Key Sessions
Sarfaraz Niazi, PhD
PLENARY KEYNOTE: Biosimilars: From Therapeutic Proteins to Gene Therapies--a Novel Perspective for Affordable Medicines
Washington State University
Jack Prior
PLENARY KEYNOTE: Are We Here Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing
Sanofi
Sarwat Khattak
KEYNOTE: What we have learned and also refined by using AI and ML in Upstream process development
Biogen
Tiffany D Rau, PhD
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
University College Cork, Ireland
Agenda September 24, 2026: Main Conference Day Two - ET (Eastern Time, GMT-05:00)
Agenda September 24, 2026: Main Conference Day Two
- ET (Eastern Time, GMT-05:00)
6:45am - 7:45am60 mins
Fun Run
Biotech Week Boston 2026 Fun Run
8:15am - 8:50am35 mins
Registration Break
Registration and Morning Coffee
8:50am - 9:00am10 mins
BPI Plenary Keynote
Welcome to BWB Day 2 / Chairperson’s Opening Remarks
8:50am - 9:00am10 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
- Nicola Ambler - Co-Founder, The CGT Circle
8:50am - 9:00am10 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Amy Shaw - Senior Director, Process Development, Genetix Biotherapeutics
8:50am - 9:00am10 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
9:00am - 9:45am45 mins
BPI Plenary Keynote
PLENARY KEYNOTE: Biosimilars: From Therapeutic Proteins to Gene Therapies--a Novel Perspective for Affordable Medicines
- Sarfaraz Niazi, PhD - Affiliate Professor, Washington State University
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
- Hari Pujar - Chief Operating Officer, Tessera Therapeutics
9:00am - 10:00am60 mins
Cell Therapy Manufacturing & Analytics
Keynote Panel Discussion: Scaling Cell Therapies- Lessons from Pioneers for Smarter, Faster, and More Affordable Ex Vivo Cell Therapy Manufacturing
- Shashi Murthy - Vice Provost for Global Innovation and Head, Dublin Innovation Institute, Northeastern University
- Arvind Natarajan - Senior Vice President, Technical Development, Iovance Biotherapeutics
- Mayo Pujols - CTO, Kyverna
- Pooja Sabhachandani - Associate Director, Science and Technology, Cell & Gene Therapy, Novartis Pharmaceuticals
- Marcia Blackmoore - Chief Commercial Officer & Customer Operations, L7 Informatics, Inc.
9:00am - 10:00am60 mins
Gene Therapy Manufacturing & Analytics
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
- Phillip Ramsey - CTO, SVP Technical Operations, Sangamo Therapeutics
- Kumar Dhanasekharan, PhD - President and CEO, Gokyo Biosciences Inc.
- Craig Malzahn - EVP, Product Development and Chief Technology Officer, Regenxbio
- Jared Simons - VP, Manufacturing, Solid Biosciences Inc.
- Keenan Bashour - VP, Manufacturing & Process Development, 4D Molecular Therapeutics
9:20am - 9:30am10 mins
Innovation and Community Stage (Exhibit Hall)
Chairperson’s Opening Remark
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Revolutionizing In Vivo Delivery: Overcoming Challenges and Advancing Therapeutic Impact
9:45am - 10:30am45 mins
BPI Plenary Keynote
PLENARY KEYNOTE: Are We Here Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing
- Jack Prior - Head of Process Monitoring & Data Science/AI Strategy, Sanofi
9:50am - 10:10am20 mins
Innovation and Community Stage (Exhibit Hall)
W. L. Gore & Associates, Inc. - Durable. Resilient. Radiation Compatible: A new advanced material tubing solution for demanding single-use bioprocessing applications
- Keith Fritsky - Product Specialist, W. L. Gore & Associates, Inc.
- Ron Gott - Technical Lead - Product Development, W. L. Gore & Associates, Inc.
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Scale-Up Strategies: Navigating the Road Ahead for In Vivo CAR-T
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
- Stephen Kennedy - Head of Technical Operations, CRISPR Therapeutics
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Building Toward Commercial Readiness: How Comparability and Process Improvements Enable Scalable and Robust TCR-T Manufacturing?
