The Project

Work packages

Nine interlocking work packages structure the HUNADIA programme — from manufacturing and trial design to evaluation and dissemination.

WP1

Management

Project management

WP2

Scientific Leadership

Scientific project leadership

WP3

Clinical Trial Design

Developing an adaptive late-stage clinical trial design.

WP4

Capacity Building

Establishing and training recruitment sites for capacity building.

WP5

Manufacturing

Preparing VR-AD-1005 for CT (chemistry, manufacturing and control).

WP6

Clinical Trial

Implementing the large-scale Phase IIb/III clinical trial

WP7

Data Management & Statistics

Data management, statistical analysis and generation of trial evidence

WP8

Evaluation & HTA

Evaluating the impact of VR-AD-1005, including a health technology assessment (HTA) / cost-effectiveness study

WP9

Outreach & Dissemination

Communication, dissemination, stakeholder engagement, regulatory compliance and exploitation.