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Delivered as a Hybrid Event from September 20-30, 2021
Live In-Person Experience Delivered September 20-23Boston Convention and Exhibition Centerkeyboard_arrow_right
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CONFERENCE DAY 3 - EST/EDT (Eastern Daylight, GMT-4)
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CONFERENCE DAY 3 - EST/EDT (Eastern Daylight, GMT-4)
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Streams
7:55am - 8:00am5 mins
Cell Culture and Upstream Processing
Chairperson's Opening Remarks
7:55am - 8:00am5 mins
Recovery & Purification
Chairperson’s Opening remarks
7:55am - 8:00am5 mins
Manufacturing Strategy & Bioprocessing 4.0
Chairperson’s Opening remarks
7:55am - 8:00am5 mins
Analytical & Quality
Chairperson's Opening Remarks
7:55am - 8:00am5 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Chairperson’s Opening Remarks
8:00am - 8:30am30 mins
Cell Culture and Upstream Processing
Cell culture media solution preparation: in-process characterization and tech transfer to CMO
- Yue Hu, Ph.D., - Scientist, Material Sciences, Janssen
8:00am - 8:30am30 mins
Recovery & Purification
Host Cell Protein Challenges in the Downstream Process Development of Non-Antibody Processes
- Naveenkumar Singh, Ph.D. - Scientist II, Process Development – Downstream, Ambrx
8:00am - 8:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Approaches to Data Sciences and Knowledge Management
8:00am - 8:30am30 mins
Analytical & Quality
Leveraging Prior Knowledge for Faster Analytical Method Validation and Transfer
- Christopher Yu, Ph.D. - Director, Protein Analytical Chemistry Quality Control, Genentech
8:00am - 9:00am60 mins
COVID-19 Development & Production
Benefits Gained from Accelerated Programs and Impact on Future of Development Timelines
8:00am - 8:30am30 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
State of the Industry
- Janet Lambert - Chief Executive Officer, Alliance for Regenerative Medicine
8:30am - 9:00am30 mins
Cell Culture and Upstream Processing
Identification and mitigation of hydroxyproline as a novel co-translational modification during cell culture development
- Shanta Boddapati - Senior Scientist, Seagen
8:30am - 9:00am30 mins
Recovery & Purification
Accelerated Depth Filter Screening to Improve Process Impurity Clearance
- Lisa D’Costa, MSc. - Senior Process Development Associate, Downstream Process Development, KBI Biopharma
8:30am - 9:00am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Realizing the Benefits of Platform Processes Through Data Leverage and Process Development Streamlining
8:30am - 9:00am30 mins
Analytical & Quality
Implementing PAT in a GMP Environment
- Sophia Levitskaya-Seaman - Analytical Development Scientist III, Lead PAT, Macrogenics
8:30am - 9:30am60 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Panel Discussion: Exploring the Massachusetts Biotech Ecosystem; Fostering Innovation, Spinning out, & Maximising Growth Potential
- Shashi Murthy, PhD - Founder & CTO, Flaskworks
- Brian Goodman, PhD - Partner, MPM
- Jennifer Griffin - VP Industrial Strategy & Investments, Mass Life Sciences
8:30am - 9:00am30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Opening remarks and Manufacturing the Future of Biofabrication with ARM
9:00am - 9:30am30 mins
Cell Culture and Upstream Processing
Technology Workshop
9:00am - 9:30am30 mins
Recovery & Purification
Technology Workshop
9:00am - 9:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Technology Workshop
9:00am - 9:30am30 mins
Analytical & Quality
Technology Workshop
9:00am - 9:30am30 mins
COVID-19 Development & Production
Technology Workshop
9:00am - 9:30am30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Tools and Technologies for Generating High Quality Cellular Starting Material
9:30am - 10:30am60 mins
Cell Culture and Upstream Processing
Networking Refreshment Break
9:30am - 10:30am60 mins
Recovery & Purification
Networking Refreshment Break
9:30am - 10:30am60 mins
Manufacturing Strategy & Bioprocessing 4.0
Networking Refreshment Break
9:30am - 10:30am60 mins
Analytical & Quality
Networking Refreshment Break
9:30am - 10:30am60 mins
COVID-19 Development & Production
Networking Refreshment Break
9:30am - 10:15am45 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Networking Refreshment Break
