Agenda

2025 Meeting Agenda

The 2025 Cell & Gene Meeting on the Mesa was delivered in a hybrid format with live programming available over the course of three days. Virtual registrants had access to all content via livestream during the program dates. Additionally, all content was made available on-demand within 24 hours of the live program time for all registrants to view. 


Agenda Sponsors:

2025 Agenda at a Glance

Live Event Dates

Arrival | Sunday, October 5

11:00am – 6:00pm Early Badge Pick-up at the Arizona Biltmore (All Attendees)

Day 1 | Monday, October 6

7:30am – 9:00am Registration & Breakfast
8:00am – 9:00am Concurrent Workshops
8:00am – 6:00pm Partnering Meetings
9:15am – 6:00pm General Session, Panel Discussions, Company Presentations
6:00pm – 8:30pm Networking Bash

Day 2 | Tuesday, October 7

7:30am – 9:00am Registration & Breakfast
8:00am – 9:00am Concurrent Workshops
8:00am – 6:00pm Partnering Meetings
9:15am – 6:00pm General Session, Panel Discussions, Company Presentations
6:00pm – 7:00pm Cocktail Reception

Day 3 | Wednesday, October 8

7:30am – 9:00am Registration & Breakfast
8:00am – 9:00am Concurrent Workshops
8:00am – 12:00pm Partnering Meetings
9:15am – 12:00pm General Session, Panel Discussions, Company Presentations
12:00pm – 1:00pm Lunch
1:00pm Conference Closes

Virtual Partnering Dates

Virtual Partnering | Thursday, October 9

12:00am – 11:59pm Virtual Partnering Meetings

Virtual Partnering | Friday, October 10

12:00am – 11:59pm Virtual Partnering Meetings

2025 Full Meeting Agenda

* All times reflect Phoenix, AZ

7:30am – 9:00am | REGISTRATION AND BREAKFAST

Sponsored by SGS Vitrology

8:00am – 9:00am | CONCURRENT WORKSHOPS

THE NEW STANDARD FOR CGT MANUFACTURING: FLEXIBILITY AND SCALABILITY
8:00am – 9:00am | FLW Ballroom G
Sponsored by Ori Biotech

Chair:

Jason Foster, CEO and Executive Director, Ori Biotech

Speakers:

Taby Ahsan, Ph.D., Vice President, Cell and Gene Therapy Operations, City of Hope

Ken Harris, Chief Strategy Officer and Head of AI, OmniaBio

Andrew Snowden, D.Phil., Senior Director, Allogeneic and Autologous Cell Therapy Development, Johnson & Johnson Innovative Medicine

Tom Wilton, Senior Vice President, Innovation Ventures, Children’s Hospital of Philadelphia

9:15am | GENERAL SESSION

ALLIANCE FOR REGENERATIVE MEDICINE BOARD VOTE AND WELCOME REMARKS
{FLW Ballroom E}
9:15am – 10:00am

Speakers:

Tim Hunt, CEO, Alliance for Regenerative Medicine (ARM)

Bob Smith, Venture Partner, OrbiMed; Chairman, Alliance for Regenerative Medicine (ARM)

COMPANY PRESENTATIONS

{FLW Ballroom F}

9:15am – 10:00am

9:15am – 9:30amFUJIFILM Cellular Dynamics
9:30am – 9:45amSpecific Biologics
9:45am – 10:00amCytiva

COMPANY PRESENTATIONS

{FLW Ballroom G}

9:15am – 10:00am

9:15am – 9:30amOpus Genetics
9:30am – 9:45amDimension Bio
9:45am – 10:00amCynata Therapeutics

10:00am – 10:30am | CONCURRENT TRACKS

INVESTING IN INNOVATION: ADVANCING GENE EDITING SOLUTIONS FOR CYSTIC FIBROSIS

{FLW Ballroom E}

10:00am – 10:30am

This panel will explore how strategic funding and collaboration are accelerating the development of next-generation gene editing technologies to address the unmet needs of patients.

