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Monday, September 21, 2020

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BioPharm Americaabout eventkeyboard_arrow_right
Startup Program
BioProcess Internationalabout eventkeyboard_arrow_right
Data Science Tools for Accelerated Product Life Cycle
Drug Product/Formulations & Fill-Finish
Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Recovery & Purification
Intensified and Continuous Processing
Analytical & Quality
Manufacturing Strategy & Bioprocessing 4.0
Speed from Gene to Market/Analytical & Quality
Speed from Gene to Market
Technology Workshop 1
Technology Workshop 2
Technology Workshop 3
Technology Workshop 4
Technology Workshop 5
Technology Workshop 6
Technology Workshop 4
Technology Workshop 5
Technology Workshop 6
Spotlight Presentation 1
Spotlight Presentation 2
Cell & Gene Therapy Bioprocessing & Commercializationabout eventkeyboard_arrow_right
Cell Therapy
Gene Edited Ex Vivo Cell Therapy
In Vivo Gene Therapy
Advanced Tools for Cell and Tissue Manufacturing: 20/20 View
Bio/Pharma Talent Acquisition & Development Summitabout eventkeyboard_arrow_right
I. Unveil Unique Talent Sourcing & Acquisition Strategies
II. Discover Innovative Talent Advancement & Development Models
11:05am - 11:15am
Chronicle Roundtable Discussion
Chronicle Roundtable Discussion
Per Hammer - Senior Product Manager, Cell & Gene Therapy Automation and Digital solutions, Cytiva, USA
Scott Sobecki - Director, Research Informatics, Vanderbilt University Medical Center, USA
Katie Golden - Laboratory Coordinator, Vanderbilt University Medical Center, USA
12:00pm - 12:20pm
The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration – a PDA and BioPhorum collaboration
The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration – a PDA and BioPhorum collaboration
Mandar Dixit - Principal Process Expert, Sartorius Stedium Biotech
3:10pm - 3:40pm
Session 4
Session 4
11:20am - 11:40am
KEYNOTE ADDRESS - Genentech's Evolve Initiative
KEYNOTE ADDRESS - Genentech's Evolve Initiative
Josefine Persson, Ph.D. - Associate Director, Purification Development, Genentech
12:00pm - 12:20pm
Scientific Track Presentation
Scientific Track Presentation
1:20am - 1:40am
High yield mRNA production process from E.Coli to highly pure mRNA
High yield mRNA production process from E.Coli to highly pure mRNA
Aleš Štrancar - CEO, BIA Separations, Slovenia
2:15pm - 3:00pm
Create a Holistic Employee Experience for Enhanced Retention
Create a Holistic Employee Experience for Enhanced Retention
Tania Philipp - Vice President, People, Vor Biopharma
11:40am - 12:20pm
Session 2
Session 2
8:20am - 8:50am
Solutions to Streamline the Industrialization of Cell Therapy Manufacturing: Review of Progress and Trends, and Collaborations in the Current Climate
Solutions to Streamline the Industrialization of Cell Therapy Manufacturing: Review of Progress and Trends, and Collaborations in the Current Climate
Kevin Lannon - Business Development – North America Cell Therapy Processing, MilliporeSigma, USA
12:00pm - 12:20pm
High Throughput Charge Variant Screening of Therapeutic Proteins
High Throughput Charge Variant Screening of Therapeutic Proteins
Guangnan Meng, PhD - Product Leader, Microfluidics, PerkinElmer, Inc.
10:30am - 11:00am
Data driven strategies for downstream processing of Plasmid DNA in viral vector production
Data driven strategies for downstream processing of Plasmid DNA in viral vector production
Thomas Parker - Process Development Scientist, Global Focal Point for Vaccines and Viral Therapies, MilliporeSigma
3:40pm - 4:00pm
Validation design and results for qPCR based residual host cell DNA testing for biologics
Validation design and results for qPCR based residual host cell DNA testing for biologics
Mike Brewer - Director, Global Principal Consultant, Regulatory, Thermo Fisher Scientific
7:30am - 7:50am
Scalable, Consistent, Cost-effective Manufacturing for Tissues and Organs
Scalable, Consistent, Cost-effective Manufacturing for Tissues and Organs
Mary Clare McCorry - Director, Technology and Process Development, Advanced Regenerative Manufacturing Institute (ARMI)
12:00pm - 2:15pm
Master Class B: Parts 1 & 2 – Negotiation for Drug Delivery (available on-demand) – Please view these prior to joining the LIVE Part 3
Master Class B: Parts 1 & 2 – Negotiation for Drug Delivery (available on-demand) – Please view these prior to joining the LIVE Part 3
3:40pm - 4:00pm
Development of a second generation PlasmidSelect resin
Development of a second generation PlasmidSelect resin
Tony Hitchcock - Technical Director, Cobra Biologics
3:40pm - 4:00pm
Optimizing Workflow Efficiency with New Innovations in Bioprocess Monitoring
Optimizing Workflow Efficiency with New Innovations in Bioprocess Monitoring
4:15pm - 5:00pm
Take a Global, Scalable Approach to Recruitment Best Practices
Take a Global, Scalable Approach to Recruitment Best Practices
Scott Gottesman - Head of Global Talent Acquisition, AVROBIO
12:20pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:20pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:20pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:20pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
2:20pm - 2:40pm
Live Q&A
Live Q&A
11:20am - 11:40am
Case Study: Best Practises for Streamlining Technology Transfer Processes
Case Study: Best Practises for Streamlining Technology Transfer Processes
Jonathan Tsang - Director, Manufacturing Sciences & Technology Biotech, Technology Transfer, Bayer
10:00am - 10:40am
PANEL: Autologous Manufacturing – What will Autologous Manufacturing of the Future Look Like?
PANEL: Autologous Manufacturing – What will Autologous Manufacturing of the Future Look Like?
Jennifer Adrian - Manager, Cellular Therapy Manufacturing Operations, bluebird bio
Adam Haskett - Associate Director, External Manufacturing, Kite Pharma
1:00am - 1:20am
Advancing ATMP’s Manufacturing: Risks and Opportunities on Next Generation Ancillary Materials
Advancing ATMP’s Manufacturing: Risks and Opportunities on Next Generation Ancillary Materials
Claudia Zylberberg - CEO, Akron Biotech
7:25am - 7:30am
Welcome from Sarah Lintern - Conference Organizer
Welcome from Sarah Lintern - Conference Organizer
2:00pm - 2:30pm
Connectivity in drug delivery – strategies from the leaders of the pack (available On Demand)
Connectivity in drug delivery – strategies from the leaders of the pack (available On Demand)
10:20am - 10:40am
Unleashing the Power of Cyclodextrins within Biologic Formulations
Unleashing the Power of Cyclodextrins within Biologic Formulations
Shiqi Hong, PhD - Senior Biopharma Scientist, Roquette
9:50am - 10:10am
Non-Gene Edited Approaches to Allogeneic CAR-T Cell Therapy
Non-Gene Edited Approaches to Allogeneic CAR-T Cell Therapy
Philippe Parone - Director, Industrialization, Celyad, Belgium
2:20pm - 2:40pm
Application of Data Analytics to Raw Materials to Better Understand and Control Variation
Application of Data Analytics to Raw Materials to Better Understand and Control Variation
Matthew Hammond, Ph.D. - Principal Scientist, Amgen
3:40pm - 4:00pm
Case Study: Accelerating Manufacturing for Investigational COVID-19 Therapeutic Candidate Lenzilumab to Prevent and Treat Cytokine Storm
Case Study: Accelerating Manufacturing for Investigational COVID-19 Therapeutic Candidate Lenzilumab to Prevent and Treat Cytokine Storm
Cameron Durrant - Chairman and CEO, Humanigen, Inc.
Melanie Lasher, PMP - Manager, Project Management – Global Strategic PMO, Catalent
12:20am - 12:40am
From Vein to Vein: How Starting Material Quality Impacts the Success of Next-Generation Therapies
From Vein to Vein: How Starting Material Quality Impacts the Success of Next-Generation Therapies
Joy Aho - PhD, Senior Product Manager, Be The Match BioTherapies, USA
8:10am - 9:15am
Coffee Break & Exhibition Viewing Time
Coffee Break & Exhibition Viewing Time
11:00am - 11:15am
Ginkgo Bioworks
Ginkgo Bioworks
12:55pm - 1:15pm
Technological advances to address oral delivery of challenging molecules (available On Demand)
Technological advances to address oral delivery of challenging molecules (available On Demand)
3:40pm - 4:00pm
Moving beyond mAbs: Evolution and scale-up of the Fibro chromatography platform
Moving beyond mAbs: Evolution and scale-up of the Fibro chromatography platform
Matthew Townsend, PhD - Senior Research Scientist, Cytiva
12:30pm - 12:50pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:30pm - 12:50pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:30pm - 12:50pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:30pm - 12:50pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
2:30pm - 2:50pm
Learnings from perfusion medium development
Learnings from perfusion medium development
Christopher Brau - Staff Scientist/Engineer, Thermo Fisher Scientific
7:30am - 7:50am
Senti Bio Case Study: Gene Modified Allogeneic MSCs and NK Cells
Senti Bio Case Study: Gene Modified Allogeneic MSCs and NK Cells
Philip Lee - COO and Co-Founder, Senti Biosciences
11:20am - 11:45am
Speaker Q&A - Raw Material, Viral Vector & Supply Chain Considerations
Speaker Q&A - Raw Material, Viral Vector & Supply Chain Considerations
Christopher Bravery - Director, Consulting on Advanced Biologicals Ltd., Member, ISCT EU Legal and Regulatory Affairs Committee, UK
Christiane Niederlaender - Director, AMBR Consulting Ltd, formerly MHRA, UK
Scott Burger - Principal, Advanced Cell & Gene Therapy, USA
Tom Walls - Global Planning and Logistics Lead, Spark Therapeutics, USA
Max Sellman - Product Manager, Gene Editing, Aldevron, USA
Sylvain Cecchini - Associate Professor of Microbiology & Physiological Systems, University of Massachusetts Medical School, USA
3:20pm - 3:40pm
Manufacturing Technologies, Facility Design and Industrialised Supply Chains for Cell and Gene Therapies
Manufacturing Technologies, Facility Design and Industrialised Supply Chains for Cell and Gene Therapies
Katie Masterson - Director, Manufacturing Operations, REGENXBIO Inc.
11:40am - 12:00pm
Flow Distribution in Commercial Depth Filter Capsules for Clarification of Cell Culture Fluid– Effects on Performance and Scale-Up
Flow Distribution in Commercial Depth Filter Capsules for Clarification of Cell Culture Fluid– Effects on Performance and Scale-Up
Negin Nejati, PhD Candidate - Research Assistant, Chemical Engineering Department, Pennsylvania State University
12:30pm - 12:50pm
Ensuring Consistency of Raw Materials & Supply for Proprietary Cell Culture Formulations
Ensuring Consistency of Raw Materials & Supply for Proprietary Cell Culture Formulations

Vitamins, amino acids, salts, sugars, and other key molecules are critical to the successful manufacture of new drug targets.  In cell culture, as cells diligently manufacture our biologics of choice, there are several non-desirable components that can affect the efficacy and safety of the final product.  Typically, these components are a byproduct of the manufacturing process of the essential raw materials and the contribution from supplier-to-supplier and lot-to-lot can vary drastically.  As regulations become tighter, it is becoming increasingly important to increase the quality and consistency of end-product by decreasing the risk of variable media performance.  Through robust trace element testing, biologic manufacturers can monitor the key raw material attributes in order to ensure desired media attributes, implement real-time control over raw material variability, and connect cell culture performance to media lot variability.  Partnering with media manufacturers with robust manufacturing capabilities, trace element analytical services, and the ability to add trace element specifications to media Certificates of Analysis help to de-risk biologic production and maximize outputs.

