News

September 1, 2009

Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-09-01-2009, Volume 21, Issue 9

A round up of news from across the globe.

Tailor-made medicine drives M&As

The growth of personalized medicine will bolster the number of alliances between diagnostics and pharmaceutical companies, according to a report from PricewaterhouseCoopers (PwC). As evidence of this trend, PwC cited the partnership announced in July 2009 between GlaxoSmithKline (GSK) and Enigma (UK), which was influenced by personalized medicine. "The partnership between Enigma and GSK enables significant progression towards the 'holy grail' of companion diagnostics — the ability to rapidly and locally test to the same accuracy standards as reference laboratories and immediately determine the correct treatment," said John McKinley, Chairman and CEO of Enigma, in a joint statement issued by the two companies.

(Tom Grill/Getty Images)

The PwC report, Diagnostics 2009: Moving towards personalized medicine, explains that a number of factors are expected to contribute to the continued drive towards personalized medicine, including regulatory agencies that are introducing requirements to test for certain biomarkers prior to prescribing certain drugs and Genentech's Citizen Petition of December 2008, which has motivated discussions regarding the diverse scientific and regulatory standards for in vitro tests. In addition, more people may also now undergo genetic testing thanks to legislation introduced in the US and Europe last year that protects individuals from genetic discrimination.

Another factor influencing personalized medicine will be the current economical crisis. Speaking exclusively to Pharmaceutical Technology Europe (PTE), Laurent Probst, Leader of the Pharmaceuticals and Life Sciences practice of PwC in Luxembourg, said: "We are convinced that the current crisis will place greater emphasis on the urgent need to develop personalized medicine."

According to Probst, government and social security deficits in many countries require urgent reforms to improve the efficiency and quality of healthcare. "The recent introduction of he Obama healthcare reform to implement reforms to help lower costs and improve healthcare quality is a good illustration of this new impulse," Probst told PTE. "As published in our Diagnostics 2009 report, significant transactions directly related to personalized medicines have taken place and we anticipate a future rise in investment."

Indeed, pharma companies have a great deal to gain by venturing into the personalized medicine market. Laurent believes that personalized medicine may reduce the gap between regulatory bodies and the pharma sector with regard to drug benefits and cost impact assessments. "Pharma companies understand the contribution of biomarkers and diagnostics in improving the design and probability of success of clinical trials," said Probst. "In addition, pressure from healthcare payers is putting more emphasis on the availability of a companion biomarker test when deciding on a drug's reimbursement."

This view was also shared by Simon Friend, Global Pharmaceuticals and Life Sciences Industry Leader at PwC. In a statement he said: "These factors will combine to accelerate the development of new diagnostics for personalized medicine. Together, we anticipate that alliances and collaboration will be inevitable as market needs expand."

www.pwc.com/pharma

New life pumped into UK pharma

In a bid to secure the future of the UK pharma industry, the sector will soon receive its own body to help employers drive the key skills agenda of the industry.

The move follows a workshop organized by Cogent Sector Skills Council and the National Skills Academy Process Industries (NSAPI), which brought together more than 30 of the country's largest industry players. "This group will put the 600 pharma employers in the UK firmly in the driving seat," Phil Jones, CEO of the National Skills Academy Process Industries, told Pharmaceutical Technology Europe (PTE). "It is their industry and they are the best people to direct the change."

Process industries (chemical, pharmaceuticals and polymers) in the UK are suffering from a severe skills shortage — 40% of the workforce is aged more than 45 years. To keep the industry alive, the sector will need to recruit 24000 apprentices and 10000 graduates during the next decade, but this won't be easy. According to Jones, the pharma industry does not have a good image. "The number of science subject graduates deciding to take employment in the manufacturing sector as opposed to finance, law or consultancy demonstrates that the pharma industry is not seen as an attractive career option," he said.

This opinion is mirrored by Michael Johnson, a recent graduate of Applied Biology, who now works at UK CMO, SCM Pharma, as a microbiology technician. Talking to PTE, he explained: "Many of my fellow graduates have steered away from science-based jobs since graduating and I am the only person from my year I know of currently working in the pharma sector. A lot of my friends think I work long hours in some dull laboratory for some pharmaceutical giant, which is certainly not the case."

Image is not the only problem; many workers — particularly graduates — also lack the skills necessary for a career in the pharma industry. "Graduates lack a broad range of skills," said Jones. "For example, biochemistry graduates often lack an understanding of statistics and process engineering."

