Sunday, February 17 |
|
| 2:00 PM - 4:00 PM | Registration |
| 4:00 PM - 4:15 PM | Conference Open (Chairs, Steering Committee) |
| 4:15 PM - 5:00 PM | Keynote Speaker: Accelerating Toward a Future State of Fast, Low Cost Development and Manufacturing of Biologics Jim Thomas, Just Biotherapeutics |
| 5:00 PM - 5:30 PM | Faster, Smarter - Using Innovation to Shift Paradigms David LeDuc, Bonnie J. Addario Lung Cancer Foundation |
| 5:30 PM - 6:00 PM | Rapid Fire Session (with poster presenters) |
| 6:00 PM - 8:00 PM | Poster Session Reception |
Monday, February 18 |
|
| 7:30 AM - 9:00 AM | Registration |
| 7:30 AM - 8:30 AM | Breakfast |
| 8:30 AM - 8:45 AM | Opening Remarks: Aine Hanly, Amgen, Stefanie Pluschkell, Pfizer |
| 8:45 AM - 9:30 AM | Keynote Speaker: Infectious Disease – Designing Biological Therapies for Global Patient Access Michael Kamarck, Vir Biotechnology |
| 9:30 AM - 2:30 PM | Session 1 Advanced Manufacturing Technologies |
| 9:30 AM - 10:00 AM | Challenges and Benefits of Implementing New Technologies in a Bioprocess Guenter Jagschies, GE Healthcare Life Sciences |
| 10:00 AM - 10:30 AM | Product Quality Control in Continuous Manufacturing Brian Turner, Sanofi |
| 10:30 AM - 11:00 AM | Break |
| 11:00 AM - 11:30 AM | Supporting the Biologics Pipeline Portfolio through Flexible Continuous Based Bioprocessing Facilities Mark Brower, Merck |
| 11:30 AM - 12:00 PM | The Evolution of Biomanufacturing and Its Impact on Process Development and Delivery of Polymodal Medicines to Patients Chetan Goudar, Amgen |
| 12:00 PM - 1:00 PM | Lunch |
| 1:00 PM - 1:30 PM | Manufacturing of the Future 2.0: The Continuing Evolution of Biologics Manufacturing Michael Vandiver, Just Therapeutics |
| 1:30 PM - 2:00 PM | Nextgen Bioprocesses: Integration of Process Intensification and Single-Use Facilities to Allow Fast to Clinic with Commercial Capable Processes Todd Luman, Boehringer-Ingelheim |
| 2:00 PM - 2:30 PM | Panel Discussion |
| 2:30 PM - 3:00 PM | Break |
| 3:00 PM - 6:00 PM | Session 2 Interactive Workshop on Advanced Manufacturing Technology Priorities: Perspectives from FDA, Industry, Vendors, Academia |
| 3:00 PM - 6:00 PM | AccBio Workshop: “Advanced Manufacturing Technology Priorities, Challenges and Opportunities” |
| 6:00 PM - 8:00 PM | Dinner |
Tuesday, February 19 |
|
| 7:30 AM - 9:00 AM | Registration |
| 7:30 AM - 8:30 AM | Breakfast |
| 8:30 AM - 9:15 AM | Keynote Speaker: How AI Transforms Medicine and Pharma Regina Barzilay, Massachusetts Institute of Technology (MIT) |
| 9:15 AM - 2:15 PM | Session 3 The use of Advanced Digital Tools and Data Capabilities for Acceleration of Biopharmaceutical Development and Manufacturing |
| 9:15 AM - 9:45 AM | Machine Learning Approaches to Developability Prediction from Antibody Sequence Tushar Jain, Adimab |
| 9:45 AM - 10:15 AM | Biologics Data Management & Analytics: A Boundaryless Approach Towards Proactive Data Analysis and Decision Making For Development & Manufacturing Shailen Singh, Merck |
| 10:15 AM - 10:45 AM | Break |
| 10:45 AM - 11:15 AM | Connecting a Global Development Organization through Digital Transformation Rick St. John, Genentech |
| 11:15 AM - 11:45 AM | Accelerating Bioprocess Development via Digital Transformation Cenk Undey, Amgen |
| 11:45 AM - 12:45 PM | Lunch |
| 12:45 PM - 1:15 PM | An Advanced Process Control Framing to Application of Analytics and Modeling for Biopharm Manufacturing Robert Guenard, Biogen |
| 1:15 PM - 1:45 PM | Digitizing Biopharmaceutical Manufacturing: A Platform for Integrating the Industrial Internet of Things and Big Data Analytics Colin Clarke, The National Institute for Bioprocessing Research and Training (NIBRT) |
| 1:45 PM - 2:15 PM | Panel Discussion |
| 2:15 PM - 2:30 PM | Break |
| 2:30 PM - 6:35 PM | Session 4 Multi-modalities for a Biology First Strategy and Speed to Patients |
| 2:30 PM - 3:15 PM | Steven Oh, US Food and Drug Administration |
| 3:15 PM - 3:45 PM | End-to-End Considerations and Choices for Commercializing Novel Therapeutics Arun Tholudur, Amgen |
| 3:45 PM - 4:15 PM | Accelerated Process Development of Autologous Cell Therapy Products Vijay Chirovolu, Gilead (Kite Pharma) |
| 4:15 PM - 4:35 PM | Break |
| 4:35 PM - 5:05 PM | The First RNAi Therapeutic: Discovery, Development and Approval of Onpattro® and Beyond Manoharan Muthiah, Alnylam Pharmaceuticals |
| 5:05 PM - 5:35 PM | AAV-Based Gene Therapy: Driving to the Future, Learning from the Past Patrick Bastek, Pfizer |
| 5:35 PM - 6:05 PM | Using Scalable Automated Manufacturing Solutions to Democratize Cell Therapies Zachary Hornby, Optera Therapeutics |
| 6:05 PM - 6:35PM | Panel Discussion |
| 6:35 PM - 7:35 PM | Poster Session |
Wednesday, February 20 |
|
| 7:30 AM - 8:00 AM | Registration |
| 7:30 AM - 8:30 AM | Breakfast |
| 8:30 AM - 9:30 AM | Session 5 Leadership and Workforce Development in Biopharma |
| 8:30 AM - 8:50 AM | Catalyzing Biopharmaceutical Manufacturing Workforce Development through Public-Private Partnership John Balchunas, NIIMBL Workforce Development Team |
| 8:50 AM - 9:10 AM | Global Talent Trends in Biotech – A Leading Edge Leadership Framework for Leading Edge Science Pascal Becotte, Russel Reynolds Associates |
| 9:10 AM - 9:30 AM | Panel Discussion |
| 9:30 AM - 12:30 PM | Session 6 Driving Development through Patient Centricity |
| 9:30 AM - 10:00 AM | Connecting Patient to Product Design Donna Luisi, Pfizer |
| 10:00 AM - 10:30 AM | Patient Centricity and Drug Delivery Solutions Atul Patel, Biogen |
| 10:30 AM - 11:00 AM | Break |
| 11:00 AM - 11:30 AM | Delivering Patient Outcomes Matthew James Clemente, Eli Lily & Company |
| 11:30 AM - 12:00 PM | Individualized mRNA-Based Cancer Immunotherapy Andreas Kuhn, BioNTech RNA Pharmaceuticals |
| 12:00 PM - 12:30 PM | Panel Discussion |
| 12:30 PM - 1:00 PM | Conference Wrap-up, closing remarks (Conference Chairs/Steering Committee) |