Chad Schwartz, PhD - Senior Product Manager, Thermo Fisher Scientific
2:00pm - 2:20pm
Utilising Single Use Technologies in Commercial Manufacturing
Utilising Single Use Technologies in Commercial Manufacturing
Weibing Ding, PhD - Director, GSK
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
4:00pm - 4:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
7:30am - 7:50am
Developing Your Manufacturing Process from A->Z
Developing Your Manufacturing Process from A->Z
Priya Baraniak - Vice President, Corporate Development, OrganaBio
11:30am - 11:50am
Optimization of Cell Culture and Differentiation
Optimization of Cell Culture and Differentiation
Jan Jensen - CEO and Founder, Trailhead Biosystems Inc.
11:50am - 12:15pm
Speaker Q&A - Gene Therapy Analytics
Speaker Q&A - Gene Therapy Analytics
Franz Schnetzinger - Director Analytical Development, Gyroscope Therapeutics
David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
Michael J. DiBiasio-White, Sr. - Sr. Scientist: BioProcess Development/Protein Sciences, Ring Therapeutics
11:40am - 12:00pm
Understanding Biopharmaceutical Manufacturing at Single Cell Resolution
Understanding Biopharmaceutical Manufacturing at Single Cell Resolution
Colin Clarke, Ph.D. - Principal Investigator, National Institute for Bioprocessing
11:45am - 12:30pm
Networking & Additional Content Viewing Time
Networking & Additional Content Viewing Time
11:20am - 11:40am
Implementing MAM into a QC Environment
Implementing MAM into a QC Environment
Ting Song - QC Specialist, Amgen
8:00am - 8:20am
Optimizing Viral Vector Production
Optimizing Viral Vector Production
Nicole Nuñez, Ph.D., - Process Development Scientist, Eureka Therapeutics, Inc.
12:00am - 12:20am
What will it take to succeed in drug delivery - A look into what's coming
What will it take to succeed in drug delivery - A look into what's coming
2:00pm - 2:20pm
FEATURED PRESENTATION: Developability to Ensure Streamlined Manufacturing
FEATURED PRESENTATION: Developability to Ensure Streamlined Manufacturing
Jonathan Kingsbury - Head of Developability & Pre-formulation, Sanofi
10:15am - 11:00am
Master Class A, part 3: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
Master Class A, part 3: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
11:00am - 11:20am
Starting Material Standardization
Starting Material Standardization
Christiane Niederlaender - Director, AMBR Consulting Ltd, formerly MHRA, UK
2:20pm - 2:40pm
Aligning the R&D and Marketing TPP to Achieve R&D and Commercial Success
Aligning the R&D and Marketing TPP to Achieve R&D and Commercial Success
Regina Au, MBA, MIM - Principal, New Product Planning/Strategic Planning, BioMarketing Insight
11:40am - 12:00pm
Evolving Cell Culture Platform to Address Amino Acid Misincorporations for Fed Batch Processes
Evolving Cell Culture Platform to Address Amino Acid Misincorporations for Fed Batch Processes
David Lee - Research Associate III, Seattle Genetics
3:20pm - 3:40pm
Computational Analysis of Antibody-HCP Interactions: Development of a New Framework
Computational Analysis of Antibody-HCP Interactions: Development of a New Framework
Maral Adeli-Koudehi, PhD - Postdoc Researcher, Purification Development, Sanofi
11:40am - 12:25pm
Networking & Poster Viewing Time
Networking & Poster Viewing Time
1:00pm - 1:05pm
End of Symposium
End of Symposium
11:40am - 12:00pm
Evaluating New CHO Hosts for a New Therapeutic Platform – What Caused Radically Different Expression and Product Quality Levels?
Evaluating New CHO Hosts for a New Therapeutic Platform – What Caused Radically Different Expression and Product Quality Levels?
Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.
11:40am - 12:00pm
Evaluating New CHO Hosts for a New Therapeutic Platform – What Caused Radically Different Expression and Product Quality Levels?
Evaluating New CHO Hosts for a New Therapeutic Platform – What Caused Radically Different Expression and Product Quality Levels?
Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.
9:25am - 10:05am
State of the Industry
State of the Industry
Michael Lehmicke - Director, Science and Industry Affairs, Alliance for Regenerative Medicine
8:00am - 8:20am
Robust Preclinical Oxygen Imager JIVA-25 for Cancer and Regenerative Medicine Therapy Development
Robust Preclinical Oxygen Imager JIVA-25 for Cancer and Regenerative Medicine Therapy Development
Mrignayani Kotecha - Co-Founder, CEO, O2M Technologies
12:30pm - 2:00pm
Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
3:40pm - 4:00pm
Accelerate Biopharmaceutical Development with an Integrated Upstream Solution
Accelerate Biopharmaceutical Development with an Integrated Upstream Solution
Jason Gustin - Director - Cell Line Development & Engineering, MilliporeSigma
3:50am - 4:20am
Phase Appropriate Thinking – Microbiology and Contamination Control
Phase Appropriate Thinking – Microbiology and Contamination Control
Donald Singer - Consultant, formerly, GSK Senior Fellow, Microbiology, Biopharmaceutical GMP Operations, USA
12:00am - 12:30am
Adherent Cell Manufacturing & Process Development
Adherent Cell Manufacturing & Process Development
Lior Raviv - Vice President, Pluristem Therapeutics Inc.
11:20am - 11:40am
KEYNOTE ADDRESS: How Digital Science Enables Integrated Development
KEYNOTE ADDRESS: How Digital Science Enables Integrated Development
Oliver Hesse - Director, Lab Automation and Data Management, Biological Development, Bayer Healthcare LLC
3:30pm - 4:15pm
Strengthen University Recruiting Functions to Appeal to a New Generation of Talent
Strengthen University Recruiting Functions to Appeal to a New Generation of Talent
Tori Caldwell - Director, Talent Acquisition and Culture, Foghorn Therapeutics
11:30am - 12:30pm
Networking Break
Networking Break
11:20am - 11:40am
NIIMBL-BioPhorum Buffer Stock Blending System - Buffer Preparation of the Future
NIIMBL-BioPhorum Buffer Stock Blending System - Buffer Preparation of the Future
Jeff Johnson - President, Biotech Design, LLC
10:05am - 10:35am
Top considerations when engaging a potential strategic partnership
Top considerations when engaging a potential strategic partnership
1:40pm - 2:25pm
Live Speaker Q&A
Live Speaker Q&A
Monique Levy - Formerly Chief Strategy Officer, BlackThorn Therapeutics, USA
12:30pm - 12:50pm
Leveraging High-Throughput Strategies to Accelerate AAV Purification Process Development
Leveraging High-Throughput Strategies to Accelerate AAV Purification Process Development
Xiaotong Fu, PhD - Sr. Engineer, Biogen
9:00am - 9:10am
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
David Smith - President and Chief Commercial Officer, Akron Biotech, USA
2:00am - 2:30am
Sourcing Appropriate Starting and Ancillary Materials for Manufacturing Cell and Gene Therapy Products
Sourcing Appropriate Starting and Ancillary Materials for Manufacturing Cell and Gene Therapy Products
Kathy Williams - VP of Quality and Reg Affairs, RoosterBio, Inc., USA
11:50am - 12:10pm
Microscale Sensors and Systems for Tissue Engineering and Organs on a Chip Applications
Microscale Sensors and Systems for Tissue Engineering and Organs on a Chip Applications
Mehmet Dokmeci - Adjunct Professors, University of California (UCLA)
11:20am - 11:40am
Cell Line Development with High Titer and Long Term Stability
Cell Line Development with High Titer and Long Term Stability
Sung Ho Hahm - CEO, Rophibio Inc.
11:00am - 11:30am
Master Class A, part 4: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
Master Class A, part 4: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
1:00pm - 1:20pm
Case study: Alleviating challenges of oral peptide delivery (available On Demand)
Case study: Alleviating challenges of oral peptide delivery (available On Demand)
12:00am - 12:30am
Implementation of “off the shelf” Closed Systems fit for every purpose
Implementation of “off the shelf” Closed Systems fit for every purpose
Ali Mohamed - VP, CMC, Immatics, USA
10:30am - 10:50am
What are the big questions AI can help answer and what's holding us back? (available On Demand)
What are the big questions AI can help answer and what's holding us back? (available On Demand)
12:30pm - 12:50pm
Enabling new bioprocess simplification and intensification strategies using advanced process technology solutions.
Enabling new bioprocess simplification and intensification strategies using advanced process technology solutions.
Alexei Voloshin, PhD - Biopharma Application Engineering Manager, 3M
12:30pm - 12:50pm
How to get the most out of your fed-batch process: strategies for production media and feed regime development as well as process intensification
How to get the most out of your fed-batch process: strategies for production media and feed regime development as well as process intensification
Andreas Castan, PhD - Strategic Technology Partnerships Leader, Cytvia
1:05am - 1:35am
Holistic Characterization of AAV Capsid Particle Using Advanced Analytical Tools
Holistic Characterization of AAV Capsid Particle Using Advanced Analytical Tools
Qin Zou, Ph.D. - Associate Research Fellow and Group Leader, Pfizer
11:30am - 12:00pm
Privacy: Data and consent in the drug development lifecycle – Regulatory compliance and ethics frameworks in the application of AI and ML (available On Demand)
Privacy: Data and consent in the drug development lifecycle – Regulatory compliance and ethics frameworks in the application of AI and ML (available On Demand)
11:40am - 12:00pm
Improvement of therapeutic protein production and quality: Coping with ER stress
Improvement of therapeutic protein production and quality: Coping with ER stress
Tae Kwang Ha - Specialist, Novo Nordisk Foundation Center for Biosustainability, DTU
12:30pm - 12:50pm
Novel technology concepts for cost-effective virus production
Novel technology concepts for cost-effective virus production
Tania Pereira Chilima - Deputy Chief Technology Officer, Univercells Technologies
2:00pm - 2:20pm
Case Study: Troubleshooting an Upstream Process Variation using MVA Approach
Case Study: Troubleshooting an Upstream Process Variation using MVA Approach
Yang Wu - Scientist II, Macrogenics
8:00am - 8:30am
Lets get moving PT session
Lets get moving PT session
11:40am - 12:00pm
Introducing the Nodexus NX One: the Easiest-to-Use, Lowest-Cost Single-Cell Sorting and Dispensing Platform
Introducing the Nodexus NX One: the Easiest-to-Use, Lowest-Cost Single-Cell Sorting and Dispensing Platform
Karthik Balakrishnan - CEO, Nodexus Inc
11:30am - 11:50am
Implementation of “off the shelf” Closed Systems fit for every purpose
Implementation of “off the shelf” Closed Systems fit for every purpose
Ali Mohamed - VP, CMC, Immatics, USA
2:00pm - 2:45pm
Live speaker Q&A
Live speaker Q&A
Joshua Horvath - Director, Early Stage Devices and Human Factors Engineering, Genentech
11:00am - 11:40am
What does precision medicine actually mean and how can AI and ML impact it? (available On Demand)
What does precision medicine actually mean and how can AI and ML impact it? (available On Demand)
2:20pm - 2:40pm
Emerging Fields Of Drug Therapies And Their Commercial Scale Production Challenges
Emerging Fields Of Drug Therapies And Their Commercial Scale Production Challenges
2:20pm - 2:40pm
Rapid Release of TOX Material from Pilot Plant in < 3 days
Rapid Release of TOX Material from Pilot Plant in < 3 days
Joe Sexton - Principal Technical Specialist, Genentech
2:50pm - 3:20pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
Baochuan Huang - Senior Director, Cell Culture Development & Manufacturing, Kiniksa Pharmaceuticals
Aaron Mack - Engineer III, Biogen
Kathryn Aron, Ph.D. - Group Leader, Cell Culture Process Development, Bristol-Myers Squibb
10:50am - 11:20am
De-risking partnerships – Best practices to working with start-ups, pharma, and novel technologies (available On Demand)
De-risking partnerships – Best practices to working with start-ups, pharma, and novel technologies (available On Demand)
9:30am - 10:15am
Master Class A, part 2: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
Master Class A, part 2: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
7:30am - 7:50am
The Case for rAAV Titration by HPLC
The Case for rAAV Titration by HPLC
Franz Schnetzinger - Director Analytical Development, Gyroscope Therapeutics
1:50pm - 2:10pm
Case Studies and Process Concepts for Continuous Chromatography
Case Studies and Process Concepts for Continuous Chromatography
Thomas Müller-Späth, PhD - Director, R&D Life Science Systems, ChromaCon AG, Switzerland
7:30am - 7:50am
Next Generation Cell Line Development & Large-Scale Bioprocessing Technology
Next Generation Cell Line Development & Large-Scale Bioprocessing Technology
Sam Wadsworth - Chief Scientific Officer, Ultragenyx Gene Therapy
2:00am - 2:20am
Early stage funding trends in Europe
Early stage funding trends in Europe
12:40am - 1:00am
Enabling the industrialization of cell and gene therapies through process development and platforms for commercial readiness
Enabling the industrialization of cell and gene therapies through process development and platforms for commercial readiness
Hartmut Tintrup - Global Head of Business Development for CGT, Lonza Pharma & Biotech
12:35am - 1:05am
Systematic Approaches for Improved AAV expression cassette design
Systematic Approaches for Improved AAV expression cassette design
Michael Roberts - Chief Technology Officer (Europe), Asklepios BioPharmaceutical, Inc.
10:30am - 10:50am
AI and genomic approaches to diagnostics in the rare-disease space (Available On Demand)
AI and genomic approaches to diagnostics in the rare-disease space (Available On Demand)
Sebastien Lefebvre - Senior Director - Data Sciences, Genomics and Bioinformatics, Alexion
2:00pm - 2:20pm
Implementing High-throughput and Automated Clonal Evaluation
Implementing High-throughput and Automated Clonal Evaluation
Jishna Ganguly - Associate Research Scientist, GSK
11:20am - 11:40am
Understanding and Mitigation of Polysorbate Hydrolysis by CHO Enzymes
Understanding and Mitigation of Polysorbate Hydrolysis by CHO Enzymes
Troii Hall, M.S. - Associate Consultant Chemist, Bioprocess Research & Development, Eli Lilly and Company
2:15pm - 3:00pm
Explore Effective Approaches for an Executive Level Search
Explore Effective Approaches for an Executive Level Search
Stephanie Angelini - Senior Vice President, Human Resources, BioCryst Pharmaceuticals
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
8:30am - 9:00am
Exhibtion Viewing Time & Networking Breakfast
Exhibtion Viewing Time & Networking Breakfast
11:30am - 11:50am
Mechanistic Understanding of Recombinant Adeno – Associated Virus Production
Mechanistic Understanding of Recombinant Adeno – Associated Virus Production
Sha Sha - Postdoc, Massachusetts Institute of Technology
10:00am - 11:30am
Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
12:50pm - 1:20pm
Intensified Upstream Processing - Scalability and Implementation of Integrated PAT from Process Development to Manufacturing
Intensified Upstream Processing - Scalability and Implementation of Integrated PAT from Process Development to Manufacturing
Melisa Carpio - Global Technology Consultant, Sartorius Stedim Biotech
3:20pm - 3:40pm
A Case Study in Applying PAT to the Continuous Biomanufacturing of Monoclonal Antibodies
A Case Study in Applying PAT to the Continuous Biomanufacturing of Monoclonal Antibodies
Moo Sun Hong - Postdoc, MIT
7:50am - 8:15am
The Importance of High Quality Raw Materials for Developing your Cell or Gene-Modified Cell Therapy: A Master Cell Bank Case Study
The Importance of High Quality Raw Materials for Developing your Cell or Gene-Modified Cell Therapy: A Master Cell Bank Case Study
Benjamin Fryer - Founder, Pluristyx, Incorporated, USA
12:15pm - 1:00pm
Networking Reception
Networking Reception
1:40pm - 2:00pm
Advancing towards clinical use of innovative dual chamber technology to deliver cutting-edge therapies treating immune-mediated disorders (available On Demand)
Advancing towards clinical use of innovative dual chamber technology to deliver cutting-edge therapies treating immune-mediated disorders (available On Demand)
12:30pm - 1:00pm
Keynote Address: Innovating Beyond Reason
Keynote
Keynote Address: Innovating Beyond Reason
8:20am - 8:50am
Large scale vector production for AAV-based gene therapies
Large scale vector production for AAV-based gene therapies
Sylvain Cecchini - Associate Professor of Microbiology & Physiological Systems, University of Massachusetts Medical School, USA
9:10am - 9:20am
Opening Remarks from the Chairperson
Opening Remarks from the Chairperson
Nick Timmins - VP Cell Technologies and Entrepreneur in Residence, ArtisanBio, USA
12:20am - 12:40am
Building Consumer Healthcare (OTC) Brands with Novel Drug Delivery in 2020
Building Consumer Healthcare (OTC) Brands with Novel Drug Delivery in 2020
11:40am - 12:00pm
Synthesis and Purification Opportunities for mRNA-Based Therapeutics
Synthesis and Purification Opportunities for mRNA-Based Therapeutics
Lucia Lapazio - R&D Biologics Development, Process Purification Development, Sanofi
12:30pm - 12:50pm
