Cold Chain Cold Chain in Canada eBook: 2014 | Page 21

Speaker Interview > Marken Sr. Director, Business Development What type of benefits can Direct-toPatient (DTP) delivery have on MultiCountry Trials? DTP delivery of clinical trial materials can facilitate access to a larger patient population and reduce the burden of long distance travel for those with late stage cancer or other debilitating conditions. The expanding global market for orphan drugs is particularly suited for DTP solutions, because of the greater geographical distribution of a smaller number of patients and the prevalence of biotechnology derived treatment options that may require more sophisticated handling during transit. In all areas of the world, Marken’s DTP delivery services make participation in clinical trials easier for the patient, which can improve enrollment, compliance and patient retention. Are there regulatory challenges specific to using DTP for clinical trials? 21 There are regulatory challenges, but DTP delivery of IMP is now being performed by Marken in many countries worldwide, and the regulatory climate is changing as more protocols are being reviewed by local authorities. Having established relationships in over 40 co