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Innovation in the horizon: What is New in the Pipeline
The recent wave of approved ATMPs has ignited a renaissance within the pharmaceutical / biotech industry. Numerous other ATMPs are currently underway to further broaden the spectrum of indications that these innovative products intend to treat. The development pipeline also displays how rapid the underlying technologies of these medicinal products is evolving and forecasts exciting and novel avenues of treatment for patients.
Within this session we will explore the latest technologies with ATMP-relevance that are in development and try to gain an insight of what the field might hold within its future. Additionally, we would like to invite the participants from different areas (academia, regulators and industry) to discuss with us what opportunities and challenges we might encounter with these novel technologies. This session is not only open for everybody with a regulatory, evidence or access background but we would also like to welcome ATMP enthusiasts that want to learn what is currently going-on within this fast-paced field.
Topics explored in this Session:
- Novel technologies intended for ATMPs:
- The road from Innovation to Clinical Trials.
- Where will the field be in 10 years?
- Challenges and opportunities emerging with these innovative technologies.
- 2nd Generation Gene Editing/ Base Editing.
- New Technology to develop CAR-T Cells.
The recent wave of approved ATMPs has ignited a renaissance within the pharmaceutical / biotech industry. Numerous other ATMPs are currently underway to further broaden the spectrum of indications that these innovative products intend to treat. The development pipeline also displays how rapid the underlying technologies of these medicinal products is evolving and forecasts exciting and novel avenues of treatment for patients.
Within this session we will explore the latest technologies with ATMP-relevance that are in development and try to gain an insight of what the field might hold within its future. Additionally, we would like to invite the participants from different areas (academia, regulators and industry) to discuss with us what opportunities and challenges we might encounter with these novel technologies. This session is not only open for everybody with a regulatory, evidence or access background but we would also like to welcome ATMP enthusiasts that want to learn what is currently going-on within this fast-paced field.
Topics explored in this Session:
- Novel technologies intended for ATMPs:
- The road from Innovation to Clinical Trials.
- Where will the field be in 10 years?
- Challenges and opportunities emerging with these innovative technologies.
- 2nd Generation Gene Editing/ Base Editing.
- New Technology to develop CAR-T Cells.
Session Chair(s)
Sam Ringle, PhD
EU Regulatory Affairs Manager
CSL Behring Innovation Gmbh, Germany
Sam is a EU Regulatory Affairs Manager at CSL Behring Innovation located in Marburg Germany. Currently, he is responsible for CSL Behring's gene therapy portfolio within the Region EU. Sam received his molecular biology diploma degree from the Saarland University with a major focus on Genetics/Epigenetics. He also holds a PhD in Biochemistry from the University of Regensburg, in which he focused on the field of gene regulation, and a master’s degree in Drug Regulatory Affairs (M.D.R.A) from the University of Bonn.
Speaker(s)
Aron F. Stein, PhD
Vice President, Global Regulatory Affairs
Sangamo Therapeutics, Inc., United States
Aron F Stein, PhD is currently the Vice President, Global Regulatory Affairs at Sangamo Therapeutic where he provides the vision, strategic direction and corporate regulatory approach for all gene and cell therapeutics. He has over 30 years of product development experience in pharmaceutical and biotechnology having responsibility for multiple drug approvals in both large and small companies. Aron earned his B.S. and PhD at Texas A&M University in toxicology and was a NIEHS postdoctoral fellow at University of Kansas Medical Center.
Sean Burns, MD
Vice President, Disease Biology and Pharmacology
Intellia Therapeutics, United States
Dr. Sean Burns is Vice President of the Disease Biology and Pharmacology team at Intellia Therapeutics, a leading genome editing company based in Cambridge, MA. In addition, Sean is a practicing endocrinologist affiliated with Massachusetts General Hospital (MGH) and Nantucket Cottage Hospital. At Intellia, he leads the company’s efforts to identify novel in vivo applications of CRISPR to treat genetic disease. Sean previously served at Intellia as medical director, and as director of Hematology and New Therapeutic Areas. Before Intellia, Sean was a physician-scientist at MGH and the Broad Institute of Harvard and MIT. Sean received his B.S. from Cornell University and his M.D. with Honors from the New York University School of Medicine.