Key Sessions
Oliver Hesse
KEYNOTE ADDRESS - How Digital Science Enables Integrated Development
Bayer
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MAIN CONFERENCE DAY TWO
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MAIN CONFERENCE DAY TWO
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7:15am - 7:55am40 mins
Coffee and Continental Breakfast
7:55am - 8:00am5 mins
Conference Opening and Welcome
8:00am - 8:05am5 mins
Plenary Session
Chairperson’s Opening Remarks
8:00am - 9:15am75 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing
- James Dean Vogel - Founder and Director , The BioProcess Institute
8:05am - 8:40am35 mins
Plenary Session
KEYNOTE ADDRESS - Collaborative Approaches Needed Between Functional Areas and Compromises Required to Effectively Speed Up and Streamline Development
8:40am - 9:15am35 mins
Plenary Session
KEYNOTE ADDRESS - How Digital Science Enables Integrated Development
- Oliver Hesse - Director, Lab Automation and Data Management, Biological Development, Bayer
9:15am - 9:55am40 mins
Spotlight Session
Rapid Cycling Chromatography and Single Pass Diafiltration for the Intensification of Downstream Processes
- Ricarda Busse - Product Manager Membrane Chromatography | Separation Technologies, Sartorius Stedim Biotech GmbH
- Hannes Landmann - Product Manager, Sartorius Stedim
9:15am - 9:55am40 mins
Networking Break
Refreshment Break in the Exhibit & Poster Hall
9:55am - 10:00am5 mins
Track 1: Cell Line Development & Engineering
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 2: Cell Culture & Upstream Processing
Chairperson's Opening Remarks
- Susan Dexter - Managing Director, Latham BioPharm Group
9:55am - 10:00am5 mins
Track 3: Recovery & Purification
Chairperson's Opening Remarks
- Susan Dexter - Managing Director, Latham BioPharm Group
9:55am - 10:00am5 mins
Track 4: BioProcessing 4.0
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 5: Intensified & Continuous Processing
Chairperson’s Opening Remarks
- Howard Levine, PhD - National Leader, BioProcess Technology Group
9:55am - 10:00am5 mins
Track 6: Cell & Gene Therapy Manufacturing
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 7: Analytical & Quality
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 8: Phase-Appropriate Process Development
Chairperson’s Opening Remarks
9:55am - 12:00pm125 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
- James Dean Vogel - Founder and Director , The BioProcess Institute
10:00am - 10:30am30 mins
Track 1: Cell Line Development & Engineering
Choosing the Best Clone: Quality, Speed and Diversity
- Zorica Dragic - Unit Head Cell Line Screening and Development, Novartis
10:00am - 10:30am30 mins
Track 2: Cell Culture & Upstream Processing
Tools to Enable Faster Initiation of Downstream Process Development Upon Receipt of Clarified Harvest
- David Brown, PhD - Scientist II, Downstream Process Development, KBI Biopharma
10:00am - 10:30am30 mins
Track 3: Recovery & Purification
Tools to Enable Faster Initiation of Downstream Process Development Upon Receipt of Clarified Harvest
- David Brown, PhD - Scientist II, Downstream Process Development, KBI Biopharma
10:00am - 10:30am30 mins
Track 4: BioProcessing 4.0
Digitally Transforming Genentech Process Development
- Rick St. John, Ph.D. - Head of Digital Sciences, Genentech, a member of the Roche Group
10:00am - 10:30am30 mins
Track 5: Intensified & Continuous Processing
Assessing Environmental Impact Through Process Data Mining
- Kristi Budzinski - Principal Product Stewardship Program Manager, Genentech
10:00am - 10:30am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Process Control strategies for Cell Therapy
- Rachel Yost - Senior Process Engineer, Juno Therapeutics Inc.
10:00am - 10:30am30 mins
Track 7: Analytical & Quality
Improve physicochemical stability of therapeutic proteins
10:00am - 10:30am30 mins
Track 8: Phase-Appropriate Process Development
FEATURED PRESENTATION - Experiences from IND to BLA – Case Studies and Lessons Learned
- Ping Huang, PhD - Director, Abbvie
10:30am - 11:00am30 mins
Track 1: Cell Line Development & Engineering
Cell Line Development with High Titer and Long Term Stability
- Sung Ho Hahm - CEO, Rophibio Inc.
