Agenda

View the 2022 Agenda!

The 2022 Cell & Gene Meeting on the Mesa will be delivered in a hybrid format with live programming available over the course of three days. 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. 

Agenda Sponsors:

Agenda Sponsor:

2022 Agenda at a Glance

Live Event Dates

ARM Board of Directors Meeting & ARM Committee Meetings (By Invitation Only)

6:45am – 9:15am Registration & Breakfast
7:45am – 8:45am Concurrent Workshops
9:00am – 6:00pm General Session, Panel Discussions, Company Presentations, Partnering
6:30pm – 9:30pm Networking Bash

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

6:45am – 9:15am Registration & Breakfast
7:45am – 8:45am Concurrent Workshops
9:00am – 12:00pm General Session, Panel Discussions, Company Presentations, Partnering
12:00pm – 1:30pm Lunch
1:30pm Conference Closes

Virtual Partnering Dates

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

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

2022 Meeting Agenda

  • Full Agenda

ON-DEMAND VIRTUAL CONTENT

Available Beginning Tuesday, October 11, 2022

  • A DIALOG BETWEEN REGULATORY AGENCIES AND INDUSTRIES AMONG ASIAN COUNTRIES WORKSHOP

In Partnership with the Forum for Innovative Regenerative Medicine (FIRM)

A DIALOG BETWEEN REGULATORY AGENCIES AND INDUSTRIES AMONG ASIAN COUNTRIES

Promoting Harmonization and Commercialization of Regenerative Medicines Among Asian Countries/Regions

The Asia Partnership Conference of Regenerative Medicine (APACRM), is aimed at harmonizing and optimizing regulations among Asian countries and regions. FIRM has organized APACRM, an annual conference, since 2018, and has closely collaborated with industrial groups such as the China Medicinal Biotech Association (CMBA) in China, Association of Biotechnology Led Enterprises (ABLE) in India, Council for Advanced Regenerative Medicine (CARM) and Strategic Center for Regenerative Medicine (SCRM) in Korea, Singapore Association of Pharmaceuticals Industries (SAPI) in Singapore, and Biotechnology and Pharmaceutical Industries Promotion Office (BPIPO) in Taiwan.  

 

The latest APACRM focused on dialog with regulators based on survey results from three working groups: non-clinical, quality assessments, and environmental impact assessment settings for cell and gene therapy products (CGTs). Through panel discussions comprised of major Asian regulatory agencies, regulation differences and their underlying rationales have been more clearly defined among the participating countries and regions.  The hope is that an environment of harmonization is cultivated by sharing experiences regarding products under development, and opinions on regulatory guidelines. Moreover, more proactive efforts on regulatory innovation (e.g., the necessity of new guidelines) regarding regenerative medicinal products can assist with regulatory harmonization and optimization across Asia. This would enable the rapid delivery of CGTs to more patients, thus achieving market maximization of CGTs throughout Asia. This session will explore prospects and challenges to promote harmonization and optimization of regulations on regenerative medicine products among Asian countries and regions.

Chair:

Masayuki (Max) Nomura, Ph.D., Chair, International Affairs Committee, Forum for Innovative Regenerative Medicine (FIRM)

Speakers:

Ryan Chang, Advisor, Acepodia

Hiroshi Karasawa, Ph.D., Scientist, Cell Therapy Research Laboratories, Daiichi Sankyo

Masaaki Miyano, Manager, CMC Regulatory Affairs Department, Chugai Pharmaceutical

Masahiko Yasumoto, Executive Officer, Deputy Division Director, R&D Division, NanoCarrier

PRE-RECORDED VIRTUAL COMPANY PRESENTATIONS

Pre-recorded virtual company presentations will be available on-demand within the platform for all delegates to view starting October 11, 2022.

