Navigating the Current Funding Slowdown While Securing Capital

What specific strategies can new biotech companies adopt beyond outsourcing to navigate the current funding slowdown while securing the capital crucial for their success?

There are so many different ways of doing this. And there's nothing particularly new about it, because I think I spent 20 years in clinical development, and we were talking about a lot of these different approaches to raising capital, then the most obvious one is probably to find a partner to support the development of an asset via some kind of equity upside, or a licensing agreement, which may provide some support with less cash burn. It could be a big innovator or a services business. And it's, as I said, the option has been around for decades. And in my experience, it was mainly clinical development. But the challenge is that not all potential partners have a business model that would support the approach. They also may want to see more data that might be available in the early stages of a drug development lifecycle. And I think that's always the challenge. Data is the challenge.

There's always grants, there's ways of securing grant funding that doesn't have any impact on equity, hard to come by. They take a lot of effort. Anyone who's been involved in any kind of grant application will know that and depending on where you are, there's potential risk around ownership of IP. And that's a possibility but comes with even more risk. So, then there's the practical things, I guess, like bootstrapping cost optimization, choosing one asset, I think we're seeing that in the sector anyway, where people because of the cost pressures have focused their attention on one of their assets rather than three, for example. But finally, and this is a really interesting one, actually, it's about building relationships, building relationships with the investor community, communicating what you're what you're doing, as Watch as you can, depending on where you are in development, differentiating yourself all of these things. So basically, your network and your ability to communicate effectively. And then with a focus on milestones to develop that that value will absolutely remain essential. It doesn't matter what's going on, I suppose in the market, that is probably non-negotiable.

While the development of novel modalities like cell and gene therapies remains promising, what are the biggest roadblocks to their widespread adoption, and how can these challenges be overcome?

I think cell and gene is probably one of the most exciting things we've seen in in so many years. But I also think it comes probably with an unprecedented set of challenges. I mean, I, when I thought about preparing for this question, you know, originally, I thought I only had two and then I was chatting to a colleague, and I'm like, crikey, there's so many more to this. Firstly, I would say getting these therapies into the healthcare system, like I remember some work done in the UK, in our hospitals to ensure they could indeed administer the first licensed Car-T Kymriah. And there was an expectation within the hospital, that they had physically close access to the neurological and cardiovascular services within a hospital. Well, if they're not positioned next to oncology, then how does that actually work? So, there's obviously infrastructure cost there. The other challenge that I came up with, and there's some others was cost to develop, because clearly these medicines are complex and unique to develop, and how they then determine a price for that then can create conflict or tension within the healthcare system. So even though the market size, I suspect is large for selling gene, collectively, a lot of therapies are quite precision and specific in maybe rare disease. So, the populations aren't that big. So, the economics are challenging.

Then, of course, in the US, we have the inflation Reduction Act, which actually, when I was doing a bit of reading earlier, doesn't really impact selling gene right now. But I suspect that will change. Of course, that's creating some uncertainty, I suppose in the states around how drugs are priced in the future, what's paid for them. But I guess some other things or maybe some more positive things, thinking about tech advancements, you know, could we speed up development, could we look at how we develop therapies and get them to market quicker, because that will then reduce the cost.

There are regulatory requirements that are revolving around cell and Gene, I think we're breaking the back of that, because we clearly are COVID vaccines were in this space. But there's still more to be done. Another uncertainty, I suppose, is the medical side of this, this sort of the risk in these cutting-edge technologies and things like immune reactions off target effects, insertional mutagenesis, and the long-term unknown. So, I mean, not to be a sort of naysayer, but are mRNA vaccines, we have no long-term data. And we all went through it because that was absolutely the right thing to do. But we don't really know what the longer-term impact is. So, a reason not to do it. But it does create some challenge. So, the long term follow up is essential. And you'll see with car T, they are doing they do post marketing follow up all the time, because of the impact on the sort of genome if you like, and I think so I think that it's challenging, but I think from a scientific and a human health perspective, it's hugely exciting. And if we could get the speed to market, the infrastructure and the regulatory side of things sort of moved forward, then these therapies would become more accessible.