The VPHi has recently tightened its collaboration with the European Medicines Agency, focussing on the common goal of speeding up the adoption process of in silico models in the regulatory drug development process. Flora Musuamba Tshinanu, our Belgian contact, has kindly released an interview for our monthly newsletter.
1. What is your role at EMA? What activities do you focus on?
I am basically an assessor at the Belgian Medicines Agency, but I have extensive activities related to regulatory procedures managed at EMA level.
My area of expertise is Pharmacometrics and I have a curiosity for computational sciences in general. In link with that, I am currently the vice-chair of the EMA Modelling and Simulation Working Party (EMA MSWP) and an alternate member of the EMA Scientific Advice Working party (SAWP).
In the MSWP, I am involved in activities related to providing our expertise for questions received from different EMA committees and working parties and related to drug centralised applications for marketing authorization, scientific advices, qualification advices and opinions, paediatric investigation plans, guideline writing, training for regulators, etc.
In the SAWP, I am involved in activities related to providing scientific support to the Committee for Medicinal Products Human Use (CHMP) for questions received from drug sponsors (mostly Pharma but also some consortia and academic groups) at different stages of their drug development programs. The questions received cover diverse topics including study design, choice of endpoints for clinical studies, dose selection, choice of study population, data analysis methods etc.
2. How in silico medicine could contribute to the modernisation of medicine?
I prefer using the term ‘Modelling and Simulation (M&S)’, but to me this is exactly the same as what you call ‘in silico medicine’ even if we have historically put the emphasis on drug effects, whereas organisation such as VPHi first took it from a disease (pathophysiology) angle. M&S has already contributed in a significant manner to optimize medicine, drug development and drug use. Fields where M&S are in now routinely applied with a high regulatory impact (i.e. M&S results are accepted in lieu of conducting dedicated clinical studies) include characterization of drug-drug interactions, dosing in special population, paediatric drug development, drug development in orphan diseases, etc.
M&S methods are now routinely used by pharmaceutical companies and drug sponsors, for example, for key decision making on the most promising drug development programs in their pipelines and for moving to key steps of their projects and to characterize some important features of their different studies.
M&S are now also increasingly used to identify the most sensitive subgroups of patients for both drug efficacy and safety, thanks to systems medicines and systems pharmacology models.
The above listed applications are contributing to faster access to better quality medicines for patients.
We, as regulators, provide guidance, advices and recommendations on the acceptability of these methods for regulatory submissions.
3. How can we speed up the adoption process of in silico models?
At the point we are standing today, in my opinion, one of the best ways to increase the good perception of models mostly by stakeholders without quantitative background - because M&S are otherwise already adopted- is to improve the (methodological and reporting) quality of the models so that the value of the models is proved post-hoc and constitutes per se an irrefutable evidence of their liability.
4. What are the challenges we shall overcome for the full adoption of in silico models in the drug development process?
Currently, the biggest challenges are coming from unreliable and low quality and immature models with poor predictive performances in their context of use that bring discredit and hamper the acceptability of models by people without quantitative background in particular.
Moreover, the fact that good standards for evaluation of some models in some particular context of use are currently lacking, is also one of the big challenges.
5. How did you first get to know about the VPH Institute? And how did you get involved with our activities?
I learned about VPHi from one member I met at a scientific meeting related to systems pharmacology. I learned more thanks to Prof Lies Geris who kindly visited me at the Belgian Medicines Agency and we exchanged about our common interests and the avenues for future collaboration.
I find it crucial that people in VPHi are aware of the regulatory initiatives and efforts related to in silico approaches and Lies and I agreed that I would be invited in some of the VPHi activities to try to make a step in that sense.
6. Why do you think it is important to have organisations like the VPH Institute?
To me organisations like VPHi could really be impactful since they bring together the experts in the field and can think and contribute to set up policies at methodological level, based on some strong academic experience.
7. What are the next steps and the initiatives we shall focus on to increase our synergies?
The next steps to me should be to work together on identifying the best standards for systems medicines and systems pharmacology model evaluation when comes to context of use relevant for regulatory applications. I believe there is currently an unmet need and there is some room for interesting synergies. I foresee the upcoming workshop on 25-26 April in Leuven as the very first step in that direction.
