Martin Rosendale, Chief Executive Officer, Maryland Life Sciences

Dr. David Agus, Chief Executive Officer, Ellison Institute for Transformative Medicine, physician, author, CBS Medical Contributor

The development of next generation engineered cell therapies has expanded into novel cell types and are designed with increasingly sophisticated engineering approaches. In this session, we will hear from two companies developing  innovative approaches for novel cell therapeutics for the treatment of a growing list of intractable diseases.  The presentations will be followed by a short Q/A session with the panelists. 

Welcome
Doug Doerfler, President and Chief Executive Officer, MaxCyte

Moderator
Sarah Meeks, Senior Vice President, Business Development, MaxCyte

Panelists
Mike Klichinsky, Co-Founder Senior Vice President, Research, Carisma Therapeutics

Michael Singer MD, PhD, Chief Scientific Officer, Cartesian Therapeutics

Manufacturing of cell and gene therapy is the bottleneck for availing this line of innovative therapies to clinical trials and patients. In this panel, we invited the world experts in cell and gene therapy to address Chemistry, Manufacturing and Controls (CMC) aspects of cGMP manufacturing of cell and gene therapy. The topics include quality by design, scaleup, process control, and product characterization and release. The goal for the panel is to share insights on how to design CGT product and production processes to allow for quality and speedy release.

Moderator
Jeffrey Hung, General Manager, Vigene Biosciences

Panelists
Matthew Hewitt, B.A, PhD, Senior Director, Scientific Solutions, Cell and Gene Therapy, Charles River Labs

David Anderson, Senior Director, Quality Site Head, Kite, a Gilead Company

 Jon Rowley, Chief Product Officer, RoosterBio

The Beyond Oncology panel will discuss applications of cell therapy beyond treatment of advanced cancers. Specific examples will include use of cell & gene therapy for treatment of autoimmune disorders such as myasthenia gravis, respiratory diseases such as ARDS and COVID-19, and rare genetic disorders such as XMEN disease. Ex-vivo cell modification strategies will be compared between different approaches and disease indications. Potential benefits of these novel approaches will be weighed against treatment risks and costs.

Moderator
Murat Kalayoglu, MD, PhD, President, Cartesian Therapeutics

Panelists
Suk See DeRavin, Clinician, Genetic Immunotherapy Section, Laboratory of Clinical Immunology and Microbiology, NIAID, NIH

Dr. Bruce Levy, Chief of Pulmonary and Critical Care Division, Brigham and Women’s Hospital, Harvard Medical School

Dr. Tahseen Mozaffar, Professor, Neurology and Laboratory Medicine, University of California, Irvine

Nicole Wood, Senior Regional Director, State Advocacy, PhRMA

Jim Jackson, Vice President, Manufacturing, Kite, a Gilead Company

With the explosion of biomanufacturing needs being driven by a rapid expansion of funding and life sciences innovations and successes, a critical question persists whether the industry can meet these current and future demands. Will the manufacturing capacity be there to deliver on the promise of great, innovative science? Should needed biomanufacturing be performed in-house with complete control of timelines, budgets and processes or out-source to companies that have the existing facilities, equipment, track record and capability, but may be delayed in offering a slot? If in-house work is on the table, companies have to consider building a new facility and organizational structure, shouldering high capital costs, and managing the long timelines associated with validation and possibly repurposing the equipment if their needs change.

Moderator
Ben Skowronski, Senior Director, Maryland Office Lead, Associate, CRB

Panelists
Craig Malzahn, Vice President, Technical Operations, RegenxBio

Harish Santhanum, Senior Director, Manufacturing Science and Technology, Kite Pharma

Thomas VanCott, PhD, Global Head of Product Development, Cell and Gene Therapy, Catalent Biologics

One of the biggest drivers of biomanufacturing has been the rapid advances in vaccine and cell therapy and their production is undergoing a record transformation. These new technologies will serve as the cornerstone for biomanufacturing facilities of the future. Our panel discussion on Revolutions in Biomanufacturing will highlight the next generation ecosystem of processes, data acquisition, analysis and software automation and how they are used to bring medicines to market faster.

Moderator
Brad Stewart, Senior Vice President of Business Development, Montgomery County Economic Development Corporation

Panelists
Jon Lenihan, Senior Director, Interim CDMO Business Unit Head

Peter Olagunju, Chief Technology Officer, TCR2 Therapeutics

Nicholas Ostrout, PhD, Global Head of Commercial Development, Lonza

Steven Walker, Senior Director and Head, Global Marketing – Early Portfolio Strategy, GSK