Chair:

Bob Smith, Venture Partner, OrbiMed; Chairman, Alliance for Regenerative Medicine (ARM)

Speaker:

Allan Reine, M.D., CEO, Prime Medicine

COMPANY PRESENTATIONS

{FLW Ballroom F}

10:00am – 10:30am

10:00am – 10:15am Moffitt Cancer Center
10:15am – 10:30am Boston Biodevelopment

COMPANY PRESENTATIONS

{FLW Ballroom G}

10:00am – 10:30am

10:00am – 10:15amElevateBio
10:15am – 10:30amQuTEM

10:30am – 11:00am | MORNING BREAK

Sponsored by OXB

11:00am – 11:30am | CONCURRENT TRACKS

COMPANY PRESENTATIONS

{FLW Ballroom F}

11:00am – 11:30am

11:00am – 11:15am Xcell Biosciences
11:15am – 11:30am Rocket Pharma

COMPANY PRESENTATIONS

{FLW Ballroom G}

11:00am – 11:30am

11:00am – 11:15amEvotec
11:15am – 11:30amARMI | BioFabUSA

11:30am – 12:30pm | CONCURRENT TRACKS

THE EVOLUTION OF CAR-T FROM NICHE TREATMENT TO MAINSTREAM CARE
{FLW Ballroom E}
11:30am – 12:30pm
Experts will discuss strategies to improve patient access, recent wins (REMS elimination), overcoming logistical bottlenecks, and extending CAR-T’s impact into earlier lines of treatment and other disease areas. With a focus on real-world outcomes and patient-centric innovation, this session offers a 360-degree view on where CAR-T is headed next—and what it will take to get there.

Chair:

Joe DePinto, Head of Cell, Gene and Advanced Therapies, McKesson

Speakers:

Warner Biddle, Executive CEO, Kyverna Therapeutics

George Eastwood, Executive Director, Emily Whitehead Foundation

Gustavo Mahler, Ph.D., CEO, Cellistic

Navneet Majhail, M.D., FASTCT Physician-in-Chief of Blood Cancers, Sarah Cannon Cancer Network

Rebecca Poehnelt, Ph.D., Vice President, Global Commercial Strategy Lymphoma, Leukemia and Cell Therapy, Johnson & Johnson Innovative Medicine

COMPANY PRESENTATIONS

{FLW Ballroom F}

11:30am – 12:30pm

11:30am – 11:45amEditas Medicine
11:45am – 12:00pmDiscGenics
12:00pm – 12:15pmCatalent
12:15pm – 12:30pmAstellas Pharma

COMPANY PRESENTATIONS

{FLW Ballroom G}

11:30am – 12:30pm

11:30am – 11:45amExcellos
11:45am – 12:00pmPrecision BioSciences
12:00pm – 12:15pmTenaya Therapeutics
12:15pm – 12:30pmNanoscope Therapeutics

12:30pm – 1:30pm | LUNCH

Sponsored by Fortrea

1:30pm – 2:30pm | CONCURRENT TRACKS

XENOTRANSPLANTATION: FUTURE OPPORTUNITIES, CHALLENGES, AND AVAILABLE GUIDANCE

{FLW Ballroom E}
1:30pm – 2:30pm
This panel will explore the evolving landscape of xenotransplantation, a type of regenerative medicine, including discussion of history, technological advances for reemergence, current state of FDA regulation, recent successes, and related tissue engineering. We will also explore numerous CMC, clinical and regulatory complexities, and ways to navigate, in order to solve the organ/tissue shortage problem.

Chair:

Michael Mendicino, Ph.D., President and Owner, Chief Consultant and Advisor, Hybrid Concepts International

Speakers:

Heather Lombardi, Ph.D., Regulatory Strategy Director, United Therapeutics Corporation

Richard McFarland, M.D., Ph.D., Chief Regulatory Officer, ARMI

Tim Schroeder, Chairman, CEO, and Founder, CTI Clinical Trial and Consulting Services

Jason Wertheim, M.D., Ph.D., Vice Dean for Research and Graduate Studies, Professor of Surgery (Transplantation), Professor of Biomedical Engineering, University of Arizona College of Medicine

SCIENCE SLAM: ADVANCING THE FRONTIER OF T CELL THERAPY IN ONCOLOGY AND RHEUMATOLOGY

{FLW Ballroom F}
1:30pm – 2:30pm
A dynamic look at the scientific, manufacturing, and commercial pathways shaping the future of autologous and allogeneic T cell therapies across different indications and patient populations.

