IN-PERSON PROGRAM AND LIVESTREAM
7:00am – 9:00am | REGISTRATION AND BREAKFAST
Sponsored by FUJIFILM Irvine Scientific
7:45am – 8:45am | CONCURRENT WORKSHOPS
DIGITAL INNOVATION FOR CELL AND GENE THERAPIES – REDEFINING MANUFACTURING THROUGH THE DIGITAL PROTOCOL
7:45am – 8:45am | Ecolab Life Sciences Ballroom
Sponsored by L7 Informatics
Chair:
Trent Carrier, Ph.D., Chief Operating Officer, L7 Informatics
Speakers:
Julien Cottineau, Ph.D., Chief Scientific Officer, Co-Founder, WhiteLab Genomics
Fabian Gerlinghaus, Co-Founder and CEO, Cellares Corporation
Kevin Gordon, Chief Digital Officer, Ori Biotech
Timothy Lu, M.D., Ph.D., Co-Founder and CEO, Senti Bio
PRIORITIZING PATIENT ACCESSIBILITY AND SUSTAINABILITY WHEN MANUFACTURING CELL THERAPIES FOR CANCER
7:45am – 8:45am | Rentschler ATMP Ballroom
Sponsored by ScaleReady
Join leading industry experts as they discuss a number of relevant topics facing the sector today including manufacturing standardization, patient accessibility and sustainability and the downside of complex automation. They will also discuss sustainability challenges when trying to commercialize and how to overcome these obstacles.
Chair:
Josh Ludwig, Global Director, Commercial Operations, ScaleReady
Speakers:
Jason Bock, Ph.D., Founder and CEO, CTMC
Steve Gavel, Chief Commercial Officer, Legend Biotech
Jeff Liter, CEO and Founder, Luminary Therapeutics
Joseph Lomakin, Ph.D., Head of Strategy, Precision Medicine, Draper
SCALING NEW HEIGHTS IN CELL AND GENE THERAPY
7:45am – 8:45am | ARM Ballroom
Sponsored by ZS
In order to overcome the challenges currently facing cell and gene therapies (C>), the next generation of manufacturers must prepare to serve small and large patient populations across a wide range of care settings to harmonize clinical workflows, reduce HCP burden and deliver therapies at a fraction of the current cost. This cannot be achieved by incrementally tweaking the existing model. Rather, it requires leapfrogging the current C> 1.0 “proof-of-concept” to deliver fundamentally new capabilities. To deliver on the promise of C> 2.0, a new approach is required, one that considers the needs more holistically across the end-to-end patient journey.
Chair:
Bill Coyle, Principal, Global Head of BioPharma Vertical, ZS
Speakers:
Taby Ahsan, Ph.D., Vice President, Cell and Gene Therapy Operations, City of Hope
Warner Biddle, Senior Vice President, Global Head of Commercial, Kite Pharma
Jonathon DiTroia, Vice President, Strategy, Cell, Gene and Advanced Therapies, McKesson
George Eastwood, Chairman of the Board, Emily Whitehead Foundation
Kristin Yarema, Ph.D., President, Cell Therapy, Poseida Therapeutics
9:00am | GENERAL SESSION
WELCOME REMARKS
{Aseptic Technologies Ballroom}
9:00am – 9:30am
Speakers:
Tim Hunt, CEO, Alliance for Regenerative Medicine (ARM)
Devyn Smith, Ph.D., CEO, Arbor Biotechnologies; Chairman, Alliance for Regenerative Medicine (ARM)
9:30am – 10:30am | CONCURRENT TRACKS
PLENARY SESSION: A DEEP DIVE INTO THE FUTURE OF ADVANCED THERAPIES
{Aseptic Technologies Ballroom}
9:30am – 10:30am
This session will feature leading executives in the advanced therapies space who will discuss a number of topics including the current state of the sector, future technologies and innovations, and a forecast on potential approvals. The session will also touch upon solutions for manufacturing and regulatory bottlenecks as the sector moves towards commercialization, as well as the evolution of reimbursement payment models.
