2021 Virtual Mini-Conference

Theme:  “COMMERCIALIZATION OF CELL & GENE THERAPY: ADVANCING TECHNOLOGY AND INNOVATION”

BSMA is bringing together the stakeholders of the embryonic Cell and Gene Therapy to confront its formidable challenge of commercialization. Under the leadership of supply chain management heads of the major Cell and Gene Therapy companies on its Steering Committee – Atara Biotherapeutics, Allogene, Bayer, Bluebird Bio, Bristol-Myers Squibb, Celgene, Gritstone Oncology, Gilead Sciences, Instil Bio, Johnson and Johnson, Kite Pharma, Novartis, Orchard Therapeutics, PACT Pharma, Sangamo, and Ultragenyx), BSMA is organizing the Conference.                     

The innovative therapy of Cell and Gene Therapy has imposed Draconian demands on the supply chain in terms of production batch of one, sixteen-day vein to vein lead time, cryogenic preservation and cold-chain logistics, chain of custody, real-time patient care, and prohibitive cost of treatment. Executives of CGT companies and service providers will address the “Issues and Answers” of raw material supply, supplier QA, apheresis, scale out of clinical and manufacturing operations, distribution and logistics, information systems, governmental compliance and efficacy of treatment.

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Our Conference Speakers & Panelists
Learn from the world’s leading executives in life sciences from leading-edge enterprises as well as by core academic group of supply chain experts from eminent institutions
Devendra Mishra

Devendra Mishra

Executive Director and Co-Founder, BSMA

Timothy Moore

Timothy Moore

President, PACT Pharma

Aileen Baquiran

Aileen Baquiran

Vice President, Supply Chain, Orchard Therapeutics

Chris Bogart

Chris Bogart

Vice President, Supply Chain, Bayer

Dawn Henke

Dawn Henke

Senior Technical Program Manager, Standards Coordinating Body (SCB)

Gary Hutchinson

Gary Hutchinson

President, Modality Solutions

Olive Sturtevant

Olive Sturtevant

Sr. Administrative Director, Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana-Farber Cancer Institute

Gregg Bodnar

Gregg Bodnar

Senior Client Engagement Manager, Be The Match BioTherapies

Peter Holman

Peter Holman

VP of Quality at ArsenalBio

David Karakas

David Karakas

Director, Procurement & Sourcing, Bluebird Bio

Matt Yedwabnick

Matt Yedwabnick

VP, Global Supply Chain Atara Biotherapeutics

Kevin Cast

Kevin Cast

Partner, Archbow Consulting

Kenny Choi

Kenny Choi

Senior Director. Process Sciences and Engineering, Instil Bio

Albert Cooksey

Albert Cooksey

Senior Vice President of Business Development and Sales, ICS

INTERIM PROGRAM FOR THE GLOBAL VIRTUAL CONFERENCE, BSMA, August 5, 2021

THEME: “COMMERCIALIZATION OF CELL & GENE THERAPY: ADVANCING TECHNOLOGY AND INNOVATION”

9:00 am – 1:15 pm Event (PST)
9:00 am – 9:10 am
“Welcome To The Revolution in Healthcare”
Devendra Mishra
,
Executive Director, BSMA

Sponsorship:
Contact Pamela Gardner,
VP, Sponsor Sales, (P: 858-349-8375)

09:10 – 9:40 am | KEYNOTE: “PACT Unique CGT Technology Platform: Eradication of Cancerous Tumors”

Presentation will be about tackling these solid tumor cancer challenges with pioneering technologies in a clinical stage with the goal to treat each patient with personalized neoTCR-based therapies across a broad range of tumor mutational burdens and solid tumor cancer types. The technology platform provides the differentiated ability to identify these neoantigens, as well as validate them as targets specific to the person’s cancer. Once validated, individualized, cancer-targeted neoTCR-T cell therapy products are manufactured for each person with cancer. It is now broadly accepted that cancer is a profoundly patient-specific disease, where no two tumors are alike.

