Karin is a food and pharma lawyer and assists food business operators, biotech companies, and manufacturers of pharmaceuticals with bringing innovative products to the market. In particular, Karin helps concluding various commercial and R&D driven (licensing) transactions. She thereby applies her specific legal and business expertise on food and pharma, including clinical trials, medical foods, Novel Foods, and food supplements. In this framework, Karin also advises on the use of nutrition and health claims in relation to food products and how to avoid using medical claims. She represents clients both in civil proceedings and before the Advertising Code Committee – a self-regulatory body competent to hear claims on food and consumer products. Karin reports current food law developments on the blog www.foodhealthlegal.com.
Function: Consultant Regulatory Affairs and Drug Development
Ineke Jonker-Hoogerkamp graduated in pharmacy at the University of Utrecht, the Netherlands followed by a PhD in pharmacokinetics at Leiden University. She has over 25 years of experience in regulatory affairs including substantial experience in the regulatory aspects of global drug development, market approval and regulatory compliance of human medicinal products and medical devices. Ineke hold senior regulatory positions in Organon and Genzyme. She worked for over 10 years as director of the Regulatory Affairs division of the consultancy company Xendo providing advice and hands-on services with her group of 20 RA consultants. Currently Ineke works as independent consultant in regulatory affairs and drug development.
Kees joined the Mibiton Foundation in 2004, a specialized fund which invested about €30 million in the innovative Dutch Life Sciences infrastructure. He holds a BSc in Electrical Engineering, a PhD in Molecular Biology (Leiden University, 1991) and learned the investment principles at the Private Equity training of the NVP (Amsterdam, 2001). During his research career in Wageningen, the Netherlands, he specialized in the molecular quality of food products and worked for various food companies. In 1999, he shifted towards the commercialization of technology at Licentec, a former company of ABN-AMRO and NPM Capital (Bilthoven). During this period, he was CEO of an Academic Medical Center start-up company, developing a bio-artificial liver device.
Since 2005, Kees represents Mibiton as a board member of BioConnection BV, a commercial pharmaceutical GMP facility at the Pivot Park (Oss, the Netherlands). In addition, he is chairman of the ‘Take-off’ Life Sciences PreSeed fund, an initiative of the Netherlands Organisation for Scientific Research (NWO) and the Dutch Ministry of Economic Affairs. Kees is part time employed at the PaulJanssen Futurelab Leiden and is currently developing the Intellectual Property and Financial modules.
As Executive Vice President, Chief Scientific Officer, Johnson & Johnson, Paul Stoffels works with leaders across the organization to set the company-wide innovation agenda. He is a member of the Johnson & Johnson Executive Committee and chairs the Johnson & Johnson R&D Management Committee.
Paul spearheads the Johnson & Johnson innovation pipeline by leading teams across the pharmaceutical, medical devices and consumer segments to discover and develop transformational healthcare solutions. He also steers Johnson & Johnson’s global public health strategy to make innovative medicines and technologies accessible in resource-poor settings.
Paul’s visionary leadership was instrumental in the launch of Johnson & Johnson Innovation in 2013, which he now leads to fuel innovative science and technology through strategic partnerships, licensing and acquisitions. Paul also oversees JJDC, the oldest corporate venture fund in the life science industry.
In addition, Paul has responsibility for safety of all products of the Johnson & Johnson Family of Companies worldwide.
Previously, in his role as Worldwide Chairman, Pharmaceuticals, Paul was responsible for advancing the therapeutic pipeline of Janssen Pharmaceutical Companies of Johnson & Johnson. Under his leadership, Janssen rejuvenated its therapeutic pipeline, launching multiple new medicines and bringing years of life and quality of life to people all over the world.
Prior to this, Paul held various R&D leadership roles within the pharmaceutical sector of Johnson & Johnson. He joined Johnson & Johnson in 2002 with the acquisition of Virco and Tibotec, where he was Chief Executive Officer of Virco and as Chairman of Tibotec, and led the development of a number of breakthrough products for the treatment of HIV.
Paul studied Medicine at the University of Diepenbeek and the University of Antwerp in Belgium and Infectious Diseases and Tropical Medicine at the Institute of Tropical Medicine in Antwerp, Belgium. He began his career as a physician in Africa, focusing on HIV and tropical diseases research.
Professor Tom Huizinga is Head of the Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands. Having graduated from the University of Amsterdam Medical School in 1986, Professor Huizinga went on to write his thesis, Neutrophil Fc-gamma receptors (cum laude). Following this, he studied at Dartmouth Medical School, New Hampshire, USA before returning to the Netherlands to train in internal medicine/rheumatology. This including 3 years spent at the Department of Rheumatology, Academic Hospital Leiden. Professor Huizinga qualified as an immunologist in 1991 and as a rheumatologist in 1997.