- Elisaveta Todorova - Associate Director, Process Development and Technology Innovation, TScan Therapeutics
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Building an AAV Production Strategy Utilizing Stable Producer Cell Lines for Scalable, Gene Therapy Manufacturing
- Ryan Schweller - Associate Director, Process Development, AskBio Inc.
10:10am - 10:20am10 mins
Innovation and Community Stage (Exhibit Hall)
Cellufine MLP™: Wide Pore Cellulose Base Bead 3D Architecture for Large Biomolecule Chromatography Applications
- Chigusa Mori - Research Scientist, JNC Corporation
10:20am - 10:30am10 mins
Innovation and Community Stage (Exhibit Hall)
10:20-10:40 Rewriting Bioprocessing with Synthetic Affinity Ligands
- Alex Shephard - Head of Product, Tozaro
10:30am - 11:25am55 mins
Break
Morning Break in Exhibit Hall
10:30am - 10:40am10 mins
Innovation and Community Stage (Exhibit Hall)
10:20-10:40 Rewriting Bioprocessing with Synthetic Affinity Ligands (Continued)
10:40am - 10:50am10 mins
Innovation and Community Stage (Exhibit Hall)
Evotec
10:50am - 11:00am10 mins
Innovation and Community Stage (Exhibit Hall)
Revolutionizing Fluid Disconnections and Tear-Down
- Spencer Juola - Product Manager, Connectors, CPC Biotech
11:00am - 11:10am10 mins
Innovation and Community Stage (Exhibit Hall)
Enzene
11:10am - 11:20am10 mins
Innovation and Community Stage (Exhibit Hall)
From Cell Sourcing to Expansion: The Role of Quality-Driven Human Raw Materials in Cell Therapy
- Alejandra Gutierrez-Guerrero - Product Manager, Cell Therapy, Grifols
11:20am - 11:25am5 mins
Innovation and Community Stage (Exhibit Hall)
11:20 - 11:40 Enhancing Suspension Cell Culture Processes with METHONOVA™ Methylcellulose
- Joshua Katz - R&D Director, Roquette Health & Pharma Solutions
11:25am - 11:30am5 mins
Cell Line Development & Engineering
Chairperson Remarks
11:25am - 11:30am5 mins
Cell Culture & Upstream Processing
Chairperson Remarks
- Daniela Espinosa Hoyos - Principal Scientist, Sanofi
11:25am - 11:30am5 mins
Downstream Processing
Chairperson Remarks
- Kabir Dhingra - Senior Scientist, Merck
11:25am - 11:30am5 mins
Digital Biomanufacturing and Data Driven Operations
Chairperson Remarks
- Madiha Khurshid - Senior Scientist, Amgen
11:25am - 11:30am5 mins
CMC Strategy & Manufacturing Performance
Chairperson Remarks
11:25am - 11:40am15 mins
Innovation and Community Stage (Exhibit Hall)
11:20 - 11:40 Enhancing Suspension Cell Culture Processes with METHONOVA™ Methylcellulose (Continued)
- Joshua Katz - R&D Director, Roquette Health & Pharma Solutions
11:30am - 12:00pm30 mins
Cell Line Development & Engineering
Metabolic Engineering of CHO Cells Towards Cysteine Prototrophy and Systems Analysis of The Ensuing Phenotype
- Laura Greenfield - Senior Scientist, Pfizer
11:30am - 12:00pm30 mins
Cell Culture & Upstream Processing
KEYNOTE: What we have learned and also refined by using AI and ML in Upstream process development
- Sarwat Khattak - Head of Cell Culture and Cell Line Development, Biogen
11:30am - 12:00pm30 mins
Downstream Processing
Leveraging Large-scale Manufacturing Experience To Improve Scalability of Resin Lifetime Studies
- Benjamin Ko, Ph.D. - Associate Director, Development Operations Drug Substance, Boehringer Ingelheim
11:30am - 12:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
Digital Twins for Biologics: Where Are We Actually Seeing Impact?