9:30am - 10:15am45 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Networking Refreshment Break
10:15am - 11:00am45 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Panel: Investment view on Innovation in Cell & Gene Therapy
- Shaan Gandhi - Director, Northpond Ventures
- Walter Kowtonuik - Principal, Third Rock
- Shinichiro (Shin) Fuse, Ph.D. - Managing Director, MPM Capital
- Michal Preminger, Ph.D., MBA - Head, Johnson & Johnson Innovation East North America, J&J
10:15am - 10:45am30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Streamlining Production of Defined Cell Lines
10:30am - 11:00am30 mins
Cell Culture and Upstream Processing
TBC
- Khandaker Siddiquee, Ph.D. - Senior Scientist, Abbott Labartories
10:30am - 11:00am30 mins
Recovery & Purification
Phospholipase B-like 2 is Not Responsible for Polysorbate Degradation in Monoclonal Antibody Drug Products
- Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
10:30am - 11:00am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Speed Up Multi-Continents Inter/Intra Company Analytical Technical Transfer
- Jia Chen - Quality Control Technical Manager, Department of Analytical Development and Quality Control, Genentech, Roche
10:30am - 11:00am30 mins
Analytical & Quality
Cruising through Analytical Technical Transfer for Commercial Launch Projects
- Jia Chen - Quality Control Technical Manager, Department of Analytical Development and Quality Control, Genentech, Roche
10:30am - 11:00am30 mins
COVID-19 Development & Production
Future of Vaccine and Therapeutic Development
10:45am - 11:15am30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Label-free Cell Selection and Purification
11:00am - 11:30am30 mins
Cell Culture and Upstream Processing
TBC
11:00am - 11:30am30 mins
Recovery & Purification
Polysorbate, The Good, The Bad and the Ugly
- Linda Yi - Senior Scientist, Analytical Development, Biogen
11:00am - 11:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Quality by Design in Analytics
- Robert Mayer - GDD TRD biologics, Novartis
11:00am - 11:30am30 mins
Analytical & Quality
Quality by Design in Analytics
- Robert Mayer - GDD TRD biologics, Novartis
11:00am - 11:30am30 mins
COVID-19 Development & Production
How will mRNA Success Impact the Bioprocessing Industry and Other Molecules
11:00am - 12:00pm60 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Dual Dialogue – Anatomy of an Acquisition: Bayer and AskBio
- Sheila Mikhail - CEO & Co-Founder, AskBio
- Marianne De Backer, MBA, PhD - EVP, Head of Strategy, BD&L, Bayer AG
11:15am - 11:45am30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Sensors for Real-time and Non-destructive Detection of Product Quality Attributes
11:30am - 12:00pm30 mins
Cell Culture and Upstream Processing
Scientific Track Presentation
11:30am - 12:00pm30 mins
Recovery & Purification
Scientific Track Presentation
11:30am - 12:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
11:30am - 12:00pm30 mins
Analytical & Quality
Scientific Track Presentation
11:30am - 12:00pm30 mins
COVID-19 Development & Production
Scientific Track Presentation
11:45am - 12:00pm15 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Spotlight Presentation
12:00pm - 1:00pm60 mins
Lunch Presentation and Networking Break
1:00pm - 1:30pm30 mins
Cell Culture and Upstream Processing
Passport Prize Giveaway in Exhibit Hall
1:00pm - 1:30pm30 mins
Recovery & Purification
Passport Prize Giveaway in Exhibit Hall
1:00pm - 1:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Passport Prize Giveaway in Exhibit Hall
1:00pm - 1:30pm30 mins
Analytical & Quality
Passport Prize Giveaway in Exhibit Hall
1:00pm - 1:30pm30 mins
COVID-19 Development & Production
Passport Prize Giveaway in Exhibit Hall
1:00pm - 1:45pm45 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Panel: Manufacturing and Distribution Strategies for Commercialising Cell & Gene Therapies
- Anne Altmeyer - Formerly, CBO, Sigilon Tx
- Kareem Reda - CBO, Elevate Bio
- Michael Hausladen - Devens Cell Therapy Facility Program Lead, BMS (pending final confirmation)
1:00pm - 1:30pm30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Scaling the Production of Tissues Using 3D Printing
1:30pm - 2:00pm30 mins
Cell Culture and Upstream Processing
Challenges of Harvest Depth Filtration for Bispecific Molecules – A Case Study
