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Craig Johnston, Operations Director of CMAC based at Strathclyde University, is a steering group member for ReMediES and one of the project’s founders. As thoughts turn to the next phase of ReMediES’ work, Craig shares his reflections on the programme’s achievements, and how its successes can be taken forward in future programmes
ReMediES has been a large collaborative project, the scale of which we hadn’t previously seen in our sector in the UK. Before ReMediES, collaborations were on the sort of scale of each of our individual workstreams. We were advised that a programme with 22 partners, and the breadth of work we wanted to undertake, would be unmanageable. We managed to achieve this super-sizing by finding coherent themes, creating technical work packages, or Apps, that sat within our two overriding workstreams for the clinical and commercial supply chains. It took longer to get everything up and running than we had hoped but, when the ADDoPT advanced digital design project was set up a year after us, they learned from our experience and were able to do things quicker.
A personal highlight for me was speaking at CPhI in Barcelona in 2016 and helping to publicise Blacktrace’s new Titan range, which was formally launched at that show. To see new products getting out into the marketplace created by dynamic British companies like Blacktrace is fantastic.
The background work undertaken in CMAC to prove continuous manufacturing supported Cambridge Reactor Design, IntensiChem and C-Tech to bring their products to market. Meanwhile, our two CMOs partners, Robinson Brothers and Thomas Swan, have been taking on board continuous processing in how they deliver their work. In App B CMAC’s work on hot melt extrusion and 3-D printing is really attracting a lot of attention as an agile means to get material into clinical trials.
I think the focus of ReMediES on small molecules was wise. It was very ambitious already and to have gone any broader, for instance into bioprocessing, would have made it almost impossible to deliver. It’s frustrating that we haven’t been able to produce clinical trial materials through the new technologies quite yet, but time has been against us and that’s certainly something for any future project.
ReMediES has not been happening in a bubble. In terms of continuous manufacturing, for instance, there’s been so much progress globally that continuous has been becoming more mainstream, particularly for drug product. As a result, I think we will see continuous break down into several different strands in any future project.
ReMediES has always only ever been a part of what the partners have been involved in, though often helping them take big steps in their own right. The financial support CMAC received from the Scottish Funding Council to engage in ReMediES has been invaluable. Along the way, CMAC’s Tier 1 membership has grown to eight leading pharma companies. CMAC also secured seven years of funding from EPSRC to be a research hub. One of the things that helped us achieve that status was to be able to point to some of the translational work we were delivering under ReMediES, translating fundamental research into industry practice.
The final full meeting of the ReMediES partners took place at the Institute for Manufacturing at Cambridge University on 13 March.
The meeting heard updates from across the workstreams, and updates on the remaining elements of the programme to be delivered by the end of June when this phase of the programme comes to an end.
The ReMediES project will be exhibiting at the Pharma Integrates conference in London on 15 and 16 November.
Meanwhile several members of the team will be speakers and taking part in conversations and panels at the conference.
Jagjit Singh Srai, Research Director of ReMediES is a panellist for the New Pharma Supply Chain strand’s discussion of ‘data-driven transformation in the pharma industry alongside’, Andrew Share from the Advanced Manufacturing Technologies team at GSK.
ReMediES Project Director, Clive Badman is a panellist for a session in the Financing the Future and Paying for Innovation on the theme of: ‘how do new commercial models change the innovation investment model?’
Alex Robertson, Senior Director of Supply Chain management at AZ is chairing a session in the strand on Outsourcing Strategies asking the question: ‘how can CDMOs play a better, more strategic role in the greater pharma supply chain and better serve their customers?’ Alex’s colleague Tim Wrate, Manufacturing Director at AstraZeneca, is a panellist for the discussion: ‘Delivering the Undeliverable, the Reinvention of CDMOs in an Era of Uncertainty’.