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
11:30am - 12:00pm30 mins
CMC Strategy & Manufacturing Performance
KEYNOTE: Lessons from Global Leadership in CMC, Technology Transfer, and Manufacturing
- Tom Gervais - Vice President, Manufacturing, Bora Biologics
11:30am - 12:00pm30 mins
Cell Therapy Manufacturing & Analytics
Process Development to Commercial Scale: Overcoming Manufacturing Bottlenecks in Next-Generation Allogenic Cell Therapies
- Nafees Rahman - Senior Director, Process Development, Nkarta, Inc.
11:30am - 12:00pm30 mins
Gene Therapy Manufacturing & Analytics
Cell Culture Advances in Recombinant AAV Manufacturing for Gene Therapy Leveraging Systems Biology and Modelling
- Madhuresh Sumit - Associate Director, Genomic Medicine CMC, Sanofi
11:40am - 11:50am10 mins
Innovation and Community Stage (Exhibit Hall)
The Razor Without a Blade: Why Bioprocess Equipment OEMs Are Leaving Recurring Consumable Revenue on the Table
- Keith Smith - President & CEO, Vonco Products, LLC
11:45am - 12:00pm15 mins
Development of Emerging Cell & Gene Therapies
High-Throughput Signal Peptide Engineering for Cell and Gene Therapy: From Single Chains to Multichain Biologics
- Tero-Pekka Alastalo - CEO, Avenue Biosciences
11:50am - 12:30pm40 mins
Innovation and Community Stage (Exhibit Hall)
PANEL: Mass LifeSciences
12:00pm - 12:30pm30 mins
Cell Line Development & Engineering
KEYNOTE: AI-Driven Cell Line Development Beyond Conception: Digitalization, Prediction & Data-Enabled Decisions
- Nathan Lewis - Professor, Co-Founder, University of Georgia, NeuImmune
12:00pm - 12:30pm30 mins
Cell Culture & Upstream Processing
Predicting the impact of diversions in a dynamic continuous process
- Ken Lee - Director, AstraZeneca
12:00pm - 12:30pm30 mins
Downstream Processing
Accelerating Downstream Technology Transfer Through Innovative GMP Solutions and Phase-Appropriate Work Packages
- Qingxuan Li - Principal Scientist, Sanofi
12:00pm - 12:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
Digital Twins in Action: De-Risking Scale-Up, Accelerating CMC, and Enabling Smarter Biomanufacturing
- Mark Duerkop - Chief Executive Officer, Novasign
- Matthias Müllner - CEO, bespark*bio
12:00pm - 12:30pm30 mins
CMC Strategy & Manufacturing Performance
Complexity and Strategies of Developing Bispecific Antibody Products - from Design to Clinics
- Yun Bai - Executive Vice President of CMC, Santa Ana Bio
12:00pm - 12:30pm30 mins
Development of Emerging Cell & Gene Therapies
Optimizing LNP Delivery and Non-Viral Vector Manufacturing as Scalable, Redosable Alternatives to Viral Vectors
- Ratnesh Joshi - Associate Director, Downstream Process Development, Editas Medicine
12:00pm - 12:30pm30 mins
Cell Therapy Manufacturing & Analytics
Modular Process Development of HSC-derived CAR-NK Cell Therapies
- Rui Tostoes - CTO, ImmuneBridge
12:00pm - 12:30pm30 mins
Gene Therapy Manufacturing & Analytics
Expanding the Upstream Toolbox: Enabling High Productivity, Robust, and Scalable AAV Production
- Sha Sha - Senior Scientist, Ultragenyx
12:30pm - 1:00pm30 mins
Cell Line Development & Engineering
Advancing CHO Cell Line Development: A Dual-Strategy Approach Using Site-Specific and Transposon-Based Integration Platforms
- Dennis Lin - Associate Director, Cell Line and Cell Culture Process Development, Bora Biologics
12:30pm - 1:00pm30 mins
Cell Culture & Upstream Processing
Sponsored Scientific Presentation
12:30pm - 1:00pm30 mins
Downstream Processing
Designing process intensification in the mAb capture step for the MSAT handoff-not just PD success
