Mark Your Calendar to Join Us Next Year September 23-26, 2024
Hynes Convention Center in BostonBoston, MAKey Sessions
Eugene Tung
KEYNOTE: Digitally Enabled Biopharmaceutical Manufacturing: Empowering a Digitally Fluent Workforce
Merck MSD
Dean Smith
What was Gained / Lost with the Harmonization of Specifications with COVID-19 Vaccines
Health Canada
keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
Main Conference - Day 3 - EST/EDT (Eastern Daylight, GMT-4)
keyboard_arrow_leftSearch & Filter
search
Streams
Main Conference - Day 3 - EST/EDT (Eastern Daylight, GMT-4)
search
Streams
7:00am - 8:00am
Rise & Shine Yoga - Registration Desk @ Boston Convention & Exhibition Center Main Lobby
Join us for a beginner yoga class at the BCEC in the Ballroom Foyer to exercise as the sun comes up. Modifications provided for more advanced students. The first 25 participants will receive a travel yoga mat to take home.
RSVP FOR YOGA
8:00am - 8:15am
Breakfast and Registration
Showing 9 of 9 Streams
Cell Culture & Upstream Processing - Room 210C
Recovery & Purification - Room 210B
Manufacturing Strategy & Bioprocessing 4.0 - Room 210A
Analytical & Quality - Room 209
Well Characterized Biologics & Biological Assays - Room 208
CGT Supply Chain, Cryopreservation, Logistics and Delivery - Room 206AB
Non Viral Delivery Development & Manufacturing - Room 205C
In Vivo Gene Therapy Manufacturing - Room 205AB
BWB Main Stage
8:15am - 8:45am
Keynote Presentation - How Biomanufacturing is Improving Its Way Into New Challenges – And How to Solve Them
- Jerry Keybl - Vice President, Avantor
8:55am - 9:00am
Chairperson’s Opening Remarks
- Christina Tsai, PhD - Associate Director, IGM Biosciences
9:00am - 9:30am
High-throughput microfluidic cell retention device for perfusion culture
- Do Hyun Park - Postdoc Associate, MIT
9:30am - 10:00am
Leveraging DoE Modeling to Optimize Cell Culture Performance Attributes of a Null Cell Pool for Developing a Process-Specific HCP Reagent
- Muhammad "Arshad" Chaudhry - Principal Engineer, Alkermes
10:00am - 10:30am
Delivering Improved Bioprocessing Workflows: The Manufacturing Science and Technology (MSAT) Service
- Ishmael Ordonez, PhD - R&D Manager of Manufacturing Science and Technology, FUJIFILM Irvine Scientific
8:15am - 8:45am
Keynote Presentation - How Biomanufacturing is Improving Its Way Into New Challenges – And How to Solve Them
- Jerry Keybl - Vice President, Avantor
8:55am - 9:00am
Chairperson’s Opening Remarks
- Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG
9:00am - 9:30am
The Regeneron Bispecific Antibody Platform: Affinity, Avidity, Functional Ligand Density, Resin Lifetime, and Resolution of mAb Species on Protein A Resin
- Sean Dinn - Manager, Process Sciences, Regeneron Pharmaceuticals
9:30am - 10:00am
Adapting a platform process development approach to achieve analytical biosimilarity
- David Brown - Principal Scientist, KBI Biopharma
10:00am - 10:30am
Advanced Process for Ultra Low Endotoxin in Scaled-up AAV Production
- Rui Xu - Vice President, OBIO TECH Inc.
8:15am - 8:45am
Keynote Presentation - How Biomanufacturing is Improving Its Way Into New Challenges – And How to Solve Them
- Jerry Keybl - Vice President, Avantor
8:55am - 9:00am
Chairperson’s Opening Remarks
- Yasser El-Sherbini - Consultant, Biopharma Excellence – PharmaLex
9:00am - 9:30am
KEYNOTE: Digitally Enabled Biopharmaceutical Manufacturing: Empowering a Digitally Fluent Workforce
- Eugene Tung - Executive Director of Manufacturing IT, Merck MSD
9:30am - 10:00am
NIIMBL’s Approach to Big Data and Data Ontology – How Will it be Accessed and Shared?
