AGENDA
10:30 PT
Registration & Exhibitor Showroom and Virtual Platform Open House
11:30 PT
Lunch (Grab & Go)
12:00 - 12:15 PT
Chairman’s Opening Remarks
12:15-1:00 PT
Discovering how Covid-19 has Changed Biopharmaceutical Manufacturing Forever
Joel Gates, Senior Director of Operations, Azzur Cleanrooms on Demand
1:00 - 1:45 PT
Facilitating the Development of Gene Therapies
Peter Marks, Ph.D., Director of Center for Biologics Evaluation and Research U.S. Food and Drug Administration
1:45 - 2:15 PT
Exhibitor Showroom and Refreshment Break
2:15 - 2:45 PT
The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 During Covid-19
Jon Thompson,Principal Consultant, CAI
2:45 - 3:15 PT
4 Tips for Enhancing Trust with Contract Organizations for Increased Efficiency and long-lasting Relationships
Luiz Barberini, Head of External Manufacturing Operations, Bayer
3:15 - 3:45 PT
Regulatory Review of Cell & Gene Therapies – Understanding CBER’s Existing Framework and Looking Ahead to PDUFA and Other Changes
Kalah Auchincloss, EVP and Deputy General Counsel, Greenleaf Health, Inc.
3:45 - 4:00 PT
Afternoon Stretch and Coffee Refresh
4:00 - 4:30 PT
Examining Next Generation Biopharmaceutical Manufacturing
David W. Vincent, MPH, PhD, CEO,VTI Life Sciences
4:30 - 5:00 PT
Creating the Biopharma Workforce of the Future
Emily Moran,VP, Viral Vector Manufacturing The Center for Breakthrough Medicines
5:45 PT
Networking Welcome Reception
7:30 PT
Exhibitor Showroom Opens and Lite Breakfast
8:30 - 9:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Digital Tools in Bioprocess Design and Optimization
Maria Papathanasiou, Lecturer, Imperial College London
CELL & GENE
Strategies for Cell and Gene Therapy Translation from Bench to Bedside
Shirley Mei, Investigator – Regenerative Medicine Program The Ottawa Hospital Research Institute
BIOPROCESS EXCELLENCE
Reflecting on the Growing Momentum for Biosimilars in the US
Antonio Moreira, Vice Provost for Academic Affairs and Professor of Chemical, Biochemical and Environmental Engineering, University of Maryland, Baltimore County (UMBC)
9:40 - 10:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
The Road to Digital Transformation in Biopharma: Moving from Change Management to Enterprise Transformation for Bioprocessing 4.0
Rosalind Beasley,VP Digital Innovation, Dot Compliance Inc
CELL & GENE
Challenges & Solutions to Tracking of Off-the-Shelf Cell Therapies
Amanda Conerty, Senior Director of CMC, Artiva Biotherapeutics
BIOPROCESS EXCELLENCE
A Packaging Engineer – Luxury or Necessity?
