Agenda

View the Initial Agenda!

The 2021 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 available on-demand within 24 hours of the live program time for all registrants to view. 

This agenda will be constantly updated so check back often for more details on the 2021 program!

  • Full Agenda

ON-DEMAND VIRTUAL CONTENT

Available Beginning Tuesday, October 12, 2021

  • DOING BUSINESS IN JAPAN – AN EVOLVING MARKET WORKSHOP
  • FROM CONCEPT TO COMMERCIALIZATION IN LIVING THERAPEUTICS: HINDSIGHT IS 20/20 WORKSHOP
  • VIRTUAL WORKSHOP
  • VIRTUAL WORKSHOP

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

 

DOING BUSINESS IN JAPAN – AN EVOLVING MARKET WORKSHOP

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 the APACRM 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. This session will focus on prospects and challenges for or against regenerative medicine to promote harmonization and optimization of the 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)

Sponsored by Charles River Labs

 

FROM CONCEPT TO COMMERCIALIZATION IN LIVING THERAPEUTICS: HINDSIGHT IS 20/20 WORKSHOP

Challenges for developing a cell therapy product evolve and shift, and reducing these risks requires experience and expertise to execute around them. From discovery through late-phase clinical trials and into commercial manufacturing, different challenges and competing priorities are ever present – from coordinating multiple CROs/CDMOs, managing clinical operations effectively, and overcoming supply chain and logistic hurdles, all while keeping in line with regulatory standards. This discussion will take a look at these and many more real-world challenges and focus on the strategies involved with mitigating risks along the way while reducing the amount of lag time involved with bringing a cell therapy product to market.

Sponsored by Pfizer

 

More information coming soon.

Sponsored by AmerisourceBergen

 

More information coming soon.

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 12, 2021.

IN-PERSON PROGRAM AND LIVESTREAM

6:45am – 9:15am | REGISTRATION AND BREAKFAST

7:15am – 8:45am | CONCURRENT WORKSHOPS

  • UNLOCKING THE POWER OF COLLABORATION TO FUEL THE INDUSTRY TRANSFORMATION FOR CELL & GENE THERAPIES WORKSHOP
  • WORKSHOP 2
  • WORKSHOP 3

7:15am – 8:45am | BlueRock Therapeutics Ballroom

Sponsored by Ernst & Young

 

UNLOCKING THE POWER OF COLLABORATION TO FUEL THE INDUSTRY TRANSFORMATION FOR CELL & GENE THERAPIES WORKSHOP

The groundwork for seamless cell and gene therapy (CGT) care delivery needs to be laid now. There are many stakeholders involved in the complexities of the CGT treatment journey that require a radically new approach from that of traditional mass-produced therapies. A complex balancing act of multi-stakeholder processes hinge on treatment advances, product availability, and the network’s ability to meet demand. And that’s before thinking about scaling CGT delivery to more than a few thousand patients. This workshop will bring together leading experts in managing interconnected supply and logistics networks, delivering superior patient experiences, manufacturing cell and gene therapies, and building world-class digital infrastructures.

Chair:

Adlai Goldberg, Global Digital, Social and Commercial Innovation Life Sciences Leader, EY

Speaker:

Orlando Serani, Program Lead Advanced Cellular Therapies Supply Chain, Johnson & Johnson

7:15am – 8:45am | Aviara Salon A

 

Sponsored by Precision ADVANCE

7:15am – 8:45am | Aviara Salon B

 

Sponsored by AmerisourceBergen

9:00am | GENERAL SESSION AND PARTNERING OPENS

WELCOME REMARKS {AVROBIO Ballroom}

9:00am – 9:15am

Speaker:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)

PLENARY SESSION: THE COMMERCIAL PIONEERS OF CAR-T THERAPY: WHERE IS THE FIELD HEADED? {AVROBIO Ballroom}

9:15am – 10:15am

Speakers:

Jennifer Brogdon, Ph.D., Executive Director, Head of Cell Therapy Research, Exploratory Immuno-Oncology, Novartis Institutes for BioMedical Research (NIBR)

Pascal Touchon, President and CEO, Atara Biotherapeutics

10:15am – 10:45am | MORNING BREAK

Sponsored by Bone Therapeutics, Cytotheryx, Invetech and POMS

10:45am – 12:00pm | CONCURRENT TRACKS

LESSONS LEARNED: THE ROLE OF PATIENT ENGAGEMENT IN APPROVALS AND PAYOR DISCUSSIONS {AVROBIO Ballroom}

10:45am – 11:15am

Chair:

Paige Bischoff, Senior Vice President of Global Public Affairs, Alliance for Regenerative Medicine (ARM)

Speaker:

Amy Nicole Nayar, Pharm.D., Vice President of U.S. Patient Advocacy and Government Affairs, Novartis Gene Therapies