- Roger Hart - Senior Fellow, NIIMBL
10:00am - 10:30am
Successful Digitalization Strategy for Biopharmaceutical and Biotechnology Processes: A Case Study
- Catarina Leitao - Senior Data Scientist, ValGenesis
8:15am - 8:45am
Keynote Presentation - How Biomanufacturing is Improving Its Way Into New Challenges – And How to Solve Them
- Jerry Keybl - Vice President, Avantor
8:55am - 9:00am
Chairperson’s Opening Remarks
- Jae Sly - Chief Business Development Officer, Obatala Sciences
9:00am - 9:30am
AbbVie’s journey into the digital strategy and transformation efforts across CMC Biologics Development space
- Alex Ruggles - Senior Scientist, AbbVie
9:30am - 10:00am
The Importance of Metabolite Analyzers in Efficient High-Throughput Cell Culture Workflows
- Erik Vandermark - Senior Scientist, Bristol Myers Squibb
10:00am - 10:30am
Advanced Cryo-EM Solutions for the Characterization of Biologic Drugs
- Karl Bertram - Managing Director, ATEM Structural Discovery
8:15am - 8:45am
Keynote Presentation - How Biomanufacturing is Improving Its Way Into New Challenges – And How to Solve Them
- Jerry Keybl - Vice President, Avantor
8:55am - 9:00am
Chairperson’s Opening Remarks
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
9:00am - 9:30am
Progress Towards Global Harmonization - FDA Perspective
- Ingrid Markovic, Ph.D. - Senior Science Advisor Office of the Center Director, CBER, FDA
9:30am - 10:00am
What was Gained / Lost with the Harmonization of Specifications with COVID-19 Vaccines
- Dean Smith - Senior Scientific Evaluator & Advisor, Health Canada
8:55am - 9:00am
Chairperson’s Opening Remarks
- Amish Patel - SVP Technical Operations, Calidi Biotherapeutics
9:00am - 9:30am
Key Considerations in Formulation and Drug Product Development for Cell Therapy
- Rafi Mohammad - Associate Director, Bayer
9:30am - 10:00am
End-to-End Execution of Supply Chain through Systems Integration
- Priya Chary - Associate Specialist, CAR T-Cell Therapy Supply Chain, Bristol Myers Squibb
10:00am - 10:30am
Charting a Resilient Path Forward: Future Proofing the Cell and Gene Therapy Supply Chain
- Andreas Kouri - Senior Vice President, Supply Chain Strategic Operations, ElevateBio
8:55am - 9:00am
Chairperson’s Opening Remarks
- Shashi Murthy, PhD - Co-Founder & CTO, Nanite
9:00am - 10:00am
Panel Discussion: Opportunities for Next Generation Non-Viral Delivery
- Shashi Murthy, PhD - Co-Founder & CTO, Nanite
- Bo Yan, PhD - Director, Head of Attribute Sciences, Beam Therapeutics
- Stefano Menegatti - Associate Professor, North Carolina State University
10:00am - 10:30am
A Next-Generation Plasmid Demonstrated to Improve Non-Viral Vector Manufacturing – NanoplasmidTM
- Patrick Paez, PhD - Technical Marketing Manager, Aldevron
8:55am - 9:00am
Chairperson’s Opening Remarks
- David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
9:00am - 9:30am
Optimizing Gene Therapy Productivity: Innovations for Efficient Downstream Processing
- Ying Hou - Director, Downstream Process Development – Gene Therapy, PTC Therapeutics, Inc
9:30am - 10:00am
High Throughput Assessment of Robustness for Early Phase AAV Downstream Processes
- Jeff Plegaria - High Throughput Process Development Senior Scientist, Spark Therapeutics
10:00am - 10:30am
A Deep Dive into Capture and Polishing of AAV
- Asa Hagner McWhirter, PhD - Principal Scientist, Cytiva
9:05am - 9:15am
Chair Opening Remarks
- Bob Castellucci - Founder and President, Partnership To Prosperity
9:15am - 10:15am
Fireside Chat: BioProcess Insider State of the Industry Q3 2023
Managing editor Dan Stanton sits down live on the BPI stage with a select panel of experts to reflect on how the quarterly movements of the biopharma industry are affecting the biomanufacturing space. Topics to be discussed include:
- Bioprocess ‘normalization’ post-COVID
- Big Pharma M&A and its impact on suppliers
- Consolidation in the bioprocess space
- Reflection on the latest macro news events
- Dan Stanton - Managing Editor, Bioprocess International, Informa Connect
- Andrew Harmon - Senior Consultant, Strategic Consulting, Latham Biopharm Group
10:15am - 10:20am
5 Minute Break
10:20am - 10:30am
