National Market Access Lead, Associate Director

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Are you truly making a difference?

This is the mantra for our client who focuses on developing innovative therapies for people coping with serious diseases the world over.

If you would consider yourself to be an expert on NHS funding and access policies and have a broad background in developing and executing strategic commissioning and access plans at a National level for highly specialised products, then we would like to speak with you.

Our client is a global biotechnology company with over 40 years of heritage working across multiple specialist therapy areas.

Ideally, we are looking for somebody with a background in developing and executing market access strategies for biologic products , and who is capable of working efficiently in a cross-functional matrix environment.

You do not need to have HEOR experience, however, working knowledge of budget impact modelling would be advantageous.

Why apply?

– Highly visible position working a priority area of the business

– Autonomous position reporting into an incredibly seasoned and empowering industry expert

– Collaborative and innovation focussed business environment

– Industry leading salary and benefits package with a big focus on wellness.

Process:

– Initial telephone interview with us on application, if you decide you would like to proceed further, we would submit your details to the hiring manager for review

– The second stage would be a relatively informal first stage interview with the hiring manager to ascertain fit both sides

– If you are still interested, and the hiring manager agrees! There will be an HR interview along with a structured assessment process which will include a variety of stakeholders from the business – it is likely that the process will extend into January 2018. However, our client is keen to close the position down within the next 4-6 weeks.

To discuss this position in detail or for any further information, please contact Wax Selection on 0844 8009021.

Medical Advisor – Oncology

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Are you frustrated by the silos and limitations of working in big pharma?

Would you like more autonomy and the ability to have a direct and positive impact on the medical affairs strategy for your business?

If so then you need to speak to our client! Our client is a well-established mid-size bio-pharmaceutical company with an exciting portfolio of existing oncology products as well as late stage pipeline in oncology, speciality and rare disease assets.

Due to the continued success and growth of the business two new positions have been created within the medical affairs directorate; if you are a GMC or GPhC and would like to learn more please contact me for an informal chat.

Benefits of the role:

  • Dynamic working environment
  • Bespoke career development plans – no more traditional talent frameworks
  • Competitive salary and benefits package
  • Solid research and development pipeline plus robust ‘invest to grow’ strategy
  • Collaborative culture
  • Highly autonomous position with the opportunity to impact the wider medical affairs strategy
  • Global career development prospects without the need to relocate from the UK

Ideally you will already be a final medical signatory with some experience of working on HTA submissions and new product/programme launches.

If you are keen to be part of something great, part of an innovative and nimble organisation that truly puts its people at the centre of everything to enable the business to deliver outstanding value to their customers and best in class treatments and services to their patients then apply today for an informal chat.

What next?…

  • Stage 1 would be an informal chat with us followed by a more structured face-time interview if you are interested in applying
  • Stage 2 we will submit your CV to the hiring manager – this will then be followed up with an initial informal meeting or telephone call with the hiring manager
  • Stage 3 will be a meeting in head office where you will get the opportunity to meet with several members of the business across the medical and commercial directorate

We would like to conclude the interview process this side of Christmas (2017!) to allow you enough time to start working your notice period.

To discuss this position in detail or for any further information, please contact Wax Selection on 0844 8009021.

Blood-based epigenetic may hold clues to autism

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Epigenetic data reveals immune-response pathways that may prove critical to understanding autism.

Using data from blood and brain tissue, a team led by researchers at Johns Hopkins Bloomberg School of Public Health found that they could gain insights into mechanisms that might help explain autism by analysing the interplay between genes and chemical tags that control whether genes are used to make a protein, called epigenetic marks.

The findings could ultimately help lead to new ways of treating and preventing the disorder.

To investigate this question, Dr Margaret Daniele Fallin, chair of the Bloomberg School’s Department of Mental Health and director of the School’s Wendy Klag Center for Autism and Developmental Disabilities and her colleagues started by surveying four different tissue types–blood and cord blood from their own collections, as well as lung and fetal brain tissue from public collections–to find small variations in the genetic code of each sample that appear to be responsible for DNA methylation state, a type of epigenetic modification, in that particular tissue.

The researchers examined millions of these genetic code variations, known as single nucleotide polymorphisms (SNPs) and found thousands that control DNA methylation in some or all tissue types. They then matched up these SNPs with those already known to be associated with autism and saw that more autism-associated genes act to control DNA methylation than would be expected by chance. This was true in both blood and fetal brain tissue.

When the researchers looked at the role of genes that were methylated by genes with code differences related to ASD, including additional genes beyond those with direct code changes, they found that the majority were involved in biological pathways that were important in immune function.

