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International Clinical Trials

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ICT: Tell us a bit about your current role and its demands?

Nadia Whittley: I have joined Pharmarama at a pivotal point in its history: we need to build on past successes and look at how we can continue to remain a trusted, valuable partner for our customers. My role is to utilise existing internal strengths, and identify the new vision and strategy to get there.

To what extent does pharma find sourcing comparator drugs logistically difficult and an unwelcome distraction from running trials?

Escalating regulatory demands, rapid globalisation of studies and the complex handling needs of contemporary medicines mean that the relationship with a comparator supplier should no longer be simply transactional. Our customers demand flexibility, reliability and know-how as a means to overcome any distraction from the focus on running a trial. We believe that pharma companies, packagers and suppliers have to work in partnership before, during and after the clinical study to anticipate logistical challenges and leverage specialist knowledge on all sides.

Why have manufacturers started to make it difficult to acquire certain products – and how can this be overcome?

I like to see this from a different viewpoint. Recent legislation redirected manufacturers’ efforts towards strengthening their processes around traceability throughout the drug supply chain, and this is something we support entirely. Comparator suppliers like us have been working hard to develop a strong network with manufacturers by providing different levels of assurance with bona fide evidence that products will only be used as part of a valid trial, thereby ensuring continuous supply for clinical trials.

Some predict that quality issues, such as temperature control, will dominate comparator sourcing in future – do you agree?

Yes, this is one of the challenges we face. Maintaining the integrity of the supply chain goes hand-in-hand with ensuring the physical integrity of the medicines we handle. The use of dedicated temperature-mapped vehicles, GPS positioning and reporting, track and trace technologies and rigorous adherence to validated procedures will ensure the client’s goal of a quality delivery of comparator drug that meets study protocol, regulatory and budgetary requirements.

Part of your work involves supplying medicines that are unlicensed in the UK and those that have been discontinued – how does this work?

Typically, we refer to unlicensed medicines as ones which are licensed in one particular country but the manufacturer has chosen not to license it elsewhere, usually for commercial reasons. Specialists or GPs choose to prescribe unlicensed medicines to provide better therapeutic solutions for their patients; our job is to source this alternative in the most cost-effective way, following a rigorous and regulated process.

Critical shortage management is a service we provide in cases where medicines are either at the end of their lifecycle or are having supply issues. The need here is to provide continuity of treatment for patients, which is where our strong network of suppliers plays a critical role.

What new and innovative ways are you exploring to expand your business?

We have started to explore the concept of ‘value innovation’, which is to look at new ways to improve the value of our current portfolio, while bringing new and innovative services to meet the increasingly challenging demands of clinical trial management. For example, combating drug counterfeiting and ensuring supply chain integrity is vital if we want to remain the most secure partner for our customers and their patients. We are looking at how we can bring new technologies to the market and reinforce further our processes to offer our customers well-deserved peace of mind.

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Nadia Whittley is Chief Executive Officer of comparator drug sourcer, Pharmarama International. A seasoned senior executive with experience leading global teams in the medical device and healthcare sectors, Nadia previously worked for Allergan, Boston Scientific, Biotronik and Medtronic.
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