Agenda

View Last Year's Agenda!

The 2023 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:

2024 Agenda at a Glance

Live Event Dates

Arrival | Sunday, October 6

1:00pm – 6:00pm Early Badge Pick-up at the Arizona Biltmore (All Attendees)

Day 1 | Monday, October 7

7:00am – 9:15am Registration & Breakfast
7:45am – 8:45am Concurrent Workshops
8:00am – 6:00pm Partnering Meetings
9:00am – 6:00pm General Session, Panel Discussions, Company Presentations
6:00pm – 9:00pm Networking Bash

Day 2 | Tuesday, October 8

7:00am – 9:15am Registration & Breakfast
7:45am – 8:45am Concurrent Workshops
8:00am – 6:00pm Partnering Meetings
9:00am – 6:00pm General Session, Panel Discussions, Company Presentations
6:00pm – 7:00pm Cocktail Reception

Day 3 | Wednesday, October 9

7:00am – 9:15am Registration & Breakfast
7:45am – 8:45am Concurrent Workshops
8:00am – 12:00pm Partnering Meetings
9:00am – 12:00pm General Session, Panel Discussions, Company Presentations
12:00pm – 1:00pm Lunch
1:00pm Conference Closes

Virtual Partnering Dates

Virtual Partnering | Thursday, October 10

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

Virtual Partnering | Friday, October 11

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

2023 Meeting Agenda

* All times are listed in Pacific Time

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&GT), 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&GT 1.0 “proof-of-concept” to deliver fundamentally new capabilities. To deliver on the promise of C&GT 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 - 9:45amGENETHON
9:45am - 10:00amDiscGenics
10:00am - 10:15amExCellThera
10:15am - 10:30amAldevron

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
9:30am – 10:30am

9:30am - 9:45amCapstan Therapeutics
9:45am - 10:00amVERIGRAFT
10:00am - 10:15amAvery Therapeutics
10:15am - 10:30amExcellos

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 - 11:00amCabaletta Bio
11:00am - 11:15amIntellia Therapeutics

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
10:45am – 11:15am

10:45am - 11:00amFibroBiologics
11:00am - 11:15amNotch 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 - 11:30amNKILT Therapeutics
11:30am - 11:45amAspen Neuroscience
11:45am - 12:00pmForm Bio
12:00pm - 12:15pmOri 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 - 1:30pmCoave Therapeutics
1:30pm - 1:45pmCaribou Biosciences
1:45pm - 2:00pmVor Bio

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
1:15pm – 2:00pm

1:15pm - 1:30pmARScience Biotherapeutics
1:30pm - 1:45pmMyeloid Therapeutics
1:45pm - 2:00pmAviadoBio

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 - 2:15pmAkadeum Life Sciences
2:15pm - 2:30pmKörber Pharma Software
2:30pm - 2:45pmSparingVision
2:45pm - 3:00pmCellistic

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 - 3:15pmPrecision BioSciences
3:15pm - 3:30pmTeknova

COMPANY PRESENTATIONS<
{Rentschler ATMP Ballroom}
3:00pm – 3:30pm

3:00pm - 3:15pmAspect Biosystems
3:15pm - 3:30pmAnocca

3:30pm – 3:45pm | CONCURRENT TRACKS

COMPANY PRESENTATION

{Ecolab Life Sciences Ballroom}
3:30pm – 3:45pm

3:30pm - 3:45pmiVexSol

COMPANY PRESENTATION
{Rentschler ATMP Ballroom}
3:30pm – 3:45pm

3:30pm - 3:45pmMana.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 - 4:15pmCTI Clinical Trial & Consulting
4:15pm - 4:30pmPrescient Therapeutics
4:30pm - 4:45pmCarisma Therapeutics
4:45pm - 5:00pmCynata Therapeutics

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
4:00pm – 5:00pm

4:00pm - 4:15pmOxford Biomedica
4:15pm - 4:30pmMcKesson
4:30pm - 4:45pmCelosia Therapeutics
4:45pm - 5:00pmChroma 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 - 5:15pmForge Biologics
5:15pm - 5:30pmOrca Bio
5:30pm - 5:45pmXintela
5:45pm - 6:00pmVersiti

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
5:00pm – 6:00pm

5:00pm - 5:15pmAffyImmune Therapeutics
5:15pm - 5:30pmAtamyo Therapeutics
5:30pm - 5:45pmCellatoz Therapeutics
5:45pm - 6:00pmReCode 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 - 9:30amAlbumedix
9:30am - 9:45amPapillon Therapeutics
9:45am - 10:00amMyrtelle
10:00am - 10:15amBlueRock Therapeutics

