Grant Hodgkins, ex of Alcon Labs, joins Jay Crowley, ex-FDA senior advisor, at the firm
USDM Life Sciences (Santa Barbara, CA), which has provided regulatory compliance consulting, validation, auditing and staff-augmentation services for life sciences clients for over a decade, has brought on a pair of leaders in the serialization/track-and-trace field for pharma and the medical-device Universal Device Identification (UDI) field. Crowley, VP for the UDI Practice, joined the firm at the end of last year, and Hodgkins, VP, Commercial Practice, came on in late April.
“We’ve been assisting life sciences companies for 15 years to meet a range of compliance objectives,” says Kevin Brown, managing partner of the firm. “The current regulatory initiatives in UDI and serialization represent a tremendous opportunity to empower both these industries not just to meet compliance goals, but to improve their overall performance, get products to market faster, and provide better security in supply chain practices,” he says.
In addition to having served as head of global data management at Alcon, Hodgkins has been the tri-chair of the GS1 Healthcare Leadership Team, co-chair of two other GS1 workgroups involved with standards-setting in product data management. Crowley has spearheaded the FDA effort to develop a reliable system to label and then track medical devices, culminating in the FDA UDI final rule published last September. Going forward, both applications are likely to depend heavily on standards being written by the GS1 organization; FDA has already designated GS1 as one of the first “accredited issuing agencies” for providing UDIs to manufacturers.
Besides the inherent crossover between drugs and devices (many drugs are now marketed via the device in which they are administered), UDI and serialization share common technical requirements and serve comparable purposes in their respective applications. “The med device industry started out behind pharma in its path, but I think they’re moving faster now,” says Crowley. “Eventually the technologies are going to converge.”
For its part, USDM joins a growing list of consulting and systems integration firms that are positioning themselves to provide needed services to pharma and device companies in implementing the new regulatory requirements. Both the UDI and serialization rules have deadlines in the 2015-2015 range and beyond; and in both industries, observers fear a coming crunch of available technical resources to meet the deadlines.