In 1997, Professor Huizinga took up the position of Rheumatologist at the Leiden University Hospital, becoming Associate Professor of Rheumatology at Leiden University in 1997 and Professor of Rheumatology at Leiden University Medical Centre in 2000. In 2006, Professor Huizinga became Head of the Department of Rheumatology at Leiden University Medical Centre.
Professor Huizinga was a member of the Annual Meeting Planning Committee of the American College of Rheumatology from 2000 to 2003, and the Annual Meeting Planning Committee of the EULAR from 2004 to 2007. In 2006, he was appointed as a member of the Henry Kunkel Society, New York. In 2005/6 he served a member of the “Verkenningscommissie Multifactoriele Aandoeningen in het Genomics Tijdperk” of the Royal Dutch Academy of Sciences.
Professor Huizinga has won various prizes throughout his academic career and has published over 400 peer-reviewed papers in the national and international literature. He is member of the editorial boards of Plos Medicine, Annals of Rheumatic Diseases, Arthritis and Rheumatism, Current Rheumatology Reviews Genes and Immunity, International Journal of Advances in Rheumatology, Joint Bone Spine Revue du Rheumatism International Edition, Current Rheumatology Reviews, Clinical and Experimental Rheumatology.
Marcel Kenter studied molecular biology at Leiden University and obtained his PhD degree for his work on the genetics of the primate Major Histocompatibility Complex (Mhc) in the immunology department of Prof Johannes van Rood (Leiden University Medical Center (LUMC), the Netherlands). He continued his post-doctoral work on virology at the department of Prof. Ab Osterhaus (Erasmus Medical Center, the Netherlands) and on gene therapy at the Daniel den Hoed Cancer Center. In 1999, he became the first executive director of the Central Committee Involving Human Subjects (CCMO); the competent authority for clinical trials with medicinal products in the Netherlands. He has been director of Paul Janssen Futurelab Leiden since 2015.
Dr Koen Andries (1951) studied Veterinary Sciences and obtained his PhD at the University of Ghent, Belgium. He joined the team of Dr. Paul Janssen in 1982. Using cell-based assays in search of antiviral compounds, his team discovered nanomolar inhibitors of uncoating of rhinoviruses, picomolar inhibitors of fusion of respiratory syncytial virus and several non-nucleoside reverse transcriptase inhibitors of HIV (TIBO’s, alpha-APA’s, and DAPY’s) with high activity against wild-type and resistant HIV-1 strains. Two of these became approved drugs: etravirine – intelence® and rilpivir – edurant®, and a third one is being developed as a microbicide in a vaginal ring to prevent HIV infection (dapivirine).
Dr Andries also led the team that discovered R207910/TMC207 (bedaquiline – sirturo®), a first in-class new anti-tuberculosis drug, and its unique mechanism of action. Bedaquiline is the first molecule with specific activity against the ATP synthase, one of the most fundamental enzymes in biology, and the first antibiotic known to interfere with the generation of energy. He grandfathered bedaquiline from discovery to early development and eventually full development as the microbiology leader. He authors 173 papers, 179 abstracts and 32 patents, and is Professor emeritus at the University of Antwerp.
Company: Medicines and Healthcare products Regulatory Agency
Function: Pharmacokinetics Assessor
Justin Hay (1980) completed his BSc (Biomedical Science) with majors in Pharmacology, Microbiology & Immunology (2001) and graduated with First Class Honours (2002). In 2007 he was conferred his PhD in Medicine (Pharmacology) from the University of Adelaide, Australia. His thesis investigated the pain sensitivity of chronic opioid users and explored novel pharmacological analgesic strategies for these patients. From March 2007, Justin was in the position of Senior Clinical Scientist at CHDR, where he investigated how biomarkers of the central nervous system could be used as a screening tool in early drug development, with a particular interest in analgesics and pain models. In 2011 he was awarded his Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and in 2014 was awarded the Graduate Certificate (with distinction) in Clinical Pharmacology from King’s College London. In October 2015 he started as Pharmacokinetics Assessor for the MHRA and is a member of the EMA’s Modelling and Simulation Working Group (MSWG).
I am a physician with a neurological and methodological background (clinical epidemiologist). Since 1992 I work as a senior clinical assessor at the Dutch Medicines Evaluation Board. As a clinical assessor I advice the Dutch Medicines Evaluation Board and the European Committee for Proprietary Medicinal Products whether a medicinal agent may be approved for a claimed indication and if so, under which conditions. The MEB I started as a generalist but may main field of interest is neurology. In this context I am member of the CNS-Working party involved in setting up regulatory Scientific Guidelines. Within the neurology my special fields of interest are Multiple sclerosis, Parkinson’s Disease and Epilepsy. As generalist I became member of the Scientific Advice Working party in 2012.