10:30am - 11:00am30 mins
Track 2: Cell Culture & Upstream Processing
SUT Innovations – Bridging the Next Generation of Enabling Operations
- Adam Goldstein - Senior Director, R+D SUT, Thermo Fisher Scientific
10:30am - 11:00am30 mins
Track 3: Recovery & Purification
SUT Innovations – Bridging the Next Generation of Enabling Operations
- Adam Goldstein - Senior Director, R+D SUT, Thermo Fisher Scientific
10:30am - 11:00am30 mins
Track 4: BioProcessing 4.0
Soft Sensor Based on 2D-Fluorescence and MARS Modeling Enabling Real-Time Estimation of Biomass
- Benjamin Bayer, Msc - Data Scientist at Novasign and PhD student at the Department of Biotechnology, Novasign/ University of Natural Resources and Life Sciences
10:30am - 11:00am30 mins
Track 5: Intensified & Continuous Processing
Economics and Ecology: The Impact of Water Reduction in Biotechnology
- Alessandro Luigi Cataldo, MSc. - Scientific Project Staff, Economic Evaluation of Biotechnological Processes, University of Natural Resources and Life Sciences, Austria
10:30am - 11:00am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Design strategies of a commercial viral vector manufacturing platform
- Kasey Chalmers - Sr. Engineer I, Gene Therapy Technology Transfer, Biogen, USA
10:30am - 11:00am30 mins
Track 7: Analytical & Quality
Developability To Ensure Streamlined Manufacturing
- Jonathan Kingsbury - Head of Developability & Pre-formulation, Sanofi
10:30am - 11:00am30 mins
Track 8: Phase-Appropriate Process Development
Road to Accelerated Commercial Launch from a Single-Use Facility Perspective
- David Page - Director, MS&T (Manufacturing Sciences & Technology), KBI Biopharma
11:00am - 11:30am30 mins
Track 1: Cell Line Development & Engineering
Implementing High-throughput and Automated Clonal Evaluation
- Jishna Ganguly - Associate Research Scientist, GSK
11:00am - 11:30am30 mins
Track 2: Cell Culture & Upstream Processing
Intact Protein Mass Spectrometry of Cell Culture Harvest Guiding Clone Selection for Multi-Specific Antibodies
- Fateme Tousi, Ph.D. - Scientist, Biologics Development – BioAnalytics, Sanofi
11:00am - 11:30am30 mins
Track 3: Recovery & Purification
Intact Protein Mass Spectrometry of Cell Culture Harvest Guiding Clone Selection for Multi-Specific Antibodies
- Fateme Tousi, Ph.D. - Scientist, Biologics Development – BioAnalytics, Sanofi
11:00am - 11:30am30 mins
Track 4: BioProcessing 4.0
Application of Data Analytics to Raw Materials to Better Understand and Control Variation
- Matt Hammond - Principal Scientist, Amgen
11:00am - 11:30am30 mins
Track 5: Intensified & Continuous Processing
Innovative Manufacturing Strategies – What are the Drivers?
- Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
11:00am - 11:30am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Instrumentation and mechanisms to drive efficient therapies
- Alan Smith, Ph.D. - Executive Vice President, Technical Operations, Bellicum Pharmaceuticals
11:00am - 11:30am30 mins
Track 7: Analytical & Quality
FEATURED PRESENTATION: Demonstrating Comparability for an Accelerated Antibody Drug Conjugate with Post-Pivotal Process Changes
- Richard Beardsley - Associate Director, Genentech
11:00am - 11:30am30 mins
Track 8: Phase-Appropriate Process Development
Case Study – mAb Late Stage Development to Enable an ADC Program
- Igor Quinones-Garcia, Ph.D. - Executive Director, Biologics Development, Mersana Therapeutics
11:30am - 12:00pm30 mins
Track 1: Cell Line Development & Engineering
Using Octet for High-Throughput Early Clone Selection
- Hongshan Li, PhD - Marketing Applications Manager, ForteBio
11:30am - 12:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Development of a second generation PlasmidSelect resin
- Tony Hitchcock - Technical Director, Cobra Biologics
11:30am - 12:00pm30 mins
Track 3: Recovery & Purification
Development of a second generation PlasmidSelect resin
- Tony Hitchcock - Technical Director, Cobra Biologics
11:30am - 12:00pm30 mins
Track 4: BioProcessing 4.0
Industry 4.0 – Taking the first step
- Loe Cameron - Senior Director - Research and Development, Pall Corporation
