Axiogenesis US Symposium

iPSC-derived Cells & Assays Come of Age

June 13, Boston, MA, USA at the Westin Waterfront

Learn how experts in the pharmaceutical industry and leading academic institutions are using Axiogenesis' cells and assays in drug discovery, safety/toxicology screening, and bioengeneering. Understand current approaches to establish and define standards for these cellular models. Get insights in case studies of iPS cells in drug development decision-making and biomedical research

 

Please see here for a review of the symposium presentations

 

Final Agenda
Monday, June 13

07:30 am

Arrival at Westin Waterfront, Boston

08:30 am

"iPSC-derived Cells & Assays Come of Age"
Felix von Haniel - Axiogenesis

08:45 am

"Standards in hiPSC / Human Cells for Organs on a Chip"
Kit Parker - Harvard School of Engineering and Applied Science / Wyss Institute for Biologically-Inspired Engineering at Harvard University

09:30 am

"Stem-Cell Derived Cardiomyocytes and Preclinical Safety: Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update"
Gary Gintant - Abbvie

 

"Axiogenesis Fresh Cor.4U Cells: A User Experience"
Greg Luerman, Axiogenesis for Jonathon Green - Abbvie

"A Six Sigma Case: Reduction of Variance in Fresh Cell Shipments"
Elena Kfoury - Axiogenesis

10:15 am

Coffee Break / Posters / Exhibits

10:45 am

"Using Peripheral Neurons in Neurotox Applications"
Payal Rana - Pfizer

11:15 am

"Target Validation Using an iPS-Cardiomyocytes-Based System"
Alina Berdichevsky - Novartis

11:45 am

Networking lunch

01:00 pm

Panel Discussion: "Establishing Global Standards for Commercial hiPSC"
Panelists: Kit Parker, Gary Gintant, Laszlo Urban, Morrie Ruffin
Moderator: Elena Kfoury

02:00 pm

Title: "Closing the Cardiac iPSC-Circle"
Heribert Bohlen

02:30 pm 

"Pre-Clinical Studies of iPSC Cell Therapies for Heart Failure"
Jordan Lancaster - University of Arizona / Avery Therapeutics

03:00 pm

"Engineering the Next-Generation of Cardiac Cell Therapies On-A-Chip"
Francesco Pasqualini - Wyss Translational Center Zürich

03:30 pm

Coffee Break / Poster Exhibits

04:00 pm

"Molecular Network Modeling of Drug-Induced Cardiotoxicity in the Space of Dose and Time"
Huan (Sharon) Wang - Havard Medical School

04:30 pm

Elena Kfoury - Axiogenesis
Summary

05:00 pm

Poster / Exhibits; Transit to Dinner

05:30 pm

Dinner Reception: The Barking Crab (Lobster Room)

 Speaker Bios

 

Standards Coordinating Body (SCB)

The SCB was initiated to address challenges and opportunities discussed in FDA (synergizing Standards efforts) and NIST (measurement assurance) meetings. The SCB brings together product developers, tools and service providers, professional societies, government entities, and academic centers with the intent to support standards development via coordination, prioritization, resource compilation, inter-laboratory data generation, participation in consensus Standards Development Organization (SDO) activities, and education & implementation for standards. The goal is to efficiently and effectively support sector regulatory submission review to improve the cost, time and resources for sector product development and approval. Creating standards creates a more uniform compliance environment and addresses and assists in future efforts for harmonization internationally of the regulatory framework for submission across the globe. The overarching contractual mechanism is planned to be an MOU between SCB and NIST, to begin the Public-Private Partnership initiative. There are planned project-specific CRADAs between NIST and a component of the SCB; these are not yet defined and will likely involve technology development. SCB has not determined the best contractual mechanism for FDA, if any. All contractual mechanisms will be defined by the appropriate staff within each Federal Partner. The SCB is currently engaging FDA for points-of-contact and potential interactions, with the understanding that there will be limits to that interaction. Additionally, NIST will seek input from other government agencies on SCB activities. As the US administrator and convener for ISO TC276, NIST will facilitate developing and publishing international standards through ISO. The preferred model for SCB a public private partnership similar to the Biomarker Consortium coordinated through the NIH foundation. The partnership will begin with a CRADA with a federal agency, likely NIST. This agency in turn can coordinate participation with other Federal entities. The SCB is also looking at the CERSI’s as a potential model and partner.

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