Overcoming drug development challenges

By Kirsty Barnes

- Last updated on GMT

Related tags: Drug, Pharmacology

The number of new drug submissions has halved since 1995, while at
the same time, pharma companies are spending three times as much
money on R&D - a hole this industry needs to dig itself out of,
and fast.

The 40 years up to 2000 were the "golden years" of pharma innovation, however, the last five years have seen a dramatic slowdown due to this escalating cost and time to development of new drugs, partly due to an exclusive regulatory focus on drug safety.

A single drug now takes over $1.2bn (€1bn) to develop due to the complexity and duration of the trials required, which are also contributing to a 50 per cent drug failure rate. This scenario, coupled with intellectual property (IP) concerns, is blocking innovation in an industry that now "fears wasting money."

"This trend won't reverse itself, it is only getting worse,"​ said Jeffery Leiden, COO, Abbott, speaking at the recent Economist Pharmaceuticals conference.

Leiden believes the decreased breakthrough in innovation and dwindling drug pipelines are not just a scientific problem but include a mixture of regulatory, business and societal issues.

"To help overcome this problem, the industry first of all needs better tools for choosing and validating successful targets,"​ he said.

"A better understanding of disease pathways, a better molecular understanding of drug capacities and an increased use of RNAi technology will all lead to increased drug discovery,"​ he said.

The next major problem to address, however, is regulatory review times, which have increased from 15 months to 25 months over the last three years.

This has seen drug companies shy away from blockbuster innovation where pathways and safety issues are less defined and markets are less understood, and move towards incremental innovation, involving less regulatory hurdles, but also less progress.

Leiden believes that a way to overcome this stagnancy is to develop a separate liability and regulatory pathway with regulators.

In particular, he believes areas of unmet need, such as Alzheimer's disease and multiple sclerosis, need a reduction in liability, with a pre-agreed goal for efficacy and safety, as well as a fast track review and prolonged patent protection to spur big innovation in these areas.

"This fast-track method does not necessarily lead to poorer drug quality or increased risk to patients,"​ said Leiden.

"HIV is a perfect example of this. The first HIV drug was launched on the market just four years after the discovery of the virus, and not a single HIV drug product has been withdrawn since,"​ he said.

Since then, HIV has been reduced from a death sentence to a chronic disease in many countries.

Leiden also believes that in general, the way that regulators assess the safety of drugs lacks a standardised approach to the risks vs benefits and a more quantitative approach is required to increase new drug approvals.

"Risks should initially be weighed according to the severity of the disease and then the risk vs benefit profile can then be tightened once better drugs become available,"​ said Leiden.

"Patients should also be educated on the true benefits and risks of pharmaceuticals so they can make their own judgements on how the risks associated with a particular drug actually compare with the risks they already take in everyday life without a second thought, such as driving a car,"​ he said.

Addressing these key issues will light the pharma industry's path to a second age of innovation.

Related topics: Clinical Development

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