October 5-7 | Arizona Biltmore

Agenda

Agenda Information

The Cell & Gene Meeting on the Mesa will host three days of expert-led panels, workshops, and networking opportunities focused on the latest advances in cell and gene therapy commercialization, investment, manufacturing, and clinical development.

 

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2026 Agenda at a Glance

Event Dates

Arrival | Sunday, October 4

12:00pm – 7:00pm Early Badge Pick-up at the Arizona Biltmore (All Attendees)

Day 1 | Monday, October 5

7:30am – 9:00am Registration & Breakfast
8:00am – 8:45am Concurrent Workshops
8:00am – 6:00pm Partnering Meetings
9:00am – 6:00pm General Session, Panel Discussions, Company Presentations
6:00pm – 8:30pm Networking Bash

Day 2 | Tuesday, October 6

7:30am – 9:00am Registration & Breakfast
8:00am – 8:45am Concurrent Workshops
8:00am – 5:00pm Partnering Meetings
9:00am – 5:00pm General Session, Panel Discussions, Company Presentations
5:00pm – 6:00pm Cocktail Reception

Day 3 | Wednesday, October 7

7:30am – 9:00am Registration & Breakfast
8:00am – 8:45am Concurrent Workshops
8:00am – 12:00pm Partnering Meetings
9:00am – 12:00pm General Session, Panel Discussions, Company Presentations

2026 Full Agenda

* All times reflect Phoenix, AZ
DOWNLOAD AGENDA

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

Sponsored by Miromatrix and United Therapeutics

8:00am – 8:45am | CONCURRENT WORKSHOPS

THE SCIENCE IS READY. WHY ISN’T THE SYSTEM? ARE WE SCALING THERAPIES – OR SCALING THE BARRIERS THAT KEEP THEM FROM PATIENTS?
8:00am – 8:45am | FLW Ballroom F
Sponsored by ScaleReady

We will discuss the biggest obstacles, including the manufacturing model, patient awareness, healthcare policies, and the importance of advocacy groups and success stories being shared beyond the tight-knit cell and gene therapy community.

Chair:

Josh Ludwig, Global Commercial Director, ScaleReady

Speakers:

Boro Dropulić, Ph.D., Executive Director and Cofounder, Caring Cross

George Eastwood, Executive Director, Emily Whitehead Foundation

Bradley Watts, CAR-T Recipient, VP

MORNING WORKSHOP: DEVELOPING EFFECTIVE CMC STRATEGIES ACROSS CELL THERAPY MODALITIES
8:00am – 8:45am | FLW Ballroom G
Sponsored by Catalent Pharma Services

The complexities associated with the development and manufacturing of cell and gene therapies has been well-documented. CMC has been the cornerstone to ensuring commercial viability and patient access to these transformative therapies. From autologous therapies that have established clinical safety and efficacy profiles to emerging innovations with allogeneic and in vivo approaches, this panel will explore how a robust CMC strategy will enable companies to win across cell therapy modalities in different disease areas and indications.

Chair:

John Tomtishen, Global Head Cell Therapy Field Application Scientists and Strategic Alliances, Catalent

Speakers:

Henrik Andersen, Ph.D., Investment Advisor, Delin Ventures; Board Member, Ori Biotech

Bruno Marques, Ph.D., Senior Vice President, Technical Operations, Morphocell Technologies

Arvind Natarajan, Ph.D., Senior Vice President, Process and Analytical Development, Iovance Biotherapeutics

Edwin Stone, Ph.D., CEO, Cellular Origins

9:00am – 9:45am | CONCURRENT TRACKS

ALLIANCE FOR REGENERATIVE MEDICINE BOARD VOTE AND WELCOME REMARKS
{FLW Ballroom E}
9:00am – 9:45am

Speakers:

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

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

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

9:00am – 9:45am

9:00am – 9:15amNysnoBio
9:15am – 9:30amARMI | BioFabUSA
9:30am – 9:45amGENETHON

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

9:00am – 9:45am

9:00am – 9:15am Sano Genetics
9:15am – 9:30am Morphocell
9:30am – 9:45am Latus Bio

