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Market Approval

profile of Henk Schuring

Henk Schuring

Sanofi Genzyme

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Company: Sanofi Genzyme

Function: VP-Head Rare Nephrology

Henk Schuring is a pharmacist with over 25 years’ experience in the pharmaceutical industry for both medicinal products and medical devices. He is a results oriented rare disease leader and a creative strategic thinker. Henk has been working in industry at various positions in Quality Assurance, Regulatory Affairs and Commercial at both European and global level,

In March 1999, Henk Schuring joined Genzyme in regulatory affairs. His last position was Head of regulatory Strategy for EMEA (Europe, Middle East, Africa) and JAPAC (Japan and Asia-Pacific).

In Nov 2014, Henk became VP-Head rare Neurology at Sanofi Genzyme and responsible for the area of rare neurology, including the Pompe franchise. In Jan 2017, he took responsibility for rare Nephrology as VP- Head of Rare Nephrological diseases, including Fabry franchise. In this role he is responsible for the global strategy for commercial products as well as for developing a strategy for the disease area. This role oversees as global lead the marketing and commercial support for commercialized products in the rare disease area in close collaboration with regions and countries.

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Market Approval

profile of Sjaak Bot

Sjaak Bot

Janssen

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Company: Janssen

Function: VP, Head of EMEA Regulatory Affairs

Sjaak is a member of the GRA Regional Regulatory Affairs Management Team as well as the Janssen EMEA Leadership Team.

He is responsible for building and leading an integrated EMEA regulatory affairs organization covering all therapeutic areas as well as all operating company regulatory teams in the Janssen EMEA organization. Sjaak drives the long-term growth strategy and vision for regulatory affairs in EMEA, including providing strategic input into product-related activities, both development and lifecycle management, as well as the engagement of Health Authorities through networking and active participation in trade association activities. Sjaak serves as a Board Member for Janssen Biologics BV (JBV) and Chairman of the JBV “Marketing Authorization Holder and Sponsor’ Committee.

Since 2009, he served as Vice President EMEA Regulatory Affair for the Immunology Therapeutic Area and lead activities in all regulatory aspects and early and late development products in the immunology profile. In addition, he led the operating company regulatory organizations in the EEA region, where he successfully implemented a platform for knowledge-sharing, harmonization, improved compliance and better efficiency.

Sjaak joined Johnson and Johnson in 2002, and prior to that, he held leadership positions in regulatory affairs, quality and reimbursement in Yamanouchi Europe and Sanofi, the Netherlands. Sjaak has a Pharmacist Degree from the University of Leiden, the Netherlands.

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Market Approval

profile of Bernd van der Meulen

Bernd van der Meulen

European Institute for Food Law / Renmin University of China Law School

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Company: European Institute for Food Law / Renmin University of China Law School

Function: Professor of Comparative Food Law

Bernd van der Meulen is a lawyer by training. From 2001 onwards, he fully focussed on the food sector, making mayor contributions through research, teaching and publication to the development of Food Law as an academic discipline in its own right.

He works both as academic and as private consultant. See www.BerndvanderMeulen.eu

He is director of the European Institute for Food Law. See www.food-law.nl

In 2018 he was appointed through the Program of Top-level Foreign Experts of the State Administration of Foreign Experts Affairs of the People’s Republic of China, Professor of Comparative Food Law at Renmin University of China Law School in Beijing.

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Intellectual Property

profile of Frank Landolt

Frank Landolt

Ablynx N.V.

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Company: Ablynx N.V.

Function: V.P. intellectual property and legal

Frank Landolt is a Dutch and European patent attorney and transactional lawyer who joined Ablynx in 2004. Frank started his career in private practice in the Netherlands, where his clients included major pharmaceutical companies, as well as some of the top biotech companies and research institutions in the Netherlands. From 2000-2004, he was Director of IP and Legal at Devgen, another Belgian biotech company. Frank holds degrees in chemistry (Leiden University), civil law (Leiden University) and business law (University of Antwerp).

