Aviara Salon B Workshops

AVIARA SALON B LIVESTREAM AGENDA

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

7:15am – 8:45am | Aviara Salon B
Sponsored by IQVIA

DEVELOPING A ROBUST EVIDENCE PACKAGE TO PREPARE FOR MARKET ENTRY WORKSHOP
When you think of bringing a new therapy to market, payers, regulators, providers, and other stakeholders are requiring robust information on effectiveness as well as the overall impact of use to understand the true value for patients and impact on the wider healthcare system. Understanding what stakeholders are looking for as part of their review process is crucial to successfully develop and communicate your value message. Careful planning during clinical development is key to develop an evidence package that is useful for regulatory filing as well as discussions with payers and providers. This panel will discuss elements and generation of this evidence package.

Welcome Remarks:
George Smith, Ph.D., Senior Director, Cell and Gene Therapy Center, IQVIA
Chair:
Adrian McKemey, Ph.D., SVP, Consulting Services, IQVIA
Speakers:
Stewart Abbot, Ph.D., Chief Operating and Scientific Officer, Adicet Bio
John Doyle, Dr.P.H., VP, Global Healthcare Innovation Lead, Pfizer
Manuel Duenas, VP, Market Access, Atara Biotherapeutics
Felix Hsu, SVP and Global Head of Advanced Therapies, WuXi AppTec
Chris McClain, VP, Sales and New Business Development, Be The Match BioTherapies
Aiman Shalabi, VP, R&D, Cell and Gene Therapies, GlaxoSmithKline

8:45am | LIVESTREAM ENDS FOR THE DAY IN AVIARA SALON B

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

7:15am – 8:45am | Aviara Salon B
Sponsored by World Courier

ALIGNING CLINICAL, MANUFACTURING, AND LOGISTICS PLATFORMS TO TREAT PATIENTS AT SCALE WORKSHOP
For advanced therapies to become a true industry, developers need to align the three platforms of manufacturing (closed and automated process), clinical (safe and efficacious) and logistics (seamless connection to patients). Without this alignment, companies risk creating a life changing therapy that can’t be made, or manufacturing a therapy that can’t be delivered. This workshop will look to understand the challenges in coordinating development across these platforms, providing lessons learned to help companies create therapies that can easily scale into globally viable commercial therapies.

7:15am – 7:25am | Welcome Remarks
Chair:
Simon Ellison, Cell and Gene Therapy Service Director, World Courier

7:25am – 7:35am | Presentation 1
Speaker:
Phil Vanek, Ph.D., GM, Cell and Gene Therapy Strategy, GE Healthcare

7:35am – 7:45am | Presentation 2
Speaker:
Dominic Clarke, Ph.D., Global Head of Cell Therapy, HemaCare; Co-Chair, Process and Product Development Committee, International Society for Cell and Gene Therapies (ISCT)

7:45am – 7:55am | Presentation 3
Speaker:
Jacqueline Barry, Ph.D., Chief Clinical Officer, Cell and Gene Therapy Catapult

7:55am – 8:45am | Moderated Discussion with All Speakers

8:45am | LIVESTREAM ENDS IN AVIARA SALON B

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