A class ACT

The name of the company is Accelerating Clinical Trials Limited, a title which precisely reflects its purpose. So far, so good. But when we hear that three of the biggest and most respected names in the life sciences sector are behind this indisputable force for good, we should investigate further – particularly as it’s based here in Birmingham. Henry Carpenter does just that.

 

Professor Charlie Craddock cuts a relaxed figure as he leads the way from the reception of the Centre for Clinical Haematology to his office, pausing to assess with a colleague Aston Villa’s chances against Chelsea later in the day.

Craddock has an easy, self-assured demeanour and he is clearly a popular and highly respected figure at the CCH, which sits in the sprawling Queen Elizabeth Hospital complex in Edgbaston – but none of this is too surprising given he is the centre’s academic director, an acknowledged global authority in blood cancer and stem cell transplantation, and has a list of roles and accolades far too long to go into.  

We are joined by two scarcely less eminent figures in the Birmingham life science’s panoply – Charles de Rohan, the former chief executive of the Binding Site, the Edgbaston-based medical diagnostics firm (which has since been sold to a healthcare giant for £2.25 billion), and Graham Silk, the co-founder (with Craddock and one other) of the blood cancer charity Cure Leukaemia and a respected West Midlands investor and businessman in his own right.

Silk, many will remember, wrote the Life Sciences Economic Sector Report at the behest of then-mayor Andy Street, although most refer to this comprehensive, in-depth document as the Silk Report.

It’s a bit of a squish in Craddock’s small, book-lined office but no one cares. We are here to talk about Accelerating Clinical Trials, the company limited by guarantee which Craddock set up with former patient Silk before persuading de Rohan to join as the company’s chair.

It is barely two years old but ACT is “starting to see real traction,” according to de Rohan.

Yes, you couldn’t pick more effective leaders, combining the academic gravitas and global contact list of Craddock, the strategic guidance of Silk and corporate know-how of de Rohan. However, they are all quick to point to what Silk describes as “a superb team of execs” as key to ACT’s success.

However, it is the possibilities of what ACT might achieve which is the real point – and that is, ultimately, to save lives by literally accelerating clinical trials. At the moment this is concentrated on blood cancers, but it is the potential of expanding it out to other diseases that leads to the possibility of it becoming a billion-pound business – a rare unicorn for the region. But more of this later.

If there is a driving force behind ACT, it is in the form of Craddock (pictured below), who has only a short time to lead the discussion before departing next door to hold a clinic.

“With many cancers, the therapeutic landscape was bleak until about 10 years ago, and 20 per cent of the patients in my clinic today,” he says pointing in the direction of the main waiting room, “would simply not have been alive a decade ago.”

Thankfully, however, there have been remarkable advances in transplant and cell therapies, and new drugs, thanks to the “trillions of pounds, dollars and euros which have been invested into basic biomedical science,” largely courtesy of some of the world’s academic institutions.

All of which would be wonderful news were it not for the fact that the adoption of these ground-breaking therapies into routine clinical practice is often painfully slow – a cause of intense frustration for both patient groups and the biotechnology companies who have developed them.

“The responsibility we have as a society is to connect patients as quickly as possible with these transformative new drugs which can mean the difference between life and death,” continues Craddock.

“The biopharmaceutical sector is now generating a tsunami of amazing clinical assets that have taken billions of pounds to develop, but before they can be adopted as a new standard of care, which allows companies to recoup the money they have invested, it is essential that data concerning the efficacy, and critically, safety is provided to regulatory bodies such as the FDA and EMA. Safety is so important – we just can’t have another Thalidomide situation.

“At present the default position for pharmaceutical companies with promising new drugs is to contract the delivery of these pivotal trials from global contract research organisations – CROs – which are huge and remote behemoths.

“By common consent this is a pretty sub-standard model – it is too slow, too expensive, and critically CROs just don’t engage with or invest in the clinical community looking after these complex patients. They are also clunky and sometimes companies have to employ three CROs to obtain all the data they need for drug approval.

“In the UK and across Europe, clinical co-operative groups caring for patients are suddenly saying if we just had the ability to deliver the pharmacovigilance and safety data like a CRO then our other advantages of scale, rapid access to genomic data and expert clinical insight would make us the ideal vehicle for clinical trial delivery.