Chair:

Josh Ludwig, Global Commercial Director, ScaleReady

Speakers:

Taby Ahsan, Ph.D., Vice President, Cell and Gene Therapy Operations, City of Hope

Leah DiMascio, Ph.D., Chief Operations Officer, March Biosciences

Jeff Liter, President and CEO, Luminary Therapeutics

COMPANY PRESENTATIONS

{FLW Ballroom G}

1:30pm – 2:30pm

1:30pm – 1:45pmTreeFrog Therapeutics
1:45pm – 2:00pmScribe Therapeutics
2:00pm – 2:15pmuniQure
2:15pm – 2:30pmWacker Bio

2:30pm – 3:30pm | CONCURRENT TRACKS

HOW PATIENT GROUPS ARE DRIVING INNOVATION AND RESEARCH IN THE CGT SECTOR
{FLW Ballroom E}
2:30pm – 3:30pm

Patient groups are increasingly shaping the future of cell and gene therapies, from advancing research priorities to catalyzing new partnerships and accelerating innovation. This discussion will highlight how patient-driven organizations and foundations are driving meaningful progress in the CGT sector, bridging the gap between patients, researchers, and industry.

Chair:

Charlene Son Rigby, CEO, Global Genes

Speakers:

Joe Katakowski, Ph.D., Director of Research, RTW Foundation

Casey McPherson, Founder and CEO, AlphaRose Therapeutics

Alana Newhouse, President, Foundation for Angelman Syndrome Therapeutics (FAST)

COMPANY PRESENTATIONS

{FLW Ballroom F}

2:30pm – 3:30pm

2:30pm – 2:45pmHealios
2:45pm – 3:00pmBlueRock Therapeutics
3:00pm – 3:15pmREGENXBIO
3:15pm – 3:30pmMEDIPOST

COMPANY PRESENTATIONS

{FLW Ballroom G}

2:30pm – 3:30pm

2:30pm – 2:45pm Kiji Therapeutics
2:45pm – 3:00pm Forge Biologics
3:00pm – 3:15pm CREATE Medicines
3:15pm – 3:30pm Avobis Bio

3:30pm – 4:00pm | AFTERNOON BREAK

Sponsored by OXB

4:00pm – 5:00pm | CONCURRENT TRACKS

INVESTING IN CELL AND GENE THERAPY: INSIGHTS FROM INDUSTRY EXPERTS
{FLW Ballroom E}
4:00pm – 5:00pm

Join top investors for a lively discussion on where the smart money is going in cell and gene therapy—what’s driving excitement, what hurdles remain, and where the biggest opportunities lie in the years ahead.

Chair:

Steve Favaloro, Chairman and CEO, Genezen

Speakers:

Josh Schimmer, M.D., Managing Director, Cantor Fitzgerald

Owen Smith, Partner, 4BIO Capital

Qing Zhang, M.D., Managing Director, LDV Partners

SCIENCE SLAM: QUALITY, SPEED, COST – PICK THREE
{FLW Ballroom F}
4:00pm – 5:00pm
Manufacturing teams still joke that you can only choose two of the three: high quality, short timelines, or low cost. This Science Slam puts that myth on trial. The session will feature case studies and data showcasing the impact of new technologies to reduce time and COGS while improving quality of the output. The presenters will discuss modular automation and smart analytics that help redraw the quality-time-money triangle for CGT manufacturing.

Chair:

Bill Lloyd, Ph.D., Vice President of R&D, Akadeum Life Sciences

Speakers:

Jason Bock, Ph.D., Founder and CEO, CTMC

Adam Bryan, Vice President, Personalized Medicine, Lonza

Shannon Eaker, Ph.D., Chief Technology Officer, Xcell Biosciences

COMPANY PRESENTATIONS

{FLW Ballroom G}

4:00pm – 5:00pm

4:00pm – 4:15pmOcugen
4:15pm – 4:30pmAspen Neuroscience
4:30pm – 4:45pmAscidian Therapeutics
4:45pm – 5:00pmEnsoma

5:00pm – 6:00pm | CONCURRENT TRACKS

COMPARABILITY TO CONTINUITY: ALIGNING LATE-STAGE MANUFACTURING CHANGES WITH GLOBAL POST-APPROVAL CONTROL IN CELL AND GENE THERAPY
{FLW Ballroom E}
5:00pm – 6:00pm
Cell and gene therapy developers often “lock” their commercial process too early, only to face painful surprises as they finalize a BLA and move into global launch. This discussion brings together regulatory strategists, analytics leads, and manufacturing heads to tackle two sides of the same CMC coin, pre- and post-approval comparability.