Bernhard Paul, General Manager, European Pharma Solutions at Johnson Matthey, joins the panel on ‘strategic alliances and innovative outsourcing’ as part of the Future of Pharma Biotech strand.
Dave Tudor, Head of Strategy for GSK’s global manufacturing and supply operations will be sitting alongside Craig Johnston, Industry Director at CMAC, on a panel as part of the Future of Pharmaceutical Manufacturing and Supply Chains strand examining ‘disruptive thinking for next-generation pharmaceuticals’.
Crystec has been awarded the CPhI Excellence in Pharma Award for Contract Services and Outsourcing. The award was presented for Crystec’s modified supercritical anti-solvent (mSAS) technology for accelerated product development, and chosen from shortlisted companies including 3M, Alcami, Catalent Pharma Services and Merck.
The winners of the CPhI Awards were announced on Tuesday 24th October during an awards gala in Frankfurt, Germany. Crystec’s CEO, Paul Thorning, said of the prestigious award: “It is our great pleasure to have been recognised for our work across the industry through our expertise in crystallisation and particle engineering. Our mSAS technology platform has the potential, not only to add value to product development programmes through improving the performance of medicines, but to streamline product development, reduce manufacturing costs and accelerate the route to market. We are very proud of our company and of the solutions that we provide for our clients, as well as our own development programmes. We are particularly honoured to have won this award in the company of such renowned organisations.”
Read more at www.crystecpharma.com
The leader of the REMEDIES Commercial Supply Chain says the pharmaceutical industry is on the cusp of a huge change.
Speaking to Research Horizons magazine, the Head of the Centre for International Manufacturing at Cambridge University, Dr Jag Srai, says the advent of continuous manufacturing combined with digital technologies are transforming supply chains through flexible production and automation, using sensors to track location, quality and authenticity, and using big data analytics on consumption patterns.
Dr Srai predicts that one of the big impacts for patients will be in using technology – matched with new approaches to manufacturing – to help people take their medicines every time they need to, perhaps at a dose that exactly matches their condition on that day:
“As in the world of e-commerce, we are at the early stages of understanding how this consumer and patient data can inform the supply chain,” says Jag. “But we can now contemplate scenarios in certain therapeutic areas, in which each dose a patient takes is fully optimised for the here and now, and manufactured continuously, or even printed on demand.”
Or in Research Horizon’s magazine (page 31) http://www.cam.ac.uk/system/files/issue_33_research_horizons.pdf
If we look at REMEDIES what do you think it can achieve?
I think it can be the beginning of transforming the pharmaceutical supply chain. I think, in reality, manufacturing has been a bit of a Cinderella within the pharmaceutical industry. We have seen plenty of money has gone into research and development, lots of money put into marketing but, for a long time, we really haven’t done much to introduce new technologies into manufacturing. I think there are many opportunities out there now for us to get a much more flexible and productive supply chain in place. REMEDIES can be the start of that and it can make an impact.
What is the power of collaboration in this rather than just Cambridge University doing it or GSK doing it or Strathclyde CMAC or any of the other partners doing it on their own?
And therein lies the power of it. It is a collaboration. In REMEDIES, what we are doing is bringing the power of the entire supply chain to bear on a number of projects and problems. They are linked. You can make small incremental changes as part of the supply chain but if you bring everybody together across the whole supply chain to try to understand where the difficulties are and to help work to put new solutions in place, then that is when you get a really high performing project.
This is not a new approach. We have pretty much stolen this approach from the aerospace and automotive industries who have been working on supply chain projects in this way for quite some time. In fact, if you look at all the advanced manufacturing supply chain projects, of which REMEDIES is one, then there are very few of these in life sciences: just three to my knowledge. But there are many, many more in the realms of aerospace and automotive, which have been showing great success .And that’s what we are trying to emulate.
So what is the value, first to UK plc and specifically to the Pharma industry, if you get this right?
