keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
Day Two - EST/EDT (Eastern Daylight, GMT-4)
keyboard_arrow_leftSearch & Filter
search
Streams
Formats
Day Two - EST/EDT (Eastern Daylight, GMT-4)
search
Streams
Formats
7:00am - 7:55am55 mins
Coffee and Registration
7:55am - 8:00am5 mins
Cell Culture & Upstream Processing
Chairperson's Opening Remarks
7:55am - 8:00am5 mins
Recovery & Purification
Chairperson's Opening Remarks
7:55am - 8:00am5 mins
Manufacturing Strategy & Bioprocessing 4.0
Chairperson's Opening Remarks
7:55am - 8:00am5 mins
Analytical & Quality
Chairperson's Opening Remarks
7:55am - 8:00am5 mins
Future Visions for Cell and Gene Therapies
Chairpersons Opening Remarks
8:00am - 8:30am30 mins
Cell Culture & Upstream Processing
Keynote Address – Upstream Process Development and Manufacturing at Pandemic Speed
- Jianlin (Jim) Xu, PhD - Scientific Director, Biologics Development, Bristol-Myers Squibb
8:00am - 8:30am30 mins
Recovery & Purification
Expedited Process Development and Validation Using HTC, Process Ranking Tools and Mechanistic/Hybrid Models
- Steve Cramer, Ph.D. - Walker Professor, RPI
8:00am - 8:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Case Study: Leveraging New Technologies and Implementing Changes in Legacy Manufacturing Processes
- Katerina Sarkovski - Director, B100 Project- Manufacturing Technology, Industrial Affairs, Sanofi
8:00am - 8:30am30 mins
Analytical & Quality
Case Study: MAM & HCP
- Kevin Carrick, Ph.D. - Senior Scientific Liason, Global Biologics, United States Pharmacopeia
8:00am - 8:40am40 mins
Future Visions for Cell and Gene Therapies
Keynote: State of the Industry and Future Perspectives for Cell and Gene Therapies
- Janet Lynch Lambert - Chief Executive Officer, Alliance of Regenerative Medicine
8:30am - 9:00am30 mins
Cell Culture & Upstream Processing
Challenges and Solutions for Successful Technology Transfer of Cell Culture Processes
- Susan Dana Jones, Ph.D. - Chief Technology Officer, Tourmaline Bio
8:30am - 9:00am30 mins
Recovery & Purification
Digital Twins for Real-Time Control of Continuous Downstream Manufacturing of mAbs
- Garima Thakur - Doctoral Researcher, Indian Institute of Technology, India
8:30am - 9:00am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Knowledge Management as a Catalyst for Speed to Patient
- Paul Hanson - Head of Lifecycle Management, Innovation, and Strategy, Interim Head of, Business Excellence, Global Manufacturing Sciences, Takeda Pharmaceuticals
8:30am - 9:00am30 mins
Analytical & Quality
Characterization Case Study
- Jill Crouse-Zeineddini, Ph.D. - Scientific Director, Amgen
8:40am - 9:20am40 mins
Future Visions for Cell and Gene Therapies
Plenary Panel Discussion: Beyond Rare Diseases - Overcoming the Challenges of Expanding to Larger Patient Populations with Cell and Gene Therapies
- Stephane Berthier - VP and General Manager, Atara Biotherapeutics
9:00am - 9:30am30 mins
Cell Culture & Upstream Processing
Biomanufacturing During a Pandemic When You’re Not Making a COVID Vaccine
- Charles Sardonini - Director, Process Engineering/Development, Genzyme
9:00am - 9:30am30 mins
Recovery & Purification
Transient Charge Variants During Cation Exchange Chromatography Gradients and Their Implications for In Silico Modeling
- Samantha Wadsworth - Process Development Engineer II, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals
9:00am - 9:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
A Tale of Two Plants: High Mix/Low Volume vs. High Volume/Low Mix in Biomanufacturing
- Paul Jorjorian - Vice President of Biologics, Thermo Fisher Scientific
9:00am - 9:30am30 mins
Analytical & Quality
Found in translation: Microproteins are a new class of potential host cell impurity in mAb drug products
- Colin Clarke, Ph.D. - Principal Investigator, National Institute for Bioprocessing Research and Training & Associate Professor, School of Chemical and Bioprocess Engineering, University College Dublin
9:20am - 9:40am20 mins
Future Visions for Cell and Gene Therapies
Plenary Panel Discussion: Future Perspectives on the Cell and Gene Therapy Industry
9:30am - 10:00am30 mins
Cell Culture & Upstream Processing
Scientific Track Presentation
9:30am - 10:00am30 mins
Recovery & Purification
Scientific Track Presentation
9:30am - 10:00am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
9:30am - 10:00am30 mins