9:45am – 10:15am | CONCURRENT TRACKS

KEYNOTE SPEAKER

{FLW Ballroom E}

9:45am – 10:15am

Speaker:

Karim Mikhail, Director, Center for Biologics Evaluation and Research (CBER), U.S. Food & Drug Administration (FDA)

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

9:45am – 10:15am

9:45am – 10:00amFoundation for Angelman Syndrome Therapeutics
10:00am – 10:15amExpressionEdits

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

9:45am – 10:15am

9:45am – 10:00amEmmecell
10:00am – 10:15amCellbox Solutions

10:15am – 10:45am | MORNING BREAK

Sponsored by Beam Therapeutics, Project Farma and RoslinCT

10:45am – 11:45am | CONCURRENT TRACKS

DELIVERING CAR-T: EXPANDING ACCESS TO TRANSFORM PATIENT CARE
{FLW Ballroom E}
10:45am – 11:45am

As CAR-T therapies continue to demonstrate transformative clinical outcomes, the industry is focused on expanding patient access while overcoming manufacturing, delivery, and reimbursement challenges. This session brings together leaders from across the field to discuss the innovations, partnerships, and strategies needed to make these potentially life-saving therapies available to more patients worldwide.

Chair:

Daniel Palmacci, Head of Specialized Modalities, Lonza

Speakers:

Catherine Bollard, M.D., Senior Vice President and Chief Research Officer, Children’s National; Professor of Pediatrics, The George Washington University

Lynelle Hoch, President, Cell Therapy Organization, Bristol Myers Squibb

Cindy Perettie, Executive Vice President and Global Head, Kite Pharma, a Gilead Company

Bruce Thompson, Ph.D, Chief Scientific Officer, Kincellis Advanced Therapies

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

10:45am – 11:45am

10:45am – 11:00amArbor Biotechnologies
11:00am – 11:15amAspen Neuroscience
11:15am – 11:30amBoston Biodevelopment
11:30am – 11:45amRocket Pharma

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

10:45am – 11:45am

10:45am – 11:00amCatalent
11:00am – 11:15amREGENXBIO
11:15am – 11:30amMetcela
11:30am – 11:45amPrecision BioSciences

11:45am – 12:15pm | CONCURRENT TRACKS

PATIENT SPOTLIGHT WITH KENDRA RILEY: RARE DISEASE MOM AND METACHROMATIC LEUKODYSTROPHY ADVOCATE
{FLW Ballroom E}
11:45am – 12:15pm

Kendra Riley is an entrepreneur and mother of three daughters, two of whom were diagnosed with the rare genetic disease Metachromatic Leukodystrophy (MLD) at the height of the COVID-19 pandemic in 2020. At the time, only one of her daughters was eligible for a life-saving gene therapy available exclusively in Milan, Italy. Since then, Kendra has dedicated herself to advocating for families affected by MLD and other rare diseases. Her efforts have helped multiple children across the country access the same life-saving treatment, inspired new research in newborn screening, and contributed to the successful FDA approval of her daughter’s treatment. She has shared her family’s journey on stages across the globe, played a key role in advancing Right to Try 2.0 legislation in more than 15 states, which just recently got introduced to Congress, and she also spoke alongside Secretary Robert F. Kennedy Jr. as he added MLD to the nation’s Recommended Uniform Screening Panel (RUSP), a milestone that will help ensure more newborns are screened for the disease and have the opportunity to receive treatment before symptoms begin.

Chair:

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

Speaker:

Kendra Riley, Rare Disease Mom and Metachromatic Leukodystrophy (MLD) Advocate

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

11:45am – 12:15pm

11:45am – 12:00pmMetagenomi Therapeutics
12:00pm – 12:15pmPrecision for Medicine

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

11:45am – 12:15pm

11:45am – 12:00pmElevateBio
12:00pm – 12:15pmEvotec

12:15pm – 1:30pm | LUNCH

Sponsored by OXB

1:30pm – 2:30pm | CONCURRENT TRACKS

CONVERGENCE VS. DIVERGENCE: GLOBAL REGULATORY PATHWAYS FOR ADVANCED THERAPIES

{FLW Ballroom E}
1:30pm – 2:30pm

Explore how leading global regulatory agencies are shaping the future of advanced therapies, highlighting where regulatory approaches align, where they differ, and what it means for developers navigating international markets.

