Category Archives: MHRA

ABPI expert urges to find new ‘blockbuster treatments’ for brain tumors

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With the Government set to invest an additional £20 million into the research, diagnosis and development of treatments for brain tumours, we need to talk more about how we are going to find the next blockbuster treatments for these devastating diseases.

Nearly 11,500 people are diagnosed with a brain tumour every year in the UK with fewer than 15% surviving beyond 10 years. This week’s announcement from the from the Department of Health and Social Care – following the death of Dame Tessa Jowell – that they would be doubling investment for brain cancer research to £40 million is a welcome commitment to helping achieve a goal our industry shares: finding innovative new treatments and cures for these diseases.

The science is advancing in laboratories here in the UK and around the world, funded and supported by charities, universities and the pharmaceutical industry, collectively we are working to fight back against this terrible disease.

Among the 7,000 medicines currently being developed by the global pharmaceutical industry, there are 58 medicines in the pipeline for brain tumours, including gliomas. Companies are actively working to find better ways to speed up medicines development to get treatments to patients sooner.

In her speech to the House of Lords in January, Dame Tessa Jowell talked candidly about her glioblastoma diagnosis and called for greater collaboration in the fight against cancer. She also talked about the speeding up of drug trials by testing more than one at a time, saying: “I am not afraid, but I am fearful that this new and important approach may be put into the ‘too difficult’ box.”

The type of clinical trials Tessa Jowell talked about have many different names: adaptive randomisation, drop-the-loser, adaptive dose-finding, adaptive seamless and the list goes on.

The one thing they all have in common is flexibility. In trials like this – that we call adaptive design clinical trials – researchers can see how patients are responding to treatments and then change or stop parts of the trial in real time.

When used appropriately, trials like this may improve efficiency, reduce cost, maximize information gained and minimize risk to the patients and sponsors. Ultimately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients. The UK is seen as a pioneer of innovative clinical trials and this involves collaboration between academia, the NHS, industry and medical research charities –  we must ensure we keep it that way in the future.

The issue is that these clinical trial types are not easy to design, plan or execute. An adaptive design will not rescue a poorly planned trial or ineffective treatment.

We need to make sure the regulatory authorities in the UK are not seen as a barrier to innovation; the MHRA and HRA are open to discussion and we need to encourage researchers and pharmaceutical companies to start conversations with them early in the process of planning an innovative clinical trial.

We think that adaptive design clinical trials could be the solution to speeding up the research and development of not only brain tumor treatments, but for all sorts of diseases. Research into small or rare patient populations could really benefit from these trials since they help us quickly rule out the drugs or drug combinations that aren’t working and give more patients the option to contribute to research and clinical trials.

We’re not alone. In February, the Department of Health and Social Care published their brain tumor research report which stated that, because brain tumors are one of the areas that have small patient populations, we need to think differently about how we conduct clinical trials and incorporate innovative trial designs.

The report provided practical recommendations for how we can work collaboratively to make quicker progress in this area. The next steps are to build on the UK’s existing strengths, ensure we have access to researchers with the right skills, and make sure that the right infrastructure is in place for us to make really make progress in this area.

Alongside their funding announcement, we welcome the Government’s commitment this week to accelerate the use of adaptive design trials. When used appropriately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients – and that’s where the real benefit lies.

As we look to the future of cutting-edge research and development for blockbuster treatments, we know we need to make the case for innovative clinical trial design, talk more about the amazing science our researchers, companies and NHS are pioneering and encourage them to have open conversations with the UK regulators to ensure that innovative clinical research is safe and effective.

Together, we won’t rest until devastating brain tumours are a thing of the past.

SOURCE: www.news-medical.net/news

EMA initiates divorce process from the UK’s MHRA

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The first stage of separation for the EMA from the UK came with the decision to relocate its headquarters to Amsterdam, and now the second stage has taken place whereby the EMA has reassigned the MHRA’s role vetting medicines to other countries.

All of this has been brought about by Brexit; the surprise decision to go ahead with uncoupling the EMA’s medicine verification process from the MHRA immediately after the deadline for Brexit will have brought even more uncertainty for UK industry.

It was expected that this decision may have been left until the end of the transition period, which will continue until the end of 2020. However, the EMA has already been swift to react to Brexit – first by announcing immediately that it would be seeking new headquarters and now by preparing early for life possible without the aid of the MHRA by March 2019.

Mike Thompson, Chief Executive of the ABPI, said: “Given that the MHRA assesses up to 20% of EU medicines, it is clearly in the EMA’s interest to continue to draw on its expertise. It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US.

“The UK Government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health.”

Theresa May had previously suggested, in a speech at the beginning of March 2018, that her government wanted the UK to be closely linked with the EMA, but this move by the EMA looks to have potentially disrupted that wish.

It could prove to be problematic to industry, if drug approvals are slowed down by the process of other member states learning to cope with new burdens, but the main concern for the UK is that it risks isolating industry based in the country, which includes giants such as GSK and AstraZeneca, as well as many other smaller companies.

The flipside to this equation is that, for the EMA, any uncertainty that is dependent upon political wrangling at the national level could spell disaster for the agency’s work if agreements are not reached. It is therefore understandable that the agency has forged ahead of relocating the 370 medicines that the MHRA and Veterinary Medicines Directorate (also UK-based) are currently rapporteur or co-rapporteur on.

SOURCE: www.pharmafile.com/news/517104

Sterling invests £6m in new milling micronisation and solid form facility

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Contract development and manufacturing organisation (CDMO) Sterling Pharma Solutions is investing £6 million into a new facility at its UK site to strengthen and expand its milling, micronisation and solid form capabilities.

The 40 acre site in Dudley, North East England, will meet growing demand for pharmaceutical API particle size control technology and expand Sterling’s laboratory capabilities to provide a full solid form offering including polymorph screening, salt selection, particle engineering and crystallisation scale-up.

Four new milling areas will house a range of new technologies, including mechanical milling, spiral jet milling and small lab scale trial mills. Supporting the CDMO’s expertise in handling potent and hazardous materials, the facility will also provide containment to handle OEB 4 classified molecules and offer ISO 8 cleanroom environments.

Kevin Cook, CEO at Sterling Pharma Solutions, said: “From our UK facility, we are building a global active pharmaceutical ingredient (API) services business with customers in the US, UK, Europe and Asia. This latest investment is an important step in bolstering our offering so we can cater for growing market demand, including the need for high potency capabilities to reflect the global drug pipeline.”

“We are proud that we can take products from proof of concept to commercial scale manufacturing all on one site and the new facility will strengthen our current offering by adding additional milling, micronisation and solid form capabilities.”

Established in 1969, Sterling’s site has a strong heritage in API services and a successful track record of compliance with both the MHRA and FDA. The investment forms part of a 15 month strategic development plan totalling almost £12m, which will also see the expansion of the CDMO’s GMP kilo laboratories and pilot plant.

Expected to be operational by mid 2018 the milling, micronisation and solid form facility will create more than 15 jobs in the next 18 months, bringing Sterling’s total workforce to around 400 employees.

Kevin continues: “Our strong growth can be attributed to a number of factors, including the emerging pharma sector in the US and big pharma demand for the complex and hazardous chemistries we provide. We have focussed our strategy on the diversification of our customer and product base, and have recently expanded our presence in the Asian markets including Japan. We will continue to invest to ensure we meet the diverse needs of our customers globally.”

SOURCE: www.manufacturingchemist.com/news/article_page