Analytical & Quality
Scientific Track Presentation
10:00am - 10:45am45 mins
Networking Refreshment Break
10:45am - 11:15am30 mins
Cell Culture & Upstream Processing
Online Measurements & Control of Product Titer & Critical Product Quality Attributes (CQAs) and Nutrients During Process Development
- Letha Chemmalil - Scientific Associate Director, Global Process Analytical Sciences & Technology, Bristol Myers Squibb
10:45am - 11:15am30 mins
Recovery & Purification
Development and Implementation of a Variable Driven Tecan Robo-Column Method that Enables Us to Perform Gradient Elutions with Robo-Columns
10:45am - 11:15am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Challenges to keep Clinical Manufacturing on track under the shadow of Covid-19 related industry wide disruptions
- Vivek Bhatnagar - Director, R & D Biopharm, Teva Pharmaceuticals
10:45am - 11:15am30 mins
Analytical & Quality
MS-based Characterization Workflows in a Biopharmaceutical Development Lab – Recent Progress, Challenges and Case Studies
- Dan Bach Kristensen - Scientist, Symphogen
10:45am - 11:15am30 mins
Cell Therapy
Process Analytics: Comparability and Process Validation Methods
10:45am - 11:15am30 mins
Gene Edited Ex Vivo Therapy
Overcoming the Scale Up and Manufacturing Challenges of Next Generation ''Off the Shelf'' Allogeneic Cell Therapies
- Mark Plavsic - Chief Operations Officer, Fate Therapeutics Inc
10:45am - 11:15am30 mins
In Vivo Gene Therapy
Improvements and Innovations in Cell Lines to Increase Yields for Gene Therapies
- Ping Liu - Senior Scientist, Head of Cell Line Development, Regenex Bio
11:15am - 11:45am30 mins
Cell Culture & Upstream Processing
Mass Spectroscopy for PAT
- Matthew Radle - Research Associate, AstraZeneca
11:15am - 11:45am30 mins
Recovery & Purification
Implementation of Modeling and Simulation in Biopharma
11:15am - 11:45am30 mins
Manufacturing Strategy & Bioprocessing 4.0
The Link Between Supply Chain Integrity and Auditing During and Post a Pandemic
- Jim Fries - CEO, RX-360
11:15am - 11:45am30 mins
Analytical & Quality
From screening to bioprocess modeling: the benefits and versatility of automated protein mass spectrometry
- Hans-Rainer Voelger - Senior scientist Pharma Research and Early Development, Roche Innovation Center Munich
11:15am - 11:45am30 mins
Cell Therapy
Potency Assays
- Knut Niss - Chief Technology Officer, Mustang Bio, USA
11:15am - 11:45am30 mins
Gene Edited Ex Vivo Therapy
iPSC Derived NK Cultures in Suspension Systems
- John Mikitsh - Engineer, Process and Product Development, Century Therapeutics, LLC
11:15am - 11:45am30 mins
In Vivo Gene Therapy
Business Advantages of Starting Early with Gene Therapy Manufacturing + Key Considerations
- Scott Bertch - Executive Director, Clinical Manufacturing Site Head, Tenaya Therapeutics
11:45am - 12:15pm30 mins
Cell Culture & Upstream Processing
Scientific Track Presentation
11:45am - 12:15pm30 mins
Recovery & Purification
Scientific Track Presentation
11:45am - 12:15pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
11:45am - 12:15pm30 mins
Analytical & Quality
Scientific Track Presentation
11:45am - 12:15pm30 mins
Cell Therapy
Scientific Track Presentation
11:45am - 12:15pm30 mins
Gene Edited Ex Vivo Therapy
Scientific Track Presentation
11:45am - 12:15pm30 mins
In Vivo Gene Therapy
Scientific Track Presentation
12:15pm - 1:25pm70 mins
Cell Culture & Upstream Processing
Sponsored Luncheon Presentation 1
12:15pm - 1:25pm70 mins
Recovery & Purification
Sponsored Luncheon Presentation 2
12:15pm - 1:25pm70 mins
Manufacturing Strategy & Bioprocessing 4.0
Sponsored Luncheon Presentation 3
12:15pm - 1:25pm70 mins
Analytical & Quality
Sponsored Luncheon Presentation 4
12:15pm - 1:25pm70 mins
Cell Therapy
Sponsored Luncheon Presentation 5
12:15pm - 1:25pm70 mins
Gene Edited Ex Vivo Therapy
Sponsored Luncheon Presentation 6
12:15pm - 1:25pm70 mins
In Vivo Gene Therapy
Sponsored Luncheon Presentation 6
12:30pm - 1:15pm45 mins
Product Stage
Panel Discussion/Round Table: Sustainability Initiatives Throughout Pharma from Corporate Policies to Bench Level Impacts
- Jennifer Wright - Director, Global EHS & Sustainability, Biogen
1:25pm - 1:30pm5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
1:25pm - 1:30pm5 mins
Recovery & Purification
Chairperson's Remarks
1:25pm - 1:30pm5 mins
Manufacturing Strategy & Bioprocessing 4.0
