Bernard Mallee: Coronavirus shows our reliance on biopharma

The industry is devoting all its resources to finding a vaccine, but we should not be complacent about the need to invest in future innovation, says Bernard Mallee

Bernard Mallee: Coronavirus shows our reliance on biopharma

The industry is devoting all its resources to finding a vaccine, but we should not be complacent about the need to invest in future innovation, says Bernard Mallee

AS the health authorities deal with the first case of Covid-19 in Ireland, the global biopharmaceutical industry is racing to find a treatment for the potentially deadly virus.

The major companies that make up the industry — GSK, AbbVie, Roche, Bayer, Gilead, Sanofi, and Johnson & Johnson — are working to contain the outbreak and develop resources to tackle future public health emergencies.

The industry is fast-tracking collaborative research and identifying suitable assets to develop diagnostics, vaccines, and treatments. It is working closely with public authorities.

Companies have been donating investigational compounds that may be able to treat coronavirus, including compounds formerly tested on other viral pathogens, such as ebola and HIV. Some companies are researching vaccine candidates for prevention and undertaking inventories of their existing research portfolios to identify potential treatments.

The industry has made millions of euros available in monetary and in-kind contributions in supporting organisations at the heart of the crisis. In China, companies donated crucial supplies, such as advanced surgical equipment, antibiotics, disinfection equipment, batch virus-testing devices, vitamins, protective clothing, goggles, masks, and gloves.

As the situation evolves, the industry is prioritising the continuity of its supply chains. It is working to prevent and mitigate potential shortages, through close co-ordination with the European Medicines Agency and other global stakeholders. Manufacturers have not so far reported any shortages or delays in production.

Vaccines are expensive and take time to develop and they require complex testing before reaching patients. Innovation in the search for any treatment or cure is complex, and investigators must follow the science, often with huge failure rates and billions of euro in investment. Take the ebola outbreak in West Africa in 2014-15. Several biopharmaceutical companies responded to the humanitarian crisis by trying to develop a vaccine, with varying degrees of success. In 2015, the first vaccine for the disease was deployed in Guinea. In 2002 and 2003, the severe acute respiratory syndrome (Sars) outbreak came and went before a vaccine could be produced. There is still no protective vaccine for Sars.

Vaccines are hard to develop. However, with the exception of access t oclean, safe drinking water, vaccination is one of the most successful and cost-effective public health interventions ever. Vaccines have rid the world of smallpox, almost eradicated polio, and has eliminated measles, diphtheria, and rubella in many parts of the world. The World Health Organisation estimates that vaccines save 3m lives every year.

As 400 delegates gather in Dublin Castle on Wednesday, for BioPharma Ambition 2020, coronavirus will be on their minds. The event, opened by the Tánaiste, Simon Coveney, is an international stage to explore the themes defining biopharmaceutical innovation right across the medicines life-cycle.

The biopharmaceutical industry is among Ireland’s most significant investors, creating 45,000 jobs that are regionally distributed. What the industry produces accounts for 62% of the country’s goods exports. We have a large biopharmaceutical manufacturing presence, relative to other big sectors and to other similar-sized countries.

None of this can be taken for granted. Product life-cycles, industry consolidation patterns, the draw of emerging markets, skills readiness, and slow speeds of adoption of new medicines in the health services are creating headwinds that could decelerate the pace at which the industry scales into the future in Ireland.

The response is to plan, together. Closer collaboration between industry and the State on the operating environment for medicines innovation and investments is the way forward.

Much of the planning for BioPharma Ambition, and for the BioPharma Policy Forum, which preceded it in December, was co-ordinated with the State. Together, we must recognise the opportunities, as well as the challenges, the industry faces. The industry has told policymakers that biopharmaceutical innovation is as important to raising clinical outcomes as it is to creating jobs; that the dividend of innovation is as much societal as it is economic. The industry’s work to find a cure for coronavirus really matters. So, too, does its commitment to the thousands of families whose livelihoods depend on a thriving industry in places such as Cork Harbour.

In identifying new opportunities for Ireland, we must heed global industry trends. One of the most important of these is the sharp growth in cell and gene therapies (CGTs). Cell therapies can treat potentially fatal blood cancers by reinfusing patients with their own engineered immune cells.

In the longer run, companies will likely target more challenging, solid tumours. At the same time, scientists are making progress on gene therapy by replacing faulty DNA to cure genetic diseases.

Major investments will be needed to create CGT manufacturing capacity and capability at sites in Ireland. We will have to meet training and skills needs linked to manufacturing this new wave of medical therapies. We will have to compete for investments against many other countries. If we move quickly, Ireland can build on our reputation as a global leader in biologics manufacturing to become a major European destination for CGT production.

The industry’s goal should be to devise and implement a strategy that supports the development, production, and provision of 21st century medicines. The strategy would guide how Ireland leverages the discovery, development, manufacture, and adoption of new medicines for the betterment of human health.

It should be clear about Ireland’s potential in emerging areas such as CGTs, Industry 4.0, immunotherapies, and genomics. It should ensure that we have the right skills and talent, tax policies that catalyse research and development and which draw new investments, robust intellectual property rights, and faster patient access to new medicines.

If we can do all this, Ireland’s future in biopharmaceutical innovation will be more assured. Just as it is leading the search for a treatment for coronavirus, the industry is calling for closer partnership with policymakers on a shared future.

Ultimately, that will be good for health outcomes and for jobs, for lives, for communities, and for science.

Bernard Mallee is director of communications and advocacy at the Irish Pharmaceutical Healthcare Association.

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