MedNous Editorial Board
Dr Chris Bailey
is Director of Development at the UK vaccine company, ImmunoBiology Ltd. Dr Bailey’s current projects involve the application of novel technologies to the development of vaccines against infectious diseases, notably influenza and tuberculosis.During his earlier career at Beecham, Celltech and Medeva, Dr Bailey gained extensive experience in new product development in the areas of vaccines, recombinant DNA products, gene therapies and small molecules, both in Europe and USA.
As one example, he dealt with the scientific and regulatory issues that arose in manufacturing, pre-clinical and clinical areas of viral vaccine development with the successful pan-European approval of Hepacare, a novel Hepatitis B vaccine.
Dr Bailey gained his PhD in microbial genetics at the University of Cambridge. He is based in Cambridge, UK.
Dr Martin Daumer
is Director of the Sylvia Lawry Centre for Multiple Sclerosis Research in Munich, Germany and chief executive officer of the IT company, Trium Analysis Online GmbH. He is also visiting lecturer for Telemedicine and Clinical Applications of Computational Medicine at the Technical University Munich and for Medical Informatics and Statistics/Biometry at the Heinrich-Heine University Düsseldorf.Dr Daumer received a diploma in Physics in 1990 and a Ph.D. in mathematics from the Ludwig-Maximilians-University Munich in 1995, having previously been a visiting researcher at CERN, Switzerland, and Rutgers University, USA.
In 1996 he established the research group, Online Monitoring in Medicine, in cooperation with the Sonderforschungsbereich 386 at the Institute for Medical Statistics and Epidemiology of the Technical University of Munich. In 1999 he founded Trium Analysis Online.
Dr Daumer has published more than 50 articles about topics in quantum physics, scattering theory, probability theory, biosignal processing, validation in biomedical databases, predictive factors and outcome measures in MS clinical trials. He holds patents for methods and devices for change-point detection and internet-based monitoring of biosignals. Several of his inventions have been developed into CE-approved medical products that are used in clinical practice.
Dr Daumer is based in Munich, Germany.
Dr Gabriele Schäffner-Dallmann
is director of biopharmaceuticals on the advisory board of NDA Regulatory Science Ltd. She has more than 20 years ofexperience in the regulation of biological and biotechnological medicinal products and the experimental testing, in particular, of antibody-containing products.
Until 2005, she was in charge of the approval of antibody-containing products at the Paul-Ehrlich-Institute, Germany's federal agency for sera, vaccines and blood products. In this role, she was involved in the European approval of biopharmaceuticals at the European Medicines Agency, acting as Rapporteur.
Dr Dallmann has been a member of the Scientific Advice Working Party, Deputy Member of the EMEA’s Committee for Medicinal Products for Human Use and an expert for CHMP working parties. Dr Dallmann frequently publishes articles and gives talks on issues related to the development and regulation of biopharmaceuticals and advanced therapies.
Before joining NDA Regulatory Science in 2006, she was Principal Consultant at PAREXEL. Dr Dallmann is a biologist with a Ph.D. in immunology from Berlin University. She is based in Freiburg, Germany.
Dr Christopher J. Holloway
is co-founder and currently Chief Scientific Officer and Group Director of regulatory affairs for the ERA Consulting Group.ERA provides regulatory and product development services to biopharmaceutical companies, and has its offices and professional staff in Germany, the UK, Australia and the US.
Prior to co-founding ERA, Dr Holloway was Managing Director of International BioResearch (IBR), and before that he was Professor of Clinical Biochemistry and Physiological Chemistry at Hannover Medical School, where he is still on the teaching faculty.
He holds a BSc in chemistry and a PhD from the University of Surrey, after which he held a Royal Society European Research Fellowship at the Max-Planck-Institute for Biophysical Chemistry in Göttingen, Germany.
John Lisman
is an attorney at the Netherlands-based, international law firm, NautaDutilh. He focuses on issues relating to the marketing authorisation, pricing and reimbursement of medicinal products and medical technology, both nationally and at the level of the European Union.From 1992 until 1999 he was a senior staff member at the Department of Pharmaceutical Affairs in the Ministry of Health and from 1999 until 2007, he was a policy advisor and legal counsel at the Medicines Evaluation Board. During these years, Mr Lisman was a member of the EU Pharmaceutical Committee, the Management Board of the EMEA and the Standing Committee for medicinal products.
He was involved in the drafting of the new EU pharmaceutical legislation which took effect in 2005. Mr Lisman publishes regularly in legal and regulatory journals and frequently gives lectures. He is on the editorial board of the Dutch journal 'Jurisprudentie Geneesmiddelenrecht' (Pharmaceutical Case Law) and of the Regulatory Affairs Journal Pharma. He is also a board member and co-founder of the Dutch Association for Pharmacy and Law and and co-chair and founder of the Legal Affairs Special Interest Area Community of the Drug Information Association.
Mr Lisman received his masters degree in Pharmaceutical Sciences from Utrecht University in 1985. In 1988, he graduated in Dutch Law from the same university. Mr Lisman is based in Amsterdam, the Netherlands.