 

AdvarraATMPSAvectas | AVROBIOCellusionCentury TherapeuticsDiscGenicsGamida CellKytopenMyrtelleQurgenTalaris

IN-PERSON PROGRAM AND LIVESTREAM

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

Sponsored by KBI Biopharma

7:45am – 8:45am | CONCURRENT WORKSHOPS

  • WHAT’S NEXT FOR CELL AND GENE THERAPIES IN 2023 AND BEYOND WORKSHOP
  • HOW INDUSTRY 4.0 PRINCIPLES WILL HELP DRIVE THE ADOPTION OF ADVANCED CELL THERAPIES WORKSHOP
  • SECRETS OF SCALE: HOW THE CONVERGENCE OF SYSTEMS BIOLOGY, ENGINEERING AND NON-CONVENTIONAL REGULATORY APPROACHES ACCELERATE CELL-BASED THERAPIES TO MARKET WORKSHOP

7:45am - 8:45am | Oxford Biomedica Ballroom

Sponsored by Precision ADVANCE 

WHAT’S NEXT FOR CELL AND GENE THERAPIES IN 2023 AND BEYOND WORKSHOP

This workshop will feature leading executives in the ATMP space who will discuss a number of topics including future technologies, the current investment environment and what innovators can do to mitigate growing market pressures. The session will also touch upon resolving manufacturing and regulatory bottlenecks as the sector moves towards commercialization, as well as the evolution of reimbursement payment models.

Chair:

Anshul Mangal, President, Precision ADVANCE and Project Farma

Speakers:

Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone Biologics

Andrew Knudten, Chief Operating Officer, Jaguar Gene Therapy

Laura Lande-Diner, Ph.D., Chief Business Officer, Satellite Bio

Robert Peters, Ph.D., Chief Scientific Officer, Ensoma

Deb Phippard, Ph.D., Chief Scientific Officer, Precision for Medicine

7:45am – 8:45am | Aviara Salon A

Sponsored by Gamma Biosciences

HOW INDUSTRY 4.0 PRINCIPLES WILL HELP DRIVE THE ADOPTION OF ADVANCED CELL THERAPIES WORKSHOP

The industry has come this far highly dependent on technologies and lessons learned from the biologics industry. How are those habits helping and hurting the progress of cell and gene therapy manufacturing? How can emerging concepts of continuous biomanufacturing, process analytical technologies (PAT), and automation help us rethink manufacturing strategies today, and for years to come? Learn from a panel of experts and industry veterans what the future will look like in advanced therapy manufacturing.

Chair:

Phil Vanek, Ph.D., Chief Technology Officer and Partner, Gamma Biosciences

Speakers:

Andy Lin, Ph.D., Vice President and Global Head of Individualized and Cell Therapy Development, Genentech

Damian Marshall, Ph.D., Vice President, Analytical Development, Resolution Therapeutics

Michael May, Ph.D., President and CEO, CCRM

Alison Moore, Ph.D., Chief Technical Officer, Allogene Therapeutics

7:45am – 8:45am | Aviara Salon B

Sponsored by Advanced Regenerative Manufacturing Institute (ARMI)
SECRETS OF SCALE: HOW THE CONVERGENCE OF SYSTEMS BIOLOGY, ENGINEERING AND NON-CONVENTIONAL REGULATORY APPROACHES ACCELERATE CELL-BASED THERAPIES TO MARKET WORKSHOP
This workshop will discuss breaking down historical barriers to scalable, consistent, cost-effective manufacturing of cell-based therapies by exploiting the convergence of systems biology, advanced process technology development, and non-conventional regulatory approaches.

Chair:

Richard McFarland, M.D., Ph.D., Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI)

Speakers:

Carter Cliff, Co-Founder and CEO, Vascugen

Esther Latres, Ph.D., Assistant Vice President of Research, JDRF International

Lloyd Rose, Ph.D., Product Manager, Warfighter Expeditionary Medicine and Treatment, U.S. Army Medical Materiel Development Activity; Program Manager, BioFabUSA

9:00am | GENERAL SESSION AND PARTNERING OPENS

WELCOME REMARKS
{UBC Ballroom}

9:00am – 9:15am

Speakers:

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

Emile Nuwaysir, Ph.D., CEO, Ensoma; Chairman, Alliance for Regenerative Medicine (ARM)

9:15am – 10:15am | CONCURRENT TRACKS

PLENARY SESSION: CURRENT TRENDS AND CHALLENGES SURROUNDING GENE THERAPY COMMERCIALIZATION
{UBC Ballroom}

9:15am – 10:15am

Chair:

Dave Lennon, Ph.D., CEO, Satellite Bio

Speakers:

Debbie Drane, Senior Vice President, Global Commercial Development and TA Strategy, CSL Behring