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

10:45am – 11:15am

COMPANY PRESENTATIONS {AVROBIO Ballroom}

11:15am – 12:00pm

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

11:15am – 12:00pm

12:00pm – 1:15pm | LUNCH

Sponsored by Pall Corporation

1:15pm – 3:30pm | CONCURRENT TRACKS

WHERE ARE WE ON THE JOURNEY TO CURE SICKLE CELL DISEASE? {AVROBIO Ballroom}

1:15pm – 2:15pm

Speaker:

Debbie Drane, Senior Vice President, Global Commercial Development, CSL Behring

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

1:15pm – 2:15pm

COMPANY PRESENTATIONS {AVROBIO Ballroom}

2:15pm – 3:30pm

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

2:15pm – 3:30pm

3:30pm – 4:00pm | AFTERNOON BREAK

Sponsored by Bone Therapeutics, Cytotheryx, Invetech and POMS

4:00pm – 6:00pm | CONCURRENT TRACKS

CURRENT REALITIES OF MAKE VS. BUY FOR CELL & GENE THERAPY MANUFACTURING {AVROBIO Ballroom}

4:00pm – 5:00pm

Speakers:

Matthew Durdy, CEO, Cell and Gene Therapy Catapult

Thomas Fellner, Ph.D., Vice President, Global Head of Sales and Program Management, Lonza

Mitchell Finer, Ph.D., Chief Scientific Officer and President of BaseCamp, ElevateBio

Nirupama (Rupa) Pike, Ph.D., Director, Enterprise Science and Innovation Partnerships, Global Corporate Accounts, Thermo Fisher Scientific

Joe Tarnowski, Ph.D., Senior Vice President, Cell and Gene Therapy Platform, GlaxoSmithKline

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

4:00pm – 5:00pm

COMPANY PRESENTATIONS {AVROBIO Ballroom}

5:00pm – 6:00pm

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

5:00pm – 6:00pm

6:00pm | PROGRAM AND PARTNERING CLOSES

6:30pm – 9:30pm | NETWORKING BASH

Sponsored by Biopharma Excellence by PharmaLex, Cognate BioServices and L7 Informatics

Mesa21-Agenda-Day2

6:45am – 9:15am | REGISTRATION AND BREAKFAST

Sponsored by Triangle Insights Group

7:15am – 8:45am | CONCURRENT WORKSHOPS

  • DEMOCRATIZATION OF TRANSFORMATIVE CELL & GENE THERAPIES WORKSHOP
  • WORKSHOP 2
  • WORKSHOP 3

7:15am – 8:45am | BlueRock Therapeutics Ballroom

Sponsored by IQVIA

 

DEMOCRATIZATION OF TRANSFORMATIVE CELL & GENE THERAPIES WORKSHOP

Recent years have seen dramatic success with gene therapy, even apparent cures for serious medical conditions (e.g., spinomuscular atrophy, sickle cell disease). Yet, for several of the diseases being cured with gene therapy, the vast majority of patients who could potentially benefit reside in low- and middle-income countries (LMIC), where such therapies are not available. The reasons underlying inaccessibility are multifold, and both near-term and long-term solutions need to be devised and implemented by the regenerative medicine industry. Near and next-term solutions come from disparate areas from utilizing information technology with patient databases/registries, to improving efficiencies and cost of manufacturing and distribution. The challenges of gene therapy implementation in LMIC span several functional areas including education and communication, regulatory, clinical preparedness, and technical / logistical aspects. Looking at the longer-range and worldwide aspirations, one initiative called the Global Gene Therapy Initiative (GGTI) includes diverse stakeholders covering broad areas of expertise from all sectors. The GGTI has set an aspirational goal of launching Phase I gene therapy clinical trials in each of two LMIC, Uganda and India, by 2024.

Chair:

Eugene Brandon, Ph.D., Head of Translational Medicine, CIRM Cell and Gene Therapy Translating Center, IQVIA

Speakers:

Jennifer Adair, Ph.D., Associate Professor, Clinical Research Division, Stem Cell and Gene Therapy Program, Fred Hutchinson Cancer Research Center

Boro Dropulic, Ph.D., General Manager and Chief Scientific Officer, Lentigen; Executive Director, Caring Cross

Eric Faulkner, Vice President, Global Real World Evidence, Novartis Gene Therapies

Mike McCullough, Chief Information Officer, National Marrow Donor Program (NMDP)/Be The Match

7:15am – 8:45am | Aviara Salon A

Sponsored by Thermo Fisher Scientific

7:15am – 8:45am | Aviara Salon B

Sponsored by Cell One Partners

9:00am | GENERAL SESSION AND PARTNERING OPENS

OVERVIEW OF ARM’S INITIATIVES {AVROBIO Ballroom}

9:00am – 9:15am

Speaker:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)

