Geoff Kitson has over 27 years experience from the pharmaceutical industry, and a broad-based international perspective on drug development, from phase I to phase IV, experience of pre-clinical work, and regulatory requirements. He has been involved in the preparation of INDs, CTXs/CTAs, MAAs and other regulatory documents. He has experience in the development of individual clinical studies, clinical trial programmes, multinational clinical trials and developing clinical strategies. In the last few years he has taken 5 products including 5 vaccines through to first in man studies, and progressed products through to Phase II/III.
Kim Ry Hejnaes,
Mr. Hejnaes has worked in the biopharmaceutical industry for more than 35 years as a protein chemistry principal scientist, project director, chief operating officer and chief executive officer hereof 20 years with Novo Nordisk and 5 years with CMC Biologics. Kim Hejnaes is the co- founder of L&K Biosciences, SMC Biotech, Hejnaes Consult, help4biotech and invest4biotech and serves as an adjunct professor in Biotechnology at University of Aalborg, Denmark. Since 1998, Kim Hejnaes has focused on outsourcing aspects of Chemistry, Manufacturing and Control (CMC) operations with involvement in a substantial number of international biotech projects over the years.
Dorrit Andersen, Regulatory
Dorrit Andersen has more than 30 years of experience in Regulatory Affairs and has served as Global Regulatory Project Director with Novo Nordisk. Before starting in Regulatory Affairs, Dorrit Andersen worked in quality, analytical development and clinical research. Dorrit Andersen has submitted several INDs and organised a vast number of meetings with regulators, e.g. FDA, EMA and EU national agencies.