- Henrik Ihre, Ph.D. - Distinguished Fellow, Cytiva
12:30pm - 1:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
Enabling Bioprocess Intensification with Planova FG1: A New Filter for High Throughput and Rapid Virus Filtration
- Christine Stouffer - Senior Research Associate, Asahi Kasei Bioprocess
12:30pm - 1:00pm30 mins
CMC Strategy & Manufacturing Performance
The Rise of Modular Manufacturing: Scalable Solutions to Accelerate Novel Therapy Development
- Bella Neufeld - VP, Operations, Teknova
12:30pm - 1:00pm30 mins
Development of Emerging Cell & Gene Therapies
Streamlining the Critical Path for AAV Gene Therapy Development: Platform Strategies to Accelerate Clinical Readiness
- Philip Wills - Chief Commercial Officer, Catalent
12:30pm - 1:00pm30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
12:30pm - 1:00pm30 mins
Gene Therapy Manufacturing & Analytics
Democratizing Gene Therapy: Upstream Innovations to Streamline CMC and Reduce Cost per Dose
- Kelly Cybulski - Principal Scientist, Cytiva
12:30pm - 12:40pm10 mins
Innovation and Community Stage (Exhibit Hall)
Chairperson’s Opening Remarks
12:40pm - 1:00pm20 mins
Innovation and Community Stage (Exhibit Hall)
12:40 - 1:20 PANEL: From Opportunity to Impact: How Community Partnerships Change Lives and Build the Future Biomanufacturing Workforce
- Rosie Cunningham - Executive Director, Life Science Cares Boston
- Zach Stanley - Executive Director, Bioversity
- Steve Favaloro - Board of Advisors, Life Science Cares Boston
1:00pm - 2:10pm70 mins
Break
Lunch Networking
1:00pm - 1:20pm20 mins
Innovation and Community Stage (Exhibit Hall)
12:40 - 1:20 PANEL: From Opportunity to Impact: How Community Partnerships Change Lives and Build the Future Biomanufacturing Workforce (Continued)
- Rosie Cunningham - Executive Director, Life Science Cares Boston
1:20pm - 1:30pm10 mins
Innovation and Community Stage (Exhibit Hall)
Sapio Sciences
- Asa Oudes - Global Head of Solution Consulting, Sapio Sciences
1:20pm - 1:30pm10 minsLive Lab
Live Labs in Exhibit Hall
Live Lab: Collect Headsets
1:30pm - 1:50pm20 mins
Innovation and Community Stage (Exhibit Hall)
Advancing Supply Resilience Through Risk-Based Innovation
- Christopher Kistler - Fellow Scientist, Catalent
1:30pm - 1:40pm10 minsLive Lab
Live Labs in Exhibit Hall
Live Lab: CPC Biotechnology
1:40pm - 1:50pm10 minsLive Lab
Live Labs in Exhibit Hall
Live Lab: Millipore
1:50pm - 2:00pm10 mins
Innovation and Community Stage (Exhibit Hall)
SynGenSys - Engineering Transcriptional Control in CHO Cells: Synthetic Promoters for Higher-Productivity Biomanufacturing
- Molly Smith - Head of CHO Expression Technologies, SynGenSys
1:50pm - 2:00pm10 minsLive Lab
Live Labs in Exhibit Hall
Live Lab: Ecolab Life Science
2:00pm - 2:10pm10 minsLive Lab
Live Labs in Exhibit Hall
Live Lab: Avantor
2:10pm - 2:15pm5 mins
Cell Line Development & Engineering
Chairperson's Remarks
2:10pm - 2:15pm5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
- Daniela Espinosa Hoyos - Principal Scientist, Sanofi
2:10pm - 2:15pm5 mins
Downstream Processing
Chairperson's Remarks
- Kabir Dhingra - Senior Scientist, Merck
2:10pm - 2:15pm5 mins
Digital Biomanufacturing and Data Driven Operations
Chairperson's Remarks
- Madiha Khurshid - Senior Scientist, Amgen
2:10pm - 2:15pm5 mins
CMC Strategy & Manufacturing Performance
Chairperson's Remarks
2:10pm - 2:15pm5 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:10pm - 2:15pm5 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Rahul Visalakshan - Innovation Lead- Global MSAT, Legend Biotech
