BIONEEDLE - Key Persons

Gijsbert Guijt graduated in Pharmacy from Leiden University in 1982 and obtained his license and registration as industrial pharmacist in 1984. In addition, he obtained an MBA from W.E. Simon School of Business Administration, Rochester, New York in 1990. He was QC manager and Qualified Person (QP) at NPBI BV (currently Fresenius KABI). Next he worked as head of the vaccines production department at RIVM (Dutch NIH). He managed the spin out of the RIVM vaccines production department into the Netherlands Vaccine Institute where he became managing director during the early years of the new organization.

Job Titles:

• CSO
• CTO
• Founder and Owner of Bioneedle Drug Delivery
• Founder and Owner of Bioneedle Drug Delivery BV and the Inventor

Gijsbert van de Wijdeven is the founder and owner of Bioneedle Drug Delivery BV and the inventor of the Bioneedle concept and technology. Over a period of 10 years he brought his idea of a vaccination technique that makes use of bioabsorbable implants from idea to proof of concept. During these years, he developed the basic elements of the Bioneedle technology: the industrial production processes, the safety and toxicology of the Bioneedles, and the technology to deliver the Bioneedles under the skin in a pain-free way. After he was informally requested by representatives from the WHO to further develop the Bioneedle technology for human use, as it can help reaching all people with life saving vaccines, it took another decade to proof for 4 commonly used vaccines that they can be stabilized in Bioneedles and that the vaccine-prefilled-Bioneedle combination product is effective and immunogenic in animals. Through this adventure, Gijsbert came into contact with dedicated experts in many countries and with a variety of expertise, without whom it would not have been possible to bring the Bioneedle Technology to the current stage of development. The adventure has taught him the skills and perseverance for performing and managing highly complex R&D projects in the Life Sciences. With Bioneedle Gijsbert has won the LAUNCH: Health prize (Kennedy Space Center, Orlando, USA) in 2010 and the Katerva Sustainability Prize (Geneva) in 2012. In 2014 Gijsbert and Bioneedle were elected Dutch National Icon. Gijsbert graduated in Animal Biology at the University of Bordeaux II, France, and obtained a Veterinary master's degree from Utrecht University, The Netherlands. Gijsbert has been a farm animal veterinarian for over 35 years and has administered more than a million injection-based vaccinations to a broad range of livestock. During these years, Gijsbert has also spent considerable time developing the Bioneedle Technology.

P.H. (Harry) Flore was born in Indonesia, and educated in Australia and in The Netherlands where he studied cell biology and finished a PhD in virology at the Agricultural University in Wageningen. He then held a postdoctoral position at Cornell University in New York for three years, designing novel vaccine strategies, after which he joined Solvay-Duphar in Weesp, The Netherlands, developing veterinary vaccines. After 10 years he moved on to Lohmann Animal Health in Cuxhaven, Germany as R&D Director for veterinary vaccines. He founded a Contract Manufacturing Organisation (now named Vibalogics) before moving on as General Manager to the Central Veterinary Institute in Lelystad, which is part of the Wageningen University Research Centre (WUR). Next he was Chief Executive Officer (CEO) of HAL Allergy in Leiden, The Netherlands. He co-founded the Contract Development and Manufacturing Organization HALIX, part of HAL Allergy Holding. HALIX is specialized in protein and virus manufacturing under BSL2/3 conditions in a GMP environment. Currently he is Chairman of the Supervisory Board of HAL Allergy Holding, HAL Allergy and HALIX. In addition, he is Scientific Advisor / Board Member in several research companies and organizations involved in biotechnological research and production, including Intravacc, CimCure, Bioneedle Drug Delivery, Biotech Training Facility and ISTAB - Hochschule Bremen, Germany.

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 a project leader and PhD student. She obtained her PhD from Leiden University in 2003 and became a registered clinical pharmacologist in 2005. From 2004 to 2007, she worked as policy coordinator in the research department of the Dutch Heart Foundation. In 2007 she returned to CHDR as interim manager of education. From 2008 to 2019, she held the position of Senior Clinical Scientist. Currently, she is Associate Director in clinical trials, and her main research focus is on general internal/infectious diseases. Recently, she has been managing a number of clinical trials with COVID-19 vaccines.

