The ABPI, a host of Royal colleges and other major healthcare organisations have created a set of principles in order to drive best practice in clinical trial reporting.

The Ethical Standards in Health and Life Sciences Group’s (ESHLSG) Clinical Trial Transparency Principles and Facts outlines standards including publishing study outcomes within 21 days and releasing significant data.

Dr Clare Gerada, Chair of the Royal College of GPs, said the document provides “much-needed clarity, as well as setting new standards for transparency and best practice”.

The ESHLSG principles are the first time that leading healthcare bodies and senior pharma representatives have agreed on a joint approach on clinical trial data and outcomes.

Deepak Khanna, co-chair of the group and President of the ABPI, said that clinical research is an “essential part of the medicine development process” and the results are a “source of information” to all researchers.

He commented: “Scientists can examine, question and utilise trial data, and that can only benefit the healthcare community and patients. I’m delighted that so many healthcare leaders are involved in this project – we will be far more effective in finding the right solutions if we work together.

“It is in all of our interests to be transparent, and it is incredibly encouraging to see the collaborations that have brought about this conference and the publication of the Principles document.”

Pharmaceutical companies should collaborate more with patients during early-stage research in order to better meet the needs of its customers, according to a new report.

Research suggests that patient perspectives are increasingly been sought during drug development to help pharma identify and define valuable new medicines.

But further collaboration is needed, the report says, in order to consider the relevance to patients of new products so that clinical trials can be designed appropriately with these points in mind.

Patient Reported Outcomes (PROs) are not a new move by pharmaceutical companies conducting research during drug development.

Pharma has used PROs in cases where appropriate measurements in clinical trials must be developed and validated as part of the drug development process. But complex planning is initially required which often delays the start of research.

PROs are seen as valuable by health regulators with the FDA and EMA working on processes to support such schemes. Reimbursement authorities also use the outcomes to define value.

Organisations are also in place to assist pharmaceutical companies to gather information from patients, carers and clinicians who share interests in a particular disease area. The EU Patient Partnership Project promotes the roles of patient organisations during clinical trials to empower them to interact with key stakeholders during research stages.

But the project has identified barriers between pharma and patient bodies including a lack of expertise and awareness of clinical research by patients and an unwillingness to enter collaboration by pharma over concerns of negative publicity.

The report, Patient Perspectives – Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge, adds that these concerns need to be corrected and that further PRO tests are conducted to ensure that pharma meets the needs of patients, regulators and reimbursement authorities in the future.

Both GlaxoSmithKline (GSK) and Eli Lilly are investing in new pharmaceutical research facilities in the UK.

GSK has provided £12m to help fund a new sustainable chemistry research facility, focusing on pharmaceutical research, at Nottingham University.

Lilly has launched new neuroscience research facilities at its Erl Wood R&D campus in Surrey, at a cost of £5.4m.

Both initiatives reflect the industry’s renewed confidence in partnership with the academic sector, triggered in part by the new ‘patent box’ legislation.

Known as the GlaxoSmithKline Carbon-Neutral Centre for Sustainable Chemistry, the new building at Nottingham University is intended to stimulate collaborations with other institutions and industry partners.

The new building, scheduled for completion in 2014, will be carbon-neutral, made from natural materials and rely on renewable energy sources.

Sir Andrew Witty, CEO of GSK, said: “The carbon-neutral laboratory will help affirm the UK as a global hub for the future of the life sciences industry. This is an opportunity to invest further in science in the UK, rethink how we approach the drug discovery process and play a role in contributing to environmental stewardship.”

“This development will be transformational in several ways,” commented Professor David Greenaway, Vice-Chancellor of the university. “The building will break new ground in sustainable construction, while the centre of excellence will shape the future of drug discovery.”

The initiative was praised by David Willetts, Minister for Universities and Science. “This new laboratory is an excellent example of collaboration between universities and industry,” he said. “It shows how businesses can benefit from the knowledge and expertise of our world-leading research base and will help keep us at the very forefront of life sciences.”

Eli Lilly’s new research facilities at Erl Wood will house 130 staff, many already employed at the site.

The investment reflects Lilly’s aim of strengthening its neuroscience portfolio, especially for the treatment of Alzheimer’s disease.

Dr Jan Lundberg, President of Lilly Research Laboratories, commented: “The UK is a great place to do bioscience research. Not only does the UK benefit from have a strong research base, the government is also able to maintain a stable pricing and reimbursement system.

“As well as financial incentives for R&D, this demonstrates that the UK government has a commitment to maintain its position as a global leader in attracting pharmaceutical investment.”

