Category Archives: NHS

Ahead of the curve

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Pharma often criticises the NHS for failing to adopt the latest therapies, arguing that NICE’s technology appraisals can drag on and that hospitals often fail to provide the recommended therapies anyway.

However in the case of CAR-T therapies, it seems that it has responded to the criticism – at least in part, anyway.

Chimeric antigen receptor T-cell (CAR-T) therapies from Novartis and Gilead were approved by the European regulators in August – and the NHS was quick to strike deals to make them available to patients in England.

At the end of August, the European Commission approved Kymriah in children and young adults aged up to 25 with refractory acute lymphoblastic leukaemia (ALL), in relapse post transplant or in second or later relapse.

Within days the NHS had announced a deal with Novartis giving paediatric patients access to its CAR-T, Kymriah (tisagenlecleucel).

And although Gilead’s CAR-T, approved for adults with relapsed or refractory large cell lymphoma, was initially rejected by NICE, the manufacturer has managed to strike a deal with the NHS to allow patients access with reimbursement from the Cancer Drugs Fund.

Novartis’ CAR-T has been rejected by NICE in its adult indication, but this could well change if the Swiss pharma strikes a similar deal.

Horizon scanning

What stands out about the CAR-T story is that NHS officials saw that these therapies were heading to market quickly, after regulators allowed them to be approved on the basis of smaller trials, something that was possible because the therapies can be very effective in the patients that respond.

NHS chief executive Simon Stevens publicly said that getting CAR-Ts to patients is a priority – even though they are costly to manufacture, and patients need intensive monitoring to ensure they do not develop the fearsome side-effects associated with the therapy.

At Kisaco Research’s Combined CAR-T conference in Berlin earlier this year, experts revealed how the NHS had already begun to develop specialist centres capable of providing the therapies.

And a mock assessment by cost-effectiveness experts prior to approval had already indicated that the therapies could be good use of NHS resources, despite their high costs.

The NHS has built on this and is working on further CAR-T centres at hospitals across the country.

Speaking after the latest deal with Gilead, Stevens said: “CAR T-cell therapy is one of the most promising new treatments in a generation for lymphoma and leukaemia, and NHS patients will now be among the first in the world to benefit.”

Dr Alasdair Rankin, director of research and patient experience at the blood cancer charity Bloodwise, said: “CAR-T therapies have shown huge promise in treating patients with lymphoma who have no other chance of cure. It’s admirable that the NHS and the pharmaceutical company have worked hard to make this pioneering treatment available so quickly, giving hope to current patients and their families.”

But as Bloodwise’s Rankin points out, getting reimbursement in place is just a first step – the experience in the US shows that despite all the prep work by hospitals, getting the therapies to patients is still a logistical challenge.

The manufacturing process involves taking a patient’s own T-cells, sending them to a lab where they are genetically modifies, before sending them back to the patient where they are re-injected to fight the cancer.

Financial results from Novartis and Gilead, and anecdotal evidence, suggests that only a few patients have received the therapies outside of clinical trials as hospitals struggled through a backlog of eligible patients.

Rankin said in a statement: “The next big challenge for the NHS will be to deliver this new and complex treatment on a scale that ensures access for the hundreds of patients with these lymphomas who could benefit from CAR-T therapy each year.

Off-the shelf

The challenges posed by CAR-T therapies are immense – but the good news is that scientists are working on ‘off-the-shelf’ drugs that are made from banks of cells and can be administered to many different patients.

These therapies promise to have similar efficacy to CAR-T, but at a fraction of the price and without the costly and time consuming electrophoresis process used to harvest the T-cells.

At the CAR-T Congress earlier this year, researchers at MD Anderson Cancer Center at the University of Texas estimated that ‘off-the-shelf’ therapies derived from natural killer (NK) cells could be made available at 1% of the cost of CAR-T cells.

CAR-NK cells would be derived from cord blood, allowing them to be stored in banks and used on several patients, vastly reducing manufacturing expenses.

There is also the possibility that future cell therapies could target solid tumours, something that is not possible with Kymriah or Yescarta.

These therapies are not able to target the antigens present on solid tumours, and the CAR-T cells are not tough enough to infiltrate tumours.

Kymriah and Yescarta are just the start – whether the NHS is agile enough to keep pace with cell therapies for cancer and other diseases as they are developed remains to be seen.

Bloodwise’s Ranking concluded: “It is likely that we are only beginning to see the benefits that CAR-T therapy can bring. Treatments will continue to improve and become more effective over the coming decade and will benefit patients with other types of cancer.”