Rob Zuiker (1968) studied medicine at the University of Amsterdam. He was employed as a physician at the Royal Dutch Navy until 2000. After obtaining a master degree in Business Administration at the Nyenrode University Breukelen, he worked as a medical advisor for Eli Lilly Netherlands. From 2007 Rob joined CHDR as a clinical research physician and has since been working on a wide range of projects. His main field of expertise is on biomarker development as a screening tool for early drug development in asthma and the central nervous system. He is registered as a clinical pharmacologist since 2012, and from 2013 onward he holds a position of senior clinical scientist in the central nervous system research group.
Company: Medicines Evaluation Board, The Netherlands
Function: Vice Chair
Between 2001 and 2013 she was member of the CHMP. During that time she was chair of the Efficacy Working Party, involved in Scientific Advice at EMA and she took part in ICH activities.
Barbara van Zwieten has a master degree in (bio)chemistry and a PhD in pharmacology from the State University of Leiden, The Netherlands
She has seven years experience as an advisor and head of the regulatory department of the Dutch subsidiary of Rhône-Poulenc. She then joined the Medicines Evaluation Board, where she first worked as a clinical assessor and later as head of the section, dealing among others with CNS products.
Barbara van Zwieten has a broad experience in methodology of clinical trials, especially for regulatory purposes and has given numerous lectures in the area of drug development.
Prof Klautz did his medical training at the University of Leiden Medical School. After medical school he spent two years as a research fellow at the Cardiovascular Research Institute of UC San Francisco from 1991-1993, after which he did his PhD in Leiden on Cardiac Mechanics, specifically in single ventricle hearts. He did his Surgical training at the Erasmus Medical Center in Rotterdam. In 2002 he returned to Leiden as a staff surgeon at the department of Cardiothoracic Surgery, where he became chair of the department in 2008. His main clinical and research interests are in mitral and aortic valve reconstruction, alternative surgical strategies in heart failure treatment, and ischemia-reperfusion injury. He is a Council Member of EACTS, and an active member in the “acquired cardiac disease domain” committee, member of the STS, the AATS and of several national organizations.
Function: Research Director Translational Biomarkers
Matthijs Moerland (1980) studied Biomedical Sciences at Leiden University. He was trained in vascular biology at the department of Cell Biology of Erasmus University Rotterdam (2002-2006, Prof F.G. Grosveld), where he obtained his PhD investigating lipoprotein metabolism and atherogenesis in humanized animal models. In 2007 he joined CHDR as senior clinical scientist in the Vascular Medicine research group, focusing on the integration of immunology, endocrinology and endovascular reactivity in translational medicine. From 2014 onwards, Matthijs Moerland is heading a separate research area, entitled Translational Biomarkers, which comprises the selection, qualification and implementation of non-routine biomarkers in drug development.
Dr. Joris Rotmans is an internist-nephrologist and associate professor at the Department of Nephrology of the Leiden University Medical Center (LUMC) in the Netherlands. He received his PhD in 2005 at University of Amsterdam on new therapeutic strategies for vascular access for hemodialysis. In 2008-2009, he did postdoctoral research on vascular tissue engineering at the Australian Institute of Bioengineering and Nanotechnology in Brisbane, Australia. Since 2010, he combines clinical work as internist-nephrologist with vascular and renal research at the Department of Nephrology of the LUMC. His main focus of research is vascular access for hemodialysis. He was the principle investigator of the DialysisXS consortium in which a novel method to generate in vivo engineered blood vessels was developed. He received the first prize at the Investors forum of the Dutch LifeScience Conference in 2013. In 2014, he received a prestigious VIDI grant from NWO that allows him to expand his research group and to continue his research on vascular tissue engineering.
Janneke Meulenberg has over 25 years of experience in the Biopharmaceutical industry. She graduated cum laude from the University of Groningen, received a PhD in Biochemistry from the University of Amsterdam and holds an MBA from RSM Erasmus University. Janneke Meulenberg started her career in industry at ID-Lelystad, where she headed a world leading R&D team developing veterinary vaccines in collaboration with Boehringer Ingelheim. She joined the management team of Amsterdam Molecular Therapeutics (now UniQure) in 2000, where she was responsible for developing Glybera® from research to registration studies. Glybera® is the first gene therapy that has received market approval in the Western World. Between 2008 and 2015, Janneke Meulenberg was CEO of ORCA Therapeutics B.V., a biopharmaceutical company developing innovative oncolytic adenoviruses and sinds 2015 she is CEO of ViciniVax BV, a company developing immunotherapeutic cancer vaccines. In 2015, Janneke Meulenberg was appointed COO of gene therapy company Arthrogen BV. She is author of numerous peer-reviewed publications, book chapters, and inventor on several patents.
