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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…
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…
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…
The proof-of-concept studies have shown promising results and bring a therapy a step closer to the clinic. But what is needed before this therapy can show its efficacy in a clinical trial? Cell therapy is a promising treatment, but its development is challenging due to its complex technology and the regulatory framework in which it continue reading…
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