Job Titles:

• Chairman
• Chairman of the Scientific Advisory Board
• Professor

Douwe Breimer is (emeritus) full professor of pharmacology since 1975. He was rector magnificus and president of Leiden University from 2005 till 2007. In addition, he was director of research of the Leiden/Amsterdam Center for Drug Research (LACDR), chairman of the Center for Bio-Pharmaceutical Sciences and chairman of the department of pharmacology of the Faculty of Pharmacy at Leiden University. His research is in the area of pharmacokinetics, pharmacodynamics, drug metabolism and drug delivery, using in vitro and animal models, as well as investigations in humans (healthy volunteers and specific patient populations). He is the (co)-author of more than 500 scientific publications and he was the supervisor of more than 50 PhD-students. He has been a member of the editorial board of numerous scientific journals. He is the founder of the Center for Bio-Pharmaceutical Sciences, which later on became part of the LACDR, and the founder of the Centre for Human Drug Research (CHDR) in Leiden, which is a research foundation aiming at studies on (new) medicines in healthy subjects and specific patient populations. He is a co-founder of Leiden Advanced Pharmacokinetics and Pharmacodynamics (LAP&P). He is also co-founder of the European League of Research Universities (LERU), of the European Federation for Pharmaceutical Sciences (EUFEPS), and of ULLA, a European consortium in pharmaceutical sciences for graduate studies. He served as president or vice-president of these organizations. He was the Chairman of the Supervisory Board of Life Sciences Partners (LSP) in Amsterdam, a major European venture capital company. He was Chairman of the Advisory Board of the Dutch Medicines Evaluation Board (CBG-MEB) and he chaired the programme committee on the "responsible use of medicines" of the National Research Council. He was also a member of the Supervisory Board of the Technical University Delft, of the Governing Body of University College Cork and of the Board of Leuven. He received several prestigious scientific distinctions, among which honorary doctorates (honoris causa) from universities in Budapest, Gent, Uppsala, London, Tokyo, Pamplona and Montreal. He is a member of the Royal Dutch Academy of Arts and Sciences, Foreign Member of the National Academy of Medicine U.S.A., Corresponding Member of the Académie Nationale de Pharmacie in Paris, Corresponding Member of the Royal Academy of Medicine of Belgium, a Fellow of the American Association of Pharmaceutical Scientists and a Fellow of the American College of Clinical Pharmacology. On the occasion of his retirement as Rector Magnificus and President of Leiden University in 2007 an asteroid was named after him (10980 Breimer; see NASA website) as well as a recently discovered rare orchid (Bulbophyllum breimerianum; see Blumea 52, pp. 1-3, 2007). As chairman of the Scientific Advisory Board, Douwe brings a wealth of knowledge and expertise as well as a vast national and international network to Bioneedle Drug Delivery.

Robert Rissmann (1977) studied pharmacy at the Free University of Berlin, Germany. He obtained his license to practice as a pharmacist in 2004 and subsequently began a PhD project in drug delivery at the Leiden Academic Center for Drug Research (Leiden University), focusing on translational dermatology. Robert successfully defended his PhD thesis on skin pharmacology in 2009. From 2010 to 2017, he was Director of Education at the Centre for Human Drug Research with an emphasis on clinical pharmacology and pharmaco-therapeutics. His research interests concern translational models in both immunology and dermatology for drug development in early-phase clinical research. He is a member of the board of the Dutch Society of Clinical Pharmacology and Biopharmacy and board member of the Education Committee of the British Pharmacological Society. In 2015, he was appointed Associate Professor at the Leiden University Medical Center. Since 2017 he has held the position of Research Director in Dermatology, and heads the Skin Pharmacology research group at CHDR. In 2020 he was appointed Professor of Translational Dermatology at Leiden University. He has published over 55 manuscripts in peer-reviewed journals and is actively involved in the supervision and training of PhD students.

Job Titles:

• CEO

Wolf Ondracek joined Bioneedle Drug Delivery in 2020, bringing more than 25 years of experience in the life sciences industry and clinical development in Europe and APAC. Prior to joining Bioneedle, he was co-founder of 3EACON, a consultancy company offering strategic management and operational support to organizations and companies that are active in the life sciences between East Asia and Western Europe. As the CEO of Promasys, a clinical data management software systems developer in the Netherlands, he led the acquisition by OmniComm Systems, a US based EDC software company, where he became senior vice-president for APAC and managing director of the Dutch subsidiary. Before joining OmniComm Systems, he was also director business development at the Centre for Human Drug Research in Leiden. In 2008 he was co-founder of Julius Clinical Research, an academic CRO that specializes in large international clinical trials, where he landed a 100 M contract with a top 5 pharmaceutical company for a global outcomes study. Wolf brings extensive experience across a broad range of areas to Bioneedle, such as business development and sales, project management and operations, data management, team and organization building, and general management. He has comprehensive knowledge of the different aspects of clinical trials and clinical drug development and has hands-on experience in providing high level management of clinical studies - from small scale, complex early phase trials all the way up to large scale, global outcomes studies. In addition, he has profound knowledge of Japanese (business) culture and language and is an experienced relation builder in other Asian countries. Wolf graduated in social sciences at the Free University in Amsterdam and has a master's degree in Japanese studies from Leiden University.