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… 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… 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… 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… 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… 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… 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… The Göttingen Minipig was developed at the University in Göttingen, Germany to meet the demand for a non-rodent model with many similarities to humans as genetic management is required to… The 4 pivotal questions you have on PDEs answered: A shared concern on how to create science-based PDEs. From a safety perspective, all companies with multifunctional pharmaceutical and chemical production…
How to Prepare Paediatric Investigational Plans (PIPs) for ATMPs: Key Clinical Science Insights
Antibody-drug conjugates: targeted cancer therapies coming of age
Patient-Driven Drug Development: Does Patient Involvement Truly Improve the Success Rates of New Treatments?
Biomarkers in early drug development
Evaluation of drug safety does not start at candidate nomination: Create value by de-risking early
Unleashing the Power of Drug Repurposing
Cell Therapy: Towards a First-in-Human Trial
How Is The Minipig Used In Drug Development?
How To Create Science-Based PDEs
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