Time is of the essence in developing medicines – we need to get faster

Global biopharmaceutical company AbbVie is working on strategies to halve the time it takes for new medicines to be created. Irish general manager Andres Rodrigo explains why changes are needed if Irish patients are to take full advantage of a successful outcome.

“A single visit to the doctor can change the future for someone who’s been diagnosed with a serious illness,” he points out. “Whether it is cancer, an autoimmune disease or a neurological disorder, patients receiving such a diagnosis retain hope but they also appreciate that life might never be quite the same again. With new knowledge comes a change in the concept of time. It becomes much more precious.”

AbbVie has more than 2,600 employees across six locations in Ireland, from Sligo to Cork and Mayo to Dublin. Its work is integrally connected to a wider global enterprise that spans more than 70 countries and involves 50,000 colleagues. An appreciation of the importance of time motivates these teams, Rodrigo notes.

“AbbVie’s people know that if we can discover, assess and manufacture new treatments quicker, patients have a better chance of more quality time spent with the people they love,” he says.

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“This is why – across the entire company – AbbVie places laser focus on identifying opportunities to speed up medicine development, assessment, manufacturing and provision. The goal is to make transformational new treatments available to doctors as fast as possible, so patients have more – and better – options.”

Historically it takes 10-15 years to bring a medicine from initial discovery through to medical approval. AbbVie has set an ambitious goal to accelerate the clinical development process and deliver medicines in half that time. Rodrigo points to a technical example to show how the science is progressing.

When a potential new treatment is discovered, it must be assessed for safety and effectiveness via multiple clinical trials. This requires a significant supply of new drugs. Their development can be complex, particularly for novel medicines called biologics, which are derived from clones of a single, origin cell.

When creating these medicines standard practice used to be – and in many cases still is – that laboratories manually isolate and screen for the origin cell. This process could take two to three months to complete. AbbVie has accelerated this significantly with cutting-edge technology that uses light to facilitate the rapid isolation and screening of a single cell in about one week.

Alongside increased manufacturing capacity and processing improvements, this technology has allowed the company to enter clinical trials one year faster.

“It’s just one example of many initiatives ongoing at AbbVie designed to accelerate the process of delivering new medicines,” says Rodrigo.

But pharmaceutical companies are only half of this story. “A second key factor governs how quickly a patient gets access to a new treatment,” he explains. “This is the speed with which individual governments can make innovative medicines available to patients in their country.

“In Ireland we need to work harder to improve the speed at which patients get access to new medicines. Patients now wait longer here than peers in all western European countries for new cancer medicines. When a company applies for an innovative cancer medicine to be made available for prescription in Ireland the process takes an average of 23 months – that’s 673 days – while in some other countries it takes just 102 days.

“We can learn from the processes adopted in other EU health systems where patients have access to all types of medicines up to three times faster than here.”

Everyone has a part to play if there is to be a significant improvement in the speed with which patients get access to new medicines, Rodrigo adds.

“A critical element is adequate Government support.,” he says. “The absence of any funding for new medicines in the recent Budget 2024 was disappointing as it will inevitably worsen the existing situation. Over three previous budgets, Government investment offered a clear statement that the State valued the ongoing provision of innovative medicines to patients in Ireland.

“A total year-on-year allocation of €98 million had enabled access to more than 120 new medicines or access to additional new uses for medicines previously approved. Funding these treatments has delivered a positive impact on the lives of thousands of Irish patients suffering from many different diseases.”

Current spending on medicines accounts for 15 per cent of the overall health budget, in line with other EU countries, Rodrigo points out.

“On a per capita basis, Ireland’s health spending is not at all out of line with peers and comes in at ninth in the EU,” he says. “New-medicines expenditure in Ireland is among the most robustly assessed of all health service outlays. New medicines that have an impact on the health budget go through a strict evaluation process to determine if they will improve efficiency and standards of care before being made available to Irish patients.”

Beyond providing important funding, everyone involved needs to work collaboratively to enhance accountability, transparency and more efficient decision-making processes, he contends.

“Early access schemes could be established for medicines when an alternative treatment option for patients is not available. This could offer patients hope whilst an assessment process is being completed and is commonplace in most other European countries.”

Doctors and patients also need to have increased opportunities to share their key perspectives in any improved process for assessing and approving new medicines, Rodrigo adds.

“Last, but not least, the State needs to review and increase the resources available to the key HSE agencies that work with companies like AbbVie on the process of assessing new treatments.

“Anyone who desires improved health outcomes in Ireland should be strongly supportive of the need to develop a new process facilitating equitable access to new medicines, one with timelines that compare with peer European countries. This is the ambition of the Sláintecare Report, something all political parties have signed up to implement.

“Our company is committed to playing its part in this regard because we believe that time matters very much for patients in need.”