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Clinical Development

profile of Erik Niks

Erik Niks

Leiden University Medical Center

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Company: Leiden University Medical Center

Function: Neurologist - Pediatric neurologist

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Clinical Development

profile of Piet Hinoul

Piet Hinoul

J&J Ethicon

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Company: J&J Ethicon

Function: Global Head, Pre-Clinical, Clinical and Medical Affairs

Piet joined J&J in 2008, after 15 years of clinical practice, as the medical director for Ethicon Women’s Health and Urology for EMEA. Since then he has successfully contributed to the product development, evidence generation and commercial launches of dozens of devices across all the Ethicon platforms.

Piet earned his MD degree from the University of Leuven and his PhD in Biomedical Sciences from the University of Amsterdam. He is a European Board-certified Gynecologist having trained in the UK and Belgium. He was division chief of urogynecology at the teaching hospital of Genk, Belgium. Piet served as President of the Flemish Society of Obstetricians and Gynecologists in 2007 and 2008. He published extensively on various topics of pelvic floor surgery, and has lectured internationally on them.

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Clinical Development

profile of Ad Sitsen

Ad Sitsen

ClinPharMed Consultancy for Drug Development

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Company: ClinPharMed Consultancy for Drug Development

Function: Owner

Prof. Dr J.M. Ad Sitsen completed his pharmaceutical studies at the State University of Utrecht in The Netherlands in March 1970 and obtained a Ph.D. in medicinal chemistry two years later. After having fulfilled his compulsory military service with the Royal Dutch Navy he began his medical studies in 1974, which he completed in 1980. He then specialized in pharmacology at the Rudolf Magnus Institute of the Medical Faculty of the University of Utrecht and subsequently trained for two years in internal medicine at the Academic Hospital of the same Medical Faculty.
In 1984 he joined N.V. Organon, a business unit of Akzo Nobel, and has been involved in the clinical development of Remeron® from the beginning and also many other compounds. He retired in 2004 and now acts as a consultant to pharmaceutical companies.
He was a member of the Dutch Health Council and a (part-time) professor of clinical pharmacology at the Medical Faculty of the Utrecht University, Utrecht, The Netherlands.

He has published approximately 100 research articles and reports and was editor of volume 6 of the Handbook of Sexology: The Pharmacology and Endocrinology of Sexual Function (Amsterdam:Elsevier, 1988). He is co-editor of the Handbook of Anxiety and Depression: A biological Approach (New York: Marcel Dekker, 1994) and editor-in-chief of the major Dutch language textbook of pharmacology.

Specialties: assessment of toxicological data, design of first time in man studies, clinical pharmacology, drug development, medical writing

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Clinical Development

profile of Wim Parys

Wim Parys

Janssen Pharmaceutica

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Company: Janssen Pharmaceutica

Function: Head of R&D Global Public Health

Wim Parys obtained a MD degree from the Katholieke Universiteit Leuven, Belgium. He was in private practice for 9 years before joining the Janssen Research Foundation in Beerse, Belgium where he held several R&D positions and developed Galantamine for Alzheimer’s Disease (marketed as Reminyl™ / Razadyne™ by Johnson&Johnson).

In 2000 he became the Head of Development at the biotech company Tibotec and relocated to the US to establish Tibotec Inc., the US based subsidiary. Under his tenure, Tibotec (then acquired by J&J) developed and launched Prezista™, Intelence™ and Edurant™, three innovative HIV drugs.

As Development Head of Janssen’s Infectious Diseases and Vaccines therapeutic area, he lead the discovery and development of other medicines for HIV, Hepatitis C (Incivo™, Simeprevir (Olysio™), MDR-TB (Sirturo™) and respiratory viral diseases.
In 2013 he became the R&D head of the newly established Global Public Health group at Janssen which focusses on research and development in the field of HIV, MDR-TB and Neglected Tropical Diseases, Malaria and Dengue.

