EPM speaks to a range of pharma players to find out how Covid-19 is affecting the various aspects of the pharmaceutical supply chain.
Covid-19
The latest strain of coronavirus – Covid-19 – has shook the world, giving countries, their health systems and indeed patients something to seriously consider. Alongside its human impact and the economic downfall caused by its spread, Covid-19 is affecting a large majority of the pharmaceutical supply chain.
Clinical Trials
With 35 candidate vaccines currently in pre-clinical development for Covid-19, the race is officially on to find a solution and prevent the virus from spreading even further. Of course, development timelines for vaccines are rarely short, and the pharma industry is facing an almost insurmountable task of developing a vaccine before Covid-19 burns itself out.
Finding a candidate isn’t necessarily the most time-consuming part of the process though. Rather, companies face the long but vitally important task of progressing a vaccine through clinical trials, so to ensure it’s safe for human use, and effective against Covid-19.
One method of data collection which could help is real world evidence (RWE) – clinical data which are produced through studies that assess how therapies perform in everyday settings.
According to Karen Ooms, executive vice president and head of statistics at clinical research organisation (CRO) Quanticate, “real world evidence (RWE) is now being utilised more in clinical trials and its use in a situation like [Covid-19], this could potentially increase the speed of approval as drug developers may not have to perform analysis on all data from a clinical trial setting.”
Data taken from patient health records for example, could help biostatisticians analyse candidate vaccines and prove their efficacy. More so, cases of self-isolation and quarantine centres “provide further environments for data collection”, according to Ooms, due to their similarities to clinical trial data collection environments.
“An area of focus would be the method for collecting data of any patients in self-isolations/quarantine and with emerging technologies could support a faster drug approval process,” Ooms says.
Of course, though time is of the essence to find a solution to stop Covid-19, rushing a vaccine through development has its own dangers, according to Ooms.
“The danger of rushing any vaccination is that the virus itself can become stronger in the meantime, which would render a vaccine ineffective or a vaccine may have safety and efficacy issues that could put patients in further danger or potentially support the virus mutating and becoming stronger,” she added.
Logistics
Given that Covid-19 has spread to almost every corner of the globe, if and when a vaccine is produced, the challenges don’t stop there.
Logistics providers will face the particularly daunting task of transporting potentially time-sensitive Covid-19 vaccines across the world to be delivered into patients. More so, vaccine developers could face a situation where the peak of the virus has passed, meaning that research and development (R&D) efforts may have been squandered and financial reimbursement opportunities limited.
However, if a vaccine is developed in time - a situation becoming more likely with expectations that Covid-19 could last into next year – then it may not just be the private sector who handles transportation.
Adam Johnson, director of Leeds-based Tudor International Freight explains how in the UK, the army could become involved.
“The government has already said soldiers may be needed to help the police maintain law and order if an epidemic ensues,” Johnson says.
Johnson goes on to explain how in these circumstances, the private sector will face challenges such as how to handle their fleet capacity when they have existing customers needing products shipped, and the risk of their own staff being absent. With the UK government estimating that up to 20% of UK employees could be away from work due to Covid-19, it’s very likely that companies involved in the pharma sector will be affected.
“If we at Tudor are being relied on to transport supplies of a vaccine speedily, to prevent suffering and even deaths, however, we’ll of course make this overwhelmingly our top priority. We’re confident our other customers will understand if their non-urgent consignments are subject to very slight delays for a temporary period while this happens,” Johnson clarified.
Supplies and materials
The importance of China’s pharmaceutical supply chain has, arguably, not been felt until the spread Covid-19. With China being the world’s largest producer of pharmaceutical ingredients, the industry in large swathes has become dependent on the nation for its exports.
One country which may be particularly affected by this development is India. John Warchus, partner and specialist in Commercial Law at Moore Blatch, explained how India’s government has already restricted the exports of 26 active pharmaceutical ingredients (APIs) – amounting to 10% of all drug exports from India.
“The reason this is so problematic is because India is the biggest supplier of generic medicines worldwide and imports 70% of its APIs from China – meaning that it will inevitably face shortages as the virus spreads that will impact its export of generic medicines," he said.
On the supply and demand side, contract development and manufacturing organisation (CDMO) Recipharm, has noted an increase in one product that could be used to treat people with Covid-19 associated pneumonia.
The CDMO noted an increase in demand for chloroquine phosphate, which is typically used to treat malaria prophylaxis and rheumatoid arthritis, but has antiviral effects and has been highlighted by the World Health Organisation as a research option to treat Covid-19.
“Recipharm is presently focussing on securing supply of its chloroquine product in case the demand suddenly increases, and new recommendations are introduced. Because of the current situation with the new coronavirus we believe it is of utmost importance to take every measure to be prepared,” the company said in a statement.