Chairperson's Remarks
1:25pm - 1:30pm5 mins
Analytical & Quality
Chairperson's Remarks
1:25pm - 1:30pm5 mins
Cell Therapy
Chairperson's Opening Remarks
1:25pm - 1:30pm5 mins
Gene Edited Ex Vivo Therapy
Chairperson's Opening Remarks
- Chris Gemmiti, Ph.D. - Executive Director of Technical Operations; Head of Early Stage CMC and Product Launch Programs, CRISPR Therapeutics
1:25pm - 1:30pm5 mins
In Vivo Gene Therapy
Chairperson's Opening Remarks
1:30pm - 2:00pm30 mins
Cell Culture & Upstream Processing
Use of Capacitance and High Resolution Optical Measurements as a Way of Continuous Monitoring of a Bioprocess
- Michael Butler - Chief Scientific Officer (CSO), National Institute of Bioprocessing Research & Training (NIBRT), Ireland
1:30pm - 2:00pm30 mins
Recovery & Purification
Implementation of a Novel Way of Pre-Use Assessment of the Pre-Packed Robocolumn and Data Management System for Trending and Visualizing
- Jay (Zizhao) Liu, Ph.D. - Senior Process Scientist, Downstream Sciences, Process Sciences Department, Regeneron
1:30pm - 2:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Quality by digital design and techno-economic modelling of RNA vaccine production
- Zoltán Kis - Research Associate, Imperial College London
1:30pm - 2:00pm30 mins
Analytical & Quality
Regulatory’s Role in Submission Risk Management
- John Alvino - Director, CMC-RA, Astrazeneca
1:30pm - 2:00pm30 mins
Cell Therapy
Improvement and Optimization Repertoire's Multi-Targeted T Cell (MTC) Manufacturing Process and Product
- Barrett J. Nehilla - Director, Analytical Development/Quality Control, Repertoire Immune Medicines
1:30pm - 2:00pm30 mins
Gene Edited Ex Vivo Therapy
Scale Up Enabling Technologies to Improve Scale Up Success for Allogeneic Cell Therapies
1:30pm - 2:00pm30 mins
In Vivo Gene Therapy
Business Advantages of Starting Early with Gene Therapy Manufacturing + Key Considerations
- Scott Bertch - Executive Director, Clinical Manufacturing Site Head, Tenaya Therapeutics
2:00pm - 2:30pm30 mins
Cell Culture & Upstream Processing
Enhanced Process Understanding of Lentiviral Manufacturing by Real Time Raman Spectroscopy
- Erin Masucci - Scientist, Janssen
2:00pm - 2:30pm30 mins
Recovery & Purification
Visualization and Characterization of Bioprocess Structures for the Development of a 3D Printing Design Cycle
- Thomas Johnson - Post-Doctoral Research Associate, Biochemical Engineering, UCL
2:00pm - 2:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
How to Implement Annex 1 in the Drug Substance World - A Consensus
- Monica Cardona - Global Senior Marketing Manager Single Use Programs, Millipore Sigma on behalf of BioPhorum
2:00pm - 2:30pm30 mins
Analytical & Quality
Analytical method development and method life-cycle in context of a risk-based Control Strategy
- Gerald Gellermann - Senior Fellow, Novartis Biologics
2:00pm - 2:30pm30 mins
Cell Therapy
Implementing Automated, Closed and Integrated Systems in Cell Therapy Manufacturing
2:00pm - 2:30pm30 mins
Gene Edited Ex Vivo Therapy
Large Scale CART Production Strategies
2:00pm - 2:30pm30 mins
In Vivo Gene Therapy
Case Study: from Biogen
- Xiaotong Fu, PhD - Sr. Engineer, Biogen
2:30pm - 3:00pm30 mins
Cell Culture & Upstream Processing
Scientific Track Presentation
2:30pm - 3:00pm30 mins
Recovery & Purification
Technology Workshop
2:30pm - 3:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Technology Workshop
2:30pm - 3:00pm30 mins
Analytical & Quality
Technology Workshop
2:30pm - 3:00pm30 mins
Cell Therapy
Scientific Track Presentation
2:30pm - 3:00pm30 mins
Gene Edited Ex Vivo Therapy
Scientific Track Presentation
2:30pm - 3:00pm30 mins
In Vivo Gene Therapy
Scientific Track Presentation
3:00pm - 4:00pm60 mins
Networking Refreshment Break in the Exhibit & Poster Hall
Plenary Session
4:00pm - 4:10pm10 mins
Plenary Session
Chairperson's Remarks
4:10pm - 4:50pm40 mins
Plenary Session
Keynote: Inside Kite’s CAR T Manufacturing Excellence
- Chuck Calderaro III - Global Head of Technical Operations, Kite Pharma
4:50pm - 5:30pm40 mins
Plenary Session
Keynote: Leading with Passion and Compassion
- John Crowley - Chairman of the Board, Chief Executive Officer, Amicus Therapeutics
5:30pm - 7:00pm90 mins
Cocktail Reception in Exhibit & Poster Hall
Get the latest news.
As it happens
Sign up to get the latest on the agenda and speakers.
Filter
Streams
Formats