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!
ON-DEMAND VIRTUAL CONTENT
Available Beginning Tuesday, October 12, 2021
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
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
6:45am – 9:15am | REGISTRATION AND BREAKFAST
Sponsored by Triangle Insights Group
7:15am – 8:45am | CONCURRENT WORKSHOPS
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
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
The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 100+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 1,200 attendees – over 20% of which are C-level executives – this conference enables key partnerships through more than 3,000 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.
October 12-14, 2021
Carlsbad, CA
