BlueRock Therapeutics Ballroom

BLUEROCK THERAPEUTICS BALLROOM LIVESTREAM AGENDA

9:00am – 9:15am

WELCOME REMARKS {BlueRock Therapeutics Ballroom}

Speaker:

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

9:15am – 10:15am

PLENARY SESSION: THE CELL AND GENE THERAPY SECTOR’S COMMERCIAL TRAILBLAZERS {BlueRock Therapeutics Ballroom}
Being first isn’t always easy. Hear from the sector’s pioneers as they share valuable lessons learned along the path to commercialization and discuss the outlook for the coming year.

Chair:

Matthew Patterson, Chairman and CEO, Audentes Therapeutics

Speakers:

Vijay Chiruvolu, Ph.D., SVP, Global Process Development – Cell Therapy, Kite, a Gilead company
Rachelle Jacques, CEO, Enzyvant
David Lennon, Ph.D., President, AveXis
Ron Philip, Chief Commercial Officer, Spark Therapeutics
Jeff Walsh, Chief Strategy Officer, bluebird bio

10:15am – 10:45am | MORNING BREAK – NO LIVESTREAM AT THIS TIME

10:45am – 12:00pm | LIVESTREAM RESUMES

FEATURED FIRESIDE CHAT: BREXIT’S EFFECT ON CELL AND GENE THERAPY REGULATION {BlueRock Therapeutics Ballroom}
10:45am – 11:15am

Chair:
Jacqueline Barry, Ph.D., Chief Clinical Officer, Cell and Gene Therapy Catapult
Speaker:
Christiane Niederlaender, Ph.D., Director, AMBR-Consulting; Former Senior Quality Assessor for Biologics, Medicines and Healthcare Products Regulatory Agency (MHRA); Former Member, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA)

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

11:15am – 11:30am
11:30am – 11:45pm
11:45am – 12:00pm

12:00pm – 1:15pm | LUNCH – NO LIVESTREAM AT THIS TIME

1:15pm – 3:30pm | LIVESTREAM RESUMES

PANEL: MYTH VS. REALITY – IMPLEMENTING PAYMENT ARRANGEMENTS FOR CELL AND GENE THERAPIES {BlueRock Therapeutics Ballroom}
1:15pm – 2:15pm
Payers and therapeutic developers are starting to implement payment-over-time and pay-for-performance arrangements. Where does the reality on the ground diverge from common perception? What role are third parties playing today and what needs to change in order for these arrangements to be widespread?

Chair:
Roger Longman, Founder and Chairman, Real Endpoints
Speakers:
John Coombs, Pharm.D., Patient Access Lead, U.S. CAR-T, Novartis
C. Bernie Good, M.D., Senior Medical Director, Center for Value-Based Pharmacy Initiatives, UPMC Health Plan
Bill Martin, VP, Pharma Strategy and Account Management, Express Scripts

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

2:15pm – 2:30pm
2:30pm – 2:45pm
2:45pm – 3:00pm
3:00pm – 3:15pm
3:15pm – 3:30pm

3:30pm – 4:00pm | AFTERNOON BREAK – NO LIVESTREAM AT THIS TIME

4:00pm – 6:00pm | CONCURRENT TRACKS – LIVESTREAM RESUMES

PANEL: CELL AND GENE THERAPY FOR NEUROLOGICAL PRODUCT INDICATIONS {BlueRock Therapeutics Ballroom}
4:00pm – 5:00pm
Durable treatments for the complex range of diseases affecting the central nervous system have long been an area of focus for the medical community. With advances in gene and cell therapy, there is a growing range of therapeutic strategies which may provide long awaited relief to myriad patient populations. This panel will review the state of development and clinical progress for these next-generation durable treatments for CNS conditions.

Chair:
Timothy Schroeder, Founder and CEO, CTI Clinical Trial & Consulting
Speakers:
Jonathan Garen, Chief Business Officer, uniQure
Emile Nuwaysir, Ph.D., President and CEO, BlueRock Therapeutics
Andre Turenne, President and CEO, Voyager Therapeutics
David Venables, Ph.D., CEO, Synpromics

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

5:00pm – 5:15pm
5:15pm – 5:30pm
5:30pm – 5:45pm
5:45pm – 6:00pm

6:00pm | LIVESTREAM ENDS FOR THE DAY

9:00am – 9:15am

OVERVIEW OF THE ALLIANCE FOR REGENERATIVE MEDICINE’S INITIATIVES {BlueRock Therapeutics Ballroom}

Speakers:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)
Matthew Patterson, Chairman, Alliance for Regenerative Medicine (ARM); Chairman and CEO, Audentes Therapeutics

PANEL: CLINICIANS WORKING WITH CAR-T THERAPIES {BlueRock Therapeutics Ballroom}
9:15am – 10:15am
Thousands of patients have now been treated with CAR-T therapies. Find out what unique challenges and rewards come with providing these treatments from those on the front lines, and learn what the experience to date suggests about the widespread use of CAR-T.

