More info about Ad Sitsen

On-campus

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

More info about Aliki Nichogiannopoulou

Company
European Patent Office

Function
Director

More info about André Elferink

On-campus

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.

More info about Andreas Wallnöfer

On-campus

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

Function
General Partner

More info about Bart Swinkels

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).

More info about Bernd van der Meulen

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.

More info about Bert Leufkens

Company
Utrecht Institute for Pharmaceutical Sciences (UIPS)

Function
Professor of Pharmaceutical Policy and Regulatory Science and Former Chair of Medicines Evaluation Board

Bert Leufkens obtained his PharmD and PhD degree from Utrecht University. From 2003-2005, he was the Scientific Director of the Utrecht Institute for Pharmaceutical Sciences (UIPS), and during 2006-2007 head of the Depart­ment of Pharmaceutical Sciences of the Faculty of Science in Utrecht. Dr Leufkens is research and policy-wise active at several (inter)national platforms on innovation, pharmaceutical policy and regulatory science (e.g. past-member EMA Pharmaco­vigilance Working Party 2005-2009, chair of Dutch Medicines Evaluation Board (MEB) 2007-2017, past- member of the EMA CHMP 2009-2015, past-Pre­si­dent of ISPE, since 2008 Scientific Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation). He is visiting professor at the Faculdade de Farmácia da Universidade de Lisboa and the Copenhagen Centre for Regulatory Science (CORS). He is (co) author of >500 papers in peer reviewed journals, book chapters and research reports.

More info about Bruno Vandermeulen

Company
Independent IP practitioner

Function
IP Lawyer - Member of the Brussels Bar

Bruno is an international IP litigation and transactional specialist with 30 years of experience in major law firms. He founded and managed the Belgian IP practice of the international law firm Bird & Bird during twenty years, where he litigated and negotiated dozens of cross border patent and technology transfer disputes in the sector of Life Sciences, Chemical and Electronics. He is currently an independent IP practitioner working in Brussels.

More info about Eline Bunnik

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.

More info about Erik Niks

On-campus

Company
Leiden University Medical Center

Function
Neurologist - Pediatric neurologist

More info about Frank Landolt

Company
Confo Therapeutics

Function
Chief Counsel Legal & Intellectual Property

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).

More info about Hans-Georg Eichler

Company
European Medicines Agency

Function
Senior Medical Officer

More info about Henk Schuring

Company
Prilenia

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.

More info about Ineke Jonker-Hoogerkamp

On-campus

Company
Paul Janssen Futurelab & 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.

More info about Inge de Lepeleire

Company
MSD Europe

Function
Director Translational Pharmacology

More info about Johan Garssen

Company
Danone/Nutricia Research

Function
Director Immunology Platform

More info about Juliane Bernholz

Company
AM Pharma

Function
Chief Operating Officer

Dr. Juliane Bernholz has over 27 years’ experience working in the pharmaceutical and biotech industry in a variety of senior R&D and business development roles. She joined AM-Pharma as Chief Operating Officer in October 2019.

Prior to joining AM-Pharma Juliane was a Compound Development Team Leader at Janssen R&D LLC in New Jersey, US, where she was responsible for leading the development of a next generation anticoagulant and CRISPR-Cas3 enhanced bacteriophage therapy. Before her time at Janssen, Juliane held a number of international leadership roles in big Pharma and Biotech companies. These included Lead for International Partnering in the Diabetes Division at Sanofi-Aventis in Frankfurt, Germany where she successfully executed a cell therapy and drug discovery collaboration deal. She also served as Senior Global Program Head of the Critical Care Franchise at Novartis Pharma, where she led work on its cystic fibrosis projects. Her prior career included a variety of senior roles at Actelion, Novartis, Ciba and Sandoz.

Juliane holds a PhD in Cell biology from the Biozentrum of the University of Basel, Switzerland.

More info about Karin Verzijden

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.

More info about Kees Recourt

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.

More info about Koen Andries

On-campus

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.

More info about Marc Martens

Company
Bird & Bird

Function
Head of Bird & Bird's Regulatory, Public & Administrative Law group in Brussels

As co-head of our International Life Sciences & Healthcare group and head of Bird & Bird's Regulatory, Public & Administrative Law group in Brussels, I provide cutting edge strategic and regulatory advice to our life sciences clients and represent them in litigation.

More info about Marcel Kenter

On-campus

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.  