SOURCE: www.pharmaphorum.com/views-analysis-oncology

Patients call for end to CF drug price row at key meeting

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Representatives of NHS England and cystic fibrosis drug company Vertex are to meet on Thursday to try and resolve a two-year impasse over access to life-changing medications.

Charities and patients called for a resolution to the ongoing pricing row, which began two years ago when NICE said Vertex’s combination therapy Orkambi (lumacaftor+ivacaftor) is too expensive for the NHS.

Orkambi is the first medicine to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation, aged six or over, and Vertex has other drugs in its pipeline that will mean a wider group of patients will get treated.

NHS England and Vertex have been locked in an increasingly bitter argument over pricing, with the manufacturer accusing the NHS of undervaluing cystic fibrosis patients.

Vertex is trying to get the NHS to fund all its approved CF drugs, and any future medications in its pipeline in a long-term deal.

In July Vertex said it received an offer worth about £500 million over five years, and more than £1 billion over 10 years for Orkambi.

This was rejected and Vertex has made veiled threats that it will consider spending its R&D budget elsewhere because of the row.

It has also refused to engage with NICE until the cost-effectiveness body changes its assessment methods.

David Ramsden, chief executive of the Cystic Fibrosis Trust has written to Vertex’s chief executive Jeffrey Leiden, and NHS England’s chief executive Simon Stevens calling for the matter to be resolved.

Ramsden urged Leiden to do “everything in [his] power” to reach an agreement, while calling on Stevens to find a way to “value and reward” the innovative drugs from Vertex.

The UK has the second largest population of patients with CF in the world, with around 10,000 people affected.

Christina Walker, from the patient group UKneedsorkambi, said the drug should be made available as soon as possible so that patients such as her son Luis can receive it.

Walker said: “It’s been a devastating summer for the campaign group while this impasse has persisted. We’ve watched our loved ones’ health decline with exacerbations, made many hospital visits and have mourned CF angels who’ve lost their final battle.

“Whether or not this situation continues unchecked is in the hands of the people from Vertex and the NHS around the table on Thursday.

“They must both compromise heavily – more than they want to – because lives are at stake and what’s the alternative? Too many people have died already. These transformational treatments can reduce the considerable suffering of this cruel condition, and patients must have them now. Time is up, and any further delay will be unforgivable.”

SOURCE: www.pharmaphorum.com/news

NICE U-turn on Crystiva for rare bone disease

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Reversing its initial decision to reject the drug, NICE has issued a positive recommendation for Kyowa Kirin’s rare disease drug Crystiva, the first treatment approved to target the underlying pathophysiology of X-Linked Hypophosphataemia (XLH).

The U-turn is good news for the Japan company, which negotiated on the price of the treatment behind closed doors after the NICE’s  conclusion that the drug wasn’t cost effective.

the UK’s cost-effectiveness watchdog is now set to recommend the twice-monthly injection for the treatment of XLH in children and young people with growing bones, with final guidance expected in October.

Tom Stratford, CEO, Kyowa Kirin International said: It is a major development that NICE has recommended Crysvita for routine use among children and young people with XLH in England and Wales.

“This marks a step change in treatment for XLH, emphasised through the emotional testimonies provided by patient groups and clinicians following the first evaluation consultation.”

Characterised by bowed or bent legs, a short stature, bone pain and delayed walking, XLH is first seen in infants but can also affect adults.

It is caused by low levels of phosphate in the blood, resulting in life-long physical disabilities.

Until now, treating this disease has consisted of multiple daily doses of phosphate and vitamin D to counteract the effects of FGF23, a protein that when produced excessively, reduces renal phosphates in the blood.

Crysvita targets this pathway by blocking the activity of FGF23, restoring phosphate blood levels by reducing phosphate loss via the kidneys.

Commenting on NICE’s decision, Oliver Gardiner, Board Member at XLH UK, said: “This is important news for children and young adults with XLH who will now be able to benefit from Crysvita routinely on the NHS.

“Access to a treatment that tackles the underlying mechanism and has the potential to avoid or mitigate substantial physical and emotional challenges, will truly make a difference to the lives of patients and their families.”

Crysvita was already accessible to patients under the NHS via the UK’s early access programme, which will be extended to allow time for NHS England to implement NICE’s final guidance.

SOURCE: www.pmlive.com/pharma_news

Novartis’ CAR T therapy Kymriah to become available on the NHS

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Novartis’ Kymriah is set to become the first CAR T therapy to become available on the NHS after it was revealed that the cancer treatment will be offered to children and young adults up to the age of 25 years old with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.