Chair:

Lola Fashoyin-Aje, M.D., Vice President, Head of Cell Therapy Regulatory Science and Strategy, AstraZeneca

Speakers:

Jon Beaman, Ph.D., Deputy Director, Innovative Medicines, Medicines and Healthcare products Regulatory Agency (MHRA)

Megha Kaushal, M.D., Acting Deputy Director, Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)

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

WORKSHOP: IF WE KNEW THEN WHAT WE KNOW NOW…THE MISTAKES WORTH MAKING…

{FLW Ballroom F}
1:30pm – 2:15pm
Sponsored by CTI Clinical Trial & Consulting

The field of advanced therapies has evolved through decades of innovation, challenges, and groundbreaking successes. From periods of early exuberance to moments of profound skepticism, the industry is now experiencing a renaissance driven by stronger financial foundations, increasing global regulatory alignment, and advances in manufacturing. This panel brings together seasoned industry leaders to reflect on the critical lessons learned across development, manufacturing, regulation, commercialization, and patient access. Panelists will share historical decisions and hard-earned insights that continue to influence current strategies and shape the future of regenerative medicine (the identities of the decision-makers will be held in confidence). Attendees will leave with a deeper understanding of the pivotal decisions, successes, and setbacks that have shaped the field—and how those lessons can inform the future of regenerative medicine as the industry enters its next phase of growth and innovation.

Chair:

Tim Schroeder, Executive Chairman and Founder, CTI Clinical Trials and Consulting

Speaker:

Jodi Cook, Ph.D., President and CEO, Skylark Bio

Dan MacLeod, Ph.D., Chief Scientific Officer, Optieum Biotechnologies

Ken Macnamara, Ph.D., CEO, Trogenix

Yael Weiss, M.D., Ph.D., CEO, Mahzi Therapeutics

INNOVATION SPOTLIGHT

{FLW Ballroom F}

 

2:15pm – 2:30pmBionova Scientific

INNOVATION SPOTLIGHTS: EMERGING TRACK

{FLW Ballroom G}

1:30pm – 2:30pm

1:30pm – 1:45pm Tacit Therapeutics
1:45pm – 2:00pm ParcelBio
2:00pm – 2:15pm InterAct Therapeutics
2:15pm – 2:30pm MKC Biotherapeutics

2:30pm – 3:30pm | CONCURRENT TRACKS

THE STARS ALIGN FOR A CGT INVESTMENT REBOUND: M&A PICKS UP, STRATEGIC PHARMA STEPS IN, AND THE REGULATORY OUTLOOK STABILIZES
{FLW Ballroom E}
2:30pm – 3:30pm

Chair:

Robert Ang, Former CEO, Vor Bio; Board Director, Kolon TissueGene

Speakers:

Ray Camahort, Ph.D., Partner, Novo Holdings

Matt Eckler, Ph.D., Principal, Public Investing, Samsara BioCapital

Craig Gordon, M.D., Founder, CEO, and Chief Investment Officer, GordonMD Global Investments

Debra Netschert, Managing Director and Portfolio Manager, Jennison Associates

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

2:30pm – 3:30pm

2:30pm – 2:45pm Kyverna Therapeutics
2:45pm – 3:00pm Kenai Therapeutics
3:00pm – 3:15pm Pluristyx
3:15pm – 3:30pm uniQure

INNOVATION SPOTLIGHTS: EMERGING TRACK

{FLW Ballroom G}

2:30pm – 3:00pm

2:30pm – 2:45pmSereNeuro
2:45pm – 3:00pmNionyx Bio

 

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

3:00pm – 3:30pm

3:00pm – 3:15pmCTI Clinical Trial & Consulting Services
3:15pm – 3:30pmCPTx

3:30pm – 4:00pm | AFTERNOON BREAK

Sponsored by Beam Therapeutics, Project Farma and RoslinCT

4:00pm – 5:00pm | CONCURRENT TRACKS

ETHICS IN THE ERA OF CELL AND GENE THERAPY
{FLW Ballroom E}
4:00pm – 5:00pm

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., 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

