Since their introduction just under three years ago REMS, or risk evaluation and mitigation strategy programmes, have emerged as one of the most challenging regulatory aspects of drug development.
Most of the difficulty lies in managing and collating multiple data types from multiple sources into a centralised coherent structure that provides an insight into the safety of a pharmaceutical product in the real world.
This was a key motivation for the new collaboration which aims to develop a novel REMS management technology based on Microsoft’s Amalga aggregation and HealthVault personal data platforms.
The firms claim the new technology will be a “first-of-its-kind” solution that PPD will use as part of its late-stage and post-market offerings to help clients fulfil their operational REMS requirements.
Lori Eberhardt, the contract research organisation’s (CRO) global VP of late stage-research, said customer need was the driver for the deal explaining that: “Clients rely on our expertise in delivering comprehensive risk management programs, which are critical to ensuring patient safety.”
PPD did not respond to Outsourcing-pharma’s request for additional information.
Q2 financials
The expansion of PPD’s development-stage offering is timely given that, for the last three months, this segment has been its biggest revenue generator according to results the firm released yesterday.
The late-stage business, which covers all of PPDs trial and post-market services, saw revenue climb 1 per cent to $333.8m while its preclinical division contributed just $7m as a result of a milestone payment from Takeda.
Overall though the US CRO struggled in Q2 with operating income across the group falling around $18m to $40m, despite a 4 per cent increase in total net revenue to $369m.
PPD attributed the operating income decline to integration expenses associated with recent acquisitions like Excel Pharmastudies and costs related to the divestiture of its compound partnering business.