Single-use system design for cGMP Cryogenic Operations
Single-use system design for cGMP Cryogenic Operations
Ross Acucena - Applications Director, Entegris LifeScience
11:25am - 11:50am
Novel Bioreactor System for Fabrication of Musculoskeletal Tissues
Novel Bioreactor System for Fabrication of Musculoskeletal Tissues
Lisa Larkin - Professor, Molecular & Integrative Physiology Professor, Biomedical Engineering, University of Michigan, USA
3:40pm - 4:00pm
Orchestrating Bioprocess in Present Manufacturing Facilities
Orchestrating Bioprocess in Present Manufacturing Facilities
Aniruddha Bose, MBA - Global Product Manager, MilliporeSigma
12:30pm - 12:50pm
Configurable, single-use TFF systems for rapid bioprocessing
Configurable, single-use TFF systems for rapid bioprocessing
David Serway - Global Director, TFF Systems and ProConnex Technology, Repligen
2:00am - 2:20am
Innovative Closed Process CAR-T Cell Therapy Platform to Streamline Approach for Manufacturing with Great Predictability
Innovative Closed Process CAR-T Cell Therapy Platform to Streamline Approach for Manufacturing with Great Predictability
Tatiana Golovina - Senior Director, Cell Therapy Process Development, WuXi Advanced Therapies, USA
3:00am - 3:30am
PANEL DISCUSSION: Spinning out from Academia and Ensuring early stage success
PANEL DISCUSSION: Spinning out from Academia and Ensuring early stage success
Elizabeth Schwarzbach - CBO, New York Stem Cell Foundation
Carlton Anderson - COO, Ambulero
Donna Rill - Chief Technology Officer, Triumvira Immunologics
12:00am - 12:20am
Drug discovery models to prioritize pathways and targets for Parkinson’s disease
Drug discovery models to prioritize pathways and targets for Parkinson’s disease
12:00pm - 12:20pm
Building a high confidence image-based clonality workflow. Is 99% clonal assurance good enough?
Building a high confidence image-based clonality workflow. Is 99% clonal assurance good enough?
Mark Stockdale - Amalgamator of Business and Biology, Solentim
3:40pm - 4:00pm
Capture of CH1-containing bispecific antibodies: An alternative to Protein A
Capture of CH1-containing bispecific antibodies: An alternative to Protein A
Steven Chamow - President, Chamow & Associates, Inc.
9:30am - 9:50am
Scalable Manufacture Platform of Human iPS-NK Cells for Off-the-Shelf Cell Therapies
Scalable Manufacture Platform of Human iPS-NK Cells for Off-the-Shelf Cell Therapies
Allen Feng - Chief Scientific Officer, HebeCell Corp., USA
11:20am - 11:40am
Polysorbate 20 As An Effective Mobile Phase Modifier in Size Exclusion Chromatography
Polysorbate 20 As An Effective Mobile Phase Modifier in Size Exclusion Chromatography
Andrew Holloway - Senior Research Associate, Seattle Genetics
11:50am - 12:15pm
Speaker Q&A - Process Development Considerations & Strategies
Speaker Q&A - Process Development Considerations & Strategies
Jon A. Rowley, Ph.D. - Founder & Chief Product Officer, RoosterBio Inc.
Erica Brust - Senior Process Engineer, Juno Therapeutics Inc., USA
Rachel Yost - Senior Process Engineer, Juno Therapeutics Inc.
Margarida Serra - Head of Stem Cell Bioengineering Lab, iBET - Instituto de Biologia Experimental e Tecnológica
11:00am - 11:40am
Networking Break
Networking Break
11:20am - 11:40am
Overcoming the Challenges of Implementing Continuous Processing
Overcoming the Challenges of Implementing Continuous Processing
Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi
11:20am - 11:40am
Overcoming the Challenges of Implementing Continuous Processing
Overcoming the Challenges of Implementing Continuous Processing
Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi
2:10pm - 2:30pm
Non Invasive PAT Techniques For Better Quality Control
Non Invasive PAT Techniques For Better Quality Control
Bruce Yu - Professor, Maryland University
2:40pm - 3:10pm
Networking Break
Networking Break
11:50am - 12:15pm
Speaker Q&A - Cell Therapy Analytics – Testing, Characterization & Validation Strategies
Speaker Q&A - Cell Therapy Analytics – Testing, Characterization & Validation Strategies
Michael Roberts - Chief Technology Officer (Europe), Asklepios BioPharmaceutical, Inc.
Qin Zou, Ph.D. - Associate Research Fellow and Group Leader, Pfizer
Jennifer L. Dashnau - Head of Analytical Development and Quality Control, Century Therapeutics, USA
12:00pm - 12:20pm
Targeted Locus Amplification (TLA) for improved clone selection, genetic characterization, clonality and genetic stability testing
Targeted Locus Amplification (TLA) for improved clone selection, genetic characterization, clonality and genetic stability testing
Martijn Kelder, PhD - Strategic Account Manager, Cergentis
12:30pm - 12:50pm
Facility-Fit Driven Development for a MAB Production Process
Facility-Fit Driven Development for a MAB Production Process
Haiou (Hio) Yang - Director, Process Development, Avid Bioservices, Inc.
12:00am - 12:20am
Closed Systems — The Solution for the Worlds Increasing Demands on CGT
Closed Systems — The Solution for the Worlds Increasing Demands on CGT
Jayanthi Grebin - Senior Business Development Manager CGT, CPC - Colder Products Company, USA
1:20pm - 1:40pm
Case Study: Creating a connected platform for pre-filled syringes while minimizing cost (available On Demand)
Case Study: Creating a connected platform for pre-filled syringes while minimizing cost (available On Demand)
2:00pm - 2:20pm
Fully Automated Platform Approach to FIH Purification Development: mAbs and Beyond
Fully Automated Platform Approach to FIH Purification Development: mAbs and Beyond
Brian Murray, PhD - Scientist, Biologics Purification Development, Sanofi
12:30am - 1:00am
Process Development Considerations for Exosomes
Process Development Considerations for Exosomes
Jon A. Rowley, Ph.D. - Founder & Chief Product Officer, RoosterBio Inc.
2:30am - 3:00am
Raw Materials: BOMs, Risks & Securing Supply
Raw Materials: BOMs, Risks & Securing Supply
Tom Walls - Global Planning and Logistics Lead, Spark Therapeutics, USA
3:20pm - 3:40pm
Fast & Efficient Downstream Process Development with Two-step Purification Platform
Fast & Efficient Downstream Process Development with Two-step Purification Platform
Beomkyu Kim, PhD - Lead Scientist, DSP Part, Samsung Biologics
3:20pm - 3:40pm
What Does Digitalization Really Mean to DS Manufacturing? A Case Study
What Does Digitalization Really Mean to DS Manufacturing? A Case Study
Bonnie Shum - Principal Engineer, Genentech
1:00pm - 1:20pm
Opening the black box: AI design for actionable and verifiable drug target prediction (available On Demand)
Opening the black box: AI design for actionable and verifiable drug target prediction (available On Demand)
Martin Akerman - Co-Founder and CTO, Envisagenics
2:00pm - 2:20pm
Metadata Analysis to Improve Efficiency and Performance of Downstream Processes
Metadata Analysis to Improve Efficiency and Performance of Downstream Processes
Leslie Wolfe, PhD - Director, Downstream Process Development, KBI Biopharma
1:50pm - 2:10pm
Upstream Raw Material Variation Monitoring and Control Strategies
Upstream Raw Material Variation Monitoring and Control Strategies
Aaron Mack - Engineer III, Biogen
7:50am - 8:15am
Break
Break
10:40am - 11:00am
CSTD Regulatory Considerations (available On Demand)
Keynote
CSTD Regulatory Considerations (available On Demand)
12:50pm - 1:20pm
Using High-Throughput Microbioreactors to Fit Raman Spectroscopy Model for Measuring Key Metabolites in Monoclonal Antibody Cell Culture Manufacturing Process
Using High-Throughput Microbioreactors to Fit Raman Spectroscopy Model for Measuring Key Metabolites in Monoclonal Antibody Cell Culture Manufacturing Process
Dan Kopec - Process Analytical Technolgy Expert, Sartorius Stedim Biotech
Michael Nelson - Senior Scientist, Merck & Co.
2:00pm - 2:20pm
Learning and challenges: Release testing and simulations for long acting parenteral products (available On Demand)
Learning and challenges: Release testing and simulations for long acting parenteral products (available On Demand)
1:50pm - 2:10pm
Guard Bands: Protecting You Against Measurement Uncertainty
Guard Bands: Protecting You Against Measurement Uncertainty
Steven Walfish - Principal Scientific Liaison, USP
12:00pm - 12:30pm
Lunch Break & Networking Lounge
Lunch Break & Networking Lounge
1:15pm - 1:35pm
Connectivity and Devices (available on demand)
Connectivity and Devices (available on demand)
3:00pm - 3:30pm
Networking and Refreshment Break
Networking and Refreshment Break
12:00am - 12:30am
Pathogen Safety Margins for Gene Therapy Manufacturing
Pathogen Safety Margins for Gene Therapy Manufacturing
Thomas Kreil - Vice President, Global Pathogen Safety, Takeda
2:00pm - 2:20pm
Implementation of Real Time, Online Monitoring Methods for Performance and Product Quality in Cell Culture Bioreactors
Implementation of Real Time, Online Monitoring Methods for Performance and Product Quality in Cell Culture Bioreactors
George Zhou, PhD - Research Fellow, Merck & Co., Inc.
1:55pm - 2:40pm
Live Speaker Q&A
Live Speaker Q&A
Arvind Rao - Associate Professor, Department of Computational Medicine & Bioinformatics, Associate Professor, Radiation Oncology, University of Michigan Medical School
8:00am - 8:20am
Delivering on the Promise of Producing Cost-Effective, High-Quality Allogeneic Immune Cell Therapies
Delivering on the Promise of Producing Cost-Effective, High-Quality Allogeneic Immune Cell Therapies
Gregory Russotti - Chief Technology Officer, Century Therapeutics LLC, USA
8:00am - 8:20am
Process Control strategies for Cell Therapy
Process Control strategies for Cell Therapy
Rachel Yost - Senior Process Engineer, Juno Therapeutics Inc.
3:00am - 3:20am
Tracking from Donor to Patient
Tracking from Donor to Patient
9:15am - 9:25am
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
Anthony Davies, Ph.D. - Founder & CEO, Dark Horse Consulting
12:00am - 12:20am
Benchtop to Bioreactor: T-cell Culture and Expansion in Chemically Defined Media
Benchtop to Bioreactor: T-cell Culture and Expansion in Chemically Defined Media
Supriya Pokkali - Sr. Scientist II, Research and Development Department, FUJIFULM Irvine Scientific, R&D (Cell & Gene Therapy), USA
11:40am - 12:00pm
Data Science and Digitalization is the Perceived Enabler for Accelerating Technology Transfer and Process Validation
Data Science and Digitalization is the Perceived Enabler for Accelerating Technology Transfer and Process Validation
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
9:10am - 9:30am
Fate Therapeutic’s Off-the-shelf, iPSC-derived CAR NK Cell Cancer Immunotherapy Programs
Fate Therapeutic’s Off-the-shelf, iPSC-derived CAR NK Cell Cancer Immunotherapy Programs
Betsy Rezner - Director, Process & Assay Development, Fate Therapeutics Inc.
10:25am - 10:30am
Welcome Address
Welcome Address
3:40pm - 4:00pm
Enabling vaccine and viral vector self sufficiency with modular manufacturing
Enabling vaccine and viral vector self sufficiency with modular manufacturing
Ellen Johnson - Enterprise Solutions Technology Leader, Cytiva
12:30pm - 12:50pm
Achieve Higher LV and AAV Titers to Increase Capacity for Cell and Gene Therapy Manufacturing
Achieve Higher LV and AAV Titers to Increase Capacity for Cell and Gene Therapy Manufacturing
Leisha Kopp - Applications Scientist, Mirus Bio LLC
12:20pm - 12:40pm
Live Q&A
Live Q&A
10:30am - 10:50am
Keynote: What will AI actually solve in the next 5–10 years? (available on Demand)
Keynote
Keynote: What will AI actually solve in the next 5–10 years? (available on Demand)
2:20pm - 2:40pm
Single-Use Assembly Standardization: innovative approaches to enable standardization
Single-Use Assembly Standardization: innovative approaches to enable standardization
Hana Sheikh - Senior Engineer, Roche-Genentech
1:50pm - 2:10pm
Case Study from Biogen: Manufacturing Intelligence and Control Strategies
Case Study from Biogen: Manufacturing Intelligence and Control Strategies
Rob Guenard, PhD - Senior Director, Global Manufacturing Science, Biogen
11:20am - 11:40am
Cell Line Development: A Case Study from Merck
Cell Line Development: A Case Study from Merck
Bo Jiang, PhD - Principal Scientist, Merck Biologics Process R&D
2:30pm - 2:50pm
The Biocontinuum™ Seed Train Platform: Driving Value and Innovation toward the Evolution of Upstream Processes
The Biocontinuum™ Seed Train Platform: Driving Value and Innovation toward the Evolution of Upstream Processes
Habib Horry - Associate Director of Marketing, Upstream Solutions, MilliporeSigma
11:40am - 12:00pm
Manufacturing in the Industry 4.0 Era: How to Balance Innovation with Performance while not Being Disrupted
Manufacturing in the Industry 4.0 Era: How to Balance Innovation with Performance while not Being Disrupted
Christos Varsakelis - Senior Manager Global Data Analytics & Innovation, GSK Vaccines
11:00am - 11:20am
Scaffold Fabrication
Scaffold Fabrication
Michael Francis - Chief Scientific Officer - Co-Founder, Embody, Faculty at EVMS
9:00am - 9:10am
Opening Remarks from the Chairperson
Opening Remarks from the Chairperson
Miguel Forte - CEO, Bone Therapeutics, Belgium
11:50am - 12:15pm
Speaker Q&A - Cryopreservation & Vein-to-vein and Downstream Considerations
Speaker Q&A - Cryopreservation & Vein-to-vein and Downstream Considerations
Donald Singer - Consultant, formerly, GSK Senior Fellow, Microbiology, Biopharmaceutical GMP Operations, USA
Jason Acker - Professor, Laboratory Medicine and Pathology, University of Alberta, Canada
David McKenna - Professor and American Red Cross Chair in Transfusion Medicine, Department of Laboratory Medicine and Pathology, University of Minnesota
Sarah Nikiforow - Asst. Professor, Stem Cell Transplantation Program, Asst. Medical Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute
2:10pm - 2:30pm
Paving the Way for Real time Product Quality Attribute Monitoring in Biologics Development
Paving the Way for Real time Product Quality Attribute Monitoring in Biologics Development
Dhanuka Wasalathanthri - Senior Scientist, Bristol Myers Squibb
3:20am - 3:50am
Fresh vs. Cryopreserved: Tightening up Supply Chains
Fresh vs. Cryopreserved: Tightening up Supply Chains
Jason Acker - Professor, Laboratory Medicine and Pathology, University of Alberta, Canada
11:30am - 11:50am
Risk-Based Approaches for Autologous CAR T-Cell Therapy Comparability
Risk-Based Approaches for Autologous CAR T-Cell Therapy Comparability
Erica Brust - Senior Process Engineer, Juno Therapeutics Inc., USA
7:50am - 8:15am
Speaker Q&A - High Throughput Applications in Production Platforms & Enabling Manufacturing Tech
Speaker Q&A - High Throughput Applications in Production Platforms & Enabling Manufacturing Tech
Sam Wadsworth - Chief Scientific Officer, Ultragenyx Gene Therapy
Thomas Kreil - Vice President, Global Pathogen Safety, Takeda
Rachel Legmann - Director, Gene Therapy & Viral Vectors, Pall Corporation
Jayanthi Grebin - Senior Business Development Manager CGT, CPC - Colder Products Company, USA
3:40pm - 4:00pm
Expediting Viral Vector Vaccines Development in a Pandemic Situation
Expediting Viral Vector Vaccines Development in a Pandemic Situation
Amelie Boulais - Head of Market Entry Strategy Viral-based Therapeutics, Sartorius Stedim Biotech
1:30pm - 2:15pm
Shape Organizational Leaders through Nimble Talent Management
Shape Organizational Leaders through Nimble Talent Management
Paul Maccaro - former Executive Director, Talent Management and Leadership Development, Pacira Pharmaceuticals
12:40am - 1:00am
Manufacturing CRISPR RNPs for Clinical Applications
Manufacturing CRISPR RNPs for Clinical Applications
Nicole Kavanaugh, Ph.D - Manager, Technical Operations, Aldevron, USA
3:40pm - 4:00pm
SymphonX™ a Generic Downstream Single-Use Purification Rig for Continuous Bioprocessing
SymphonX™ a Generic Downstream Single-Use Purification Rig for Continuous Bioprocessing
Charles Heise, PhD - Senior Staff Scientist BioProcess Strategy & Development, FUJIFILM Diosynth Biotechnologies
3:40pm - 4:00pm
SymphonX™ a Generic Downstream Single-Use Purification Rig for Continuous Bioprocessing
SymphonX™ a Generic Downstream Single-Use Purification Rig for Continuous Bioprocessing
Charles Heise, PhD - Senior Staff Scientist BioProcess Strategy & Development, FUJIFILM Diosynth Biotechnologies
10:30am - 10:50am
Patient-Focused Drug Delivery - The View from biohaven pharmaceuticals (available On Demand)
Patient-Focused Drug Delivery - The View from biohaven pharmaceuticals (available On Demand)
Vlad Coric, MD - CEO and Director, Biohaven Pharmaceuticals
2:15pm - 2:45pm
To go IPO or remain private?
To go IPO or remain private?
11:45am - 12:05pm
Fireside Chat: Using AI to optimize drug selection and development (available On Demand)
Fireside Chat: Using AI to optimize drug selection and development (available On Demand)
11:50am - 12:15pm
Speaker Q&A - High Throughput Applications in Production Platforms & Enabling Manufacturing Tech
Speaker Q&A - High Throughput Applications in Production Platforms & Enabling Manufacturing Tech
Sha Sha - Postdoc, Massachusetts Institute of Technology
Nicole Nuñez, Ph.D., - Process Development Scientist, Eureka Therapeutics, Inc.