11:30am - 12:00pm30 mins
Track 5: Intensified & Continuous Processing
Driving Value and Innovation in Upstream Technologies with The BioContinuum™ Intensified Seed Train Platform
- Sarah Hove - Head of Customer Engagement, MilliporeSigma
11:30am - 12:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
AAV process development guidance based on cost modeling
- David Bohonak, Ph.D. - Vaccine and Gene Therapy Market Segment Manager, MilliporeSigma
11:30am - 12:00pm30 mins
Track 7: Analytical & Quality
On demand process analytics for cell therapy products: Bringing the power of Flow Cytometry to the manufacturing floor
- Amanda Trent - Director of Assay Development & Migration, Accellix
11:30am - 12:00pm30 mins
Track 8: Phase-Appropriate Process Development
Integration of Cedex Technology for Standardized Cell Culture Monitoring Analytics in GMP Manufacturing
- Kate Lee - Senior Engineer, Genentech/Roche
12:00pm - 1:00pm60 mins
Networking Luncheon in the Exhibit & Poster Hall
1:00pm - 1:05pm5 mins
Track 1: Cell Line Development & Engineering
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 2: Cell Culture & Upstream Processing
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 3: Recovery & Purification
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 4: BioProcessing 4.0
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 5: Intensified & Continuous Processing
Chairperson's Opening Remarks
- Howard Levine, PhD - National Leader, BioProcess Technology Group
1:00pm - 1:05pm5 mins
Track 6: Cell & Gene Therapy Manufacturing
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 7: Analytical & Quality
Chairperson’s Opening Remarks
1:00pm - 1:05pm5 mins
Track 8: Phase-Appropriate Process Development
Chairperson’s Opening Remarks
1:00pm - 2:40pm100 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
- James Dean Vogel - Founder and Director , The BioProcess Institute
1:05pm - 1:35pm30 mins
Track 1: Cell Line Development & Engineering
Application of Pool Cell Lines Rather Than Clones To Reduce Time To Clinic:
- Yves Durocher, PhD - Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada
1:05pm - 1:35pm30 mins
Track 2: Cell Culture & Upstream Processing
Cell Culture Process Controls, Novel Sensors and Real-Time Monitoring Methods: A Case Study from Genentech
- Sanket Dahotre - Engineer I, iLabs, Genentech
1:05pm - 1:35pm30 mins
Track 3: Recovery & Purification
Smaller and Faster – Using High Throughput PD to Develop and Qualify a Protein A Micro-Model
- Doug MacDonald - Principal Scientist, Seattle Genetics
1:05pm - 1:35pm30 mins
Track 4: BioProcessing 4.0
TELECONFERENCE: Application of Automation and Robotics in Biomanufacturing
- David Wolton - Operations Consultant, PM Group
1:05pm - 1:35pm30 mins
Track 5: Intensified & Continuous Processing
Propagation of Process Disturbances in Continuous Integrated Biomanufacturing
- Alois Jungbauer - Professor and Chair, Laboratory of Protein Technology and Downstream Processing, Austrian Center of Biotechnology, Department of Biotechnology, University of Natural Resources and Life Sciences Vienna
1:05pm - 1:35pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Optimizing Viral Vector Production
- Nicole Nunez - Process Development Scientist, Eureka Therapeutics, Inc.
1:05pm - 1:35pm30 mins
Track 7: Analytical & Quality
Connecting the Analytics with the Process and Not Having Disconnected Parts
- Bingchuan Wei, Ph.D. - Technical Development Scientist, Protein Analytical Chemistry, Genentech
1:05pm - 1:35pm30 mins
Track 8: Phase-Appropriate Process Development
Connecting the Analytics with the Process and Not Having Disconnected Parts
- Bingchuan Wei, Ph.D. - Technical Development Scientist, Protein Analytical Chemistry, Genentech
1:35pm - 2:05pm30 mins
Track 1: Cell Line Development & Engineering
Efforts To Achieve Therapeutic Protein Production with Improved Speed, Productivity and Product Quality while Significantly Reducing Costs
- Amy Shen - Technical Development Principal Scientist and Group Leader, Genentech Inc.
