Genzyme Muscles Into Heart Surgery
Genzyme Surgical is intent on making a name for itself in cardiac surgery, and banking on a hybrid strategy to distinguish itself from giant competitors like Medtronic and Guidant. Its plan is to combine traditional surgical instruments, from which it expects to derive most of its near-term growth, with longer-term plays in biomaterials and biotherapeutics, a strategy it calls biosurgery. As a tracking stock of Genzyme Corp., it has the advantage of being able to tap into Genzyme's deep expertise in gene and cell therapies in order to develop therapies for severe heart failure. But as it puts in place a diverse portfolio of expertise, it runs the risk of spreading itself too thin. Moreover, it faces skepticism from Wall Street and criticism that it doesn't have the critical mass to be a player in the fastest growing area of cardiac surgery--minimally invasive beating heart surgery, where it is trying to make inroads. Genzyme Surgical executives say that it is forging a new path in a field rife with tradition and that ultimately it will have more to offer cardiac surgeons than its competitors--moreover, it is not reliant upon the success of any one product.
You may also be interested in...
Having rejected a bid by Medtronic, Cyberonics believes its epilepsy business is the basis for much bigger opportunities. Cyberonics holds key method patents on a device for vagus nerve stimulation, which it refers to as an "implantable pacemaker for the brain." It believes the technology has far-reaching clinical applications for neurological disorders traditionally treated by drugs. A body of literature demonstrates the product's efficacy and ease of use in selected epilepsy patients. The product has been FDA approved and on the market since 1997. However, Cyberonics has yet to prove its device will work in broader applications like depression, which have larger markets but also significant competition from drugs.
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.