Aleš Štrancar - CEO, BIA Separations, Slovenia
2:40pm - 3:20pm
Running 96-well plates on the Cedex Bio HT Analyzer
Running 96-well plates on the Cedex Bio HT Analyzer
2:40pm - 3:20pm
Running 96-well plates on the Cedex Bio HT Analyzer
Running 96-well plates on the Cedex Bio HT Analyzer
9:10am - 10:00am
PANEL: COVID-19: Trailblazers in the CGT Industry
PANEL: COVID-19: Trailblazers in the CGT Industry
Chris Gemmiti, Ph.D. - SVP of Operations, Sentien Biotechnologies Inc.
Camillo Ricordi - Stacy Joy Goodman Professor of Surgery and Chief, Division of Cellular Transplantation, Distinguished Professor of Medicine, Professor of Biomedical Engineering, Microbiology and Immunology, Director, Diabetes Research Institute and Cell Transplant Center, University of Miami, Fellow, National Academy of Inventors, USA, Member, Italian Supreme Council of Health, USA
Racheli Ofir - Vice President Research & Intellectual Property, Pluristem Therapeutics Inc., Israel
John Lewis Ph.D. - Co-founder and CEO, Aegis Life Inc. and Entos Pharmaceuticals
Lawrence Thompson, Ph.D. - Senior Principal Scientist & Group Leader, Pfizer
Claudia Berrón - Senior Vice President, Business Development and Commercial Operations, BioPharma Production, Avantor
1:20pm - 1:40pm
Brain delivery of biologics – VIA cerebrospinal fluid (available On Demand)
Brain delivery of biologics – VIA cerebrospinal fluid (available On Demand)
2:20pm - 2:40pm
CHO Cell Engineering Targets: Reducing Cell-Cell Aggregate Formation and Insulin Degradation in Culture Media, Two Case Studies
CHO Cell Engineering Targets: Reducing Cell-Cell Aggregate Formation and Insulin Degradation in Culture Media, Two Case Studies
Shahram Misaghi, PhD - Senior Scientist, Genentech, Inc
2:00pm - 2:20pm
Transitioning from Chemistry Based Purification to Protein Based Purification for Antisense Oligonucleotides
Transitioning from Chemistry Based Purification to Protein Based Purification for Antisense Oligonucleotides
Robert Gronke, PhD - Senior Principal Scientist, Technical Development, Biogen, Inc
2:30am - 3:00am
PANEL DISCUSSION: Partnering Solutions for Staffing and Recruitment Issues in the CGT Space
PANEL DISCUSSION: Partnering Solutions for Staffing and Recruitment Issues in the CGT Space
Andrew Rigoglioso - Associate Director, Talent Acquisition, Cell Therapy Development & Operations, Bristol Myers Squibb
Jennifer Royal-Fitch - Lead Recruiter, Gene Therapy Program & The Orphan Disease Center, Univeristy of Pennsylvania
Brittany Adcock - Talent Acquisition Partner, HR Talent Strategy & Acquisition, Cell Therapy Development, Bristol Myers Squibb
11:30am - 11:50am
Product Dependent Cryopreservation Protocols
Product Dependent Cryopreservation Protocols
David McKenna - Professor and American Red Cross Chair in Transfusion Medicine, Department of Laboratory Medicine and Pathology, University of Minnesota
3:40pm - 4:00pm
Rapid Generation of Production Cell Lines with Superior Titers and >99% Monoclonality for Complex Antibody Molecules
Rapid Generation of Production Cell Lines with Superior Titers and >99% Monoclonality for Complex Antibody Molecules
Anupam Singhal, PhD - Product Manager, Antibody Therapeutics, Berkeley Lights, Inc.
2:00pm - 2:20pm
A Multi-Omics Platform to Guide Rational Process Development for Recombinant Protein Expression
A Multi-Omics Platform to Guide Rational Process Development for Recombinant Protein Expression
Yizhou Zhou, PhD - Scientist II, Protein Cell Line Development, Biogen
2:30pm - 2:50pm
A case study in the development of a robust and high-producing upstream process
A case study in the development of a robust and high-producing upstream process
Baochuan Huang - Senior Director, Cell Culture Development & Manufacturing, Kiniksa Pharmaceuticals
12:40pm - 1:40pm
Lunch Break
Lunch Break
11:40am - 12:00pm
Strategic Analytics: case studies on automation and data/knowledge management in the context of proteins
Strategic Analytics: case studies on automation and data/knowledge management in the context of proteins
Richa Sarin - Scientist, Technical Development, Biogen
10:00am - 11:00am
PANEL: Investment in the CGT space: trends, technologies and early stage success
PANEL: Investment in the CGT space: trends, technologies and early stage success
Mike Zhao - Senior Vice President, MSQ Ventures
Jak Knowles - VP Venture Investments, Head of Pharma Investments, Leaps by Bayer
Joey Mason - Head of the Life Sciences Fund, M Ventures, The Netherlands
Dominic Schmidt - Partner, Syncona Investment Management Ltd., UK
2:30pm - 2:50pm
Improved data quality and workflow efficiency for host cell protein contaminant analysis with microfluidic, automated immunoassays.
Improved data quality and workflow efficiency for host cell protein contaminant analysis with microfluidic, automated immunoassays.
Rob Durham, PhD - Director of Service and Scientific Support, Gyros Protein Technologies
4:15pm - 5:00pm
Closing Remarks & Virtual Cocktail Party
Closing Remarks & Virtual Cocktail Party
3:20pm - 3:40pm
TBD
TBD
2:00pm - 2:20pm
Manufacturing Facility Design and Operating Strategy at a Growing Biopharmaceutical Company
Manufacturing Facility Design and Operating Strategy at a Growing Biopharmaceutical Company
Craig Curless - Senior Director of Manufacturing, Macrogenics, Inc.
12:20am - 12:40am
Commercializing Gene Therapies: From Process Development to Manufacturing
Commercializing Gene Therapies: From Process Development to Manufacturing
Rachel Legmann - Director, Gene Therapy & Viral Vectors, Pall Corporation
12:40am - 1:00am
Technology innovation for cost-effective viral vector manufacturing
Technology innovation for cost-effective viral vector manufacturing
Mohammed Elfar - Production Innovation Manager, Univercells Technologies
1:40pm - 2:20pm
Session 3
Session 3
12:30pm - 12:50pm
Meeting the market needs for process intensification through the application of the right chromatography technologies
Meeting the market needs for process intensification through the application of the right chromatography technologies
David Johnson - Team Lead Chromatography Systems Product Management, Sartorius Stedim Biotech
11:00am - 11:30am
Spatially Uniform Cell Growth, pH, and Metabolite Distribution in a Fixed-Bed Bioreactor
Spatially Uniform Cell Growth, pH, and Metabolite Distribution in a Fixed-Bed Bioreactor
Michelle Olson - Senior Scientist, Bioprocess R&D, Pall Biotech, USA
2:20pm - 2:40pm
Multivariate Process Monitoring Along with PAT for Bioprocessing Manufacturing for Process Performance and Quality Attributes
Multivariate Process Monitoring Along with PAT for Bioprocessing Manufacturing for Process Performance and Quality Attributes
Denizhan Yilmaz - Senior Scientist, Sanofi
11:00am - 11:20am
Regulatory and scientific justifications for CMC Changes - Case studies of modified release products (available On Demand)
Keynote
Regulatory and scientific justifications for CMC Changes - Case studies of modified release products (available On Demand)
11:40am - 12:00pm
Bispecific Molecule Formats and Concepts for Cell Line Development
Bispecific Molecule Formats and Concepts for Cell Line Development
Valerie Schmieder - PostDoc, Boehringer Ingelheim
10:10am - 10:30am
The Potential CAR-NK
The Potential CAR-NK
Kathryn Corzo - Head of Development Oncology Cell Therapies, Takeda
12:30am - 1:00am
Development of modern biologics and cell therapy products through global CMOs
Development of modern biologics and cell therapy products through global CMOs
Vadim Klyushnichenko - VP Pharmaceutical Development and Quality, Calibr at Scripps Research
11:10am - 11:40am
AEX membrane for full AAV capsid enrichment
AEX membrane for full AAV capsid enrichment
Adam Hejmowski - Research Scientist, Pall Biotech, USA
2:20pm - 2:40pm
High-Resolution Optical and Dielectric Methods for Monitoring Cells in Bioprocesses
High-Resolution Optical and Dielectric Methods for Monitoring Cells in Bioprocesses
Michael Butler - Principal Investigator in Cell Technology, National Institute of Bioprocessing Research & Training (NIBRT), Ireland
12:30pm - 12:50pm
Innovative Spray Dryer for Thermosensitive Microorganisms.
Innovative Spray Dryer for Thermosensitive Microorganisms.
Audrey Maudhuit, PhD - Process Engineer, Fluid Air
2:20pm - 2:40pm
QX ONE Droplet Digital PCR for Cell Line Development
QX ONE Droplet Digital PCR for Cell Line Development
Brandon McKethan, PhD - Field Application Specialist, Bio-Rad Laboratories, Inc.
1:30pm - 2:15pm
Generate a Consistent Pipeline of Highly Qualified Candidates
Generate a Consistent Pipeline of Highly Qualified Candidates
Amy Lurier - Head of Talent Acquisition and People,, Triplet Therapeutics
2:10pm - 2:30pm
Continuous Formulation of High Value Biotherapeutics Using Novel Membrane Systems with Reduced Buffer Usage
Continuous Formulation of High Value Biotherapeutics Using Novel Membrane Systems with Reduced Buffer Usage
Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair and Professor of Chemical Engineering, The Pennsylvania State University
12:30pm - 12:50pm
Development of Perfusion Culture Media for mAb-Producing CHO Cells
Development of Perfusion Culture Media for mAb-Producing CHO Cells
Tom Fletcher - Scientific Director, FUJIFILM Irvine Scientific
3:30pm - 4:15pm
Drive Organizational Commitment by Leveraging Support of Senior Leaders
Drive Organizational Commitment by Leveraging Support of Senior Leaders
Marlo Manning - Vice President, Human Resources, Collegium Pharmaceutical Inc.
2:20pm - 2:40pm
Smaller and Faster – Using High Throughput PD to Develop and Qualify a Protein A Micro-Model
Smaller and Faster – Using High Throughput PD to Develop and Qualify a Protein A Micro-Model
Doug MacDonald - Principal Scientist, Seattle Genetics
11:40am - 12:00pm
Regulations For Interchangeability Studies for Biosimilars
Regulations For Interchangeability Studies for Biosimilars
12:50pm - 1:20pm
Addressing Data, Metadata and DOE Challenges in Miniaturised Purification Workflows
Addressing Data, Metadata and DOE Challenges in Miniaturised Purification Workflows
Arne Vandenbroucke, PhD - Senior Automation Engineer, Synthace, Ltd
7:50am - 8:15am
Speaker Q&A - Auto vs. Allo Manufacturing & Infrastructure
Speaker Q&A - Auto vs. Allo Manufacturing & Infrastructure
Geoffrey Hodge - Chief Technical Officer, Unum Therapeutics
Gregory Russotti - Chief Technology Officer, Century Therapeutics LLC, USA
1:00am - 1:20am
Pharma Open Innovation: Bayer’s Case Study
Pharma Open Innovation: Bayer’s Case Study
11:20am - 11:40am
EU/MDR/IVDR combination product and companion product considerations
EU/MDR/IVDR combination product and companion product considerations
11:50am - 12:15pm
Automated Cell Harvesting Isolation Technologies
Automated Cell Harvesting Isolation Technologies
Sonia Bulsara - Application Specialist Manager, US & Canada, Cell and Gene Therapy, Cytiva, USA
9:00am - 9:30am
Master Class A, part 1: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
Master Class A, part 1: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)
11:40am - 12:00pm
Advanced Real-Time Monitoring of Biologics In Continuous Perfusion Bioprocesses Using Raman Spectroscopy
Advanced Real-Time Monitoring of Biologics In Continuous Perfusion Bioprocesses Using Raman Spectroscopy
Mengyao Li - Post Doc Next Generation High-Densit,Advanced Process & Manufacturing Technology, Novartis Pharma AG
11:40am - 12:00pm
Advanced Real-Time Monitoring of Biologics In Continuous Perfusion Bioprocesses Using Raman Spectroscopy
Advanced Real-Time Monitoring of Biologics In Continuous Perfusion Bioprocesses Using Raman Spectroscopy
Mengyao Li - Post Doc Next Generation High-Densit,Advanced Process & Manufacturing Technology, Novartis Pharma AG
11:40am - 12:00pm
Continuous and Integrated Bioprocess Development for Novel Modalities
Continuous and Integrated Bioprocess Development for Novel Modalities
Ricardo Silva, PhD - Senior Scientist, Animal Cell Technology Group, iBET - Instituto de Biologia Experimental e Tecnológica, Portugal
2:00pm - 2:20pm
Introducing Techniques Which Allows for Early Clone Identification
Introducing Techniques Which Allows for Early Clone Identification
Mark Tié - Scientist, Biogen
11:50am - 12:15pm
Speaker Q&A - Auto vs. Allo Manufacturing & Infrastructure
Speaker Q&A - Auto vs. Allo Manufacturing & Infrastructure
Ali Mohamed - VP, CMC, Immatics, USA
Philip Lee - COO and Co-Founder, Senti Biosciences
Vadim Klyushnichenko - VP Pharmaceutical Development and Quality, Calibr at Scripps Research
Shyam Patel - Director Business Development, California Institute for Regenerative Medicine
10:40am - 11:00am
Live Speaker Q&A Panel
Live Speaker Q&A Panel
11:40am - 12:00pm
Polysorbate Degradation and Particle Formation in Biotherapeutics
Polysorbate Degradation and Particle Formation in Biotherapeutics
Karen Rutherford, PhD - Technical Development Sr. Scientist, Genentech
11:40am - 12:00pm
Application of Models for Advanced Biomanufacturing Towards a Digital Twin
Application of Models for Advanced Biomanufacturing Towards a Digital Twin
Marianthi Ierapetritou - Bob and Jane Gore Centennial Chair of Chemical & Biomolecular Engineering, University of Delaware
1:00am - 1:20am
Comparison of qPCR and ddPCR methods for the analysis of Residual DNA
Comparison of qPCR and ddPCR methods for the analysis of Residual DNA
Sumaya Dauleh - Senior Analyst, Intertek, UK
2:10pm - 2:30pm
Implementation of an Integrated Approach for Fingerprinting Cell Culture Media
Implementation of an Integrated Approach for Fingerprinting Cell Culture Media
Kathryn Aron, Ph.D. - Group Leader, Cell Culture Process Development, Bristol-Myers Squibb
3:45pm - 4:15pm
The Convergence of AI and Medicine
The Convergence of AI and Medicine
11:20am - 11:40am
NMR spectroscopy illuminates the path for process development of glycoconjugate vaccines
NMR spectroscopy illuminates the path for process development of glycoconjugate vaccines
Kelly Sackett - Principal Scientist, Pfizer
1:20pm - 1:40pm
AI for clinical trial design and management – failing fast (available On Demand)
AI for clinical trial design and management – failing fast (available On Demand)
11:20am - 11:40am
Artificial Intelligence, Machine Learning and Data Science: How to Utilise in Bioprocessing?
Artificial Intelligence, Machine Learning and Data Science: How to Utilise in Bioprocessing?
Michael Sokolov - COO and Co-founder, Datahow AG
1:00am - 1:20am
Standardized Viral Vector and Plasmid Manufacturing and Analytics
Standardized Viral Vector and Plasmid Manufacturing and Analytics
Jeffrey Hung - Chief Commercial Officer, Vigene Biosciences, Inc., USA
3:40pm - 4:00pm
Selection and Implementation of an Intensified Manufacturing Platform
Selection and Implementation of an Intensified Manufacturing Platform
Priyanka Gupta - Head of Market Entry Strategy, Segment Protein-based Therapeutics, Sartorius Stedim Biotech
11:20am - 11:40am
Development of a Near Real Time Bioreactor Measurement System for Glycans and Application to Model Building and Control of Product Quality Attributes
Development of a Near Real Time Bioreactor Measurement System for Glycans and Application to Model Building and Control of Product Quality Attributes
Brandon Downey - Principal Engineer, R&D, Lonza
11:15am - 12:00pm
Fireside chat: Pricing
Keynote
Fireside chat: Pricing
3:20pm - 3:40pm
Economics and Ecology: The Impact of Water Reduction in Biotechnology
Economics and Ecology: The Impact of Water Reduction in Biotechnology
Alessandro Cataldo, PhD - Economic Evaluation of Biotechnological Processes, University of Natural Resources and Life Sciences
12:20am - 12:40am
The Indiebio Accelerator Model
The Indiebio Accelerator Model
8:20am - 8:50am
Implementing Rapid Microbiological Methods for Cell and Gene Therapy
Implementing Rapid Microbiological Methods for Cell and Gene Therapy
Evonne R. Fearnot - Marketing Manager, Roche CustomBiotech, United States
Sarah Snykers - QC Manager, Celyad, Belgium
Sowmya Viswanathan - Scientist, University Health Network, Canada
2:00pm - 2:20pm
The Economics of Seed Train Intensification
The Economics of Seed Train Intensification
Jianlin (Jim) Xu, PhD - Principal Scientist, Bristol-Myers Squibb
1:00am - 1:30am
Closed, automated and controlled upstream processing for iPSC-derived cell therapies
Closed, automated and controlled upstream processing for iPSC-derived cell therapies
Mustafa Munye - Lead Scientist, Cell and Gene Therapy Catapult
3:20pm - 3:40pm
A Technical End-to-End Project Review to Ensure Commercial Viability
A Technical End-to-End Project Review to Ensure Commercial Viability
Benjamin Neunstoecklin, Ph.D. - Lead Process Engineer, Bayer
10:50am - 11:10am
Business models for AI in Drug Discovery (available On Demand)
Business models for AI in Drug Discovery (available On Demand)
12:20am - 12:40am
Targeting the morphological impact of disease
Targeting the morphological impact of disease
12:30pm - 12:50pm
Optimization of Downstream Processing: A Case Study for Enhanced Monoclonal Antibody Purification
Optimization of Downstream Processing: A Case Study for Enhanced Monoclonal Antibody Purification

