AGENDA
11:30 PT
Registration & Exhibitor Showroom and Virtual Platform Open House
1:00 - 1:15 PT
Chairman’s Opening Remarks
1:15 - 1:45 PT
Examining Next Generation Biopharmaceutical Manufacturing
David W. Vincent, MPH, PhD, CEO, VTI Life Sciences
1:45 - 2:30 PT
Discovering how Covid-19 has Changed Biopharmaceutical Manufacturing Forever Delivery
Ravi Samavedam, President & COO, Azzur Cleanrooms on Demand Dan Dernbach, VP of Operations at Azzur Cleanrooms on Demand, Azzur Group"
2:30 - 3:00 PT
Smart Manufacturing and Contamination Control Strategies for Bio-Pharmaceuticals as ATMPs
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
3:00 - 3:30 PT
Exhibitor Showroom and Think Tank Sessions
3:45 - 4:15 PT
Using Process Analytical Technology (PAT) Tools in Biopharmaceutical & Pharmaceutical Manufacturing
Venkatesh Srinivasan, Vice President, Global MSAT-BT, Bayer
3:45 - 4:15 PT
Creating the Biopharma Workforce of the Future
Emily Moran, VP, Viral Vector Manufacturing, The Center for Breakthrough Medicines
4:15 - 4:45 PT
Advances and Trends in Aseptic Fill / Finish for Targeted Therapy Products
Keith Dodson, Vice President of GlobalBusiness Development, Automated Systems of Tacoma (AST)
4:15 - 4:45 PT
4 Tips for Enhancing Trust with Contract Organizations for Increased Efficiency and long-lasting Relationships
Luiz Barberini, Head of External Manufacturing Operations, Bayer
4:45 - 5:30 PT
Data Integrity and Biopharmaceutical Manufacturing
Dominic Mancini, Senior Director MSAT, OrganaBio, LLC
Marc Diament, CEO & Founder, Integral Biometrics
Roque Redondo, Senior Technical Consultant, PharmEng Technology
5:30 - 7:30 PT
Game Night - Trivia Welcome Reception
8:00 - 8:45 PT
Registration & Breakfast
8:45 - 9:00 PT
Opening Remarks
9:00 - 9:50 PT
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, Bluebirdbio
9:50 - 10:35 PT
The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 During Covid-19
Jon Thompson, Principal Consultant, CAI
10:00 - 10:25 PT
In-Silico Process Development, Data Management and Data Access on CMC Acceleration
Umay Saplakoglu, Chief Digital Officer, Global General Manager, Cytiva
10.35 - 11:00 PT
Networking break
11:00 - 11:45 PT
Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
Ravi Samavedam, President & COO, Azzur Cleanrooms on Demand
Dan Dernbach, VP of Operations at Azzur Cleanrooms on Demand, Azzur Group
Emily Moran, VP, Viral Vector Manufacturing, The Center for Breakthrough Medicines
11:00 - 11:45 PT
Remote Monitoring and Big Data Advance Upstream Automation and on-line monitoring in BioPharma Manufacturing
11:45 - 12:30 PT
Challenges & Solutions to Distributing and Tracking of Off-the-Shelf Cell Therapies
Amanda Conerty, Sr. Director of CMC, Artiva Biotherapeutics
11:45 - 12:30 PT
Building a Modern Manufacturing Enterprise on the Foundation of IoT, Data-Driven Decision-Making and Digital Technologies
Bryan Ennis, CEO, BTR
12:30 - 1:40 PT
Lunch
1:40 - 2:15 PT
Improving the Supply Chain for the Biopharma Industry – What Covid-19 Vaccine Production is Teaching Us
Kelly Smeltzer, Senior Principal Consultant, CAI
2:15 - 2:55 PT
Regulatory Considerations for Expedited Programs
Kimberley Buytaert-Hoefen, Director of Regulatory Affairs, Azzur
Eric Good, Director of Compliance, ProPharma Group
2:15 - 2:55PT
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, Governance, Risk and Compliance Lead, Capgemini
2:15 - 2:55PT
Enabling Successful Process Validation in Biopharmaceutical Manufacturing
Rahul Rajan Kaushik, VP, Protein/Antibody Process Development & Manufacturing, Fibrogen
2:55 - 3:25 PT
Exhibitor Showroom and Think Tank Sessions
3:25 - 3:40 PT
Networking break
3:40 - 4:15 PT
Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
Priya Baraniak | Vice President, Corporate Development | OrganaBio
4:15 - 4:45 PT
Digital Tools in Bioprocess Design and Optimisation
Maria Papathanasiou | Lecturer | Imperial College London
4:45 - 5:15 PT
Partnering for Success – Collaborations between Industry and Academia