More info about Maurits Westerik

Company
Coupry

Function
IE/IT lawyer

More info about Nacer Lounis

On-campus

Company
Janssen Pharmaceutica

Function
Senior Principal Scientist

More info about Oliver Bisazza

Company
Medtronic

Function
Former Director Regulatory Policy

More info about Onno van de Stolpe

Company
Galapagos

Function
Former CEO

Onno van de Stolpe founded Galapagos  in 1999 and has served as Chief Executive Officer and member of the board of directors from 1999 to April 2022. From 1998 to 1999, he was the Managing Director of Genomics at IntroGene BV (later Crucell NV, which was acquired by Johnson & Johnson Services, Inc. in 2011). Prior to joining IntroGene in 1998, he was Managing Director of Molecular Probes Europe BV. He established the European headquarters after joining Molecular Probes, Inc. in the United States. Previously, he worked for The Netherlands Foreign Investment Agency in California, where he was responsible for recruiting biotechnology and medical device companies to locate in the Netherlands. Mr. van de Stolpe started his career as Manager of Business Development at MOGEN International NV in Leiden. He received an MSc degree from Wageningen University. Mr. van de Stolpe has previously served as a member of the board of directors of DCPrime BV and as a member of the supervisory board of the Stichting Institute for Human Organ and Disease Model Technologies.

More info about Paul Stoffels

Company
Galapagos

Function
CEO

Paul Stoffels joined Galapagos as Chief Executive Officer in April 2022, and is an executive member and the Chairman of our Board of Directors since 26 April 2022. He also is a member of the Executive Committee at Galapagos. Prior to that, he was Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson where he set the company’s wide innovation agenda and led its pharmaceutical R&D-pipeline, as well as other external initiatives. Before that, he was worldwide Chairman of Pharmaceuticals of Johnson & Johnson which, under his leadership, significantly rejuvenated its product pipeline and adopted a transformational R&D-operating model, which resulted in the launch of 25 innovative medicines across the globe. Dr. Stoffels joined Johnson & Johnson in 2002, following the acquisition of Virco and Tibotec, where he was Chief Executive Officer and Chairman respectively, and where he led the development of several breakthrough products for the treatment of HIV. Dr. Stoffels also is a member of the Supervisory Board of Philips Healthcare in the Netherlands.

More info about Pierre Peeters

Company
Curare Consulting

Function
Early Clinical Development Expert

Pierre Peeters is a registered clinical pharmacologist working more than 35 years in the pharmaceutical industry, merely in early clinical drug development. He is a subject matter expert in clinical pharmacology in the broadest sense and has been involved in and/or responsible for the study design and conduct of several hundred early clinical trials as well as more than fifty (early) clinical development plans in various indications. He is able to quickly analyse and advise on complex matters at a strategic level and has an impressive track record of projects in which he efficiently led scientific, operational and/or integration teams to excellent results within the deadlines set. He has a strong drive and collaborative leadership style with the conviction and ability to delegate to all levels, and at the same time act as an energetic team player.  Pierre has a strategic view on innovative drug development with an in-depth knowledge of project- and lean drug development tools as well as a broad experience with operational and financial processes in early drug development. Before joining CURARE, Pierre held senior scientific and/or leadership positions at the Centre for Human Drug Research (CHDR), Organon (currently MSD) and Pharma Bio-Research (now PRA), all located in the Netherlands.

More info about Piet Hinoul

On-campus

Company
Virtual Incision

Function
Chief Medical Officer

A global healthcare executive, Piet Hinoul, M.D., Ph.D., brings 30 years of healthcare experience to Virtual Incision, of which the past 15 have been spent in the medtech industry. In his past roles, Piet has served as Senior V.P., Global Head Medical Affairs at Novocure, and V.P., Global Head for Medical, Clinical, and Pre-Clinical Affairs for the surgical subsidiary of Johnson & Johnson, Ethicon. Piet is a European Board-certified gynecologist whose work has been published extensively on various surgery topics and who has lectured internationally throughout his career on the fields of urogynecology, surgery, and medical device innovation. Piet earned his M.D. from the University of Leuven, and his Ph.D. in biomedical sciences from the University of Amsterdam.

More info about Richard Shull

Company
Shell

Function
Head of Deal Structuring and Trading Fundamentals

More info about Rick Kuntz

Company
Medtronic

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

Dr. Rick Kuntz was Medtronic’s Senior Vice President, Chief Medical and Scientific Officer of Medtronic and served as a member of the Company’s Executive Committee until 2021. In this role, Kuntz oversaw the company’s medical affairs, health policy and reimbursement, clinical research activities, and corporate technology.

More info about Saco de Visser

Company
Paul Janssen Futurelab Leiden

Function
Teacher 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.

More info about Sjaak Bot

Company
Janssen

Function
Former VP, Head of EMEA Regulatory Affairs

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

More info about Tine de Marez

On-campus

Company
Johnson & Johnson

Function
Senior Director, Compound Development Team Leader TB

More info about Ton van der Hoven

Company
SurgVision BV

Function
CEO