Topic: METc (=Medisch Ethische Toetsingscommissie UMCG)   

(Medisch Ethische Toetsingscommissie UMCG)

Research falling under the Medical Device Regulation (MDR) and/or ‘Medical Research Involving Human Subjects Act’ (WMO) must be reviewed beforehand by an independent committee of experts: the ‘Medical Research Ethics Committee’ (MREC or METc). Without an approval from this committee, the research may not start. The purpose of the review is to safeguard the rights, safety and welfare of the test subjects participating in this research. Therefore, the METc plays an essential role if you want to do a research study involving human subjects and test products for clinical applications.

Do you know when you need to consult a ‘Medical Research Ethics Commitee’?

Have you submitted a proposal to them in the past?

Any specific question regarding a project you are working on?

No matter if you replied yes or no to these questions: we are pretty sure you can learn something new also this time and have an interactive discussion at the first IB of 2023.

Speakers: 

Joke Ummels: Research ethics officer – Medical Ethics Review Board – (ambtelijk secretaries) METc at the University Medical Center Groningen (UMCG) 

Jelmer Sjollema: assistant professor and principal investigator at the UMCG. He is also the Director of the Master Programme Biomedical Engineering, Faculty of Science and Engineering (RUG) en Member of the medical ethics review committee (METC) at the UMCG, where he is giving specific advice on the use of clinical products. 

Moderator: 

Jan Willem Veldsink, Program Lead Business Development Innovation Institute at the UMCG 

Explore the latest developments in mental disorders during our upcoming Innovation Booster on 16 February.
We will dive into natural language processing and machine learning in psychiatry with Iris Sommer & Alban Voppel. Learn about the impact of mental health disorders on patients and society, and discover new ways to personalize mental health care with the web-based e-health tool PETRA hosted by Harriette Riese. And we will discuss the role of repetitive negative thinking and how it can be objectively tracked by machine-learning-augmented measurements together with Marlijn Besten.

Topic: Mental disorders 

Speakers: Alban Voppel (1), Harriëtte Riese (2), Marlijn Besten (3) 

Presentations:

1. Alban Voppel: Mental health disorders have a large impact on patients and society. A majority of these disorders have unique language characteristics, from incoherence to more monotonous speech. In this presentation, I will present recent research from the UMCG using natural language processing and machine learning in psychiatry, with a focus on psychosis. 
2. PETRA is a web-based e-health tool for personalized diaries in mental health care (www.petrapsy.nl). The personalized diaries are based on scientific studies on the experience sampling method (ESM) or ecological momentary assessment (EMA). PETRA is integrated in the personal health record systems of several mental health care institutes. PETRA facilitates clinicians and patients to co-create a personalized diary and visualizes the gathered data in a clinically relevant way. 
3. Repetitive negative thinking has been associated with a high risk to develop and maintain Major Depressive Disorder. With our recent work at the UMCG and RUG we examine how rumination plays a role in the vulnerability for depression and how rumination can be objectively tracked by machine-learning-augmented measurements.

Topic: Boosting your drug delivery

Subtitle: Platform technologies for nanomedicine and dosage form development in the Groningen Research Institute of Pharmacy (GRIP).  

In this innovation booster we will illustrate the technologies and expertise available in our institute, which could boost and support the development of nanomedicines, targeted drugs and dosage forms.

Six short pitches from GRIP researchers will illustrate the available technologies and expertise. After the pitches, there will be plenty of time for networking and the speakers can be approached individually for further questions.

Speakers: Wouter Hinrichs (1), Klaas Poelstra (2), Anna Salvati (3), Christoffer Åberg (4), Peter Olinga (5), Erik Frijlink (6) 

1) Wouter Hinrichs: in this pitch we will illustrate the available technologies and expertise for the stabilization of biopharmaceuticals by sugar glass technology and the development of solid dosage forms, such as powders for inhalation, tablets for oral administration and microneedles for transdermal administration among others. 

2) Klaas Poelstra: this pitch will present the available expertise for the design of targeted drugs, i.e., for the identification of key target receptors in diseased tissue and the design and testing of receptor-recognizing peptides that can be used to target them. 

3) Anna Salvati: here we will present the expertise and methods available for the characterization of nanomedicines once applied in biological fluids (stability, and nanomedicine corona) and nanomedicine interactions with targeted/non targeted cells (interaction with receptors, mechanism of uptake and eventual impact on cell functions). 

4) Christoffer Åberg: this pitch will illustrate methods to quantify cell uptake of drugs/nanomedicines (in terms of absolute numbers), determine their intracellular distribution using microscopy and kinetic modelling of nanomedicine distribution. 

5) Peter Olinga: in this pitch we will present our platform of ex vivo human models of different organs and diseases which can be used to test nanomedicines, targeted drugs and other drug formulations and ensure they are effective and non-toxic. 

6) Erik Frijlink: Collaborations with different research groups at the Groningen research institute of Pharmacy are an excellent way for companies or research institutes to develop their active pharmaceutical ingredient into an advanced dosage form. This pitch will illustrate different contract forms which have been used within GRIP to establish such research collaborations. Different ways on how IP contracts can be set up will be presented. A few examples from past projects will be presented.   

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