Chair:

Don Fink, Ph.D., Master Practice Expert, Regulatory, Dark Horse Consulting

Speakers:

Ignacio Núñez, Chief Operations Officer, CellReady

Ana Sousa, Chief Regulatory Officer, Aspen Neuroscience

Philip Wills, Ph.D., Chief Commercial Officer, Cell and Gene Therapy, Catalent Pharma Solutions

Anne Marie Woodland, Senior Vice President, Regulatory Affairs and Quality, Beam Therapeutics

COMPANY PRESENTATIONS

{FLW Ballroom F}

5:00pm – 6:00pm

5:00pm – 5:15pmTouchlight
5:15pm – 5:30pmCapricor Therapeutics
5:30pm – 5:45pmAldevron
5:45pm – 6:00pmSmartCella

COMPANY PRESENTATIONS

{FLW Ballroom G}

5:00pm – 6:00pm

5:00pm – 5:15pmLife Edit
5:15pm – 5:30pmCellares
5:30pm – 5:45pmProfluent
5:45pm – 6:00pmMKC Biotherapeutics

6:00pm | PROGRAM AND PARTNERING CLOSES

6:00pm – 8:30pm | NETWORKING BASH

Sponsored by ElevateBio and The Money Channel NYC

7:30am – 9:00am | REGISTRATION AND BREAKFAST

Sponsored by Miromatrix and United Therapeutics

8:00am – 9:00am | CONCURRENT WORKSHOPS

SCALING SMART: COLLABORATIVE COMMERCIALIZATION AND PROCESS AUTOMATION APPROACHES FOR DYNAMIC MARKETS
8:00am – 9:00am | FLW Ballroom E
Sponsored by Thermo Fisher Scientific

Chair:

Betty Woo, Ph.D., Management Consultant, Cell, Gene and Advanced Therapies, Thermo Fisher Scientific

Speakers:

Jennifer Cannon, Ph.D., President Commercial Operations, Thermo Fisher Pharma Services

Wolfram Carius, Ph.D., Board Member, BlueRock Therapeutics

Jennifer MacDonald, M.D., Chief Operating Officer, Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA

Brian Shy, M.D., Ph.D., Lab Director, UCSF Cellular Transplantation GMP Facility

LESSONS LEARNED FROM COMMERCIAL CTS IN THE ADVANCEMENT OF IPSC-DERIVED THERAPIES
8:00am – 9:00am | FLW Ballroom F
Sponsored by FUJIFILM Cellular Dynamics

Chair:

Delara Motlagh, Ph.D., Chief Operating Officer, FUJIFILM Cellular Dynamics

Speakers:

Seth Ettenberg, Ph.D., President and CEO, BlueRock Therapeutics

Katy Spink, Ph.D., President and Chief Operating Officer, Dark Horse Consulting Group

Vanguel Trapkov, Ph.D., Senior Director, Strategic Options and Assessment, Oncology and Cell Tx Lead, Bristol Myers Squibb

ACCELERATING CURES: BUILDING THE DIGITAL BACKBONE FOR THE FUTURE OF SCALABLE CELL THERAPIES
8:00am – 9:00am | FLW Ballroom G
Sponsored by L7 Informatics

Personalized cell therapies hold extraordinary promise, but getting them to patients faster requires tackling unprecedented complexity in manufacturing, scale-up, and global delivery. This independent thought-leadership session brings together leaders from DFCI, CTMC, and Cellipont—moderated by Marcia Blackmoore of L7 Informatics—for a principled, idea-driven discussion on the future of advanced therapies. Together, they will explore the speed imperative, the human impact of delays, and the role of a connected digital backbone in transforming today’s breakthroughs into tomorrow’s cures. With diverse perspectives across science, operations, and clinical delivery, the panel will offer clear, actionable insights for how the field can move from promise to global impact.

Chair:

Marcia Blackmoore, Vice President, Customer Operations, L7 Informatics

Speakers:

Jason Bock, Ph.D., Founder and CEO, CTMC

Carolyn Lutzko, Ph.D., Scientific Director, Novel Cell Therapy, Dana-Farber Cancer Institute

Daniel Ramirez, Vice President Operations, Site Head, Cellipont Bioservices

9:15am | GENERAL SESSION

ARM STRATEGIC INITIATIVES AND GROW UPDATE
{FLW Ballroom E}
9:15am – 9:45am

Speakers:

Rita Johnson-Greene, Chief Operating Officer, Alliance for Regenerative Medicine (ARM)

COMPANY PRESENTATIONS

{FLW Ballroom F}

9:15am – 9:45am

9:15am – 9:30am Avectas
9:30am – 9:45am Portal Bio

COMPANY PRESENTATIONS

{FLW Ballroom G}

9:15am – 9:45am

9:15am – 9:30amLogomix Biotechnology
9:30am – 9:45amSatellite Biosciences

9:45am – 10:30am | CONCURRENT TRACKS

APPLYING THE LESSONS OF CGT COMMERCIAL SUCCESSES TO THE NEXT GENERATION OF PRODUCTS
{FLW Ballroom E}
9:45am – 10:30am

This panel will highlight a few of the success stories in CGT commercialization, and discuss lessons learned that can be applied to the next wave of promising CGT products making the high-stakes transition from the clinic to the market. Participants will also discuss the role of big biopharma in successful commercialization, either through acquisitions or partnerships.