WORKSHOP: FROM MODEL TO MEDICINE: LEVERAGING NAMS TO ACCELERATE CGT DRUG DEVELOPMENT, DE-RISK CANDIDATES, AND IMPROVE CAPITAL EFFICIENCY
{FLW Ballroom F}
4:00pm – 4:45pm
FUJIFILM Cellular Dynamics

Chair:

Nina Bauer, Ph.D., Executive Vice President, Strategy and Commercial, FUJIFILM Cellular Dynamics

Speakers:

Kyung Jin Lee, Ph.D., Chief Technology Officer, Organoids by Southwest (OXSW)

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

Tayler Shebly, Executive Director, Regulatory CMC & GMP Quality, Lilly Regenerative Medicine

INNOVATION SPOTLIGHT

{FLW Ballroom F}

 

4:45pm – 5:00pmTreeFrog Therapeutics

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

4:00pm – 5:00pm

4:00pm – 4:15pmMEDIPOST
4:15pm – 4:30pmComplement Therapeutics
4:30pm – 4:45pmAscidian Therapeutics
4:45pm – 5:00pmHarro Höfliger

5:00pm – 6:00pm | CONCURRENT TRACKS

PROCESS IMPROVEMENT FOR CELL AND GENE THERAPIES: THE COMPARABILITY QUANDARY
{FLW Ballroom E}
5:00pm – 6:00pm

Explore how cell and gene therapy manufacturers can improve processes while navigating the complexities of comparability. Industry experts will discuss practical strategies for managing process changes, maintaining product consistency, and meeting regulatory expectations.

Chair:

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

Speakers:

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

Amol Ketkar, Chief Manufacturing and Technical Operations Officer, Resolution Therapeutics

Michael Paglia, Chief Technology Officer, ElevateBio

Rajiv Vaidya, Head of Manufacturing Science and Technology, Andelyn Biosciences

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

5:00pm – 6:00pm

5:00pm – 5:15pm Cytiva
5:15pm – 5:30pm Children’s National Hospital
5:30pm – 5:45pm Restem Group
5:45pm – 6:00pm Aurion Biotech

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

5:00pm – 6:00pm

5:00pm – 5:15pmPolTREG
5:15pm – 5:30pmScribe Therapeutics
5:30pm – 5:45pmAspect Biosystems
5:45pm – 6:00pmAABB

6:00pm | PROGRAM AND PARTNERING CLOSES

6:00pm – 8:30pm | NETWORKING BASH

Sponsored by Andelyn Biosciences, ABL-Ascend, Catalent Pharma Services and Sumitomo Pharma America

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

Sponsored by Precision for Medicine

8:00am – 8:45am | CONCURRENT WORKSHOPS

WHY JAPAN, WHY NOW: INVESTMENT OPPORTUNITIES AND ASIA GATEWAY STRATEGY
8:00am – 8:45am | FLW Ballroom F
Sponsored by FIRM

Why are global companies continuing to invest in Japan? This session brings together leaders from Japan’s Ministry of Economy, Trade and Industry (METI), the Forum for Innovative Regenerative Medicine (FIRM), and Bristol Myers Squibb (BMS) to discuss Japan’s industrial strategy for cell and gene therapy, the role of public-private partnerships in accelerating commercialization, and why global biopharmaceutical companies continue to invest in Japan.

  • Japan’s Industrial Strategy for Cell and Gene Therapy

Speaker:

Shoki Nishio, Deputy Director, Bio-Industry Division, Ministry of Economy, Trade and Industry (METI)

  • Acceleration of Industrialization of Regenerative Medicine in Japan

Speaker:

Jotaro Suzuki, Ph.D., Vice Chairperson and Representative Director, Forum for Innovative Regenerative Medicine (FIRM)

  • A Global Enterprise’s Perspective: The Importance of Public-Private Partnerships in Building a Successful Ecosystem in Japan

Speaker:

Eunice Kim, Vice President, Global Commercial Cell Therapy Hematology, Bristol Myers Squibb (BMS)

WORKSHOP: CAN EX VIVO REACH MILLIONS? INNOVATIONS THAT COULD MAKE IT POSSIBLE

8:00am – 8:45am | FLW Ballroom G

Sponsored by Cellares

The next wave of cell therapy may be defined not by increasingly complex manufacturing, but by innovations that make cell therapies simpler, more reproducible, and scalable for large autoimmune populations. As the field moves beyond bespoke, individualized manufacturing models, this panel will explore the scientific and manufacturing advances that could unlock commercially viable cell therapies for diseases affecting millions of patients. Industry leaders will discuss emerging approaches across cell engineering, process intensification, automation, quality, and manufacturing scale, and what it will take to move promising therapies from breakthrough clinical data to broad patient access.

