Following in the footsteps of the first two very successful meetings in Cork (2017) and Frankfurt (2018) the 3rd PEARRL Annual Open Scientific Symposium took place at the National and Kapodistrian University of Athens from 12 to 13 June 2019.
The title of the symposium was “Model Informed Drug Development”. Thirty-five PEARRL consortium members, ten external speakers from Europe and twenty preregistered external attendees from Europe and the USA participated.
On the first day, the PEARRL Coordinator provided a brief overview on the consortium and its objectives before the talks under the theme of Lead optimisation through pre-clinical development started with Professor J. Dressman speaking on Pharmaceutical Profiling in the Pharmaceutical Industry by highlighting relevant challenges. The second talk was given by another PEARRLer, Professor M. Kuenz, who focused on digital approaches from drug candidate selection to computational pharmaceutics which are currently considered by Pharmaceutical Industry and the first brief presentation given by Daniel Price (ESR3) on the use of COSMOquick as a predictor of drug/excipient interactions in enhanced dosage forms completed the first session. After the coffee break Dr. Jochem Alsenz (Roche, Switzerland) delivered a very well structured talk on various high throughput biopharmaceutical screening methodologies applied in industry and the morning session closed with three brief presentations by Patrick O’Dwyer (ESR10; Small scale screening for drug specific questions), Felix Ditzinger and Georgia Tsakiridou (ESR2 and ESR4; Solid dispersions based on modelling rationale) and Niklas Koehl and Roxana Ilie (ESR1&ESR14; A guide to bioenabling formulation selection in development: focus on lipid based approaches). After lunch the first day shifted its focus to model informed pre-clinical development. The first speaker, Dr. James Butler (GSK, UK) presented an excellent talk on the role of rDCS in guiding preclinical pharm development, followed by Christian Wagner (Merck, Germany), who talked about the role of PBPK modelling in guiding preclinical pharmaceutical development. After the coffee break, Sandy Van Hemelryck (J&J, Belgium) discussed the role of animal modelling in preclinical pharm development in her talk entitled “Preclinical Bioavailability Strategy for Decisions on Clinical Drug Formulation Development”, and the first day concluded with two more brief presentation by Chara Litou (ESR6; The role of biorelevant testing in formulation development) and Christina Pentafragka (ESR7; Using luminal data for modelling absorption in the fed state).
The theme of the second day was “Clinical development through to pharmaceutical product lifecycle management”. Dr. Butler gave his second informative and interesting talk of that symposium on formulating for first in man studies, and Dr. Bertil Abrahamsson (AstaZeneca, Sweden) followed on the challenges that are typically faced when transitioning to the final formulation. After coffee short break, Dr. Neil Parrott (Roche, Switzerland) talked on the usefulness of PBPK modelling in predicting food effects on drug absorption and Dr. Masoud Jamei (Certara, UK) discussed applications of PBPK modelling in predicting complex drug-drug interactions. The morning session finished with three brief presentations by Angela Effinger (ESR15; Targeting GI diseases), Mariana Guimaraes (ESR12; In vitro evaluation of drugs/drug products for paediatrics), and Marina Statelova (ESR11; In silico evaluation of drugs/drug products for paediatrics). The afternoon session started with a PEARRL speaker, Dr. L. Kalantzi, who talked on the usefulness of modelling and simulation in the development of generics. Dr. Essam Ahmed Ghazaly Kerwash (MHRA, UK) then talked from a regulatory perspective on the use and qualification of PBPK modelling and after the coffee break, Ian Flawn Orpana (Verto Pharma AB, Sweden) talked on Statistical Process Control (SPC) in Manufacturing and Quality Control of Drug Products. The second day of the symposium concluded with three brief talks by Sandra Jankovic (ESR5; Emerging process analysers in pharmaceutics), Ioannis Loisios (ESR13; Establishing virtual bioequivalence trials simulation using population-based PBPK modelling) and Raphael Paraiso ( ESR8; The role of in vitro and in silico tools to support bioequivalence studies).
Overall, the Symposium provided the attendees with an open, up-to-date and transparent appraisal of recent advances on Model Informed Drug Development aspects which are expected to assist in shortening development timelines and reduce ethical issues relating to animal and human testing.