Chair:

Eytan Abraham, Ph.D., Chief Commercial and Technology Officer, Minaris Advanced Therapies

Speakers:

Dan Kirby, Chief Commercial Officer, Iovance Biotherapeutics

Johanna Rossell, Senior Vice President, General Manager Rare Diseases, Sumitomo Pharma America

Helen Sabzevari, Ph.D., President and CEO, Precigen

Curran Simpson, President and CEO, REGENXBIO

COMPANY PRESENTATIONS

{FLW Ballroom F}

9:45am – 10:30am

9:45am – 10:00amCTI Clinical Trial & Consulting
10:00am – 10:15amMarch Biosciences
10:15am – 10:30amFractyl Health

COMPANY PRESENTATIONS

{FLW Ballroom G}

9:45am – 10:30am

9:45am – 10:00am Trogenix
10:00am – 10:15am Charles River
10:15am – 10:30am Likarda

10:30am – 11:00am | MORNING BREAK

Sponsored by OXB

11:00am – 12:00pm | CONCURRENT TRACKS

GENE EDITING GETS PERSONAL: THE STORY OF BABY KJ AND A NEW ERA IN MEDICINE
{FLW Ballroom E}
11:00am – 12:00pm

This session will examine the groundbreaking case of Baby KJ, exploring its implications for families, science, and industry as gene editing enters a new era. Panelists will discuss the technological, regulatory, and commercial hurdles that remain, while reflecting on the profound personal impact of these therapies for patients and their communities.

Chair:

Sadik Kassim, Ph.D., Chief Scientific Officer and Chief Technology Officer, Danaher Genomic Medicines

Speakers:

Maria Kefalas, Ph.D., Founder, MLD Voices and The Callope Joy Foundation

Devyn Smith, Ph.D., CEO, Arbor Biotechnologies

Fyodor Urnov, Ph.D., Director, Technology and Translation, Innovative Genomics Institute; Professor, MCB Department, University of California, Berkeley

Tom Wilton, Senior Vice President, Innovation Ventures, Children’s Hospital of Philadelphia

SCIENCE SLAM: COMPARABILITY STUDIES – WALKING THE TIGHTROPE

{FLW Ballroom F}

11:00am – 12:00pm

Comparability studies are critical for ensuring that changes in manufacturing processes or different versions of a product maintain similar quality, safety, and efficacy. The goal of the comparability exercise is to evaluate the pre- and post-change in the final drug product and establish a case for the products being comparable. Successfully “walking the tightrope” of comparability studies involves striking a delicate balance between scientific precision, process/manufacturing considerations, and regulatory requirements to ensure final product reproducibility without changing the profile and meeting the safety and efficacy requirements.

Chair:

Rupa Pike, Senior Director and Global Head of Strategic Alliances, Catalent Pharma Solutions

Speakers:

Michael Mendicino, Ph.D., President and Owner, Chief Consultant and Advisor, Hybrid Concepts International

Allen Callaway, Director, Global CMC Regulatory Affairs, Johnson & Johnson

Karin McIntosh, Vice President and Head of Regulatory Affairs, Orca Bio

COMPANY PRESENTATIONS

{FLW Ballroom G}

11:00am – 12:00pm

11:00am – 11:15amSkylark Bio
11:15am – 11:30amEG 427
11:30am – 11:45amAviadoBio
11:45am – 12:00pmPoltreg

12:00pm – 12:30pm | CONCURRENT TRACKS

LIVING BEYOND CAR-T: MARCI MCCUE’S JOURNEY AS THE FIRST MS TRIAL PATIENT TREATED
{FLW Ballroom E}
12:00pm – 12:30pm

In this fireside chat, Marci McCue, the first patient to participate in a CAR-T cell therapy trial for multiple sclerosis, shares her powerful story of diagnosis, clinical trial enrollment, and life after treatment. This conversation will highlight the patient perspective, explore the realities of trial access and recovery, and offer a call to action for the cell and gene therapy community to design more patient-centered pathways.