Chair:

Lara Silverman, Ph.D., Co-founder and Chief Science Officer, Coralis Bio

Speakers:

Gwendolyn Binder, Ph.D., President, Science and Technology, Cabaletta Bio

Fabian Gerlinghaus, Co-founder and CEO, Cellares

Stephen Dilly, Ph.D., President and CEO, Sonoma Biotherapeutics

9:00am | CONCURRENT TRACKS

SPOTLIGHT ON ARM AND PRECISION FOR MEDICINE’S 2026 CELL AND GENE THERAPY EXECUTIVE SURVEY
{FLW Ballroom E}
9:00am – 9:30am

Chair:

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

Speaker:

Harpreet Singh, M.D., Chief Medical Officer, Precision for Medicine

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

9:00am – 9:30am

9:00am – 9:15am EXTHYMIC
9:15am – 9:30am Circio

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

9:00am – 9:30am

9:00am – 9:15amRheumaGen
9:15am – 9:30amTouchlight

9:30am – 10:15am | CONCURRENT TRACKS

IN VIVO THERAPIES: CURRENT PROGRESS AND FUTURE DIRECTIONS
{FLW Ballroom E}
9:30am – 10:15am

Chair:

Francesca Vitelli, Ph.D., Vice President and Global Head, Process and Analytical Development and Innovation, Minaris Advanced Therapies

Speakers:

Anne-Virginie Eggimann, Vice President and Chief Development Officer, Lilly Regenerative Medicine

John Leonard, M.D., President and CEO, Intellia Therapeutics

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

Raja Srinivas, Co-founder, Asimov

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

9:30am – 10:15am

9:30am – 9:45amSanBio
9:45am – 10:00amMilliporeSigma
10:00am – 10:15amArovella Therapeutics

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

9:30am – 10:15am

9:30am – 9:45am CREATE Medicines
9:45am – 10:00am VERIGRAFT
10:00am – 10:15am Germfree

10:15am – 10:30am | MORNING BREAK

Sponsored by Beam Therapeutics, Project Farma and RoslinCT

10:30am – 11:15am | CONCURRENT TRACKS

LESSONS FROM THE CLINIC TO THE MARKET: MANAGING SAFETY, ACCESS, AND MANUFACTURING IN GENE THERAPIES
{FLW Ballroom E}
10:30am – 11:15am

Chair:

Louis Cicchini, Ph.D., Senior Director, Scientific Affairs and Enterprise Partnerships, CGT, Cencora

Speakers:

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

Gaurav Shah, CEO and Co-founder, Rocket Pharma

Curran Simpson, President and CEO, REGENXBIO

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

WORKSHOP: THE MANUFACTURING DECISIONS THAT QUIETLY DRIVE COGS
How CGT companies should structure automation and engineering before GMP scale-up turns early choices into technical debt.

{FLW Ballroom F}

10:30am – 11:15am

Sponsored by Invetech

Many cell and gene therapy companies are focused on improving manufacturability, reducing cost of goods (COGS), and preparing for commercial scale. Yet some of the most expensive manufacturing challenges originate much earlier, when process, equipment, automation, and resourcing decisions are made without a clear view of future GMP requirements and operational realities. This session will explore the manufacturing decisions that can quietly create technical debt long before scale-up begins. Drawing on perspectives from therapy developers, manufacturing leaders, and engineering experts, the discussion will examine how organizations determine which capabilities to build internally, where external engineering partners can create leverage, and how early process architecture, technology selection, and automation decisions can influence future cost, complexity, deviations, tech transfer burden, and scalability. Panelists will discuss practical considerations, including where internal teams are most often stretched, how companies evaluate build-versus-partner decisions, and what successful engineering and manufacturing models look like in practice. Attendees will leave with a clearer framework for making early manufacturing and automation decisions that support long-term commercialization goals while avoiding costly downstream rework. 