Chair:
Anshul Mangal, President, Project Farma and Precision ADVANCE
Speakers:
Phil Cyr, Senior Vice President, Precision Value & Health
Derek Hicks, Chief Business Officer, Intellia Therapeutics
Ann Lee, Ph.D., Chief Technical Officer, Prime Medicine
Bob Smith, Senior Vice President, Global Gene Therapy Business, Pfizer
Sumit Verma, Senior Vice President Global Strategic Manufacturing, Iovance Biotherapeutics
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
9:30am – 10:30am
| 9:30am – 9:45am | GENETHON |
| 9:45am – 10:00am | DiscGenics |
| 10:00am – 10:15am | ExCellThera |
| 10:15am – 10:30am | Aldevron |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
9:30am – 10:30am
| 9:30am – 9:45am | Capstan Therapeutics |
| 9:45am – 10:00am | VERIGRAFT |
| 10:00am – 10:15am | Avery Therapeutics |
| 10:15am – 10:30am | Excellos |
10:30am – 10:45am | MORNING BREAK
Sponsored by Forian and Orgenesis
10:45am – 11:15am | CONCURRENT TRACKS
SPOTLIGHT SESSION
{Aseptic Technologies Ballroom}
10:45am – 11:15am
Chair:
Devyn Smith, Ph.D., CEO, Arbor Biotechnologies; Chairman, Alliance for Regenerative Medicine (ARM)
Speaker:
Nicole Verdun, M.D., Director, Office of Therapeutic Products (OTP), U.S. Food and Drug Administration (FDA)
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
10:45am – 11:15am
| 10:45am – 11:00am | Cabaletta Bio |
| 11:00am – 11:15am | Intellia Therapeutics |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
10:45am – 11:15am
| 10:45am – 11:00am | FibroBiologics |
| 11:00am – 11:15am | Notch Therapeutics |
11:15am – 12:15pm | CONCURRENT TRACKS
INVESTING IN CELL AND GENE THERAPIES – DEAL MAKERS AND DEAL BREAKERS
{Aseptic Technologies Ballroom}
11:15am – 12:15pm
Chair:
Matthew Hewitt, Ph.D., Vice President, Technical Officer Cell and Gene Therapy and Biologics, Charles River Laboratories
Speakers:
Valerie Dixon, Managing Director, Morgan Stanley
Daniella Kranjac, Founding Partner, Managing Director, Dynamk Capital
Sean Mackay, Operating Partner, Casdin Capital
SCIENCE SLAM: AUTOLOGOUS IPSC-DERIVED CELL THERAPIES – PROMISE, PROGRESS, AND CHALLENGES
11:15am – 12:15pm | Ecolab Life Sciences Ballroom
Sponsored by Cellino
This Science Slam will explore the potential of iPSC-based therapies, provide an overview of recent progress in the field, and address potential challenges for this critical therapeutic modality.
Chair:
Marinna Madrid, Ph.D., Co-Founder & Chief Product Officer, Cellino
Speakers:
Kapil Bharti, Ph.D., Scientific Director, National Eye Institute (NEI)
Kevin D’Amour, Ph.D., Chief Scientific Officer, Stemson Therapeutics
Xiaokui Zhang, Ph.D., Chief Scientific Officer, Aspen Neuroscience
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
11:15am – 12:15pm
| 11:15am – 11:30am | NKILT Therapeutics |
| 11:30am – 11:45am | Aspen Neuroscience |
| 11:45am – 12:00pm | Form Bio |
| 12:00pm – 12:15pm | Ori Biotech |
12:15pm – 1:15pm | LUNCH
Sponsored by Notch Therapeutics
1:15pm – 2:00pm | CONCURRENT TRACKS
CLOSING THE CELL AND GENE THERAPY WORKFORCE GAP
{Aseptic Technologies Ballroom}
1:15pm – 2:00pm
ARM released its Workforce Report Gap Analysis for the Cell and Gene Therapy Sector, highlighting how the need for continued investment into developing a skilled workforce for the sector is key in enabling patient access to these advanced therapeutics across the United States (US). This panel will discuss current barriers to effective workforce education and provide strategies for scaling successful training models across the US and worldwide.
