The coronavirus pandemic may have inspired collaboration and co-operation on an unprecedented scale within the life sciences industry as the best and brightest minds united in an attempt to curb the virus. Yet there is no doubt it has caused significant disruption for companies involved in research and development (R&D) as they battle to maintain focus on managing the present while trying to predict and prepare for the future.
A recent McKinsey Report on the impact of the pandemic on the life sciences industry suggested that R&D leaders say they are spending an average of 40 to 50 per cent of their time on crisis management, as clinical trials are disrupted and employee health and safety brings an even heightened level of responsibility.
According to Matt Moran, director of BioPharmaChem Ireland (BPCI), life sciences companies headquartered in Ireland have displayed their inherent resilience by remaining fully operational throughout the pandemic so far.
“To date, things have been working quite well for us,” he says of BCPI’s members. “We haven’t seen any major fall-off in output, the numbers are holding up quite well. We see it as critical that we are able to provide medicines generally, whether they’re for Covid-19 or not. Ireland is a very important centre for essential supplies so we have had to keep the show on the road.”
‘Staggering shifts’
Any disruption has been as a result of efforts to comply with the necessary health and safety requirements, Moran notes.
“In order to comply with the guidance they’ve had to put in place local measures to ensure social distancing, so staggering shifts etc, but they would have been doing things like hand hygiene anyway because that’s how they work,” he says.
Damien Flanagan, partner at KPMG, notes that companies have had to oversee the implementation of stringent Covid-19 control protocols, including temperature checks on arrival and during the course of a day, social distancing, restricted access with only operators allowed on site, while R&D engineers and managers, finance and administration personnel etc have worked, and continue to work, remotely.
Flanagan says life sciences and medical technology companies have had to be agile in their response to the pandemic, looking at not only the short-term implications on production but also the long-term impact of the virus on how they do business.
“One particular multinational medical technology client redeployed resources from early stage R&D projects into R&D projects which are closer to completion in order to ensure that they are reaching commercialisation as early as possible,” he says. “This will have a longer-term impact on the delivery timing for new product and process improvement projects.”
Ken Hardy, also a partner at KPMG, adds that companies are already thinking ahead, to ensure continuity of supply in a post-Covid world.
“We may see more pharma companies diversify their supply chain to de-risk Covid-19 related stoppages/shortfalls from some suppliers, and we expect that this would lead to greater R&D activity in terms of broadening production capability as a function of material supply, or lack thereof.”
Clinical trials
Hardy agrees that for some medical device manufacturers, clinical trials have continued. “However, the timeline for the trials will need to be extended in order to meet the patient recruitment numbers which have been impacted by the pandemic,” he says.
Internationally, the progress of several ongoing clinical trials has certainly been stymied by the pandemic, while other potential drug candidates have been relegated to the sidelines as pharma companies shift their focus to coronavirus. Some surveys suggest that more than 50 per cent of companies have paused recruitment for the majority of trials and 75 per cent have paused site activation for the majority of trials.
Moran agrees this is a major issue, but he points to the unprecedented collaboration taking place as biopharma giants and smaller life sciences outfits shift their focus to the virus.
A number of biopharmaceutical multinationals based in Ireland have been heavily involved in efforts to find a Covid-19 vaccine or therapeutic; the July stimulus included €25 million in funding grants for this. “Gilead and Pfizer are just two examples, and Dublin-based APC are partnering with an Australian company to develop a vaccine here in Ireland,” Moran says.
Michael Finn, partner at Pinsent Masons agrees. The life sciences and technology litigation specialist believes it’s important to recognise the significant collective efforts made by the industry to tackle the pandemic, including repurposing product lines to manufacture essential medicines and working together to rapidly develop vaccines. Despite this, he admits there is no question the virus has disrupted normal activity and plagued drug development efforts.
“Like all businesses, life sciences companies have had to manage disruption due to the impacts of lockdowns and new health and safety requirements for the workplace,” he says.
Clinical trials were significantly affected, though this is beginning to come back on track, Finn adds. “According to Global Data Pharma on August 7th, there have been 1,129 disrupted clinical trials with 546 clinical trials resumed after disruption,” he says.
Finn agrees that undoubtedly the pandemic has accelerated change: “The pandemic has seen a growth in collaboration models and the importance of data sharing like never before.”
“With treatments beginning to produce results, we are seeing companies step up to manufacture products discovered by others. The use of technology and AI in drug discovery has been growing in recent years, and that too has accelerated. On the patient facing side, telehealth and digital health technologies have seen a rapid uptake as consultations with healthcare professionals are conducted remotely.”
All agree the key challenge for life sciences companies is to maintain business as usual amid the uncertainty.
“Whilst it is important to focus on the provision of essential medicines and the discovery of a vaccine to tackle the pandemic, companies are also, and rightly so, prioritising the continued supply of medicines to treat other illnesses,” says Finn.
“With the fast moving situation and differing approach nation to nation, companies are being flexible and agile to maintain and adapt operations for safe working and to ensure consistent supply.”