“ACT is exactly that model. We have aggregated extremely skilled clinicians working in big metropolitan centres across the country creating a catchment region of 25 million. Working together through funded national research nurse networks – the Trials Acceleration Programme (TAP) and IMPACT (a bone marrow transplant trial network) we have already demonstrated the UK’s ability to accelerate recruitment to pivotal blood cancer trials.

“But what we really needed was a trial delivery vehicle that is commercially competitive with the CRO sector that can quickly give pharmaceutical companies the quality of data around efficacy and safety. And that’s exactly what ACT has done.”

It’s worth noting at this point that ACT is set up differently from many in the life and health sciences sectors. Yes, it’s a commercially nimble company limited by guarantee – nothing unusual about that – but it follows the Quaker model whereby all profits are reinvested, in ACT’s case into a charitable foundation, DIDACT Foundation. This charity is overseen by leading UK haematologists to fund training and further trials that might not be of interest to pharma companies but will help patients.

Its governance model is also distinct from universities, those seats of academia where so much of the research in this area traditionally takes place; reading between the lines, the decision-making process is much quicker this way.

Currently, ACT has obtained £5 million from three charities, Cure Leukaemia, NHSBT and Anthony Nolan. This may not be a huge figure, but we should bear in mind that it is only just emerging from its infancy. And more to the point trials are opening and beginning to bring in money which in turn means it is able to compete with the CRO sector.

“We went to the American Society of Haematology’s annual meeting in December last year,” says Craddock. “Ordinarily it’s very difficult to get a global pharma company to put a new drug into the UK – but now they are biting our hands off to understand how they can place trials of their new drugs through ACT.

“We met with 30 companies in a three-day period, and they are saying that the UK – providing it has this ability to deliver the trials of the quality needed to get the drug licensed, and with its clinicians, its world-class science, and its clinical and regulatory advice – creates a highly effective one-stop shop that they can’t get from CROs.

“This will allow ACT to move to being a financially sustainable proposition probably in about 18 months as we generate a surplus that gets reinvested back into more nurses for the patients, in stark contrast to the global CRO sector where the shareholders on Wall Street take the profit rather than it finding its way back to improve patient outcomes.”

I wonder whether the ACT model is pioneering. Yes it is, according to de Rohan, because of the virtuous circle it has created: all the profits that are generated from the commercial trials go back into a charity which then funds investigator-initiated trials.

The funds are then channeled through the same network of research nurses through the two groups, the TAP and IMPACT nurses.

“The clinicians understand that the speed in getting the trials done means that the money will flow through faster for more research,” says de Rohan (pictured below). “That is why it is a pioneering virtuous circle – the money stays within the ecosystem rather than flowing out into the pockets of shareholders.

“It’s in their interest to recruit patients in quickly and to get the trials done quickly.”

If ACT is to become the success which many in the health sector believe is possible, this will surely be partly due to the fact that it was set up for the right reasons by people acting for the general good rather than to boost the mood of their bank manager. De Rohan admits that he joined the industry 30 years ago for altruistic reasons (“to do something for the good of society”), and Craddock seems totally uninterested in lining his wallet.

The same goes for Silk, though of the trio he is the one perhaps most personally aware of the importance of speed; a patient himself with leukaemia 20 years ago, he had been given three years to live, but thanks to the swift access to a clinical trial his life was saved and he has gone on to make a full recovery.

This, incidentally, was when he met Craddock and the duo went on to create Cure Leukaemia with another patient.

“When we created Cure Leukaemia, the whole purpose was to take luck out of the whole process and create an infrastructure which would allow the acceleration of drugs through to patients – and that really is what ACT is now,” says Silk.

“The ultimate is to start spinning out into other disease disciplines as and when we’re ready. We’re not there at the moment but we can’t be far away and if there are other Charlie Craddocks around in lung or breast or brain or whatever the other areas might be, then this could be done quickly.

“The likes of Sir John Bell, the government’s life sciences advisor, and Kate Bingham [who chaired the government’s vaccine taskforce during Covid] are saying this is absolutely scalable as a model.

“That is why ACT could end up a unicorn in the fulness of time.”

The heads on the experienced shoulders of Craddock, Silk and de Rohan are wise enough to accept there is a long way to go before ACT can be considered an out-and-out success.