Chair:
Nirupama Pike, Ph.D., Senior Director, Global Head of Strategic Alliances and Field Scientists, Cell Therapy, Catalent Pharma Solutions
Speakers:
Kelvin Lee, Ph.D., Director, NIIMBL
Timothy Miller, Ph.D., CEO, President and Co-Founder, Forge Biologics
Stephen Ward, Ph.D., Chief Manufacturing Officer, Cell and Gene Therapy Catapult
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
1:15pm – 2:00pm
| 1:15pm – 1:30pm | Coave Therapeutics |
| 1:30pm – 1:45pm | Caribou Biosciences |
| 1:45pm – 2:00pm | Vor Bio |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
1:15pm – 2:00pm
| 1:15pm – 1:30pm | ARScience Biotherapeutics |
| 1:30pm – 1:45pm | Myeloid Therapeutics |
| 1:45pm – 2:00pm | AviadoBio |
2:00pm – 3:00pm | CONCURRENT TRACKS
A PERSPECTIVE FROM THE TRENCHES – CHALLENGES OF BUDGETING FOR GENE THERAPIES, INNOVATIVE PAYMENT SYSTEMS THAT WORK FOR MEDICAID DEPARTMENTS AND WHAT THE STATES NEED FROM US HHS
{Aseptic Technologies Ballroom}
2:00pm – 3:00pm
Chair:
Thomas Barker, Partner, Foley Hoag; General Counsel, US HHS; Counsel to the CMS Administrator; Adjunct Professor, Health Law, George Washington University School of Law
Speakers:
Paul Jeffrey, Pharm.D., Former Senior Director of Pharmacy, MassHealth
Karen Kimsey, Former Director, Virginia Department of Medical Assistance Services
Scott McGoohan, Executive Director, Policy and Alliance Development, Vertex Pharmaceuticals
SCIENCE SLAM: INNOVATING AAV VECTORS TO ACHIEVE BETTER GENE THERAPY OUTCOMES
2:00pm – 3:00pm | Ecolab Life Sciences Ballroom
Sponsored by MilliporeSigma
As the use of gene therapies grows and evolves, the breadth of indications and treated patient populations will increase. These changes necessitate improvements in efficacy, quality, and manufacturability that are difficult to achieve with current and traditional approaches. This session will present unique innovations in AAV gene therapies that leverage changes to capsids or the cargo they carry to enable better production, delivery, and therapeutic outcomes. The panelists will also discuss how early, coordinated collaboration across innovation, process development, and CMC teams is essential to reduce risk along the pathway to clinical trials and commercialization.
Chair:
Daniel Teasley, Ph.D., Head of Strategic Marketing, Biologics and Viral Vectors, MilliporeSigma
Speakers:
Rodolphe Clerval, CEO, Coave Therapeutics
TJ Cradick, Ph.D., Chief Scientific Officer, Excision BioTherapeutics
An Song, Ph.D., Chief Development Officer, 4DMT
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
2:00pm – 3:00pm
| 2:00pm – 2:15pm | Akadeum Life Sciences |
| 2:15pm – 2:30pm | Körber Pharma Software |
| 2:30pm – 2:45pm | SparingVision |
| 2:45pm – 3:00pm | Cellistic |
3:00pm – 3:30pm | CONCURRENT TRACKS
SPOTLIGHT SESSION: FRONTIERS OF IMMUNE HEALTH – ADVANCEMENTS IN CELL THERAPY FOR AUTOIMMUNE DISEASES
{Aseptic Technologies Ballroom}
3:00pm – 3:30pm
Chair:
Alberto Santagostino, Cell and Gene CDMO Business Unit Head, Lonza
Speakers:
Kristi Jones, CEO, NexImmune
Tracey Lodie, Ph.D., Chief Scientific Officer, Quell Therapeutics
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
3:00pm – 3:30pm
| 3:00pm – 3:15pm | Precision BioSciences |
| 3:15pm – 3:30pm | Teknova |
COMPANY PRESENTATIONS<
{Rentschler ATMP Ballroom}
3:00pm – 3:30pm
| 3:00pm – 3:15pm | Aspect Biosystems |
| 3:15pm – 3:30pm | Anocca |
3:30pm – 3:45pm | CONCURRENT TRACKS
COMPANY PRESENTATION
{Rentschler ATMP Ballroom}
3:30pm – 3:45pm
| 3:30pm – 3:45pm | Mana.bio |
3:45pm – 4:00pm | AFTERNOON BREAK
Sponsored by Forian and Orgenesis
4:00pm – 5:00pm | CONCURRENT TRACKS
THE IMPORTANCE OF ETHICS IN GENE AND CELL THERAPY
{Aseptic Technologies Ballroom}
4:00pm – 5:00pm
With the recent technical and commercial success of cell and gene therapies comes select challenges facing the field. Many of these challenges can be categorized as “ethical” issues confronting leaders in the field and other key stakeholders. This panel will explore a broad range of some of the most difficult ethical dilemmas facing the industry.
Chair:
Tim Hunt, CEO, Alliance for Regenerative Medicine (ARM)
Speakers:
J. Benjamin Hurlbut, Ph.D., Associate Professor, School of Life Sciences, Arizona State University
Janet Lambert, Former CEO, Alliance for Regenerative Medicine (ARM)
Rob Perez, Operating Partner, General Atlantic; Founder and Chairman, Life Science Cares
Tay Salimullah, Vice President, Head Global Value and Access, Novartis Gene Therapies
Durhane Wong-Rieger, Ph.D., President and CEO, Canadian Organization for Rare Diseases
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
4:00pm – 5:00pm
| 4:00pm – 4:15pm | CTI Clinical Trial & Consulting |
| 4:15pm – 4:30pm | Prescient Therapeutics |
| 4:30pm – 4:45pm | Carisma Therapeutics |
| 4:45pm – 5:00pm | Cynata Therapeutics |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
4:00pm – 5:00pm
| 4:00pm – 4:15pm | Oxford Biomedica |
| 4:15pm – 4:30pm | McKesson |
| 4:30pm – 4:45pm | Celosia Therapeutics |
| 4:45pm – 5:00pm | Chroma Medicine |
5:00pm – 6:00pm | CONCURRENT TRACKS
CELL AND GENE THERAPIES MANUFACTURING: EXPLORING NEXT-GENERATION PLATFORM TECHNOLOGIES AND FUTURE INNOVATIONS
{Aseptic Technologies Ballroom}
5:00pm – 6:00pm
This panel will provide an in-depth update on the latest advancements in platform technologies for cell and gene therapies manufacturing. Experts will discuss the current state of the field and shed light on what to expect in the near future. Join us as we explore the emerging trends, challenges, and potential breakthroughs that will shape the future of manufacturing in the cell and gene therapies industry.
