The Battle Between Safety and Drug Innovation - a View from DIA EuroMeeting

I recently attended the DIA EuroMeeting, hosted in cloudy, cool but charming Monaco, the event brought together the best and brightest minds in Life Sciences globally. Over the course of the past three days, there has been much debate and discussion around the event’s 14 key themes but perhaps the biggest buzz has surrounded the battle between innovation and the stringent regulatory requirements that can limit the volume of innovation from the industry.

Monaco

Consumers want more effective drugs with fewer side effects. Regulators want safer drugs, however increasingly this means for the industry that there are more regulatory hoops to jump through before they can market a new medicine.

Full mapping of the human genome and new technological advances in research and development have meant that the promise of personalised medicine is closer than ever before. Personalised drugs are like tailored clothing versus one-size fits all. Historically, medicines have been one-size fits all — approved on the effects to the ‘average’ person with outliers experiencing more extreme side effects to general public. With personalised medicines, it could be possible to have several versions of the same medicines based on human biological differences, thus reducing side effects for distinct biology types.

However that will exponentially increase the volume of safety approvals required. With personalised medicine, the industry would be able to provide effective medicine tailored to the individual with limited side effects and maximum efficacy but in terms of drug development one compound would require multiple regulatory and safety processes. With a new drug taking on average, 6-8 years to get from research to pharmacy, for a drug with 10 different personalisations, it would equate to between 60-80 process years under the same requirements. Such innovation means that there is the potential for more ‘candidates’ to be travelling through the drug development pipeline, however the size of the pipe is limited by the bandwidth of regulatory authorities.

So the challenge everyone is talking about is how do we make the process better? How do we collaborate and provide oversight and regulatory bodies with the information they need to approve safer drugs without constricting the pipeline and being stuck in costly red tape for years?

From speaking to the industry, innovation in communication and collaboration technology seems to be the frontrunner in improving the process. Being able to communicate quicker, with a secure process that allows regulatory bodies to review submissions without reducing quality is what everyone wants. Nirvana will be achieved when the diameter of the pipe is large enough to safely accelerate the rate at which these bodies can sort, evaluate and approve new candidates and drug companies can get new medicines to patients faster for better quality of life for all.

The IntraLinks booth at DIA EuroMeeting