Chair:

Kelly Kester, Director, Portfolio Strategy and Planning, Advanced Therapy Solutions, Cardinal Health

Speaker:

Marci McCue, First MS Patient to Trial CAR-T Cell Therapy

COMPANY PRESENTATIONS

{FLW Ballroom F}

12:00pm – 12:30pm

12:00pm – 12:15pmPersista Bio
12:15pm – 12:30pmLaverock Therapeutics

COMPANY PRESENTATIONS

{FLW Ballroom G}

12:00pm – 12:30pm

12:00pm – 12:15pmPapillon Therapeutics
12:15pm – 12:30pmnChroma Bio

12:30pm – 1:30pm | LUNCH

Sponsored by Kincell Bio

1:30pm – 2:30pm | CONCURRENT TRACKS

SCALING THE FUTURE: HOW BIG BIOPHARMA IS INFLUENCING WHAT’S NEXT IN CELL AND GENE THERAPY

{FLW Ballroom E}
1:30pm – 2:30pm
Explore how large biopharma companies are shaping the future of cell and gene therapy through strategic partnerships, internal innovation, and market integration. Leaders will share perspectives on sustainable commercial models, global access planning, and the long-term impact of CGT on the broader biopharma landscape.

Chair:

Daniel Palmacci, Head and President, Specialized Modalities and Member of the Executive Committee, Lonza

Speakers:

Fred Chereau, Senior Vice President, Strategy and Business Development, Alexion

Christy Siegel, Pharm.D., Senior Vice President and US Therapeutic Area Head, Immunology, Novartis

Richard Smith, Ph.D., Vice President, Drug Discovery, Kite

Richard Wilson, Senior Vice President, Primary Focus Lead, Genetic Regulation, Astellas

COMPANY PRESENTATIONS

{FLW Ballroom F}

1:30pm – 2:30pm

1:30pm – 1:45pmOutpace Bio
1:45pm – 2:00pmImmusoft
2:00pm – 2:15pmAseptic Technologies
2:15pm – 2:30pmFibroBiologics

COMPANY PRESENTATIONS

{FLW Ballroom G}

1:30pm – 2:30pm

1:30pm – 1:45pmKyverna Therapeutics
1:45pm – 2:00pmViralgen
2:00pm – 2:15pmKenai Therapeutics
2:15pm – 2:30pmS.Biomedics

2:30pm – 3:30pm | CONCURRENT TRACKS

EQUITY AT SCALE: EXPANDING ACCESS TO CELL AND GENE THERAPIES ACROSS BORDERS
{FLW Ballroom E}
2:30pm – 3:30pm

This panel will explore how industry leaders can work together to expand equitable global access to cell and gene therapies by addressing regulatory, commercial, and ethical considerations across borders.

Chair:

Tim Hunt, CEO, Alliance for Regenerative Medicine (ARM)

Speakers:

Lisa Deschamps, CEO, AviadoBio

Matthew Durdy, Chief Executive, Cell and Gene Therapy Catapult

Kevin FitzGerald, S.J., Ph.D., Chair, Department of Medical Humanities, Associate Professor, Creighton University

James Wilson, M.D., Ph.D., President and CEO, GEMMABio; Professor of Medicine and Pediatrics, University of Pennsylvania Perelman School of Medicine

COMPANY PRESENTATIONS

{FLW Ballroom F}

2:30pm – 3:30pm

2:30pm – 2:45pm Arbor Biotechnologies
2:45pm – 3:00pm Ernexa Therapeutics
3:00pm – 3:15pm InspiroGene
3:15pm – 3:30pm ExCellThera

COMPANY PRESENTATIONS

{FLW Ballroom G}

2:30pm – 3:30pm

2:30pm – 2:45pmAspect Biosystems
2:45pm – 3:00pmCoJourney
3:00pm – 3:15pmAileron AI
3:15pm – 3:30pmAstraveus

3:30pm – 4:00pm | AFTERNOON BREAK

Sponsored by OXB

4:00pm – 5:00pm | CONCURRENT TRACKS

BUILDING RESILIENCE: SUPPLY CHAIN INNOVATIONS FOR CELL AND GENE THERAPY MANUFACTURING
{FLW Ballroom E}
4:00pm – 5:00pm

As the cell and gene therapy field scales, resilient and patient-centered supply chains are critical for timely, consistent delivery. This panel will explore strategies in managing raw & starting materials, innovative digital tools & AI, and sustainable partnerships to ensure quality, traceability, and reliability.