The finding wasn’t surprising, Dr Fallin explains–numerous studies have identified abnormal gene expression of immune genes in autism samples and environmental experiences such as prenatal infection or prenatal exposure to pollutants that can ramp up immune responses are risk factors for ASD. However, none of the genetic code mutations directly identified in autism had pointed to these pathways. It is only when considering which other genes they may regulate that this biology is revealed.

More study on these biological pathways, she says, could lead to specific genes or proteins that could be modifiable with pharmaceuticals or other interventions, possibly offering new ways to prevent or treat ASD.

Researchers have long known that chemical modifications, a collection of “marks” on DNA known as the epigenome, play a key role in how cells operate by guiding differences between various tissue types in a given individual’s body, despite the fact that they all carry the same genetic code.

“The reason a brain cell is different from a heart cell is because of the epigenome, which affects which parts of a cell’s DNA are read,” says study Dr Fallin. “Think of it like an encyclopedia with a bunch of tabs. Cells don’t need to read the entire encyclopedia; they jump to the tabs they need to get things done.”

The current work shows that changes in the genetic code of a particular gene can control epigenetic marks at different genes, implying that a gene’s genetic code can affect whether other genes are turned on and off, which makes it important to understand the function of all genes involved, not just the one with the so-called misspelling.

“Our findings suggest that looking only at genes with misspellings related to autism might be too narrow a focus,” said Dr Fallin. “Instead of looking solely at the genes directly implicated in autism through their genetic code changes, we really should be also studying the functions of the other genes implicated by these changes in genetic code through epigenetic connections. “

“We made our findings here by comparing brain data to blood data,” she says, “but the vast majority we could have learned from the blood.”

SOURCE: www.europeanpharmaceuticalreview.com/news/68455

Albendazole-antibiotic combination shortens therapy for parasitic diseases

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Researchers have found a way of reducing the treatment required for lymphatic filariasis and onchocerciasis from several weeks to seven days.

Researchers have found a way of significantly reducing the treatment required for lymphatic filariasis and onchocerciasis from several weeks to seven days.

By targeting Wolbachia, a bacterial symbiont that the filarial parasites need to live, the team has discovered a drug synergy that enables effective treatment over a shorter time.

Researchers provide proof-of-concept of a radical improvement to the targeting of Wolbachia via a drug synergy between the anthelmintic drug albendazole and antibiotics.

As part of the A*WOL programme, we have screened all registered drugs for anti-Wolbachia activity, which has allowed us to look at repurposing existing and registered drugs against these debilitating conditions.

The combination of an antibiotic and the anti-worm drug albendazole provided the greatest surprise when they acted synergistically to reduce the treatment time from weeks to days, opening up the opportunity to scale-up this approach at the community level” said Professor Mark Taylor from the Liverpool School of Tropical Medicine.

The team believe that their work is of immediate public health importance because the drugs that have been used, rifampicin and albendazole, are already registered. “These drugs can be tested in infected people as soon as possible,” continued Prof Taylor.

Dr Joe Turner, LSTM first author on the paper, added, “The discovery of drug synergy between a common anthelmintic and different classes of antibiotics is also exciting because even more, potent synergism may be evident when we combine with our next generation, ‘designer’ anti-Wolbachia drugs currently in development as part of the A*WOL programme. Potentially, we may be in a position to reduce curative treatment time frames down to five days or less for filariasis, with better acceptability and reduced costs for patients and local health systems”

What is Lymphatic filariasis?

Lymphatic filariasis (LF), which can cause elephantiasis or hydrocele, swelling of the limbs or scrotum and onchocerciasis, also known as river blindness affect millions of people in some of the world’s poorest communities. Both are caused by filarial parasites for which the bacterial symbiont Wolbachia is essential for development.

Filarial Neglected Tropical Diseases are prioritised for elimination, in line with fulfilment of the 2030 United Nations Sustainable Development Goals. A consensus of expert opinion, including the WHO, and major donors, USAID and UK DFID, considers that successful implementation of a macrofilaricidal or permanent sterilising drug would greatly accelerate the endgame elimination of lymphatic filariasis and onchocerciasis.

Traditional treatment for these conditions require repetitive, long-term mass drug administrations, and although targeting the symbiont with doxycycline has proved clinically effective, it is programmatically challenging due to the long treatment time and exclusion of pregnant women and children.

SOURCE: www.europeanpharmaceuticalreview.com/news/68466

Genetic test could help fight secondary breast cancer

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Thousands of breast cancer patients at risk of developing aggressive secondary tumours could benefit from a potential new genetic test.

A study led by researchers at the University of Sheffield has shown women with breast cancer who lack a key genetic marker are more likely to respond to a treatment that can prevent the disease spreading to their bones.

Secondary cancer, known as metastasis, is the most common cause of death in breast cancer patients as there are few effective treatments once it has taken root.

