It was great to see stakeholders from across the life sciences ecosystem come together with a common agenda of making it easier to bring innovative drugs to patients at the Empower Halpin protocols launch at the Houses of Parliament on Monday.

As there were so many eminent speakers on the panel I confined my remarks to commenting on what would help Les not only someone with Motor Neurone Disease, but also as a successful businessman with a track record of successful investment and Chairman of Halpin Neurosciences, a privately-owned biotech company.

I argued that we need to change two sets of rules at the same time to get more novel therapies to patients quicker:

  • First we need to change the rules that govern drug development to reduce the time and cost of bringing drugs to market.
  • Second we need to change the rules governing investment management to also fit the risk and return profile for the good of society.

If the drugs could reach patients earlier and be applied to a wider number of conditions, and if the testing regime was simpler, this would help spur significantly more companies into developing new drugs.
Here I echoed the comments of others on the panel – the regulatory regime is out of kilter with the public mood. The risk appetite of patients with terminal diseases is different to that of regulators who have a legal responsibility to regulating medicines.

However, regulators need to change to reflect that fact and patients have a key role to play in helping them on that journey. The US Food and Drug Administration and the European Medicines Agency have started to get patients involved in key committees, but, their pace is glacial. I wondered if this was an agenda UK policymakers could take up?

Speeding things up is vital. To create greater incentives for truly innovative new medicines the BIA has long advocated for the new routes that can be used to get breakthrough medicines through to patients sooner and we have outlined this in the early access scheme we have proposed to the UK government.

We’ve already seen successes using conditional approval and flexibility in the evidence needed in orphan diseases. It was great to hear from Simon Lem of Vertex about how their Cystic Fibrosis drug Kalydeco is a great recent example of how patients can benefit from breakthrough products when things go well.

Although some good work has been done we need to keep going. It inspires those of us in industry to know that patients want this to happen and I believe this campaign can deliver the speed and focus to ensure regulators start to listen.

While the BIA has led the charge on an earlier access scheme, which could be used to deliver existing drugs to more patients in need, there is a second set of rules (and attitudes) that also need to be challenged: the rules that govern investment in risk from big financial institutions – like pension funds. Currently, there is no incentive for pension funds in the UK to invest in what matters to patients – it’s considered too risky.

It would be pointless to have lots of people starting companies but being unable to fund them as there will always be a cost for developing drugs however much we speed up the process or change the regulations.
However in the USA there are a lot more investors prepared to invest in innovative drugs because in part investment rules force big pension funds to invest a small part of their funds in riskier investments like biotech.

I believe we should campaign to ensure all UK long term investments have some degree of risk investment (which is where growth is most likely for returns). This should provide a greater pool of capital to invest in breakthrough science for treatments, especially for the smaller companies who are most likely to take the biggest risks. Here Les’ career expertise as an investor is vital – to make a real breakthrough we need to make investments in biotech as speedy and attractive as an investment into an app or technology platform.

If we can change the regulators approach to risk and speed up drug development and change the change the risk attitude of investors we will deliver more innovative products to patients sooner.