Chair:

Erica Menser, Senior Director of Business Development, Cell & Gene Therapy, Invetech

Speakers:

Matthew Hewitt, Ph.D., Vice President, Chief Technical Officer, Manufacturing Business Division, Charles River Laboratories

Kim Raineri, Chief Technology Officer, Aspen Neuroscience

Joseph Sieling, Senior Director, CMC Innovation, Legend Biotech

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

10:30am – 11:15am

10:30am – 10:45amSartorius
10:45am – 11:00amCell & Gene Therapy Catapult
11:00am – 11:15amBOOST Pharma

11:15am – 11:45am | CONCURRENT TRACKS

PLATFORM TECHNOLOGIES ACROSS MODALITIES
{FLW Ballroom E}
11:15am – 11:45am

How does platforming differ between iPSC and AAV technologies? This discussion will bring together leaders across the field to examine the science, manufacturing, regulatory, and business considerations shaping platform approaches.

Chair:

Jessica Carmen, Ph.D., Chief Commercial Officer, RoslinCT

Speakers:

Gilmore O’Neill, President and Chief Executive Officer, Editas Medicine

Ana Sousa, Chief Regulatory Officer, Aspen Neuroscience

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

11:15am – 11:30am Ray Therapeutics
11:30am – 11:45am Clarion Cells

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

11:15am – 11:45am

11:15am – 11:30amNanoscope Therapeutics
11:30am – 11:45amAccellix

11:45am – 12:15pm | CONCURRENT TRACKS

PATIENT SPOTLIGHT WITH LEE GREENWOOD: NOA’S DAD AND CANAVAN DISEASE ADVOCATE
{FLW Ballroom E}
11:45am – 12:15pm

Lee has been an advocate at the federal, state and local levels for decades. He fell in love with the possibility of policy while working in the senate in Washington, D.C. After law school he began his advocacy career on behalf of mental health practitioners. He and his partner, Lori, had a two-year interlude to live in southeastern Turkey, then moved back to the States where he worked for a state representative in Boston. For 6+ years he built the advocacy department for a national animal welfare organization. He now serves as Director of Government Affairs for an international management company. Lee and Lori became rare disease advocates when their youngest daughter, Noa, was diagnosed with Canavan Disease just before her first birthday. Big sister Max and adorable pup, Gracie quickly joined the effort and it’s now a full-family affair. The whole crew lives happily and chaotically in Boston.

Chair:

Kinnari Patel, Pharm.D., CEO, RTW Institute

Speaker:

Lee Greenwood, Noa’s Dad and Canavan Disease Advocate

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

11:45am – 12:15pm

11:45am – 12:00pmInspiroGene™ by McKesson
12:00pm – 12:15pmTenaya Therapeutics

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

11:45am – 12:15pm

11:45am – 12:00pmGenetix Biotherapeutics
12:00pm – 12:15pmLyGenesis

12:15pm – 1:30pm | LUNCH

Sponsored by Kenai Therapeutics

1:30pm – 2:15pm | CONCURRENT TRACKS

INSIDE THE AUTOIMMUNE REVOLUTION

{FLW Ballroom E}
1:30pm – 2:15pm

Discover how cell and gene therapies are transforming the treatment of autoimmune diseases, with leaders discussing the latest clinical advances, emerging approaches, and the path toward broader patient impact.

Chair:

Sara Mills, Vice President, Regulatory Affairs, CMC and AlloNK Program Lead, Artiva Biotherapeutics

Speakers:

Warner Biddle, CEO, Kyverna Therapeutics

Gwendolyn Binder, Ph.D., President, Science and Technology, Cabaletta Bio

Dilip Patel, Senior Vice President, Value, Access and Policy, Autolus Therapeutics

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

1:30pm – 2:15pm

1:30pm – 1:45pm SmartCella
1:45pm – 2:00pm Avectas
2:00pm – 2:15pm Ntrans Technologies