2:10pm - 2:15pm5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
2:10pm - 2:20pm10 mins
Innovation and Community Stage (Exhibit Hall)
From Lab to Launch: The Right Systems That Scale with Every Stage
- Amy Vasquez - Systems Architect, Strategic Information Group
2:15pm - 2:45pm30 mins
Cell Line Development & Engineering
Expression System & Integration Technology Choices
- Dong Seong Cho - Technical Development Associate Scientist, Genentech
2:15pm - 2:45pm30 mins
Cell Culture & Upstream Processing
Enabling Sample-Free Bioreactor Operation Through Raman-Based pH Monitoring
- Alyssa Melville - Engineer, Cell Culture Development, Biogen (USA)
2:15pm - 2:45pm30 mins
Downstream Processing
Current Insights and Future Directions for Host Cell Protein Challenges in Antibody Manufacturing
- Younghoon Oh - Principal Scientist, J&J Innovative Medicine
2:15pm - 2:45pm30 mins
Digital Biomanufacturing and Data Driven Operations
Predict, Prevent, Perfect: The New Era of Intelligent Biologics Manufacturing
2:15pm - 2:45pm30 mins
CMC Strategy & Manufacturing Performance
Biomanufacturing Initiative - CMC Strategy & Manufacturing Performance
- Laura Pierce - Biomedical Engineer, NIST
2:15pm - 2:45pm30 mins
Development of Emerging Cell & Gene Therapies
Practical Applications of AI and Machine Learning in GMP Manufacturing
- Jainish Kothari - Cell Therapy GMP Specialist, Bayer Pharmaceuticals
2:15pm - 2:45pm30 mins
Cell Therapy Manufacturing & Analytics
An Integrated Analytical Control Strategy - Execution Roadmap to Support Automation for Cell Therapies
- Stephan Krause - Executive Director, Analytical Strategy, Cell Therapies Global Quality, Bristol Myers Squibb
2:15pm - 2:45pm30 mins
Gene Therapy Manufacturing & Analytics
High Throughput Process Development for Anion Exchange Chromatography of AAV
- Lukas Maloney - Process Development Engineer I, Regeneron
2:20pm - 3:00pm40 mins
Innovation and Community Stage (Exhibit Hall)
PANEL: The Value-Alignment Era: Building Durable Careers in a Shifting Policy Landscape
- Joanne Kamens - CEO, Women In Bio
- Lisa Stanek - Senior Vice President, R&D, Life Biosciences and EWIB Volunteer
- Cissy Young - Managing Director, Life Sciences & Venture Capital,, True Search
- Nicola Ambler - Co-Founder, The CGT Circle
2:45pm - 3:15pm30 mins
Cell Line Development & Engineering
Leveraging Transposase-Based Expression Systems for Complex Biologics Quality
- Mark Blenner - Professor, University of Delaware
2:45pm - 3:15pm30 mins
Cell Culture & Upstream Processing
From Prediction to Control: Tuning Lactate Metabolism Using Raman Enabled Automated Lactate Control
- Gayatri Dhara - Principal Scientist, Bioprocess Research & Development, Pfizer
2:45pm - 3:15pm30 mins
Downstream Processing
Project Lexy: A Context-Driven Data Mapping Framework for Downstream Process Development
- Benjamin Borow - Associate Scientist, Bristol-Myers Squibb
2:45pm - 3:15pm30 mins
Digital Biomanufacturing and Data Driven Operations
FEATURED PRESENTATION: Optimizing Upstream Processes Through Digital Approaches
- Michael Betenbaugh - Professor, Department of Chemical & Biomolecular Engineering, Johns Hopkins University
2:45pm - 3:15pm30 mins
CMC Strategy & Manufacturing Performance
Establishment of Limit of In Vitro Cell Age (LIVCA) for Biologics Manufacturing Process
- Sharyn Farnsworth - Director of Upstream Process Development, FUJIFILM Diosynth Biotechnologies
2:45pm - 3:15pm30 mins
Development of Emerging Cell & Gene Therapies
Leveraging Platform-Based, Multi-Attribute LC Assays to Characterize Multi-components Prime Editing (PE) RNA-LNP