- Ehsan Borujeni - Principal Scientist, Global BioProcess Development, Downstream, Bristol-Myers Squibb
1:30pm - 2:00pm30 mins
Recovery & Purification
Challenges of Harvest Depth Filtration for Bispecific Molecules – A Case Study
- Ehsan Borujeni - Principal Scientist, Global BioProcess Development, Downstream, Bristol-Myers Squibb
1:30pm - 2:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Attribute Modelling in the QC Space
- Rachel Mullen - Senior Analytical Scientist, Regeneron
1:30pm - 2:00pm30 mins
Analytical & Quality
Attribute Modelling in the QC Space
- Rachel Mullen - Senior Analytical Scientist, Regeneron
1:30pm - 3:00pm90 mins
COVID-19 Development & Production
Regulatory Perspectives on Future of Review and Approval Process
1:30pm - 2:00pm30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Generating Complex Scaffolds and Harnessing Native Material Architecture
1:45pm - 2:30pm45 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Panel: Talent Acquisition, Development and Retention in Novel Therapeutics
- Andrew Rigoglioso - Associate Director, TA, Cell Therapy Development & Ops, BMS
- Juliette Hilliard - Director, TA, Novartis GT
- Georgette Verdin - Chief HRO, Avrobio
2:00pm - 2:30pm30 mins
Cell Culture and Upstream Processing
Development of a Harvest Solution – A Fully Synthetic Depth Filter with Anion Exchange
2:00pm - 2:30pm30 mins
Recovery & Purification
Development of a Harvest Solution – A Fully Synthetic Depth Filter with Anion Exchange
2:00pm - 2:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
CMO Quality Oversight Challenges and FDA’s Perspective
- Wenyan Liao - ASQ Certified Quality Auditor, Sr. QA Disposition, External Biologics (Global Quality), Takeda Pharmaceutical Company Limited
2:00pm - 2:30pm30 mins
Analytical & Quality
CMO Quality Oversight Challenges and FDA’s Perspective
- Wenyan Liao - ASQ Certified Quality Auditor, Sr. QA Disposition, External Biologics (Global Quality), Takeda Pharmaceutical Company Limited
2:00pm - 2:30pm30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Maturation Techniques and Bioreactor Culture for Tissue Generation
2:30pm - 3:00pm30 mins
Cell Culture and Upstream Processing
Panel Discussion - Integrating USP and DSP
2:30pm - 3:00pm30 mins
Recovery & Purification
Panel Discussion - Integrating USP and DSP
2:30pm - 3:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Presentation and Presenter TBD
2:30pm - 3:00pm30 mins
Analytical & Quality
TBC
2:30pm - 3:00pm30 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Networking Refreshment Break
2:30pm - 3:00pm30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Networking Refreshment Break
3:00pm - 3:05pm5 mins
Cell Culture and Upstream Processing
Close of BPI 2021
3:00pm - 3:05pm5 mins
Recovery & Purification
Close of BPI 2021
3:00pm - 3:05pm5 mins
Manufacturing Strategy & Bioprocessing 4.0
Close of BPI 2021
3:00pm - 3:05pm5 mins
Analytical & Quality
Close of BPI 2021
3:00pm - 3:05pm5 mins
COVID-19 Development & Production
Close of BPI 2021
3:00pm - 3:45pm45 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Panel: A Global View of Value, Regulatory Considerations & Access for Novel Therapies
- Greg White - Senior Director , Global Market Access Policy, Janssen
- Kristin Wolff - Senior Director, Global Government Affairs & Public Policy, Bluebird
- Manal Morsy, MD, PhD, MBA - Senior Vice President, Head Global Regulatory Affairs, Athersys, Inc.
- Roland DeAngelis - SVP, Commercial Operations, Vericel (pending final confirmation)
3:00pm - 3:30pm30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Maturation Techniques and Bioreactor Culture for Tissue Generation
3:30pm - 4:00pm30 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
Trends for the Future of Biomanufacturing
3:45pm - 4:30pm45 mins
Cell & Gene Therapy Manufacturing and Commercialization – Partnering Track
Panel: Patient Case Management & Developing Patient journey methods for Cell & Gene Therapies
- Shefali Shah - Independent Consultant, Indi
- Sarah Nikiforow - Clinical Instructor of Medicine, Dana-Farber Cancer Institute
- Kris Elverum - SVP, BD & Strategy, Rubius Tx
4:00pm - 4:05pm5 mins
Cell Therapy and Tissue Engineering Track Advanced Tools for Cell and Tissue Manufacturing
End of Day
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