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Market Approval

profile of Eline Bunnik

Eline Bunnik

Erasmus MC

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Company: Erasmus MC

Function: Assistant professor Medical Ethics and Philosophy of Medicine

Eline Bunnik is an assistant professor at the Department of Medical Ethics and Philosophy of Medicine at Erasmus MC in Rotterdam. Her research interests include ethical issues in genetics and genomics, predictive medicine, and epigenetics, prenatal screening, research ethics, including informed consent and the handling of incidental findings, the use of biomarkers in research and clinical care, and early access to investigational drugs. Eline leads several research projects within the context of research grants she obtained from ZonMw, NWO (Maatschappelijk Verantwoord Innoveren (MVI)), BBMRI-NL and Erasmus MC. Also, she is involved as an ethics adviser and researcher in European research projects funded through IMI-EPFIA, H2020 and COST. Eline teaches medical ethics and research ethics at undergraduate, graduate and post-graduate levels at Erasmus MC and elsewhere. She is a member of the medical research ethics committee (METC), the committee for incidental findings at Erasmus MC, the Working Group for Ethical and Legal Issues of the Vereniging Klinisch Genetici Nederland (VKGN), and the ZonMw-funded ELSI Servicedesk and ELSI Personalised Medicine research consortium.

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Intellectual Property

profile of Maurits Westerik

Maurits Westerik

Bird & Bird

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Company: Bird & Bird

Function: Senior Counsel

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Intellectual Property

profile of Andrea Kamage

Andrea Kamage

Johnson & Johnson

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Company: Johnson & Johnson

Function: Patent Group Leader

Andrea Kamage is a licensed United States patent attorney with over 20 years of experience in the field of Intellectual Property. She is currently Patent Group Leader, Johnson & Johnson, where she supports the J&J vaccine businesses and small molecule and biologic therapeutics.  Her practice includes all aspects of intellectual property such as patent prosecution, due diligence, transactions, and patent litigation support. She has over a decade of experience in private practice, where she concentrated on pharmaceutical and biotechnology related patent prosecution, opinions and pharmaceutical patent ligation.

She received her JD from Georgetown University Law Center, her M.S. from The George Washington University and her B.S. from Marywood College.

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Intellectual Property

profile of Bart Swinkels

Bart Swinkels

NLO

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Company: NLO

Function: Partner

Bart Swinkels has 24 years of experience in life science patenting. As a Dutch and European patent attorney and partner at NLO (European Patent and Trademark Attorneys) he specializes in drafting and prosecuting complex patent applications in all areas of biotechnology, including molecular biology, genomics, immunology, gene therapy, antibodies, drug targeting, metabolic engineering, bioinformatics, microbiology, and classical and molecular plant genetics. Bart advises biotech firms on their IP strategy and is also frequently engaged in biotech patent litigation.

Bart holds a MSc in (bio)chemistry (cum laude, 1985) and a PhD in molecular biology under Prof. Piet Borst, from the University of Amsterdam (1989). Prior to joining NLO in 2000 he headed the IP department of the Pharming Group in Leiden (Netherlands) and he has worked as a European patent attorney with DSM/Gist-brocades in Delft (Netherlands). Previously he also worked as a molecular biologist in both academic and industrial research settings at Gist-brocades, the University of California at San Diego and the Netherlands Cancer Institute.

In addition, Bart is the Dutch representative in the Biotech Committee of the Institute of Professional Representatives before the European Patent Office (EPI).

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Intellectual Property

profile of Karin Verzijden

Karin Verzijden

Axon Lawyers

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Company: Axon Lawyers

Function: Food and Pharma Lawyer

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.

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Market Approval

profile of Ineke Jonker-Hoogerkamp

Ineke Jonker-Hoogerkamp

Eagle Pharma Consult

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Company: Eagle Pharma Consult

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.

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Intellectual Property

profile of Kees Recourt

Kees Recourt

Mibiton Foundation

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Company: Mibiton Foundation

Function: Investment Manager

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.

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Clinical Development

profile of Paul Stoffels

Paul Stoffels

Johnson & Johnson

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Company: Johnson & Johnson

Function: Chief scientific officer

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.

