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Day 4 - ET (Eastern Time, GMT-05:00)
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Day 4 - ET (Eastern Time, GMT-05:00)
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8:30am - 8:55am
Coffee and Registration
Showing 3 of 3 Streams
Well Characterized Biologics & Biological Assays
Analytical & Quality
BWB Main Stage
8:55am - 9:00am
Chairperson’s Opening Remarks
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
10:00am - 10:30am
Strategies to Streamline and Standardize Process Characterization toward Effective Late-Phase Activities and Successful Validation Campaigns
8:55am - 9:00am
Chairperson’s Opening Remarks
9:00am - 9:30am
AbbVie’s journey into the digital strategy and transformation efforts across CMC Biologics Development space
- Dana Filoti, Ph.D. - Associate Director, CMC Scientific Architecture, AbbVie Bioresearch Center
9:30am - 10:00am
The Importance of Metabolite Analyzers in Efficient High-Throughput Cell Culture Workflows
- Eric 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
9:05am - 9:15am
Chair Opening Remarks
- Bob Castellucci - Founder and President, Partnership To Prosperity
9:15am - 10:15am
Panel: BioProcess Insider State of the Industry Q3 2023
- Dan Stanton - Managing Editor, Bioprocess International, Informa Connect
- Andrew Harmon - Senior Consultant, Strategic Consulting, Latham Biopharm Group
10:15am - 10:20am
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
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 Enhanced Transfection and Lower Production Costs
- Leisha Kopp - Senior Field Applications Scientist, Mirus Bio LLC
11:00am - 11:15am
Fast Manufacturing Setup with 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 3 of 3 Streams
Well Characterized Biologics & Biological Assays
Analytical & Quality
BWB Main Stage
11:15am - 11:45am
Complexity & Expectations of Infectious Titer Assay
- Svitlana Rose - Scientist I, Solid Biosciences
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, Automated Control Concepts LLC
11:15am - 11:45am
Developing Analytical Methods for Bi-Specific and More Complex Molecules
- Anirban Adhikari - Global Technical & CMC Director, Lonza
11:45am - 12:15pm
Leveraging Risk-based Approach, Process Knowledge and Selecting Appropriate Strategies to Design Process Relevant Impurity Clearance Challenge Studies
- Raj Prabu Vijayakumar Saraswathi - Principal Scientist, Biologics Process Development, Alkermes
12:15pm - 12:45pm
Next Generation Approaches in Cell Line Development and Characterization for Biotherapeutics Applications
- Anis Khimani, PhD - Senior Strategy Leader, PerkinElmer, Inc
11:15am - 11:30am
Fast Manufacturing Setup with Pre-Engineered Process Solution
- 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 - ., 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
Break
12:20pm - 12:45pm
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
12:45pm - 1:00pm
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
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 and Secretary, 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
Passport Giveaway
Showing 2 of 2 Streams
Well Characterized Biologics & Biological Assays
Analytical & Quality
1:55pm - 2:00pm
Chairperson’s Remarks
2:00pm - 2:30pm
Next Generation Therapies have Next Generation Analytical Challenges
- Mary Beth Pelletier, PhD - Associate Director, QC Analytical Technology, 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
2:00pm - 2:30pm
Next Generation Therapies have Next Generation Analytical Challenges
- Mary Beth Pelletier, PhD - Associate Director, QC Analytical Technology, 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
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