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Our Publications & Reports

At Lygature, we disseminate our knowledge and thinking about how to further develop public-private partnerships in general, and in our areas of focus. A selection of publications can be found on this page.

General reports

CTMM: Translating science into better healthcare. FES program: June 2016. [PDF file]
TI Pharma: New tracks to medicines. FES program: April 2014. [PDF file]
Partners in the Polder, A vision for the life sciences in the Netherlands and the role of public-private partnerships. Den Haag. Chapter Health can be found at pages 110-134. October 2009. [PDF file]

Public Private Partnerships

De Vrueh, R. L., Crommelin, D. J. Reflections on the Future of Pharmaceutical Public-Private Partnerships: From Input to Impact. Pharmaceutical Research 34, 1985-99. (2017)
De Vrueh, R. L., Awad, W., Stolk, A., Dijcks, F. A., Rijnders, T. W., & Janssen, J. W. Deal watch: Roles and strategies for health foundations in public-private partnerships. Nature Reviews Drug Discovery 13, 406-406. (2014)
Awad, W., Stolk, A., Dijcks, F., & Vrueh de, R. Health Foundations Facilitate Translational Research Through Public-Private Partnerships. Leiden: TI Pharma. (2013) [PDF]
Denee, T. R., Sneekes, A., Stolk, P., Juliens, A., Raaijmakers, J. A., Goldman, M., & Janssen, J. W. Measuring the value of public–private partnerships in the pharmaceutical sciences. Nature Reviews Drug Discovery 11, 419-419. (2012)

Data/research infrastructure

van Gool, A., Bietrix, F., Caldenhoven, E., Zatloukal, K., Scherer, A., Litton, J., ... Ussi, A.E. Bridging the translational innovation gap through good biomarker practice. Nature Reviews Drug Discovery. 2017, -, -. ISSN 1474-1776 . IF: 47.120.PMID: 28450744
Wilkinson, M. D., Dumontier, M., Aalbersberg, I. J., Appleton, G., Axton, M., Baak, A., & Bouwman, J. et al. The FAIR Guiding Principles for scientific data management and stewardship. Scientific data 3. (2016)

Sharing resources

Maass A.H., Vernooy K., Wijers S.C., van 't Sant J., Cramer M.J., Meine M., Allaart C.P., De Lange F.J., Prinzen F.W., Gerritse B., Erdtsieck E., Scheerder C.O., Hill M.R., Scholten M., Kloosterman M., Ter Horst I.A., Voors A.A., Vos M.A., Rienstra M., Van Gelder I.C. Refining success of cardiac resynchronization therapy using a simple score predicting the amount of reverse ventricular remodelling: results from the Markers and Response to CRT (MARC) study. Eurospace (2017)
Kingwell, K. European Lead Factory hits its stride. Nature Reviews Drug Discovery 15, 221-222. (2016)
Karawajczyk, A., Orrling, K. M., de Vlieger, J. S., Rijnders, T. W., & Tzalis, D. The European Lead Factory: A Blueprint for Public–Private Partnerships in Early Drug Discovery. Frontiers in Medicine 3, 75. (2016).
Laverty, H., Orrling, K. M., Giordanetto, F., Poinot, M., Ottow, E., Rijnders, T. W., & Jaroch, S. The European lead factory—an experiment in collaborative drug discovery. Journal of Medicine Development Sciences 1, 20-33. (2016)
Mullard, A. European lead factory opens for business. Nature Reviews Drug Discovery 12, 173-175. (2013)

Regulatory innovation

Klein K., Scholl J.H.G., De Bruin M.L., Van Puijenbroek E.P., Leufkens H.G.M., Stolk P. When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection. Clin Pharmacol Ther. Sep 15 2017
Hussaarts L., Mühlebach S., Shah VP., McNeil S., Borchard G., Flühmann B., Weinstein V., Neervannan S., Griffiths E., Jiang W., Wolff-Holz E., Crommelin DJA., de Vlieger JSB. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Ann N Y Acad Sci Apr 26. [Epub ahead of print] (2017)
Klein, K., Scholl, J.H., Vermeer, N.S., Broekmans, A.W., Van Puijenbroek, E.P., De Bruin, M.L., Stolk, P. Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. Drug Safety 39, 185-192. (2016)
Crommelin, D. J., & de Vlieger, J. S. (Eds.). Non-biological complex drugs: the science and the regulatory landscape 20. Springer. (2015)
Klein, K., De Bruin, M.L., Broekmans, A.W., Stolk, P. Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers. BioDrugs 29, 373-379. (2015)
Schellekens, H., Stegemann, S., Weinstein, V., de Vlieger, J. S., Flühmann, B., Mühlebach, S., & Crommelin, D. J. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider. The AAPS journal 16, 15-21. (2014)
Escher. Improving the EU system for the marketing authorization of medicines - Learning from regulatory practice. Leiden: Escher – The TI Pharma Platform for Regulatory Innovation. (2014) [PDF file]

A full list of publications on non-biological complex drugs co-authored by our team can be found here.

Hussaarts, L., van der Weijde, K., Dome, P., Kourany-Lefoll, E., Reinhard-Rupp, J., de Vrueh, R., & Pediatric Praziquantel Consortium. Drug research and development programs for neglected tropical diseases: A crucial role for expert meetings. PLOS Neglected Tropical Diseases 11. (2017)
Kourany-Lefoll, E., & Keiser, J. & Vrueh de, R. Positive action: Pediatric Praziquantel Consortium. European Biopharmaceutical Rev. 10-15. (2015)
Orrling KM, Verheij HJ, Leurs R. Fast track to new drugs. PEN: Science & Technology, 11, 194-195. (2014)
Iyer, J.K., Janssen, J.W., Leurs, R., & Crommelin, D. Neglected no more. Fostering Innovation in the Neglected Diseases. Preclinical drug discovery. Genesis: 62. (2009)