Chair:
Gregory Hale, M.D., Senior Medical Director, Hematology and Oncology, Medpace
Speakers:
Prasad S. Adusumilli, M.D., Head, Solid Tumors Cell Therapy, Cellular Therapeutics Center; Vice Chair, Department of Surgery; Deputy Chief, Thoracic Surgery, Memorial Sloan Kettering Cancer Center
Dimitrios Tzachanis, M.D., Ph.D., Associate Clinical Professor of Medicine, UC San Diego Blood and Marrow Transplant Program
John A. Zaia, M.D., Aaron D. Miller and Edith Miller Chair in Gene Therapy; Director, Center for Gene Therapy, City of Hope

10:15am – 10:45am | MORNING BREAK – NO LIVESTREAM AT THIS TIME

10:45am – 12:15pm | LIVESTREAM RESUMES

FEATURED SPEAKER: ADVANCING GENE THERAPIES GREAT AND SMALL {BlueRock Therapeutics 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

PANEL: WHEN DOES INVESTING IN CELL AND GENE THERAPY MAKE BUSINESS SENSE? {BlueRock Therapeutics Ballroom}
11:15am – 12:15pm
The cell and gene therapy industry is undergoing a critical inflection point as is evident in large financing deals, exciting clinical data and landmark regulatory approvals. However assets also face challenges such as high development costs and significant manufacturing complexities. Through a presentation and panel discussion, this session will define drivers of cost of development and cost of goods and provide a framework for assessing investment potential of cell and gene therapy assets.

Chair:
Delfi Krishna, Ph.D., Director, Cell and Gene Therapy Platform, R&D Strategy, Portfolio and Operations, GSK
Speakers:
Brian Bronk, Ph.D., Head of Business Development, Rare Diseases and Blood Disorders, Global Business Development and Licensing, Sanofi
Bradley Campbell, President and Chief Operating Officer, Amicus Therapeutics
Jerel Davis, Ph.D., Managing Director, Versant Ventures
Mitchell Finer, Ph.D., Chief Scientific Officer, ElevateBio; President, ElevateBio Base Camp
Toby Freyman, Ph.D., Senior Director, Center for External Innovation; Head of Rare Disease Business Development, Takeda Pharmaceuticals International

12:15pm – 1:30pm | LUNCH – NO LIVESTREAM AT THIS TIME

1:30pm – 2:45pm | LIVESTREAM RESUMES

SPOTLIGHT SESSION: THE EVOLUTION OF CELL AND GENE THERAPY IN CHINA {BlueRock Therapeutics Ballroom}
1:30pm – 2:00pm
Senior executives active in the region will share their experience and outlook on the cell and gene therapy industry in China, with advice for those considering expansion or are new to the market.

Chair:
Li Chen, Ph.D., VP, Gene Synthesis and Mol LCS, BID, LSG, Thermo Fisher Scientific
Speakers:
Felix Hsu, SVP and Global Head of Advanced Therapies, WuXi AppTec
Yuling Li, Ph. D., CEO, Zhejiang Innoforce Pharmaceuticals Co. Ltd.
BG Rhee, Ph.D., CEO, SCM Lifescience; Chairman, Council for Advanced Regenerative Medicine (CARM) Korea

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

2:00pm – 2:15pm
2:15pm – 2:30pm
2:30pm – 2:45pm

2:45pm – 3:15pm | AFTERNOON BREAK – NO LIVESTREAM AT THIS TIME

3:15pm – 6:00pm | LIVESTREAM RESUMES

PANEL: THE IMPACT OF UNIVERSAL DONOR CELLS AND iPSCs ON THE CELL THERAPY INDUSTRY {BlueRock Therapeutics Ballroom}
3:15pm – 4:15pm
Since the discovery of pluripotent stem cells in the early 1980’s, the promise of fit-to-purpose cell replacement therapy has occupied the imaginations of many in the medical and patient communities. Progress was slowed by both technical and ethical challenges, but with the discovery of the iPSC source in 2006, many of these hurdles were overcome and the pace of research and clinical development accelerated dramatically. Further, genetic and biomaterials modification to this limitless supply of cells has opened new doors to allogeneic stem cell-derived cell therapy, including the associated promise of lower costs and higher accessibility. This panel will explore the ways in which iPSCs, and more specifically iPSCs modified for allogeneic use, have changed the way in which we think about the commercial viability of cell therapies.

