Scheduled for June 13, 2016, in Boston, Massachusetts, Axiogenesis is hosting an American symposium titled, “iPSC Derived Cells & Assays Come of Age.” Hosted at the Westin Waterfront, the symposium will explore how experts in the pharmaceutical industry and leading academic institutions are using Axiogenesis’ cells and assays in drug discovery, safety/toxicology screening, and bioengineering. It will also present current approaches to establish and define standards for these cellular models.
Expected to be widely attended by representatives from the pharmaceutical sector, symposium attendees will also view case studies of iPS cells in drug development decision-making and biomedical research.
Featured speakers for the event include:
- Kit Parker, Tarr Family Professor of Bioengineering and Applied Physics at Harvard will be speaking on “Standards in hiPSC / Human Cells for Organs on a Chip.” With a M.S. in Mechanical Engineering and PhD in Applied Physics from Vanderbilt University, Dr. Parker’s research includes cardiac cell biology and tissue engineering, traumatic brain injury, and biological applications of micro- and nanotechnologies.
- Gary Gintant, Research Fellow at Abbvie will give an update on the CiPA effort, as well as present on “Establishing an Internal iPSC Platform.” Gintant is a Research Fellow in the Department of Integrative Pharmacology, Integrated Science and Technology, at AbbVie. He is also involved in multiple internal drug discovery and safety initiatives and serves on journal editorial boards, NIH study sections, and Safety Pharmacology Society committees.
- Payal Rana of Pfizer will talk about her challenges and successes on “Using Peripheral Neurons in Neurotox Applications.” With more than 12 years of research experience in early drug discovery and toxicology, Rana is a Senior Research Scientist within Pfizer’s Investigational Toxicology Group for Drug Safety R&D (DSRD).
- Jordan Lancaster, professor at the University of Arizona and CSO of Avery Therapeutics will present his “Pre-clinical Studies of iPSC Cell Therapies for Heart Failure.” Lancaster is also involved with cardiovascular disease research at the Sarver Heart Center, where he explores the use of stem cells for therapeutic application in ischemic heart failure.
- Francesco Pasqualini, of the Wyss Translational Center Zürich will give his vision on “Engineering the Next-Generation of Cardiac Cell Therapies On-A-Chip.” Pasqualini got his PhD in Engineering Sciences from the Universita Politecnica delle Marche, later worked as a post-doctoral fellow at the Wyss Institute at Harvard University, and is now a Senior Scientist and Scientific Coordinator position at the Wyss Translational Center and Institute for Regenerative Medicine.
- Huan (Sharon) Wang, of Harvard Medical School will present her “Molecular network modeling of drug-induced cardiotoxicity in the space of dose and time.” Wang received her PhD from University of Colorado, during which time she integrated the disciplines of molecular biology and biomaterial engineering to publish several papers related to cardiac valve tissue engineering and cellular signaling. Dr. Wang is now a postdoctoral research associate within the Laboratory of Systems Pharmacology at Harvard Medical School.
- Alina Berdichevsky from Novartis will share her approach for “Target Validation Using an iPS-Cardiomyocytes-based System.” With a M.Sc. from the Weitzmann Institute of Science and a PhD from MIT, Berdichevsky is now a Laboratory Head at the Novartis Institute for Biomedical Research, where she leads a team of scientists that identify small molecules and targets for novel therapeutics in the area of metabolic disease.
- And others
The symposium also includes a panel discussion on the topic of “Establishing Global Standards for Commercial hiPSC,” led by Kit Parker, Gary Gintant, and Morrie Ruffin. The purpose of the panel is to encourage attendee conversation about this core industry issue and to facilitate intra-symposium collaboration.
To view the full agenda and to register, view: http://bit.ly/1TC4RA2
The topic of establishing global standards for iPSC-derived cell products is critical to a wide range of stem cell industry stakeholders, including representatives from across the pharmaceutical, biotechnology, and chemical sectors. The symposium aims to support standards development to increase cross department and company comparison allowing interpretation of data and reduce risk and variance.
Specifically, Axiogenesis believes the goal of standards development 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 will support a more uniform compliance environment and will address and assist in future efforts for harmonization internationally of the regulatory framework for submission across the globe. Similarly, the Standards Coordinating Body (SCB) and the National Institute of Standards and Technology (NIST) are working toward establishing iPS cell standards for preclinical and clinical applications, efforts in which Axiogenesis is actively involved.
The SCB will be addressing challenges and opportunities discussed in FDA (synergizing Standards efforts) and NIST (measurement assurance) meetings. The SCB will bring together product developers, tools and service providers, professional societies, government entities, and academic centers with the intent to support standards development.
The SCB’s stakeholder Consortium will also work with NIST through the Collaborative Research and Development Agreement (CRADA) mechanism. As the U.S. administrator and convener for ISO TC276, NIST will facilitate developing and publishing international standards through ISO.
Axiogenesis’ Role in Creating Global Standards for Human iPSCs
Founded in 2001 and headquartered in Cologne, Germany, Axiogenesis specializes in induced pluripotent stem cell (iPSC) products, including in vitro models of healthy and diseased cell types and tissues. The company also has an American subsidiary that was founded in 2014 and is located in Philadelphia, Pennsylvania. Axiogenesis’ current focus lies on the development and validation of functional assays using neuronal and cardiac cells, although it is actively expanding into new areas.
While Cellular Dynamics International has long been known for iPSC-derived cell types for use by big pharma, Axiogenesis has accelerated its position as a key market leader in this area through a focus on functional assay using its Cor.4U human cardiomyocyte product family, including the integration of cardiac fibroblasts. Cor.4U cells are used in applications for single cell analysis to high-throughput screening (HTS) in early cardiac safety and safety assessment as well as in cardiovascular drug development.
In the neural field Axiogenesis is offering various iPSC-derived neuronal sub-types including dopaminergic neurons (Dopa.4U), peripheral neurons (Peri.4U), CNS neurons (CNS.4U) and Astrocytes (Astro.4U).
Importantly, Axiogenesis has also differentiated itself by including a commercial use label license with every sale. Companies are not required to sign a “scope of use contract” and are free to use the cells types to develop and pursue commercial applications.
As a result of its expansion, Axiogenesis now serves a broad range of European and American large pharmaceutical companies, including Pfizer, Boehringer Ingelheim, Abbvie, and others, all of which are presenting at this symposium on June 13th.