It occurs when cancer cells spread to another site in the body. Around 70 per cent of secondary breast cancer patients have tumours in the bone.

Large scale clinical trials indicate a group of bone strengthening drugs known as bisphosphonates can help prevent the disease from spreading to bone in breast cancer patients if given early enough.

“The difficulty is identifying which patients will benefit from these drugs,” said Professor Robert Coleman, emeritus professor of medical oncology who led the new study. “It only seems to be effective in some patients, particularly older women, while others show no response and in some younger women it may even be harmful.”

The new study, which is published in the journal Lancet Oncology, has shown it may be possible to identify women who will benefit from bisphosphonates by using a test that looks for a gene known as MAF. Women who do not carry the gene – approximately 80 per cent of women with breast cancer – were found to benefit from the bone strengthening treatment.

Professor Coleman said: “If the test is negative for this gene, then they can be offered this bone strengthening treatment, which can give them a better chance of surviving their cancer.”

A test for the gene, known as MAFTest, has been developed by a Spanish medical company called Inbiomotion following work conducted at the Institute for Research in Biomedicine (IRB) in Barcelona.

The new study, which is published in the journal Lancet Oncology, was part of an international phase 3 clinical trial involving 3,360 women with stage II or III breast cancer.

The results need to be confirmed in a second trial, currently underway in the United States, before the test is likely to receive approval for wider use in patients. But if successful, it could be incorporated into the routine testing of breast cancer patients to see if they could benefit from bisphosphonate treatments such as zoledronic acid. Those found not to carry the gene could be given the drug after having surgery and radiotherapy for their primary tumour in an effort to prevent the cancer from spreading.

Around 50,000 women are diagnosed with breast cancer in the UK each year and the disease claims the lives of 11,500 annually.

“The discovery made at IRB Barcelona and tested in the current study could be of great use to clinicians and would avoid unnecessary treatment of patients who would not benefit or could be harmed by the treatment,” added Professor Roger Gomis, leader of the growth control and cancer metastasis group at IRB Barcelona, who was a co-author on the study.

SOURCE: www.sheffield.ac.uk/news

Symbiosis Pharmaceutical Services opens US office

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Symbiosis Pharmaceutical Services, a Scottish contract manufacturing organisation (CMO) has opened an office in North America in response to continued demand from US-based biotechnology companies for its vial filling expertise.

The sterile filling specialist’s commercial site in Cambridge, Boston, MA, supports clients on both the East and West Coast, as well as giving the CMO a base for reaching new customers in this territory. The company is currently on a recruitment drive to strengthen its US commercial team.

Increased demand for both liquid and lyophilised formulations in injectable dosage forms at Symbiosis has been driven mainly by biotech firms looking for an outsourcing partner with small-scale aseptic manufacturing capabilities to support clinical trials.

Colin MacKay, CEO at Symbiosis Pharmaceutical Services, said: “Given Cambridge [Boston] is the epicentre of the global biotech community, it was the ideal location for us to open an office in the US. So far it has been a great success and we foresee that continuing as we continue to reflect the demand from US-based biotechnology firms looking for small-scale aseptic manufacturing resources.”

“Back in 2015, we took the decision to strategically focus on the North American market after we identified a surge in funding for early stage biotech companies, which are exactly the type of drug development company that are best suited to seek our manufacturing scale and specialist capabilities.”

“As expected, our expertise in filling biologic and small molecule products, combined with our ability to offer rapid access to sterile manufacturing slots, has been very well received by pre-clinical and phase I-II biotech and pharma companies, which has helped to fuel our steady growth.”

“Since strengthening our US-focused personnel and developing our relationships with networks like ISPE and MassBio, we have significantly grown our US client base, which is projected to account for around half of our revenues in 2017. Opening the office on the US East Coast has added to the success of the company’s growth strategy.”

For the last 12 months, Symbiosis has grown revenues by 40% and has also continued to recruit steadily, increasing staff by 30% to meet demand for its aseptic fill/finish service.

MacKay said: “At a macro level, demand for biologic and highly potent products is likely being driven by the increased emphasis on the development of treatments for small patient populations in the case of orphan indications, new oncology products requiring containment capabilities and novel tailored personalised medicines.”

“Those kind of products require specific GMP manufacturing skills for the small-scale production of sterile batches for clinical trials, hence the clear uptake in demand for what we do at Symbiosis.”

SOURCE: www.manufacturingchemist.com/news

Eurofins makes £4 million investment in new Scottish facility

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Eurofins Scientific, a specialist in bioanalytical testing, has opened a new pharmaceutical chemistry and microbiology facility in Livingston, Scotland, following a £4 million investment.

The 5800 m2 facility will become one of the largest dedicated testing sites of its kind in the UK and the biopharmaceutical product testing (BPT) UK business, plans to double employee numbers in the next five years.

