Frequently Asked Questions
General questions on the PEARRL project
How many partners are involved in the PEARRL project?
The PEARRL Network is composed out of 9 Beneficiaries and 10 Partner Organisations.
What are the main objectives of the PEARRL project?
The main objectives of PEARRL are to deliver novel bioenabling formulations and new biopharmaceutics tools to predict their in vivo performance as means to improve efficiency and cost-competitiveness in drug development, facilitating earlier access of patients to “breakthrough therapies”
What is the PEARRL's work plan?
The research of PEARRL is divided in three workpackages: WP1 is about Bio-enabling formulation, WP2 is about biopharmaceutical tools and WP3 is about in silico methods. Every workpackage includes 5 ESRs.
When did the PEARRL project start?
The PEARRL project officially started on 1. May 2016
How many countries are involved in the project?
The 9 Beneficiaries involved come from 6 different countries (Ireland, Germany, United Kingdom, Switzerland, Belgium, Greece)
Why are bio-enabling formulations necessary?
Poor water solubility of new drug candidates is a main pharmaceutical challenge to avoid erratic and highly variable absorption following oral administration. To facilitate effective and safe medications, bio-enabling formulations are therefore needed.
What is Biopharmaceutics?
The study of the physico-chemical principles that govern the behavior of the drug substance and drug product in the living organism (e.g. the human body), and the understanding of how the administered drug will influence pharmacodynamic and pharmacokinetic processes. Changes in these mechanisms can be caused by differences in pharmaceutical properties, such as the solubility of the drug form used in the dosage form, the particle size, stability of the active ingredient, etc.
How is the bioequivalence of paediatric medicinal products tested?
At present, there is no specific regulatory guideline dedicated to bioequivalence studies for paediatric medicines. Therefore, bioequivalence studies for paediatric medicines are usually performed according to the general regulatory guidelines on drug product bioequivalence and are usually conducted in adult subjects.
What happens after PEARRL?
The need for further research in all three areas of the PEARRL’s work packages (formulation design, in vitro test, in silico models) is evident. PEARRL was only the start for new collaborations as well as 15 highly trained and educated scientists, which will be able to spread and apply their knowledge in the field. Besides the collaboration of the European partners will continue and further funding is sought. The planning for PEARRL-2 has started and is on-going.
How are projects of the different work packages linked?
There are manifold links and collaborations between the ESR projects. In general, formulations developed in work package (WP) 1 can be tested with either a well established or new developed in vitro test of WP 2. Also, in vivo investigations facilitate collaboration between WP 1 and 2. Last the building of an in silico model needs formulations, in vitro and in vivo data facilitating many collaborations across all WPs. After initial work (e.g. formulation development) more and more of such collaborations are established.
Why is the involvement of regulatory authorities important in the PEARRL project?
Regulatory authorities create the guidelines for the production, development and marketing of drugs and medical devices. Consequently, the mutual understanding between regulatory authorities and researchers on regulatory requirements and scientific knowledge and improvement is a key factor in making sure safe and better drugs reach patients faster.
Where can I find similar positions/projects?
Euraxess is a pan-European initiative, supported by the European Union, connecting professional researchers to job, funding and collaboration opportunities.
What are Marie Skłodowska-Curie Actions (MSCA)?
MSCA are a set of major mobility research grants promoting interdisciplinary research and international collaborations while supporting scientists all over the globe. It was created by the European Union/European Commission to support research in the European Research Area (ERA). Established in 1996 as Marie Curie Actions and known since 2014 as Marie Skłodowska-Curie Actions, the fellowship programme aims to foster the career development and further training of researchers at all career stages. More information maybe found here: https://ec.europa.eu/programmes/horizon2020/en/h2020-section/marie-sklodowska-curie-actions
What is Horizon 2020?
Horizon 2020 is a research and innovation programme from the European Union that aims to promote world-class science and to deliver innovation by making the collaboration between public and private sector easier.
What does PEARRL stand for?
PEARRL stands for Pharmaceutical Education and Research with Regulatory Links.
What is the duration of the PEARRL project?
The duration of the project is 48 months (4 years)
Do you have general questions on the PEARRL project?
Questions related to ESRs and their research projects
How many ESRs are in the project?
In total, there are 15 ESRs working on the PEARRL Project. An overview of the researchers and their projects can be found under https://www.pearrl.eu/researchers.html
Where are the PEARRL ESRs located?
ESRs are spread across academic and industrial sites across Europe. Part of what makes PEARRL so unique is this mixture of academic and industrial insight. Furthermore, this is complimented by support and input from major regulatory agencies across the EU, including the EMA, who have also hosted each of the ESRs for a 3-month regulatory science secondment.