An optimized downstream process is needed to efficiently manufacture and support the more than one thousand antibody therapeutics currently in clinical development.  Although technological advancements such as chromatography resins with higher binding capacities, in-line process monitoring, and digitization has improved antibody manufacturing, downstream processing is still a major bottleneck. Herein, we will present an optimized downstream purification process that utilizes a novel approach to connect unit operations such as affinity chromatography resin, viral inactivation and cation exchange polishing steps. Additionally, we demonstrate the use of novel buffers and additives for column washing and generation to increase impurity clearance in a single step to meet quality requirements while simultaneously reducing overall process time.  We have screened various buffer additives and identified few for use in affinity chromatography step that can remove at least 50% more host cell protein impurities and antibody aggregates in a single step as compared to traditional approaches. In totality, these additives utilized in conjunction with optimized purification process represents a highly efficient and advantageous approach to obtaining purified monoclonal antibodies.

Jungmin Oh - Manager - New Product Development, Avantor
12:10pm - 12:55pm
Exhibition Viewing Time & Live Labs
Exhibition Viewing Time & Live Labs
12:40am - 1:00am
The Digital Story: How Bayer is Playing It
The Digital Story: How Bayer is Playing It
1:30am - 2:00am
Starting Material Standardization for Auto and Allo Cell Therapies
Starting Material Standardization for Auto and Allo Cell Therapies
Scott Burger - Principal, Advanced Cell & Gene Therapy, USA
1:40am - 2:00am
Accelerating Viral Vector Commercialization Through Suspension Platform with Greater Predictability
Accelerating Viral Vector Commercialization Through Suspension Platform with Greater Predictability
Steve Tottey - Associate Director, Downstream Process Development, WuXi Advanced Therapies, USA
Yiyu Dong - Head Cell Line Development, WuXi Advanced Therapies, USA
8:15am - 9:00am
Exhibition Viewing Time & Live Labs
Exhibition Viewing Time & Live Labs
3:20pm - 3:40pm
Influencing Protein Production Utilizing Metabolomics and Reducing Bottlenecks
Influencing Protein Production Utilizing Metabolomics and Reducing Bottlenecks
Nathan Lewis, PhD - Associate Professor, Department of Pediatrics, University of California, San Diego
12:00pm - 12:30pm
Scientific & Technology Presentations
Scientific & Technology Presentations
12:00pm - 12:20pm
S-CHOice : Accelerated, High-Performing Cell Line Development at Samsung Biologics
S-CHOice : Accelerated, High-Performing Cell Line Development at Samsung Biologics
John Gill - Director, Cell Line Development, Samsung Biologics
9:20am - 10:05am
The role of patient advocacy groups and disease foundations in our ecosystem
The role of patient advocacy groups and disease foundations in our ecosystem
3:05am - 4:05am
Catalyzing Innovation Partnerships in a COVID-19 Era
Catalyzing Innovation Partnerships in a COVID-19 Era
3:40pm - 4:00pm
A Development Strategy for Identificaation and Improvement of Lactate Metabolism Variations
A Development Strategy for Identificaation and Improvement of Lactate Metabolism Variations
Yongho Ahn - VP, Head of CDO R&D Team, Samsung Biologics
11:20am - 11:40am
Utilizing Prior Knowledge Assessments of Process Characterization Cell Culture and Purification Operations to Accelerate FMEA Risk Assessments During Process Design
Utilizing Prior Knowledge Assessments of Process Characterization Cell Culture and Purification Operations to Accelerate FMEA Risk Assessments During Process Design
Coral Fung Shek - Process Development Associate Scientist, Amgen
3:15pm - 3:45pm
New players in the healthcare space
New players in the healthcare space
3:40pm - 4:00pm
Using Octet for High-Throughput Early Clone Selection
Using Octet for High-Throughput Early Clone Selection
Hongshan Li, PhD - Marketing Applications Manager, Sartorius
12:40pm - 1:00pm
Live Speaker Q&A Panel
Live Speaker Q&A Panel
2:20pm - 2:40pm
Control Strategy for Beta-Glucan Impurities in Downstream Processes
Control Strategy for Beta-Glucan Impurities in Downstream Processes
Mahsa Rohini, Ph.D. - Scientist, Pivotal Drug Substance, Process Development, Amgen
12:30pm - 12:50pm
COVID-19 as a Catalyst for Risk-Based Multi-Site PPQ
COVID-19 as a Catalyst for Risk-Based Multi-Site PPQ
Abel Hastings - Director of Process Sciences, FUJIFILM Diosynth Biotechnologies
2:20pm - 2:40pm
Strategic Approach for Upstream Process Development of Glycosylated Fusion Proteins
Strategic Approach for Upstream Process Development of Glycosylated Fusion Proteins
Kiran Andra - Scientist, Alexion Pharmaceuticals Inc
2:20pm - 2:40pm
Improving Product Quality Through Cell Culture Process Intensification
Improving Product Quality Through Cell Culture Process Intensification
Yan Wang - Senior Scientist, Amgen
2:20pm - 2:40pm
Improving Product Quality Through Cell Culture Process Intensification
Improving Product Quality Through Cell Culture Process Intensification
Yan Wang - Senior Scientist, Amgen
9:15am - 9:20am
Opening remarks
Opening remarks
1:00pm - 1:20pm
Building a data foundation for AI and ML applications (available On Demand)
Building a data foundation for AI and ML applications (available On Demand)
7:50am - 8:10am
Development of Modular Biofabrication Platforms for Diverse Tissue Engineering Applications
Development of Modular Biofabrication Platforms for Diverse Tissue Engineering Applications
George Joseph Christ - Professor of Biomedical Engineering and Orthopaedic Surgery, University of Virginia
10:00am - 10:20am
Impact of Surfactants on Product Stability, and its Implication on Specification
Impact of Surfactants on Product Stability, and its Implication on Specification
Weiqiang Cheng, PhD - principal scientist, Takeda
2:00pm - 2:20pm
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Anita Kundu - Senior Associate Scientist, Pfizer
2:00pm - 2:20pm
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Anita Kundu - Senior Associate Scientist, Pfizer
10:40am - 11:00am
Live Q&A
Live Q&A
2:00pm - 2:20pm
KEYNOTE ADDRESS: Automated Material Traceability in End-To-End Continuous Biomanufacturing for Batch Disposition
KEYNOTE ADDRESS: Automated Material Traceability in End-To-End Continuous Biomanufacturing for Batch Disposition
Nuno Pinto, PhD - Associate Principle Scientist, Merck & Co., Inc.
2:00pm - 2:20pm
KEYNOTE ADDRESS: Automated Material Traceability in End-To-End Continuous Biomanufacturing for Batch Disposition
KEYNOTE ADDRESS: Automated Material Traceability in End-To-End Continuous Biomanufacturing for Batch Disposition
Nuno Pinto, PhD - Associate Principle Scientist, Merck & Co., Inc.
3:20pm - 3:40pm
Closed, Automated and Controlled Upstream Processing for iPSC-derived Cell Therapies
Closed, Automated and Controlled Upstream Processing for iPSC-derived Cell Therapies
Mustafa Munye - Lead Scientist, Cell and Gene Therapy Catapult
3:40pm - 4:00pm
Accelerating Cell Culture Development through Practical Application of Innovation Technologies
Accelerating Cell Culture Development through Practical Application of Innovation Technologies
Elena Gontarz - Manager of Scientific and Technical Affairs, Thermo Fisher Scientific
12:20am - 12:40am
How to Commercially Scale T-cell Allogeneic Therapies
How to Commercially Scale T-cell Allogeneic Therapies
Jesse Trekker - Business Manager, Catalent Cell and Gene Therapy, Belgium
3:40pm - 4:00pm
Live Q&A
Live Q&A
12:30pm - 12:50pm
Novel laser-based analyzer for real-time biophysical characterization of biologics
Novel laser-based analyzer for real-time biophysical characterization of biologics
Craig Magee, PhD - Director, Business Development - Life Sciences, DRS Daylight Solutions
12:00am - 12:20am
Next-generation transfection reagent for large scale AAV manufacturing
Next-generation transfection reagent for large scale AAV manufacturing
Mathieu Porte - R&D Production Manager, Polyplus-transfection, France
8:20am - 8:50am
Speaker Q&A
Speaker Q&A
Mary Clare McCorry - Director, Technology and Process Development, Advanced Regenerative Manufacturing Institute (ARMI)
Priya Baraniak - Vice President, Corporate Development, OrganaBio
George Joseph Christ - Professor of Biomedical Engineering and Orthopaedic Surgery, University of Virginia
Lisa Larkin - Professor, Molecular & Integrative Physiology Professor, Biomedical Engineering, University of Michigan, USA
Mehmet Dokmeci - Adjunct Professors, University of California (UCLA)
Mrignayani Kotecha - Co-Founder, CEO, O2M Technologies
8:50am - 9:00am
Speaker Q&A
Speaker Q&A
11:20am - 11:40am
Applying Systems Biology Tools for Process Understanding and Improvements
Applying Systems Biology Tools for Process Understanding and Improvements
Michael Betenbaugh - Professor, Johns Hopkins University
1:50pm - 2:30pm
PANEL DISCUSSION: Working Together: How Systems & Synthetic Biology Can Combine To Improve Protein Production
PANEL DISCUSSION: Working Together: How Systems & Synthetic Biology Can Combine To Improve Protein Production
2:45pm - 3:15pm
Building your biotech from the ground up
Building your biotech from the ground up
2:20pm - 2:40pm
Developability Requiremnts for ADCs
Developability Requiremnts for ADCs
Marieke Zhao - Director, Cell Line Development, Mersana Therapeutics
1:45pm - 2:15pm
Fireside chat: The mentor/mentee relationship
Keynote
Fireside chat: The mentor/mentee relationship
1:00pm - 1:20pm
Ionic liquids for drug delivery (available On Demand)
Ionic liquids for drug delivery (available On Demand)
11:40am - 12:00pm
Strategies for Maximizing the Impact of Process Intensification – Assessing Implications of Scale & Technologies
Strategies for Maximizing the Impact of Process Intensification – Assessing Implications of Scale & Technologies
Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
11:40am - 12:00pm
Strategies for Maximizing the Impact of Process Intensification – Assessing Implications of Scale & Technologies
Strategies for Maximizing the Impact of Process Intensification – Assessing Implications of Scale & Technologies
Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
2:20pm - 2:40pm
Impact of Accelerated Products on CMC Requirements
Impact of Accelerated Products on CMC Requirements
Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
11:40am - 12:00pm
Continuous from the Ground Up? Exploring Continuous Manufacturing Approaches in Early Development
Continuous from the Ground Up? Exploring Continuous Manufacturing Approaches in Early Development
Thomas Ransohoff, MS - Chief Operating Office, 4th Dimension Bioprocess, Inc.
9:20am - 10:00am
PANEL: Strategies and Challenges in Manufacturing and Commercialization
PANEL: Strategies and Challenges in Manufacturing and Commercialization
Thomas Bollenbach - Chief Technology Officer, Advanced Regenerative Manufacturing Institute
Chris Gemmiti, Ph.D. - SVP of Operations, Sentien Biotechnologies Inc.
Kai Pinkernell - Chief Medical Officer (CMO) & Chief Development Officer, Medigene
Ger Brophy - Executive Vice President, Biopharma Production, Avantor, USA
1:30am - 2:00am
Advancing Manufacturing of hPSC-based products for cardiac cell therapy
Advancing Manufacturing of hPSC-based products for cardiac cell therapy
Margarida Serra - Head of Stem Cell Bioengineering Lab, iBET - Instituto de Biologia Experimental e Tecnológica
11:20am - 11:45am
Speaker Q&A
Speaker Q&A
Mary Clare McCorry - Director, Technology and Process Development, Advanced Regenerative Manufacturing Institute (ARMI)
Michael Francis - Chief Scientific Officer - Co-Founder, Embody, Faculty at EVMS
Benjamin Fryer - Founder, Pluristyx, Incorporated, USA
Sonia Bulsara - Application Specialist Manager, US & Canada, Cell and Gene Therapy, Cytiva, USA
Jan Jensen - CEO and Founder, Trailhead Biosystems Inc.
10:35am - 11:00am
Fireside chat: Maximizing value in an M&A
Keynote
Fireside chat: Maximizing value in an M&A
11:20am - 11:40am
Choosing the Best Clone: Quality, Speed and Diversity
Choosing the Best Clone: Quality, Speed and Diversity
12:30pm - 12:50pm
Improving Manufacturing Strategy by Closing your Process with Sterile Connectors
Improving Manufacturing Strategy by Closing your Process with Sterile Connectors
Todd Andrews - Director, Application & Business Development – Biopharma, CPC - Colder Products Company
11:20am - 11:40am
Modulating Product Quality through Process Characterization and Development
Modulating Product Quality through Process Characterization and Development
Yelena Ilin - Scientist, Sanofi
11:20am - 11:40am
Regulatory Strategies for Continuous Processing
Regulatory Strategies for Continuous Processing
11:20am - 11:40am
Regulatory Strategies for Continuous Processing
Regulatory Strategies for Continuous Processing
3:20pm - 3:40pm
Raman Spectroscopy for Process Monitoring and Lessons Learned in Development & Manufacturing
Raman Spectroscopy for Process Monitoring and Lessons Learned in Development & Manufacturing
Nobel Vale - Research Scientist II, Bristol-Myers Squibb
12:05pm - 12:25pm
Conversational AI and Voice Assistance (available On Demand)
Conversational AI and Voice Assistance (available On Demand)
2:00pm - 2:20pm
Developability: Analytical Platform Approaches for Complex Proteins
Developability: Analytical Platform Approaches for Complex Proteins
Sarah Auclair - Scientist, Sanofi
11:40am - 12:00pm
Use of Developability Assessments in a MID-SIZE Biotech Company
Use of Developability Assessments in a MID-SIZE Biotech Company
David Kahn, Ph.D. - Vice President, Biopharmaceutical Development, Macrogenics
1:00am - 1:30am
Feedback from the Industry Alliance Partnership (IAP) & CIRM Partnership and Commercialization Opportunities
Feedback from the Industry Alliance Partnership (IAP) & CIRM Partnership and Commercialization Opportunities
Shyam Patel - Director Business Development, California Institute for Regenerative Medicine
10:05am - 10:55am
PANEL: Reimbursement Models for Novel Therapies
PANEL: Reimbursement Models for Novel Therapies
Frank Zhang - Head of Market Access, uniQure
Lisa Deschamps - SVP, Chief Business Officer, Novartis Gene Therapies
Phillip D. Carter - , Biopharma Executive
Shefali Shah - Independent Consultant, Shefali Shah Consulting, LLC
Sunil Karnawat - Vice President of Marketing & Sales, Ultragenyx Pharmaceutical
3:40pm - 4:00pm
Riffyn Nexus: A Digital Backbone for Process Development & Tech Transfer
Riffyn Nexus: A Digital Backbone for Process Development & Tech Transfer
Loren Perelman, PhD - Vice President of Scientific Solutions, Riffyn
11:15am - 11:25am
Q&A
Q&A
7:30am - 7:50am
Data Governance and Data Integrity as a framework during Process Development
Data Governance and Data Integrity as a framework during Process Development
Sara Levy - CSV & Data integrity Manager, Pluristem Therapeutics Inc.
9:00am - 9:10am
Coffee Break & Exhibition Viewing Time
Coffee Break & Exhibition Viewing Time
1:20am - 1:40am
Bayer's LEAPS
Bayer's LEAPS
9:00am - 9:15am
Registration & Networking Lounge Open
Registration & Networking Lounge Open
10:45am - 10:50am
Welcome Address
Welcome Address
10:55am - 11:05am
Could we go paperless for cell therapy manufacturing? Vanderbilt adopts Chronicle software
Could we go paperless for cell therapy manufacturing? Vanderbilt adopts Chronicle software
Scott Sobecki - Director, Research Informatics, Vanderbilt University Medical Center, USA
12:20pm - 12:40pm
Aseptic Filling for Gene Therapies and Next-Generation Biologics with Closed Robotic Workcells
Aseptic Filling for Gene Therapies and Next-Generation Biologics with Closed Robotic Workcells
Thomas Page, PhD - VP, Engineering and Asset Development, Fujifilm Diosynth Biotechnologies Texas
10:40am - 11:10am
Meeting Demand for Vaccine and Gene Therapy Large Scale Manufacturing
Meeting Demand for Vaccine and Gene Therapy Large Scale Manufacturing
Elie Hanania - Director, Upstream Process Development, Fujifilm Diosynth, USA
2:00pm - 2:20pm
KEYNOTE ADDRESS: Progress Towards Achieving Single-Cycle Process Development
KEYNOTE ADDRESS: Progress Towards Achieving Single-Cycle Process Development
Randal Bass, Ph.D. - Vice President of Process Design, Just - Evotec Biologics
3:20pm - 3:40pm
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
3:20pm - 3:40pm
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
3:20pm - 3:40pm
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
3:20pm - 3:40pm
Streamlining Product Quality Attributes Characterization Using Ion Exchange Chromatography Coupled to Native Mass Spectrometry
Streamlining Product Quality Attributes Characterization Using Ion Exchange Chromatography Coupled to Native Mass Spectrometry
Leah Wang - Principal Scientist, Pfizer
2:20am - 3:05am
Fostering diversity in and through biotech investment
Fostering diversity in and through biotech investment
2:00am - 2:30am
Manufacturing and quality control of cell therapies
Manufacturing and quality control of cell therapies
Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, Bioprocessing Technology Institute
2:20pm - 2:40pm
Assessing Environmental Impact Through Process Data Mining
Assessing Environmental Impact Through Process Data Mining
Kristi Budzinski - Principal Product Stewardship Program Manager, Genentech
2:00pm - 2:05pm
End of Workshop
End of Workshop
3:20pm - 3:40pm
Rapid Manufacturing Platform for Biologics
Rapid Manufacturing Platform for Biologics
Yves Durocher, PhD - Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada
11:40am - 12:00pm
Microchip electrophoresis with high pressure mass spectrometry detection for at-line nutrient monitoring
Microchip electrophoresis with high pressure mass spectrometry detection for at-line nutrient monitoring
Seth Madren - Scientist II, Biogen
1:35am - 1:55am
Successful Gene Therapy Manufacturing and Commercialization - A Round Table Discussion
Successful Gene Therapy Manufacturing and Commercialization - A Round Table Discussion
Brandy Sargent - Editor, Cell Culture Dish, USA
Clive Glover - Director, Strategy Cell & Gene Therapy, Pall, United Kingdom
Tony Hitchcock - Technical Director, Cobra Biologics
Jane Barlow - MD, MPH, MBA, Jane Barlow & Associates, LLC , USA
Tracy TreDenick-Fricke - Head of Regulatory and Quality, BioTechLogic, USA
Mani Krishnan - VP & GM Biopharma & Ce Business Unit, Sciex, USA
12:50pm - 1:20pm
Key challenges and potential solutions for eliminating bottlenecks and optimizing biopharma downstream processes
Key challenges and potential solutions for eliminating bottlenecks and optimizing biopharma downstream processes
Christiane Schwittay - Director, Strategic Marketing Biopharma Production, Avantor
4:15pm - 5:00pm
Strategize for Clear Succession Planning by Nurturing Top Talent
Strategize for Clear Succession Planning by Nurturing Top Talent
Lara Martinez Gonzalez - Head of Talent Strategy and Design, Alexion Pharmaceuticals
Ryan Dixon - Director of Talent Management, Organization Performance and Culture, Biogen
11:30am - 11:50am
Emerging upstream bioprocessing and analytical tools for vector manufacture
Emerging upstream bioprocessing and analytical tools for vector manufacture
Michael J. DiBiasio-White, Sr. - Sr. Scientist: BioProcess Development/Protein Sciences, Ring Therapeutics
12:30am - 12:35am
Exposing the Content of Different AAV Fractions after Ultracentrifugation
Exposing the Content of Different AAV Fractions after Ultracentrifugation
David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
8:50am - 9:10am
Coffee Break & Exhibition Viewing Time
Coffee Break & Exhibition Viewing Time
7:50am - 8:15am
Speaker Q&A - Cell Therapy Analytics – Testing, Characterization & Validation Strategies
Speaker Q&A - Cell Therapy Analytics – Testing, Characterization & Validation Strategies
Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, Bioprocessing Technology Institute
Lara Ionescu Silverman - Senior Director, Research and Development, DiscGenics
Barrett J. Nehila - Associate Director, Analytical Development, Torque Therapeutics
12:00am - 12:20am
Many Shots on Goal: Evotec’s Business Model
Many Shots on Goal: Evotec’s Business Model
2:40pm - 3:20pm
Networking Forum and Exhibitor “Meet and Greet”
Networking Forum and Exhibitor “Meet and Greet”
2:40pm - 3:20pm
Networking Forum and Exhibitor “Meet and Greet”
Networking Forum and Exhibitor “Meet and Greet”
2:40pm - 3:20pm
Networking Forum and Exhibitor “Meet and Greet”
Networking Forum and Exhibitor “Meet and Greet”
2:40pm - 3:20pm
Networking Forum and Exhibitor “Meet and Greet”
Networking Forum and Exhibitor “Meet and Greet”
2:40pm - 3:20pm
Networking Forum and Exhibitor “Meet and Greet”
Networking Forum and Exhibitor “Meet and Greet”
2:40pm - 3:20pm
Networking Forum and Exhibitor “Meet and Greet”
Networking Forum and Exhibitor “Meet and Greet”
2:40pm - 3:20pm
Networking Forum and Exhibitor “Meet and Greet”
Networking Forum and Exhibitor “Meet and Greet”
11:35am - 11:55am
Pandemic prevention through gene therapy delivery (available On Demand)
Pandemic prevention through gene therapy delivery (available On Demand)
11:40am - 12:00pm
Key Considerations in Formulation and Drug Product Development for Gene Therapy
Key Considerations in Formulation and Drug Product Development for Gene Therapy
Rafi Mohammed - Staff Development Scientist, Bayer U.S. LLC Pharmaceuticals
1:20pm - 1:55pm
Responsible AI and machine learning for drug discovery and development (available On Demand)
Responsible AI and machine learning for drug discovery and development (available On Demand)
12:00am - 1:00am
BioPharm America Startup Pitch Competition
BioPharm America Startup Pitch Competition
2:20pm - 2:40pm
Early Engineering and Formulation Approaches to Improve Physicochemical Stability of Therapeutic Peptides
Early Engineering and Formulation Approaches to Improve Physicochemical Stability of Therapeutic Peptides
Lin Zhang, Ph.D. - Research Scientist, BioTechnology Discovery Research, Eli Lilly and Company
7:50am - 8:15am
Speaker Q&A - Cell Therapy Process Development
Speaker Q&A - Cell Therapy Process Development
Lior Raviv - Vice President, Pluristem Therapeutics Inc.
Sara Levy - CSV & Data integrity Manager, Pluristem Therapeutics Inc.
Mustafa Munye - Lead Scientist, Cell and Gene Therapy Catapult
11:20am - 11:40am
Exploring the Linkage Between Cell Culture Process Parameters and Downstream Processing Utilizing a Placket-Burman Design for a Model Monoclonal Antibody
Exploring the Linkage Between Cell Culture Process Parameters and Downstream Processing Utilizing a Placket-Burman Design for a Model Monoclonal Antibody
Kurt Brorson, PhD - Vice President, Technical, Parexel International
2:15pm - 3:00pm
LIVE: Master Class B, part 3: Negotiation for drug delivery innovation
LIVE: Master Class B, part 3: Negotiation for drug delivery innovation
1:00pm - 1:45pm
Diversity and inclusion: Cultivating the next generation of biotech execs
Diversity and inclusion: Cultivating the next generation of biotech execs
10:00am - 10:40am
Session 1
Session 1
12:30pm - 12:50pm
2.5X Lentiviral Vector Bioreactor Yield Increase and Simplified Execution with Innovative Tangential Flow Depth Filtration
2.5X Lentiviral Vector Bioreactor Yield Increase and Simplified Execution with Innovative Tangential Flow Depth Filtration
Michael Bransby - Director of Process Technology, Repligen
7:30am - 7:50am
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Lara Ionescu Silverman - Senior Director, Research and Development, DiscGenics
11:10am - 11:40am
Innovations in drug delivery that are shaping the future of drug product science and manufacturing (available On Demand)
Innovations in drug delivery that are shaping the future of drug product science and manufacturing (available On Demand)
12:20pm - 12:50pm
Live Speakers Discussion Forum
Live Speakers Discussion Forum
12:00pm - 12:30pm
Live Speaker Q&A
Live Speaker Q&A
John Reynders - Chief Data Scientist, Reynders Consulting
2:30pm - 3:15pm
Live Speaker Q&A
Live Speaker Q&A
11:30am - 11:50am
Augmenting Automated Analytics for Cell & Gene Therapy Manufacture
Augmenting Automated Analytics for Cell & Gene Therapy Manufacture
Veeren Chauhan - Nottingham Research Fellow in Bio-inspired Therapeutics in the Advanced Materials & Healthcare Technologies, University of Nottingham
1:40am - 2:00am
VCs and early stage funding
VCs and early stage funding
11:20am - 11:40am
Intensified Seed Train Expansion
Intensified Seed Train Expansion
Luis Fernando Ayala Solares - Scientist, Life Science, Upstream R&D, Merck KGaA
BioPharm America - AI Applications for Drug Discovery Development
12:00am - 12:20am
Drug discovery models to prioritize pathways and targets for Parkinson’s disease