9:15am – 10:15am | CONCURRENT TRACKS

THE PAST, PRESENT & FUTURE OF GENE DELIVERY {AVROBIO Ballroom}

9:15am – 10:15am

Speakers:

Peter Nell, Ph.D., Chief Business Officer and Head of Therapeutics, Mammoth Biosciences
Devyn Smith, Ph.D., CEO, Arbor Biotechnologies

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

9:15am – 10:15am

10:15am – 10:45am | MORNING BREAK

Sponsored by Bone Therapeutics, Cytotheryx, Invetech and POMS

10:45am – 12:15pm | CONCURRENT TRACKS

INNOVATIVE REGULATORY PATHWAYS FOR NEXT-GENERATION TREATMENTS {AVROBIO Ballroom}

10:45am – 11:15am

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

10:45am – 11:15am

POLICY UPDATES AND THEIR IMPACT ON CELL & GENE THERAPY {AVROBIO Ballroom}

11:15am – 12:15pm

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

11:15am – 12:15pm

12:15pm – 1:30pm | LUNCH

Sponsored by Yposkesi

1:30pm – 2:45pm | CONCURRENT TRACKS

THE INFORMATION PATIENTS WANT ABOUT REGENERATIVE MEDICINE {AVROBIO Ballroom}

1:30pm – 2:00pm

Chair:

Jennifer Braswell, Ph.D., Executive Director, ARM Foundation

Speaker:

Pat Furlong, Founding President and CEO, Parent Project Muscular Dystrophy (PPMD)

Leonard Valentino, M.D., President and CEO, National Hemophilia Foundation

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

1:30pm – 2:00pm

COMPANY PRESENTATIONS {AVROBIO Ballroom}

2:00pm – 2:45pm

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

2:00pm – 2:45pm

2:45pm – 3:15am | AFTERNOON BREAK

Sponsored by Bone Therapeutics, Cytotheryx, Invetech and POMS

3:15pm – 6:00pm | CONCURRENT TRACKS

PERSONALIZING CARDIOVASCULAR THERAPIES TO ADDRESS THE UNDERLYING CAUSES OF DISEASE {AVROBIO Ballroom}

3:15pm – 4:15pm

Speakers:

Faraz Ali, CEO, Tenaya Therapeutics

Jordan Lancaster, Ph.D., Co-founder and CEO, Avery Therapeutics

Emile Nuwaysir, Ph.D., President and CEO, BlueRock Therapeutics

Jacob Sten Petersen, DMSc., Corporate VP and Head of Stem Cell R&D, Novo Nordisk

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

3:15pm – 4:15pm

COMPANY PRESENTATIONS {AVROBIO Ballroom}

4:15pm – 6:00pm

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

4:15pm – 6:00pm

6:00pm | PROGRAM AND PARTNERING CLOSES

6:45am – 9:15am | REGISTRATION AND BREAKFAST

Sponsored by CPC

7:15am – 8:45am | CONCURRENT WORKSHOPS

  • WORKSHOP 1
  • WORKSHOP 2
  • WORKSHOP 3

7:15am – 8:45am | BlueRock Therapeutics Ballroom

Sponsored by Sartorius

7:15am – 8:45am | Aviara Salon A

7:15am – 8:45am | Aviara Salon B

9:00am | GENERAL SESSION AND PARTNERING OPENS

ARM CLOSING STATEMENTS {AVROBIO Ballroom}

9:00am – 9:15am

Speaker:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)

9:15am – 10:45am | CONCURRENT TRACKS

SYNTHETIC BIOLOGY APPLICATIONS IN CELL & GENE THERAPY {AVROBIO Ballroom}

9:15am – 9:45am

Speakers:

Timothy Lu, M.D., Ph.D., Co-founder and CEO, Senti Bio

Ali Nahvi, Ph.D., Head of New Therapeutic Modalities, Spark Therapeutics

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

9:15am – 9:45am

WHAT CELL & GENE THERAPY INVESTORS ARE LOOKING FOR NOW {AVROBIO Ballroom}

9:45am – 10:45am

Speakers:

Gbola Amusa, M.D., Partner and Chief Scientific Officer, Chardan

Chris Garabedian, Chairman and CEO, Xontogeny

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

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

9:45am – 10:45am

10:45am – 11:00am | MORNING BREAK

Sponsored by Bone Therapeutics, Cytotheryx, Invetech and POMS

11:00am – 12:00pm | CONCURRENT TRACKS

DOSING AND REDOSING IN GENE THERAPY {AVROBIO Ballroom}

11:00am – 12:00pm

Speakers:

Jonathan Garen, Chief Business Officer, uniQure

Sheila Mikhail, CEO and Co-Founder, AskBio

Timothy Miller, Ph.D., CEO, President and Co-Founder, Forge Biologics

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

11:00am – 12:00pm

12:00pm – 1:30pm | LUNCH

1:30pm | CONFERENCE CLOSES

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