- Minjia Wang - Analytical Development Scientist II, Prime Medicine
2:45pm - 3:15pm30 mins
Cell Therapy Manufacturing & Analytics
Automated Closed-System Expansion of Pluripotent Stem Cells: Enhancing Process Consistency and Reproducibility for Cell Therapy Manufacturing
- Sheila Sharifzad - Process Development Scientist - Cell Therapy, Bayer
2:45pm - 3:15pm30 mins
Gene Therapy Manufacturing & Analytics
Effective Tech Transfer of Manufacturing Processes to CDMO Partners
- Hunter Reese - Senior Scientist, AskBio
3:00pm - 3:20pm20 mins
Innovation and Community Stage (Exhibit Hall)
Single Use Support
- Dominic Lobgesang - Senior Expert Product Management Equipment, Single Use Support
3:15pm - 3:45pm30 mins
Cell Line Development & Engineering
Evolving Cell Line Development for next-generation biotherapeutics
- Sigma Mostafa, PhD - Chief Scientific Officer, KBI Biopharma
3:15pm - 3:45pm30 mins
Cell Culture & Upstream Processing
Cell Culture Media Optimization as a Strategic Lever for Biosimilar Productivity and Product Quality
- Jeraldine Mendoza - Sr. Technical Support Scientist, OPM Biosciences
3:15pm - 3:45pm30 mins
Downstream Processing
Sponsored Presentation
3:15pm - 3:45pm30 mins
Digital Biomanufacturing and Data Driven Operations
Enabling Data-Driven Process Intensification with Multivariate Analytics and PAT
- Gregory Casee - Data Scientist, Sartorius
3:15pm - 3:45pm30 mins
CMC Strategy & Manufacturing Performance
Intensification of protein A capture step using membrane technology
- Anupama Kante, PhD - Scientist Downstream Process Development, Avid Bioservices
3:15pm - 3:45pm30 mins
Development of Emerging Cell & Gene Therapies
Unlocking the Promise of In Vivo CAR-T: CMC Strategies for Scalable, Rapid, and Accessible Cell Therapies
- Huiyi Zhu - Head of US Project Management, ProBio
3:15pm - 3:45pm30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
3:15pm - 3:45pm30 mins
Gene Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
3:20pm - 3:25pm5 mins
Innovation and Community Stage (Exhibit Hall)
15:40 - 16:00 Turning Integrated Bioprocess Data into Predictive Decisions with Models and AI
- Soichiro Shimoda - Bioprocess Solution Manager, Yokogawa Electric Corporation
3:45pm - 4:30pm45 mins
Break
Afternoon Break
3:45pm - 4:00pm15 mins
Innovation and Community Stage (Exhibit Hall)
15:40 - 16:00 Turning Integrated Bioprocess Data into Predictive Decisions with Models and AI (Continued)
- Soichiro Shimoda - Bioprocess Solution Manager, Yokogawa Electric Corporation
4:20pm - 4:30pm10 mins
Innovation and Community Stage (Exhibit Hall)
16:20 - 17:00 PANEL: Latinos in Bio Founder Showcase: Building Innovation Across Life Sciences-From MedTech to Biomanufacturing
- Andrew Rodriguez - Interim CEO & C-suite Advisor, AJS Consulting Company LLC
- Salvador Diaz-Bazan - Co-founder, CFO, Bonds Biosystems
- Kristina Fontanez - Founder, CEO, Adept Scientific
- Maria Artunduaga - Founder, CEO, Samay
4:30pm - 5:00pm30 mins
Cell Line Development & Engineering
Fast Tracking CHO Cell Line Development Using Integrated Engineering Strategies
- Jacqualyn Schulman, Ph.D. - Principal Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
4:30pm - 5:00pm30 mins
Cell Culture & Upstream Processing
AI-assisted foam control in benchtop bioreactors
- Allison Tang - Senior Scientist, Merck
4:30pm - 5:00pm30 mins
Downstream Processing
Fireside Chat: Innovative Approaches to Impurity Removal in Complex Biologics
- Jin Yu - Senior Scientist, Process Development Downstream, Amgen
- Florian Settele, Ph.D. - Managing Director, Navigo Proteins GmbH
