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Long Acting Medicines for Complex Therapeutics Needed Now

Periodic Reporting for period 1 - LongActNow (Long Acting Medicines for Complex Therapeutics Needed Now)

Reporting period: 2019-10-01 to 2021-09-30

There is a current, future and global need for the development of additional long acting (LA) drug formulations that achieve extended release dosage forms that are stable, predictable and which can be applied across multiple and complex Active Pharmaceutical Ingredient (API) groups.
Enabling innovative therapies and drug formulations that meet these requirements at an industrial scale will not only unlock potential cost efficiencies for pharmaceutical manufacturers, but also, and importantly, it will result in more effective therapies at lower cost for vulnerable patient groups such as those facing chronic illness or those living in the developing world.

LongActNow will deliver industrially-informed, interdisciplinary training to five Early Stage Researchers (ESRs) in relevant areas of expertise including crystallisation, solution behaviour modelling and solvent switching, pharmacokinetics and formulation.
ESRs will also benefit from exposure to industrial research environments as part of their career development training. The 3-year contract will provide a well-defined research and training programme with access to excellent supervision and research infrastructure, a personalised career development plan and an research ecosystem that promotes network-building, mentorship and collaboration.

LongActNow is a Marie Skłodowska-Curie ITN action (MSCA) led by a consortium of significant international academic and industrial centres: University of Limerick (UL), Synthesis and Solid State Pharmaceutical Centre (SSPC), Trinity College Dublin (TCD), Technische Universität Dortmund (TUD) and Janssen Pharmaceutica (Janssen).
The MSCA programmes equip researchers with the necessary skills and international experience for a successful career, either in the public or the private sector. The MSCA programme responds to the challenges sometimes faced by researchers, offering them attractive working conditions and the opportunity to move between academic and other settings.

In keeping with the ethos of MSCA actions, LongActNow aims to:

1. INVESTIGATE
Investigate bottom-up technologies, with potential for upscaling and process integration, for production of LA stable crystal suspensions and for solvent-switching, including means for process control;
2. UNDERSTAND
Gain a more in-depth understanding of the end-to-end impact of excipients on the crystallization processes (nucleation, stabilization, crystal growth, polymorphism control, solvent switch) by modelling the molecular interactions that take place during crystallization and stabilization; and

3. VERIFY
Verify the research outcomes by comparing the resulting technology with current upscaled top-down technologies and applying selected technologies and methodologies for a selection of highly challenging APIs available at Janssen
In the first year of the project the ESRs have all been recruited and are currently located across the consortium’s team sites, in Ireland, Germany and Belgium. Together with their academic and industrial supervisors the ESRs have designed their personal career development plans and have been integrated into the LongActNow network as well as the various institutions where they are currently seconded. The LongActNow website is active and contains biographies and introductory videos to the ESRs (www.longactnow.eu). The ESRs have also engaged in outreach activities with the Marie Curie Scholarship network and the Women in Engineering UC newsletter.
The team has a selection of recurring meetings that ensure alignment of the individual ESR projects and the continuous training and development or the researchers, including:
LongActNow Monthly Meeting
LongActNow Technical Review meeting (once every two months)
Biannual Consortium Meeting (twice a year)
Advisory Board Meeting (once a year)
LongActnow coffee morning (once every two weeks)
LongActNow Journal Club (once a month)
Individual LongActNow ESR meetings with supervisors
Actions from the LongActNow committees (i.e. recruitment, research, training, data management and ESR committees) are incorporated into the LongActNow Monthly Meeting as agenda items as appropriate and are then lead by the respective Chair. The respective policies on data management, publication and open science strategies have all been agreed and signed by all members of the consortium.
The ESRs have received technical and generic skills training from their currently institutions, and all ESRs participated in a Solid State Pharmaceutical Workshop, designed and organised by LongActNow supervisors Sarah Hudson (UL) and Lidia Tajber (TCD) in collaboration with the SSPC. All ESRs have started their experimental work in the lab with the generation of API solubility data (both empirical and modelled), the screening of suitable excipients for a panel of APIs and the optimisation of process parameters during top down (milling) and bottom up (supercritical spray drying and liquid antisolvent precipitation) production of API suspensions is currently being conducted. The ESRs have conducted a literature review and are also in the process of writing some of their research into articles for publication.
LongActNow will enhance the career perspectives and employability of the ESRs and contribute to their skills development with its uniquely designed training plan. There is a current as well as future market need for researchers trained and skilled in innovative and advanced formulation approaches. The pharmaceutical sector in Europe invested €35 billion in R&D in 2016. It is one of the top performing high-technology sectors, employing nearly 750,000 people directly (3 to 4 times more indirectly). Several market-oriented reports, including MarketsandMarkets (TM), highlight global sales forecasts of $1-3 trillion in nano-pharmaceuticals by 2020, and $789.7 billion in injectable drug delivery by 2024. To tap into this market, it is essential for the EU to maintain its competitive edge in pharmaceutical manufacturing. The exposure of ESRs to an inspiring international, multidisciplinary and multicultural collaboration with world-class academic and industrial researchers will enhance their innovation potential and open career perspectives. After completing their PhD degrees, all five ESRs will possess a set of technical and soft skills making them highly employable in the pharmaceutical industrial sector world-wide, in multinationals and SMEs alike, as well as in academia, with a possibility of pursuing a “dual”, inter-sectoral career.
Technically, the project will develop a platform technology that will expedite the development of complex therapeutics into long acting injectable suspensions. It will use empirical and in silico based approaches to design the formulation composition and enable the selection of the production method and process parameters best suited to the properties of the therapeutic agent required.
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