1:35pm - 2:05pm30 mins
Track 2: Cell Culture & Upstream Processing
Asparagine Metabolism and its Importance for the Development of Feeds for High Producing Cell Lines During Fed-Batch Bioreactor Production
- Sandra Bennun Serrano, PhD - Staff Engineer, Regeneron Pharmaceuticals
1:35pm - 2:05pm30 mins
Track 3: Recovery & Purification
Rapid Release of TOX Material from Pilot Plant in < 3days
- Joe Sexton - Principal Technical Specialist, Genentech
1:35pm - 2:05pm30 mins
Track 4: BioProcessing 4.0
Panel Discussion: Steps Toward Digital Transformation – Overcoming Setup, Data Management, Integration Solutions and Security Challenges
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
- Melisa Carpio - Application Professional, Cell Culture Technologies, Sartorius Stedim NA
- Moritz von Stosch - Senior Manager, Process Systems Biology and Engineering Center of Excellence, Technical R&D, GlaxoSmithKline
1:35pm - 2:05pm30 mins
Track 5: Intensified & Continuous Processing
Predictive & Mechanistic CEX Modeling Based Process Design for a Protein Therapeutic
- Juliane Diedrich, Dipl.-Ing - Sr. Associate Scientist, Amgen
1:35pm - 2:05pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Please move to another track
1:35pm - 2:05pm30 mins
Track 7: Analytical & Quality
Topic TBD
- Marc Verhagen - Sr. Director Biologics Development, Sanofi
1:35pm - 2:05pm30 mins
Track 8: Phase-Appropriate Process Development
Topic TBD
- Marc Verhagen - Sr. Director Biologics Development, Sanofi
2:05pm - 2:10pm5 mins
Track 1: Cell Line Development & Engineering
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 2: Cell Culture & Upstream Processing
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 3: Recovery & Purification
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 4: BioProcessing 4.0
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 5: Intensified & Continuous Processing
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 6: Cell & Gene Therapy Manufacturing
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 7: Analytical & Quality
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 8: Phase-Appropriate Process Development
Transition to Technology Workshops
2:10pm - 2:40pm30 mins
Track 1: Cell Line Development & Engineering
Total Cell Line Development – a holistic A-Z approach for scientists planning a cell line development lab.
- Mark Stockdale - Amalgamator of Business and Biology, Solentim
2:10pm - 2:40pm30 mins
Track 2: Cell Culture & Upstream Processing
Facility-Fit Driven Development for a MAB Production Process
- Haiou (Hio) Yang - Principal Scientist, Process Development, Avid Biosciences, Inc.
2:10pm - 2:40pm30 mins
Track 3: Recovery & Purification
Using column chromatography? Switch to Single Use Polishing AEX Membrane for Next Gen Downstream Processing
- Matthew Peters - Senior Application Engineer, 3M
2:10pm - 2:40pm30 mins
Track 4: BioProcessing 4.0
Strategies for Bringing Cell and Gene Therapies to Market
- Erich Bozenhardt - Process Manager, IPS - Integrated Project Service LLC
2:10pm - 2:40pm30 mins
Track 5: Intensified & Continuous Processing
Intensification of upstream operations with automated perfusion
- Radhika Jayakar - New Product Introduction Leader, GE Healthcare
2:10pm - 2:40pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Technology Workshop 6
2:10pm - 2:40pm30 mins
Track 7: Analytical & Quality
Technology Workshop 7
2:10pm - 2:40pm30 mins
Track 8: Phase-Appropriate Process Development
Technology Workshop 7
2:40pm - 3:30pm50 mins
Refreshment Break in the Exhibit & Poster Hall
3:30pm - 4:00pm30 mins
Track 1: Cell Line Development & Engineering
Introducing Techniques Which Allows for Early Clone Identification
- Mark Tié - Scientist II, Cell Line Development, Biogen
3:30pm - 4:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Machine Learning In Bioprocess Development: A Journey From The Current Status To The Future
- Moritz von Stosch - Senior Manager, Process Systems Biology and Engineering Center of Excellence, Technical R&D, GlaxoSmithKline
3:30pm - 4:00pm30 mins
Track 3: Recovery & Purification
The Challenges of Harvest and Downstream Processing for Bispecific Antibodies
- Ji Zheng, PhD - Associate Director, Celgene
3:30pm - 4:00pm30 mins
Track 4: BioProcessing 4.0
Machine Learning In Bioprocess Development: A Journey From The Current Status To The Future
- Moritz von Stosch - Senior Manager, Process Systems Biology and Engineering Center of Excellence, Technical R&D, GlaxoSmithKline
3:30pm - 4:00pm30 mins
Track 5: Intensified & Continuous Processing
Digitalization of Biomanufacturing
- Amos Lu, Ph.D. - Postdoctoral Associate, Department of Chemical Engineering, MIT
