Appendix A
Workshop Agenda
Applying Systems Thinking to Regenerative Medicine: A Workshop
October 22–23, 2020
Virtual Workshop
TIMELINE:
October 22: 11:00 a.m.–4:00 p.m. ET
October 23: 10:00 a.m.–2:00 p.m. ET
DAY 1: October 22, 2020
| 11:00 a.m. ET |
Welcome from the Forum Co-Chairs
TIM COETZEE, Forum Co-Chair Chief Advocacy, Services, and Research Officer National Multiple Sclerosis Society |
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KATHY TSOKAS, Forum Co-Chair Regulatory Head of Regenerative Medicine & Advanced Therapy Johnson & Johnson |
| 11:10 a.m. |
Introduction and Charge to the Workshop Speakers and Participants
ANNE PLANT, Workshop Planning Committee Co-Chair Fellow, National Institute of Standards and Technology |
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KRISHNENDU ROY, Workshop Planning Committee Co-Chair Robert A. Milton Chair Professor Director, Engineering Research Center for Cell Manufacturing Technologies National Science Foundation Engineering Research Center for Cell Manufacturing Technologies Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Wallace H. Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University |
SESSION I: INTRODUCTION TO SYSTEMS THINKING CONCEPTS
Moderator: Claudia Zylberberg, Akron Biotech
Session Objectives:
- Provide important background and an introduction to systems thinking approaches and related terminology.
- Explore specific examples of how systems thinking has been applied to areas of health and medicine, including potential opportunities in the regenerative medicine space.
| 11:20 a.m. |
An Introduction to Systems Thinking
WILLIAM BIALEK John Archibald Wheeler/Battelle Professor in Physics, Lewis-Sigler Institute for Integrative Genomics Princeton University |
| 11:35 a.m. |
Applying Systems Thinking to the Development of Regenerative Medicines
PETER ZANDSTRA Director, Michael Smith Laboratories Director and Professor, School of Biomedical Engineering The University of British Columbia |
| 11:50 a.m. |
Computational Approaches for Systems-Level Data Collection
SUI HUANG Professor Institute for Systems Biology |
| 12:05 p.m. | Q&A with the Speakers and Participants |
| 12:30 p.m. | Break |
SESSION II: THE CHALLENGE OF CRITICAL QUALITY ATTRIBUTES: THE ROLE OF SYSTEMS THINKING
Moderator: Anne Plant, National Institute of Standards and Technology
Session Objective:
- Understand the challenges associated with identifying critical quality attributes in the discovery, regulation, and manufacturing of regenerative medicine products and how systems thinking approaches may be applied.
| 1:00 p.m. |
Fireside Chat: Systems Thinking and the Regulation of Regenerative Medicine Products
AMY ABERNETHY Principal Deputy Commissioner of Food and Drugs Food and Drug Administration |
| 1:15 p.m. | Q&A with the Audience |
| 1:30 p.m. | Costs Associated with Not Implementing Systems Thinking Approaches—A Panel Discussion |
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Moderator:
JANE LEBKOWSKI President Regenerative Patch Technologies |
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Panelists: ADRIAN BOT Vice President and Global Head, Translational Medicine Kite Pharma, Inc. |
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BALA MANIAN
Chief Executive Officer Mojave Bio, Inc. |
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DOUGLAS OLSON
President and Chief Executive Officer, BUHLMANN Diagnostics Corp. Scientific Advisory Board Member, Cell Manufacturing Technologies |
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SALLY TEMPLE
Scientific Director, Principal Investigator, and Co-Founder Neural Stem Cell Institute |
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| 2:15 p.m. | Break |
SESSION III: CHALLENGES ASSOCIATED WITH DATA COLLECTION, AGGREGATION, AND SHARING
Moderator: Sadik Kassim, Vor Biopharma
Session Objectives:
- Discuss how big data can be leveraged to identify which patients will respond best to a particular regenerative medicine.
