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

has more than 25 years of
experience in drug development and regulatory strategy. She is a former regulator at the Paul-Ehrlich-Institute in Germany, a consultant, and most recently, an entrepreneur, having founded the internet platform, Pharmatching.com, for companies seeking to outsource projects relating to drug development. Dr Dallmann has developed a training course on biopharmaceutical regulatory affairs and consults on these products. She is a biologist with a Ph.D. in immunology from Berlin University and currently a lecturer on biopharmaceuticals at Freiburg University in 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 and consultant at the Netherlands-based firm, Lisman Legal Life sciences BV, a law, consultancy and training practice focusing on innovation in the pharmaceutical, biotechnology and medical device industries.

Trained as a pharmacist, Mr Lisman practises law and consultancy from a scientific angle. He was previously a policy advisor and legal counsel to the Dutch Medicines Evaluation Board and to the Ministry of Health.

He has also been a member of the pharmaceutical committee of the European Union, the management board of the European Medicines Agency and a member of the European Commission’s main advisory committee for medicinal products for human use. Mr Lisman received his masters’ degree in pharmaceutical science from Utrecht University in 1985 and his law degree from the same university in 1988. He trained as a lawyer at the international law firm, NautaDutilh.

Professor Chris Mason

is Professor of Regenerative Medicine Bioprocessing at University College London in London, UK.

Prof Mason has a Clinical Sciences degree from Imperial College in London, a Medical Degree from St. Thomas’s Hospital and a PhD in tissue-engineering from University College London.

He is a Fellow of the Royal College of Surgeons. He also leads the Regenerative Medicine Bioprocessing Group in the Advanced Centre for Biochemical Engineering at University College London and is also Senior Editor of the journal, Regenerative Medicine.

Prof Mason is co-founder and Director of the London Regenerative Medicine Network and is on the founding Steering Committee for the UK National Stem Cell Network.

Dr Jean-Claude Muller

is a special advisor to a number of international institutions having recently been a senior vice president in research and development at Sanofi-Aventis. During his 25 years at the French multinational, Dr Muller was in charge of establishing long-term strategic corporate opportunities and identifying and assessing potential break-through technologies. In 2009 he was the chief architect of Sanofi-Aventis’ research and development vision for the period to 2015 and in 2007, he was architect of the company’s research and development initiative in China. In recent years, he was instrumental in establishing alliances between Sanofi-Aventis and a number of research-intensive companies including Regeneron and Human Genome Science in the US, Mitsubishi and Tanabe in Japan, Oxford Biomedica in the UK and Genfit in France.

From 1983 to 1994, Dr Muller was a scientist-in-charge in cardiovascular programmes at Synthélabo in Paris, France and a research fellow and later project leader, from 1974 to 1982, at  Roche in Basle, Switzerland and Nutley, New Jersey, US.

Dr Muller is currently a board member of the University René Descartes, Paris and of the Deniker Foundation, Paris. He was the founder and president, from 2005 until 2009, of the Pôle de Compétitivité Medicen, the Paris Biomedical Sciences Cluster. From 1996 until 1998 he was chairman of the European Federation of Medicinal Chemistry.

Dr Muller holds a PhD in chemistry from the University of Strasbourg, France and was a post-doctoral fellow with Professor Jean-Marie Lehn, Nobel Laureate in 1987. He is based in Paris, France.

Dr John Purves

Dr John Purves is a life science consultant having recently retired from the European Medicines Agency where he worked for 14 years, first as head of the biotechnology and biological products sector and most recently, as head of the sector for the quality of medicines. He was involved in many areas dealing with biological medicinal products, including biosimilar, influenza and advanced therapy products. Prior to joining the EMA, Dr Purves was manager of the biotechnology and biological unit at the UK Medicines Control Agency, now the Medicines and Healthcare products Regulatory Agency. At the UK agency, he was involved in the drafting of a number of European Union guidelines including those on the manufacture and control of recombinant-DNA products and products derived from human blood and plasma. Dr Purves also oversaw efforts to minimise the risk of the transmission of spongiform encephalopathies to humans through medicinal products.

Dr Purves graduated in pharmacy from the Heriot Watt University in Edinburgh in 1968 and received his doctorate in pharmaceutical microbiology from the University of Strathclyde in 1973. Following university, he worked in research and development at Smith and Nephew Ltd in the UK.