Christine Fox, President, Novartis Gene Therapies

Matthew Klein, M.D., Chief Operating Officer, PTC Therapeutics

Thomas Klima, Chief Commercial Officer, bluebird bio

Leslie Meltzer, Ph.D., Chief Medical Officer, Orchard Therapeutics

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

9:15am – 10:15am

9:15am – 9:30amAspen Neuroscience
9:30am – 9:45amBioCentriq
9:45am – 10:00amEncoded Therapeutics
10:00am – 10:15amBlueRock Therapeutics

10:15am – 10:45am | MORNING BREAK

Sponsored by Accelerated Biosciences, Exothera, Minaris Regenerative Medicine and Triangle Insights Group

10:45am – 12:15pm | CONCURRENT TRACKS

EVALUATING THE QUALITY OF TISSUE ENGINEERED PRODUCTS
{UBC Ballroom}

10:45am – 11:15am
Tissue engineered products, which are complex living structures, have unique considerations with respect to characterization and release testing. This expert panel will discuss challenges associated with potency assays, stability testing, and scaling manufacturing.

Chair:

Jane Lebkowski, Ph.D., President, Regenerative Patch Technologies

Speakers:

Geoff Hamilton, Co-Founder and CEO, Stemson Therapeutics

Kevin Healy, Ph.D., Senior Vice President Regulatory Affairs, Pharmacovigilance, and Quality, Enzyvant Therapeutics

Eric Roos, Chief Business Development Officer, Aspect Biosystems

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

10:45am – 11:15am

10:45am – 11:00amCabaletta Bio
11:00am – 11:15amExCellThera

COMPANY PRESENTATIONS
{UBC Ballroom}

11:15am – 12:15pm

11:15am – 11:30amIntellia Therapeutics
11:30am – 11:45am4D Molecular Therapeutics
11:45am – 12:00pmTenaya Therapeutics
12:00pm – 12:15pmPTC Therapeutics

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

11:15am – 12:15pm

11:15am – 11:30amKyverna Therapeutics
11:30am – 11:45amQuell Therapeutics
11:45am – 12:00pmAegle Therapeutics
12:00pm – 12:15pmEnsoma

12:15pm – 1:15pm | LUNCH

Sponsored by Notch Therapeutics

1:15pm – 3:30pm | CONCURRENT TRACKS

THE CURRENT STATE OF INVESTMENT IN CELL AND GENE THERAPY
{UBC Ballroom}

1:15pm – 2:15pm
What is the state of investment in cell and gene therapy globally and the outlook for the rest of 2022 and beyond? This panel will discuss the availability and deployment of capital, from the perspective of venture capital, mergers and acquisitions, and contract manufacturing.

Chair:

Bob Smith, Senior Vice President, Global Gene Therapy Business, Pfizer Inc.

Speakers:

Matthew Durdy, Chief Executive, Cell and Gene Therapy Catapult

Amy DuRoss, President, Cell and Gene Therapies, CSafe Global; Senior Advisor, Frazier Healthcare Partners

Albert Hwang, M.D., Managing Director, Morgan Stanley

Dmitry Kuzmin, Ph.D., Managing Partner, 4BIO Capital

Becky Pferdehirt, Ph.D., Investment Partner, Andreessen Horowitz

Josh Schimmer, M.D., Senior Managing Director, Evercore

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

1:15pm – 2:15pm

1:15pm – 1:30pmCTI
1:30pm – 1:45pmMission Bio
1:45pm – 2:00pmSigilon Therapeutics
2:00pm – 2:15pmOssium Health

COMPANY PRESENTATIONS
{UBC Ballroom}

2:15pm – 3:30pm

2:15pm – 2:30pmuniQure
2:30pm – 2:45pmRocket Pharmaceuticals
2:45pm – 3:00pmHelixmith
3:00pm – 3:15pmSernova
3:15pm – 3:30pmHomology Medicines

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

2:15pm – 3:30pm

2:15pm – 2:30pmSensorion
2:30pm – 2:45pmArbor Biotechnologies
2:45pm – 3:00pmLogicBio
3:00pm – 3:15pmWuXi Advanced Therapies
3:15pm – 3:30pmViralgen Vector Core

3:30pm – 4:00pm | AFTERNOON BREAK

Accelerated Biosciences, Exothera, Minaris Regenerative Medicine and Triangle Insights Group

4:00pm – 6:00pm | CONCURRENT TRACKS

GENE EDITING ACCELERATES: THE FIRST GENERATION NEARS APPROVAL WHILE NEW APPROACHES PROGRESS THROUGH THE CLINIC
{UBC Ballroom}

4:00pm – 5:00pm
The first-ever approval of a CRISPR gene-editing therapy could be less than a year away, while base editing has already entered the clinic and the first in-vivo CRISPR approaches progress in clinical trials. Panelists will discuss the milestones the sector has recently reached in gene-editing, and forecast the breakthroughs of the near- and longer-term future.

