“The pandemic has taught us to shorten approval times for new drugs”

The days of hearing on the news that a drug has been successful in mice but would not be applied to humans for fifteen years have ended. This is confirmed by those responsible for institutional relations of four large pharmaceutical companies in the Round Table organized to address the ‘New challenges of biomedicine’ on the second day of the ‘II Symposium of the Health Observatory ‘organized by EL ESPAÑOL and Invertia.

David beas, Government Affairs & Market Access Director en Janssen; Federico Plaza, Director of Government Affairs of Roche Farma in Spain; Calvente born, Director of Corporate Affairs at Novartis Farmaceutica; and Marta Moreno, Director of Corporate Affairs and Market Access at AstraZeneca, have been in charge of explaining how the health crisis caused by the Covid-19 pandemic has served to streamline relations with administrations in terms of drug approval and financing deadlines.

“Out of every 1,000 new molecules, only one reaches the market, with a cost close to 2,000 million euros “, Beas warned at the beginning to illustrate the difficulties of biomedical research. Health digitization is an opportunity to develop new drugs with more therapeutic targets to benefit more patients:” It is not necessary have a lot of data, but have quality data “.

Digital interconnection also makes it possible to advance in the financing model based on the real effectiveness of the drugexplained Plaza. In the case of a drug designed to improve cancer survival, he exemplifies, if the result is modest, the payment will be less, but if it is above clinical standards, it will be higher. “The fair price of a drug is not a box, it is its clinical benefit in real life,” he says, something that can be measured today with Big Data.

The directors have also wanted to dismantle the myth that pharmaceutical companies “negotiate” the price of drugs with administrations: their results are “valued” in trials, they explain, but it is the authorities who set it. In this sense, Calvente has held the negotiation of early access models that have allowed new drugs to reach patients without further therapeutic options. “We must make room for new generics and biosimilars so that innovation enters and reaches patients,” he says.

Moreno, for his part, celebrates AstraZeneca’s “courage” for having worked “in a disruptive way” for provide its vaccine “non-profit and in perpetuity for the most disadvantaged countries, and in record time. “His antigen, he stresses, has been the most widespread in the world, and the pharmaceutical company is now working on new molecules. One of its most promising trials is that of a highly effective monoclonal antibody for immunosuppressed patients.

The need for “trust” and “collaboration” between public and private entities has been the constant that has dominated the debate. A healthcare system “robust” and digitized to measure biomarkers it will help develop personalized medicine, Moreno argued. The “co-responsibility” in financing, explains Plaza, is another key point to change the mentality: “It is not public spending, it is investment in health,” he points out.

“With the pandemic, working together, we have reduced the drug approval time from 14 years to two,” confirms the Roche representative. “We have been able to develop a vaccine in record time but with the collaboration of the administrations, which have been very flexible”, confirms that of Janssen. “Together, together, together, public and private sector, sharing data, looking for innovative solutions, to obtain results in a timely manner “, the one from Novartis finally clinched.

Beas ended by reflecting on a phrase used as a slogan at the beginning of the vaccination campaign: that no Spaniard was going to receive the vaccine later than any other European. “Spain, in terms of clinical trials, is a world leader,” he argues, but the terms for approving a new drug are still longer on average than in the rest of the EU. “We must work to gain competitiveness as a country,” he concludes.

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