ORBIS project – where have we arrived?

Authors

DOI:

https://doi.org/10.20883/medical.e936

Keywords:

international and intersectoral project, drug synthesis, solid state pharmaceuticals, oral and skin delivery, biorelevant dissolution, biomedical analysis

Abstract

The Open Research Biopharmaceutical Internships Support project (ORBIS) was a response to the scientific, economic, and social challenge of increasing the effectiveness and productivity of the drug development process, both for innovative and (super)generic drugs. The overarching objective of the ORBIS project was to form a transnational and intersectoral cooperation network of academic and industrial organisations delivering a joint research programme. The research aimed at improving the preclinical pathway of drug development and manufacturing, focusing on technological and methodological improvements of the existing processes. The participating staff from all institutions have developed new skills, were exposed to new work and research environments, and have significantly broadened their career perspectives. More than 450 months of secondments were completed, and over 175 early-stage and experienced researchers participated in the exchange. This review aims to present some aspects of the scientific, training, and organisational activities of the consortium, bringing together representatives of both the academic sector as well as small and medium-sized pharmaceutical enterprises.

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References

Rudzki PJ, Milanowski B, Tajber L, Garbacz G, Jakubowska E, Rychter M, et al. Otwarcie międzynarodowego i międzysektorowego projektu ORBIS (Horyzont 2020). Farm Pol. 2018;74(7):413–6.

Jakubowska E, Davin S, Dumicic AD, Garbacz G, Juppo A, Michniak-Kohn B, Rudzki PJ, Smułek W, Strachan C, Syarkevych O, Tajber L, Lulek J. ORBIS (Open Research Biopharmaceutical Internships Support) – building bridges between academia and pharmaceutical industry to improve drug development. JMS. 2020 Mar 31;89(1):e419. doi: 10.20883/medical.419

Machado Cruz R, Boleslavská T, Beránek J, Tieger E, Twamley B, Santos-Martinez MJ, Dammer O, Tajber L. Identification and Pharmaceutical Characterization of a New Itraconazole Terephthalic Acid Cocrystal. Pharmaceutics. 2020 Aug 6;12(8):741. doi: 10.3390/pharmaceutics12080741.

Skotnicki M, Jadach B, Skotnicka A, Milanowski B, Tajber L, Pyda M, Kujawski J. Physicochemical Characterization of a Co-Amorphous Atorvastatin-Irbesartan System with a Potential Application in Fixed-Dose Combination Therapy. Pharmaceutics. 2021 Jan 18;13(1):118. doi: 10.3390/pharmaceutics13010118.

Lulek J, Grynkiewicz G, Jachowicz R, Kopeć K, Krause A, Kuźmierkiewicz W, Maciejewska B, Moszczyński-Petkowski R, Rachoń J, Rudzki P. Strategia Farmaceutyczna dla Europy: czy synteza substancji czynnych może stać się polską specjalnością? Nauka. 2021;3:47-66. doi: 10.24425/nauka.2021.136326

Skupin-Mrugalska P, Minko T. Development of Liposomal Vesicles for Osimertinib Delivery to EGFR Mutation-Positive Lung Cancer Cells. Pharmaceutics. 2020 Sep 30;12(10):939. doi: 10.3390/pharmaceutics12100939.

Paczkowska-Walendowska M, Dvořák J, Rosiak N, Tykarska E, Szymańska E, Winnicka K, Ruchała MA, Cielecka-Piontek J. Buccal Resveratrol Delivery System as a Potential New Concept for the Periodontitis Treatment. Pharmaceutics. 2021 Mar 20;13(3):417. doi: 10.3390/pharmaceutics13030417.

Bartkowiak A, Lewandowicz J, Rojewska M, Krüger K, Lulek J, Prochaska K. Study of viscoelastic, sorption and mucoadhesive properties of selected polymer blends for biomedical applications. J Mol Liq. 2022;361:119623.

Dan A, Vaswani H, Šimonová A, Grząbka-Zasadzińska A, Li J, Sen K, Paul S, Tseng YC, Ramachandran R. End-point determination of heterogeneous formulations using inline torque measurements for a high-shear wet granulation process. Int J Pharm X. 2023 Jun 12;6:100188. doi: 10.1016/j.ijpx.2023.100188.

Froelich A, Osmałek T, Jadach B, Puri V, Michniak-Kohn B. Microemulsion-Based Media in Nose-to-Brain Drug Delivery. Pharmaceutics. 2021 Feb 2;13(2):201. doi: 10.3390/pharmaceutics13020201.

Zhang J, Froelich A, Michniak-Kohn B. Topical Delivery of Meloxicam using Liposome and Microemulsion Formulation Approaches. Pharmaceutics. 2020 Mar 21;12(3):282. doi: 10.3390/pharmaceutics12030282.

Zhang ZJ, Osmałek T, Michniak-Kohn B. Deformable Liposomal Hydrogel for Dermal and Transdermal Delivery of Meloxicam. Int J Nanomedicine. 2020 Nov 24;15:9319-9335. doi: 10.2147/IJN.S274954.

Osmałek T, Froelich A, Jadach B, Tatarek A, Gadziński P, Falana A, Gralińska K, Ekert M, Puri V, Wrotyńska-Barczyńska J, Michniak-Kohn B. Recent Advances in Polymer-Based Vaginal Drug Delivery Systems. Pharmaceutics. 2021 Jun 15;13(6):884. doi: 10.3390/pharmaceutics13060884.

