[PD Test]Regulatory conference highlights fast-track drug licensing models

Officials from Singapore’s Ministry of Health and Health Sciences Authority (HSA) discussed ways to speed regulatory processes to get new drugs into the commercial markets faster at the Asian Regulatory Conference, held recently in Singapore.

Fast-tracking drugs via more post-market surveillance-based models rather than traditional but time-consuming pre-market trial model was a key theme during the conference, which was attended by speakers and representatives from pharmaceutical companies and academic organizations around the world.

“If we can track [drugs] more in the post-market stage, we can potentially accelerate the introduction of the drug into the population,” said Dr. John Lim, HSA CEO.

Lim and colleague Dr. Raymond Chua, group director of the Health Products Regulation Group at the HSA, both highlighted a model of adaptive licensing called NEWDIGS (New Drug Development Paradigms Programme) in partnership with the Massachusetts Institute of Technology’s Center for Biomedical Innovation.

The program taps pharmaceutical research and development pipelines and clinical research data to target drug products that have shown benefits in patient subgroups but perhaps not in the wider cohort.

Such drugs would not pass muster for widespread release and are typically shelved.

But under adaptive licensing programs, these products can receive conditional licensing whereby they may only be administered to those subgroups for which they have shown benefit and they must be followed up post-market to collect further safety and efficacy data. The results of the follow up can be used to determine further licensing and public policy.

“There is concern that pipelines for development are not yielding useful new products,” Lim said. “With NEWDIGS, if there is an indication that a product is not suitable for a mass market but it is for a small population, we can allow earlier entry for that population, track [the drug] and monitor it in relation to that population. Then we can introduce more of these specialized, personalized medications faster.”

Lim said an adaptive licensing program like NEWDIGS could help bring new drugs to a specialized market several years earlier than the average 12-14 years necessary for the normal drug development and licensing process.

Similar rolling-admissions-type licensing programs already exist in regulatory bodies like the US Food and Drug Administration or the European Medicines Agency, for example.

Introducing a fast-track licensing model is in line with Singapore’s efforts to stand at the vanguard of biomedical research, development and commercialization, in which the government has invested billions.

In an opening talk, Health Minister Amy Khor noted that the Singaporean government has committed S$16.1 billion for research and innovation (S$3.7 billion for the existing biomedical sector) until 2015.

“The Agency for Science, Technology and Research and the rest of the research community knows this [program] is in the pipeline and that we are downstream [from them],” Lim said. “It is definitely part of the landscape.”

The NEWDIGS is ready for a pilot launch as soon as a suitable product is available. In theory, the program is a good target for therapies for chronic diseases and for diseases without many effective therapeutic options, but Lim said the first candidate won’t be a high-risk drug.

“We don’t want to just try anything on the population,” he said.