How much Money does this really save us? | Economic Modeling of Multi-Column Chromatography for Protein A
- Jennifer Knister - Product Specialist, Multi-Column Chromatography, Tosoh Bioscience
Showing 2 of 2 Streams
Break
BWB Main Stage
10:30am - 11:15am
Morning Break in the Exhibit & Poster Hall
10:30am - 10:40am
How much Money does this really save us? | Economic Modeling of Multi-Column Chromatography for Protein A (Continued)
- Jennifer Knister - Product Specialist, Multi-Column Chromatography, Tosoh Bioscience
10:40am - 11:00am
Overcoming Gene Therapy Development Barriers with Better Transfection and Lower Production Costs using Novel Transfection and Enhancer Formulations
- Leisha Kopp - Senior Field Applications Scientist, Mirus Bio LLC
11:00am - 11:15am
[11:00-11:30] Simplified Manufacturing Setup with Sartorius ProcessGo; a Pre-Engineered Process Solution
- Cecilia Annerén - Head of Product Management, Sartorius Stedim Data Analytics AB, Sartorius Stedim
- Lorraine Borland - Manager of Process Technologies, Sartorius
Showing 9 of 9 Streams
Cell Culture & Upstream Processing - Room 210C
Recovery & Purification - Room 210B
Manufacturing Strategy & Bioprocessing 4.0 - Room 210A
Analytical & Quality - Room 209
Well Characterized Biologics & Biological Assays - Room 208
CGT Supply Chain, Cryopreservation, Logistics and Delivery - Room 206AB
Non Viral Delivery Development & Manufacturing - Room 205C
In Vivo Gene Therapy Manufacturing - Room 205AB
BWB Main Stage
11:15am - 11:45am
Opportunities and Challenges in Developing a Fully Connected Continuous Manufacturing Process for Biologics
- Himanshu Gadgil, Ph.D - CEO, Enzene Biosciences Ltd.
11:45am - 12:15pm
Platform development of perfusion N-1 bioreactor using in-line biocapacitance probe
- Emily Rittershaus - Senior Scientist, Process Development Upstream Biologics Development, Bristol Myers Squibb
12:15pm - 12:45pm
The Advanced Instruments Ecosystem & AI: engineering efficiencies and speeding up biotherapeutic development
- Benjamin Duckless - Field Application Scientist, Advanced Instruments
11:15am - 11:45am
The Paveway™ PLUS workflow: de-risking lead strain selection with early insights into product quality
- Adokiye Berepiki - Technical Project Leader, FUJIFILM Diosynth Biotechnologies
11:45am - 12:15pm
Engineering of New Ligands for Viral Vectors
- Cristina Peixoto - Head of Bioproduction Unit, iBET
12:15pm - 12:45pm
Introducing a Novel HipH Resin for Bispecific Antibody Purification
- Tony Thomas - Field Application Scientist, Purolite
11:15am - 11:45am
PAT Applications to Biomanufacturing: Raman for cell culture and antibody production
- George Zhou, PhD - Principal Scientist, Merck & Co., Inc.
11:45am - 12:15pm
Fostering Adoption of Modeling and Computational Methods in Biopharmaceutical Manufacturing at Regeneron Pharmaceuticals
- Massimiliano Colella - Principal Engineer, Regeneron Pharmaceuticals
12:15pm - 12:45pm
Non-screening Media Development within 1 Month: AlfaOPA™ Platform
- Michael Chen, PhD - CEO & Co-founder, Great Bay Bio
11:15am - 11:45am
Developing Analytical Methods for Bi-Specific and More Complex Molecules
- Anirban Adhikari - Global Technical & CMC Director (Analytical Development), Lonza
11:45am - 12:15pm
Improving Plasmid Stability and Quality with the NBx Bioproduction Platform
- Matthew Weinstock - Chief Technology Officer, Novel Biologics
12:15pm - 12:45pm
Next-Generation Approaches in Cell Line Development and Characterization for Biotherapeutics Applications
- Anis H. Khimani, Ph.D. - Senior Strategy Leader, Revvity
11:45am - 12:15pm
Accelerated Tech Transfer of Customized Flow Cytometry Assay by Spectral Flow Cytometer
- Greg Gmyrek - Senior Scientist, Scorpius BioManufacturing
12:15pm - 12:45pm
Digital Framework meets the challenges of Flexible and Single-Use Bioprocess Manufacturing
- Chris Monchinski - Vice President Manufacturing Intelligence, Automated Control Concepts LLC
11:15am - 12:15pm
Preparing Supply Chain Infrastructure, Planning for Commercial Readiness and Surge in Cell and Gene Therapies on the Market
- Amish Patel - SVP Technical Operations, Calidi Biotherapeutics
- Bob Amareld - Head of Supply Chain, Precision BioSciences, Inc.
