Marian Mitroiu, Remy Francisca, Jorn Mulder and Désirée Veening-Griffioen will defend their thesis in the upcoming months.
PhD defense Marian Mitroiu
On 12 December 2022 at 10.15 AM Marian Mitroiu will defend his thesis entitled “Estimands in clinical drug development: from design to regulatory assessment” at Utrecht University. Marian performed his research at the Clinical Trial Methodology Department, Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht (UMC Utrecht) under the supervision of Prof. Kit Roes (Radboud University Medical Center (Radboud UMC)/MEB), dr. Steven Teerenstra (Radboud UMC/MEB), dr. Katrien Oude Rengerink (UMC Utrecht/MEB) and Frank Pétavy (European Medicines Agency). His PhD research project was jointly conducted with the Methodology Working Group at the MEB.
In his research, he investigated the (implicit) use of estimands in the pre-estimand era in clinical trials for regulatory evaluation and approval to understand what estimands may correspond to efficacy investigations and to common efficacy analyses. Additionally, he developed data-generating models that take into account the association between clinical outcomes and intercurrent events.
Since August 2021 he’s working as a Senior Principal Biostatistician at Biogen (Zürich, Switzerland).
The PhD ceremony will also be live-streamed. The link to this livestream will be available a week before the defense.
PhD defense Remy Francisca
On 17 January 2023 at 1 PM, Remy will defend his thesis entitled “Investigating additional risk minimisation measures for medicines in the European Union” at Erasmus University Rotterdam (EUR). Remy performed his research under the supervision of Prof. Miriam Sturkenboom (Utrecht University), dr. Sabine Straus (MEB/EUR) and dr. Inge Zomerdijk (MEB).
In his research, Remy investigated several aspects of additional risk minimisation measures (aRMMs), such as: frequency and determinants of aRMM requirements at authorisation as well as post-authorisation, and effectiveness evaluation for medicines authorised with aRMMs.
Next to performing his PhD-research, Remy has been a pharmacovigilance assessor at the MEB from 2015 until 2019. Since August 2020 he’s working as an internal medicine physician in training.
The PhD ceremony will also be live-streamed. The link to the livestream can be requested at science@cbg-meb.nl.
PhD defense Jorn Mulder
On 25 January 2023 at 2.15 PM Jorn Mulder will defend his thesis entitled “The authorisation of anti-cancer medicinal products; Clinical benefit, precision medicine and regulatory flexibility” at Utrecht University (UU). Jorn performed his research under the supervision of Prof. Ton de Boer (UU/MEB), Prof. Emile Voest (Netherlands Cancer Institute), dr. Marjon Pasmooij (MEB) and dr. Violeta Stoyanova (MEB).
His research focuses on the challenges and difficulties related to the evaluation and authorisation of (new) anticancer medicinal products. Research topics include regulatory designations, single-arm trials, investigator-initiated trials and post-authorisation measures.
Next to performing his PhD-research, Jorn has been a clinical assessor in the field of oncology at the MEB. He will continue his work as a clinical assessor at the MEB after his PhD.
The PhD ceremony will also be live-streamed. The link to this livestream will be available a week before the defense.
PhD defense Désirée Veening-Griffioen
On 17 March 2023 at 12.15 PM Désirée Veening-Griffioen will defend her thesis entitled “Selection of animal models for drug efficacy” at Utrecht University (UU). Désirée performed her research under the supervision of Prof. Ellen Moors (UU), Prof. Huub Schellekens (UU), dr. Peter van Meer (MEB/UU) and dr. Wouter Boon (UU).
In her research, Désirée aimed to primarily understand the selection of animal models of efficacy in drug development. She looked into how animal models are currently selected and showed the impact of current animal model selection on translatability of the results for Alzheimer’s disease. In addition, Désirée demonstrated that, for different disease areas and animal models, when assessing animal models on the extent to which they resemble the human disease with the developed Framework to Identify Models of Disease (FIMD), a differentiation between more and less predictive animal models can be made.
The first two years, Désirée worked fulltime on her PhD. Since April 2020, she combined her position as a registered Biosafety Officer at MSD Animal Health with her PhD-research.
The PhD ceremony will also be live-streamed. The link to this livestream will be available a week before the defense.