The Managing Director of SCM, Shirley Dann, agrees. "There is a lack of understanding of what we do in laboratories and in the general pharma industry. This is compounded by the fact that there is little opportunity for students to gain any knowledge of what we do, which is not being helped by the decreasing number of manufacturing companies," she explained to PTE. She also believes that the situation will only get worse; the shortage of places for students to gain work experience will lead to a lack of relevant experience

However, the new skills body is hopeful that it will turn the situation around. "The Skills Academy will coordinate the implementation of solutions and deliver real change," said Jones.

Six key areas have been identified as priorities: risk-based assessment; careers and retention of staff; innovation in pharma operations; management and leadership in a global industry; graduates and higher level provision; and Science, Technology, Engineering and Mathematics (STEM) education and support for young people.

"Solutions will include foundation degrees, industry placements and graduate training," said Jones. "We will also aim for greater utilization of the non-graduate population especially apprenticeships and laboratory technicians."

A range of sub-groups will now work on the issues raised at the workshop before meeting again in autumn to create an action plan. "These sub-groups will aid the transition of the NSAPI into full effectiveness for the pharma sector.

"The pharma industry has many specific needs if it is to fill the skills gaps and shortages," said Jones. "This new, employer-driven group brings together a team of authoritative and influential people who understand the industry and what needs to be done to make the changes that are essential and urgent if the industry is to remain competitive."

www.scm-pharma.com

www.process.nsacademy.co.uk

An exclusive interview with Phil Jones can be read at: www.pharmtech.com/skills

Rats help knock out human diseases

Transgenic rats, created using a novel application of Sigma-Aldrich's (MO, USA) CompoZr zinc finger nuclease (ZFN) technology, could aid the development of animal models of human diseases. The technology enables the mutation of specific genes, which can be passed down heritably, according to the results of the study "Knockout Rats via Embryo Microinjection of Zinc Finger Nucleases", published in Science.

(Martin Harvey/Getty Images)

Knockout mice have been used in scientific studies for years, but the knockout rat will be as valuable or maybe even more valuable to science. "Rats provide a closer physiological model to human disease than mice and are often used to test the efficacy of drugs or treatments for diseases," David Smoller, President of the Research Biotech Business Unit at Sigma-Aldrich, explained during an exclusive interview with Pharmaceutical Technology Europe (PTE). Rats are ideal as models for human diseases; approximately 90% of the rat's 25000–30000 estimated genes are analogous to those in humans.

However, the creation of transgenic rats has not been easy. "Researchers began creating knockout mouse models in the 1990s through embryonic stem cell manipulation, but this technique does not work well in rats," said Smoller. "A handful of knockout rats have been available for several years, but their use was limited because of the impracticality and the inefficiency of producing them with previous techniques, which were untargeted, costly and time consuming."

The knockout rat was a joint effort by scientists at the Medical College of Wisconsin, Sangamo Biosciences (CA, USA), Sigma-Aldrich, Open Monoclonal Technology (CA, USA) and INSERM (France). Sigma-Aldrich's CompoZr platform, which uses ZFN technology, enabled the researchers to target and precisely manipulate the rat genome to produce permanent and heritable changes. This breakthrough, according to Smoller, has been well received by the pharmaceutical and academic community. "Researchers who know the current limitations in both targeted gene editing and biological models for disease research have been eager to see how well our knockout models perform," he explained to PTE.

Sigma-Aldrich now intends to develop rats with targeted gene deletions for research at its new Sigma Advanced Genetic Engineering (SAGE) laboratory in St. Louis (MO, USA), which was opened in August 2009. SAGE Labs offers off-the-shelf rats with common gene knockouts as well as custom knockout rats with gene deletions per the request of researchers. Meanwhile, the company's partners will also be hard at work. "Our research partners at the Medical College of Wisconsin, led by Dr Howard Jacob, are exploring further ZFN-mediated gene editing by attempting multiple knockouts in a single organism," said Smoller. "Open Monoclonal Technology, led by Dr Roland Buelow, is attempting to develop a fully human monoclonal antibody platform based on transgenic rats, and our partners at Sangamo are exploring other uses of ZFN technology, including its use in a clinical trial for HIV treatment."