3rd PEARRLs of Wisdom Week at the National and Kapodistrian University of Athens from 10th to 14th June 2019.
Next week, the 3rd Annual meeting of the PEARRL network, the PEARRLs of Wisdom Week, will take place at the National and Kapodistrian University of Athens, Faculty of Pharmacy, Greece from 10th to 14th June 2019.
The local organisers, Prof. Christos Reppas, Dr. Maria Vertzoni and their team have been working tirelessly to set up an exciting programme full of stimulating scientific workshops and presentations as well as countless networking opportunities.
Over 60 participants will be travelling to Greece from all over the globe to join the PEARRL network over the course of this 5-day event (10th to 14th June 2019). As PEARRL is a European Training Network (ETN) which delivers a unique research and training programme for 15 Early Stage Researchers (ESR) a highlight includes the Science Slams (closed event) where the 15 Early Stage Researchers who have been working on the PEARRL project for close to three years will present their research and outcomes. The full programme and agenda of the PEARRLs of Wisdom Week, Athens 2019 are available on http://www.pearrl.eu/am2019.html.
Further highlights of the PEARRLs of Wisdom Week are the days open to interested external stakeholders. Following the success of the open symposia days in Cork 2017 and Frankfurt 2018 we have also invited a number of external experts including top scientists in the field of oral drug product development to present at this year’s Symposium on Model Informed Drug Development (registration is now closed), including:
More information on the Symposium, with speaker bibliographies, can be found on http://www.pearrl.eu/rss2019.html
To receive live updates and photos during the event follow us on twitter @pearrl_eu
On the 14th March 2019, Daniel Price (ESR3) visited Maricourt High School in Liverpool, UK to talk about drug development, commercialisation and careers in the pharmaceutical industry. Daniel also shared more specific information about the PEARRL project and how mesoporous silica can be used to overcome low drug solubility. The 35 students were engaging and interested and have since followed up by sharing CVs and questions to Daniel. Daniel has been invited back to give talks to a wider group of students in the next school year.
Industrial commentary by Dr. Rene Holm on bridging the gaps between academic research and industrial drug product developments in Advanced drug delivery reviews
PEARRL's Dr. Rene Holm (Jannsen) recently published a review in Advanced Drug Delivery Reviews highlighting the importance of joint academia-industry research consortia, such as PEARRL, for advancing innovation in the pharmaceutical drug development field. Dr. Holm gives examples of where academia and industry have successfully collaborated withing large multi-partner networks to produce major advances in scientific understanding and novel drug delivery technologies. He also highlights the importance that all stakeholders in the the Pharmaceutical ecosystem (figure insert), including academia, industry, CRO's, service/technology providers, etc., are involved in such consortia, so that new technological advances meets the needs of the various stakeholders, including patients, regulators and industry. Finally he emphasizes the need that future funding calls for similar academic-industry consortia focusing on addressing 'gaps in academic research and the needs of industrial product development' and sharing the data so all stakeholders can benefit. The full article can be accessed here R. Holm, Bridging the gaps between academic research and industrial product developments ..., Adv.Drug Deliv. Rev., https://doi.org/10.1016/j.addr.2019.01.009
PEARRL publishes an open access special issue of J. Pharm. Pharmacol. on approaches for accelerating R&D for faster #accesstomedicines
In February 2019, the PEARRL network published a special 'PEARRL themed' issue in Journal of Pharmacy & Pharmacology on innovative drug development strategies tailored to facilitate earlier access to new oral medicines. This dedicated issue of the J. Pharm. Pharmacol. hosts a collection of eleven review articles that showcase the research topics that are the focus of the PEARRL consortium. The objective of these review articles is to provide an up‐to‐date review on the current status of the target areas of research and to highlight approaches which can be used to streamline oral drug product. Each of the 15 ESRs in PEARRL contributed, both individually and collectively, to publishing these reviews. In addition, our industrial partners made significant contributions to these joint publications, which serves to highlight the industrial relevance of these reviews. Overall, 34 authors from 11 institutions within the PEARRL network were involved in preparing this special issue. We do hope you enjoy the read!