• Discuss attempted methods for generative chemistry and virtual screening
•  Implementation of data mining techniques to identify alternative indications for drugs in pipeline

Andy Lee - COO, Vincere Biosciences
12:20am - 12:40am
Targeting the morphological impact of disease
Marzieh Haghighi - Postdoctoral Associate, Broad Institute of Harvard and MIT
10:30am - 10:50am
What are the big questions AI can help answer and what's holding us back? (available On Demand)

- Provide examples of opportunities for AI in pharma/biotech
- Share the challenges that Pfizer and industry are facing in adopting AI
- Discuss strategies for moving forward and transforming R&D

Peter Henstock - Machine Learning and AI Technical Lead, Pfizer; and Lecturer, Harvard University
10:30am - 10:50am
AI and genomic approaches to diagnostics in the rare-disease space (Available On Demand)
Sebastien Lefebvre - Senior Director - Data Sciences, Genomics and Bioinformatics, Alexion
10:30am - 10:50am
Keynote
Keynote: What will AI actually solve in the next 5–10 years? (available on Demand)
  • Landscape, regulatory and business overview
  • High-level summary of use cases 
  • Where should investment be made and what could be the best strategic decisions?
Emir Roach - Global Head of Emerging Technologies and Digital Health Partnerships, Takeda
10:50am - 11:10am
Business models for AI in Drug Discovery (available On Demand)

• Focus on discovery for many to build IP and attract investment – is this where the economic payoff is?

•What is the best model to use? Develop a platform, or develop a pipeline?

•Financing and Investor Models

•How do traditional pharma position themselves vs. the new emerging companies getting into the healthcare space?

•Where do small companies vs. larger companies focus energies?

•What partnerships are the most valuable?


Ed Addison - CEO, Cloud Pharmaceuticals
11:00am - 11:40am
What does precision medicine actually mean and how can AI and ML impact it? (available On Demand)

Precision medicine promises more efficacious therapeutics and more cost-efficient R&D. Join this session as panelists discuss:

- What does precision medicine translate to in the R&D process?

- How is AI and ML relevant, even essential, to this evolution of R&D?

- What is working well and what can we look forward to?

- Where are the bottlenecks and what are solutions?


Monique Levy - Formerly Chief Strategy Officer, BlackThorn Therapeutics, USA
Colin Hill - Chairman, CEO and Co-Founder, GNS Healthcare
Renee Deehan - VP Computational Biology, Quartz Bio
Tanya Wallace - Head of Biology, Blackthorn Therapeutics
11:30am - 12:00pm
Privacy: Data and consent in the drug development lifecycle – Regulatory compliance and ethics frameworks in the application of AI and ML (available On Demand)

•HIPAA Compliance – what will this involve/mean moving forward?
•Patient consent as linked to data privacy
•Data sharing
•Include representatives from: Integrated healthcare delivery systems, insurance, privacy, and pharma

Kathleen Snyder - Technology Transactions Group, Wilson Sonsini Goodrich & Rosati, USA
Kevin Hua - Senior Manager, AI/Data Mining Development, Bayer
Faisal Khan - Executive Director, Advanced Analytics and Artificial Intelligence, AstraZeneca
11:45am - 12:05pm
Fireside Chat: Using AI to optimize drug selection and development (available On Demand)
  • Predictive drug efficacy 
  • Radiology & image recognition 
  • Remove subjectivity from trial data
John Vandermosten - Senior Biotechnology Analyst, Zacks Investment Research
Panna Sharma - CEO, Lantern Pharma
12:00pm - 12:30pm
Live Speaker Q&A

Join program participants and other attendees for a moderated Q&A session.

John Reynders - Chief Data Scientist, Reynders Consulting
12:05pm - 12:25pm
Conversational AI and Voice Assistance (available On Demand)
  • Overview of conversational AI
  • General statistics on the usage of voice assistants and their growth globally
  • Developing the concept of the digital trial concierge
  • Practical considerations
  • What’s next: platform integration, higher levels of interaction



Stephen Ruhmel - Associate Director, Janssen Clinical Innovation, Johnson & Johnson
Timothy Chen - Mobile Health Director, Medidata
1:00pm - 1:20pm
Opening the black box: AI design for actionable and verifiable drug target prediction (available On Demand)

•How are people validating the decisions made by AI?
•If we can provide better experimentally validated targets – will drug discovery become more valuable?
•Would better validation lead to re-risking the development process?

Martin Akerman - Co-Founder and CTO, Envisagenics
1:00pm - 1:20pm
Building a data foundation for AI and ML applications (available On Demand)
  • How a strategy/foundation can be built to enable AI
  • What can be built to determine models needed
  • What data can drive
Patrick Combes - WW Technical Leader - Healthcare & Life Sciences, Amazon Web Services
1:20pm - 1:40pm
AI for clinical trial design and management – failing fast (available On Demand)

•Can the central dogma of clinical trials be challenged?

•How can the clinical trials process be made more efficient? Overcoming barriers and enabling better outcomes

•Using RWE to leverage trial design and predict outcomes

•Clinical trial models, i.e., Hybrid, etc.


Colin Hill - Chairman, CEO and Co-Founder, GNS Healthcare
1:20pm - 1:55pm
Responsible AI and machine learning for drug discovery and development (available On Demand)
  • What credibility and assessments for an AI system
  • Data exploration as it feeds into AI and Machine Learning systems
  • Oversight of the data, algorithms and overall systems
Arvind Rao - Associate Professor, Department of Computational Medicine & Bioinformatics, Associate Professor, Radiation Oncology, University of Michigan Medical School
Nirmal Keshava - VP, Data Analytics and Innovation Science, Cerevel Therapeutics
Ashwini Ghogare - Manager, AI-Enabled Drug Discovery, Global Strategy Group, MilliporeSigma
Abe Heifets - CEO and Co-Founder, Atomwise
1:40pm - 2:25pm
Live Speaker Q&A

Join Speakers from the AI Applications For Drug Discovery and Development track for a live in person Q&A session. Use this opportunity to connect with program participants as well as other attendees.

Monique Levy - Formerly Chief Strategy Officer, BlackThorn Therapeutics, USA
1:55pm - 2:40pm
Live Speaker Q&A

Join this live session to connect with program participants and other attendees

Arvind Rao - Associate Professor, Department of Computational Medicine & Bioinformatics, Associate Professor, Radiation Oncology, University of Michigan Medical School
BioPharm America - Drug Delivery Partnerships 1
12:00am - 12:20am
What will it take to succeed in drug delivery - A look into what's coming
Cornell Stamoran - VP, Corporate Strategy, Catalent Pharma Solutions
12:20am - 12:40am
Building Consumer Healthcare (OTC) Brands with Novel Drug Delivery in 2020
Bob Nissen - President, Nissen Consulting
9:00am - 9:30am
Master Class A, part 1: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)

Strategic alliances have a growing importance in most companies, both large and small, and have significant influence on long-term corporate success. At the same time these collaborative relationships between partners with often significant organizational and cultural differences are frequently challenging and complex, and therefore require careful and diligent management for maximum impact.

In this half-day interactive workshop key concepts and tools to address the various parts of the alliance lifecycle, from alliance strategy to search, negotiation, launch, working and closing phase, are discussed.

Christoph Huwe - Director, Strategic Alliance Management, Bayer Pharmaceuticals
9:30am - 10:15am
Master Class A, part 2: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)

Strategic alliances have a growing importance in most companies, both large and small, and have significant influence on long-term corporate success. At the same time these collaborative relationships between partners with often significant organizational and cultural differences are frequently challenging and complex, and therefore require careful and diligent management for maximum impact.

In this half-day interactive workshop key concepts and tools to address the various parts of the alliance lifecycle, from alliance strategy to search, negotiation, launch, working and closing phase, are discussed.

Christoph Huwe - Director, Strategic Alliance Management, Bayer Pharmaceuticals
10:15am - 11:00am
Master Class A, part 3: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)

Strategic alliances have a growing importance in most companies, both large and small, and have significant influence on long-term corporate success. At the same time these collaborative relationships between partners with often significant organizational and cultural differences are frequently challenging and complex, and therefore require careful and diligent management for maximum impact.

In this half-day interactive workshop key concepts and tools to address the various parts of the alliance lifecycle, from alliance strategy to search, negotiation, launch, working and closing phase, are discussed.

Christoph Huwe - Director, Strategic Alliance Management, Bayer Pharmaceuticals
10:25am - 10:30am
Welcome Address
Srini Sridharan - Group Director, Materials Science & Engineering, Bristol-Myers Squibb
10:30am - 10:50am
Patient-Focused Drug Delivery - The View from biohaven pharmaceuticals (available On Demand)
Vlad Coric, MD - CEO and Director, Biohaven Pharmaceuticals
10:40am - 11:00am
Keynote
CSTD Regulatory Considerations (available On Demand)
Lana Shiu - Executive Director, Medical Device Regulatory Affairs, Global Regulatory Affairs and Safety, Amgen
10:45am - 10:50am
Welcome Address
Joshua Horvath - Director, Early Stage Devices and Human Factors Engineering, Genentech
10:50am - 11:20am
De-risking partnerships – Best practices to working with start-ups, pharma, and novel technologies (available On Demand)
Patrick Anquetil - CEO, Portal Instruments, Inc.
Mindy Katz - Director of Product, Sorrel
John Merhige - CCO, Credence MedSystems
Stefan Koenig - Global Program & Brand Lead, Takeda
11:00am - 11:30am
Master Class A, part 4: Alliance management - concepts and tools to make the best out of your partnerships (available On Demand)

Strategic alliances have a growing importance in most companies, both large and small, and have significant influence on long-term corporate success. At the same time these collaborative relationships between partners with often significant organizational and cultural differences are frequently challenging and complex, and therefore require careful and diligent management for maximum impact.

In this half-day interactive workshop key concepts and tools to address the various parts of the alliance lifecycle, from alliance strategy to search, negotiation, launch, working and closing phase, are discussed.

Christoph Huwe - Director, Strategic Alliance Management, Bayer Pharmaceuticals
11:00am - 11:20am
Keynote
Regulatory and scientific justifications for CMC Changes - Case studies of modified release products (available On Demand)

A drug product rarely remains unchanged throughout its lifecycle. When changes in raw materials, formulation, process, shelf-life, specification or test methods are needed during product development or commercialization, it is essential to evaluate and understand the potential impacts of these changes on the quality, safety and efficacy of the product. To ensure quality and performance, an array of law, regulations and guidelines need to be followed. In addition, scientific justifications based on product and process understanding can also play an important role, especially when changes are outside of the prescriptive regulatory guidance. This presentation will discuss regulatory requirements and scientific justifications that can be used to support different CMC changes for modified release products, including examples of justifying specification revision, multiple related formulation and process changes and biowaivers based on both quantitative and qualitative in vitro-in vivo relationship.

Yihong Qiu - Senior Research Fellow, Formulation Sciences, AbbVie
11:10am - 11:40am
Innovations in drug delivery that are shaping the future of drug product science and manufacturing (available On Demand)

A well-considered drug delivery system can maximize the effectiveness of innovative small molecule and biologic therapies. But how do you choose the best system for your drug? Do you choose a cost-effective, off-the-shelf platform or invest in developing a custom drug delivery device? There are pros and cons for each option—and there is also a third path to consider. Adapting an existing platform device with a few custom attributes tailored to your molecule can offer the best of both worlds.

Doug Boyd - Manager, Medical Devices, Battelle
11:20am - 11:40am
EU/MDR/IVDR combination product and companion product considerations
Liliana Omar - Regulatory and Quality Project Director, Covance
11:35am - 11:55am
Pandemic prevention through gene therapy delivery (available On Demand)

The Defense Advanced Research Projects Agency (DARPA) has issued a bold goal of developing a functionally integrated platform to deliver 20,000 doses of a pandemic prevention treatment in less than 60 days from the identification of the threat. To address this challenge, AstraZeneca has developed multiple In Vivo Expressed Biologic modalities providing robust protection for weeks to months in various animal models. This presentation will focus on the development and delivery of an mRNA construct coding for an anti-influenza monoclonal antibody and present early pre-clinical evidence of its efficacy.

Shawn Davis - Senior Director, Head of Drug Delivery, AstraZeneca
12:00pm - 2:15pm
Master Class B: Parts 1 & 2 – Negotiation for Drug Delivery (available on-demand) – Please view these prior to joining the LIVE Part 3

Drug delivery innovations have the potential to create significant value and their successful delivery to the market depends on the seamless collaboration between multiple parties. All major stakeholders in the innovation process will typically engage in multiple negotiations along the way from the first ideation of a novel product to its market introduction and beyond. These negotiations often span various areas including product profile, timelines, funding, and distribution of the value created.

The interactive half-day master class provides an overview of proven negotiation practices and illustrates how to apply these in the dynamic environment of drug delivery innovation.

Please view parts 1 and 2, and play the game with your group partner prior to joining the live session at 2:15pm 

Ralph Lipp - President and CEO, Lipp Life Sciences
12:55pm - 1:15pm
Technological advances to address oral delivery of challenging molecules (available On Demand)

Since the advent of controlled release technologies, several advancements have been made to maximize the therapeutic effect of drug molecules. Despite these developments, there are still several gaps especially for compounds that show site specific absorption or require drug to release at certain time of the day to improve the therapeutic outcome.

Recent advancements utilizing more robust drug delivery systems based on gastro-retentive delivery system and chronological delivery of drugs have been made to address the needs of such challenging molecules.

This presentation will cover the differentiating features of these next generation technologies and therapeutic utility for a wide range of molecules and disease conditions. We will present case studies of example drugs in clinical development using these technologies and describe how they can potentially improve the drug’s efficacy and tolerability.

Pavan Handa - SVP, Business Development and Strategy, Kashiv BioSciences
1:00pm - 1:20pm
Case study: Alleviating challenges of oral peptide delivery (available On Demand)

This talk will cover some unique strategies to alleviate challenges of oral peptide delivery. Pre-clinical data from a recent case study will be shared.

Aktham Aburub - Research Fellow, Product Design & Development, Eli Lilly
1:15pm - 1:35pm
Connectivity and Devices (available on demand)
Amir Tahric - VP, Business Development, Sensile Medical
David Christen - Head Software Development and Application Software Engineering, Sensile Medical
1:20pm - 1:40pm
Case Study: Creating a connected platform for pre-filled syringes while minimizing cost (available On Demand)

A case-study on the development of a connected, smart PFS platform will be reviewed to show the challenges and solutions to balance the benefits of digitalization with other important drivers as user experience, device cost and environmental sustainability.

Objectives:

  • In Depth analysis of a smart PFS platform, weighting the benefits of reliable data against the challenges related to renovate a well consolidated drug delivery system.
  • Review a “case-study” for the development of an add-on connectivity module adaptable to existing PFSs, analysing in depth the challenges and the associated technological solutions proposed by Flex’s Health Solution Design Centre.

Audience takeaways:

  • Create awareness about benefits vs challenges related to the introduction of electronics on a well-established Primary Packaging Material platform (PFS)
  • Insights of the technologies explored and prototyped in a real-world case study
  • Highlights on the full development process for a “smart modules” as add-on for existing medical devices.
Yossef Schvetz - Director, Industrial Design and User Experience, Flex
1:40pm - 2:00pm
Advancing towards clinical use of innovative dual chamber technology to deliver cutting-edge therapies treating immune-mediated disorders (available On Demand)

Kezar and Credence will provide an overview of Kezar’s KZR-616 and its targeted therapies, as well as why the Credence Dual Chamber Reconstitution Syringe is a good fit for KZR-616 and its Self-Injecting Patients.

Evan Lewis - SR Director, Pharmaceutical Development, Kezar Life Sciences
John Merhige - CCO, Credence MedSystems
2:00pm - 2:30pm
Connectivity in drug delivery – strategies from the leaders of the pack (available On Demand)
Yasemin Karanis - Consultant, Thought Leadership, IQVIA
David Braun - Global Head, Connected Health and Medical Device Business Solutions, Merck KGaA
Christopher Kovalchick - Director, Mechanical Engineering, Eli Lilly and Company
Terry Reed - Director, Business Development, AstraZeneca
2:00pm - 2:45pm
Live speaker Q&A

Join program participants of the Drug Development Partnerships Track and other attendees for this moderated Q&A.

