Introduction As pharmaceutical drugs become physically larger, from small molecules to biologics to gene and cell therapies, so their molecular complexity increases. Small molecule drugs can be defined at the… Cellular starting material in ATMP manufacturing A challenge that many developers of ATMP products are faced with is the selection and qualification of starting material. The large diversity of ATMP… 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… 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… 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…
Identity analytics: For cell-based therapies, the analytics, in addition to the process, are the product
From source to product: Starting material challenges in ATMP development
How to successfully develop and validate molecular biomarkers for use in clinical trials
What is the Right Dose for Patients: An Introduction for Laymen
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
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