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3D-PharmXchange is proud to announce its collaboration with Antleron in the Living Factory 4.0 project. Antleron is a Leuven-based R&D company that develops custom bioprocess solutions for cell & gene therapy applications, with a focus on personalized and digital manufacturing. The Living Factory 4.0, supported by the CrossRoads program, aims to revolutionize the development and production of continue reading…
Introduction In our previous blog entitled ‘Biomarkers in early development‘, we highlighted the different types of biomarkers and their applications in (early) drug development. We discussed that biomarkers have the potential to speed up and enhance the chances of success of a clinical development program. A biomarker can, for example, define a patient subset most continue reading…
Introduction In my role as a consultant and in conversations with individuals who have limited experience in clinical drug development, I often find that there is some confusion between the terms “dose” and “exposure” (the plasma or local concentration of a drug). While these terms are related, they refer to distinct concepts, and understanding the continue reading…
Advanced Therapeutic Medicinal Products (ATMPs)—which include gene therapies, cell therapies, and tissue-engineered products — represent a new frontier in medicine, particularly in addressing serious and life-threatening conditions. To ensure that these innovative therapies are safe and effective for children, the preparation of Paediatric Investigational Plans (PIPs) is crucial. Under Paediatric Regulation (EC) No 1901/2006, [1] continue reading…
Empowering Dutch Biotech: Navigating Innovation and Market Success with the Dutch Regional Development Agencies on November 21, 2024 Ronald van der Geest, partner at 3D-PharmXchange, has been invited to attend the Life Sciences & Health ROMs Day, to advise the regional investment agencies on how to become even more effective in bringing Dutch Biotech ventures continue reading…
Antibody-drug conjugates (ADCs) are currently at the forefront of the drug development revolution occurring in oncology delivering on the long-standing promise of a highly effective and selective cancer treatment. They are among the fastest-growing drug classes in oncology with a remarkable surge in marketing approvals in recent years. Nine ADCs were FDA approved from 2017 continue reading…
In recent years, the biotechnology industry has seen a transformative shift towards patient-driven drug development. At 3D-PharmXchange, we have experienced firsthand the impact that patient involvement can have on the development of new therapies. It has already been well described that patients bring a unique perspective that often reshapes the design of clinical trials. Their continue reading…
The EMA glossary defines a biological marker, or biomarker, as ‘an objective and quantifiable measure of a physiological process, pathological process or response to a treatment (excluding measurements of how an individual feels or functions)’. Similarly, the FDA defines a biomarker as ‘a defined characteristic that is measured as an indicator of normal biological processes, continue reading…
Drug development is a daunting and difficult task where all the puzzle pieces need to click to result in an efficacious and safe treatment for patients. It is a high-risk endeavor involving many different scientific and non-scientific disciplines over a long period of time. The current estimates to develop a drug are about 2.3 continue reading…
Drug repurposing, also called drug repositioning, reprofiling or retasking, is the process of identifying a new use for an existing medicine/active substance outside the scope of the original indication(s). It includes new therapeutic uses for existing medicines, different formulations of the same medicine, and/or creating new combinations of medicines or medicines with medical devices[1]. Drug continue reading…
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