Joshua Horvath - Director, Early Stage Devices and Human Factors Engineering, Genentech
2:15pm - 3:00pm
LIVE: Master Class B, part 3: Negotiation for drug delivery innovation

Drug delivery innovations have the potential to create significant value and their successful delivery to the market depends on the seamless collaboration between multiple parties. All major stakeholders in the innovation process will typically engage in multiple negotiations along the way from the first ideation of a novel product to its market introduction and beyond. These negotiations often span various areas including product profile, timelines, funding, and distribution of the value created.

The interactive half-day master class provides an overview of proven negotiation practices and illustrates how to apply these in the dynamic environment of drug delivery innovation.

In Part 3, participants will Debrief the group about their negotiation outcomes. Ralph will discuss learnings, summarize key points and answer potential questions. 

Ralph Lipp - President and CEO, Lipp Life Sciences
2:30pm - 3:15pm
Live Speaker Q&A

Join program participants and other attendees for this moderated Q&A session

Srini Sridharan - Group Director, Materials Science & Engineering, Bristol-Myers Squibb
BioPharm America - BioPharm America: Innovation and Investing
12:00am - 12:20am
Many Shots on Goal: Evotec’s Business Model

This series of talks features different models of innovation, why they work, and how they contribute to the biotech ecosystem. In this fireside chat, Thomas Hanke from Evotec's BRIDGES initiative will discuss some of the different partnerships that drive early innovation.

Stephanie Marrus - Managing Director Entrepreneurship, UCSF
Thomas Hanke - EVP, Head, Academic Partnerships, Evotec
12:20am - 12:40am
The Indiebio Accelerator Model

This series of talks features different models of innovation, why they work, and how they contribute to the biotech ecosystem. In this fireside chat, Stephen Chambers from IndieBio will discuss the role accelerators play in the biotech ecosystem.

Stephanie Marrus - Managing Director Entrepreneurship, UCSF
Stephen Chambers - Managing Director, IndieBio NY
12:40am - 1:00am
The Digital Story: How Bayer is Playing It

This series of talks features different models of innovation, why they work, and how they contribute to the biotech ecosystem. In this chat, Douglas Lee discusses how digital innovation, internally and externally, is developing in tandem with biotech business models.

Stephanie Marrus - Managing Director Entrepreneurship, UCSF
Douglas Lee - VP, Head Digital and Data Science, Business Development & Licensing, Bayer
1:00am - 1:20am
Pharma Open Innovation: Bayer’s Case Study

This series of talks features different models of innovation, why they work, and how they contribute to the biotech ecosystem. In this fireside chat, Chandra Ramanathan discusses a global approach to sourcing and supporting biotech innovation.

Stephanie Marrus - Managing Director Entrepreneurship, UCSF
Chandra Ramanathan - Global Head, Pharma R&D Open Innovation, Bayer
1:20am - 1:40am
Bayer's LEAPS

This series of talks explores models of financial support and financing for biotech startups and early stage companies. Speakers will identify the key elements, financial and otherwise, needed to ensure a stable foundation for future growth and development of biotech companies and the therapeutics they deliver to patients.

Steve Dickman - CEO, CBT Advisors
Jürgen Eckhardt - Head, Leaps by Bayer
1:40am - 2:00am
VCs and early stage funding

This series of talks explores models of financial support and financing for biotech startups and early stage companies. Speakers will identify the key elements, financial and otherwise, needed to ensure a stable foundation for future growth and development of biotech companies and the therapeutics they deliver to patients.

Steve Dickman - CEO, CBT Advisors
Kevin Johnson - Co-Founder and Partner, Medicxi
2:00am - 2:20am
Early stage funding trends in Europe

This series of talks explores models of financial support and financing for biotech startups and early stage companies. Speakers will identify the key elements, financial and otherwise, needed to ensure a stable foundation for future growth and development of biotech companies and the therapeutics they deliver to patients.

Steve Dickman - CEO, CBT Advisors
Regina Hodits - General Partner, Wellington Partners Life Sciences
2:20am - 3:05am
Fostering diversity in and through biotech investment
Elliott Francis - Director, Diversity and Inclusion, BIO (Biotechnology Innovation Organization)
Celia Economides - Senior VP, Strategy and External Affairs, Kezar Life Sciences
Paul Hastings - President and CEO, Nkarta Therapeutics
Sara Nayeem - Partner, NEA
3:05am - 4:05am
Catalyzing Innovation Partnerships in a COVID-19 Era

The world has changed in 2020, making partnerships to accelerate healthcare innovation more important than ever. Since the start of the COVID-19 pandemic, transformation to the innovation ecosystem is enabling and accelerating early scientific discoveries by investing and partnering with innovators with the potential to positively impact human health. In this fireside chat, leaders from Johnson & Johnson Innovation share insights and perspectives about catalyzing innovation partnerships in the COVID-19 era, along with Thirty Madison’s CEO Steven Gutentag and Polaris Partners’ Managing Partner Amy Schulman.

Julie Hamill - Sr. Director, External Innovation Strategy and Programs, Johnson & Johnson Innovation
Stacy Feld - Head, Johnson & Johnson Innovation, West North America, Australia & New Zealand, Johnson & Johnson Innovation
Steven Gutentag - CEO and Co-Founder, Thirty Madison
Amy Schulman - Managing Partner, Polaris Partners
BioPharm America - Startup Program
12:00am - 1:00am
BioPharm America Startup Pitch Competition

Qualifying startup companies have been invited to pitch their company using no more than four slides and four minutes. Our panel of judges will determine the winner by the quality and effectiveness of the pitch.

Participating Companies:

Ciscovery Bio Inc.

Ardan Pharma

Element Therapeutics

EndoCrine

MediGear International Corp

Mira Chaurushiya - Partner, 5AM Ventures
Anjali Kumar - Sr. Director External Innovation Search and Evaluation, Johnson & Johnson Innovation
Matthew Miessau - Associate, Epidarex, Epidarex
Anna Turetsky - Principal, Venture Investments, The Mark Foundation for Cancer Research
BioPharm America - Drug Delivery Partnerships 2
1:00pm - 1:20pm
Ionic liquids for drug delivery (available On Demand)

Small molecule API structures are often relatively large in size with structural flexibility, weakly ionizing functional groups of multiple types and highly delocalized. These properties impart ideal conditions for room-temperature ionic liquid formation with suitable counter ions. API ionic liquids are increasingly becoming hot topics of drug delivery research, with a particular advantage for dermal delivery. Several examples of drug delivery enhancement in pre-clinical molecules will be discussed.

Simone Alidori - Investigator, Drug Delivery, GlaxoSmithKline
1:20pm - 1:40pm
Brain delivery of biologics – VIA cerebrospinal fluid (available On Demand)

Brain delivery of biologics such as antibodies and nucleic acid therapeutics via the intravenous (IV) route results in limited partitioning to the brain due the blood-brain barrier (BBB). The cerebrospinal fluid (CSF) may provide a better access point to brain by bypassing the BBB. The talk outlines literature –reported as well as more recent findings on impact of CSF access location and delivery flow rates on distribution of biologics to different brain regions.

Shraddha Sadekar - Scientist, PKPD, Genentech
2:00pm - 2:20pm
Learning and challenges: Release testing and simulations for long acting parenteral products (available On Demand)
Manuel Sanchez-Felix - Senior Fellow, Novel Delivery Technologies, Novartis Institutes for BioMedical Research (NIBR)
BioPharm America - LeadingBiotech Boston CEO&BD
9:00am - 9:15am
Registration & Networking Lounge Open
9:15am - 9:20am
Opening remarks
Wendy Nelson - CEO, Leading Biotech
Robert Perez - Founder and Chairperson, Life Science Cares
9:20am - 10:05am
The role of patient advocacy groups and disease foundations in our ecosystem
Samantha Singer - Entrepreneur-In-Residence, Third Rock Ventures
Chris Garabedian - CEO, Xontogeny, and Former CEO, Sarepta
Jenn McNary - Founder, One Rare, Beauhawks
Michele Rhee - Patient Affairs, Enzyvant
10:05am - 10:35am
Top considerations when engaging a potential strategic partnership
Daniela Iwanski - VP, Govig & Associates
Chandra Ramanathan - Global Head, Pharma R&D Open Innovation, Bayer
Steve Tregay - Managing Partner, BioInnovation Capital
Patrick Tricoli - CEO, Nanobiotix US and Global Head of Business Development, Nanobiotix
10:35am - 11:00am
Keynote
Fireside chat: Maximizing value in an M&A
Wendy Nelson - CEO, Leading Biotech
Gary Glick - Founder and Executive Chair, IFM
11:00am - 11:15am
Ginkgo Bioworks
Jason Kelly - Co-Founder and CEO, Ginkgo Bioworks
11:15am - 12:00pm
Keynote
Fireside chat: Pricing
Bruce Booth - Partner, Atlas Venture
Andy Plump - President, R&D, Takeda Pharmaceuticals
12:00pm - 12:30pm
Lunch Break & Networking Lounge
12:30pm - 1:00pm
Keynote
Keynote Address: Innovating Beyond Reason
Noubar Afeyan - Founder and CEO, Flagship Pioneering
1:00pm - 1:45pm
Diversity and inclusion: Cultivating the next generation of biotech execs

What can we do as an industry to cultivate the next generation of leaders and innovators and encourage diversity (beyond just gender diversity) while doing so?

Robert Perez - Founder and Chairperson, Life Science Cares
Barbara Fox - CEO, Rheos Medicines
Daniel Lynch - Chairperson of the Board, Surface Oncology
Adelene Perkins - CEO, Infinity Pharmaceuticals
Jennifer Petter - Founder and CSO, Arrakis Therapeutics
1:45pm - 2:15pm
Keynote
Fireside chat: The mentor/mentee relationship

How does an entrepreneur find a mentor? What does such a relationship look like and how to ensure each party gets the most out of it?

Wendy Nelson - CEO, Leading Biotech
Michael Bonney - Executive Chair, Kaleido Biosciences
Carrie Bourdow - CEO, Trevena
2:15pm - 2:45pm
To go IPO or remain private?
Marian Nakada - VP, Venture Investments, Johnson & Johnson Innovation
Ankit Mahadevia - Founder and CEO, Spero Therapeutics
Brian McVeigh - CBO, Zafgen
Donald Nicholson - Former CEO, Nimbus Therapeutics
2:45pm - 3:15pm
Building your biotech from the ground up

What does it take to get your company up and running? What pitfalls do you want to avoid? Lessons learned from those that have done it!

Carolyn Morgan - CEO, Precision Effect
PJ Anand - Founder and CEO, Alcyone Lifesciences
Jodie Morrison - CEO, Cadent Therapeutics
Bernat Olle - CEO, Vedanta Biosciences
3:15pm - 3:45pm
New players in the healthcare space
Arthur Hiller - Independent Consultant and CBO, Nuritas
Imran Eba - Partner, Action Potential Venture Capital
Mike Pellini - Managing Partner, Section 32
3:45pm - 4:15pm
The Convergence of AI and Medicine
Jennifer Lum - Managing Partner, Biospring Partners
Vik Bajaj - Managing Director, Foresite Capital Management
Anne Heatherington - Sr. VP and Head of Data Sciences Institute (DSI) with Research and Development, Takeda Pharmaceuticals
Iya Khalil - Global Head of the AI Innovation Center, Novartis
4:15pm - 5:00pm
Closing Remarks & Virtual Cocktail Party
BioProcess International - Data Science Tools for Accelerated Product Life Cycle
10:00am - 11:30am
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
11:30am - 12:30pm
Networking Break
12:30pm - 2:00pm
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
2:00pm - 2:05pm
End of Workshop
BioProcess International - Drug Product/Formulations & Fill-Finish
10:00am - 10:20am
Impact of Surfactants on Product Stability, and its Implication on Specification
Weiqiang Cheng, PhD - principal scientist, Takeda
10:20am - 10:40am
Unleashing the Power of Cyclodextrins within Biologic Formulations

Therapeutic proteins are prone to aggregation during manufacturing, transportation and storage. Cyclodextrins have been successfully used to mitigate aggregation of monoclonal antibodies. Dr. Hong´s presentation will help us understand the stabilization mechanism of Hydroxylpropyl ß-Cyclodextrins (KLEPTOSE® HP or HPB) in reducing aggregation of bevacizumab, a monoclonal antibody.

This study offers deeper understanding of the mechanistic role of KLEPTOSE® in bevacizumab formulations by weakening the bevacuzimab-bevacuzimab association, and demonstrates the thermal and oxidative stability of KLEPTOSE® itself. KLEPTOSE® is a viable option for reducing aggregation of bevacizumab and extending its shelf life.

Lastly, Dr. Hong will also highlight some rapidly establishing applications of HPβCD in the gene therapy and vaccine delivery. The presentation will provide a snapshot into the potential applications of HPBCD in biologic formulations.

Shiqi Hong, PhD - Senior Biopharma Scientist, Roquette
10:40am - 11:00am
Live Speaker Q&A Panel
11:00am - 11:40am
Networking Break
11:40am - 12:00pm
Key Considerations in Formulation and Drug Product Development for Gene Therapy
Rafi Mohammed - Staff Development Scientist, Bayer U.S. LLC Pharmaceuticals
12:00pm - 12:20pm
The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration – a PDA and BioPhorum collaboration
Mandar Dixit - Principal Process Expert, Sartorius Stedium Biotech
12:20pm - 12:40pm
Aseptic Filling for Gene Therapies and Next-Generation Biologics with Closed Robotic Workcells
Thomas Page, PhD - VP, Engineering and Asset Development, Fujifilm Diosynth Biotechnologies Texas
12:40pm - 1:00pm
Live Speaker Q&A Panel
1:00pm - 1:05pm
End of Symposium
BioProcess International - Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
10:00am - 10:40am
Session 1
10:40am - 11:00am
Live Q&A
11:40am - 12:20pm
Session 2
12:20pm - 12:40pm
Live Q&A
12:40pm - 1:40pm
Lunch Break
1:40pm - 2:20pm
Session 3
2:20pm - 2:40pm
Live Q&A
2:40pm - 3:10pm
Networking Break
3:10pm - 3:40pm
Session 4
3:40pm - 4:00pm
Live Q&A
BioProcess International - Cell Line Development & Engineering
11:20am - 11:40am
Cell Line Development with High Titer and Long Term Stability
Sung Ho Hahm - CEO, Rophibio Inc.
11:20am - 11:40am
Cell Line Development: A Case Study from Merck
Bo Jiang, PhD - Principal Scientist, Merck Biologics Process R&D
11:20am - 11:40am
Applying Systems Biology Tools for Process Understanding and Improvements
Michael Betenbaugh - Professor, Johns Hopkins University
11:20am - 11:40am
Choosing the Best Clone: Quality, Speed and Diversity
11:40am - 12:00pm
Improvement of therapeutic protein production and quality: Coping with ER stress
Tae Kwang Ha - Specialist, Novo Nordisk Foundation Center for Biosustainability, DTU
11:40am - 12:00pm
Introducing the Nodexus NX One: the Easiest-to-Use, Lowest-Cost Single-Cell Sorting and Dispensing Platform
Karthik Balakrishnan - CEO, Nodexus Inc
11:40am - 12:00pm
Bispecific Molecule Formats and Concepts for Cell Line Development
Valerie Schmieder - PostDoc, Boehringer Ingelheim
12:00pm - 12:20pm
High Throughput Charge Variant Screening of Therapeutic Proteins

We need to monitor properties of biotherapeutic proteins closely throughout the development and manufacturing process. Besides sizing, concentration, purity, and glycosylation pattern, it is important to characterize charge heterogeneity and profiles of proteins. In this presentation, we will share recent development of LabChip® charge variant analysis assay. We will also discuss how to achieve speed and efficiency in high-throughput charge variant analysis and screening of biotherapeutic proteins by applying LabChip® microfluidic technologies.

Guangnan Meng, PhD - Product Leader, Microfluidics, PerkinElmer, Inc.
12:00pm - 12:20pm
Building a high confidence image-based clonality workflow. Is 99% clonal assurance good enough?

The application of high-resolution imaging to confirm single-cell deposition has alleviated many of the risks of taking forward a non-clonal cell line.  With many new technologies coming to the market, the mathematics driving these risk-benefit analyses for clonal derivation are discussed in context to strategies employed by CLD laboratories.

Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:00pm - 12:20pm
Targeted Locus Amplification (TLA) for improved clone selection, genetic characterization, clonality and genetic stability testing

Comprehensive genetic characterization has become mandatory in pharmaceutical cell line development, clone selection and ensuring consistent and safe production of biologicals. Conventional technologies such as Southern Blot and FISH are costly, time-consuming and do not provide complete information on transgene integrity and integration sites. Cergentis’ Targeted Locus Amplification (TLA) technology constitutes a paradigm shift in cost-effectively and completely resolving transgene integrity, integration site(s) and concatemers on the single nucleotide level, within 7 working days. Cergentis supports all leading pharmaceutical companies for genetic quality control of their (CHO) cell line development, gene therapy products and transgenic animal models. This seminar will elaborate on the application of TLA-based assays in cell line selection and characterization of cell banks, clonality and genetic stability as well as its use in regulatory filings. We will discuss some case studies and share recent and upcoming developments in our services and products.

Martijn Kelder, PhD - Strategic Account Manager, Cergentis
12:00pm - 12:20pm
S-CHOice : Accelerated, High-Performing Cell Line Development at Samsung Biologics

It can be a critical decision by any institution to select right host cell line; it can impact quality, cost of goods and timeline. The presentation describes development studies of S-CHOice, Samsung’s proprietary cell line, which can help achieve high quality product, adding value to Samsung’s one-stop CDMO capability.