The full list of articles can be accessed from her:
THE PEARRL REVIEWS ‐ innovative drug development strategies tailored to facilitate earlier access to new oral medicines: Journal of Pharmacy and Pharmacology : Vol 71 , No 4 https://onlinelibrary.wiley.com/toc/20427158/2019/71/4
The 3rd PEARRL Annual Meeting will be held at National and Kapodistrian University of Athens, Department of Pharmacy, Greece from Monday, 10 June 2018 to Friday 14 June 2019. The local organisers, Prof. Christos Reppas, Dr. Maria Vertzoni and their team, have pulled out all the stops in planning for what is shaping up to be an exciting scientific meeting. Building on the success of the 2017 and 2018 Annual Meetings and associated Symposia, the theme of the 2019 PEARRL symposium has been selected to be Model Informed Drug Development. As the symposium is open, we are expecting significant interest from external participants*.
The agenda has been published on the website, which includes up to 25 presentations dedicated to exploring the use of modelling tools for streamlining drug development. The theme on the 12th June is on "Lead optimisation through to pre-clinical development" and on the13th June the focus moves to "Model informed Clinical development through to emerging trends in pharmaceutical product lifecycle management".
An exciting list of external speakers has already been confirmed which includes:
· Jochem Alsenz, F. Hoffmann- La Roche Ltd. Basel, Switzerland
· Bertil Abrahamsson, AstraZeneca R&D, Sweden
· James Butler, GlaxoSmithKline, UK
· Sandy Van Hemelryck, Janssen Pharmaceutica, Belgium
· Masoud Jamei, Certara, United Kingdom
· Neil John Parrott, F. Hoffmann- La Roche Ltd., Basel, Switzerland
· Christian Wagner, Merck Group, Germany
In addition, a key highlight of the 2019 meeting is that all ESRs will present at this open symposium on topics related to research in the PEARRL network. For More information on the symposium, with speaker bibliographies, please visit https://www.pearrl.eu/rss2019.html.
*So if you are interested in attending on 12th and/or 13th you should register your interest via the website. Please note spaces are limited so early registration is essential!
As PEARRL is a European Training Network (ETN) which delivers a unique research and training programme for 15 ESRs, three additional days of research and training activities are scheduled on 10th, 11th and 14th for PEARRL members. Further details on the agenda for these ‘PEARRLs of Wisdom days’ can be viewed here https://www.pearrl.eu/am2019.html
To receive live updates and photos during the event follow us on twitter @pearrl_eu
Female STEM students from St Brendan's sixth form college had the opportunity to hear about the PEARRL project.
The talk provided fantastic insight into the world of pharmaceuticals and many members of the female audience left feeling empowered to pursue a career within the field and research opportunities with the European Training Network.
Read the full article: www.stbrn.ac.uk/info/news-and-blogs/news/female-stem-students-inspired/
PEARRL researcher Professor Jennifer Dressman features in the latest “Highly Cited Researchers” worldwide!
PEARRL researcher Professor Jennifer Dressman was recently recognised for her exceptional research publications in pharmaceutical science and technology. Professor Dressman features in the latest “Highly Cited Researchers” list. The Highly Cited List is produced by Clarivate Analytics for the Web of Science, and recognises the most influential researchers who are leading the way in solving the world’s biggest challenges in across diverse scientific fields, including engineering, neuroscience, mathematics, and social sciences, among others. Determined on a global basis, these are researchers who are most highly cited in research publications by their peers, positioning them in the very highest strata of influence and impact. Professor Dressman is now being recognised among this elite group of researchers, which includes 17 Nobel laureates.
Professor Dressman‘s research publications are classified in the top 1% of the most cited papers in ‘Pharmacology and Toxicology’ research globally. She has published >300 research publications, which have been cited in excess of 10,000 times and has an overall h-index of 63. Her research has provided significant advances in the field of pharmaceutical technology and biopharmaceutics, specifically in shedding new insights into strategies to improve drug solubility for enhancing oral delivery, her pioneering the use of Biorelevant dissolution testing and in advancing the use of physiologically based pharmacokinetic (PBPK) modelling to achieve quantitative predictions of oral absorption.
More information about Professor Dressman’s research can be found at her university website.