“Our ability to guarantee supply chain integrity ultimately guarantees the outcome of the clinical trial,” said Nadia Whittley, recently appointed head of Pharmarama International, a UK wholesaler and importer of licensed and unlicensed medicines for clinical trials and private prescriptions.
‘It might sound easy’
Whittley told Outsourcing-Pharma.com the company, rebranded from BR Pharma a few years ago, purchases and delivers worldwide, to countries including Singapore, China, Turkey, Canada, Nigeria, South Africa and the EU.
There was an “enormous amount of hurdles” in the process, Whittley told us.
“Our clinical trials division deals with pharmaceutical companies of all sizes, from big pharma to much smaller sized companies.
“It might sound so easy – you buy it in Country A and deliver in Country B, but a company can have different needs in terms of where you buy.
“They might ask you to buy from multiple countries and deliver to multiple countries, or to buy in several countries and deliver to one. They might need a special formulation, and need for it to be packaged and labelled and shipped in very specific way. For instance, if we source a drug that needs to be kept at -5°C, and we buy in Pakistan and send to Australia.”
Much of Pharmarama’s work involves sourcing comparator drugs for rivals’ clinical trials. We asked whether pharmaceutical companies made it difficult to obtain their drugs for rivals’ trials.
“That depends how good your comparator supplier is!” said Whittley. “Companies have exclusive deals with importers. Pfizer or GSK or Novartis could have an exclusive deal with us – although I’m not saying they do – and if any company in the world wants a comparator from them, they would have to come to us.
“[Obtaining comparator drugs] depends on how we develop relationship and trust and how rewarding the relationship is.”
The ‘worst-case scenario’
One of the main requirements pharmaceutical companies make of distributors like Pharmarama is ensuring with absolute certainty they are dealing with reliable companies, Whittley told us.
Pharma firms supplying drugs are wary their product may be used for a different clinical trial from the one originally declared. At the other end of the supply chain, companies fear receiving counterfeit medicines – “the worst-case scenario and an enormous problem for pharmaceutical companies,” said Whittley.
“That’s why dealing with traffic companies becomes a must for pharmaceutical companies. Our Quality Assurance department is almost as big as Sales.”
“The company does not import from India, Pakistan or China,” Drew Patel, head of unlicensed medicines, added, saying it preferred “Australia, Canada, the USA, the EU – anywhere we have confidence in the supply chain.”
The whole industry stressed the need for a reliable supply chain, Whittley added, but “to us, we are the supply chain.”
The company’s competitors include Clinigen, Kali and Idis, said the CEO, who claimed Pharmarama’s business model of performing quality control checks in one, in-house location, avoided potentially risky multiple steps in the supply chain.
The company told us it called in management consultants last week to look at rivals and find “an area that is not completely serviced,” and was likely to announce an expansion of its competencies in the next three or four months.