Scientist, Regeneron

MS-Based Glycolipid Analysis in Biotherapeutic R&D for Alpha-Gal Syndrome (AGS) and Melanoma Tumors
Ying Sheng, PhD, Senior Scientist, Analytical Chemistry, Regeneron Pharmaceuticals Inc.

The Journey to Qualifying TCID50, an Infectivity Assay for AAVs
Chin Ying Angela Shiu, Process Development Engineer, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals Inc.

Simple, Tunable Online Glycopeptide Enrichment for LC-MS Glycoproteomics and Therapeutic Protein Characterization
Yunlong Zhao, PhD, Senior Principal Scientist, Analytical Chemistry, Regeneron Pharmaceuticals

Assessing AAV Stability on Affinity Resin and the Effects of Extended Binding Times on Impurity Removal and Transduction Efficiency
Lukas Bongers, PhD Student, Gene Therapy Technical R&D, Roche Diagnostics GmbH

Precision in Process: Advanced Assays and Workflows Using Cedex Bioanalyzers.
Ryan Lybarger, Roche CustomBiotech

Delineation of AAV Critical Quality Attributes (CQA’s) through Degradative Pathway Studies
Jill Bradley-Graham, PhD, Principal Scientist, GMU BioAnalytics Characterization, Sanofi

PANEL DISCUSSION: CMC and Quality of RNA-Based Medicines
Panelist: Wei-Chiang Chen, PhD, Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi

Leveraging AI and Kinetic Modeling to Accelerate Vaccine-Formulation Development and Stability Prediction
Sahar Esmaeili Samani, Scientist, Vaccine Drug Product Development, Sanofi

Implementing Assay-Automation Systems
Lusheng Fan, PhD, Senior Scientist, mRNA Center of Excellence, Sanofi

LNP Development
Xin Jin, PhD, Scientist, Biological Drug Product Development, Sanofi

Advancing Downstream Process Development of Multivalent Nanobody Therapeutics through Mechanistic Modeling
Lijuan Li, PhD, Associate Director, Process Modeling, Global CMC Development, Data Sciences, Sanofi

HTP MS Chemical Liability Screen
Xiaohua Liu, PhD, Principal Scientist, Sanofi

Media Development for Intensified Bioprocessing to Improve Productivity
Yuxin Liu, Senior Scientist, Sanofi Group

Comparative Analysis of Laser Diffraction Techniques to Evaluate Particle Sizing of Protein Formulations
Rahul Misra, PhD, Scientist, Biophysics and Process Analytical Technology, Sanofi

KEYNOTE PRESENTATION: Cell Line Design Strategies for Improving Biotherapeutic Expression
Jack J. Scarcelli, PhD, Senior Director, Head of Cell Line Development, Sanofi

Cell Culture Digital Twins Enabling Efficient Scale-Up and Tech Transfer
Brooke Tam, PhD, USP Modeling Expert, Sanofi

Optimizing an AAV Harvest Process Development of a Mixing Scale-Down Model for Enhanced Filtration Performance
Yaozhong Zhang, PhD, Principal Scientist, Purification Process Development, Genomic Medicine CMC, Sanofi Group

KEYNOTE PRESENTATION: Adaptive Development: Aligning Cell-Line Optimization with Process Improvements for Enhanced Speed and Productivity
Christina S. Alves, PhD, Head, US Biologics Process Development, Takeda

Model-Driven in silico Strategies for Upstream Bioprocess Development
Zhuangrong Huang, PhD, Senior Staff Engineer, Takeda Pharmaceutical Co. Ltd.

On-Column Capping of ThiomAb
Kai Ni, PhD, Bioprocess Engineer, Downstream, Takeda Development Center Americas, Inc.