Medical Innovation Exchange

Product development: The hurdles faced by life sciences firms

What are the major challenges Life Sciences companies face in new product development?

In this interview, Cameron Izadi, Senior Vice President of Fingerpaint Market Access, is in the hotseat to discuss some of the most pressing challenges faced by life sciences companies in developing new products and therapies.

Indeed, a growing hurdle, Cameron says, relates to evolving the design of clinical trials to meet the needs of stakeholders beyond traditional regulatory bodies.  

“One of the major challenges now is trying to design clinical trials, afford clinical trials, and conduct trials over a time period that not only satisfies the regulatory bodies, but also the payers,” he tells Fierce Biotech’s Rebecca Williamson.

This, Cameron says, becomes more critical with the increasing need to deliver on the value of innovation through outcomes data and other metrics prioritized by payers.  

The conversation then turns to how organizations can start to mitigate some of these challenges. Here, Cameron introduces Fingerpaint Market Access work, explaining how developing a more standardized approach to embedding a US market access perspective into product strategies as early as Phase 2 in the development program can increase the likelihood of delivering better clinical value to patients, payers and life science companies.

Watch the full interview to discover more.

Rebecca Willumson: 

Hi, there. I’m Rebecca Willumson. I’m the publisher of Fierce Biotech, and I’m here today with Cameron Izadi, Senior Vice President of Fingerpaint Market Access. Cameron, thanks so much for joining me today.

Cameron Izadi:

Thank you for having me.

Rebecca Willumson:

So, Cameron, tell me what are the major challenges Life Sciences companies face in new product development?

Cameron Izadi

Yeah. I’m sure there’s several challenges, and I’ll try and answer this through my lens of expertise, which is really on the market access side. So, if we reflect on the history of clinical evidence, that’s typically delivered by organizations to regulatory bodies. They’re very clinical focused, somewhat narrowly focused on the needs of the regulatory bodies. And I think as we’re starting to move even more forcefully and aggressively into an environment that’s focused on drug costs, outcomes, there’s really a need and an increasing desire of US payers to want more outcomes-based data to support the coverage that they’re providing for these drugs. And so, I think one of the major challenges now is trying to design clinical trials and afford clinical trials that are getting more costly and do them in the right time period that not only satisfies the regulatory bodies, but also the payers. And that requires investments in outcomes, easier done in oncology where it’s survival and all those metrics.

But in non-oncology, non-cardiovascular spaces, it gets a little harder in terms of proving hard outcomes, reductions in events that might lead to reductions in hospitalizations, readmissions, even disease modification. And those are the elements that I think are becoming much more important and a much greater focus, especially in the context of all the energy being put on drug pricing. And it’s definitely necessary to start justifying the value of different products. I think the new one now is the Inflation Reduction Act, obviously hitting a lot of the headlines. And as you think about that, that’s just one more risk that a lot of development teams have to now factor into an already risky project, which is the clinical design.

And so what we’re seeing a lot of clients do now is reevaluate their entire clinical programs, trying to evaluate and prioritize different assets based upon the risk exposure to the IRA, really trying to redesign their clinical trials to determine what are the right indications to pursue or right indication to pursue, whether there’s a desire to also change the formulation from a small molecule to a biologic to extend the lifecycle post-approval, or even start hitting things like head-to-head studies because now Health and Human services are asking for much more value within these clinical trials to support coverage by the government. And so, I think these are two of probably many challenges that already exist and one that I think organizations should start focusing on.

Rebecca Willumson:     

So, tell me, how can companies rethink their approach to maximize impact in developing and commercializing new therapies?

Cameron Izadi

I think it comes down to integrating a US market access perspective earlier into the development programs as early as phase two, and that really means an integration between medical and commercial. What we’re starting to do is help organizations standardize an approach, really starting to look at how do you project what the world will look like 10 years from now, which is extremely hard to do. And as you layer in the Inflation Reduction Act, there’s a lot of disruption that that’s going to cause, but it’s an important consideration when you’re starting to evaluate the strategy. And I think the medical teams, the commercial teams, can really collaborate and understand what’s the right market, what’s the right patient, what’s the right strategy?

They can really start to define a clinical program and a marketing strategy that’s not only going to deliver the clinical value to the right patient, but the financial value back to the organization. And we think that integration is so important early on that we’ve started to commit a lot of resources to helping global organizations figure out how do they create that alignment with US market access teams, and how do they create those standardized processes that can really stand over time and deliver the insights those organizations need. At the end of it comes down to delivering a strategy and a forecast, and so incorporating a lot of that transparency and the assumptions behind it becomes much more important as well.

Rebecca Willumson:     

So, you mentioned IRA, what impact do you think the Inflation Reduction Act will have on strategies for future product launches?

Cameron Izadi

Yeah. There’s some products that won’t be affected. There’s some products that’ll have some marginal effect, and then there’s some products that’ll certainly be affected much more than others, and there’s variability. I think for those products that will be affected, there’s a compression in timeline now from the day of FDA approval to when it could potentially face negotiations with CMS, whether that’s seven or 11 years, it depends on the formulation. What that does now is it shortens the timeframe for generating enough revenue to deliver a return on investment for the clinical program. And so, the important thing is here, it does come down to integration once again in making sure that the US market access is integrated earlier into the program, because what we can start to see, really one of the biggest levers on delivering ROI is price. And so, what we might start to see is programs coming and delivering innovative medicines with great clinical profiles that can support higher drug prices.

In order to do that, US market access has to be integrated earlier into the process together with marketing and together with medical to develop the right clinical programs. At the same time, it takes execution. And so sometimes what we’ve got to start thinking about is, what is the right market development to start executing on? When’s the right time to start implementing market development activities? And again, integration between medical, marketing and access becomes so much more important in developing the market earlier so that it’s primed for that uptake in utilization upon FDA approval, and then it’s passed to the US teams where, again, I think flawless execution becomes so much more important in focusing the promotional efforts on the right patients, on the right physicians to maximize utilization as early as possible.

Rebecca Willumson:

Well, that feels like a good place to stop. Thank you so much for joining me today. I appreciate it.

Cameron Izadi

Thank you.

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