Single-chain variable fragments (scFvs) penetrate tissue more effectively than full antibodies and are simpler to produce, but the mutant proteins that define a tumor are predominantly intracellular and therefore inaccessible to conventional antibodies. What is accessible is the mutation-derived peptide displayed on ce...
Sarfaraz K. Niazi, Matthias Magoola, Zamara Mariam· npj Drug Discovery· 0 citations
Follow-on approval processes in the United States are conducted through three distinct legal pathways: abbreviated new drug applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act; applications under section 505(b)(2); and biosimilar applications under section 351(k) of the Public Health Service A...
Rare diseases affect hundreds of millions of individuals worldwide, primarily resulting from genetic factors, with many presenting during childhood. Advances in genome sequencing increasingly enable identification of the responsible gene in more patients; however, only a limited selection of therapies exists to correct...
Sarfaraz K. Niazi· Communications Medicine· 0 citations
It is argued that the hallmarks framework, while historically essential, is no longer sufficient on its own to capture contemporary cancer care, and repositions the discussion around enabling technologies that operate across and beyond individual hallmarks.
A systematic evaluation of thermodynamic, kinetic, transport, transport, and microenvironmental constraints can identify candidates likely to fail on physical grounds prior to substantial investment in synthesis and translational research, thereby conserving resources for the inherently experimental validation of biolo...
Sarfaraz K. Niazi· Frontiers in Drug Discovery· 0 citations
The Dynamic Protein Structure Paradox is defined as the apparent conflict between structural accuracy and functional underdetermination and DPSP is developed as an integrative evidentiary assessment framework rather than a new theory or paradigm.
Sarfaraz K. Niazi· Cells· 0 citations
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