Those straddling the different worlds of regulators and pharma companies are finding themselves torn on how much regulation is too much or too little.
There’s that age-old scene in many police dramas through the years of one cop who does things by their own rules, scorning the chief who keeps telling them to do things by the book.
Inevitably, it turns out that doing things outside of the standard rules saves the day.
While this is true in the world of cinema, there’s a very good reason why, understandably, in the world of biopharmaceuticals this course of action isn’t taken without serious consequences.
This might be a somewhat simplistic comparison, but there exists in the industry a fine balancing act between those producing the drugs and those regulating them which results in the former sometimes arguing that regulation can stifle innovation.
After all, the healthcare industry is crying out for new medication, especially antibiotic candidates given that only two have been created in the past 70 years sparking fears of an ‘antibiotic apocalypse’.
So what is it actually like working at the coalface of biopharma regulation and for the big players working within a regulatory framework? Particularly, in consideration of the technological progress in biopharma and computer science in recent years, leading to unprecedented breakthroughs made using artificial intelligence, 3D printing and ultra-advanced genetic techniques such as CRISPR.
To get a sense of the different focuses and nuances between the two, Siliconrepublic.com spoke to David L Chesney, principal and general manager for the pharma consultancy firm DL Chesney Consulting; and Dr Moheb Nasr who recently retired as a member of GlaxoSmithKline’s (GSK) governance board for product development.
A two-way street
Both men are speakers at the upcoming BioPharma Ambition event to be held on 21 and 22 February in the Printworks, Dublin Castle, and they have decades between them in the industries on both sides.
In his consulting practice, Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, making him more than qualified to know whether the pace of change makes it a challenge for the industry to keep up.
“Yes,” Chesney agreed, “but it is an equal challenge for the regulators to keep up with the rapid pace of change, particularly when new and novel technologies are becoming more prevalent in the industry.
“It is a two-way street, and there needs to be a good level of partnering between the industry and the regulators to maintain an appropriate balance and to protect the public from unreasonable risks … because these technologies emerge from the industry, and sometimes from academia, so regulators need to engage and keep their technical skills current.”
Disagreement on striking a balance
Nasr, however, said that the current industry model and post-approval regulations don’t provide enough incentives to improve and/or redevelop currently marketed products. In addition, there exists an industry unwillingness to accept or address unknown risks.
This caution isn’t without merit as, in the past, drug regulation has often been born from a reaction to crises, such as the elixir sulphanilamide scandal in the US of the 1930s, and the European thalidomide scandal of the 1960s.
For Chesney, these scandals are a sign of where uncontrolled regulation had disastrous results, but how much they can be loosened or tightened continues to prove a difficult problem to solve.
“Regulation is necessary to provide assurance that the safety and efficacy balance is maintained, but regulators also must realise there is no public health value in inhibiting innovation. I suppose reasonable people can and will disagree on how that balance should be struck.”
Equally sympathetic to both sides of the argument is Nasr who has spent a significant amount of time both in the industry side through GSK, and the regulator side as part of the US Food and Drug Administration (FDA).
Rapidly changing concerns
Nasr admitted that the concerns and issues of the industry became much clearer to him once he made the move from the FDA.
“I have a better, hands-on understanding of industry issues and concerns now [more] than I did 10 years ago,” he said.
“I strongly believe in the need to have an appropriate regulatory oversight to ensure product efficacy, safety and quality. Patients and consumers need that.”
But who of the two determines what is appropriate and sufficient?
“Regulations and enforcement should depend on the manufacturer, the product and associated risks,” Nasr added.
“This will require flexible regulatory systems that are routinely adjusted and updated. This is different from what we have today with a one-size-fits-all approach. This will allow more regulatory flexibilities and reliance on industry policing itself combined with more severe penalties for intentional non-compliance.”
BioPharma Ambition takes place in the Printworks, Dublin Castle on 21 and 22 February 2018.
Updated, 9 February 2018 at 4.35pm: An earlier version of this article mistakenly stated that Dr Moheb Nasr transitioned from a career in the pharma industry to one in regulation when, in fact, it was the other way around. Changes have been made to correct this error.