Chair:
Robert Preti, Ph.D., President and CEO, Hitachi Chemical Advanced Therapeutics Solutions; GM, Hitachi Chemical Regenerative Medicine Business Sector
Speakers:
Stewart Abbot, Ph.D., Chief Operating and Scientific Officer, Adicet Bio
Usman Azam, M.D., President and CEO, Tmunity Therapeutics
Tim Lu, M.D., Ph.D., Co-Founder and CEO, Senti Biosciences
Bastiano Sanna, Ph.D., CEO, Semma Therapeutics
Dan Shoemaker, Ph.D., Chief Scientific Officer, Fate Therapeutics

COMPANY PRESENTATIONS {BlueRock Therapeutics Ballroom}

4:15pm – 4:30pm
4:30pm – 4:45pm
4:45pm – 5:00pm
5:00pm – 5:15pm
5:15pm – 5:30pm
5:30pm – 5:45pm
5:45pm – 6:00pm

6:00pm | LIVESTREAM ENDS FOR THE DAY

9:00am | GENERAL SESSION OPENS – LIVESTREAM BEGINS

9:00am – 9:15am

OVERVIEW OF THE ARM FOUNDATION FOR CELL AND GENE MEDICINE {BlueRock Therapeutics Ballroom}

Speakers:

Morrie Ruffin, Co-Founder and Senior Advisor, Alliance for Regenerative Medicine; Executive Director, ARM Foundation for Cell and Gene Medicine
Stewart Parker, Chairperson, ARM Foundation for Cell and Gene Medicine

FEATURED SPEAKERS: EMILY WHITEHEAD’S JOURNEY TO CAR-T – NO LIVESTREAM AT THIS TIME {BlueRock Therapeutics Ballroom}
9:15am – 9:45am

Speakers:
Emily Whitehead, Co-Founder, Emily Whitehead Foundation
Tom Whitehead, Co-Founder, Emily Whitehead Foundation

PANEL: A LOOK INTO THE CRYSTAL BALL – WHAT DOES THE FUTURE HOLD FOR GENE EDITING? {BlueRock Therapeutics Ballroom}
9:45am – 10:45am
This dynamic panel discussion featuring executives from leading gene editing companies will explore the major milestones and advances anticipated in the near term (12 month), midterm (5 year), and long term (10+ year) timeframes for these promising therapies. This session will also consider how the rapidly evolving climate surrounding these technologies will potentially impact the future of the sector’s success.

Chair:
Robert Smith, SVP, Global Gene Therapy Business, Pfizer
Speakers:
Cindy Collins, President and CEO, Editas Medicine
Michael Dombeck, SVP, Corporate Development, Precision BioSciences
Sandy Macrae, Ph.D., President and CEO, Sangamo Therapeutics
Arthur Tzianabos, Ph.D., President and CEO, Homology Medicines

10:45am – 11:00am | MORNING BREAK – NO LIVESTREAM AT THIS TIME

11:00am – 12:00pm | LIVESTREAM RESUMES

PANEL: INNOVATION AROUND MANUFACTURING TECHNOLOGIES {BlueRock Therapeutics Ballroom}
11:00am – 12:00pm
In biotechnology, a good idea born in a lab too often fails to make it to clinical and commercial reality due to challenges in scalability, production, and characterization. For cell, gene, and tissue engineered products these challenges are particularly acute. It has even reached the point in which investors have begun seek a scalable platform over a promising idea. This panel will explore the next-generation technologies enabling the scalable, transferable, and cost-effective manufacture of regenerative medicine products and discuss the ways in which the regenerative medicine industry must continue to develop fit-for-purpose platforms to address sector specific CMC challenges.

Chair:
Kelvin Lee, Ph.D., Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
Speakers:
Nina Bauer, Ph.D., Chief Commercial Officer, FloDesign Sonics
Jian Irish, Ph.D., SVP, Global Head of Manufacturing, Kite, a Gilead company
Jerry Keybl, Ph.D., Head of Cell and Gene Therapy Manufacturing, MilliporeSigma
Alberto Santagostino, Head, Cell and Gene Technologies Business Unit, Lonza Pharma & Biotech
Jason Slingsby, Ph.D., Chief Business Officer, Oxford Biomedica

12:00pm | LIVESTREAM ENDS

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