While both Gilead and Novartis’ CAR T therapy were awarded marketing authorisation in the European Union just last week, NICE were quick to reject Gilead’s CAR T therapy Yescarta on the grounds that it was too expensive.

However Novartis’ one time cancer treatment is now set to become available through the UK’s national healthcare system.

Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland, said: “This decision to make our revolutionary CAR-T therapy, Kymriah (tisagenlecleucel) available so soon after being licensed is the result of our close collaboration with NHS England and NICE, with flexibility shown by all parties to ensure young patients can access this life-saving treatment as quickly as possible.”

The custom made treatment, which uses an individual’s own immune cells to combat cancer, has the potential to extend survival and significantly improve quality of life for children and young adults whose prognosis is poor.

However the cancer therapy comes with a high price tag, costing $475,000 in the United States. Meanwhile the list price for Gilead’s alternative Yescarta is just $373,000 in the US. Nevertheless the price that has been negotiated between Novartis and NICE will be kept confidential.

SOURCE: www.pharmafile.com/news/518554

NICE rejects Gilead’s CAR-T, immediately after EU approval

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Novartis and Gilead’s CAR-T therapies have been approved in Europe – and the UK’s NICE immediately slapped down the latter, saying it is too expensive for regular NHS use in England and Wales.

Novartis’ CAR-T, Kymriah (tisagenlecleucel) has not yet been reviewed by NICE’s committees, as the cost-effectiveness body received the manufacturer’s dossier much later.

But if NICE’s decision on Gilead’s CAR-T (chimeric antigen receptor T-cell) therapy, Yescarta (axicabtagene ciloleucel) is anything to go by, Novartis may also have difficulties securing market access on England’s NHS.

In its document summarising its assessment of Gilead’s drug, NICE noted the good response rates, overall survival and progression-free survival data from clinical trials of Yescarta in diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma in people who have had two or more systemic therapies.

But NICE said there was a lack of comparator data with standard care of salvage chemotherapy, so it was unable to quantify the exact size of the drug’s benefit.

Gilead has kept the list price a secret, and NICE merely said that the cost per Quality Adjusted Life Year was in excess of £50,000, its upper limit for medicines given to patients at the end of their lives.

However the medicine does not come cheaply – in the US Gilead set a list price of $373,000, for the therapy, a single shot of a patient’s own T-cells, harvested and genetically modified to destroy certain blood cancer.

NICE’s independent assessment committee also considered whether Yescarta could be reimbursed on an interim basis by the Cancer Drugs Fund until new clinical data comes to light.

But the committee said Yescarta does not have plausible potential to be cost-effective.

Meindert Boysen, director of the centre for health technology evaluation at NICE, said: “CAR-T is an exciting innovation in very difficult to treat cancers, with a promise of cure for some patients.”

“We have been working with the companies involved, and with NHS England, with the aim of ensuring that patients in England are among the first to have access to these new treatments in Europe.”

“Although promising, there is still much more we need to know about CAR-T, and unfortunately, in this case, we are not able to recommend axicabtagene ciloleucel for use in the NHS in England at the cost per patient set by (Gilead’s subsidiary) Kite Pharma.”

However in the long term, it looks likely that CAR-T therapies will be available for NHS patients: as revealed by pharmaphorum earlier this year, the NHS has been doing extensive groundwork ahead of their approval, including setting up specialist centres.

The approved indications for Yescarta are adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

Kymriah has been approved for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

SOURCE: www.pharmaphorum.com/news

Collaborative working is key for the NHS and pharma

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Both the NHS and pharma recognise the need and the opportunity to collaborate in order to improve patient care and outcomes, and this was a key theme for discussions at the recent HSJ Life Sciences Forum, which united thought leaders across the healthcare spectrum. 

One way in which industry can work in mutually beneficial partnership with the NHS is by looking beyond the usual promotional plans and tactics, to how it can share valuable clinical evidence and information online by accessing NHS staff intranets. This can enable pharma to build its reputation and strengthen customer relationships whilst improving NHS staff knowledge and expertise.

There is a particular need to support NHS staff on the health economic benefits of complex speciality medicines, as indicated in McKinsey & Company’s recent Medical Affairs: Key Imperatives for Engaging and Educating Physicians in a Digital World report.

It states: “There is an increasing need for education and high-quality information, given the proliferation of specialty and more complex medicine.” The industry has to play an important role in collaborating with the NHS to keep staff abreast of the latest innovations and evidence to support the drive for outcomes-focused reimbursement models.