Emily Hopewell, Director, Cell and Gene Therapy Manufacturing, Indiana University
5:15 - 5:30 PT
Closing Remarks for the Day
5:30 - 7:30 PT
Cocktail Reception
8:00 - 8:55 PT
Registration & Breakfast
8:55 - 9:00 PT
Opening Remarks
9:00 - 9:30 PT
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)
9:30 - 10:00 PT
Future-Proofing Life Sciences for the Regulated-Cloud
Bryan Ennis, CEO, BTR
10:00 - 10:25 PT
In-Silico Process Development, Data Management and Data Access on CMC Acceleration
Umay Saplakoglu, Chief Digital Officer, Global General Manager, Cytiva
10:25 - 10:45PT
Networking break
10:45 - 11:15 PT
Leveraging Flexible Networks, Cutting-Edge Innovation in a Quality Culture
10:45 - 11:15 PT
Realizing the Paradigm Shift to a Smarter Manufacturing Process
Chor Sing Tan | Strategy Manager Growth Initiatives | Cytiva
11:15 - 11:45 PT
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
11:15 - 11:45 PT
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
11:45 - 12:30 PT
Exhibitor Showroom and Think Tank Sessions
12:30 - 1:45 PT
Networking Luncheon
1:45 - 2:15 PT
Supply Chain Resiliency – Manage Through Disruption
Dominic Mancini, Senior Director, MSAT, OrganaBio
2:15 - 2:45PT
A Packaging Engineer – Luxury or Necessity?
Jan Gates, President/Advisor Packaging Engineer, PackWise Consulting
2:45 - 3:30 PT
Increasing Efficiencies and Reduced Development Timelines in Bioprocess Development and Manufacturing through Hybrid Modeling
Mark Duerkop, CEO, Novasign GmbH
3:30 - 3:45 PT
Closing Remarks
3:45 PT
End of Biopharmaceutical Manufacturing University
BIOPHARMACEUTICAL MANUFACTURING UNIVERSITY
November 8th – 10th
Take Advantage of Early Bird pricing through October 1st!
More than ever before, the past 18 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. KENX is excited to announce the Biopharmaceutical Manufacturing University event taking place November 8 – 10 in San Diego. This hybrid-format program will provide you with real world case studies and industry insights as to how the biopharma manufacturing industry can transform for a better future.
Topics Being Covered at the Biopharmaceutical Manufacturing University Hybrid Event Include:
- Understanding Process Validation in Biotechnology Manufacturing
- Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
- Examining How New Technologies are Affecting Biopharmaceutical Manufacturing
- Reflecting on the Growing Momentum for Biosimilars in the US
- Creating an Agile Culture to Be Ready to Adapt to New Innovative Ways of Working
- Discovering how Covid-19 has Changed Biopharmaceutical Manufacturing Forever Delivery
- Removing Bottlenecks: Improving the Supply Chain for the Biopharma Industry
- Data Integrity and Biopharmaceutical Manufacturing
- Remote Observation Technologies – Revolutionizing the Pharma Manufacturing Space
- Technology Advancements for Drug Product Manufacturing
- Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
- The Changing Regulatory Processes after The Global Pandemic
- Cautionary Tales of Centralized Pharmaceutical Manufacturing
- Advances in Next-Generation Drug Substance Manufacturing of Biologics
- The Digitization of CMC – The Future for Regulatory Submissions
- Moving from Change Management to Enterprise Transformation
- What is the Vision for AI in Biopharma Manufacturing?
- Data Analytics in Biopharma Manufacturing
- Barriers to User-Adoption of Innovative Technology in Biopharmaceutical Manufacturing
- The Potential of Hybrid Process Modeling and Digital Twins to Master the Goals of Bioprocessing 4.0
- What Does a Modern BioPharmaceutical Manufacturing Facility Look Like?
- The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 During Covid
- Rapid and Cost-Effective Deployment of Modular Biopharma Manufacturing Facilities
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.
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
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