Chair:

Priya Baraniak, Ph.D., Chief Commercial and Development Officer, Pluristyx

Speakers:

Kevin Chinn, Ph.D., Vice President, Head of Cell and Gene Service Line, Cencora

Bryan Holmes, Vice President, Digital and Technology Solutions, Andelyn Biosciences

Raja Srinivas, Ph.D., Co-founder, Asimov

Panteli Theocharous, Ph.D., FRCPath, Director of the Board, The Malcom Orlando Ivy Foundation (TMOIF); CEO, VectorGen

SCIENCE SLAM: THE FUTURE OF ANALYTICS – ACCELERATING PATIENT ACCESS THROUGH RAPID RELEASE
{FLW Ballroom F}
4:00pm – 5:00pm

As the cell and gene therapy field scales, release testing remains a key bottleneck between manufacturing and patient access. Rapid methods, from sterility to mycoplasma, promise to cut timelines dramatically. This Science Slam will spotlight how companies are utilizing technological advancements to strategically align with evolving regulatory guidance for rapid release testing and analytics to help get products to patients faster.

Chair:

Cynthia Martino, Ph.D., Head of R&D, Bionique

Speakers:

Samuel Molina, Executive Director, MSAT, American Red Cross

Mike Paglia, Chief Technology Officer, ElevateBio, BaseCamp

Melissa Rodriguez, Ph.D., Director of Quality Control, Cellipont Bioservices

COMPANY PRESENTATIONS

{FLW Ballroom G}

4:00pm – 5:00pm

4:00pm – 4:15pm Myrtelle
4:15pm – 4:30pm AGC Biologics
4:30pm – 4:45pm Form Bio
4:45pm – 5:00pm StimulusBio

5:00pm – 6:00pm | CONCURRENT TRACKS

EXPANDING HORIZONS: BUILDING THE CGT MARKET ACROSS ASIA-PACIFIC
{FLW Ballroom E}
5:00pm – 6:00pm

As gene and cell therapies advance across Asia-Pacific markets, stakeholders are encountering both convergence and complexity across regulatory, commercial, and manufacturing pathways. This panel brings together biotech leaders and commercialization experts to explore how APAC markets are evolving—and how developers can align with regulators, scale effectively, and deliver access for patients across borders. This session will provide a 360-degree view of what’s required to move advanced therapies from lab to patient across the APAC landscape.

Moderator:

Matthew Hewitt, Ph.D., Vice President, CTO Manufacturing Business Division, Charles River Laboratories

Speakers:

Mathias Kroll, Ph.D., Chief Business Officer, Cynata Therapeutics

Antonio Lee, Ph.D., Global President and CEO, MEDIPOST

Yoshiaki Maruyama, Ph.D., Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA)

Francis Pang, Senior Vice President, Global Market Access and International Geographic Expansion, Orchard Therapeutics

COMPANY PRESENTATIONS

{FLW Ballroom F} 5:00pm – 6:00pm

5:00pm – 5:15pm Porton Advanced
5:15pm – 5:30pm Axent Biosciences
5:30pm – 5:45pm Anocca
5:45pm – 6:00pm Broken String Biosciences

COMPANY PRESENTATIONS

{FLW Ballroom G}
5:00pm – 6:00pm

5:00pm – 5:15pmCHO Plus
5:15pm – 5:30pmAkadeum Life Sciences
5:30pm – 5:45pmTessera Therapeutics
5:45pm – 6:00pmEvia Bio

6:00pm | PROGRAM AND PARTNERING CLOSES

6:00pm – 7:00pm | COCKTAIL RECEPTION

Sponsored by Precision for Medicine

7:30am – 9:00am | REGISTRATION AND BREAKFAST

8:00am – 9:00am | MORNING WORKSHOP

PARTNERING FOR PROGRESS: DRIVING INNOVATION IN CELL AND GENE THERAPY
8:00am – 9:00am | FLW Ballroom F
Sponsored by Terumo Blood and Cell Technologies

Chair:

Veerle D’Haenens, General Manager, Global Therapy Innovations, Terumo Blood and Cell Technologies

Speakers:

Colleen Maiden, Executive Director, Business Development Cell and Gene Therapy, American Red Cross

Barbara Ressler, Ph.D., Vice President, Manufacturing Process Sciences, RoslinCT

David Smith, Ph.D., Vice President, Development, Made Scientific

Bruce Thompson, Ph.D., Chief Technology Officer, Kincell

9:00am | GENERAL SESSION

COMPANY PRESENTATION

{FLW Ballroom F}

9:15am – 9:30am

9:15am – 9:30amArtiva Biotherapeutics

COMPANY PRESENTATION

{FLW Ballroom G}

9:15am – 9:30am

9:15am – 9:30amGENETHON

9:30am – 10:15am | CONCURRENT TRACKS

ACCELERATING DEVELOPMENT THROUGH REGULATORY FLEXIBILITY: EVOLVING ENDPOINTS IN GENE THERAPY
{FLW Ballroom E}
9:30am – 10:15am

