Romaldas Mačiulaitis

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The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing(More)
Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. They have therefore been subject to considerable interest(More)
In the past decade, the therapeutic value of mesenchymal stromal cells (MSCs) has been studied in various indications, thereby taking advantage of their immunosuppressive properties. Easy procurement from bone marrow, adipose tissue or other sources and conventional in vitro expansion culture have made their clinical use attractive. Bridging the gap between(More)
The first two authors contributed equally to this work. 1Committee for Advanced Therapies (CAT), European Medicines Agency, London, UK; 2Clinics of Nephrology, Institute of Physiology and Pharmacology, Lithuanian Health Science University, Kaunas, Lithuania; 3European Medicines Agency, London, UK; 4University of Pharmacy, Palermo, Italy; 5Danish Medicines(More)
Application of any new biomarker to support safety-related decisions during regulated phases of drug development requires provision of a substantial data set that critically assesses analytical and biological performance of that biomarker. Such an approach enables stakeholders from industry and regulatory bodies to objectively evaluate whether superior(More)
Current advances in stem cell research and innovative biological approaches in the field of tissue engineering and regenerative medicine could eventually translate into prospective clinical applications. Various adult organs and tissues harbor stem and progenitor cells that could potentially be used to repair, regenerate, and restore a variety of different(More)
Over the last decade DLW employing ultrafast pulsed lasers has become a well-established technique for the creation of custom-made free-form three-dimensional (3D) microscaffolds out of a variety of materials ranging from proteins to biocompatible glasses. Its potential applications for manufacturing a patient's specific scaffold seem unlimited in terms of(More)
Renal tubular acidosis (RTA) more frequently develops in case of chronic diseases of inflammatory-immunological origin. RTA is well known to be associated with chronic liver disease (CLD), with nephrolithiasis, common cases of RTA occur among cancer patients. Abnormalities in the expression or function of band 3 in cell membrane may play a role in the(More)
BACKGROUND In the European Union (EU), a medicinal product needs a marketing authorization (MA) to be placed on the market. The EU's medicinal products' legislative framework allows for a reduced application for medicines outside their data exclusivity. One such type of application is the well-established use (WEU) medicinal product application (i.e.(More)
In the past decade, novel cell-based products have been studied in patients with acute and chronic cardiac disease to assess whether these therapies are efficacious in improving heart function and preventing the development of end-stage heart failure. Cardiac indications studied include acute myocardial infarction (AMI), refractory angina, and chronic heart(More)