John Gill - Director, Cell Line Development, Samsung Biologics
12:20pm - 12:30pm
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
12:20pm - 12:50pm
Live Speakers Discussion Forum
12:30pm - 12:50pm
Live Speakers Discussion Forum
Mark Stockdale - Amalgamator of Business and Biology, Solentim
1:50pm - 2:30pm
PANEL DISCUSSION: Working Together: How Systems & Synthetic Biology Can Combine To Improve Protein Production
2:00pm - 2:20pm
Implementing High-throughput and Automated Clonal Evaluation
Jishna Ganguly - Associate Research Scientist, GSK
2:00pm - 2:20pm
A Multi-Omics Platform to Guide Rational Process Development for Recombinant Protein Expression
Yizhou Zhou, PhD - Scientist II, Protein Cell Line Development, Biogen
2:00pm - 2:20pm
Introducing Techniques Which Allows for Early Clone Identification
Mark Tié - Scientist, Biogen
2:20pm - 2:40pm
CHO Cell Engineering Targets: Reducing Cell-Cell Aggregate Formation and Insulin Degradation in Culture Media, Two Case Studies
Shahram Misaghi, PhD - Senior Scientist, Genentech, Inc
2:20pm - 2:40pm
QX ONE Droplet Digital PCR for Cell Line Development

Genetic stability and characterization of the transgene copy number is a critical quality attribute in cell line development and production. Droplet Digital PCR enables copy number discrimination with high precision to facilitate stable clone screening. The new QX ONE ddPCR System is an integrated solution that combines automated walk-away operation with advanced multiplexing, for unmatched precision in absolute quantification.

Brandon McKethan, PhD - Field Application Specialist, Bio-Rad Laboratories, Inc.
2:20pm - 2:40pm
Developability Requiremnts for ADCs
Marieke Zhao - Director, Cell Line Development, Mersana Therapeutics
3:20pm - 3:40pm
TBD
3:20pm - 3:40pm
Influencing Protein Production Utilizing Metabolomics and Reducing Bottlenecks
Nathan Lewis, PhD - Associate Professor, Department of Pediatrics, University of California, San Diego
3:20pm - 3:40pm
Rapid Manufacturing Platform for Biologics
Yves Durocher, PhD - Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada
3:40pm - 4:00pm
Accelerate Biopharmaceutical Development with an Integrated Upstream Solution

CHOZN GS® is a cell line development platform that has been successfully used for the expression of biotheapeutic proteins (around the globe),OR (for a decade) OR(for hundreds of biopharmaceutical development projects). The platform combines a ZFN- modified glutamine auxotrophic cell line, optimized cell culture media and feeds, an expression vector, documentation and protocols, which provide a turnkey solution for the development of stable, high producing clones.

Although the CHOZN GS® platform is successfully used for the isolation of high-expressing and stable clones, time and resource demands to develop these clones are high due to the relative infrequency of transgene random integration into stable loci.   One vector element that can overcome this challenge is the UCOE® technology.  UCOE®, short for Ubiquitous Chromatin Opening Element, is a piece of naturally occurring DNA derived from the 5’ control regions of the promoters of essential housekeeping genes.  These regions have evolved to prevent silencing of their linked genes by maintaining these genes in an open state.

When UCOE® sequences are included within the CHOZN® expression plasmid, the rate of high producing clones within the pools is increased multi-fold.  Therefore, inclusion of UCOE® sequences within the expression plasmid can be used to reduce screening and scale up efforts over the course of CLD without compromising productivity goals.  The multi-fold increase in high producing clones can help ensure CLD success with hard to produce molecules and identify more pools and clones that match both titer and quality criteria.  Finally, this increase in high producing clones may be used to enact changes to the cell line development protocol itself, leading to a drastic reduction in time and resources required for this critical first step in biotherapeutic manufacturing.

Jason Gustin - Director - Cell Line Development & Engineering, MilliporeSigma
3:40pm - 4:00pm
Rapid Generation of Production Cell Lines with Superior Titers and >99% Monoclonality for Complex Antibody Molecules

This presentation will introduce how the Beacon system enables users to generate cell lines secreting traditional and non-traditional antibody molecules with >99% monoclonality assurance in under 1 week.  Case studies will highlight how Beacon users are rapidly generating cell lines with titers superior to clones selected with alternative CLD methods.

Anupam Singhal, PhD - Product Manager, Antibody Therapeutics, Berkeley Lights, Inc.
3:40pm - 4:00pm
Using Octet for High-Throughput Early Clone Selection

Overview the needs and challenges for HT early clone selection

  • ForteBio platforms using the robust and easy to use Dip and Read Octet systems for clone screening  and selection in the early stage based on titer and specificity binding  assays (bispecifics, Glycan and Fc receptors) while using the same samples.  
  • Assay development and optimization recommendations for high-throughput early clone selection

Hongshan Li, PhD - Marketing Applications Manager, Sartorius
BioProcess International - Cell Culture & Upstream Processing
11:20am - 11:40am
Overcoming the Challenges of Implementing Continuous Processing
Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi
11:20am - 11:40am
Modulating Product Quality through Process Characterization and Development
Yelena Ilin - Scientist, Sanofi
11:40am - 12:00pm
Flow Distribution in Commercial Depth Filter Capsules for Clarification of Cell Culture Fluid– Effects on Performance and Scale-Up
Negin Nejati, PhD Candidate - Research Assistant, Chemical Engineering Department, Pennsylvania State University
11:40am - 12:00pm
Understanding Biopharmaceutical Manufacturing at Single Cell Resolution

In this talk, single cell RNASeq of a model CHO cell line producing an anti IL-8 monoclonal antibody will be presented. Through this analysis, transcriptome profiles of > 3,500 individual CHO cells were acquired revealing heterogeneity in the expression of heavy and light chain mRNA and enabling the association of host cell mRNA levels with these variations in transcription of the recombinant protein.

Colin Clarke, Ph.D. - Principal Investigator, National Institute for Bioprocessing
11:40am - 12:00pm
Evolving Cell Culture Platform to Address Amino Acid Misincorporations for Fed Batch Processes
David Lee - Research Associate III, Seattle Genetics
11:40am - 12:00pm
Advanced Real-Time Monitoring of Biologics In Continuous Perfusion Bioprocesses Using Raman Spectroscopy
Mengyao Li - Post Doc Next Generation High-Densit,Advanced Process & Manufacturing Technology, Novartis Pharma AG
1:50pm - 2:10pm
Upstream Raw Material Variation Monitoring and Control Strategies
Aaron Mack - Engineer III, Biogen
2:00pm - 2:20pm
Case Study: Troubleshooting an Upstream Process Variation using MVA Approach
Yang Wu - Scientist II, Macrogenics
2:00pm - 2:20pm
Implementation of Real Time, Online Monitoring Methods for Performance and Product Quality in Cell Culture Bioreactors
George Zhou, PhD - Research Fellow, Merck & Co., Inc.
2:10pm - 2:30pm
Implementation of an Integrated Approach for Fingerprinting Cell Culture Media
Kathryn Aron, Ph.D. - Group Leader, Cell Culture Process Development, Bristol-Myers Squibb
2:20pm - 2:40pm
High-Resolution Optical and Dielectric Methods for Monitoring Cells in Bioprocesses
Michael Butler - Principal Investigator in Cell Technology, National Institute of Bioprocessing Research & Training (NIBRT), Ireland
2:20pm - 2:40pm
Strategic Approach for Upstream Process Development of Glycosylated Fusion Proteins
Kiran Andra - Scientist, Alexion Pharmaceuticals Inc
2:30pm - 2:50pm
A case study in the development of a robust and high-producing upstream process

A holistic approach to upstream process development will result in processes that are more robust as they are scaled up. Kiniksa worked in collaboration with Cytiva to conduct a DoE study on new media and determine the best combination of single-use bioreactor components to improve cell culture performance, increase titer, and ultimately develop a scalable process.

Baochuan Huang - Senior Director, Cell Culture Development & Manufacturing, Kiniksa Pharmaceuticals
2:50pm - 3:20pm
Live Speakers Discussion Forum
Baochuan Huang - Senior Director, Cell Culture Development & Manufacturing, Kiniksa Pharmaceuticals
Aaron Mack - Engineer III, Biogen
Kathryn Aron, Ph.D. - Group Leader, Cell Culture Process Development, Bristol-Myers Squibb
3:20pm - 3:40pm
Closed, Automated and Controlled Upstream Processing for iPSC-derived Cell Therapies
Mustafa Munye - Lead Scientist, Cell and Gene Therapy Catapult
3:20pm - 3:40pm
Raman Spectroscopy for Process Monitoring and Lessons Learned in Development & Manufacturing

Raman spectroscopy is a spectroscopic, RTA, and PAT technology that can be in monitoring bioprocesses in real-time by creating predictive models. This presentation will look at the ability of using Raman to provide real-time trending of data in upstream process in development and manufacturing. The evolution of this technology and implementing ideas such as feedback control will be discussed, along with the lessons learned in the process getting this technology to into the hands of manufacturing.

Nobel Vale - Research Scientist II, Bristol-Myers Squibb
3:40pm - 4:00pm
Optimizing Workflow Efficiency with New Innovations in Bioprocess Monitoring
3:40pm - 4:00pm
A Development Strategy for Identificaation and Improvement of Lactate Metabolism Variations

There have been many studies for the lactate metabolism in CHO cell culture, as it is known to affect productivity and culture longevity significantly. The presentation shares Samsung’s strategy for the identification and improvement of lactate metabolism variations, describing solution to lactate re-accumulation, which leads to successful scale-up for production.

Yongho Ahn - VP, Head of CDO R&D Team, Samsung Biologics
BioProcess International - Recovery & Purification
11:20am - 11:40am
KEYNOTE ADDRESS - Genentech's Evolve Initiative

Genentech Representative Invited

Josefine Persson, Ph.D. - Associate Director, Purification Development, Genentech
11:20am - 11:40am
NIIMBL-BioPhorum Buffer Stock Blending System - Buffer Preparation of the Future
Jeff Johnson - President, Biotech Design, LLC
11:20am - 11:40am
Understanding and Mitigation of Polysorbate Hydrolysis by CHO Enzymes
Troii Hall, M.S. - Associate Consultant Chemist, Bioprocess Research & Development, Eli Lilly and Company
11:20am - 11:40am
Exploring the Linkage Between Cell Culture Process Parameters and Downstream Processing Utilizing a Placket-Burman Design for a Model Monoclonal Antibody
Kurt Brorson, PhD - Vice President, Technical, Parexel International
11:40am - 12:00pm
Synthesis and Purification Opportunities for mRNA-Based Therapeutics
Lucia Lapazio - R&D Biologics Development, Process Purification Development, Sanofi
11:40am - 12:00pm
Polysorbate Degradation and Particle Formation in Biotherapeutics
Karen Rutherford, PhD - Technical Development Sr. Scientist, Genentech
11:40am - 12:00pm
Use of Developability Assessments in a MID-SIZE Biotech Company
David Kahn, Ph.D. - Vice President, Biopharmaceutical Development, Macrogenics
1:50pm - 2:10pm
Case Studies and Process Concepts for Continuous Chromatography
Thomas Müller-Späth, PhD - Director, R&D Life Science Systems, ChromaCon AG, Switzerland
2:00pm - 2:20pm
Fully Automated Platform Approach to FIH Purification Development: mAbs and Beyond
Brian Murray, PhD - Scientist, Biologics Purification Development, Sanofi
2:00pm - 2:20pm
Metadata Analysis to Improve Efficiency and Performance of Downstream Processes
Leslie Wolfe, PhD - Director, Downstream Process Development, KBI Biopharma
2:00pm - 2:20pm
Transitioning from Chemistry Based Purification to Protein Based Purification for Antisense Oligonucleotides
Robert Gronke, PhD - Senior Principal Scientist, Technical Development, Biogen, Inc
2:10pm - 2:30pm
Continuous Formulation of High Value Biotherapeutics Using Novel Membrane Systems with Reduced Buffer Usage
Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair and Professor of Chemical Engineering, The Pennsylvania State University
2:20pm - 2:40pm
Rapid Release of TOX Material from Pilot Plant in < 3 days
Joe Sexton - Principal Technical Specialist, Genentech
2:20pm - 2:40pm
Smaller and Faster – Using High Throughput PD to Develop and Qualify a Protein A Micro-Model
Doug MacDonald - Principal Scientist, Seattle Genetics
2:20pm - 2:40pm
Control Strategy for Beta-Glucan Impurities in Downstream Processes
Mahsa Rohini, Ph.D. - Scientist, Pivotal Drug Substance, Process Development, Amgen
2:30pm - 2:50pm
Learnings from perfusion medium development

With the increasing interest in perfusion, there is an increased demand for media designed to address the specific application needs inherent in the process . We will discuss the goals, learnings, and results from the recent development of a new perfusion medium. Data will be presented around some of the early testing challenges and demonstrating the resulting final behavior in different perfusion environments. We will also outline best practices for screening medium candidates for a perfusion process.

Christopher Brau - Staff Scientist/Engineer, Thermo Fisher Scientific
3:20pm - 3:40pm
Computational Analysis of Antibody-HCP Interactions: Development of a New Framework
Maral Adeli-Koudehi, PhD - Postdoc Researcher, Purification Development, Sanofi
3:20pm - 3:40pm
Fast & Efficient Downstream Process Development with Two-step Purification Platform
Beomkyu Kim, PhD - Lead Scientist, DSP Part, Samsung Biologics
3:20pm - 3:40pm
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
3:40pm - 4:00pm
Development of a second generation PlasmidSelect resin

To address the growing demand for plasmid DNA, Cobra Biologics have embarked on a collaborative project with Cytiva (formerly GE Healthcare) to develop a second generation Plasmid Select resin based on Cytiva’s Capto bioprocessing resin. This presentation with look at the needs within the plasmid DNA market and how this collaboration has sought to address this market opportunity.

Tony Hitchcock - Technical Director, Cobra Biologics
3:40pm - 4:00pm
Capture of CH1-containing bispecific antibodies: An alternative to Protein A

Bispecific antibodies (BsAb) are an important and growing class of protein therapeutics.  BsAb are designed to recognize and bind to two different antigens, often for the purpose of retargeting immune effector cells to kill cancer cells.  Currently two BsAb (blinatumomab, catumaxomab) are approved as therapeutics in the US and Europe.  Using UniRatTM human heavy chain antibody technology, we have produced several BsAb, each targeting a tumor antigen and CD3.  Our lead BsAb are monoclonal IgG4 antibodies engineered in the CH2 and hinge domains to silence Fc-function and prevent arm exchange, respectively.  The molecules comprise 3 chains, two non-identical human heavy chains—one full length, the other derived from the UniRatTM and lacking the CH1 domain. The third is a human kappa light chain bound to the full-length heavy chain.  Correct pairing of heavy chains is achieved through knobs-into-holes technology.  For this and many BsAb, the use of Protein A for capture is problematic due to the presence of Fc-containing product variants in the crude BsAb mixture.  In designing a manufacturing process for BsAb, alternative Fc affinity methods for capture were investigated and a suitable alternative was found.  Properties and performance characteristics of an alternative capture method will be discussed.

Steven Chamow - President, Chamow & Associates, Inc.
3:40pm - 4:00pm
Riffyn Nexus: A Digital Backbone for Process Development & Tech Transfer

Scaling-up and transferring processes to manufacturing requires a non-trivial array of software capabilities to deliver organizational speed and flexibility, including data connectivity, data automation, ease of use, analytics-ready data, and secure, global data access. In this presentation, we show how Riffyn Nexus, the world’s first process data system, supports dynamic, modular bioprocessing development and tech transfer activities with clean, connected processes and real-time data analytics. Companies using Riffyn Nexus have achieved 2X faster development cycles and 4X productivity gains in their R&D projects.

Loren Perelman, PhD - Vice President of Scientific Solutions, Riffyn
BioProcess International - Intensified and Continuous Processing
11:20am - 11:40am
Development of a Near Real Time Bioreactor Measurement System for Glycans and Application to Model Building and Control of Product Quality Attributes
Brandon Downey - Principal Engineer, R&D, Lonza
11:20am - 11:40am
Intensified Seed Train Expansion
Luis Fernando Ayala Solares - Scientist, Life Science, Upstream R&D, Merck KGaA
11:40am - 12:00pm
Continuous and Integrated Bioprocess Development for Novel Modalities
Ricardo Silva, PhD - Senior Scientist, Animal Cell Technology Group, iBET - Instituto de Biologia Experimental e Tecnológica, Portugal
11:40am - 12:00pm
Continuous from the Ground Up? Exploring Continuous Manufacturing Approaches in Early Development
Thomas Ransohoff, MS - Chief Operating Office, 4th Dimension Bioprocess, Inc.
12:00pm - 12:30pm
Live Speakers Discussion Forum
12:00pm - 12:30pm
Scientific & Technology Presentations
2:00pm - 2:20pm
The Economics of Seed Train Intensification
Jianlin (Jim) Xu, PhD - Principal Scientist, Bristol-Myers Squibb
2:00pm - 2:20pm
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Anita Kundu - Senior Associate Scientist, Pfizer
2:00pm - 2:20pm
KEYNOTE ADDRESS: Automated Material Traceability in End-To-End Continuous Biomanufacturing for Batch Disposition
Nuno Pinto, PhD - Associate Principle Scientist, Merck & Co., Inc.
2:20pm - 2:40pm
Multivariate Process Monitoring Along with PAT for Bioprocessing Manufacturing for Process Performance and Quality Attributes
Denizhan Yilmaz - Senior Scientist, Sanofi
2:20pm - 2:40pm
Improving Product Quality Through Cell Culture Process Intensification
Yan Wang - Senior Scientist, Amgen
2:20pm - 2:40pm
Assessing Environmental Impact Through Process Data Mining