Agenda

2025 Meeting Agenda

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

2025 Featured Speakers

Emer Cooke

Executive Director, European Medicines Agency

James Wilson, M.D., Ph.D.

President and CEO, GEMMABio

Paul Stoffels, M.D.

Chair of the Board and CEO, Galapagos

2024 Agenda at a Glance

Live Event Dates

12:00pm – 5:00pm Badge Pick-up in the Rome Cavalieri Lobby (All Attendees)

Time TBD ARM Board of Directors Meeting (By Invitation Only)

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

7:30am – 9:00am Registration
9:00am – 6:00pm General Session, Panel Discussions, Company Presentations, Workshops and Partnering Meetings
6:00pm – 7:00pm Cocktail Reception

7:30am – 9:00am Registration
9:00am – 12:00pm General Session, Panel Discussions, Company Presentations, Workshops and Partnering Meetings
12:00pm – 1:00pm Closing Lunch

Virtual Partnering Dates

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

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

2025 Meeting Agenda

Agenda Sponsor:

  • Full Agenda

7:30am – 9:00am | REGISTRATION

8:00am | PARTNERING OPENS

9:00am | GENERAL SESSION

WELCOME REMARKS

{Salone dei Cavalieri, Section 3&4}

9:00am – 9:30am

Speakers:

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

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

9:30am – 10:15am | CONCURRENT TRACKS

KEYNOTE SPEAKER: EMER COOKE, EXECUTIVE DIRECTOR, EUROPEAN MEDICINES AGENCY
{Salone dei Cavalieri, Section 3&4}

9:30am – 10:15am

Moderator:

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

Speaker:

Emer Cooke, Executive Director, European Medicines Agency

COMPANY PRESENTATIONS
{Salone dei Cavalieri, Section 2}

9:30am – 9:45amAccelerated Biosciences
9:45am – 10:00amCUTISS
10:00am – 10:15amCHO Plus

10:15am – 10:45am | MORNING BREAK

10:45am – 12:15pm | CONCURRENT TRACKS

COMMERCIALIZING ATMPS: MOVING FROM INNOVATION TO MARKET SUCCESS

{Salone dei Cavalieri, Section 3&4}

10:45am – 11:30am
This panel will discuss the journey of commercializing ATMPs, focusing on key challenges and strategies for bringing innovative therapies to market, with insights from industry experts in manufacturing, R&D, and regulatory pathways.

Moderator:

Behnam Baghbaderani, Ph.D., Vice President, Global Head of Commercial and Program Management, Lonza

Speakers:

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

Kinnari Patel, Pharm.D., President, Head of R&D and Chief Operating Officer, Rocket Pharma

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

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

10:45am – 11:00amQuTEM
11:00am – 11:15amEvox Therapeutics
11:15am – 11:30amMaxCyte

JOINT CLINICAL ASSESSMENT OF ATMPS: CLINICAL TRIALS, PATIENT ACCESS AND EU COMPETITIVENESS

{Salone dei Cavalieri, Sections 3&4}

11:30am – 12:15pm
This panel will explore the Joint Clinical Assessment of ATMPs, focusing on its impact on clinical trials, patient access, and the EU’s global competitiveness, with insights from experts across industry, patient advocacy, and healthcare.

Moderator:

Miguel Forte, M.D., Ph.D., CEO, Kiji Therapeutics

Speakers:

Alex Bloom, Ph.D., Chief Technology Officer, AviadoBio

Antonella Cardone, CEO, Cancer Patients Europe (CPE)

François Houÿez, Information and Access to Therapies Director, Health Policy Advisor, EURORDIS-Rare Diseases Europe

Pierluigi Russo, Ph.D., Technical Scientific Director AIFA, Italy

Andreas Ziegler, M.D., Senior Physician, Neuropediatrics and Metabolic Medicine, University of Heidelberg

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

11:30am – 11:45am Cellares
11:45am – 12:00pm Rocket Pharmaceuticals
12:00pm – 12:15pm Autolus

12:15pm – 1:15pm | LUNCH

1:15pm – 3:15pm | CONCURRENT TRACKS

INVESTOR SPOTLIGHT SESSION

{Salone dei Cavalieri, Section 3&4}

1:15pm – 1:45pm

Moderator:

Matthew Durdy, Chief Executive, Cell and Gene Therapy Catapult

Speaker:

Jim Birchenough, M.D., Chairman and Global Co-Head, Barclays Biopharmaceutical Investment Banking

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

1:15pm – 1:30pmNanite
1:30pm – 1:45pmWhiteLab Genomics

SCIENCE SLAM: OCULAR INDICATIONS
{Salone dei Cavalieri, Section 3&4}

1:45pm – 2:45pm

Moderator:

Amit Rakhit, M.D., Chief Development Officer, BlueRock Therapeutics

Speakers:

Daniel Chung, Ph.D., Chief Medical Officer, SparingVision

Andrew Ramelmeier, Ph.D., Chief Technology Officer, Adverum Biotechnologies

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

1:45pm – 2:00pm uniQure
2:00pm – 2:15pm Arbor Biotechnologies
2:15pm – 2:30pm Minaris
2:30pm – 2:45pm Vor Bio

KEYNOTE SPEAKER: DR. JAMES WILSON

{Salone dei Cavalieri, Section 3&4}

2:45pm – 3:15pm

Moderator:

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

Speaker:

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

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

2:45pm – 3:00pmRheumaGen
3:00pm – 3:15pmCoave Therapeutics

3:15pm – 3:45pm | AFTERNOON BREAK

3:45pm – 6:00pm | CONCURRENT TRACKS

COLLABORATIVE INNOVATIONS IN CELL AND GENE THERAPY MANUFACTURING: BRIDGING REALITY AND AUTOMATION

{Salone dei Cavalieri, Section 3&4}

3:45pm – 4:30pm

Moderator:

Josh Ludwig, Global Director, Commercial Operations, ScaleReady

Speakers:

Stephen Ward, Ph.D., Chief Technology Officer, Cell and Gene Therapy Catapult

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

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

3:45pm – 4:00pmCatalent
4:00pm – 4:15pmForge Biologics
4:15pm – 4:30pmAtamyo Therapeutics

THE IMPORTANCE OF ETHICS IN GENE AND CELL THERAPY

{Salone dei Cavalieri, Section 3&4}

4:30pm – 5:15pm

Moderator:

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

Speakers:

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

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

Adora Ndu, Pharm.D., Chief Regulatory Officer, Executive Vice President, Portfolio Strategy and Management, BridgeBio Pharma

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

4:30pm – 4:45pm AviadoBio
4:45pm – 5:00pm Umoja BioPharma
5:00pm – 5:15pm Evotec International

TISSUE THERAPEUTICS: THE PROMISE OF RATIONALLY DESIGNED TISSUES TO REPLACE LOST FUNCTION

{Salone dei Cavalieri, Section 3&4}

5:15pm – 6:00pm
Panelists will discuss recent advances in the design and development of tissue therapeutics including applications of perfusion technologies and bioprinting to bring next order treatments to patients with limited options.

Moderator:

Julie Allickson, Ph.D., Chief Technology Officer, Mayo Clinic Center for Regenerative Biotherapeutics

Speakers:

Petter Björquist, Ph.D., CEO, VERIGRAFT

Tamer Mohamed, Founder and CEO, Aspect Biosystems

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

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

5:15pm – 5:30pm TreeFrog Therapeutics
5:30pm – 5:45pm Cellular Origins
5:45pm – 6:00pm Novartis Contract Manufacturing

6:00pm | PROGRAM AND PARTNERING CLOSES

6:00pm – 8:00pm | NETWORKING BASH

Sponsored by Dark Horse Consulting and Intertek

7:30am – 9:00am | REGISTRATION

8:00am | PARTNERING OPENS

9:00am – 10:30am | CONCURRENT TRACKS

ARM STRATEGIC INITIATIVES

{Salone dei Cavalieri, Section 3&4}

9:00am – 9:15am

Speaker:

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

COMPANY PRESENTATION

{Salone dei Cavalieri, Section 2}

9:00am – 9:15amFibroBiologics

KEYNOTE SPEAKER: DR. PAUL STOFFELS
{Salone dei Cavalieri, Section 3&4}

9:15am – 9:45am

Moderator:

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

Speaker:

Paul Stoffels, M.D., Chair of the Board and CEO, Galapagos

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

9:15am – 9:30amEvolved.Bio
9:30am – 9:45amSmartCella

REGULATORY CONVERGENCE FOR ATMPS: BUILDING GLOBAL STANDARDS
{Salone dei Cavalieri, Section 3&4}

9:45am – 10:30am

Moderator:

Anne-Virginie Eggimann, Chief Regulatory Officer, Tessera Therapeutics

Speakers:

Julian Beach, Executive Director Healthcare Quality and Access, MHRA

Sol Ruiz, Ph.D., Head, Unit of Biotechnology and Advanced Therapies, Spanish Medicines Agency

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

9:45am – 10:00am Ensoma
10:00am – 10:15am Portal
10:15am – 10:30am Life Edit Therapeutics

10:30am – 10:45am | MORNING BREAK

10:45am – 12:15pm | CONCURRENT TRACKS

INVESTING IN THE ATMP SECTOR: TRENDS, OPPORTUNITIES, AND RISKS

{Salone dei Cavalieri, Section 3&4}

10:45am – 11:30am
Join leading investors and industry experts as they delve into the dynamic ATMP investment landscape, analyzing market trends, funding opportunities, and potential challenges.

