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Looming EU IDMP mandates are only part of the potential applications
As hinted at earlier, Veeva Systems, which is increasingly becoming a multipurpose IT platform for all things in life sciences, has taken the wraps off Veeva Network Product Master, a second offering from its Network Suite of applications. A year ago, it commercialized its first Network application, Customer Master; both systems make use of evolving technology in master data management (MDM), but for quite different applications. On its face, Customer Master connects readily with Veeva’s original and best-known application, Multichannel CRM for sales force automation; sales reps want to be able to connect with prescribers using the freshest available data, which Customer Master accesses through the company’s OpenData database.
With Product Master, considerably different business goals are being targeted: organizing relevant data on products (brands, dosage forms, packaging, components such as medication guides, and potentially all the information that identifies a product, in multiple languages and for multinational markets). This has obvious value simply in keeping track of what products are available in what forms and for what markets, but the potential utility goes well beyond that, explains Jim Cushman, recently hired GM of Veeva Network. “Product master data systems evolved from earlier efforts known as product information management (PIM), which was useful for catalogs and other compilations,” says Cushman, who has worked in this field at IBM and elsewhere. “Now, modern MDM technology allows for hierarchies of information to be developed, and to connect, for example, sales data with the product information. Product Master will enable a variety of business- and compliance-related tasks to be carried out much faster and more efficiently.”
Like all of Veeva’s products, Product Master is offered in a multitenant, cloud-based fashion; there is no hardware to purchase and the software and its upgrades are managed via a subscription service. Veeva touts the fact that Product Master is pre-built exclusively for life sciences applications; other vendors of MDM technology offer similar product MDM, but the systems would need to be tailored to the users’ requirements. Cushman says that the company is already targeting a next application of Product Master: tying the product data to its Customer Master so that, for example, a marketing manager could track which versions of a product are being ordered by which healthcare organizations (which sounds eminently practical in theory, but which is quite hard to achieve in practice).
Product MDM is not currently an obligation of US pharma manufacturers (although most manufacturers use MDM or other IT tools to manage their inventory of products and components), but this is about to change in Europe, where a multiyear effort, the Identification of Medical Products (IDMP) Task Force has been beavering away at a comprehensive data-management effort to manage not just commercial movement of products, but also clinical research efforts and healthcare outcomes such as adverse events. (An acronym related to IDMP is SPOR: Substance, Product, Organization and Referential data; the IDMP Task Force is operating under the aegis of the European Medicines Agency.) Earlier, a July 2016 deadline had been set for the initial phase of mandated practices, but the overall effort is sliding into a roughly defined schedule over the next several years.
To an outsider, SPOR and IDMP looks like a valiant effort to gather essentially all data about all things pharma, and make it accessible to regulators and healthcare providers; MDM tools are assumed to be available to make all this happen. It’s quite puzzling, however, that the IDMP effort is occurring on a track parallel to, but separate from, the Falsified Medicines Directive, which is an EU effort with a hard deadline (early 2019) for traceable information to authenticate commercial products. That directive, in turn, is very similar to the US effort organized under the Drug Supply Chain Security Act, for which US manufacturers and suppliers to the US market are already building labeling and tracking systems. All these things are in motion—but where they’re going to end up is hard to say.