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Showing of Streams
Showing of Streams
9:00am - 10:00am 60 mins
Cell & Gene Connect - Partnering Track
Continental Breakfast
10:00am - 11:30am 90 mins
Cell & Gene Connect - Partnering Track
Welcome Remarks & Opening Panel: Evolving Landscape of Cell & Gene Therapies
  • Patricia Reilly - Vice President of Intelligence Alliances and Product Unification, Pharma intelligence, Informa
  • Morrie Ruffin - Managing Partner, Adjuvant Partners
more
11:30am - 12:30pm 60 mins
Cell & Gene Connect - Partnering Track
Panel: New Partnering Models: R&D, Hospitals, Manufacturers
  • Boro Dropulic - Chief Science Officer and General Manager, Lentigen Technology Inc., A Miltenyi Biotec Company
  • Michelle Berg - Vice President, Patient Affairs and Community Engagement, Abeona Therapeutics, USA
  • Walter Kowtonuik - Principal, Third Rock Ventures, USA
more

It takes a village to develop new therapies.
In the quickly evolving field of regenerative medicine, it takes collaboration amongst different stakeholders to bring new therapies to market. How are patient advocacy groups, researchers, hospitals, manufacturers, and others working together to bring promising new research into life-saving treatments? Leaders in this field will share their best practices in partnering with others to reach shared goals.

12:00pm - 1:00pm 60 mins
Raw Materials Workshop
Registration and Continental Breakfast
12:00pm - 1:00pm 60 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Registration and Continental Breakfast
12:30pm - 1:30pm 60 mins
Cell & Gene Connect - Partnering Track
Lunch Presentations
1:00pm - 1:15pm 15 mins
Raw Materials Workshop
Chairperson's Opening Remarks
1:00pm - 1:15pm 15 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Chairperson's Opening Remarks
  • Thomas Bollenbach - Chief Technology Officer, AMRI
more
1:15pm - 3:15pm 120 mins
Raw Materials Workshop
Session One
  • Omer Butt - Director, CMC Regulatory Affairs, Athersys, Inc, USA
  • Rosemary Versteegen, PhD - CEO, International Serum Industry Association
more
  • Elimination of variations, especially in starting and raw materials/ 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 customised raw materials
  • Assessment of origin and impurity profiles
  • Best practise for providing documented evidence of purity, potency, consistency and stability
  • Supplier agreements and ensuring sufficient supply chain for large scale commercial manufacturing
  • Analytical testing
1:15pm - 1:45pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Keynote Address – Engineered Tissue Manufacturing: Lessons Learned from Large Scale Commercialization
  • Katie Faria - Director, Product and Process Development, Organogenesis Inc., USA
more
1:30pm - 2:30pm 60 mins
Cell & Gene Connect - Partnering Track
Panel: Public/Private Partnerships
  • Issi Rozen - Chief Business Officer, Broad Institute
  • Dan Gincel - VP University Partnerships, TEDCO Executive Director, MD Stem Cell Research Fund, Maryland Stem Cell Research Fund, USA
more

With the complex nature of cell & gene therapies, novel collaborations are needed to turn exciting research into viable treatments. How are private research institutions working together with public entities to gain funding and additional resources to facilitate the advancement of new therapies? Learn how successful partnership models can be instrumental in taking research from the lab to the clinic.

1:45pm - 2:15pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Regulatory Considerations for Tissue Engineered Product Development
  • Yong Fan - Senior Consultant, A2Z Reg Solutions, USA
more
2:15pm - 2:45pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Multi-platform-based Characterization of Cell Products and Processes: Identification of CQAs and Application of QbD Principles
  • Carolyn Yeago - Associate Director of Research, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, USA
more
2:30pm - 3:30pm 60 mins
Cell & Gene Connect - Partnering Track
Panel: Commercialization and Market Access
  • Moderator Amanda Micklus - Principal Analyst, Datamonitor Healthcare
  • Rachael Anatol - Deputy Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation (pending final approval), FDA, CBER, USA
  • Martha Rook - Head, Gene Editing and Novel Modalities, MilliporeSigma
more

As clinical advances continue to be made and new treatments and potential cures are being developed, how can we ensure that patients will have access to these life changing products? How are new guidelines such as RMAT designation facilitate the approval of new drugs? What types of novel pricing models are being developed to address the high costs of these products? Industry experts will discuss the new paths available for bringing these advanced therapies to market.