Moderator:

Sven Kili, Partner, Saisei Ventures

Speakers:

Lucia Faccio, Ph.D., Partner, Sofinnova Partners

Tim Lohoff, Ph.D., Senior Associate, Forbion

Owen Smith, Partner, 4BIO Capital

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

10:45am – 11:00am GENESPIRE
11:00am – 11:15am Allarta Life Science
11:15am – 11:30am Cellistic

EXPANDING ACCESS TO CAR-T THERAPIES: OVERCOMING BARRIERS AND DRIVING ADOPTION

{Salone dei Cavalieri, Section 3&4}

11:30am – 12:15pm
This panel will address the barriers preventing broader access to CAR-T therapies, such as logistical, financial, and regulatory challenges. Experts will share insights on how to drive adoption and improve patient access to these transformative treatments.

Moderator:

Rupa Pike, Ph.D., Senior Director and Global Head of Strategic Alliances, Catalent

Speakers:

David Fontana, Ph.D., Chief Operations Officer and Chief Business Officer, Umoja Biopharma

Phung Osborn, Vice President, Head of Global Market Access, Cell Therapy, Bristol Myers Squibb

Dilip Patel, Senior Vice President, Pricing and Market Access Strategy, Autolus

Panteli Theocharous, Ph.D., Chief Therapeutics Officer, Head of Medical and Scientific Affairs, Garuda Therapeutics

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

11:30am- 11:45am BlueRock Therapeutics
11:45am- 12:00pm Kiji Therapeutics
12:00pm- 12:15pm Precigen

12:15pm – 1:15pm | LUNCH

1:15pm – 2:45pm | CONCURRENT TRACKS

FROM PITCH TO PROGRESS: KEY TAKEAWAYS FROM SUCCESSFUL FUNDRAISING FOR ATMPS
{Salone dei Cavalieri, Section 3&4}

1:15pm – 1:45pm
This session will share key insights and strategies from successful fundraising efforts for ATMPs, covering the critical elements that attract investors and drive progress from pitch to funding. Experts will highlight best practices for navigating the fundraising process and securing support for innovative therapies.

Moderator:

Anshul Mangal, President, Project Farma

Speaker:

Robert Ang, President and CEO, Vor Bio

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

1:15pm – 1:30pm Charles River Laboratories
1:30pm – 1:45pm Cell and Gene Therapy Catapult

SCIENCE SLAM: DIABETES – CELL AND TISSUE THERAPY APPROACHES TO PROVIDE DURABLE THERAPEUTIC SOLUTIONS

{Salone dei Cavalieri, Section 3&4}

1:45pm – 2:45pm

Moderator:

Eytan Abraham, Ph.D., Chief Commercial and Technology Officer, Minaris Regenerative Medicine

Speakers:

Bernd Muehlenweg, Ph.D., Senior Vice President, Head of Global Business Development, Cell Therapy, Evotec; Non Executive Director, Sernova

Vlad Seitan, Ph.D., Chief Scientific Officer, Laverock Therapeutics

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

1:45pm – 2:00pmAdverum Biotechnologies
2:00pm – 2:15pmPDC*line Pharma
2:15pm – 2:30pmXintela
2:30pm – 2:45pmVerve Therapeutics

FEATURED SPEAKER: DR. KAREN AIACH-PIGNET

{Salone dei Cavalieri, Section 3&4}

2:45pm – 3:15pm
Join us for an insightful fireside chat with Karen Aiach-Pignet, CEO of Genespire and Founding Executive Member of the International Rare Diseases Research Consortium (IRDiRC). As a pioneer in the field of rare diseases, Karen will share her invaluable experience in leading global initiatives to accelerate the development of treatments for rare and complex conditions.

Speaker:

Karen Aiach-Pignet, CEO, Genespire; Founding Executive Member, International Rare Diseases Research Consortium (IRDiRC)

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

2:45pm – 3:00pmAstellas Pharma
3:00pm – 3:15pmVERIGRAFT

3:15pm – 3:45pm | AFTERNOON BREAK

3:45pm – 6:00pm | CONCURRENT TRACKS

CELL AND GENE THERAPIES IN THE MIDDLE EAST: CURRENT STATUS AND FUTURE OUTLOOK

{Salone dei Cavalieri, Section 3&4}

3:45pm – 4:30pm
Join us as we explore the current landscape of cell and gene therapies in the Middle East, highlighting regional advancements, challenges, and opportunities for growth in this emerging market. Experts will also discuss the future outlook and potential for broader adoption in the region.