The future for the knockout rat seems bright; altogether transgenic animal sales and services, according to Smoller, are valued at approximately $1billion (€709 million). "We expect the strong initial demand will only grow when the research community sees how well these models perform," said Smoller.

"We see a great future for this technology and knockout rats, especially as our understanding of the genetic basis of disease grows day by day."

Smoller is also confident about the future of ZFN technology, which he believes may be able to generate gene knockouts in other animals for disease research. He added: "We are also exploring the use of ZFNs for the targeted knock-out of multiple genes within the same animal. The ability to perform multiple-gene deletions will allow us to address more complex genetic diseases and could be a boon for the biotech industry."

An exclusive interview with David Smoller can be read at: www.pharmtech.com/knockout

News bites

EMEA and FDA collaborate

The EMEA and the FDA have launched an initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. A number of key objectives have been outlined, including periodic information exchanges and collaborative GCP inspections.

Read more at: www.pharmtech.com/GCP

Threat to chemical sector

The UK's biggest union, Unite, has called for government intervention to avert what could be a crisis in the UK chemical sector. Dow Chemical recently closed facilities in the UK and this could initiate a domino effect of plant closures from companies unable to obtain certain chemicals.

Read more at: www.pharmtech.com/chemical

Detained medicines rise

Statistics published by the European Commission show an increase of 118% in the number of medicines detained by EU customs in 2008 compared with 2007. There was also a significant increase (57%) in the number of counterfeit medicines in 2008 compared with 2007.

Read more at: www.pharmtech.com/customs~

Animal rights terrorism

The CEO of Novartis, Daniel Vasella, has been hit by a string of attacks from animal rights activists, which include a fire at his holiday home and vandalism of his parents' graves.

Read more at: www.pharmtech.com/novartis

PTE has also conducted an exclusive interview with a security support company, the Pilgrims Group, about the threats posed by animal rights extremist groups.

Read the interview at: www.pharmtech.com/pilgrims

Pfizer Vs. Nigeria

An agreement has been reached between Pfizer and Nigeria's Kano State government following the long-running Trovan trial, which stems from the accusation that Pfizer illegally tested the antibiotic Trovan (trovafloxacin) on children in 1996 during a meningitis outbreak.

Read more at: www.pharmtech.com/nigeria

The FDA's six-step plan

FDA Commissioner Margaret Hamburg has outlined steps to improve the effectiveness and timeliness of the FDA's regulatory and enforcement system. Hamburg believes these steps will ensure that "warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible."

Read more at: www.pharmtech.com/sixstep

Amcor acquires Alcan

Amcor has offered to acquire parts of Alcan Packaging, including its pharma packaging division. "With the addition of Alcan Packaging to the team, our global footprint and network of facilities is excellent," Javier Rojo, Executive Vice President Sales of Amcor Flexibles Healthcare, said in a statement.

www.amcor.com

Using sticky webs

GlaxoSmithKline has granted 42 Technology worldwide pharmaceutical rights to a new precision powder dispensing technology, which the company refers to as "sticky web" technology, that can quickly print powdered APIs onto edible or inert webs coated with adhesive to create a novel dose form.

Read more at: www.pharmtech.com/stickywebs

Clinical trials corruption

As pharma turns its eyes to Asia, Africa, Latin America and Eastern Europe for top-line revenue growth and cost-effective clinical trials, Jim Miller warns of the potential for compromising ethical business situations and how the actions of a CRO could tarnish the sponsor's reputation.

www.pharmtech.com/corruption

ASTM updates guidelines

A laboratory study by researchers at the US National Institute of Standards and Technology and the Nanotechnology Characterization Laboratory of the US National Cancer Institute has enabled ASTM International to update its guidelines for a technique for measuring the size of nanaoparticles in solutions.

www.nist.gov

Partnering with Russia

A partnership that includes Eli Lilly and the Chao Center (IN, USA) will provide training to the Rozdravnadzor, which is considered the Russian equivalent of the FDA. Training goals include improving the Russian agency's knowledge of cGMP, and advancing the country's standards for pharma manufacturing and quality control.

www.thechaocenter.com

www.lilly.com

PTE's new look website

Pharmaceutical Technology Europe (PTE) offers you a brand new website with a new look that merges the content from PTE with that of our sister publication Pharmaceutical Technology North America. The site now offers you more peer-reviewed articles, exclusive features, industry commentaries, expert opinions, news and more!

www.pharmtech.com