Reconsidering Risk, Before It's Too Late
Drugmakers have always preferred to in-license late-phase product candidates over earlier-stage ones. This value equation rests on the theory that drug candidates steadily shed risk as they move through development. But that's not necessarily so. Phase III products may in fact be riskier than most marketing and business-development people commonly assume.
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Bristol-Myers Squibb's licensing arrangement for ImClone's Erbitux--both its upfront cash value and its subsequent level of disappointment--continues to define the industry's late-stage dealmaking. Genta's development and marketing alliance with Aventis for Genta's phase III anti-cancer chemosensitizer, Genasense, is no exception: the deal is both bigger, and smaller, than it might once have been had BMS and ImClone not stirred up the dealmaking pot. The Genta product was one of the only remaining unpartnered, important late-stage cancer projects available from a biotech company. It commanded a hefty price --at $135 million in upfront and near-term assured cash terms, and another $345 million in milestones. Before ImClone, Aventis says, it could have gotten this deal for less money. But if the ImClone transaction hadn't gone suddenly south (the FDA in December refused to accept ImClone's BLA submission for Erbitux), Aventis might also have had to pay far more.
Manufacturers Should Map Processes, Bolster Quality Culture To Tackle Data Integrity Problems in The Microbiology Lab
To reduce the opportunity for data integrity failures in the microbiology lab, manufacturers should map out the workflow so that activities and expectations for employees are clearly spelled out. Having formalized processes will ensure that employees don’t cut corners.
Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.