However, it is clear that pharma needs to modify its approach and consider different multi-channel methods, since the McKinsey report shows that although physicians’ use of digital content for discussion, research and collaboration continues to grow, “81% of physicians are dissatisfied with their interactions with biopharmaceutical companies, and more than 40% no longer perceive a ‘need’ for medical support from pharma”. Physicians’ dissatisfaction was said to be driven by a perceived lack of personalised, relevant content (28%) and appropriate communication channels (17%).

The highly regulated environment in which pharma operates is referenced in the McKinsey report as being partly to blame for industry’s failure to provide the kind of targeted, personalised digital communications for HCPs that are commonplace for customers in many other industries.

This isn’t helped by the rapid pace of structural change within the NHS, where new care models are emerging in different areas across England, key stakeholders often hold a number of roles and responsibilities, and collaborative decision-making is becoming increasingly important.

Despite these barriers, industry already has a wealth of approved and compliant information that can be shared through NHS staff intranets, as part of a more collaborative partnership approach both on and offline. This can enable NHS staff to gain easy access to vital information to help improve outcomes in key care pathways.

Content could range from clinical evidence papers, to trials results reported in conference highlights and clinical guidelines. Reports and outcomes from joint working initiatives that show, for example, how the re-design of a care pathway, combined with new treatments, is improving patient outcomes, could also provide valuable insight nationally and regionally.

By supporting continuing professional development (CPD), with knowledge-improving modules/quizzes, industry can add value to the cash-strapped NHS and help HCPs, who are finding it increasingly difficult to access traditional CPD courses, owing to funding cuts.

While historically the industry has prioritised promotional budgets and activity to drive sales performance, now is the time to explore equally measurable and focused routes to sharing the huge range of valuable clinical information at its disposal in order to work more closely with the NHS and help to optimise the performance of NHS staff. This, in turn, will build relationships, reputation and value for both the NHS and pharma.

As the resource constrained and cash strapped NHS looks for ways to collaborate with the life sciences industry to further improve and optimise patient outcomes, there is a substantial opportunity for the industry to align its own objectives by capitalising on its data, information and evidence.

SOURCE: www.pharmaphorum.com/views-and-analysis

 

Europe’s first allogeneic stem cell therapy rejected by NICE

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Cost regulators for the NHS in England and Wales have not approved funding for TiGenix and Takeda’s Alofisel – the first allogeneic stem cell therapy to be approved for use across the European Union – for use in Crohn’s patients.

The therapy (previously referred to as Cx601) was approved in March to treat complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

Perianal fistulas, a common complication of Crohn’s disease, occur when an abnormal passageway develops between the rectum and the outside of the body, potentially leading to incontinence and sepsis. Complex fistulas, which are rare, are more treatment resistant than simple fistulas.

Alofisel (darvadstrocel) is a local administration of allogeneic (donor derived) expanded adipose-derived stem cells (eASCs).

In clinical trials underpinning the drug’s approval, patients receiving the treatment showing a 44 percent greater probability of achieving combined remission compared to placebo, while a follow-up analysis (at 52 weeks and 104 weeks post-treatment) confirmed sustained efficacy and safety, according to the firms.

However, in draft guidelines, the National Institute for Health and Care Excellence said Alofisel showed only a modest improvement in the proportion of people with complex perianal fistulas achieving complete remission compared with placebo in one clinical trial.

“Reliable follow-up results are only available for up to one year, so it is unclear how long the treatment benefit will last,” according to the guidelines.

Because of this, cost-effectiveness estimates are “highly uncertain” and the committee was unable to conclude on the most plausible cost-effectiveness estimate, NICE said.

SOURCE: www.pharmatimes.com/news

From molecule to medicine, the importance of persistence

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Here, Dr Sheuli Porkess, deputy chief scientific officer, Association of the British Pharmaceutical Industry (ABPI), outlines how the pharmaceutical industry takes a substance from molecule to medicine and how the process requires persistence.

A report last week from the Office of Health Economics (OHE) shows the amazing impact medicines have had on the NHS and more widely. The antipsychotic chlorpromazine, first used in the NHS in 1954, paved the way for deinstitutionalisation and community-based care for people with mental illness. In 1948, there were almost 400,000 cases of measles in England and Wales, and 327 people died. By 2015 the number of cases of measles in England and Wales had fallen below 1,200.

These medicines, and others, had a variety of benefits including better clinical outcomes, saving lives, improving quality of life, greater health service efficiency and wider societal impacts. But making medicines is a complicated and costly business. It costs billions of pounds and can take decades. Successes can change the world; failures are an inevitable part of the discovery and development process. But when medicines get through the development process, they can clearly change millions of lives.