Chair:
Raj Prabhakar, Chief Business Officer, Rocket Pharmaceuticals
Speakers:
P.J. Brooks, Ph.D, Deputy Director, Office of Rare Diseases Research, NCATS, NIH
Shawdee Eshghi, Ph.D., Head of Cell Therapy, Ginkgo Bioworks
Ken Prentice, Vice President, Head of Process and Product Development, Shape Therapeutics
Mercedes Segura Gally, Ph.D., Vice President, Process Development, ElevateBio
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
5:00pm – 6:00pm
| 5:00pm – 5:15pm | Forge Biologics |
| 5:15pm – 5:30pm | Orca Bio |
| 5:30pm – 5:45pm | Xintela |
| 5:45pm – 6:00pm | Versiti |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
5:00pm – 6:00pm
| 5:00pm – 5:15pm | AffyImmune Therapeutics |
| 5:15pm – 5:30pm | Atamyo Therapeutics |
| 5:30pm – 5:45pm | Cellatoz Therapeutics |
| 5:45pm – 6:00pm | ReCode Therapeutics |
6:00pm | PROGRAM AND PARTNERING CLOSES
6:00pm – 9:00pm | NETWORKING BASH
Sponsored by American Red Cross, Bionique, ReciBioPharm and UBC
7:00am – 9:00am | REGISTRATION AND BREAKFAST
Sponsored by TAAV Biomanufacturing Solutions
7:45am – 8:45am | CONCURRENT WORKSHOPS
7:45am – 8:45am | Ecolab Life Sciences Ballroom
Sponsored by Thermo Fisher Scientific
ADVANCING MANUFACTURING AUTOMATION IN CELL AND GENE THERAPY – INSIGHTS FROM STRATEGIC COLLABORATIONS AND EMERGING TECHNOLOGIES
The effective implementation and integration of technological advancements in cell and gene therapy manufacturing can be significantly impacted by the development of long-term strategic collaborations, to support technology transfer and process integration. This panel will explore emerging technologies and key factors that have critically contributed to successful establishment of a robust clinical manufacturing process. Panelists will also examine the current state of cell therapy processing, gaps to be addressed, advancements in manufacturing automation, and discuss considerations for future design strategies using emerging AI/ML tools.
Chair:
Betty Woo, Ph.D., Vice President, Cell, Gene and Advanced Therapies, Thermo Fisher Scientific
Speakers:
Ivie Aifuwa, Ph.D., Director, Development Engineering and Automation, Bristol Myers Squibb
Seth Ettenberg, Ph.D., President and CEO, BlueRock Therapeutics
Dan Herring, General Manager, Advanced Therapies, Patheon
7:45am – 8:45am | Rentschler ATMP Ballroom
Sponsored by Azzur Group
EVERYTHING, EVERYWHERE, ALL AT ONCE – SIMPLIFYING THE PATHWAY TO EARLY-PHASE ATMP MANUFACTURING
Navigating the landscape of early-phase ATMP manufacturing can seem like stepping into a multiverse of quality, facility, and scheduling challenges. In this panel discussion, hear from leaders in cell and gene therapy, as well as innovative service providers about how to maintain control of your process and accelerate your time to the clinic while traversing this tricky landscape.
Chair:
Erik Clausen, Managing Partner, CG Life
Speakers:
Adam Bartley, Vice President Technical Operations and Facilities, Editas Medicine
Scott Nudelman, Co-Founder and Managing Principal, Vitrian
Ravi Samavedam, Chief Innovation Officer, Azzur Group
Andrew Sandford, President of BaseCamp, ElevateBio
7:45am – 8:45am | ARM Ballroom
Sponsored by FUJIFILM Irvine Scientific
ACCELERATING THE PATH TO SUCCESS: THE SIGNIFICANCE OF SUPPLIER PARTNERSHIPS IN THE DEVELOPMENT PROCESS
Working with a flexible, responsive partner can be a catalyst for driving innovation and finding solutions to complex challenges. The key is finding a supplier who works closely with customers to identify and eliminate bottlenecks in development and manufacturing.
