AsianScientist (Jan. 31, 2013) – Singapore’s Health Sciences Authority (HSA) is implementing a new drug development regulatory model to accelerate the translation of drugs into the clinic.
Professor John Lim (CEO of HSA) and Dr. Raymond Chua (Group Director, Health Products Regulation Group, HSA) elaborated on this new initiative, called the the New Drug Development Paradigms (NEWDIGS) program, at the 2013 Asia Regulatory Conference conducted by the Drug Information Association.
To an audience of healthcare regulators across Asia, Chua discussed why there was a sore lack of efficiency in the research and development (R&D) of new drugs. According to Eroom’s law, the number of new drugs approved by the U.S. Food and Drug Administration (FDA) per billion dollars (inflation-adjusted) spent on R&D has halved roughly every nine years since 1950, he said.
“Even with the cost of medicine increasing, this rising incremental gain in healthcare is unfortunately not sustainable,” he said.
Chua said that there is a pressing need to balance market access of new drugs (shorter timeline with higher level of uncertainty) with the need for evidence development (more clinical studies leading to delayed market access), hence the dilemma faced by pharmaceutical companies and regulatory authorities today.
“More studies and data needed to bring quality and efficacy of medicines will translate into slower and lesser number of new innovator drugs hitting the market, which could mean that the unmet medical needs of our patients might not be answered. On the other hand, as regulators, we cannot ignore the need for this data, but neither do we want to allow new drugs to hit the market quicker and with a higher level of uncertainty,” he said.
‘Magic moment’ between pre- and post-licensing
Chua explained that the traditional drug licensing model is defined by a single “magic moment” between pre- and post-licensing, where the use of a drug is tightly controlled in a narrowly defined pre-licensing population. This involves clinical trials conducted on narrowly defined and relatively homogeneous patient cohorts which are free from complicating conditions.
Once approved, however, Chua said that most drugs are used in uncontrolled settings by large heterogeneous patient populations with confounding factors, such as by patients using multiple drugs, leading to post-market drug withdrawals in some cases, such as the withdrawal of Vioxx and Avandia.
These concerns have led to a strategic shift in the drug regulatory approval process, he said. HSA is partnering with Massachusetts Institute of Technology’s Center for Biomedical Innovation in the NEWDIGS project, an initiative that intends to catalyze innovation in the pharmaceutical drug development paradigm.
One key aspect of NEWDIGS activities is focused on ‘adaptive licensing’ approaches, he said.
“The evaluation of all drugs is not binary, but a continuum,” said Chua. “In adaptive licensing, this artificial dichotomy of the ‘magic moment’ is replaced by a graded and more tightly managed and more timely market entry of products.”
In contrast to the traditional model of licensing, adaptive licensing seeks to maximize the positive impact of new drugs on public health by balancing judicious access for patients with securing long-term, real world information on benefit and harm, Chua explained.
After initial conditional authorization, the initial use of the drug would be limited to patients most likely to benefit, he said, which can be expanded after assessing the efficacy and safety data obtained in real life.
Obstacles to implementing this model
But Chua cautioned that several obstacles that stood in the way of implementing adaptive licensing.
“Will the trade-off between earlier market access and increasing uncertainty about benefits and risks be accepted by all healthcare stakeholders?” he said, referring to the patients, payers, drug developers, and regulators involved.
He also asked whether it was possible to have robust and reliable evidence development post initial marketing authorization, which would require the setting up of appropriate legal and ethical frameworks and robust post market surveillance tools. Reimbursement issues and the proper communication of benefits and risks to stakeholders and the public also had to be addressed.
The NEWDIGS team is currently working on an initial demonstration with sponsor assets, said Chua. These assets focus on oncology, ophthalmology, cardiovascular diseases, and vaccine development.
“We are hopeful that for certain types of drugs for specific population sub-groups, in Singapore’s context, that means more chronic disease issues. We hope HSA can work with our partners and pioneer a model like this for Singapore and the rest of the world,” said Prof. John Lim.
Copyright: Asian Scientist Magazine; Photo: Sanofi Pasteur/Flickr/CC.
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