That said, the prevailing mood in Craddock’s office is one of optimism over what the future holds. There are several reasons for this.

De Rohan mentions the personnel involved, including “the chairs of each of the charities that fund ACT, a few very seasoned trialists, a very talented group of execs – real experts who have come out of the traditional CRO space.

“Proof that we are doing the right thing lies in all those who want to join us,” he says. “I find that really gratifying.”

Silk echoes Craddock’s observations on the vastly increased speed of drugs and therapies.

“The world is creating more and more treatments,” he says. “The whole genomic explosion is going to come through in so many areas. There’s a tidal wave of new treatments emerging, hence the need to create this network and infrastructure to enable them to get that access to patients.

“The whole evolution of the genomic process is driven by the pharma sector, which is fully front-on commercial. We decided we had to be overtly commercial as well, perhaps becoming a bit of a disruptor in the NHS.

“What separates what we do with our commercial success is that we distribute the profits through the DIDACT Foundation and that then goes out to the environment of the network to enable more trials to be run. So we actually become self-sustainable.”

There is a sense that Silk (below) is quietly satisfied that the team has been able to prove to the naysayers that speeding up the clinical trials process is most certainly possible.

“It’s interesting,” he says, “because when we started Cure Leukaemia a lot of people said, oh this won’t work, the Trials Acceleration Programme hasn’t got a chance, reasoning that it had never been done before.

“There’s a phrase – success has many fathers, failure is an orphan – which basically means that many people will seek credit for success, but few will accept responsibility for failure. We dared to try.”

From what we hear, the greater the success of ACT, the greater hope would be for swift, effective clinical trialing and ultimately more lives will be saved.

So why is the government not investing?

“I think it merits investment, certainly,” says de Rohan. “But it needs to retain its independence as a company, and it should be allowed to work commercially.”

Silk agrees. “Yes, I would love to see government money coming in, though they often want to see proof of something before they invest.

“The interesting thing is, if they ended up giving us, say, £50 million pounds, we would give them the value back in drugs multiple times over.

“We’ve spoken to politicians on both sides of the political divide and I think once the election gets out of the way and we can start moving forward with whoever the next regime is going to be we might find we’ve got more traction with them.”

There is one final piece in the jigsaw which give Craddock, de Rohan and Silk the belief that ACT is on firm footing, and that is Birmingham itself.

Indeed, Silk doesn’t rule out the possibility of the city becoming Britain’s life sciences answer to Silicon Valley.

Craddock draws a parallel with history.

“The Industrial Revolution was probably one of the most important events in human history. Why did it happen in areas such as Dudley, Cradley Heath and the Black Country?” he asks.

“It was because of a confluence of the critical raw materials – coal, water and clay.

“If you think about Birmingham’s potential as a global life sciences centre, it is uniquely attractive because it has one of the largest populations in Europe, critically it is ethnically diverse, stable, and it is right at the heart of Britain.

“Now that we have built these national networks which accelerate trial recruitment so effectively, all we needed was the catalyst of a clinical trial delivery vehicle that can deliver for global pharma what they need.

“I sit on advisory boards with global pharma every month, and if you can’t deliver the quality of data at speed, they are simply not interested in partnering with you. However, now that the ACT infrastructure and its linked trials networks can accelerate delivery of registration standard trial data it’s a very different conversation indeed, and the UK is seen as a highly attractive partner.

“Why is it that the CRO sector has flourished historically? It’s because it provided the quality of trials data companies needed.

“But what we’re showing with ACT is that when clinicians groups work together with inspired financiers and charities, the unique assets of the NHS can be fused into a trial delivery vehicle which is commercially nimble resulting in a win-win for patients and the pharmaceutical sector. That’s what we’ve done and this game-changing proposition is now attracting the interest of global pharma.

“If we get this right and the ACT model flourishes, and you then scale this into other diseases as Graham says, you rapidly increase patient access to novel therapies whilst at the same time growing a private-sector cluster with the potential to create tens of thousands of jobs around Birmingham.

“This is the growth opportunity for life sciences in the UK and it plays to our core strategic assets just as the great figures of the Industrial Revolution, Brindley, Watt and Wedgwood, would have wanted us to do.”