MDS restructuring had little impact on early stage; VP

23-Nov-2009 - Last updated on 23-Nov-2009 at 10:21 GMT

The splitting up of MDS Pharma Services had little impact on the remaining business as there was limited integration anyway, according to a VP who detailed how the divestitures have allowed resources to be focused on core strengths.

MDS has initiated an extensive restructuring programme, selling off its late-stage division and Central Labs, and this has allowed it focus on what it believes is the “core strength” of Pharma Services, which may also be sold if an appropriate deal can be put in place.

Despite two sizeable divestitures occurring in the past six months there has been “very limited impact” on the remaining business, which is focused on discovery through to Phase IIa, according to James Miskel III, vice president (VP), operations, early clinical research at MDS.

At AAPS 2009 Miskel explained to Outsourcing-Pharma that, although two years ago the company had hoped to become an end-to-end service provider, there was limited interaction between the early stage and the divested businesses and this minimised disruption.

The main loss was cardiac services capacity at Central Labs. Miskel said that before the divestiture Central Labs performed around 50 per cent of early stage’s cardiac work, with the remainder being outsourced, notably to ERT, and the loss of in-house capacity has led to investment.

MDS has added new equipment and custom software to streamline its cardiac safety studies. By adding these Miskel claims MDS can cut associated costs and times. Furthermore, bringing the service in-house allows for a rapid turnaround that can generate savings for MDS and its clients.

This is intended to strengthen operations at MDS’ remaining business, which Miskel believes was always its “core strength”. He added that the late stage business never achieved the “critical mass” needed to be a major player and this factored into the decision to divest the operation.

Creative trial design

Miskel said that pharma has is now more interested in creative trial design, such as use of adaptive practices, and MDS has acted to accommodate these requests.

For instance, by running by running single and multiple ascending dose (SAD and MAD) studies in parallel MDS was able to cut that stage of development by 12 weeks.

In addition MDS has begun performing more Phase I trials in patient populations, giving early indications of efficacy, safety and bioavailability in the target group, and Miskel believes this has reached “critical mass”.

He gave an example in which MDS worked with a sponsor to perform a Phase I ascending dose study in healthy volunteers and used data this generated to treat patients in the second part of the trial.