- Nick Bayrakdarian - Vice President, US Cell Therapy Operations, Gamida Cell Inc.
- Brian Taylor - Executive Vice President, Biopharma Solutions, SmartLabs
12:15pm - 12:45pm
Maximizing Impact: Treat More Cell and Gene Therapy Patients with Smart Resource Utilization
- Stefanie Leysen - CGT Solution Manager, Bluecrux
11:45am - 12:15pm
Machine Learning-Driven Design of Non-Viral Delivery Vehicles for In Vivo Gene Therapies
- Shashi Murthy, PhD - Co-Founder & CTO, Nanite
12:15pm - 12:45pm
Crazy Simple Nanoparticle Characterization with Stunner
- Nelis Denys - Product Manager, Stunner & Lunatic, Unchained Labs
11:15am - 11:45am
Development of a Harvest Clarification Platform Process for Recombinant AAV
- Chen Wang - Scientist, Purification Process Development, Genomic Medicine Unit CMC Process Development, Sanofi
- Ethan Butler - Senior Scientist, Sanofi
11:45am - 12:15pm
Challenges with Enriching Full Capsids for rAAV Therapeutics
- Aaron Collier - Senior Scientist – Downstream Process Development, Passage Bio
12:15pm - 12:45pm
Next-Generation Nanofiber Technology Enables Efficient Downstream Processing of Viral Vectors, Extracellular Vesicles, and Nucleic Acid Targets
- Ian Scanlon - DSP Lead, ATMP Purification, Astrea Bioseparations
11:15am - 11:30am
[11:00-11:30] Fast Manufacturing Setup with Pre-Engineered Process Solution (Continued)
- Cecilia Annerén - Head of Product Management, Sartorius Stedim Data Analytics AB, Sartorius Stedim
- Lorraine Borland - Manager of Process Technologies, Sartorius
11:30am - 11:50am
Accelerating Commercialization and Improving Efficiency Across the Network Through Digital Transformation
- Anthony DeBiase - Offering Manager, Rockwell Automation
11:50am - 12:10pm
Cell Culture Solutions to Unlock Your Cell Performance
- Alyssa Master - Vice President, Sales Enablement and Customer Experience, Nucleus Biologics
12:10pm - 12:15pm
5 Minute Break
12:15pm - 12:45pm
[12:15-1:00] Panel Discussion: Outlining the Processes and Methods for Increasing Sustainability in BioProcessing
- Kenneth Wu - Executive Director, Corporate Sustainability, Gilead Sciences
- Jason Cordeiro - Chief Operating Officer, MassBio
- Kyle Cahill - Senior Director, Environmental Sustainability Disclosure and Engagement Lead, Takeda
- Sri Madabhushi - Principal Scientist, Merck & Co., Inc.
- Horacio Caperan - Executive Director for External Affairs, MIT Joint Program on the Science and Policy of Global Change
Showing 2 of 2 Streams
Break
BWB Main Stage
12:45pm - 1:55pm
Lunch in the Exhibit & Poster Hall
12:45pm - 1:00pm
[12:15-1:00] Panel Discussion: Outlining the Processes and Methods for Increasing Sustainability in BioProcessing (Continued)
- Kenneth Wu - Executive Director, Corporate Sustainability, Gilead Sciences
- Jason Cordeiro - Chief Operating Officer, MassBio
- Kyle Cahill - Senior Director, Environmental Sustainability Disclosure and Engagement Lead, Takeda
- Sri Madabhushi - Principal Scientist, Merck & Co., Inc.