Koos (Jacobus) Burggraaf (1959) graduated in BioPharmaceutical Sciences (MSc) and Medicine (MSc) at Leiden University with a specialization in clinical pharmacology and qualified cum laude as an MD at Leiden University. Since 1990 he has held several positions at the Centre for Human Drug Research where he also obtained his PhD. He is professor ‘Translational Drug Development’ at the Leiden Academic Center for Drug Research. He is a board certified clinical pharmacologist and has held clinical attachments at several hospitals mainly in internal medicine since 1997. He is a full member of several (inter)national societies on clinical pharmacology and member of the board of the Dutch Association of Clinical Pharmacology. He is a member of the Leiden educational team for clinical pharmacologists and actively involved in the training of PhD students. He has published over 125 manuscripts in peer-reviewed journals. His main focus of interest has been on early drug development (phase I/II), with special emphasis on biologicals, including method development (in particular in cardiovascular medicine, endocrinology, endothelial function, immuno-inflammation, gastrointestinal function), and pediatric drug research.
Ingrid de Visser – Kamerling (1975) graduated in Medical Biology from Leiden University in 1998. She subsequently worked at the Centre for Human Drug Research as project leader and PhD student. She obtained a PhD degree from Leiden University (2003) and became registered clinical pharmacologist (2005). From 2004 – 2007 she worked as policy coordinator at the research department of the Netherlands Heart Foundation. In 2007 she returned at CHDR as interim manager of education until 2008. From 2008 onward she holds a position of senior clinical scientist in the field of immunology and cardiovascular research. She is also the secretary of CHDR’s Scientific Advisory Board.
Geert Jan Groeneveld was trained as a Neurologist at the University Medical Center Utrecht and performed his PhD on the subject: “New pharmacotherapeutic treatment strategies for Amyotrophic Lateral Sclerosis”. Before joining CHDR, Geert Jan worked on enzyme replacement therapy for Pompe Disease and on a gene therapy project for Parkinson’s Disease at biotechnology company Genzyme. Since 2009 he is Research Director at the Centre for Human Drug Research (CHDR) in Leiden, and is responsible for research in the areas of neurology and pain. He is also a staff-member at the department of Neurology of VU University Medical Center, Amsterdam, where he performs clinical work as a neurologist. His primary scientific interest is in early phase drug development for the treatment of neurodegenerative diseases and neuropathic pain. He has published more than 35 scientific articles and is actively involved in the training of PhD students at CHDR.
Function: Head of Education and Clinical Pharmacologist
Saco de Visser became a registered clinical pharmacologist and obtained his PhD degree from Leiden University in 2003. After two years of business development at the Centre for Human Drug Research (CHDR) in the Netherlands, he worked at the Netherlands Organisation for Health Research and Development (ZonMw) setting up a subsidy programmes for Orphan and Expensive drug outcome research. In addition Saco was Director of Cluster Development at Leiden Bio Science Park and Medical Liaison for pipeline sourcing in North-West Europe at Nycomed (currently Takeda). Since 2016, he combines his position as Programme Officer for Public-private drug research collaboration at ZonMW with his position as Head of Education at Paul Janssen Futurelab Leiden.
Adam Cohen (1952) graduated in Pharmacy and Medicine from Leiden University. He subsequently joined the department of Clinical Pharmacology of the Wellcome Research Laboratories in Beckenham, UK where he obtained experience in early drug development. This work led to a PhD thesis about the development of an antihistamine (acrivastine) and an antiepileptic (lamotrigine). Further training in internal medicine was obtained at King’s College Hospital in London. Phase II-III drug development experience was obtained as European Clinical project leader for t-PA at Wellcome. Since 25 years, he is director of the Centre for Human Drug Research (CHDR). CHDR also play an increasingly prominent role providing consultancy to pharmaceutical industries, with special emphasis on early drug development. He is professor of Clinical Pharmacology at Leiden University and has a clinical attachment at the department of nephrology at Leiden University Medical Centre. He is author of more than two hundred publications about a wide range of clinical pharmacological subjects. He is executive editor of the British Journal of Clinical Pharmacology.
Function: Former site head early stage development
Pierre Peeters is Chief Operations Officer, responsible for all financial and operational activities within CHDR. In addition, Pierre is Research Director for food studies, as well as microdose studies. Pierre has more than 30 years experience in pharmaceutical industry, both at a CRO as well as, in medium/large Pharma (Organon, Merck /MSD) where he was responsible for the study design, conduct and reporting of several hundred early clinical trials and clinical development plans in various indications. Pierre received his degree in Chemistry at the University of Nijmegen and his PhD in Bio Pharmaceutics at Utrecht University. He is a registered Clinical Pharmacologist.