The session will examine the acceleration of gene therapy development when traditional clinical endpoints are not feasible. Panelists will discuss totality of evidence approaches, evolving endpoints, and lessons from FDA interactions and pilot programs. The discussion will highlight opportunities for regulatory flexibility while maintaining rigorous standards across rare and non-rare disease contexts.

Chair:

Monica Veldman, Director, Global Regulatory Policy, Alliance for Regenerative Medicine (ARM)

Speakers:

Rachel McMinn, Ph.D., Founder and CEO, Neurogene

Nicholas Richardson, D.O., Vice President, Clinical Development, Precision for Medicine

Louise Rodino-Klapac, Ph.D., President, R&D and Technical Operations, Sarepta Therapeutics

Keith Wonnacott, Ph.D., Vice President, Regulatory Affairs, LEXEO Therapeutics

COMPANY PRESENTATIONS

{FLW Ballroom F}

9:30am – 10:15am

9:30am – 9:45amGC Therapeutics
9:45am – 10:00amGenVivo
10:00am – 10:15amRheumaGen

COMPANY PRESENTATIONS

{FLW Ballroom G}

9:30am – 10:15am

9:30am – 9:45amMayo Clinic
9:45am – 10:00amVitalant
10:00am – 10:15amForta Bio

10:15am – 11:00am | CONCURRENT TRACKS

UNLOCKING NON-TRADITIONAL FUNDING PATHWAYS FOR CELL AND GENE THERAPY COMMERCIALIZATION
{FLW Ballroom E}
10:15am – 11:00am

As traditional venture capital becomes more risk-averse, cell and gene therapy developers are increasingly exploring alternative paths to fund and scale their innovations. This panel will spotlight public and institutional funding models that are enabling developers to advance breakthrough therapies while building strong and sustainable businesses.

Chair:

Audrey Greenberg, Venture Partner, Mayo Clinic

Speakers:

Ahmed Mousa, M.D., General Manager, Lafana Life Sciences

Jason Roos, Ph.D., Acting Director, ARPA-H

Jonathan Thomas, Ph.D., President and CEO, CIRM

COMPANY PRESENTATIONS

{FLW Ballroom F}

10:15am – 11:00am

10:15am – 10:30amLatus Bio
10:30am – 10:45amCPTx
10:45am – 11:00amAABB (Association for the Advancement of Blood & Biotherapies)

COMPANY PRESENTATIONS

{FLW Ballroom G}

10:15am – 11:00am

10:15am – 10:30amBlueWhale Bio
10:30am – 10:45amFocused Ultrasound Foundation
10:45am – 11:00amTozaro

11:00am – 12:00pm | CONCURRENT TRACKS

UNDERSTANDING THE IMPACT OF MFN AND TARIFFS ON THE CELL AND GENE THERAPY SECTOR
{FLW Ballroom E}
11:00am – 12:00pm

Global pricing policies like Most Favored Nation (MFN) rules and evolving tariff structures are reshaping the economics of cell and gene therapy — from raw material imports to international launch planning. This session will break down the real-world implications for developers, manufacturers, and investors, with insights from leaders navigating policy turbulence in real time.

Chair:

Marc Samuels, CEO, ADVI Health

Speakers:

Erica Cischke, Vice President, Government Affairs, Alliance for Regenerative Medicine (ARM)

John Hermanek, Vice President, Global Market Access and Government Affairs, Immatics

Dilip Patel, Senior Vice President, Access and Market Development, Autolus

Laurel Todd, Head of Policy and Market Access Operations, Iovance Biotherapeutics

COMPANY PRESENTATIONS

{FLW Ballroom F}

11:00am – 11:45am

11:00am – 11:15am BBG Advanced Therapies
11:15am – 11:30am Allele Biotechnology & Pharmaceuticals
11:30am – 11:45am Bionova Scientific

COMPANY PRESENTATIONS

{FLW Ballroom G}

11:00am – 11:45am

11:00am – 11:15am Secretome Therapeutics
11:15am – 11:30am Be Biopharma
11:30am – 11:45am Xintela

12:00pm – 1:00pm | LUNCH

1:00pm | CONFERENCE CLOSES

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