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Showing of Streams
Showing of Streams
11:00am - 12:00pm 60 mins
Info
Cell & Gene Connect - Partnering Track
Welcome Remarks & Opening
  • Patricia Reilly - Vice President of Intelligence Alliances and Product Unification, Pharma intelligence, Informa
  • Janet Lynch Lambert - CEO, Alliance for Regenerative Medicine
12:00pm - 1:00pm 60 mins
Raw Materials Workshop
Registration
12:00pm - 1:00pm 60 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Registration
12:00pm - 1:00pm 60 mins
Cell & Gene Connect - Partnering Track
Panel: Evolving Landscape of Cell & Gene Therapies
  • Mike Druckman - Partner and Chair, Cell, Tissue and Gene Therapies Team, Hogan Lovells
  • Greg Di Russo - VP, Asset Team Lead, Pfizer
  • Lawrence Klein - Head, Strategy and Business Development, CRISPR Therapeutics
  • Federico Mingozzi - Chief Scientific Officer, Spark Therapeutics
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
1:00pm - 2:00pm 60 mins
Cell & Gene Connect - Partnering Track
Lunch & Refreshments
1:15pm - 2:00pm 45 mins
Raw Materials Workshop
Regulatory guidance surrounding raw materials - USP Chapter <1043>, <92> and EMA’s Ph. Eur. General Chapter 5.2.12
  • Omer Butt - Director, CMC Regulatory Affairs, Athersys, Inc, USA
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
1:45pm - 2:15pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Regulatory Considerations for Tissue Engineered Product Development
  • Richard McFarland - Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI), USA
2:00pm - 2:45pm 45 mins
Raw Materials Workshop
The Critical role of cGMP testing in Successful Commercialization of RoosterBio’s CliniControlTM Products
  • Mithu Majumder - Project Manager, RoosterBio Inc., USA
2:00pm - 3:00pm 60 mins
Info
Cell & Gene Connect - Partnering Track
New partnering models: It takes a village to develop new therapies
  • Boro Dropulic - Chief Science Officer and General Manager, Lentigen Technology Inc., A Miltenyi Biotec Company
  • Tim Miller - President and CEO, Abeona Therapeutics
  • Gabriela Apiou - Director, Translational Research Training and Development, Mass General Hospital Research Institute

In the quickly evolving field of regenerative medicine, it takes collaboration among 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.

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
2:45pm - 3:15pm 30 mins
Raw Materials Workshop
Networking Refreshment Break
2:45pm - 3:15pm 30 mins
Info
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Bridging the gap between Technology and data availability
  • Rami Mitri - CEO/Founder, One Hill Solutions, USA

The FDA and the Industry are both pushing for new developments and the incorporation of the latest technologies as part of their goal for greater process understanding in the development of new products. In order to maximize the benefits of these technologies researchers must have instant data availability. Software must keep up to the pace of these developments. In today's world, a combination of collaborations and partnerships between different vendors are essential to bring all of these technologies together. This discussion will review these collaborations and technologies....

3:00pm - 4:00pm 60 mins
Info
Cell & Gene Connect - Partnering Track
Public/private partnerships
  • Moderator Dan Gincel - VP University Partnerships, TEDCO Executive Director, MD Stem Cell Research Fund, Maryland Stem Cell Research Fund, USA
  • Issi Rozen - Chief Business Officer, The Broad Institute of Harvard and MIT
  • Timothy Herpin - Chief Business Officer, Caribou Biosciences

With the complex nature of cell and 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.

3:15pm - 4:00pm 45 mins
Raw Materials Workshop
Feedback from the ISIA
  • Rosemary Versteegen, PhD - CEO, International Serum Industry Association
3:15pm - 3:45pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Networking Refreshment Break
3:45pm - 4:15pm 30 mins
Info
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
  • Dan Kopec - Technology Expert, PAT, Sartorius Stedim Biotech North America, USA

Process Analytical Technologies (PAT) enable the production of higher quality and more consistent  biologic drugs and  regenerative therapies.  This, all at reduced cost of goods (CoGS),  higher process flexibility. and faster time to market.  This reality is motivating Bio-processors to move toward  Automation, where new modalities and more challenging market dynamics are the new norm.

