Immerse yourself in a day dedicated to raw materials for cell and gene therapies. Topics to be covered include:

• Elimination of variations, especially in starting and rawnmaterials/ ancillary materials and manual manufacturing steps

• GMP-grade raw materials

• Regulatory guidance surrounding raw materials - USP Chapter <1043>, <92> and EMA’s Ph. Eur. General Chapter 5.2.12

• Automated systems linked to the removal of variation in raw materials

• Developments in manufacturing augmenting a greater need for higher quality raw materials and customized raw materials

• Assessment of origin and impurity profiles

• Best practice for providing documented evidence of purity, potency, consistency and stability

• Supplier agreements and ensuring sufficient supply chain for large scale commercial manufacturing

• Analytical testing

Speakers include:

• Omer Butt, Director, CMC Regulatory Affairs, Athersys Inc, USA
• Mithu Majumder, Project Manager, RoosterBio Inc, USA
• Rosemary Versteegen, CEO, ISIA, USA

1:00: Chairperson’s Opening Remarks
Tom Bollenbach, Ph.D., Chief Technology Officer, Advanced Regenerative Manufacturing Institute

1:15: Keynote Address – Engineered Tissue Manufacturing: The Failures of the Past are the Lessons for Today
Katie Faria, Director of Product and Process Development, Organogenisis

1:45: Regulatory Considerations for Tissue Engineered Product Development
Yong Fan, Senior Consultant, A2Z Reg Solutions, USA

2:15: Multi-platform-based Characterization of Cell and Tissue Processes: Application of DOE and QbD Principles
Carolyn Yeago, Assoc. Director of Research, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, USA

2:45: Role of Data Management and Artificial Intelligence in Automation of Biomanufacturing Process Development

3:15: Networking Refreshment Break

3:45: Integrated, Closed System PAT Analytics for Advanced Auto Feedback Control of CPPs in Single Use Bioreactors – Reactive Analytics

4:15: Automation and Robotics in Large-Scale Engineered Tissue Manufacturing

4:45: Adherent Cell Manufacturing Matters: Production Platform and Media Strategies Drives Cell Production Economics
Jon A. Rowley, Chief Executive & Technology Officer, RoosterBio Inc.

5:15: Panel Discussion

5:50: Chairperson’s Closing Remarks and Look Ahead

*Produced in association with ARMI

The Cell & Gene Connect is a partnering program focused on business development opportunities in the cell and gene therapy sectors. The 1-day program will highlight opportunities for valuable partnerships, best practices for collaborating with new stakeholders, the latest research developments, plus commercialization and market access solutions.

11:00am: Welcome Remarks & Opening Panel: Evolving Landscape of Cell & Gene Therapies
Patricia Reilly, Head of Intelligence Alliances & Product Unification, Pharma intelligence | informa
Morrie Ruffin, Co-Founder and Senior Advisor

12:30am: Panel Discussion: New Partnering Models: R&D, Hospitals, Manufacturer
Boro Dropulic, Chief Scientific Officer & General Manager, Lentigen Technology, Inc A Miltenyi Company
Michelle Berg, Vice-President, Patient Affairs and Community Engagement, Abeona
Walter Kowtoniuk, Global Genes Advisor and Principal, Third Rock Ventures

1:30pm: Lunch presentations

2:30pm: Panel Discussion: Public/Private Partnerships
Issi Rozen, Chief Business Officer, Broad Institute
Dan Gincel, Executive Director of Maryland Stem Cell Research Fund

3:30pm: Panel Discussion: Market Access
Moderator: Amanda Micklus, Principal Analyst, Datamonitor Healthcare
Panelists:
FDA: Rachael Anatol, Ph.D., Deputy Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation
Martha Rook, Head of Gene Editing and Novel Modalities, MilliporeSigma / EMD Millipore

4:30pm: Presentations

5:00pm: Panel Discussion: Next Generation Therapies
Moderator: Jessica Carmen, Director of Business Development, Cellular Therapies, MaxCyte, Inc.
Panelists:
Sarah Haecker Meeks, VP Business Development, Synpromics, Ltd
Michael Nowak, Navan Technology

*Partnering meetings will take place from 11:30am - 6:00pm