INNOVATION SPOTLIGHTS: EMERGING TRACK

{FLW Ballroom G}

1:30pm – 2:15pm

1:30pm – 1:45pm Ernexa Therapeutics
1:45pm – 2:00pm Granza Bio
2:00pm – 2:15pm Perpetuu Bio

2:15pm – 3:15pm | CONCURRENT TRACKS

LEADERSHIP PERSPECTIVES: BEYOND THE BREAKTHROUGH

{FLW Ballroom E}
2:15pm – 3:15pm

Hear from industry leaders as they discuss the opportunities and challenges of advancing cell and gene therapies from late-stage development through commercialization, sharing perspectives from both recently commercialized products and programs approaching pivotal milestones.

Chair:

Tiffani Manolis, Vice President, General Manager, Cell Biology, Thermo Fisher Scientific

Speakers:

Nate Fernhoff, Ph.D., CEO and Co-founder, Orca Bio

Adriana Herrera, CEO, Pierre Fabre Pharmaceuticals

Shankar Musunuri, Ph.D., Chairman of the Board, CEO and Co-founder, Ocugen

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

2:15pm – 3:15pm

2:15pm – 2:30pm Viralgen
2:30pm – 2:45pm March Biosciences
2:45pm – 3:00pm Immusoft
3:00pm – 3:15pm Artiva

INNOVATION SPOTLIGHTS: EMERGING TRACK

{FLW Ballroom G}

2:15pm – 3:15pm

2:15pm – 2:30pm Organoids by Southwest
2:30pm – 2:45pm BioCurie
2:45pm – 3:00pm Skylark Bio
2:45pm – 3:00pm BlueWhale Bio

3:15pm – 3:30pm | AFTERNOON BREAK

Sponsored by Beam Therapeutics, Project Farma and RoslinCT

3:30pm – 4:15pm | CONCURRENT TRACKS

THE PATIENT VOICE: SHAPING THE DEVELOPMENT OF CELL AND GENE THERAPIES
{FLW Ballroom E}
3:30pm – 4:15pm

Discover how patient advocacy is shaping the future of cell and gene therapy development, from clinical trial design and regulatory engagement to improving access and outcomes for the communities these therapies are intended to serve.

Chair:

Michael Pearlmutter, CEO, RARE Foundation

Speakers:

Kara Berasi, Pharm.D., CEO, Haystack Project

Allyson Berent, Chief Science Officer, Foundation for Angelman Syndrome Therapeutics

Panteli Theocharous, Ph.D., FRCPath, Chief Therapeutics and Clinical Strategy Officer, and President of Europe, Worldwide Clinical Trials

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

3:30pm – 4:15pm

3:30pm – 3:45pmAstellas
3:45pm – 4:00pmSumitomo Pharma America
4:00pm – 4:15pmForm Bio

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

3:30pm – 4:15pm

3:30pm – 3:45pm AGC Biologics
3:45pm – 4:00pm Cellular Origins
4:00pm – 4:15pm Virica Biotech

4:15pm – 5:00pm | CONCURRENT TRACKS

CHINA AND THE FUTURE OF GLOBAL CELL AND GENE THERAPY DEVELOPMENT
{FLW Ballroom E}
4:15pm – 5:00pm

Explore China’s growing influence in cell and gene therapy and how global partnerships, innovation, and evolving regulatory strategies are shaping the next generation of advanced therapy development.

Chair:

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

Speakers:

Jason Foster, CEO and Executive Director, Oribiotech

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

Lijun Wang, Founder and CEO, CoJourney

INNOVATION SPOTLIGHTS

{FLW Ballroom F}

4:15pm – 5:00pm

4:15pm – 4:30pm Vitalant
4:30pm – 4:45pm Mirai Bio
4:45pm – 5:00pm Mayo Clinic

INNOVATION SPOTLIGHTS

{FLW Ballroom G}

4:15pm – 5:00pm

4:15pm – 4:30pmForge Biologics
4:30pm – 4:45pmiCell Gene Therapeutics
4:45pm – 5:00pmSpecific Biologics

5:00pm | PROGRAM AND PARTNERING CLOSES

5:00pm – 6:00pm | COCKTAIL RECEPTION

Sponsored by LEON

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

8:00am – 8:45am | MORNING WORKSHOP

MORNING WORKSHOP: DEVELOPING STANDARDIZED PLATFORMS FOR NEXT GENERATION T-CELL THERAPIES
8:00am – 8:45am | FLW Ballroom E
Sponsored by Aldevron

Programmable cellular therapies are becoming dramatically more capable, but their growing complexity risks making development slower, more expensive, and harder to scale. The next major advance for the field will come from treating engineering, manufacturing, analytics, and regulatory translation as reusable platforms rather than one-off product builds. Platform-based development can convert powerful new cell engineering tools and synthetic biology advances into faster, more consistent, and more accessible medicines.