How often do the ESRs meet?
All 15 ESRs meet at least once per year during the PEARRLs of Wisdom Week. Apart from that, we have some additional meetings such as the Kick-off meeting or the Midterm review meeting. Usually, we also meet other ESRs when we are attending conferences, participating at training workshops or when we are on our secondments.
What are the secondments?
The ESRs have the opportunity to gain experience in the working environment of a Regulatory Agency or a Pharmaceutical Industry, by doing a three-months internship in one of the Regulatory and Industrial partner of the PEARRL program
What kind of training is provided for the ESR's within PEARRL?
Each ESR has the opportunity to attend local and specific training courses tailored to their research area. Additionally, monthly research webinars are provided and once per year all members of the PEARRL consortium meet at the PEARRL wisdom week, which provides further training for all ESRs. Specific training courses outside the ESRs are also provided to broaden the knowledge like for example PBPK modelling or multivariate data analysis.
How many conferences do ESRs attend each year?
There is no set number for attended conferences for each ESR. Therefore, each student can attend as many as he/she wants as long as the scientific gatherings are relevant for the project. Typically, involvement in local scientific actions is highly appreciated.
Do you have questions about the ESRs or their research projects?
Scientific research questions
What is an in silico tool?
In silico is the Latin term for "In silicon". In recent years, this term has been adapted to apply to any task performed using computers (referring here to the silicon that makes up computer chips). In the context of the PEARRL project, in silico tools refer to any of a number of computer software and modelling approaches that can be applied to improve the efficiency of drug development of poorly soluble drugs. One example of such an in silico tool is the software SimCyp® which is modelling software that can predict the pharmacokinetic and pharmacodynamic performance of a drug based on inputted parameters. May ESRs within the PEARRL project are utilizing this tool and others to achieve the over-riding goals of the PEARRL project.
What is Biorelevant performance testing?
Biorelevant performance testing refers to the use of in vitro tests such as dissolution, and solubility testing for evaluation of drug products. For oral administered products, this includes simulation of the composition of gastrointestinal fluids (biorelevant media) and simulation of gastrointestinal hydrodynamics (gastrointestinal volumes, motility patterns, and gastrointestinal transit times). Understanding of systems physiology when compared to an healthy adult allows adaptation of these tests to specific populations, such as paediatric patients and disease states.
Why is the development of in vitro and in silico biopharmaceutics tools and methods for paediatric formulations important?
Specifically-tailored in vitro and in silico biopharmaceutics tools and methods are needed to capture the maturation and growth changes occurring at different developmental stages from birth to adulthood, as most of the currently existing tools and methods reflect adult physiology and anatomy. These are utilised to predict in vivo drug product performance and guarantee the medicines safety and efficacy while reducing human clinical study burden, which is all the more essential for a successful paediatric medicines development for ethical and recruitment reasons related to paediatric clinical trials.
Shall a drug be taken with or without food?
The answer varies with the drug and drug product. In general, the aim is to administered drugs orally so that food effects are not likely. If this is not possible, specific instructions are provided by the prescribing physician and/or are included in the Summary of Product Characteristics (SPC) leaflet.
Can we predict food effects a priori in the lab?
Depending on the drug and the drug product, qualitative predictions may be possible on an average basis. One of the objectives of PEARRL project is to improve the predictability of food effects on oral drug absorption by better understanding relevant intraluminal processes in humans.
What is PBPK modeling?
Physiologically based pharmacokinetic (PBPK) modeling and simulation is a mechanistic approach based in mathematical equations. PBPK can be used to simulate the pharmacokinetic profile of a drug in different species by integrating the physicochemical properties of the compound with the physiology of the species.
Why are small scale biopharmaceutic tools useful?
Small-scale tools allow for the use of small amounts of drug, as quantities of drug are extremely scarce in the early stages of development. In addition, the use of small-scale experiments allows for reducing the quantity of media and reagents required for testing, which helps to reduce expense.
What kind of bio-enabling formulations are developed in WP1?
The formulations being developed in WP1 can be differentiated in two main categories. The first part of formulations covers certain solid dispersion techniques that can be further divided in the three parts: Hot melt extrusion, solvent-based dispersions and mesoporous systems. The second part consist of lipid based formulations.
What are the biorelevant media?
Biorelevant media are media that follow more closely the composition of human and/or animal (e.g. dog) fluids in the stomach and intestinal tract designed to simulate the fasted and fed states in the stomach, small intestine and colon. Media simulating the fluids in the gastrointestinal tract in disease states or in special populations (e.g. pediatric) have already been developed or are under development.
Do you have further questions about the PEARRL research area?