4:30pm - 5:00pm30 mins
Digital Biomanufacturing and Data Driven Operations
AI in Action: Accelerating Upstream Development with Predictive Insights
- Lenora Dieyi - Modeling & Simulation Engineer - Investigator, Drug Product Development, GSK
4:30pm - 5:00pm30 mins
CMC Strategy & Manufacturing Performance
Developing a Robust Lyophilization Process for Manufacturing a Bispecific Antibody Drug Product
- Xiaofeng Lu, Ph.D., - Principal Research Scientist,, AbbVie
4:30pm - 5:30pm60 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Starting with the End in Mind: Designing Smart and Phase Appropriate Manufacturing for Successful Cell and Gene Therapy Development
- Khandan Baradaran - Principal, Mill Creek Consulting LLC
- Bo Yan, PhD - Senior Director, Analytical Development, Beam Therapeutics
- Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
- Amy Shaw - Senior Director, Process Development, Genetix Biotherapeutics
4:30pm - 5:00pm30 mins
Cell Therapy Manufacturing & Analytics
Case Study: Harnessing AI & Digitalization for Cell Therapy Manufacturing Optimization and Process Control
- Rashed Harun - Scientist, Genentech
4:30pm - 5:00pm30 mins
Gene Therapy Manufacturing & Analytics
Development of Membrane Processes for Continuous Purification of Adeno-associated Virus for Gene Therapies
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair, Chemical Engineering, Penn State University
4:30pm - 5:00pm30 mins
Innovation and Community Stage (Exhibit Hall)
16:20 - 17:00 PANEL: Latinos in Bio Founder Showcase: Building Innovation Across Life Sciences-From MedTech to Biomanufacturing (Continued)
5:00pm - 5:30pm30 mins
Cell Line Development & Engineering
Glycoengineered CHO cell production and secretion of a hepatitis C virus envelope-based vaccine candidate improves biochemical properties and immunogenicity
- Thomas Fuerst - Professor, Department of Cell Biology and Molecular Genetics Director, Center Glycoengineering of Advanced Biologics, University of Maryland
5:00pm - 5:30pm30 mins
Cell Culture & Upstream Processing
Fireside Chat: What Actually Changed Upstream in the Last 5 Years?
- A Representative - ., ATCC
- Karna Shah - Associate Director, AbbVie
5:00pm - 5:30pm30 mins
Downstream Processing
Predicting formulation computability in the subcutaneous space
- Lalitha Ramasubramanian - Senior Scientist, Gilead Sciences
5:00pm - 5:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
Defining Digital Twins in a Biomanufacturing Environment
- Kim Wilson - Business Value Consultant Expert, Life Sciences & Healthcare Industry, Dassault Systèmes' Life Sciences & Healthcare
- Vicki Pearson - Global Life Science Segment Director, Schneider Electric
5:00pm - 5:30pm30 mins
CMC Strategy & Manufacturing Performance
A Systematic Approach to Responding to Microbial Contamination Events in Biopharmaceutical Manufacturing
- Hilary Chan - Principal QC Scientist, Takeda
5:00pm - 5:30pm30 mins
Cell Therapy Manufacturing & Analytics
Case Study from Arcellx: Application of MOI Titrations to Evaluate Vector Lots and Aid Process Decisions and Process Control
- Brian Murphy - VP Cell Process Science, Arcellx
5:00pm - 5:30pm30 mins
Gene Therapy Manufacturing & Analytics
Analytical Control Strategy for Successful Method Transfer to Commercial Testing Lab
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
5:30pm - 6:00pm30 mins
Break
Coaches to Networking Party
6:00pm - 9:30pm210 mins
Break
Networking Party at the Museum of Science
9:30pm - 9:35pm5 mins
Break
Close of Day Two
* 活动内容有可能不事先告知作更动及调整。