March 26-28, 2019

Boston, USA

Workshop A
TUESDAY, MARCH 26, 2019

08.30 - 11.00
Improving the Translation of Antigen Specific Therapies into the Clinic Across Disease Indications
Workshop Leader: Julia Greenstein, VP- Research Strategy , JDRF Workshop Leader: Simi Ahmed, Director, Research , JDRF

 

The purpose of this workshop is to bring together experts across autoimmune fields to discuss common challenges facing clinical translation of antigen specific therapies. Topics of key relevance
include defining a late stage preclinical development path of therapeutic candidates, common cross disease challenges in identifying reliable mechanistic markers of immune effects of
antigen specific therapies, possible need for de-bulking therapies or other combinations to ensure success of these types of therapies, and how multiple stakeholders might come together in public-private partnership to overcome common hurdles.

Hear & Discuss About:

 

  • Need for harmonized approaches in this space and novel ways to address them
  • Blood mechanistic markers to evaluate treatment and therapeutic response of antigen specific therapies
  • Improving the predictability and effective utilization of preclinical models as pre-requisites for clinical testing
  • Lessons learnt from successful clinical testing of antigen specific therapies across diseases

Julia Greenstein, VP- Research Strategy , JDRF

Julia Greenstein is the Vice President of Research Strategy at JDRF. She has been at JDRF for over 10 years beginning in the Beta cell portfolio and serving in a variety of roles in the Cure and Prevention portfolios. Previously she was CEO of Immerge BioTherapeutics, Inc., a Novartis Pharma/BioTransplant JV and has held the roles CSO at BioTransplant and VP of Discovery Research at ImmuLogic Pharmaceutical Corp. She received her PhD in Microbiology from University of Rochester Medical School.  She did postdoctoral training at the University of Rochester Medical School and the Dana Farber Cancer Institute of Harvard Medical School and was an Assistant Professor the Dana Farber Cancer Institute. In addition, she serves on the Board of Directors of The Sage Colleges and is on the University of Rochester Regional Cabinet.

Simi Ahmed, Director, Research , JDRF

Simi T. Ahmed, Ph.D., is a Director of Research and lead of the Immune Therapies Program at JDRF. She is responsible for creating and implementing the vision and strategy of this program, with core emphasis on the establishment of effective disease modifying immunotherapies for T1D. Her experiences range from basic research to translational medicine, and draw from effective partnerships within the public and private sectors. Prior to joining JDRF, Dr. Ahmed completed her postdoctoral training in Dr. James E. Darnell’s laboratory at The Rockefeller University in New York. She holds a bachelor’s degree in Biophysical Chemistry from Dartmouth College and a doctorate in Immunology from the Weill Graduate School of Medical Sciences of Cornell University.

Workshop B
TUESDAY, MARCH 26, 2019

11.30 - 14.00
Antigen-Specific Tolerance Induction: Robust Strategies to Improve Clinical Trials Efficacy & Success Rate
Workshop Leader: Andreas Lutterotti, MD; Assistant Professor- Experimental Therapy Research in Multiple Sclerosis , University of Zurich

 

This interactive workshop session will delve deep into the challenges associated with the lack of robustness in terms of proof of concept in the field of antigen-specific immune tolerance induction, clinical efficacy in relation to mechanism of action and strategic considerations for developing clinical trial protocols to optimize successful translation into and through different phases of clinical trials.

Hear & Discuss About:

 

  • How to document clinical efficacy in relation to mechanism of action?
  • Outcome measure
  • Clinical trial protocols and critical steps to consider (phase IIa as PoC component)
  • Regulatory issues (advanced therapy medicinal products (ATMP) versus biological, nanoparticle)

Andreas Lutterotti, MD; Assistant Professor- Experimental Therapy Research in Multiple Sclerosis , University of Zurich

Andreas Lutterotti is assistant professor for “Experimental Therapy Research in Multiple Sclerosis and Other Neurological Diseases” at the University of Zurich since August 2014, as well as a senior physician at the Department of Neurology, Section Neuroimmunology and MS Research (nims), University Hospital Zurich. He has earned his medical doctor’s degree at the Medical University in the Clinical Department of Neurology, Innsbruck and was certified in Neurology in 2012. His core expertise is the development and implementation of experimental therapies in the field of multiple sclerosis and other autoimmune diseases. He is Co-Founder of Cellerys AG, a company developing a cell based therapy to induce immune tolerance in MS.

 

Workshop C
TUESDAY, MARCH 26, 2019

14.30 - 17.00
Considerations for Combination Strategies for Tolerizing Immunotherapies
Workshop Leader: Amy Rosenberg, Supervisory Medical Officer and Division Director, Office of Biotechnology Products , CDER/FDA Workshop Leader: Ranjeny Thomas, Professor of Rheumatology at University of Queensland; Director , Dendright

 

This informative workshop highlights potential regulatory and R&D strategies to combine antigen-specific immune tolerance approaches with other therapies in order to open up the potentials to address a wider unmet patient need across various therapeutic areas.

Hear & Discuss About:

 

  • When might combination strategies be applicable to treatment of autoimmune disease?
  • What types of combination strategies might be used in autoimmune disease and is there evidence from the clinic already?
  • Does combination always mean simultaneous?
  • How could immunomonitoring be applied to trials of combination tolerising therapies?
  • Considerations for clinical trial design
  • How does the regulatory landscape change if developing a combination therapy based on two unapproved drugs?

Amy Rosenberg, Supervisory Medical Officer and Division Director, Office of Biotechnology Products , CDER/FDA

Amy Rosenberg received her MD from Albert Einstein College of Medicine and is Board Certified in Internal Medicine. She was a post-doctoral fellow at NCI in Al Singer’s lab. She joined CBER, FDA in 1988, becoming Director of the Division of Therapeutic Proteins, CBER/CDER in 2000 (now DBRR3 in the Office of Biotechnology Products, CDER). She has been a driving force in risk evaluation and mitigation pertaining to the immunogenicity of therapeutic proteins (Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products) and in the elucidation and implementation of immune tolerance induction protocols in clinical settings. She co-edited the AAPS/Springer Book “Biobetters: Protein Engineering to Approach the Curative”.

Ranjeny Thomas, Professor of Rheumatology at University of Queensland; Director , Dendright

Professor Thomas is Professor of Rheumatology at University of Queensland, Translational Research Institute, consultant rheumatologist at Princess Alexandra Hospital and fellow of the Australian Academy of Health and Medical Sciences. Her research seeks to understand autoimmune disease and restoration of immune tolerance. Through this work, she developed and tested the first rheumatoid arthritis vaccine. She has also contributed major insights into how the microbiome is involved in causing spondyloarthropathy leading to the development of disease biomarkers and therapeutic strategies. Ranjeny is founder and a director of the spin-off company, Dendright, which is developing immunotherapy for autoimmune diseases.