There are broadly three stages to creating a new medicine: research, development and approval. Here’s how it works:

Drug discovery and development

The process usually starts with chemical compounds or biological molecules. With advances in technology over the last few years, we can screen compounds that have the potential to become treatments faster than ever before. AstraZeneca — a British pharmaceutical company — launched a new screening robot in 2016 called ‘NiCoLA-B’ which is able to test 300,000 compounds a day. Its job is to find those chemicals that show the slightest potential of being useful as a medicine.

The research stage benefits hugely from collaborative partnerships between the pharmaceutical industry, charities and universities, all working together to find a potential medicine. This stage can take four to five years and takes about 22% of the total budget it takes to find a treatment. Each compound has a less than 0.01% chance of success.

Preclinical research

From a batch of about 10,000 compounds screened in the drug discovery phase, only about 10–20 go into the pre-clinical phase, where scientists determine how safe a medicine might be through testing in cells and animals as well as using computational models.

Clinical research

If any of those 10-20 compounds show real potential of being turned into something useful, they’re developed in to a medicine that will move into clinical trial stage. There are three steps: Phase I involves about 20 to 100 volunteers. If medicines are successful here, they will move onto Phase II where they are tested in people with the disease.

Phase III can include up to 5,000 patients. Going through the three phases can take six or seven years. Over half, or about 65%, of the money it takes to make a medicine is spent in the development stage.

Phase IV clinical trials are after the medicine has a licence and are there to help monitor the medicine’s safety and help clinicians better understand how the medicine works in everyday life, not just in clinical trials.

Approval

The final stage is when regulators review the medicine and it can get ‘market authorisation’ — which shows the medicine is safe and effective. By this point, the manufacturing of the medicine has been scaled up. Only one medicine of 5,000–10,000 compounds discovered will make it to this stage.

The approval processes last anywhere from six months to two years. The medicine is continually monitored once it starts being prescribed for patients.

Researching and developing medicines takes a lot of time and work along the way; there is no guarantee that any particular medicine will make it through the various stages of this highly regulated process. The process is fascinating and once medicines get through this system, their impact can be huge.

Of course, the pharmaceutical industry is pioneering new ways to find treatments. The future looks exciting and how we detect, diagnose and treat disease is set to change significantly.

Advances in medical technology and the miniaturisation of diagnostics, wearables and devices will have a huge impact on our lives and could help people with chronic diseases to remain out of hospital.

Advances in understanding how cells monitor and repair damaged DNA enables us to develop game-changing treatments for cancer. Progress in immuno-oncology sees patients own immune cells used to attack cancer cells, and stem cell therapy is treating rare sight conditions.

We see AI and synthetic biology used for treating malaria, HIV and hepatitis. Gene-editing technology is happening in labs right now, identifying new disease targets, accelerating the discovery of novel treatments.

Passionate pioneers, such as those who invented the groundbreaking treatments in the report, have always been at the heart of our industry and it’s exciting to imagine what their successors could achieve in the next 70 years.

SOURCE: www.epmmagazine.com/opinion

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

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

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

Life Sciences sector responds to report on the impact of Brexit

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The Business, Energy and Industrial Strategy (BEIS) Committee report calls on the Government to secure a post-Brexit deal to protect patients and the UK’s pharmaceutical industry.

“The impact of Brexit on the pharmaceutical sector’ makes several recommendations which industry welcomes. This includes the need to secure the closest possible regulatory alignment with the EU as well as minimum border friction. Patients are at risk of harm and the UK pharmaceutical sector could lose its status as a world leader,” the report says.

The Committee also concluded that “what little benefits there may be from regulatory divergence, these would be greatly overshadowed by the costs and loss of markets and influence the UK would face.”

A joint statement by the Association of the British Pharmaceutical Industry (ABPI) and the UK BioIndustry Association (BIA) – whose chief executives, Mike Thompson and Steve Bates, provided evidence to the Committee – said:

“Every month, 45 million packs of medicine move from the UK to the EU, with 37 million moving the other way.

Today’s Select Committee Report is right – a Brexit ‘no deal’ would significantly damage public health, patient access to medicines and the UK’s leading pharmaceutical sector. This must be avoided at all costs.

“Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.”

The ABPI represents innovative research-based biopharmaceutical companies and is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, which supplies more than 80% of all branded medicines used by the NHS.

SOURCE: www.manufacturingchemist.com/news