Goldman Sachs jumps in, takes a board seat
TraceLink, the North Reading, MA, IT vendor that has carved out a leadership position in the software necessary for life sciences companies to meet the requirements of the Drug Supply Chain Security Act (DSCSA), has had a third round of private investment, receiving funds from its earlier-round investors and now from Goldman Sachs. In making the announcement, TraceLink noted that there are now 50 countries that will have some form of pharma traceability instituted by 2020; in the US, most manufacturers are aiming at a November 2017 deadline for having individual unique barcodes on each package of pharma products entering into commercial distribution.
The company claims over 450 clients currently, which break down (according to a recent quarterly statement) to 27% pharma manufacturers and their CMOs, 10% wholesale distributors, and the remainder, dispensing companies such as pharmacy chains and health systems.
Jason Kreuziger from Goldman Sachs and Amish Jani of FirstMark Capital (the original funder of TraceLink) have joined its Board of Directors.
TraceLink continues to stress its foundation as a completely cloud-based (on Amazon Web Services), multitenant architecture as the best approach to meeting DSCSA compliance. “Unlike the common approach that most companies take to rent data center space from Amazon and stand up a hosted environment, TraceLink has taken advantage of AWS as a platform as a service (PaaS) by engineering our applications, business logic, workflows, exception handling, user management and network architecture from scratch within the AWS multitenant environment,” says a company spokesperson.
But the competition is intensifying: SAP, which introduced its Advanced Track and Trace for Pharma a little over a year ago, claims a couple dozen major multinationals as clients, mostly using an on-premise IT architecture (although it recently began working with business partners on cloud-based implementations). It, and other players in the market, argue that multitenant architecture essentially forces all clients to undergo platform updates at the same time, and that private-cloud, single-tenant architectures can provide better security for the highly valuable trade data.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.