Moderator:

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

Speakers:

Fatma Alhashimi, Ph.D, Director, First Stem Cell and Genomics Laboratory; Chairperson, Dubai Stem Cell Congress

Hala Audi, CEO, Unizima

Ahmed Mousa, M.D., General Manager, Lafana Holding

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

3:45pm – 4:00pmGENETHON
4:00pm – 4:15pmEG 427
4:15pm – 4:30pmCTI

ADVANCING GENE THERAPIES FOR RARE DISEASES: IMPLEMENTING NOVEL STRATEGIES FOR NOT-FOR-PROFIT INNOVATION

{Salone dei Cavalieri, Section 3&4}

4:30pm – 5:15pm

Moderator:

James Miskin, Ph.D., Special Advisor to the CEO, ViroCell Biologics

Speakers:

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

Maryam Mokhtarzadeh, M.D., Senior Director, Regulatory Strategy, REGENXBIO

Hilary Schultz, CEO and Founder, Persephoni BioPartners

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

4:30pm – 4:45pmLuminary Therapeutics
4:45pm – 5:00pmAnocca
5:00pm – 5:15pmAspect Biosystems

ADVANCING GLOBAL CELL AND GENE THERAPY MANUFACTURING IN 2025: CHALLENGES, INNOVATIONS, AND FUTURE DIRECTIONS

{Salone dei Cavalieri, Section 3&4}

5:15pm – 6:00pm

Moderator:

Luca Alberici, Ph.D., Executive Vice President, Global Cell and Gene Technologies and General Manager, AGC Biologics

Speakers:

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

Robert Hughes, Global Head of Technical Operations, Senior Vice President, Galapagos

Alessandro Linciano, Site Manufacturing Science and Technology Head, Cell and Gene Therapy, Novartis

Myriam Makhloufi, Chief Strategy Officer, TreeFrog Therapeutics

Ignacio Núñez, Chief Operations Officer, CellReady

COMPANY PRESENTATIONS

{Salone dei Cavalieri, Section 2}

5:15pm – 5:30pm Laverock Therapeutics
5:30pm – 5:45pm Virica Biotech
5:45pm – 6:00pm TBD

6:00pm | PROGRAM AND PARTNERING CLOSES

6:00pm – 7:00pm | COCKTAIL RECEPTION

Sponsored by Aseptic Technologies

7:30am – 9:00am | REGISTRATION

8:00am | PARTNERING OPENS

9:00am | GENERAL SESSION

DAY 3 OPENING REMARKS AND CONFERENCE SUMMARY

{Salone dei Cavalieri, Section 3&4}

9:00am – 9:15am

Speaker:

Paolo Morgese, Vice President, Public Affairs Europe, Alliance for Regenerative Medicine (ARM)

REVOLUTIONIZING CANCER TREATMENT: INNOVATIONS IN CELL AND GENE THERAPY
{Salone dei Cavalieri, Section 3&4}

9:15am – 10:00am

Moderator:

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

Speakers:

Eric Halioua, Ph.D., CEO, PDC*line Pharma

Reagan Jarvis, Ph.D., CEO and Scientific Founder, Anocca

INDUSTRIALIZATION OF ATMPS: ADVANCING MANUFACTURING THOUGH ROBOTICS, AI AND DIGITALIZATION
{Salone dei Cavalieri, Section 3&4}

10:00am – 11:00am
This panel will explore how the industrialization of ATMPs can be advanced through robotics, AI, and digitalization, drawing lessons from industry giants. Experts will discuss how large data, mass customization, and large-scale production can drive efficiencies and innovation in ATMP manufacturing.

Moderator:

Jason Foster, CEO, Oribiotech

Speakers:

Ricardo Baptista, Ph.D., Chief Technical Officer, SmartCella

David Del Bourgo, CEO and Co-founder, WhiteLab Genomic

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

NEW PAYMENT MODELS: RECENT EXPERIENCES IN EUROPE AND IN THE U.S.
{Salone dei Cavalieri, Section 3&4}

11:00am – 12:00pm

Moderator:

Mark Battaglini, Chief Strategy Officer, Alliance for Regenerative Medicine (ARM)

Speakers:

Stefano Benvenuti, Public Affairs Manager, Fondazione Telethon

Debbie Drane, Senior Vice President, Strategic Projects, CSL

Liz Fowler, Ph.D., Former Director, CMS Innovation Center; Former Vice President, Global Health Policy, Johnson & Johnson

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

12:00pm | PROGRAM AND PARTNERING CLOSES

12:00pm – 1:00pm | CLOSING LUNCH

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