Systems Biology: The Post Proteomics Era Begins?
Several 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.
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Pharmacogenomics has disappointed advocates who saw the opportunity to apply a discovery tool to the near-term goal of increasing approval chances and marketability for late-stage and marketed compounds. In return, they hoped to take a percentage of the highest-cost segment of the pharmaceutical budget. But Big Pharma is by and large not using pharmacogenomics for late-stage and marketed compounds: senior executives don't believe there's enough evidence it works and are afraid of limiting the marketability of the products by segmenting broad target populations into niches. Some also worry about uncovering potential side-effects that non-pharmacogenomic trials wouldn't reveal. Nonetheless, pharmacogenomics has made it to Big Pharma: most companies, for example, are banking samples from clinical trials to be pharmacogenomically tested retrospectively, thereby informing future trials. Not that this means the pharmacogenomics specialists will be able to sign high-value deals with the commercial side of drug companies, who believe that pharmacogenomic analysis is available from a number of sources, including internal ones, and feel they own the key assets for creating meaningful programs: compounds and patient samples. Instead, pharmacogenomics will find its place first as a discovery technology, integrated with other methods for finding, validating and prioritizing targets. That means that to succeed selling pharmacogenomics, biotechs will have to combine their pharmacogenomic assets with other discovery technologies, perhaps through mergers. An alternative: use their technologies to find drug products that they can themselves develop, perhaps later out-licensing them.
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Supreme Court’s six conservative justices say Constitution doesn’t guarantee a woman’s right to abortion services nor prohibit states from regulating or banning the services. Dissenting liberal members decry decision as erasing women’s constitutional rights.