Lilly’s involvement in neuroscience research goes back two decades. The company’s drug solanezumab, currently in phase III development, has potential to slow the progression of Alzheimer’s disease.

Dr Lundberg also emphasised the importance of partnership between industry and academia. “Collaboration is absolutely essential to ensure innovative new medicines reach patients,” he said. “The science behind drug discovery is becoming more challenging.”

German pharmaceutical giant Boehringer Ingelheim (BI) is building a new $65m R&D facility at its US headquarters in Ridgefield, Connecticut.

The new facility, according to BI, will undertake “production of active pharmaceutical ingredients used in early development activities”.

While not employing new staff, the new R&D site – which will replace a smaller current site – will support the company’s research activity in the region.

This development follows another new building project in Ridgefield commenced by BI in August: a $42m drug safety assessment site for non-clinical safety studies, scheduled for completion in 2013.

The two new buildings represent a total investment of more than $100 million in the Connecticut operation.

Jim Baxter, BI’s Senior VP of Development for US Operations, said that the company’s investment in new buildings shows its commitment to supporting and developing its US research base: “When they say the site is critical to BI’s future, they mean it.”

Boehringer Ingelheim has invested more than $350 million in the US in 2011, with new projects in Iowa, Missouri and Ohio and the acquisition of a business from Amgen in California.

New research shows that SME growth provides the best prospect for economic recovery in the UK. But, as private equity firm ECI notes, finding the cash to reach out to global partners and markets can be a critical hurdle.

With continued pressure on governments across the Western world to reduce their expenditure, together with sustained macro-economic uncertainty and a tightening of bank funding, times are not necessarily easy for the average healthcare company – which often relies on the public purse for reimbursement and debt funding for growth. One might therefore expect the short-term outlook for growth to be somewhat muted, despite the backdrop of positive longer-term demographic drivers of demand.

Hence it is interesting that a recent survey of UK SME businesses by ECI Partners, a UK-based midmarket private equity firm, has found executives to be generally positive about growth prospects over the next 12 months, with 74% of respondents anticipating headcount growth and 60% expecting double-digit turnover growth.

The results met with a warm response from the Government, with Mark Prisk, Minister of State for Business and Enterprise, saying: “It’s good news that despite a tough few months, nearly three-quarters of the SMEs surveyed by ECI are looking to recruit over the next year and half expect to see substantial profit growth in that period. Up and down the country, it is Britain’s SMEs that are driving our economic recovery.”

Reaching out

This year, the survey conducted each summer by ECI Partners gained responses from a total of 246 chief executives from UK growth companies from a range of sectors with turnover between £10m and £200m. The results paint a positive picture against the gloomy economic backdrop of the Eurozone crisis and sluggish UK economy, and suggest that there remains growth potential amongst SME businesses – which account for around a third of UK private sector employment.

Steve Tudge, a Managing Director of ECI, commented: “Despite the barriers to growth, which are principally cited as a weaker macro-environment and funding constraints, we continue to be optimistic about the prospects for good mid-market companies.”

Executives see the key growth drivers to be increasing international sales – with Europe and the USA remaining the dominant international markets, though India and China are becoming more important – and organic growth through investment in sales and marketing and new product development. Over 40% of companies are also planning to increase their use of overseas suppliers to improve their margins.

Internal cash flows are viewed as the most likely source of funding for this growth, though around half of respondents say they are likely to seek bank debt within the next 12 months (despite continued complaints about its cost and due diligence requirements) and around 40% are also likely to look at private equity backing. Fewer than 10% of companies see the public markets as accessible, perhaps reflecting the recent volatility and liquidity issues associated with the AIM market.

Healthcare respondents are less bullish about high growth than their peers in other sectors, and are noticeably less positive about growth than they were last year. This no doubt reflects, in part, the political uncertainty surrounding the current UK healthcare reforms and the public sector spending constraints that are impacting on the health and social care sectors.

Despite this, companies remain more confident of raising growth financing – and of raising it from private equity firms, with over 50% saying that was a likely consideration over the next year.

Financing growth

What does all this mean for SME healthcare businesses in the UK? The sector certainly faces challenges in responding to Government spending cuts, which are tending to put pressure on margins if not always on volumes.

However, opportunities for growth remain amidst these challenges, particularly for companies who are able and willing to venture beyond the UK in order to seek new customers and cheaper suppliers.

Of course, this internationalisation can put a strain on smaller businesses, which may lack the scale to fully support an international infrastructure. Private equity groups with experience and expertise in this process can potentially offer support to management teams in this position – whether by making introductions, sharing best practice or simply financing the required infrastructure.

