Abstract

The way in which pharmaceuticals and biopharmaceuticals are being researched, developed and delivered to patients has changed significantly in the last 10 years.  New models of working with partner organisations to achieve the vision and outcomes of precision medicine and value added healthcare have necessitated this change.  In conjunction, the models by which contract givers and contract acceptors work together in achieving these new approaches are also requiring to change. 

The days of “command and control” do not meet with the expectations of 21st century collaborative working and a shift from a mind-set of “what’s in it for me” to “what’s in it for we” has the power to build alliances and partnerships which not only recognise but deliver on meeting the needs of all the stakeholders, building a mutually agreed set of objectives and deliverables that look to the long term rather than the here and now, unlocking innovation and ultimately improving patient outcomes.

In this article we will explore the journey required to align the cultures of both “Contract Giver” and “Contract Acceptor” towards a collaborative mind-set such that the potential benefits of Vested®  Outsourcing can be realised by all the stakeholders.

ESTABLISHING THE REGULATORY CONTEXT

It is difficult in the current and future world of pharmaceutical and biopharmaceutical development not to consider out-sourcing and out-tasking as integral aspects of bringing a new drug from the early stages of discovery through to regular manufacture, global distribution and patient utilisation.  The days of “making what we sell and selling what we make” have gradually been consigned to past practice in today’s global marketplace. The necessity of healthcare economics to address both the costs of developing and making pharmaceuticals but also pricing and re-imbursement within a healthcare environment whereby approved drugs are subject to much more scrutiny regarding improving patient outcomes and providing health economics that start to address aging populations, the associated costs of delivering these modern healthcare systems are driving a review and evolution of how businesses interact and collaborate to meet these needs.

From the perspective of the regulatory stakeholders, the relationship between “Contract Givers” and “Contract Acceptors”, as defined in the rules and regulations of Good ...