EDITORIAL SECTION

Articles

Pharmaceutical Business Strategy: Transformation, Regulation, Outsourcing and Growth

The pharmaceutical industry is standing at an unusual crossroads Patent cliffs are steeper regulators are tougher patients expect more transparency and payers are pushing back harder on price In this environment a strong Pharma Business Strategy is no longer a slide deck exercise for the boardroom its the difference between a company that scales globally and one that quietly fades into irrelevanc...

From Lab to Market: The Journey of a New Drug

The process of synthesizing a new drug takes many years and several phases and all of them are important for the drug safety and efficacy Which from the first identification in a lab to the final approval of use by the public is a process that takes over years and this involves work done by scientists various agencies and other health care givers

From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy

Every pharmaceutical executive can recite the journey from molecule to market Far fewer can say with confidence at which point in that journey their manufacturing strategy became capable of withstanding a regulatory inspection The distinction matters more than it once did Approval timelines are compressing

Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics

People respond very differently to medications depending on their weight age inborn capability to metabolize drugs the individual characteristics of the disease or the presence of comorbidities The wellknown assumption that one size fits all has clearly revealed all its limitations and become questionable Notably among humans pediatric patients represent

Harnessing the Intracellular Machinery to Degrade Cellular Proteins

A countless number of proteins including growth factors receptors and cytokines play a pivotal role during the onset and exacerbation of numerous human diseases including cancer autoimmune and inflammatory disorders Of these proteins extracellular and membraneassociated proteins represent around of human proteome

Brain Delivery of Biologics with Trojan Horse Shuttles: Remembering Paracelsus

Paracelsus in the th century established the principle of toxicology that the dose of a medicinal defines the difference between a remedy and a toxic effect

Techno Trends

University of Dundee’s Cabamiquine Shows Promise for Single-Dose Malaria Treatment

Researchers at the University of Dundee have reported encouraging clinical results for cabamiquine a novel antimalarial compound being developed as a potential singledose treatment for malaria

Projects

Genentech to Invest US$750 Million in Oregon Device Fill-Finish Facility

Genentech a member of the Roche Group plans to invest approximately US million in a new device fillfinish manufacturing facility at its acre campus in Hillsboro Oregon The project will add endtoend manufacturing

Research Insights

One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases

Idarubicine is a mainstay of the treatment strategy for hematological cancer The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies

whitepaper

Post-Translational Modifications in Drug Discovery: From Molecular Regulation to Clinical Impact

For decades the central dogma of molecular biology has anchored our understanding of cellular function DNA to RNA to protein But this linear view is incomplete A growing body of evidence shows that much of biologys