Pandemic planning: GSK’s Dr Neil Formica
pharmafile | September 1, 2009 | Feature | Research and Development |Â Â GlaxoSmithKline, Vaccine, h1n1Â
Throughout his career in vaccines and pandemic planning, Dr Neil Formica has had to tolerate gibes of doom-merchant. But now, with the arrival and scale of the swine-flu crisis, there is a sense his years of groundwork in the area are validated.
He is softly spoken and admits to a degree of shyness, but speaks confidently about his expertise: “A lot of the work I have done in the last five years has been preparing for this event; a lot of the processes that have been activated with the pandemic were processes that were planned to be activated for years.”
Formica has not always been part of the industry, and his new vital and top-level job as a senior medical advisor for pandemics didnt exist until a few months ago.
He joined GSK in May 2009, just after the H1N1 outbreak in Mexico, which was first reported in April. He was originally to come from Australia to the UK to work on GSKs cervical cancer vaccine Cervarix, but the demand for a full-time advisor on the swine-flu crisis was more urgent, and Formica’s CV fitted the bill.
Pandemic disease is volatile and despite huge advancements in science, it is still impossible to fully predict the outcomes or control such an outbreak. In 1918 an H1N1 influenza virus killed somewhere between 20 and 40 million people globally.
But despite the unknowns, Formica, who comes from a career spanning medicine, public health, academia and pharmaceuticals, says notional planning is essential.
“The problem we have always had is the uncertainty around it, because until May it was a theoretical event. But even though theoretical, it was felt to be serious enough that all these activities needed to occur. GSK obviously invested a lot in doing clinical trials and getting mock-up licences approved in Europe.”
Pandemic preparation over the last decade, according to Formica, was prompted by the strain of bird flu (H5N1) that broke out in Hong Kong back in 1997. It was at this point that a mass outbreak soon seemed both potentially serious and inevitable.
He says: “There were a few cases of H5N1 at that time, then it went away for a while and came back later. Those kinds of events really started triggering a lot of activities between governments and manufacturers, and public health people in surveillance worldwide. Because it was recognised that influenza is a virus that can mutate and cause serious illness, based on the history of whats happened in previous pandemics.”
Formica says his confidence in GSKs handling of the crisis is down to this intense preparation, and the clinical trials that began as far back as the late nineties to better understand the viruses and vaccines that could be used against them.
But despite the planning efforts from companies and governments, it is clear there is a degree of uncertainty that remains over the pandemic.
As a worse case scenario, some have predicted as many as 65,000 deaths in the UK as a result of the current H1N1 strain, though in truth the number is unknown.
When asked, Formica can do little to substantiate any figures. Though his manner is genial and bright, his essential message is less upbeat, and unfortunately can only contribute further to his moniker as a harbinger of doom.
“I think its impossible to really come up with a number [of people it is going to affect]. But I think the fact that almost everyone doesnt have any immunity to this virus suggests that over time most of us will get infected with it.”
Public health in Australia
The opinion does seem bold, but Formica’s expertise in the sector qualifies it. His career began back in his home country of Australia. Having studied medicine in Sydney he spent five years in the public hospital system. He completed his public health training then moved to Melbourne, where he worked for two years at the health department in the state of Victoria, dealing with public health issues in disease control.
He specialised in public health infectious diseases, focusing on disease prevention on a population rather than individual case level, and was involved in university research in the same area. He then crossed over to industry to work at CSL for five years, the Australian company which is also currently making H1N1 vaccines, before joining GSK.
“I’ve got a fairly broad perspective of the health system and public health, and now the industry side of it as well. This helps because you understand more the perspective of the Department of Health, having worked in similar environments in the past.”
In his current role, his responsibilities include liaising with GSK’s vaccine research base in Belgium, and supplying the necessary information back to the Department of Health and vice versa.
!Because the plans for clinical development of the H1N1 vaccine are being developed in consultation with the EMEA, they have been progressively changing over time. So we have a role here to keep the government updated with the most recent information and feed that into their health policy mechanisms.!
He is also charged with providing medical and scientific support to the pandemic group in the UK, and responding to queries from government, the public and practising clinicians.
Overall as a company GSK has not shied away from saying exactly how much it invested in the area of pandemic, in the face of claims it is profiteering on drugs geared towards the crisis.
Chief executive Andrew Witty claims the company had spent 18 years and at least $3 billion preparing for another influenza pandemic.
Since the outbreak began, GSK has cranked up its manufacturing capacity across the globe. In Australia it has hired additional staff to help with the production of antiviral Relenza.
Moreover, previously dormant production lines in its Canadian and German vaccine plants – set up previously in anticipation of the event – are now activated. The plants are also running much longer hours and weekends in order to fulfil GSK contracts to supply over 200 million doses worldwide.
So compounded with the vaccines activity of other companies too, and the years of preparation, can the immunisation programmes restrict the numbers potentially affected by the virus?
True to form, Formica’s response has an air of foreboding that comes with the job. He finishes: “The pandemic at the moment is milder than what people were preparing for in terms of the severity of the disease. But because of the capacity of flu to mutate and change there is still the potential that things could get worse.”
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