Jan Gates, President/Advisor Packaging Engineer, PackWise Consulting
10:30 - 11:00 PT
Exhibitor Showroom and Networking Refreshment Break
11:00 - 12:00 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Smart Manufacturing and Contamination Control Strategies for Bio-Pharmaceuticals as ATMPs
Richard Denk, Senior Consultant Aseptic Processing & Containment SKAN AG
CELL & GENE
Digital Transformation – A Key to the Success of Cell and Gene Therapies
Per Hammer, Head of Automation and Digital, Cell & Gene Therapy, Cytiva
BIOPROCESS EXCELLENCE
Creating an Agile Culture to Be Ready to Adapt to New Innovative Ways of Working
Brent Gendleman, Innovation Lead IT Advisory Services, Azzur Jordyne Blaise, Director of Diversity, Equity & Inclusion, Bluebird bio
12:00 - 1:00 PT
Exhibitor Showroom and Networking Luncheon
1:10 - 1:55 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Realizing the Paradigm Shift to a Smarter Manufacturing Process
Chor Sing Tan, Strategy Manager Growth Initiatives, Cytiva
CELL & GENE
Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
Emily Moran, VP, Viral Vector Manufacturing, The Center for Breakthrough Medicines
BIOPROCESS EXCELLENCE
Partnering for Success – Collaborations between Industry and Academia
Emily Hopewell,Director, Cell and Gene Therapy Manufacturing Indiana University
2:05 -2:55 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Leveraging Flexible Networks, Cutting-Edge Innovation in a Quality Culture
Ellyn Ludden, Principal Consultant, CAI Lisa Hawkins, Principal Consultant, CAI
CELL & GENE
Leveraging Platform Technologies for Gene Therapies
Mari Salmi, Director of Process Development Scientist, GenCure
SUPPLY CHAIN
Accelerating Innovation in Ultracold and Cryogenic Medicines Supply Chain Distribution
Eric Elbel, Senior Manager of Supply Chain Logistics, AVROBIO
2:55 - 3:25 PT
Exhibitor Showroom and Afternoon Stretch
3:25 - 4:10 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Unleashing the Value of Quality by Design Through Continuous Process Verification, Manufacturing Anomaly Capture & AI-enabled Proactive Quality Response
Stephen McCarthy, VP, Digital Innovation, Honeywell Sparta Systems
CELL & GENE
Regulatory Considerations for Expedited Programs
Kimberley Buytaert-Hoefen, Director of Regulatory Affairs, Azzur
BIOPROCESS EXCELLENCE
Implementing Modern QC Tests Strategies Today Instead of Tomorrow
Audrey Chang, Executive Director of Biologics Testing Solutions, Charles River
4:20 - 5:05 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Increasing Efficiencies in Bioprocess Development and Manufacturing through Digital Process Development
Mark Duerkop, CEO, Novasign GmbH
CELL & GENE
Advances and Trends in Aseptic Fill / Finish for Targeted Therapy Products
Keith Dodson, Vice President of Business Development Automated Systems of Tacoma (AST)
SUPPLY CHAIN
Improving the Supply Chain for the Biopharma Industry – What Covid-19 Vaccine Production is Teaching Us
Kelly Smeltzer, Sr Principal Consultant, CAI
5:05 PT
Close of Day Two
7:30 PT
Exhibitor Showroom Opens and Lite Breakfast
8:30 - 9:20 PT
Select Between Think Tank Sessions
SMART MANUFACTURING
BioProcessing - How AI and Machine Learning Are Changing the Manufacturing Landscape
CELL & GENE
Cost Management in Cell & Gene Therapies
SUPPLY CHAIN
Real-time Risk Management - Using Data and Technology to Enhance GDP Compliance and Supply Chain Security
9:30 - 10:20 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Continuous Process Improvement in Commercial Product LCM – Focusing on Perfusion Systems
Prasad Pathange, Director of MSAT BT DS Labs, Bayer
CELL & GENE
The What and When of GMP for Critical Material in Cell & Gene Therapies
Dominic Clarke, Chief Technical Officer, Cell & Gene Therapy, Discovery Life Sciences
BIOPROCESS EXCELLENCE
Underserved Patient Populations: Developing, Manufacturing and Supplying Age-Appropriate Medicines for Children
Daniel Schaufelberger, VP CMC, NGT BioPharma Consultants LLC and Adjunct Assistant Professor, Johns Hopkins University School of Medicine
10:20 - 10:50 PT
Exhibitor Showroom and Networking Refreshment Break
10:50 - 11:35 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Remote Inspections, Enforcement Trends and Enforcement Examples
Eric Good, Director of Compliance, ProPharma Group
CELL & GENE
Cell & Gene Therapy Beyond Oncology
Emily English, Senior Director for Regulatory Affairs & Quality, Cartesian Therapeutics
SUPPLY CHAIN
Automation and Visibility - Effectively Combining People, Processes and Technology to Deliver Supply Chain at Scale
M. Dave Malenfant, Director of Outreach & Partnerships, Center for Supply Chain Innovation Neeley School of Business
11:45 - 12:45 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
Priya Baraniak, Vice President, Corporate Development, OrganaBio
CELL & GENE
How R&D with Cloud Bioreactors can Accelerate Process Development
Kris Tyner, Senior Director, Bioprocessing, Culture Biosciences
SUPPLY CHAIN
Using Digital Twins to Improve the Biopharmaceutical Supply Chain
Amar Chahal, Senior Vice President – Global Marketing, Strategy and Corporate Development, Cold Chain Technologies, LLC; Alok Bhanot, Chief Technology Officer, Cloudleaf, Inc.