The new facility will allow the BPT business to expand its finished product and raw materials testing, and increase capacity to deal with higher volumes.

A greater number of technical specialists will also be available to work on method development and validation.

GMP microbiology contract testing will be a focus, alongside elemental impurity testing, which has benefited from the purchase of new equipment to enhance the capability of inductively coupled plasma mass spectrometry (ICP-MS) testing, enabling the company to meet growing demand for this service.

Eurofins will also invest in more high-performance liquid chromatography equipment, increasing its capacity by 40%.

Alison Clayton, General Manager, said the Livingston site would be one of the largest of all the Eurofins UK sites, which form part of a network of laboratories working together across the UK, Ireland and Europe.

“The large investment in the facility will position the company in the best place to attract new customers thanks to greatly increased capacity and is in line with Eurofins’ intent to attract significant future growth and development opportunities,” she said.

Eurofins BPT UK business will move from its current site in Newbridge, Edinburgh. The Livingston facility will also house new laboratories for Eurofins’ water testing business.

The investment follows Eurofins’ acquisition of Exova’s pharmaceutical, food and water testing business in the UK and Ireland in July 2016, and the subsequent purchase of ILS’s pharmaceutical business in October 2016.

Eurofins BPT UK’s work is critical to drug development compliance testing prior to products being released to market. The company is a crucial part of the supply chain in facilitating the release of products and ultimately benefiting patient health.

The business is part of Eurofins Scientific, an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries worldwide.

SOURCE: www.manufacturingchemist.com/news

AZ tops annual R&D spend in UK, Roche is greatest pharma spender worldwide

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

New findings of a report by PwC have revealed the biggest spenders in R&D worldwide as global spending hits $700 billion, with Roche coming out on top within the pharmaceutical industry with a total expenditure of $11.4 billion in 2017, a 14% increase on the previous year which brought in a huge 21.9% of its total income.

Even with these impressive figures, the company made it only to seventh on the global list, beaten by the likes of Samsung, Intel and Alphabet, while Amazon topped the chart with a massive $16.1 billion injected into research – a 28% increase over 2016 and responsible for almost 12% of the firm’s total revenue.

Elsewhere in the global top ten were MSD with $10.1 billion which drew around a quarter of the firm’s income after an increase in investment of 51% over 2016 – far and away the most in the top 20 – and Novartis, which made $9.6 billion with a tiny 0.6% increase in spending.

In the UK, the pharmaceutical industry was far more dominant when it came to R&D spend, with AstraZeneca topping the list with $5.9 billion, followed by GlaxoSmithKline with $4.5 billion – the only pharma companies to make the top ten in the region.

The report also highlights the threat that protectionism economic policy poses to the UK and the US, with 52% of 562 surveyed R&D leaders believing that the Trump Administration’s import and export approaches and the uncertainty of Brexit will have a moderate or significant impact on R&D efforts in the future.

John Potter, a partner in PwC’s consulting arm, said: “To deliver innovation, many of world’s largest companies rely on shifting talent, money, and ideas across borders. If policies in the major global economic powers start to focus more inwardly, however, this would cast uncertainty over companies’ innovation plans and their current models would need to evolve.”

SOURCE: www.pharmafile.com/news/515465

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

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

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

TiGenix’s Crohn’s fistulas treatment wins orphan drug status

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Belgian biopharmaceutical group TiGenix is one step closer to getting its first-in-class Crohn’s fistulas disease treatment to the US market following an orphan drug designation from the Food and Drug Administration (FDA).

The drug – currently known as Cx601 – could potentially treat ‘complex’ perianal fistulas in patients with Crohn’s disease who have had an inadequate response to at least one conventional or biologic therapy.

Dr Maria Pascual, vice president regulatory affairs and corporate quality, TiGenix, said: “The granting of orphan drug status by the FDA is a significant step forward in the Cx601 development programme.”

The designation follows results of the phase III ADMIRE-CD II trial, a randomised, double-blind, placebo-controlled study designed to confirm the efficacy and safety of Cx601 – a suspension of allogeneic adipose-derived stem cells.

It was found that a single dose of Cx601 was significantly more likely to heal perianal fistulas in Crohn’s patients and stop them coming back for at least a year compared to placebo.

Pascual added: “The FDA’s recognition of Cx601 as an orphan drug brings a number of potential financial benefits and is aligned with our ongoing work seeking expedited pathways towards product approval in the US.”

The move follows the FDA’s plan to eradicate its orphan designation backlog within 90 days, which was announced by commissioner Scott Gottlieb back in July this year.

Meanwhile, TiGenix and partner Takeda has said it will explore expedited pathways to accelerate the submission and review process for US regulatory approval of Cx601.

SOURCE: www.pmlive.com/pharma_news