Chair:

Sadik Kassim, Ph.D., Chief Scientific Officer, DHR Omics Platform, Danaher

Speakers:

Loren Schoch, Vice President, Gene Editing Therapeutics, Aldevron

Brian Shy, M.D., Ph.D., Assistant Professor, UCSF Department of Laboratory Medicine, Director, UCSF Investigational Cell Therapy Program

9:00am | GENERAL SESSION

9:00am – 10:00am | MAIN PROGRAM

INNOVATIVE COMMERCIAL MODELS FOR RARE DISEASES

{FLW Ballroom E}

9:00am – 10:00am

Rare disease therapies require new approaches to commercialization. Join industry leaders as they discuss innovative business models, partnerships, and funding strategies that are expanding patient access and supporting long-term success.

Chair:

Philip Wills, Ph.D., Chief Commercial Officer, Catalent Pharma Solutions

Speakers:

Vanessa Almendro Navarro, Ph.D., Chief Commercialization Officer, City of Hope

Paul Ayoub, Ph.D., CEO and Co-founder, Rarity PBC

Daria Fedyukina, Ph.D., Program Manager, Health Science Futures, ARPA-H

Craig Martin, Founder and CEO, Orphan Therapeutics Accelerator

Shyam Patel, Ph.D., Associate Vice President of Patient Access, California Institute for Regenerative Medicine (CIRM)

10:00am – 11:00am | MAIN PROGRAM

IPSCS COME OF AGE: FROM PROMISE TO REALITY

{FLW Ballroom E}

10:00am – 11:00am

Induced pluripotent stem cells (iPSCs) are rapidly moving from scientific promise to clinical reality. Hear from leaders advancing the technologies, manufacturing, and therapeutic applications driving the next generation of regenerative medicine.

Chair:

Jeff Ross, Ph.D., President, Miromatrix a United Therapeutics Company

Speakers:

Liza Loidolt, General Manager, Cell and Gene Therapies, Terumo Blood and Cell Technologies

Delara Motlagh, President and Chief Operating Officer, FUJIFILM Cellular Dynamics

Johanna Rossell, Senior Vice President, General Manager, Regenerative Medicine, Sumitomo Pharma America

Jason Wertheim, M.D., Ph.D., Vice Dean for Research and Graduate Studies, University of Arizona College of Medicine, Tucson

11:00am – 12:00pm | MAIN PROGRAM

LEVERAGING AI IN CELL & GENE THERAPY: SUCCESSES, CHALLENGES, AND WHAT IS NEXT
{FLW Ballroom E}
11:00am – 12:00pm

Artificial intelligence is rapidly reshaping every stage of the cell and gene therapy lifecycle—from target discovery and clinical development to manufacturing, regulatory review, and commercialization. Join leaders from across the ecosystem as they discuss where AI is delivering real value today, the challenges that remain, and what the next wave of innovation could mean for advanced therapies.

Chair:

Steve Goldenberg, Co-founder and CEO, Coralis Bio

Speakers:

Charlotte Guzzo, Founder and Chief Operating Officer, Sano Genetics

Ali Kazzaz, Chief Commercial Officer, Rose BioSolutions

Steven Oh, Ph.D, Director, Office of Cellular Therapy and Human Tissue, U.S. Food and Drug Administration (FDA)

Cliff Wallace, Vice President, Quality, Artiva Biotherapeutics

Sarah Stabenfeldt, Ph.D., Assistant Vice President and President’s Professor, School of Biological and Health Systems Engineering, Arizona State University

12:00pm | CONFERENCE CLOSES

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