- Highlight challenges in data collection and data sharing such as small sample size in clinical trials, proprietary issues, and patient privacy.
| 2:45 p.m. |
Data Challenges with Omics Analysis and Disease Modeling
LARSSON OMBERG Vice President, Systems Biology Sage Bionetworks |
| 3:00 p.m. |
Using Big Data for Clinical Stratification of Patients
ATUL BUTTE Priscilla Chan and Mark Zuckerberg Distinguished Professor Director, Bakar Computational Health Sciences Institute University of California, San Francisco |
| 3:15 p.m. | Moderated Panel Discussion |
| 3:45 p.m. | Reflections on Day 1 and Preview of Day 2 |
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ANNE PLANT, Workshop Planning Committee Co-Chair Fellow, National Institute of Standards and Technology |
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KRISHNENDU ROY, Workshop Planning Committee Co-Chair Robert A. Milton Chair Professor Director, Engineering Research Center for Cell Manufacturing Technologies National Science Foundation Engineering Research Center for Cell Manufacturing Technologies Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Wallace H. Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University |
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| 4:00 p.m. | Adjourn Workshop Day 1 |
DAY 2: October 23, 2020
| 10:00 a.m. ET |
Welcome and Overview of Day 2
ANNE PLANT, Workshop Planning Committee Co-Chair Fellow, National Institute of Standards and Technology |
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KRISHNENDU ROY, Workshop Planning Committee Co-Chair Robert A. Milton Chair Professor Director, Engineering Research Center for Cell Manufacturing Technologies National Science Foundation Engineering Research Center for Cell Manufacturing Technologies Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Wallace H. Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University |
SESSION IV: CHALLENGES AND OPPORTUNITIES ASSOCIATED WITH SYSTEMS-LEVEL ANALYSIS AND MODELING
Moderator: Malcolm Moos, Food and Drug Administration
Session Objectives:
- Discuss the current state of the art of systems thinking approaches and how these approaches are being used to inform identification of important variables to measure.
- Illuminate current gaps in knowledge and areas for further study.
| 10:10 a.m. |
Developing Algorithms for Single-Cell Genomics
ELANA FERTIG Associate Professor, Oncology Johns Hopkins University |
| 10:25 a.m. |
Adopting Metabolic Modeling Tools in the Biopharmaceutical Industry
ANNE RICHELLE Senior Specialist, Metabolic Modeling GlaxoSmithKline |
| 10:40 a.m. |
Modeling Dynamic Data to Identify a Reduced Variable Space
PAUL FRANCOIS Associate Professor, Department of Physics McGill University |
| 10:55 a.m. | Moderated Panel Discussion |
| 11:15 a.m. | Break |
SESSION V: ADDRESSING REGENERATIVE MEDICINE MANUFACTURING AND SUPPLY CHAIN CHALLENGES WITH SYSTEMS-LEVEL APPROACHES
Moderator: Krishnendu Roy, Georgia Institute of Technology
Session Objective:
- Highlight opportunities where systems thinking approaches could address inefficiencies with manufacturing and the supply chain related to regenerative medicine.
| 11:45 a.m. |
Overview of Artificial Intelligence in Cell and Gene Therapies
IYA KHALIL Global Head of the AI Innovation Center Novartis |
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SESHU TYAGARAJAN
Global Head, Late-Stage Chemistry, Manufacturing, and Control Strategy Novartis |
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| 12:00 p.m. |
Modeling the Manufacturing Process in Regenerative Medicine
THERESA KOTANCHEK Chief Executive Officer Evolved Analytics, LLC |
| 12:15 p.m. |
Supply Chain and Cost Modeling
BEN WANG Gwaltney Chair in Manufacturing Systems Professor and Executive Director Georgia Tech Manufacturing Institute |
| 12:30 p.m. | Moderated Panel Discussion |
| 1:00 p.m. | Break |
SESSION VI: EXPLORING ISSUES OF WORKFORCE DEVELOPMENT RELATED TO SYSTEMS THINKING
| 1:20 p.m. | Challenges and Opportunities for Training and Workforce Development in Data Science, Artificial Intelligence, and Computational Biology: A Panel Discussion |
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Moderator:
TOM BOLLENBACH Chief Technology Officer Advanced Regenerative Manufacturing Institute |
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Panelists:
JOHN BALCHUNAS Workforce Director The National Institute for Innovation in Manufacturing Biopharmaceuticals |
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ALISON GAMMIE
Director of Training, Workforce Development and Diversity National Institute of General Medical Sciences National Institutes of Health |
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DAWN TILBURY
Assistant Director, Engineering National Science Foundation |
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ROBERT ZAMBON
Senior Director, Data Strategy and External Innovation Johnson & Johnson |
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| 1:50 p.m. |
Reflections from the Workshop and Final Comments
ANNE PLANT, Workshop Planning Committee Co-Chair Fellow, National Institute of Standards and Technology |
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KRISHNENDU ROY, Workshop Planning Committee Co-Chair Robert A. Milton Chair Professor Director, Engineering Research Center for Cell Manufacturing Technologies National Science Foundation Engineering Research Center for Cell Manufacturing Technologies Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Wallace H. Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University |
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| 2:00 p.m. | Adjourn Workshop Day 2 |
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