- Horacio Caperan - Executive Director for External Affairs, MIT Joint Program on the Science and Policy of Global Change
1:00pm - 1:05pm
5 Minute break
1:05pm - 1:45pm
Panel: Talent Acquisition, Retention and Training Strategies for the Biotech and Pharma Industries
- Anna O'Driscoll - Chief People Officer, Cellarity
- Adam Thomas - Chief People Officer, Synlogic
- Jeanne LeClair - Vice President of Economic Development and Partnerships, Massachusetts Life Sciences Center
- Manny Contomanolis - Director, Office of Career Services, Harvard University
- Karen Anderson - Chief People Officer, Centessa Pharmaceuticals
- Erika Marder - Global Head of HR for Research & Development, Takeda Pharmaceutical
1:45pm - 1:55pm
[13:45-2:00] Passport Giveaway
Showing 7 of 7 Streams
Cell Culture & Upstream Processing - Room 210C
Recovery & Purification - Room 210B
Manufacturing Strategy & Bioprocessing 4.0 - Room 210A
Analytical & Quality - Room 209
Well Characterized Biologics & Biological Assays - Room 208
In Vivo Gene Therapy Manufacturing - Room 205AB
BWB Main Stage
1:55pm - 2:00pm
Chairperson’s Remarks
- Chao Ma - Principal Scientist, Upstream Process Development, Bioprocess Research & Development, Pfizer
2:00pm - 2:30pm
Continuous Bioprocessing: Regulatory and Manufacturing perceptive
- Yasser El-Sherbini - Consultant, Biopharma Excellence – PharmaLex
2:30pm - 3:00pm
Leveraging High-Throughput Tools to Accelerate Upstream Process Development for AAV Gene Therapy
- Ningning Xu - Senior Scientist, Cell culture process development, Genomic Medicine Unit (GMU) CMC, Sanofi
3:00pm - 3:30pm
Development of next-generation CHOK1 host cells to enable improved productivity and manufacturing
- Sherman Ku, PhD - Principal Scientist, Just – Evotec Biologics
1:55pm - 2:00pm
Chairperson’s Remarks
- Tom Ransohoff - Principal, RTI Consulting, LLC
2:00pm - 2:30pm
Using Clarification Innovation to Eliminate Endonuclease from an AAV Production Process
- Garima Thakur - Process Development Engineer III, Regeneron Pharmaceuticals
2:30pm - 3:00pm
Using Crystallization tech to improve AAV yields
- Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
3:00pm - 3:30pm
Novel Ligands and Modalities for the Purification of Gene Editing Products: CRISPR-Cas and Viral Vectors
- Stefano Menegatti - Associate Professor, North Carolina State University
1:55pm - 2:00pm
Chairperson’s Remarks
- Mario Sinani - Principal Consultant, Pore Solution LLC
2:00pm - 2:30pm
Optimization of Ultra- and Diafiltration processes. How digital bioprocess twins can accelerate process development of these underestimated unit operations
- Maximilian Krippl - Head of Bioprocess Modeling Consulting, Novasign
2:30pm - 3:00pm
How hybrid modeling and transfer learning can increase insight and reduce development timelines
- Alessandro Butté - CEO, DataHow
3:00pm - 3:30pm
Panel Discussion: Investing in Technology: What should go where and when?
- Sean Hart - Chief Executive Officer & CSO, LumaCyte
- Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG
- Yasser El-Sherbini - Consultant, Biopharma Excellence – PharmaLex
- Taylor Chartier - Chief Executive Officer, Modicus Prime
- James Colley - IT Phorum Director, Biophorum
1:55pm - 2:00pm
Chairperson’s Remarks
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
2:00pm - 2:30pm
Next Generation Therapies have Next Generation Analytical Challenges
- Mary Beth Pelletier, PhD - Head of Gene Therapy Quality, Biogen
2:30pm - 3:00pm
Characterization of Full/Empty Capsids for AAV Gene Therapy
- Andrea Sobjak - Director, Janssen R&D
3:00pm - 3:30pm
Analytical Strategies for Gene-Edited Hematopoietic Stem Cell Therapies
- Brent Morse - Principal Consultant, Dark Horse Consulting Group
1:55pm - 2:00pm
Chairperson’s Remarks
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
2:00pm - 2:30pm
Next Generation Therapies have Next Generation Analytical Challenges
- Mary Beth Pelletier, PhD - Head of Gene Therapy Quality, Biogen
2:30pm - 3:00pm
Characterization of Full/Empty Capsids for AAV Gene Therapy
- Andrea Sobjak - Director, Janssen R&D
3:00pm - 3:30pm
Analytical Strategies for Gene-Edited Hematopoietic Stem Cell Therapies
- Brent Morse - Principal Consultant, Dark Horse Consulting Group
1:55pm - 2:00pm
Chairperson’s Remarks
- David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
2:00pm - 2:30pm
Viral Reduction Filters for Gene Therapy Drug Production
- Namila Fnu - Downstream Process Development Scientist, Spark Therapeutics
2:30pm - 3:00pm
Development of a Continuous Platform for rAAV Manufacturing via Mechanistic Modeling
- Tam Nguyen - Scientist, BioNTech US / Massachusetts Institute of Technology
1:55pm - 2:00pm
[13:45-2:00] Passport Giveaway
3:30pm - 3:35pm
End of Event 2023
Get the Latest Event Updates
Sign up to get the latest event updates and information.
Filter
Streams