Classic  bioprocessing methods are no longer satisfactory;  where manual sampling and offline analysis is characterized by; slow, inaccurate, and disjointed data.   Further, Operator intensive, manual control methods are severely data limited.   Advanced automation is the clear solution,  whereby reactive analytics and advanced statistical software can be applied to gain the PAT/QbD (Quality by Design) advantage to clearly define, monitor and control your process.

The good news is that there are now modern, scalable, in-situ, and systems integrated, advanced sensors/ software,  which can provide robust and real time feedback and control, in a closed monitoring system.   With these new tools,   we can achieve a much safer, more efficient,  and risk averse process when we utilize this real time data in an auto feedback loop,  to control our CPP’s within a tighter design space,  and do this with as little human intervention as possible while building a foundation for real time advanced statistical process visualization.

This workshop will highlight the possibilities of PAT/QBD with practical applications and implementation of auto feedback loops for a range of bioprocessing applications;   cell therapy,  protein therapeutics, and tissue engineering.

4:00pm - 4:45pm 45 mins
Raw Materials Workshop
Q&A and Session Wrap Up
  • Rosemary Versteegen, PhD - CEO, International Serum Industry Association
  • Omer Butt - Director, CMC Regulatory Affairs, Athersys, Inc, USA
  • Mithu Majumder - Project Manager, RoosterBio Inc., USA
4:00pm - 5:00pm 60 mins
Info
Cell & Gene Connect - Partnering Track
Commercialization and Market Access
  • Moderator Amanda Micklus - Principal Analyst, Datamonitor Healthcare
  • Panelist Jayson Slotnik - Partner, Health Policy Strategies, Inc.
  • Kristin Wolff - Director, Global Government Affairs and Public Policy, bluebird bio

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.

4:15pm - 4:45pm 30 mins
Workshop on Process Development and Manufacturing Scale Up for Engineered Tissues
Automation in Large-Scale Engineered Tissue Manufacturing
  • Vivek Puthezath - Vice-President, Northeast Operations, E-Volve Systems, USA
4:45pm - 4:55pm 10 mins
Raw Materials Workshop
Chairperson's Closing Remarks and Look Ahead
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.
5:00pm - 6:00pm 60 mins
Info
Cell & Gene Connect - Partnering Track
Panel: Next Generation Therapies
  • Sarah Haecker Meeks - Vice President, Business Development, Synpromics, USA
  • Chris Mason - Chief Science Officer, AvroBio
  • Stefanos Theoharis - Senior VP, Corporate Development and Partnering, Cell Medica
  • Chris Gemmiti, Ph.D. - Head of Operations, Sentien Biotechnologies Inc.

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
  • Panelist Jon A. Rowley, Ph.D. - Chief Executive & Technology Officer, RoosterBio Inc.
  • Moderator Thomas Bollenbach - Chief Technology Officer, AMRI
  • Panelist Katie Faria - Director, Product and Process Development, Organogenesis Inc., USA
  • Panelist Richard McFarland - Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI), USA
  • Panelist Carolyn Yeago - Associate Director of Research, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, USA
  • Panelist Rami Mitri - CEO/Founder, One Hill Solutions, USA
  • Panelist Dan Kopec - Technology Expert, PAT, Sartorius Stedim Biotech North America, USA
  • Panelist Vivek Puthezath - Vice-President, Northeast Operations, E-Volve Systems, USA
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
6:00pm - 8:00pm 120 mins
Info
An Evening of Diversity and Inclusion
PANEL DISCUSSION: Lead the Way: How to Champion Diversity and Inclusion in Life Sciences
  • Moderator Edie Stringfellow - Director of Diversity and Inclusion, MassBio
  • Speaker Joan Reede - Dean for Diversity and Community Partnership, Harvard Medical School
  • Roundtable Moderator Ramsey Johnson - Founder, OUTBio
  • Roundtable Moderator Nicole Gilmore, NEVCA and Hack.Diversity
  • Roundtable Moderator Marshall Milner - Executive Director of Science Training Programs, University of Massachusetts Boston
  • Roundtable Moderator Erica Colonero - Partner & Co-Founder, VisionSpring, Inc
  • Roundtable Moderator Lauren Laidlaw - Executive Director, BioPharma Executive Council

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.