Dańczak-Pazdrowska A, Gornowicz-Porowska J, Polańska A, Krajka-Kuźniak V, Stawny M, Gostyńska A, Rubiś B, Nourredine S, Ashiqueali S, Schneider A, Tchkonia T, Wyles SP, Kirkland JL, Masternak MM. Cellular senescence in skin-related research: Targeted signaling pathways and naturally occurring therapeutic agents. Aging Cell. 2023 Jun;22(6):e13845. doi: 10.1111/acel.13845.

Danielak D, Banach G, Walaszczyk J, Romański M, Bawiec M, Paszkowska J, Zielińska M, Sczodrok J, Wiater M, Hoc D, Kołodziej B, Garbacz G. A novel open source tool for ELISA result analysis. J Pharm Biomed Anal. 2020 Sep 10;189:113415. doi: 10.1016/j.jpba.2020.113415.

Hincker A, Frey K, Rao L, Wagner-Johnston N, Ben Abdallah A, Tan B, Amin M, Wildes T, Shah R, Karlsson P, Bakos K, Kosicka K, Kagan L, Haroutounian S. Somatosensory predictors of response to pregabalin in painful chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled, crossover study. Pain. 2019 Aug;160(8):1835-1846. doi: 10.1097/j.pain.0000000000001577.

Karaźniewicz‑Łada M, Kosicka‑Noworzyń K, Rao P, Modi N, Xie YL, Heysell SK, Kagan L. New approach to rifampicin stability and first‑line anti‑tubercular drug pharmacokinetics by UPLC‑MS/MS. J Pharm Biomed Anal. 2023;235:115650. doi: 10.1016/j.jpba.2023.115650.

Kaza M, Karaźniewicz-Łada M, Kosicka K, Siemiątkowska A, Rudzki PJ. Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse? J Pharm Biomed Anal. 2019 Feb 20;165:381-385. doi: 10.1016/j.jpba.2018.12.030.

Rudzki PJ, Biecek P, Kaza M. Incurred Sample Reanalysis: Time to Change the Sample Size Calculation? AAPS J. 2019 Feb 11;21(2):28. doi: 10.1208/s12248-019-0293-2.

Haznar-Garbacz D, Hoc D, Garbacz G, Lachman M, Słomińska D, Romański M. Dissolution of a Biopharmaceutics Classification System Class II Free Acid from Immediate Release Tablets Containing a Microenvironmental pH Modulator: Comparison of a Biorelevant Bicarbonate Buffering System with Phosphate Buffers. AAPS PharmSciTech. 2022 Jul 26;23(6):203. doi: 10.1208/s12249-022-02310-z.

Juszczyk E, Kisło K, Żero P, Tratkiewicz E, Wieczorek M, Paszkowska J, Banach G, Wiater M, Hoc D, Garbacz G, Sczodrok J, Danielak D. Development and Bio-Predictive Evaluation of Biopharmaceutical Properties of Sustained-Release Tablets with a Novel GPR40 Agonist for a First-in-Human Clinical Trial. Pharmaceutics. 2021 May 28;13(6):804. doi: 10.3390/pharmaceutics13060804.

Danielak D, Milanowski B, Wentowski K, Nogowska M, Kątny M, Rogowski P, Konwicki Ł, Puk E, Pieczuro J, Bawiec M, Garbacz G, Lulek J. Physiologically Based Dissolution Testing in a Drug Development Process-a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions. AAPS PharmSciTech. 2020 Jun 2;21(5):161. doi: 10.1208/s12249-020-01662-8.

Malaviya R, Abramova EV, Rancourt RC, Sunil VR, Napierala M, Weinstock D, Croutch CR, Roseman J, Tuttle R, Peters E, Casillas RP, Laskin JD, Laskin DL. Progressive Lung Injury, Inflammation, and Fibrosis in Rats Following Inhalation of Sulfur Mustard. Toxicol Sci. 2020 Dec 1;178(2):358-374. doi: 10.1093/toxsci/kfaa150.

Danielak D, Krejčí T, Beránek J. Increasing the efficacy of abiraterone - from pharmacokinetics, through therapeutic drug monitoring to overcoming food effects with innovative pharmaceutical products. Eur J Pharm Sci. 2022 Sep 1;176:106254. doi: 10.1016/j.ejps.2022.106254.

Kaza M, Sokolovskyi A, Rudzki PJ. 10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented? Pharm Res. 2020 Jul 13;37(7):140. doi: 10.1007/s11095-020-02871-3.

Grynkiewicz G, Maruszak W. Open Space Knowledge and Data and Their Influence on Natural Products Based Self‑Medication Trends. Cancer Stud Ther. 2019;4(3):1–3. doi: 10.31038/CST.2019435.

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Published

2023-09-30

How to Cite

1.
Skotnicki M, Jakubowska E, Smułek W, Davin S, Tajber L, Lulek J. ORBIS project – where have we arrived?. JMS [Internet]. 2023 Sep. 30 [cited 2024 May 12];92(3):e936. Available from: https://jms.ump.edu.pl/index.php/JMS/article/view/936

Issue

Section

Invited Editorials
Received 2023-09-26
Accepted 2023-09-29
Published 2023-09-30