Keynote Speaker:  Timothy Moore, President, PACT Pharma

09:40 – 10:40 am | PANEL: “Overcoming the Challenges of Cell and Gene Therapy: The Lifeline of the Healthcare Revolution”

The pipeline of Cell and Gene Therapies has been growing rapidly since the first one, Kymriah of Novartis, was approved in 2019. Research suggests that by 2030, up to 60 new cell and gene therapies could be launched, treating upwards of 350,000 patients How do you incorporate the technology, processes and insights necessary to ensure your clinical trial needs are met fully? How can scientific and operational expertise simplify and streamline complex trial design? Today’s drug development environment was largely designed around small molecules and biologics such as proteins and monoclonal antibodies, a constrained system that has not significantly changed in 50 years. The executives will discuss their challenges and solutions.

Panelists:
Aileen Baquiran, Vice President, Supply Chain, Orchard Therapeutics
Chris Bogart, Vice President, Supply Chain, Bayer
Matt Yedwabnick, VP, Global Supply Chain, Atara Biotherapeutics
Kevin Cast, Partner, Archbow Consulting
Moderator: Devendra Mishra, Executive Director, BSMA

10:40 – 11:40 am | PANEL: “Harmonizing Best Supply Chain Practices for Apheresis”

Several Apheresis-related organizations are formulating standards for various aspects of the critical function of Apheresis in the evolving Cell and Gene Therapy. SMEs will explore how to simplify and improve the interface with Apheresis centers in areas of operations, systems, packaging, storage and logistics (particularly cold chain). Issues of compliance with regulatory standards will also be addressed. Listening to the Voice of the Customer and taking innovative, remedial steps will be the guiding principle for the exchange. Representatives from Standards Bodies (FACT and SCB) will present progress made and the challenges ahead.

Panelists:
Dawn Henke, Senior Technical Program Manager, Standards Coordinating Body (SCB)
Gary Hutchinson, President, Modality Solutions
Olive Sturtevant, Sr. Administrative Director, Connell & O’Reilly Families, Cell Manipulation Core Facility, Dana-Farber Cancer Institute)
Gregg Bodnar, Senior Client Engagement Manager, Be The Match BioTherapies
Moderator: Peter Holman, Global Apheresis Integration Lead and Head of Apheresis Operations, Novartis

11:40 am- 12:05 pm | “Navigating the Process Development Challenges of Cell & Gene Therapy”

Presentation will identify the unique challenges of developing and scaling out manufacturing processes of autologous cell therapies. Manufacturing for Cell and Gene Therapy has three intrinsic challenges, namely 1. The starting material, the blood or tumor cells of the patient to be cured, is always different and unique, 2. There is no buffer inventory for the production batch of one, and 3. Enabling technologies have not caught up to the needs of the industry. These systems-level challenges must be addressed early in development, where the direction of the organization’s strategy can be molded appropriately.

Speaker: Kenny Choi, Senior Director. Process Sciences and Engineering, Instil Bio

12:05 – 12:30 pm | “How to Industrialize Strategic Sourcing of Raw Materials and Supplies?”

Challenges faced by the nascent industry to qualify suppliers who understand the stringent requirements and forge a business relationship will be addressed. The just in time nature of the therapy imposes an unprecedented demand on suppliers. A robust and resilient supply chain requires manufacturers to strategically source raw materials and identify backup suppliers where possible, and where backup options do not exist, work with suppliers to de-risk their supply chain. Manufacturers are also working with CMOs for certain critical raw materials and processes that are capacity constrained which impact both pricing and availability to service market demands. Industry approach to audit suppliers will be discussed.

Speaker:  David Karakas, Director, Procurement & Sourcing, Bluebird Bio

12:30 – 12:55 pm | “Labeling, Packaging & Logistics – The Achilles Heel of the CGT Delivery”

Just-in-time packaging and labeling is critical to meeting the critical need of the patient. Labeling at the ultracold temperatures adds significant complexity in the primary and secondary packaging and labeling. The labels selected must be validated to perform at these ultracold temperatures. Subsequently, the design and documentation of temperature and the identity and security chains of custody in a 21 CFR part 11 environments have to be assured in the cold chain delivery network.

Speaker:  Albert Cooksey, Senior Vice President of Business Development and Sales, AmerisourceBergen (ICS)

12:55 – 01:00 pm  | Wrap Up: “Where do we go from here?”

Devendra Mishra, Executive Director, BSMA

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2021 BSMA Mini-Conference Parade of Sponsors

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