Chair:

Tim Farries, Ph.D., Principal Consultant, Senior Director, Biopharma Excellence

Speakers:

Fred Chereau, President and CEO, LogicBio

Albert Seymour, Ph.D., President and CEO, Homology Medicines

Mark Shearman, Ph.D., Executive Vice President and Chief Scientific Officer, Editas Medicine

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

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

4:00pm – 5:00pm

4:00pm – 4:15pmAthersys
4:15pm – 4:30pmAffyImmune Therapeutics
4:30pm – 4:45pmBellicum Pharmaceuticals
4:45pm – 5:00pmAmplo Biotechnology

COMPANY PRESENTATIONS
{UBC Ballroom}

5:00pm – 6:00pm

5:00pm – 5:15pmHealios K.K.
5:15pm – 5:30pmPrecision BioSciences
5:30pm – 5:45pmSenti Biosciences
5:45pm – 6:00pmArcellx

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

5:00pm – 6:00pm

5:00pm – 5:15pmNexImmune
5:15pm – 5:30pmIn8Bio
5:30pm – 5:45pmGradalis
5:45pm – 6:00pmLykan Bioscience

6:00pm | PROGRAM AND PARTNERING CLOSES

6:30pm – 9:30pm | NETWORKING BASH

Sponsored by BioPharma Excellence by PharmaLex, QbD Vision and ScaleReady

Mesa22-Agenda-Day2_CS4

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

Sponsored by Pall Corporation

7:45am – 8:45am | CONCURRENT WORKSHOPS

  • APPROACHES TO IMPLEMENTING AUTOMATION IN CELL THERAPY MANUFACTURING WORKSHOP
  • THE FUTURE OF CDMO NETWORKS IN CELL AND GENE THERAPY WORKSHOP
  • ACCELERATING CGTX DISCOVERY AND DEVELOPMENT THROUGH USE OF ADVANCED PHENOTYPIC MODELS AND MACHINE LEARNING TECHNOLOGIES WORKSHOP

7:45am – 8:45am | Oxford Biomedica Ballroom

Sponsored by Thermo Fisher Scientific

APPROACHES TO IMPLEMENTING AUTOMATION IN CELL THERAPY MANUFACTURING WORKSHOP

The need for standardization and automation are critical drivers of innovation in cell therapy manufacturing. Implementation of an automated, closed workflow minimizes open processes and manual touchpoints, increases reproducibility, and improves traceability; this has the potential to reduce manufacturing failures and lower COGS thereby facilitating increased patient access. In this workshop, we sit down with industry experts to discuss various approaches to cGMP manufacturing of gene-modified cell therapies at industrial scale.

 

Chair:

Betty Woo, Ph.D., Vice President and General Manager, Cell and Gene Therapy, Thermo Fisher Scientific

Speakers:

Ivie Aifuwa, Ph.D., Associate Director, Process Technology Development, Bristol Myers Squibb

Dmitry Fradkin, Director, Automation and Systems Development, Kite Pharma

Fred Parietti, Ph.D., Co-Founder and CEO, Multiply Labs

7:45am – 8:45am | Aviara Salon A

Sponsored by IQVIA

THE FUTURE OF CDMO NETWORKS IN CELL AND GENE THERAPY WORKSHOP

This workshop will feature leading executives who will discuss a number of topics surrounding CDMO networks including bottlenecks in personnel capabilities and facilities along with preclinical pipeline driving capacity and workforce requirements. The session will also touch upon downstream requirements such as clinical sites capabilities, data systems, access and diversity, and regulatory bandwidth.