3:30pm - 4:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Development of modern biologics and cell therapy products through global CMOs
- Vadim Klyushnichenko - VP Pharmaceutical Development and Quality, Calibr at Scripps Research
3:30pm - 4:00pm30 mins
Track 7: Analytical & Quality
Streamlining Product Quality Attributes Characterization Using Ion Exchange Chromatography Coupled to Native Mass Spectrometry
- Leah Wang - Principal Scientist, Pfizer
3:30pm - 4:00pm30 mins
Track 8: Phase-Appropriate Process Development
Full Scale Production of a Therapeutic Neurotoxic Protein by Cell-Free Expression
- Philip Probert, PhD - Senior Upstream Scientist, Centre for Process Innovation Limited
3:30pm - 5:00pm90 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
- James Dean Vogel - Founder and Director , The BioProcess Institute
4:00pm - 4:30pm30 mins
Track 1: Cell Line Development & Engineering
Using Machine Learning/Automation For Clone Selection
- Kim Le - Senior Scientist & Group Leader, Amgen
4:00pm - 4:30pm30 mins
Track 2: Cell Culture & Upstream Processing
Big Data Analytics For Biopharmaceutical Manufacturing
- Colin Clarke, Ph.D. - Principal Investigator, National Institute for Bioprocessing
4:00pm - 4:30pm30 mins
Track 3: Recovery & Purification
Transitioning from Chemistry Purification to Protein Purification for ASOs
- Robert Gronke, PhD - Senior Principal Scientist, Technical Development, Biogen, Inc
4:00pm - 4:30pm30 mins
Track 4: BioProcessing 4.0
Big Data Analytics For Biopharmaceutical Manufacturing
- Colin Clarke, Ph.D. - Principal Investigator, National Institute for Bioprocessing
4:00pm - 4:30pm30 mins
Track 5: Intensified & Continuous Processing
Data Science or PAT as Control Strategies for Continuous Biomanufacturing?
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
4:00pm - 4:30pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Feedback from the Industry Alliance Partnership (IAP) & CIRM Partnership and Commercialization Opportunities
- Shyam Patel - Director Business Development, California Institute for Regenerative Medicine
4:00pm - 4:30pm30 mins
Track 7: Analytical & Quality
Analytical Characterization of Therapeutic Proteins: A Case Study by Bristol-Myers Squibb
- Jing Li - Research Investigator II, Bristol-Myers Squibb
4:00pm - 4:30pm30 mins
Track 8: Phase-Appropriate Process Development
Topic TBD
4:30pm - 5:00pm30 mins
Track 1: Cell Line Development & Engineering
Panel Discussion: Cell Line Development: Considerations for the Future
- Sung Ho Hahm - CEO, Rophibio Inc.
- Barbara Tevelev - Senior Scientist, Molecular Discovery, Cell Line Development, Bioprocess Research and Development, Pfizer
- Anupam Singhal, PhD - Product Manager, Antibody Therapeutics, Berkeley Lights, Inc.
4:30pm - 5:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Making Better Decisions With Data: How We Are Using Models To Improve Outcomes In Process Development And Manufacturing
- Yingying Zheng - Data Scientist, Amgen
4:30pm - 5:00pm30 mins
Track 3: Recovery & Purification
Applying Existing Chromatographic and Electrophoretic Methods to Characterize and Release Antibodies and Antibody Drug Conjugates (Located in Mission City M3)
- Andrew Holloway - Senior Research Associate, Seattle Genetics
4:30pm - 5:00pm30 mins
Track 4: BioProcessing 4.0
Making Better Decisions With Data: How We Are Using Models To Improve Outcomes In Process Development And Manufacturing
- Yingying Zheng - Data Scientist, Amgen
4:30pm - 5:00pm30 mins
Track 5: Intensified & Continuous Processing
Multivariate process monitoring along with PAT for bioprocessing manufacturing for process performance and quality attributes
- Denizhan Yilmaz - Senior Scientist, Sanofi
4:30pm - 5:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
PANEL: CMO landscapes for new product initiatives: Novel outsourcing models
- Shyam Patel - Director Business Development, California Institute for Regenerative Medicine
- Vadim Klyushnichenko - VP Pharmaceutical Development and Quality, Calibr at Scripps Research
4:30pm - 5:00pm30 mins
Track 7: Analytical & Quality
Polysorbate 20 As An Effective Mobile Phase Modifier in Size Exclusion Chromatography
- Andrew Holloway - Senior Research Associate, Seattle Genetics
4:30pm - 5:00pm30 mins
Track 8: Phase-Appropriate Process Development
Cell Line Development for Multi-specific Antibodies Guided by High Throughput Mispairing Screening of Harvest
- Fateme Tousi, Ph.D. - Scientist, Biologics Development – BioAnalytics, Sanofi
5:00pm - 6:00pm60 mins
BPI WEST Exhibit Hall Reception
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