Chair:
Mayasari Lim, Ph.D., Associate Director, FUJIFILM Irvine Scientific
Speakers:
Haro Hartounian, Ph.D., Founder and CEO, BioCentriq
Tim Kelly, Ph.D., CEO, RoosterBio
Dave Smith, President and Chief Commercial Officer, Akron Biotech
9:00am | GENERAL SESSION
UPDATE ON ARM’S GROW INTERNSHIP PROGRAM
{Aseptic Technologies Ballroom}
9:00am – 9:15am
Speaker:
Rita Johnson-Greene, Chief Operating Officer, Alliance for Regenerative Medicine (ARM)
9:15am – 10:15am | CONCURRENT TRACKS
PLENARY SESSION: OPPORTUNITIES AND BENEFITS OF EARLY PATIENT ENGAGEMENT IN CELL AND GENE THERAPY DEVELOPMENT
{Aseptic Technologies Ballroom}
9:15am – 10:15am
Patients and caregivers impacted by one of the 10,000 rare diseases recognize their lives depended in not only becoming experts in their given disease, but also in the clinical development, regularly process and access decision making. In this session, you will hear from patients and caregiver experts who are driving drug development for their communities and working to improve policies that impact access to treatments and diagnostics. This session will highlight the critical role of patients and the necessity of patient engagement across all stages of product/platform development, the challenges and opportunities which lie therein, and the benefits realized by the developer with early patient engagement.
Chair:
Julia Jenkins, Executive Director, EveryLife Foundation for Rare Diseases
Speakers:
Evren Ayik, ASMD Advocate and Member of YARR
Pat Furlong, Founding President and CEO, Parent Project Muscular Dystrophy (PPMD)
Jennifer Panagoulias, Head of Regulatory and Policy, Foundation for Angelman Syndrome Therapeutics (FAST)
Adrienne Shapiro, Board Member, Sick Cells
Christine Waggoner, President and Co-Founder, Cure GM1 Foundation
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
9:15am – 10:15am
| 9:15am – 9:30am | Albumedix |
| 9:30am – 9:45am | Papillon Therapeutics |
| 9:45am – 10:00am | Myrtelle |
| 10:00am – 10:15am | BlueRock Therapeutics |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
9:15am – 10:15am
| 9:15am – 9:30am | InGel Therapeutics |
| 9:30am – 9:45am | Life Edit Therapeutics |
| 9:45am – 10:00am | RoslinCT |
| 10:00am – 10:15am | STRM.BIO |
10:15am – 10:45am | MORNING BREAK
Sponsored by Forian and Orgenesis
10:45am – 11:15am | CONCURRENT TRACKS
SPOTLIGHT SESSION: ARE CGTS A GOOD CLINICAL BET?
{Aseptic Technologies Ballroom}
10:45am – 11:15am
Mark Trusheim of Tufts NEWDIGS unveils new data on clinical success rates for cell and gene therapy, in a conversation with Tenaya Therapeutics CEO Faraz Ali.
Chair:
Faraz Ali, CEO, Tenaya Therapeutics
Speaker:
Mark Trusheim, Strategic Director, NEWDIGS, Tufts Medical Center
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
10:45am – 11:15am
| 10:45am – 11:00am | Athersys |
| 11:00am – 11:15am | Arbor Biotechnologies |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
10:45am – 11:15am
| 10:45am – 11:00am | March Biosciences |
| 11:00am – 11:15am | Capsida Biotherapeutics |
11:15am – 12:15pm | CONCURRENT TRACKS
ACCELERATED APPROVAL: CATALYZING ADVANCEMENTS IN THE CELL AND GENE THERAPY FIELD
{Aseptic Technologies Ballroom}
11:15am – 12:15pm
The accelerated approval pathway allows therapies that treat serious conditions and fill an unmet medical need, including rare and ultrarare genetic diseases, to be approved based on a surrogate endpoint. In recent years, we have been seeing cell and gene therapy product approvals through this pathway. This panel aims to discuss the regulatory environment, misconceptions, and key learnings from recently approved products.
