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Open Research Biopharmaceutical Internships Support

Deliverables

1st School on pharmaceutical preformulation testing of APIs and dosage forms.

The 1st Summer School will be organised and hosted by Trinity College Dublin in cooperation with APC. The programme will consist of lectures on the state of the art and recent advances in preformulation studies, as well as practical workshops and hands-on demonstrations of various API and dosage form characterisation techniques, e.g. thermal analysis or X-ray diffraction. The Summer School will be based on the expertise both from the ORBIS partners (especially TCD as the member of Synthesis and Solid State Pharmaceutical Centre) and invited external experts in preformulation studies from academia and industry. Apart from upskilling ORBIS ESRs in the area of preformulation studies, the Summer School will offer an excellent academia-industry networking opportunity by gathering the members of all Consortium Partners, as well as an opportunity to demonstrate the capabilities of TCD and APC.

Mid-term meeting.

This meeting will take place in Warsaw. The purpose of this meeting is to assess the fulfillment of all aspects (scientific, research, training, management, etc) of the project described in the Grant Agreement- Annex no.1. The structure of the work plan will be reviewed. Particular attention will be paid to the training activities and secondments aspects including activities across different sectors of the ORBIS consortium.

Workshop on dosage forms and drug delivery systems.

The workshop will be hosted in Helsinki directly after 2nd Summer School, while ZNT as an industrial partner will be responsible for the programme organisation. The event will be directed specifically to the ORBIS members and will consist of meetings, presentations and discussions on the scientific outcomes of the activities described in WP2. The case studies demonstrated by the participants will focus especially on topics such as: - design and development of polymeric micro- and nanoparticles, minitablets and self-microemulsifying systems, - application of novel spectroscopic and imaging approaches for structural characterisation of solid formulations, - implementation of Quality by Design principles to manufacturing process, - design of topical and transdermal delivery system, including ionic liquids or microemulsion-based solid systems. The workshop is intended to create a favorable environment for knowledge sharing between all ORBIS members and an opportunity to discuss the outcomes of secondments as well as further research collaboration between industrial and academic participants. Moreover, the event will also foster the soft skills development for the involved ESRs, who will have an excellent opportunity for the public presentation of their scientific results and secondments experience in the form of posters and/or short oral presentations.

Kick-off meeting.

Kick of meeting will take place in Poznan at coordinator place. It provides high level information about the project and help: to set expectations across the entire team, to crack the ice that can inhibit team communication to ensure that every consortium partner understand the ORBIS vision, objectives, benefits, deliverables and milestones, thereby helping the all team be successful.

2nd School on oral dosage and drug delivery systems.

The Summer School will be organised and hosted by UoH. The programme will consist of lectures on the state of the art and recent progress in the development of oral dosage forms and advanced delivery systems, such as nano- and microparticles, minitablets, self microemulsifying drug delivery systems (SMEDDS) or mesoporous materials. Apart from the lectures, some of which are planned to be given by external high-profile experts in the field of oral drug delivery, School participants will be involved in practical exercises on different formulation techniques (e.g. fluid bed granulation, spray drying, minitablets) and advanced techniques for in-depth characterisation of dosage forms (e.g. various modifications of Raman spectroscopy) owing to UoH capabilities. Apart from upskilling ORBIS ESRs in the area of oral drug delivery studies, the Summer School will offer an excellent academia-industry networking opportunity by gathering the members of all Consortium Partners.

Open Workshop on process development of drug substances.

The workshop will be hosted in Dublin directly after 1st Summer School, while FMK as an industrial partner will be responsible for the programme organisation. The event will be directed specifically to the ORBIS members and will consist of meetings, presentations and discussions on the scientific outcomes of the activities described in WP1. The case studies demonstrated by the participants will focus especially on topics such as continuous scalable synthesis of APIs, development of key synthetic transformations or process validation and transfer. The workshop is intended to create a favorable environment for knowledge sharing between all ORBIS members and an opportunity to discuss the outcomes of secondments as well as further research collaboration between industrial and academic participants. Moreover, the event will also foster the soft skills development for the involved ESRs, who will have an excellent opportunity for the public presentation of their scientific results and secondments experience in the form of posters and/or short oral presentations.

ORBIS website launched + Social media channels established.

The ORBIS website will be designed as a main platform for communication of ORBIS participants with multiple audiences. The aims, key contributors and the current progress of the action will be presented on an interactive and dynamic website, driven by participating organisations and WP6 leaders and powered by a professional web-site administrator. The website content will be addressed to both peer scientists and the general public. News for media, placed periodically in a dedicated section, will be provided by ORBIS researchers and translated into a popular style by website WP6 dedicated editor. The website will gather data on ORBIS members and activities as well as will feature a constantly updated collection of publications, lectures and training materials created by ORBIS participants. The information presented on the portal will be also oriented for potential users of ORBIS achievements and for the wider research and innovation community, including national and international technology transfer centres as well as SMEs, to amplify the potential impact of this action. To increase global project visibility on the Internet, the dissemination of results on ORBIS website will be supported by social media channels. Regular updates will be posted for professionals on ResearchGate and for general public on Twitter and Facebook. Both ORBIS website and social media chanells will be launched at the very beginning of the project and will be operated by PUMS. All ORBIS participants will be involved in creation of website content and updates.

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Publications

Incurred Sample Reanalysis: Time to Change the Sample Size Calculation?

Author(s): Piotr J. Rudzki, Przemysław Biecek, Michał Kaza
Published in: The AAPS Journal, Issue 21/2, 2019, ISSN 1550-7416
DOI: 10.1208/s12248-019-0293-2