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Pig Genetic Engineering: Regulation and Clinical Trials

Friday September 24, 2021 - 22:25 to 23:30

Room: General Session

210.1 Regulation in Europe from the Investigator’s Perspective

Henk-Jan Schuurman, Netherlands

Managing Director
SchuBiomed Consultancy



Henk-Jan Schuurman was trained in Chemistry, and received his PhD in 1977 from Utrecht University, the Netherlands. After a university position in clinical and experimental Immunology/Internal Medicine/Pathology, he joined pharmaceutical industry in 1992: he then served pharma/biotech companies in Switzerland, United Kingdom and USA in various positions at the interface between research and clinical development, in the area of biomedical science with emphasis on (xeno)transplantation. In 2006 he was appointed Professor of Surgery to support preclinical studies at the University of Minnesota, USA. The focus of his work during these decades in his career was on translational research, and this gradually included also business and regulatory affairs. Dr Schuurman has widely published in the field of (medical) immunology, including transplantation biology, immunodeficiency, immunopathology and immunotoxicology, in all these areas with respect to translational medicine and experimental animal modeling. Between 2006 and 2020 he was Associate Editor of the journal ‘Xenotransplantation’. In 2010 Dr Schuurman founded Schubiomed Consultancy, providing consultancy in the biomedical sector, in particular transplantation and xenotransplantation, with focus on advanced nonclinical research in preparation for first-in-man trials, including regulatory aspects and animal modeling (translational value). Henk-Jan brings a broad worldwide expertise in regulatory affairs of xenotransplantation addressing the various approaches with respect to regulation of cells, tissues an organs of xenogeneic origin.

Key publications during the last years:

  • Yamamoto, H Hara, H Iwase, A Jagdale, M H Bikhet1, MA Morsi, YC Huy, Q Nguyen, Z-Y Wang, DJ Anderson, J| Foote, D Ayares, DE Eckhoff, DKC Cooper: The final obstacle to successful pre-clinical xenotransplantation? Xenotransplantation 2020; 27: e12596.
  • H-J Schuurman, K Hoogendoorn: Solid organ xenotransplantation at the interface between research and clinical development: regulatory aspects. Xenotransplantation 2020; 27: e12608.
  • L Scobie, H-J Schuurman (guest editors): Introduction to the theme issue on regulatory aspects of Xenotransplantation. Xenotransplantation 2020; 27: e12620.
  • H-J Schuurman, ML Graham: What is the best way to administer islets in cell therapy for diabetes patients? (Commentary). Int J Surgery 2019: 71: 47-48.
  • H-J Schuurman: Xenotransplantation: Over 25 years of engagement at the interface between academia and industry. In: DKC Cooper, editor, Recollections of pioneers in xenotransplantation research, Chapter 15, pp 289-309. Nova Science Publishers, New York, 2018. ISBN 978-1-53613-946-4 (eBook).
  • H-J Schuurman, L Bühler: Theme issue on Xenotransplantation in Asia (Editorial). Xenotransplantation 2019; 26: e12499.
  • WJ Hawthorne, PJ Cowan, LH Bühler, SYi, R Bottino, RN Pierson III,  C Ahn, A Azimzadeh, E Cozzi, P Gianello, JRT Lakey, M Luo, S Miyagawa, MM Mohiuddin, C-G Park, H-J Schuurman, L Scobie, M Sykes, J Tector, RR Tönjes,  E Wolf, JR Nunez, W Wang: Third WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials, Changsha, Hunan, China, December 12-14, 2018. Xenotransplantation 2019; 26: e12513.
  • T Yamamoto, H Hara, J Foote, L Wang, Q Li, EC Klein, H-J Schuurman, H Zhou, J Li, AJ Tector, Z Zhang, M Ezzelarab, R Lovingood, D Ayares, DE Eckhoff, DKC Cooper, H Iwase: Life-supporting kidney xenotransplantation from genetically-engineered pigs in baboons: a comparison of two immunosuppressive regimens. Transplantation 2019 ; 103: 2090-2104. doi: 10.1097/TP.0000000000002796.
  • H-J Schuurman: Regulatory aspects of clinical xenotransplantation. Int J Surgery (special issue on Xenotransplantation) 2015; 23: 312-321.
  • ML Graham, H-J Schuurman: Pancreatic islet xenotransplantation. Drug Discov Today: Dis Model 2017, ddmod.2017.11.004.
  • PJK van Meer, ML Graham, H-J Schuurman: The safety, efficacy and regulatory triangle in drug development: impact for animal models and the use of animals. Eur J Pharmacol 2015; 759: 3-13.
  •  Noordergraaf, A Schucker, M Martin, H-J Schuurman, B Ordway, K Cooley, M Sheffler, K Theis, C Armstrong, L Klein, D Hansen, M Olson, L Schlechter, T Spizzo: Pathogen elimination and prevention within a regulated, Designated Pathogen Free, closed pig herd for long-term breeding and production of xenotransplantation materials. Xenotransplantation 2018; 25: e12428.
  • ML Graham, H-J Schuurman: Validity of animal models of type 1 diabetes, and strategies to enhance their utility in translational research. Eur J Pharmacol 2015; 759: 221-230.
  • DKC Cooper, P Cowan, JA Fishman, BJ Hering, M Mohiuddin, RN Pierson III, DH Sachs, H-J Schuurman, AJ Tector, RR Tönjes: Joint FDA-IXA Symposium, September 20, 2017. Xenotransplantation 2017; 24: e12365.

Presentations by Henk-Jan Schuurman