Chair:
Nimi Chhina, Ph.D., Executive Director, Head of Global R&D and Regulatory Policy, BioMarin
Speakers:
Anne-Virginie Eggimann, Chief Regulatory Officer, Tessera Therapeutics
Fran Gregory, Vice President, Emerging Therapies, Cardinal Health
Curran Simpson, Chief Operating Officer, REGENXBIO
Nicole Verdun, M.D., Director, Office of Therapeutic Products (OTP), U.S. Food and Drug Administration (FDA)
SCIENCE SLAM: ROAD TO SCALABILITY AND ACCESS TO IPSC-DERIVED THERAPIES
11:15am – 12:15pm | Ecolab Life Sciences Ballroom
Sponsored by Cell and Gene Therapy Catapult
iPSC-derived therapies are heralded as the panacea for allogeneic therapies and have the potential to provide scalability, economy and access to patients around the globe. However, many hurdles remain around manufacturing, regulations and market access. This session will discuss approaches and next steps towards commercialization of PSC-based therapies, including manufacturing innovations for scale, product characterization, as well as regulatory perspectives around starting materials.
Chair:
Jacqueline Barry, Ph.D., Chief Clinical Officer, Cell and Gene Therapy Catapult
Speakers:
Stefan Braam, Ph.D., Chief Technology Officer, Cellistic
Jennifer Dashnau, Ph.D., Vice President, Analytical Development and Quality Control, Century Therapeutics
Salka Elbøl Rasmussen, Ph.D., Head of Cell Therapy Innovation, Novo Nordisk
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
11:15am – 12:15pm
| 11:15am – 11:30am | Ray Therapeutics |
| 11:30am – 11:45am | InVitria |
| 11:45am – 12:00pm | Affinia Therapeutics |
| 12:00pm – 12:15pm | Andelyn Biosciences |
12:15pm – 1:15pm | LUNCH
Sponsored by iVexSol
1:15pm – 1:45pm | CONCURRENT TRACKS
SPOTLIGHT SESSION: PRECISION DNA TARGETING – ABOVE AND WITHIN GENOME EDITING
{Aseptic Technologies Ballroom}
1:15pm – 1:45pm
Chair:
Devyn Smith, Ph.D., CEO, Arbor Biotechnologies; Chairman, Alliance for Regenerative Medicine (ARM)
Speakers:
Alex Harding, M.D., Senior Vice President, Head of Business Development, CRISPR Therapeutics
Hari Pujar, Ph.D., Chief Operating Officer, Tessera Therapeutics
Laura Sepp-Lorenzino, Ph.D., Chief Scientific Officer, Intellia Therapeutics
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
1:15pm – 1:45pm
| 1:15pm – 1:30pm | Center for Gene Therapy at Nationwide Children’s Hospital Institute |
| 1:30pm – 1:45pm | Capricor |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
1:15pm – 1:45pm
| 1:15pm – 1:30pm | Nanite |
| 1:30pm – 1:45pm | TreeFrog Therapeutics |
1:45pm – 2:45pm | CONCURRENT TRACKS
COMPANY PRESENTATIONS
{Aseptic Technologies Ballroom}
1:45pm – 2:45pm
| 1:45pm – 2:00pm | Arcellx |
| 2:00pm – 2:15pm | Rocket Pharmaceuticals |
| 2:15pm – 2:30pm | Agathos Biologics |
| 2:30pm – 2:45pm | Poseida Therapeutics |
SCIENCE SLAM: THE ROLE OF MRNA IN ENABLING A NEW GENERATION OF IMMUNO-ONCOLOGY PRODUCTS
1:45pm – 2:45pm | Ecolab Life Sciences Ballroom
Sponsored by Cytiva
mRNA has recently been demonstrated as a flexible aid for immuno-oncology ranging from a tool in the cell therapy workflow to targeted cancer therapies. The panel will address various challenges, opportunities and promise of mRNA use in immuno-oncology treatments.
Chair:
Scott Ripley, Ph.D., General Manager, Nucleic Acid Therapeutics and Precision Nanosystems, Cytiva
Speakers:
Adrian Bot, M.D., Ph.D., Chief Scientific Officer, Capstan Therapeutics
Andy Geall, Ph.D., Co-founder and Chief Development Officer, Replicate Biosciences
Sadik Kassim, Ph.D., Chief Technology Officer, Genomic Medicines, Danaher Corporation
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
1:45pm – 2:45pm
| 1:45pm – 2:00pm | Kiji Therapeutics |
| 2:00pm – 2:15pm | Shape Therapeutics |
| 2:15pm – 2:30pm | Satellite Bio |
| 2:30pm – 2:45pm | Allarta Life Science |
2:45pm – 3:15pm | AFTERNOON BREAK
Sponsored by Forian and Orgenesis
3:15pm – 4:15pm | CONCURRENT TRACKS
A RECORD SETTING YEAR FOR CELL AND GENE THERAPIES – HOW DO WE KEEP THE MOMENTUM GOING?