There are significant sums of capital available for investment from the UK private equity industry, and there remains an appetite to invest in market-leading healthcare businesses. Thus private equity should be considered seriously as an option by management teams in the healthcare industry who are looking to fund growth to help their companies succeed in the current economic environment.

ECI is a private equity group that has been investing in mid-market growth businesses for over 35 years. It invests across sectors, with a focus on UK and Irish companies. Healthcare companies in its current portfolio include a primary care provider (Harmoni), assisted living specialists (Premier Bathrooms, DLP) and medical software companies (Clinisys, Ascribe).

The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

Bristol-Myers Squibb has entered into a strategic partnership with Singapore-based ASLAN Pharmaceuticals for the licensing and development of one of its investigational oncology compounds.

Under the agreement, ASLAN has the rights to develop and commercialise BMS-777607, a small molecule inhibitor of the MET receptor tyrosine kinase for treatment of solid tumours, in China, Australia, Korea, Taiwan and other selected Asian countries. BMS will retain rights for the rest of the world.

ASLAN will also complete and fund the development of the compound under a pre-agreed programme that will initially target gastric and lung cancers.

Francis Cuss, Senior Vice President, Research, BMS, says the agreement is part of the company’s “Oyster strategy” which aims to produce “high-quality data that may be used to further develop and commercialise the medicine worldwide”.

“As part of our biopharma strategy, Bristol-Myers Squibb seeks to seed companies in key markets with promising investigational medicines of continued interest to Bristol-Myers Squibb,” he said.

A vibrating gel injected into the vocal tissues of the throat could restore vocal capacity to people whose voices have been damaged by surgery.

The new gel (pictured), developed by Harvard Medical School surgeon Steven Zeitels in partnership with MIT bioscientist Bob Langer, can vibrate up to 200 times per second, mimicking the action of human vocal cords.

Their research has been partly funded by singers Roger Daltrey (of The Who) and Steven Tyler (of Aerosmith), both of whom have suffered loss of singling ability following surgery, thought its main funding source is the Institute of Laryngology and Voice Restoration.

It has recently been reported that Dr Zeitels is helping to treat singer Adele, who has had to cancel her 2011 tour to undergo surgery to alleviate issues with her throat.

Injected directly into the vocal cords, the gel responds to breath and muscle tension by vibrating.

Zeitels is a professor of laryngeal surgery whose patients include singer Julie Andrews as well as Daltrey and Tyler. He was directed to Langer by a number of scientific experts.

Langer is famous for his work on anti-cancer drugs that starve tumours of their blood supply, including Roche’s Avastin, and on time-release drug delivery technologies for chemotherapy.

Creating artificial vocal cords requires a durable material that can bond with the existing tissue and respond correctly to muscle contractions and air movement. Langer has developed a polyethylene glycol gel tailored at the molecular level.

“With synthetic materials, the beauty is you can tailor them and build in the degradation rate or mechanical strength you need because you’re making them from scratch,” Langer commented.

Zeitels and Langer plan to test the gel in a cancer patient for the first time in 2012.

New funding for medical technology research by companies, clinicians and academics aims to promote innovative approaches to the prevention, diagnosis and treatment of diseases in the NHS.

The National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme has allocated up to £13m for research projects, and has launched a call for proposals.

The NIHR i4i programme funds projects through prototype and commercial development until a technology is ready for clinical testing, bringing together academic or clinical researchers and technical experts from industry.

The programme has been updated in two ways:

• Research projects in Wales, as well as in England, are now eligible for i4i.
• Instead of being divided between early- and late-stage product development awards, applications will all be submitted through a single route.

As well as looking for technologies that will benefit NHS patients, the NIHR i4i programme supports collaboration between researchers in industry, the NHS and the academic field. Each approved proposal will bring together researchers from at least two of these sectors.

NIHR particularly welcomes proposals from SMEs and from teams that have previously succeeded in developing and commercialising new technologies.

Martin Hunt, NIHR i4i Programme Director, said: “In the present economic climate, it is becoming increasingly difficult for medtech companies to secure funding for new, innovative technologies. The NIHR i4i programme provides a valuable funding opportunity for the medtech sector.”

This year’s i4i funding covers a “much broader” range of projects than last year’s, he noted. “The amount of funding awarded is determined by the nature and scale of the proposed research activity and we are considering projects seeking larger funding amounts than before.”

Outline research proposals must be submitted by 5pm on Wednesday 7 December 2011. Further details are available at www.i4i.nihr.ac.uk.