 

Chair:

Amritha Jaishankar, Ph.D., Executive Director, MSCRF

 

Speakers:

Eytan Abraham, Ph.D., Vice President, Business Head of Cell, Gene and Nucleic Acids Franchises, Resilience

Abla Creasey, Ph.D., Vice President, Therapeutics Development, California Institute for Regenerative Medicine (CIRM)

Haro Hartounian, Ph.D., President and CEO, BioCentriq

Alan Moore, Chief Strategy Officer, Center for Breakthrough Medicines

Nicholas Ostrout, Ph.D., Senior Advisor, Cell and Gene Therapy Corporate Strategy, Charles River Laboratories

7:45am – 8:45am | Aviara Salon B

ACCELERATING CGTX DISCOVERY AND DEVELOPMENT THROUGH USE OF ADVANCED PHENOTYPIC MODELS AND MACHINE LEARNING TECHNOLOGIES WORKSHOP

This panel will explore the ways in which next-generation engineered in-vitro models can be combined with innovations in machine learning applications to drive more rational development of complex cell and gene therapy products. Leveraging advances in in-vitro model development (ex. engineered iPSC-derived tissues) as a starting point for discovery, AI/ML platforms can help make connections and correlations between cause and effect in CGTx development at a rapid pace, ultimately driving towards faster, cheaper, and more accurate therapeutic outputs. This model is already established in the small molecule space, and this panel will explore how this will translate to the CGTx industry.

Chair:

Adam Roose, Vice President, Cell and Gene Commercial Strategy, Adjuvant Partners

Speakers:

Isaac Bentwich, M.D., Founder and CEO, Quris Technologies

Robert Deans, Ph.D., Chief Scientific Officer, Synthego

Keith James, Ph.D., Senior Vice President, Drug Discovery, insitro

Emmanouil Metzakopian, Ph.D., Vice President, Research and Development, bit.bio

9:00am | GENERAL SESSION AND PARTNERING OPENS

9:00am – 10:15am | CONCURRENT TRACKS

UPDATE ON ARM’S GROW INTERNSHIP PROGRAM
{UBC Ballroom}

9:00am – 9:15am

Speaker:

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

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

9:00am – 9:15am

9:00am – 9:15amMilliporeSigma

PLENARY SESSION: CELL THERAPY COMMERCIALIZATION TODAY AND PREPARING FOR THE FUTURE
{UBC Ballroom}

9:15am – 10:15am

Chair:

Amy Butler, Ph.D., President, Biosciences Division, Thermo Fisher Scientific

Speakers:

Diana Brainard, M.D., CEO, AlloVir

Friedrich Graf Finckenstein, M.D., Chief Medical Officer, Iovance Biotherapeutics

Cintia Piccina, Pharm.D., Chief Commercial Officer, Adaptimmune

Paul Staid, Vice President and Head of Global Supply Chain, Cell Therapy Operations, Bristol-Myers Squibb

Pascal Touchon, President and CEO, Atara Biotherapeutics

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

9:15am – 10:15am

9:15am – 9:30amForge Biologics
9:30am – 9:45amImStem Biotechnology
9:45am – 10:00amAldevron
10:00am – 10:15amMarken

10:15am – 10:45am | MORNING BREAK

Sponsored by Accelerated Biosciences, Exothera, Minaris Regenerative Medicine and Triangle Insights Group

10:45am – 12:15pm | CONCURRENT TRACKS

KEYNOTE SPEAKER: TAKING CELL AND GENE THERAPY TO THE NEXT LEVEL
{UBC Ballroom}

10:45am – 11:15am

Speaker:

Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

10:45am – 11:15am

10:45am – 11:00amCarisma Therapeutics
11:00am – 11:15amLuminary Therapeutics

OPPORTUNITIES FOR REGULATORY CONVERGENCE IN CELL AND GENE THERAPY
{UBC Ballroom}

11:15am – 12:15pm
Disparate requirements from one country to the next, from pre-clinical tests to manufacturing, make it difficult for developers to efficiently ensure patients across borders have access to therapies, particularly to rare disease patients whose numbers in any one geography may be very small. Representatives from the US Food and Drug Administration, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency will discuss areas where regulators can and are cooperate on common standards, and what next steps are being envisioned to improve equitable access to critical CGT medicines.