{Aseptic Technologies Ballroom}
3:15pm – 4:15pm
Chair:
Amy Butler, Ph.D., President, Biosciences, Thermo Fisher Scientific
Speakers:
Michael Cooke, Ph.D., Senior Vice President, Cell and Genetic Therapies Research, Vertex Pharmaceuticals
Debbie Drane, Senior Vice President, Global Commercial Development and TA Strategy, CSL Behring
Abigail Jenkins, President and CEO, Gamida Cell
Thomas Klima, Chief Commercial and Operating Officer, bluebird bio
Cokey Nguyen, Ph.D., Executive Vice President, Chief Scientific and Technical Officer, Atara Biotherapeutics
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
3:15pm – 4:15pm
| 3:15pm – 3:30pm | Senti Bio |
| 3:30pm – 3:45pm | Precigen |
| 3:45pm – 4:00pm | Adverum Biotechnologies |
| 4:00pm – 4:15pm | Quell Therapeutics |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
3:15pm – 4:15pm
| 3:15pm – 3:30pm | ImmPACT Bio |
| 3:30pm – 3:45pm | Stemson Therapeutics |
| 3:45pm – 4:00pm | Evia Bio |
| 4:00pm – 4:15pm | Ensoma |
4:15pm – 6:00pm | CONCURRENT TRACKS
COMPANY PRESENTATIONS
{Aseptic Technologies Ballroom}
4:15pm – 6:00pm
| 4:15pm – 4:30pm | Autolus |
| 4:30pm – 4:45pm | Atara Biotherapeutics |
| 4:45pm – 5:00pm | Gamida Cell |
| 5:00pm – 5:15pm | REGENXBIO |
| 5:15pm – 5:30pm | Ocugen |
| 5:30pm – 5:45pm | Sernova Corp |
| 5:45pm – 6:00pm | 4D Molecular Therapeutics |
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
4:15pm – 6:00pm
| 4:15pm – 4:30pm | Astellas Pharma |
| 4:30pm – 4:45pm | Century Therapeutics |
| 4:45pm – 5:00pm | S. Biomedics |
| 5:00pm – 5:15pm | MEDIPOST |
| 5:15pm – 5:30pm | Ossium Health |
| 5:30pm – 5:45pm | Miromatrix Medical |
| 5:45pm – 6:00pm | Curate Biosciences |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
4:15pm – 6:00pm
| 4:15pm – 4:30pm | Garuda Therapeutics |
| 4:30pm – 4:45pm | Coeptis Therapeutics |
| 4:45pm – 5:00pm | Diorasis Therapeutics |
| 5:00pm – 5:15pm | Aurion Biotech |
| 5:15pm – 5:30pm | Be Biopharma |
| 5:30pm – 5:45pm | MaxCyte |
| 5:45pm – 6:00pm | ClearPoint Neuro |
6:00pm | PROGRAM AND PARTNERING CLOSES
6:00pm – 7:00pm | COCKTAIL RECEPTION
Sponsored by Precision ADVANCE
7:00am – 9:00am | REGISTRATION AND BREAKFAST
Sponsored by Stäubli Corporation
7:45am – 8:45am | CONCURRENT WORKSHOPS
7:45am – 8:45am | Ecolab Life Sciences Ballroom
Sponsored by SmartLabs
YOUR CELL AND GENE THERAPY DREAM LABS – OPERATING STRATEGIES TO ENSURE YOUR RUNWAY IS KENOUGH
Volatile conditions in the biopharma funding market and the rise of novel therapies make it imperative that a company’s operating strategies be managed in a way that successfully shepherd assets forward in a cost-efficient manner. For start-up companies with one or two assets, stretching runway to reach the next milestone is top of mind when satisfying investors and securing additional investment. Midsize and larger companies must also marshal resources strategically in their race to get assets into the clinic in a hypercompetitive research environment. Companies can choose to outsource, insource, or defer costs at every stage of R&D and across dozens of different workflows. During this interactive discussion, hear how leaders pursuing novel therapies are weighing their strategies for resourcing to support great science while meeting the practical and economic considerations of R&D.
Chair:
Amrit Chaudhuri, Co-Founder and CEO, SmartLabs
Speakers:
Seth Ettenberg, Ph.D., President and CEO, BlueRock Therapeutics
Raphaël Ognar, President, CEO and Co-Founder, NKILT Therapeutics
Dhvanit Shah, Ph.D., President and CEO, Garuda Tx
Joanne Smith-Farrell, Ph.D., CEO, Be Biopharma
7:45am – 8:45am | Rentschler ATMP Ballroom
Sponsored by World Courier
STREAMLINING CLINICAL TRIAL SUCCESS – THE POWER OF PARTNERSHIPS
The rapid growth and potential of CGTs in treating previously untreatable conditions is undeniable. However, this growth emphasizes the need for seamless coordination and management in clinical trials to ensure success and improve the patient experience. This workshop will explore how the right partnership mix between CROs and specialty logistics companies can address patient pain points and enhance patient engagement and trial participation. Listen to experts discuss; the advantages of a complimentary site network, leveraging satellite storage options, the importance of time-sensitive deliveries, along with the role of regulatory compliance in ensuring successful trial execution.
