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 Onno van de Stolpe

Company
Galapagos B.V.

Function
CEO

Onno van de Stolpe founded our company in 1999 and has served as our Chief Executive Officer and a member of our board of directors from 1999 to the present. 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 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 Henk Schuring

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.

More info about Sjaak Bot

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.

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 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.