2:45pm - 3:15pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Role of Data Management and Artificial Intelligence in Automation of Biomanufacturing Process Development
3:15pm - 3:45pm 30 mins
Raw Materials Workshop
Networking Refreshment Break
3:15pm - 3:45pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Networking Refreshment Break
3:30pm - 4:30pm 60 mins
Cell & Gene Connect - Partnering Track
Presentations
3:45pm - 5:50pm 125 mins
Raw Materials Workshop
Session Two
  • Mithu Majumder - Project Manager, RoosterBio Inc., USA
more
  • Elimination of variations, especially in starting and raw materials/ 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 customised raw materials
  • Assessment of origin and impurity profiles
  • Best practise for providing documented evidence of purity, potency, consistency and stability
  • Supplier agreements and ensuring sufficient supply chain for large scale commercial manufacturing
  • Analytical testing
3:45pm - 4:15pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Integrated, Closed System PAT Analytics for Advanced Auto Feedback Control of CPPs in Single Use Bioreactors – Reactive Analytics
4:15pm - 4:45pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Automation and Robotics in Large-Scale Engineered Tissue Manufacturing
4:30pm - 4:45pm 15 mins
Cell & Gene Connect - Partnering Track
Break
4:45pm - 5:15pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Adherent Cell Manufacturing Matters: Production Platform and Media Strategies Drives Cell Production Economics
  • Jon A. Rowley, Ph.D. - Chief Executive & Technology Officer, RoosterBio Inc.
more
4:45pm - 6:00pm 75 mins
Cell & Gene Connect - Partnering Track
Panel: Next Generation Therapies
  • Moderator Jessica Carmen - Director, Business Development, Cellular Therapies, MaxCyte, Inc., USA
  • Sarah Haecker Meeks - Vice President, Business Development, Synpromics, USA
  • Michael Nowak - Managing Partner, Nowak Ventures LLC, USA
more

With exciting progress in the development and commercialization of cell and gene therapies, and CRISPR, CAR-T, and other technologies becoming more mainstream, what are some of the new advances in this field? How are these technologies going to transform healthcare? Are we getting closer to developing cures for diseases instead of treatments for the symptoms?

5:15pm - 5:50pm 35 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Panel Discussion – Title TBD
  • Jon A. Rowley, Ph.D. - Chief Executive & Technology Officer, RoosterBio Inc.
more
5:50pm - 6:00pm 10 mins
Raw Materials Workshop
Chairperson's Closing Remarks and Look Ahead
5:50pm - 6:00pm 10 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Chairperson's Closing Remarks and Look Ahead
  • Thomas Bollenbach - Chief Technology Officer, AMRI
more
6:00pm - 7:00pm 60 mins
Main Conference
Drink's Reception
6:00pm - 8:00pm 120 mins
An Evening of Diversity and Inclusion
PANEL DISCUSSION: Lead the Way: How to Champion Diversity and Inclusion in Life Sciences
more

We all agree that diversity and inclusion is an integral part of a successful organization’s culture. What can you do to make sure that diversity of race, gender, sexual orientation, backgrounds and perspectives is part of your company’s DNA? Hear from industry executives who are leading the way by implementing diversity and inclusion programs at their companies and organizations. Panelists will discuss what it takes to be a leader that drives diversity throughout an organization, and other actionable takeaways to get conversations about inclusion moving throughout your organization.


Roundtable Reception

Following the panel, join attendees for cocktails and conversation at an interactive networking reception. Members of the life science community who are forging the path for diversity will lead roundtable discussions throughout the room. Meet a potential mentor, connect with other attendees, and have substantive conversations about diversity and inclusion.


For more details please visit https://lifesciences.knect365.com/diversity-inclusion/

*Separate Registration Required. Cost to attend is $55 until July 31st, $65 until August 31st, and $75 thereafter. You may add this to your package during the online registration or by emailing register@knect365.com.