12:45 - 1:15 PT
Exhibitor Showroom and Grab and Go Lunch
1:15 - 2:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Data Integrity and Biopharmaceutical Manufacturing
Dominic Mancini, Vice President, Operations, OrganaBio, LLC Marc Diament, CEO & Founder, Integral Biometrics Roque Redondo, Senior Technical Consultant, PharmEng Technology
BIOPROCESSING EXCELLENCE
Diversity in Clinical Research
Jordyne Blaise, Vice President, Diversity, Equity and Community Engagement, Circuit Clinical
SUPPLY CHAIN
Improve Supply Chain Visibility, Shipment ETA’s and Workflow Automation with Location Intelligence
Bart Coppelmans, Global Head of Industry Solutions for Supply Chain & Logistics, HERE Technologies
2:30 PT
Afternoon Stretch and Coffee Break
2:45 - 3:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Enabling Successful Process Validation in Biopharmaceutical Manufacturing
Rahul Rajan Kaushik, VP, Protein/Antibody Process Development & Manufacturing, Fibrogen
CELL & GENE
Discover an Allogeneic MSC Source for the Regenerative Medicine Supply Chain
Jessica Snyder, Bioprocessing Application Scientist, RoosterBio
SUPPLY CHAIN
How the Covid Vaccine Distribution Challenge was Overcome?
Amar Chahal, Senior Vice President – Global Marketing, Strategy and Corporate Development, Cold Chain Technologies, LLC
3:30 PT
Afternoon Stretch and Coffee Break
3:40 - 4:25 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Cloud Does Not Bite! How to Enhance the Pharma, Biotech and Life Science Industry by Implementing Modern IT Solutions with a Compliant Regulatory Control Framework
Agata Mizera, Cybersecurity Senior Manager in Risk Advisory in Deloitte
CELL & GENE
How Analytics Enables Manufacturing Automation, Process Robustness and Delivers Patient Access to Life-Saving Cell-Based Therapies
To be Announced
SUPPLY CHAIN
Supply Chain Resiliency – Manage Through Disruption
Dominic Mancini, Vice President, Operations,, OrganaBio
4:25 PT
Close of Conference
Early Bird Pricing Ends April 29!
More than ever before, the past 24 months has outlined the need for rapid, scalable and cost-effective vaccine, diagnostic, and therapeutic development. It also showcased the importance of flexibility and the need for the biopharmaceutical manufacturing industry to adapt to changing market demands. Additionally, we’ve recognized the importance of the supply chain as it applies to pharma and biopharma companies, particularly as all industries across the globe are experiencing difficulties across the supply chain.
- Hear from industry experts in biopharma manufacturing with their personal case studies and use-case stories
- Understand how Smart Manufacturing is taking over the Biopharmaceutical Manufacturing Industry
- Examine the role AI, Machine Learning, Data Analytics will continue to change the Biopharma Manufacturing process
- Receive the opportunity to collaborate with your peers across the industry
- Understand the importance of flexible manufacturing and the future of the workforce to biopharma manufacturing
Testimonials
“This is the first time I am attending a Virtual Conference, Love how interactive it is and also the Whova app is great.”