Source website Johnson & Johnson

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Clinical Development

profile of Tom Huizinga

Tom Huizinga

Leiden University Medical Centre

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Company: Leiden University Medical Centre

Function: Head of the Department of Rheumatology

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.

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Clinical Development

profile of Marcel Kenter

Marcel Kenter

Paul Janssen Futurelab Leiden

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Company: Paul Janssen Futurelab Leiden

Function: Director

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.

 

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Clinical Development

profile of Koen Andries

Koen Andries

Janssen Pharmaceutica NV

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Company: Janssen Pharmaceutica NV

Function: VP Scientific Fellow Infectious Diseases Discovery

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.

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Clinical Development

profile of Andreas Wallnöfer

Andreas Wallnöfer

BioMed Partners Venture Capital (former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd.)

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Company: BioMed Partners Venture Capital (former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd.)

Function: General Partner

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Clinical Development

profile of Justin Hay

Justin Hay

Medicines and Healthcare products Regulatory Agency

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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).

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Clinical Development

profile of André Elferink

André Elferink

Dutch Medicines Evaluation Board

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Company: Dutch Medicines Evaluation Board

Function: Clinical epidemiologist

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.

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Clinical Development

profile of Rob Zuiker

Rob Zuiker

CHDR

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Company: CHDR

Function: Senior Clinical Scientist

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.

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Clinical Development

profile of Barbara J. van Zwieten-Boot

Barbara J. van Zwieten-Boot

Medicines Evaluation Board, The Netherlands

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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.

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Clinical Development

profile of Hans-Georg Eichler

Hans-Georg Eichler

European Medicines Agency

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Company: European Medicines Agency

Function: Senior Medical Officer

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Clinical Development

profile of Robert Klautz

Robert Klautz

Leiden University Medical Centre

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Company: Leiden University Medical Centre

Function: Thoracic Surgeon

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.

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Clinical Development

profile of Matthijs Moerland

Matthijs Moerland

CHDR

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Company: CHDR

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.

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Clinical Development

profile of Joris Rotmans, MD, PhD

Joris Rotmans, MD, PhD

LUMC

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Company: LUMC

Function: internist-nephrologist

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.

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Clinical Development

profile of Janneke Meulenberg

Janneke Meulenberg

Arthrogen

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Company: Arthrogen

Function: CEO

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.

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Clinical Development

profile of Inge de Lepeleire

Inge de Lepeleire

MSD Europe

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Company: MSD Europe

Function: Director Translational Pharmacology

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Clinical Development

profile of Koos Burggraaf

Koos Burggraaf

CHDR

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Company: CHDR

Function: Research Director CVS & Metabolism

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.

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Clinical Development

profile of Johan Garssen

Johan Garssen

Danone/Nutricia Research

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Company: Danone/Nutricia Research

Function: Director Immunology Platform

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Clinical Development

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Ingrid de Visser

CHDR

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On-campus

Company: CHDR

Function: Senior Clinical Scientist

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.

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Clinical Development

profile of Rick Kuntz

Rick Kuntz

Medtronic

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Company: Medtronic

Function: Senior Vice President and Chief Scientific, Clinical and Regulatory Officer

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Clinical Development

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Geert Jan Groeneveld

CHDR

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On-campus

Company: CHDR

Function: Research Director CNS

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.

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Clinical Development

profile of Oliver Bisazza

Oliver Bisazza

Medtronic

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Company: Medtronic

Function: Director Regulatory Policy

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Clinical Development

profile of Saco de Visser

Saco de Visser

Paul Janssen Futurelab Leiden

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Company: Paul Janssen Futurelab Leiden

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.

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Clinical Development

profile of Adam Cohen

Adam Cohen

Centre for Human Drug Research

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On-campus

Company: Centre for Human Drug Research

Function: CEO and clinical pharmacologist

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.

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Clinical Development

profile of Richard Shull

Richard Shull

Shell

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Company: Shell

Function: Head of Deal Structuring and Trading Fundamentals

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Clinical Development

profile of Pierre Peeters

Pierre Peeters

Organon

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Company: Organon

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.

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