Showing the value of regulatory intelligence in pharma [Podcast]

In this episode of Conversations in Healthcare, Carolyn Hynes from AstraZeneca discusses the importance of regulatory intelligence.

In this episode of Conversations in Healthcare, Mike Ward, Global Head of Thought Leadership, Life Science & Healthcare at Clarivate, speaks with Carolyn Hynes, Director of Regulatory Intelligence at AstraZeneca and Celine Rodier, Senior Health Policy Manager at Clarivate about the importance of regulatory intelligence and its potential return investment for companies.

The pharmaceutical industry is among the most regulated of all commercial sectors. To be able to discover, develop, manufacture and sell medicines, pharmaceutical companies have to comply with masses of regulations, which despite efforts to find global standards, can still differ significantly between different markets.

Moreover, being compliant with today’s regulations is not necessarily sufficient because the regulatory environment itself keeps evolving. It is important that companies future proof their activities by anticipating future changes to those rules.

Mike Ward:

Carolyn and Celine, thanks very much for joining me. Carolyn, what is regulatory intelligence and how does it differ or fit into regulatory affairs?

Carolyn Hynes:

I think of regulatory intelligence (RI) as a very specialized role within the regulatory affairs function. Some of the key words that spring to mind when I think about intelligence are being able to process multiple information sources and make some meaningful outputs that can particularly, for example, support the development of regulatory strategy. I also think RI is very much driven by the business needs. The company’s portfolio, its interests and the area in which it’s developing its assets will all feed into the requirements for their regulatory intelligence function.

Mike Ward:

Celine, what’s your take on this topic?

Celine Rodier:

I would first say that it is a very valid question and a question that is quite often asked among regulatory intelligence professionals. There are many different definitions of RI which exist at the moment, but to make it short and as Carolyn said, basically RI is all the activities that takes information from surveys and regular monitoring into actionable insights that are meaningful to the business. By actionable and meaningful, I mean for example, to comment on draft guidelines, to influence policy or to give strategic advice on how to build a robust submission plan. I would also say that regulatory intelligence also helps to maintain compliance in an organization and again, to develop robust strategies. Regulatory intelligence is also able to influence, for example, the involvement in trade associations or professional organizations.

In fact, regarding your point, our regulatory intelligence and regulatory affairs match together. I would say that regulatory intelligence plays a crucial role for regulatory affairs, which on their side are more to apply these regulatory requirements. They are really the primary point of contact with the regulators along the product lifecycle. They’re here to ensure that their company meets the regulatory requirements in the different activities of the organization, whether they are from the submission, to the manufacturing or even the advertising of the given drugs or other pharmaceutical products. In small organizations, in fact, regulatory affairs and regulatory intelligence are quite often, these functions are conducted by the same people. And this is why regulatory intelligence may be a challenge for these people. We need to prioritize the regulatory affairs function.

Carolyn Hynes:

I just wanted to jump in to echo Celine’s point there. I think medium and large companies have realized a value in having specialized groups that focus on regulatory intelligence and indeed policy, and the value of having a group that can develop their expertise in monitoring the external environment in knowledge sharing and communication. Whereas, as Celine said, smaller companies, it might be the regulatory affairs person having to do all of that as well as developing the strategy, taking care of the filing, taking care of the post-licensing life cycle activities.

Mike Ward:

This may seem an impertinent question Carolyn, but what does a typical workday for a regulatory intelligence executive look like?

Carolyn Hynes:

I think as I alluded to at the start, different companies will have different scopes for what their regulatory intelligence groups will do. However, there are similarities in terms of things like communicating key updates from regulatory authorities, could be around commenting on guidelines, so draft legislation or assessing a final piece of legislation and any impact that might have on our processes and procedures. It could be an ad hoc query about a regulatory procedure, about precedence, about commercial regulatory intelligence that feeds into the development of a strategy. I definitely think that you will be involved on a daily basis in a number of different activities at one time. Also as I said, being open to things arising that day that you need to look into.

Mike Ward:

What sort of tools or strategies do you have to use to gather and also assess the regulatory intelligence that you are developing?

Carolyn Hynes:

I think in terms of the amount of information that is out there now and the ability for individuals be that in a group or an individual person working in regulatory affairs has really just exploded, particularly in the last decade I would say, both in terms of what is available to access directly the information coming from health authorities, the different types of systems that are available to us, commercial systems, internal systems that we might build to share and communicate news on the external environment with our colleagues in our regulatory affairs teams, and indeed across functions within our companies.

In recent years, I’ve seen more of these sort of commercial tools that can help mine all of these multiple sources, sort of helping with that communication and curation of the information. That can be time saving for RI professionals in that there are tools that can help detect all of the changes that might be going on that you could then pick out. Say your company’s interested in particular tumor types or disease areas. You can then filter that information perhaps using portals or internal websites to reach colleagues.

There’s a range of tools and systems that are both internal and external that you might use.  I think communication as well, and some of the other areas where you might find intelligence from people that are working on the submissions, perhaps going to health authority meetings around their projects. There’s a whole challenge of picking up that sort of intelligence as well. Particularly in big companies, how do you bring people together to share and really extract that knowledge that your colleagues might be getting in the course of their day to day regulatory project work?

Mike Ward:

Where in that medicines’ discovery development manufacturer, large delivery timeline, does regulatory intelligence have an impact? And if the answer is across the whole board, where do you think it has potentially the most impact?

Carolyn Hynes:

I think just like regulatory affairs as a function isn’t now just seen as something that happens at the end of dog development. Once all the trials have been done and the data to support your target label have been created, it’s not then handed over then to regulatory just to take care of the filing. I think increasingly the whole concept of regulatory science and regulatory affairs having an input to strategy very early in the lifecycle is taking place. Regulatory is involved quite a way out of sort of the actual regulatory submission approval review aspect.

In that sense, you will have queries to support the strategy from preclinical through clinical, then obviously the review and approval stage, and then also the lifecycle management of that product. There are still issues that will arise around knowing what’s going on externally, knowing if there are any changes to the guidelines that we need to follow or what’s going on with our competitors; that will be important. I think that’s how I would think of it as having a useful input across a number of stages of development.

The above is a partial transcript from this episode. Full episode questions discussed include:

  • What metrics or key performance indicators can you use to demonstrate a return on investment?
  • What tools or strategies should you consider for developing and assessing regulatory intelligence?
  • Where in the drug development timeline does regulatory intelligence have an impact?
  • How has regulatory intelligence evolved in recent years and what elements do you think are going to further evolve as we go forward?

Click here to listen to the full episode.

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We’ve also released a complimentary report on this podcast topic, Showing the value of regulatory intelligence in pharma.

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