If we start at the very top of that picture at the very highest level what we are seeing in the UK and other countries is an increase in population, and an increase in older people within that population. We are seeing enormous pressure on healthcare costs. At the same time, it is getting more and more expensive to bring new medicines to market. So were trying to find ways of addressing that challenge: reducing the cost of bringing products to patients.
That’s the very top line which is patient centric. But it’s also true to say that between 2008 and 2013 we have seen a 19% reduction in pharmaceutical manufacturing in the UK. This is largely due, I think, to products being outsourced to low-cost countries. And that’s a dreadful shame when we can bring new technologies to bear that are more efficient, add better quality and give lower manufacturing costs. So, REMEDIES is there to try to reverse that trend in pharmaceutical manufacturing moving away from UK. It is there to encourage more pharmaceutical manufacturing in the UK, seeding the introduction of new technologies.
It is also about introducing new ways of working that can give us a supply chain that has less of a problem with right first time manufacturing. At the moment, we are operating at a roundabout three sigma. We could be operating at around five sigma with much improved quality and much shorter supply chains with the introduction of new technologies; less money tied up in stock; fewer shortages for patients.
So, I think in terms of UK plc we should be creating more jobs and certainly sustaining jobs as we bring back the manufacture of products from overseas.
On paper the project ends in March 2018. What do you believe are the next steps now that the ball is so clearly rolling?
I think it falls into a number of opportunities. First of all, we need to increase the publicity on this program. You will have heard Andy Jones in feedback as an independent observer to our recent partners meeting say that this was the most inspirational programme that he had seen in a long time. I think we genuinely have some very good results both from the platforms and the applications. Results that can see new equipment being sold and better productivity. We need to get better at telling people what we are achieving.
I don’t think it should be too hard to persuade government and Innovate UK given that they have pumped money into the aerospace and automotive industries and seen great results, and, with similar encouragement in the pharmaceutical sector, we should be able to see equally impressive results in terms of smarter more responsive supply chain and a better service to patients at lower cost. I want to seek further investment in collaborative projects in pharmaceutical manufacturing.
Beyond this we need to let companies know of the great opportunities we are creating so that we can get a better uptake of projects in pharmaceutical manufacturing.
Crystec and Juniper Pharma Services are working together as part of the Advanced Manufacturing Supply Chain Initiative (AMSCI) project, ReMediES. Juniper Pharma Services will bring its expertise in characterisation, formulation development and GMP production to the supercritical fluid (SCF) manufacturing platform, ultimately reshoring this high value manufacturing process to the United Kingdom.
Read the full press release here: http://www.juniperpharma.com/juniper-and-crystec-sign-agreement-for-next-generation-medicines/.
Following the recent release of capital spend and funds for recruitment, a full Remedies consortium partner meeting was held at the IfM Cambridge to review progress on individual project workstreams and agree forward plans.
The review meeting included workstream presentations, break-out sessions evaluating emerging opportunities and cross-project linkages, and feedback from external advisors. The full partner meeting followed separate steering group and workstream leaders’ meetings earlier in the week as well as several individual workstream meetings held at the IfM. External advisors complimented the team on the progress made and on the organisation and review structures for this multi-workstream, multi-strand activity. Prospective partners Johnson Matthey and AMT joined the meeting to discuss the proposed new workstream on ‘enzymes in flow’. A key issue was how to link up with other relevant stakeholders beyond the Remedies project as keen interest from other pharmaceutical firms was noted, particularly in relation to the platform projects and selected application workstreams.
The next meeting of the full partner group will be held at the new Technology Innovation Centre, part of the CMAC University of Strathclyde facilities, in Glasgow, March 2016.
The REMEDIES (RE-configuring MEDIcines End-to-end Supply) project has accelerated into its next phase following the approval of £11.2m of government funding. The project is further strengthened by an £11m contribution from industry, matching the figure raised through Round 4 of the Advanced Manufacturing Supply Chain Initiative (AMSCI).