Fast-forward: Larry Liberti on the evolving landscape of pharma regulation


Larry Liberti

Larry Liberti has served as executive director of the Centre for Innovation in Regulatory Science (CIRS) since 2009. In that capacity, he has been actively involved in promoting best practices in the regulatory aspects of the development of medicines, especially in the emerging markets. He has worked in the fields of pharmaceutical regulatory affairs, communications and clinical R&D for four decades and is a prolific author and often-invited speaker at scientific events around the world. He received his doctorate in international regulatory policy through Utrecht University’s Institute for Pharmaceutical Sciences in the Netherlands, where his research centered on facilitated regulatory pathways (FRPs) with particular focus on emerging markets.

Liberti sat down recently with Donald Johnston, senior marketing communication director, life sciences, at Clarivate Analytics, to discuss the future of drug development.

Q: How do you foresee that the development of drugs will change over the next five years?

Liberti: There are three things. One is the integration of the three main concepts now of quality, safety and efficacy with the fourth concept of value. So that now we’re not only talking about regulatory approval, but we’re talking about access. We are going to be focusing on quality, safety, efficacy and the value component to be able to ensure that products can be accessed by healthcare systems.

Another has to do with the growing number of countries that are participating in ICH [the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use] with more and more countries now becoming full members or having closer relationships with ICH. That should bring a greater degree of alignment to global drug development and to the way that regulatory submissions are being made. I think that is something that will have a long-term impact.

And the third is kind of an offshoot of that which is that there will be more shared activities across agencies. What that means is that large agencies might start combining their forces to share certain responsibilities. For example, now the FDA and the EMA are piloting sharing their ability to do inspections and to share inspection reports. We are going to see even more of this in the emerging countries wherein their agencies will be relying on the decisions of other competent agencies such that the emerging agencies can expedite the review of medicines by relying on prior reviews and only doing the kind of work that they feel will add value relevant to their country’s population. That kind of reliance is going to also transform how drug development will occur because drugs will likely be created in a way that keys into target countries that will generate the first approvals and then that will allow a trickle-down to other countries, which will be using reliance mechanisms to approve those products for their countries.

Q: If I am a biopharma CEO, or another executive in a senior role – in whatever region – how do I ensure my company is ready for these changes?

Liberti: What we are seeing is that there is an earlier emphasis – early as in early in development – on creating studies that address not only safety and efficacy, but also address the concept of value for example by integrating patient-reported outcomes, that then can be used to verify the actual value of that product, sometimes in comparison to other existing therapies. Having that kind of information integrated into your development plan from the earliest stages is going to be a critical component.

Another really important component is what we call “scientific advice.” The company should plan on taking advice from regulators and from the health technology assessors, or the payers, early on in development, getting their feedback as to what expectations those stakeholders have and addressing those expectations as best as possible in the development plan to be able to have an opportunity for more positive outcomes when submissions are actually made.

There is one other important stakeholder, too, and that is the patient. Bringing the patient early into drug development will also be a critical component of ensuring that drugs are actually being developed that meet a specific need.

Q: CIRS is focused particularly on regulation. How do you see the approach to regulation changing over the next five years?

Liberti: We have to look at two arenas – one being the established regulatory agencies and the other being the growing and maturing agencies.

For the established agencies, they will continue to be the benchmarks of what I would call “deep quality evaluations” of the dossiers. They will be the ones that actually get into the nitty-gritty of the dossier and will serve as the reference agencies – and that will continue.

Where I see the evolution then is in the growing agencies. Some of them will want to develop their capabilities and capacity to do the same thing – to be able to do full reviews of new drug dossiers and to be able to serve as a regional reference agency. Other agencies will continue to develop their local expertise but to be able to rely on prior decisions and not have the expectation of doing full reviews of dossiers but doing what are called “abridged” or “verification” reviews that don’t require the in-depth expertise and infrastructure required to review an entire dossier.

This post is adapted from a wide-ranging interview with Larry Liberti that covers issues of regulatory convergence and harmonization; the promise of FRPs, especially in emerging markets; how the industry can improve R&D productivity; the future of clinical trials; and trends in medical devices and chemistry, manufacturing and controls. The full transcript is available here.