Chair:

Jessie Hanrahan, Ph.D., Chief Regulatory Officer, AavantiBio

Speakers:

Patrick Celis, Ph.D., Lead Scientific Officer, ATMP Office, European Medicines Agency (EMA)

Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)

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

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

11:15am – 12:15pm

11:15am – 11:30amNotch Therapeutics
11:30am – 11:45amPrescient Therapeutics
11:45am – 12:00pmCurate Biosciences
12:00pm – 12:15pmCapricor Therapeutics

12:15pm – 1:15pm | LUNCH

Sponsored by Curate Biosciences

1:15pm – 2:45pm | CONCURRENT TRACKS

LESSONS LEARNED FROM THE BLUEBIRD BIO ICER ASSESSMENTS
{UBC Ballroom}

1:15pm – 1:45pm

Chair:

Brent Rice, Senior Vice President and Chief Commercial Officer, Autolus Therapeutics

Speaker:

Clark Paramore, Vice President, Value Demonstration, bluebird bio

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

1:15pm – 1:45pm

1:15pm – 1:30pmRay Therapeutics
1:30pm – 1:45pmCoave Therapeutics

COMPANY PRESENTATIONS
{UBC Ballroom}

1:45pm – 2:45pm

1:45pm – 2:00pmREGENXBIO
2:00pm – 2:15pmOcugen
2:15pm – 2:30pmLineage Cell Therapeutics
2:30pm – 2:45pmAlloVir

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

1:45pm – 2:45pm

1:45pm – 2:00pmAGTC
2:00pm – 2:15pmRegenerative Patch Technologies
2:15pm – 2:30pmSparingVision
2:30pm – 2:45pmMiltenyi Biomedicine

2:45pm – 3:15pm | AFTERNOON BREAK

Sponsored by Accelerated Biosciences, Exothera, Minaris Regenerative Medicine and Triangle Insights Group

3:15pm – 6:00pm | CONCURRENT TRACKS

NEW BUSINESS MODELS FOR MANUFACTURING INVESTMENT
{UBC Ballroom}

3:15pm – 4:15pm
Effective investment in manufacturing is key to a successful development program. Alternatives to the classic approaches of build in house vs. use a CMO are emerging. The panel will explore different models for increasing manufacturing capacity and how these can assist with pain points such as talent acquisition and retention.

Chair:

Susan Nichols, Chief Business Officer, ViroCell Biologics

Speakers:

Eric Blair, Chief Commercial Officer, Andelyn Biosciences

Frédéric Desdouits, Ph.D., CEO, TreeFrog Therapeutics

Behzad Mahdavi, Ph.D., Senior Vice President, Biopharma Manufacturing and Life Sciences Tools, Ginkgo Bioworks

Daniel Smith, Ph.D., Executive Director, Global Cell and Gene Therapy Portfolio, Charles River Laboratories

Arthur Tzianabos, Ph.D., Venture Partner, 5AM Ventures; Chair of the Board, Homology Medicines

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

3:15pm – 4:15pm

3:15pm – 3:30pmAlbumedix
3:30pm – 3:45pmMiromatrix
3:45pm – 4:00pmPBS Biotech
4:00pm – 4:15pmVERIGRAFT

COMPANY PRESENTATIONS
{UBC Ballroom}

4:15pm – 6:00pm

4:15pm – 4:30pmOrchard Therapeutics
4:30pm – 4:45pmAtara Biotherapeutics
4:45pm – 5:00pmAutolus
5:00pm – 5:15pmPoseida Therapeutics
5:15pm – 5:30pmVor Bio
5:30pm – 5:45pmEnzyvant
5:45pm – 6:00pmInstil Bio

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

4:15pm – 6:00pm

4:15pm – 4:30pmCardinal Health
4:30pm – 4:45pmElevateBio
4:45pm – 5:00pmMaxCyte
5:00pm – 5:15pmMedpace
5:15pm – 5:30pmTerumo BCT
5:30pm – 5:45pmCryoport Systems
5:45pm – 6:00pmTeknova

6:00pm | PROGRAM AND PARTNERING CLOSES

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

Sponsored by Gift of Life

7:45am – 8:45am | CONCURRENT WORKSHOPS

  • ADDRESSING THE PRODUCTION NEEDS OF CELL AND GENE THERAPEUTICS: NEW STRATEGIES FOR A CHANGING WORLD WORKSHOP
  • DIGITAL TRANSFORMATION: INTEGRATING AUTOMATED DATA MANAGEMENT SYSTEMS TO ADVANCE CGT MANUFACTURING AND IMPROVE PROCESS CONTROL WORKSHOP

7:45am – 8:45am | Oxford Biomedica Ballroom

Sponsored by SmartLabs

ADDRESSING THE PRODUCTION NEEDS OF CELL AND GENE THERAPEUTICS: NEW STRATEGIES FOR A CHANGING WORLD WORKSHOP

Join this session to hear experts debate the following industry challenges:

  • Austere funding and the financial environment impacting facility development
  • Challenges in methods transfer and the effect this has on outsourcing of production
  • How complex CMC requirements demand more proprietary and complex QC/QA

Chair:

Brian Taylor, Head of Biopharma Solutions, SmartLabs

Speakers:

Wolfram Carius, Pharm.D., Executive Vice President, Cell and Gene Therapy, Bayer

Justin Skoble, Ph.D., Vice President of Technical Operations, Caribou Biosciences

Sarah Yuan, Ph.D., Chief Technical Operations Officer, Sigilon Therapeutics

7:45am – 8:45am | Aviara Salon A

Sponsored by L7 Informatics

DIGITAL TRANSFORMATION: INTEGRATING AUTOMATED DATA MANAGEMENT SYSTEMS TO ADVANCE CGT MANUFACTURING AND IMPROVE PROCESS CONTROL WORKSHOP

This workshop discussion will explore ways in which advancements in data capture, data interrogation and analytics will improve advanced therapies product manufacture. Innovations in data processing will help to optimize manufacturing and process development efforts, decreasing associated time and costs. The session will explore how some of the most advanced technology companies are refining and implementing these processes.

Chair:

Trent Carrier, Ph.D., Chief Operating Officer, L7 Informatics

Speakers:

Sammy Datwani, Ph.D., Senior Vice President, Development, Synthego

Kevin Gordon, Chief Digital Officer, Ori Biotech

Delara Motlagh, Ph.D., General Manager, Cell Therapy Technologies, Terumo BCT

Yan Zhang, Ph.D., CEO, Mission Bio

9:00am | GENERAL SESSION AND PARTNERING OPENS

9:00am – 10:45am | CONCURRENT TRACKS

ARM CLOSING STATEMENTS

{UBC Ballroom}

9:00am – 9:15am

Speaker:

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

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

9:00am – 9:15am

9:00am – 9:15amCook MyoSite

SPOTLIGHT SESSION: THE PATIENT PERSPECTIVE ON CELL AND GENE THERAPY
{UBC Ballroom}

9:15am – 9:45am

Chair:

Craig Martin, CEO, Global Genes

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

9:15am – 9:45am

9:15am – 9:30amCynata Therapeutics
9:30am – 9:45amGENETHON

NEW DEVELOPMENTS AND ADVANCEMENTS IN THE WORLD OF PSCS
{UBC Ballroom}

9:45am – 10:45am

Chair:

Alberto Santagostino, Senior Vice President, Head of Cell and Gene Technologies, Lonza

Speakers:

Melissa Carpenter, Ph.D., Chief Scientific Officer, Regenerative Medicine, ElevateBio

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

Osvaldo Flores, Ph.D., CEO, Century Therapeutics

Damien McDevitt, Ph.D., President and CEO, Aspen Neuroscience

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

9:45am – 10:45am

9:45am – 10:00amMEDIPOST America
10:00am – 10:15amXintela
10:15am – 10:30amTrakCel
10:30am – 10:45amCellares

10:45am – 11:00am | MORNING BREAK

Sponsored by Accelerated Biosciences, Exothera, Minaris Regenerative Medicine and Triangle Insights Group

11:00am – 12:00pm | CONCURRENT TRACKS

THE FUTURE OF GENE DELIVERY: IN SEARCH OF GAME-CHANGING IN VIVO APPLICATIONS
{UBC Ballroom}

11:00am – 12:00pm

Chair:

Faraz Ali, CEO, Tenaya Therapeutics

Speakers:

Adrian Bot, M.D., Ph.D., Chief Scientific Officer and Executive Vice President of R&D, Capstan Therapeutics

Gary Fortin, Ph.D., Chief Operating Officer, Shape Therapeutics

Philip Johnson, M.D., CEO, Interius Biotherapeutics

Yvette Leung, Head of Corporate Development, Dyno Therapeutics

Emile Nuwaysir, Ph.D., President and CEO, Ensoma; Chairman, Alliance for Regenerative Medicine (ARM)

COMPANY PRESENTATIONS
{Oxford Biomedica Ballroom}

11:00am – 12:00pm

11:00am – 11:15amVersiti
11:15am – 11:30amCapsida Biotherapeutics
11:30am – 11:45amExcision BioTherapeutics
11:45am – 12:00pmVectorY

12:00pm – 1:00pm | LUNCH

Sponsored by Theragent

1:00pm | CONFERENCE CLOSES

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