Systems Biology: The Post Proteomics Era Begins?
Executive SummarySeveral emerging companies are building platforms around the concept of systems biology, which is premised on the idea that drug and diagnostic discovery require studying the ways in which the various elements of biological systems-including, but not limited to, genes and proteins-integrate and interact within an organism or function. This ambitious undertaking requires an arsenal of high-throughput technology and expertise drawn from a myriad of disciplines including chemistry, bioanalysis, molecular and cell biology, medicine, and informatics. The immediate challenge facing aspiring systems biology companies is to sustain themselves by creating sufficient value from their expansive technologies during the years it will take to come up with a novel diagnostic or therapeutic. Along with traditional discovery deals, as well as deals to resurrect partners' projects which have failed for lack of understanding about their proper use, several players are proposing interim steps to create product businesses, like using their technologies to find undervalued in-licensing candidates.
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.