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
9:15am – 10:15am

9:15am - 9:30amInGel Therapeutics
9:30am - 9:45amLife Edit Therapeutics
9:45am - 10:00amRoslinCT
10:00am - 10:15amSTRM.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 - 11:00amAthersys
11:00am - 11:15amArbor Biotechnologies

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
10:45am – 11:15am

10:45am - 11:00amMarch Biosciences
11:00am - 11:15amCapsida 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 - 11:30amRay Therapeutics
11:30am - 11:45amInVitria
11:45am - 12:00pmAffinia Therapeutics
12:00pm - 12:15pmAndelyn 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 - 1:30pmCenter for Gene Therapy at Nationwide Children's Hospital Institute
1:30pm - 1:45pmCapricor

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
1:15pm – 1:45pm

1:15pm - 1:30pmNanite
1:30pm - 1:45pmTreeFrog Therapeutics

1:45pm – 2:45pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS
{Aseptic Technologies Ballroom}
1:45pm – 2:45pm

1:45pm - 2:00pmArcellx
2:00pm - 2:15pmRocket Pharmaceuticals
2:15pm - 2:30pmAgathos Biologics
2:30pm - 2:45pmPoseida 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 - 2:00pmKiji Therapeutics
2:00pm - 2:15pmShape Therapeutics
2:15pm - 2:30pmSatellite Bio
2:30pm - 2:45pmAllarta 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 - 3:30pmSenti Bio
3:30pm - 3:45pmPrecigen
3:45pm - 4:00pmAdverum Biotechnologies
4:00pm - 4:15pmQuell Therapeutics

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
3:15pm – 4:15pm

3:15pm - 3:30pmImmPACT Bio
3:30pm - 3:45pmStemson Therapeutics
3:45pm - 4:00pmEvia Bio
4:00pm - 4:15pmEnsoma

4:15pm – 6:00pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS
{Aseptic Technologies Ballroom}
4:15pm – 6:00pm

4:15pm - 4:30pmAutolus
4:30pm - 4:45pmAtara Biotherapeutics
4:45pm - 5:00pmGamida Cell
5:00pm - 5:15pmREGENXBIO
5:15pm - 5:30pmOcugen
5:30pm - 5:45pmSernova Corp
5:45pm - 6:00pm4D Molecular Therapeutics

COMPANY PRESENTATIONS
{Ecolab Life Sciences Ballroom}
4:15pm – 6:00pm

4:15pm - 4:30pmAstellas Pharma
4:30pm - 4:45pmCentury Therapeutics
4:45pm - 5:00pmS. Biomedics
5:00pm - 5:15pmMEDIPOST
5:15pm - 5:30pmOssium Health
5:30pm - 5:45pmMiromatrix Medical
5:45pm - 6:00pmCurate Biosciences

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
4:15pm – 6:00pm

4:15pm - 4:30pmGaruda Therapeutics
4:30pm - 4:45pmCoeptis Therapeutics
4:45pm - 5:00pmDiorasis Therapeutics
5:00pm - 5:15pmAurion Biotech
5:15pm - 5:30pmBe Biopharma
5:30pm - 5:45pmMaxCyte
5:45pm - 6:00pmClearPoint 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 - 9:30amBioCentriq
9:30am - 9:45amCryoport Systems
9:45am - 10:00amPBS Biotech

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
9:15am – 10:00am

9:15am - 9:30amVesigen Therapeutics
9:30am - 9:45amUmoja Biopharma
9:45am - 10:00amImmusoft

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
{Ecolab Life Sciences Ballroom}
10:00am – 10:45am

10:00am - 10:15amTrakCel
10:15am - 10:30amViralgen Vector Core
10:30am - 10:45amShoreline Biosciences

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
10:00am – 10:45am

10:00am - 10:15amKytopen
10:15am - 10:30amAccelerated Biosciences
10:30am - 10:45amOutpace 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 - 11:15amTenaya Therapeutics
11:15am - 11:30amMekonos
11:30am - 11:45amCellares
11:45am - 12:00pmKincell Bio

COMPANY PRESENTATIONS
{Rentschler ATMP Ballroom}
11:00am – 12:00pm

11:00am - 11:15amLaverock Therapeutics
11:15am - 11:30amDimension Inx
11:30am - 11:45amApprentice.io
11:45am - 12:00pmXcell Biosciences

12:00pm – 1:00pm | LUNCH

1:00pm | CONFERENCE CLOSES

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