CSV Manager, Meitheal Pharmaceuticals, Inc.
“Great presentations, speakers, and interaction by both onsite and remote participants. Whova has been the best virtual conference platform I’ve experienced over the past few years.”
-ISO IT CSV and SQA Manager, AmerisourceBergen
BIO-SUPPLY CHAIN DISTRIBUTION & PROGRAM MANAGEMENT
- Accelerating Innovation in Ultracold and Cryogenic Medicines Supply Chain Distribution
- Improving the Supply Chain for the Biopharma Industry – What Covid-19 Vaccine Production is Teaching Us
- Automation and Visibility: Effectively Combining People, Processes and Technology to Deliver Supply Chain at Scale
- Accelerating Innovation Across Your E2E Supply Chain to Drive Efficiency and Improve Speed to Market
- Using Digital Twins to Improve the Biopharmaceutical Supply Chain
- Real-time Risk Management: Using Data and Technology to Enhance GDP Compliance and Supply Chain Security
- How the Covid Vaccine Distribution Challenge was Overcome
- Supply Chain Resiliency – Manage Through Disruption
- Improve Supply Chain Visibility, Shipment ETA’s and Workflow Automation with Location Intelligence
CELL & GENE THERAPY – STRATEGIES FOR RAPID ADVANCEMENT AND COST MANAGEMENT
- Strategies for Cell and Gene Therapy Translation from Bench to Bedside
- Challenges & Solutions to Tracking of Off-the-Shelf Cell Therapies
- Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
- Leveraging Platform Technologies for Gene Therapies
- Advances and Trends in Aseptic Fill / Finish for Targeted Therapy Products
- The What and When of GMP for Critical Material in Cell & Gene Therapies
- Optimizing Transfection Process in Suspension Cells to Reduce Dramatically the Cost of Goods of AAV Gene Therapy
- How Can Analytics Enable Manufacturing Automation, Process Robustness, and Deliver Patient Access to Life-Saving Cell-Based Therapies?
- An Allogeneic MSC Source Accelerated the First Cell Therapy for Covid-19 Associated Lung Fibrosis
- Gene Editing and Emerging Technologies
SMART MANUFACTURING AND BIOPROCESSING EXCELLENCE
- Digital Tools in Bioprocess Design and Optimization
- The Road to Digital Transformation in Biopharma: Moving from Change Management to Enterprise Transformation for Bioprocessing 4.0
- Smart Manufacturing and Contamination Control Strategies for Bio-Pharmaceuticals as ATMPs
- Realizing the Paradigm Shift to a Smarter Manufacturing Process
- Leveraging Flexible Networks, Cutting-Edge Innovation in a Quality Culture
- Unleashing the Value of Quality by Design Through Continuous Process Verification, Manufacturing Anomaly Capture & AI-enabled Proactive Quality Response
- Increasing Efficiencies in Bioprocess Development and Manufacturing through Digital Process Development
- Using Process Analytical Technology (PAT) Tools in Biopharmaceutical & Pharmaceutical Manufacturing
- Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
- Data Integrity and Biopharmaceutical Manufacturing
- Enabling Successful Process Validation in Biopharmaceutical Manufacturing
Who Should Attend:
Attendees will come from biopharmaceutical companies, pharma, biotech companies, medtech companies and their peripherals across the globe and will bring together all those individuals involved with the manufacturing process.
VPs/Directors/Managers & Heads of:
- Manufacturing
- Engineering
- R&D / Research & Development
- Process Improvement
- Quality
- Supply Chain
- Operations
- Innovation
- Plant/Site/Facilities
- Quality
- Strategy
- Business Development
- Technology
- IT/Information Technology
- AI
- Data & Analytics
Titles will include:
- Chief Engineering Officer
- Chief Manufacturing Officer
- Chief Scientific Officer
- Chief Innovation Officer
- Chief Technology Officer
- Chief Operations Officer
- Chief Quality Officer
- Chief Data Analytics Officer
