AccBio Technical Program

 

 

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)