Chair:
Kelly Frend, Senior Manager, Personalized Supply Chain, AmerisourceBergen World Courier
Speakers:
Mimi Choon-Quinones, Ph.D., Founder and Board of Trustees Chairman (Volunteer), Partners for Patients NGO
Diego Correa, M.D., Ph.D., Vice President and Global Head, Cell & Gene Therapy Center of Excellence, IQVIA
Kilian Kelly, Ph.D., CEO and Managing Director, Cynata Therapeutics
9:00am | GENERAL SESSION
ARM CLOSING STATEMENTS
{Aseptic Technologies Ballroom}
9:00am – 9:15am
Speaker:
Mark Battaglini, Chief Strategy Officer, Alliance for Regenerative Medicine (ARM)
9:15am – 10:00am | CONCURRENT TRACKS
FIRESIDE CHAT: HEADWINDS AND TAILWINDS FACING PATIENTS, PROVIDERS, AND PRODUCERS
{Aseptic Technologies Ballroom}
9:15am – 10:00am
Chair:
Marc Samuels, CEO, ADVI Health
Speaker:
Ellen Lukens, Deputy Director, Center for Medicare & Medicaid Innovation
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
9:15am – 10:00am
| 9:15am – 9:30am | BioCentriq |
| 9:30am – 9:45am | Cryoport Systems |
| 9:45am – 10:00am | PBS Biotech |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
9:15am – 10:00am
| 9:15am – 9:30am | Vesigen Therapeutics |
| 9:30am – 9:45am | Umoja Biopharma |
| 9:45am – 10:00am | Immusoft |
10:00am – 10:45am | CONCURRENT TRACKS
MEDICARE – A LOOK FORWARD ON THE CELL THERAPY LANDSCAPE
{Aseptic Technologies Ballroom}
10:00am – 10:45am
Chair:
Marc Samuels, CEO, ADVI Health
Speakers:
Stephanie Farnia, Principal, Nimitt Consulting
Marianne Hamilton Lopez, Ph.D., Senior Research Director, Biomedical Innovation, Duke-Margolis Center for Health Policy
Brent Rice, Senior Vice President, Chief Commercial Officer and Site Head (US), Autolus Therapeutics
Keren Shani, Executive Director, Cell & Gene Therapy, Trinity
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
10:00am – 10:45am
| 10:00am – 10:15am | Kytopen |
| 10:15am – 10:30am | Accelerated Biosciences |
| 10:30am – 10:45am | Outpace Bio |
10:45am – 11:00am | MORNING BREAK
Sponsored by Forian and Orgenesis
11:00am – 12:00pm | CONCURRENT TRACKS
UNVEILING INNOVATIVE SOLUTIONS TO FAST-TRACK PATIENT ACCESS
{Aseptic Technologies Ballroom}
11:00am – 12:00pm
The cell and gene therapy field is rapidly evolving, and advancements in manufacturing technologies have played a crucial role in accelerating patient access to life-saving treatments. This panel brings together industry leaders to discuss the next generation of manufacturing solutions. Listen to experts discuss manufacturing strategies to reduce vein-to-vein time, ways to improve scalability, new innovations in integrated digital systems and the importance of industry partnerships.
Chair:
Jenifer Wheat, Chief Commercial Officer, OmniaBio
Speakers:
Claire Aldridge, Ph.D., Chief Strategy Officer, Form Bio
Ken Forman, Senior Director, Product Strategy, IDBS
Maya Fuerstenau-Sharp, Ph.D., Head of Marketing, Cell Culture Technologies, Sartorius CellGenix
Chris Stevens, Chief Patient Supply Officer, Spark Therapeutics
COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
11:00am – 12:00pm
| 11:00am – 11:15am | Tenaya Therapeutics |
| 11:15am – 11:30am | Mekonos |
| 11:30am – 11:45am | Cellares |
| 11:45am – 12:00pm | Kincell Bio |
COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
11:00am – 12:00pm
| 11:00am – 11:15am | Laverock Therapeutics |
| 11:15am – 11:30am | Dimension Inx |
| 11:30am – 11:45am | Apprentice.io |
| 11:45am – 12:00pm | Xcell Biosciences |
12:00pm – 1:00pm | LUNCH
1:00pm | CONFERENCE CLOSES
The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 110+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 2,000 attendees – over 20% of which are C-level executives – this conference enables key partnerships through more than 5,000 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.
October 6-8, 2025
Arizona Biltmore
Phoenix, AZ
