Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

AstraZeneca and Ceram Research, a materials development company based in the UK, have signed an agreement whereby Ceram will develop its inorganic-based controlled release technology in a feasibility study for delivering select AstraZeneca compounds. 

, Ceram CEO, Tony Kinsella, said, “This technology, if successfully implemented, could provide AstraZeneca with an alternative formulation approach for delivering these compounds.”

Ceram said that controlled release is just one of the technologies being worked on by the company’s experts. Other projects involve multielement substituted hydroxyapatite for orthopaedic device coating applications.  In addition, Cerma is hoping to expand its business into the US and Europe. 

“Our work is focussed on commercial development of materials for industrial applications,” said Kinsella.  “We have, for example, recently helped Greatbatch Medical to gain FDA (510K) approval of a coating implant submission. We have also worked with GlaxoSmithKline in the proving of its Sensodyne toothpaste.”

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AstraZeneca and Ceram Research, a materials development company based in the UK, have signed an agreement whereby Ceram will develop its inorganic-based controlled release technology in a feasibility study for delivering select AstraZeneca compounds.

AstraZeneca and Ceram Sign R&D Agreement

 to Hameln Pharmaceuticals GmbH after observing “significant” cGMP violations for finished pharmaceuticals at the company’s facility in Hameln, Germany. The letter, dated Dec. 17 2012, was posted on FDA’s website earlier this week.

The Warning Letter relates to an inspection conducted in June 2012. FDA observed several violations including a lack of education, training and experience for specific tasks. As an example, FDA says that one employee examining plates was unable to read and accurately record microbial counts. Employees involved in sterile filling operations were also not following procedures, such as glove-change frequency, the handling of dropped objects, personnel monitoring and sample acquisition. 

Since the inspection, Hameln has issued several responses to FDA. Although the company has retrained employees, however, FDA wants to know why the company was unable to identify and mitigate the lapses in the first place. 

FDA also noted a lack of (or inappropriately followed) written procedures designed to prevent microbial contamination of sterile drug products, citing that FDA smoke study videos were not sufficient to evaluate Class A airflow. Hameln has provided a written evaluation of the studies, but FDA is not convinced and has asked for additional evidence or a repeat of smoke studies. 

Another observation of the FDA was Hameln’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas. For example, FDA said, “There was no justification for the failure to place nonviable probes in locations related to the risk of exposed containers and product.” FDA also claims that nonviable probes were in locations that provided information of little value in terms of monitoring how environmental conditions may impact the product. 

In one of its responses, Hameln explained that one of its restricted barrier system units is difficult to use and that the company would redesign it by March 31, 2013. FDA has asked the company to explain the risks that may have occurred when producing previous batches with the old design, as well as risk-mitigation efforts. 

FDA also added that inspectors observed additional violations, which are not detailed in the letter. 

FDA has issued a Warning Letter to Hameln Pharmaceuticals GmbH after observing "significant" cGMP violations for finished pharmaceuticals at the company?s facility in Hameln, Germany.

Hameln Pharmaceuticals Receives FDA Warning Letter

The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products. The guideline offers guidance on all stages of clinical drug development for anticancer medicines and covers the use of biomarkers, combination therapy studies and the choice of endpoints in confirmatory trials. 

According to EMA, a large number of anticancer compounds have been developed but very few have successfully obtained a marketing authorisation because of poor activity or inappropriate safety profiles. “Until non-clinical models with good predictive properties have been defined, this situation is likely to remain essentially unchanged,” explained the 

, “and the absence of such models is considered the greatest hurdle for efficient drug development within the forseeable future. 

Among other topics, the guideline highlights how biomarkers can help identify the target population that is most likely to benefit from the proposed compound. In addition, the guideline focuses on the importance of confirmatory trials that demonstrate a product’s clinical benefits.

Guidance is also provided for combination studies, such as combinations of drugs with minimal activity as a monotherapy, but synergistic effects when combined, as well as combinations of conventional cytotoxics. 

The guideline will come into effect on 1 July 2013. 

EMA’s guideline on anticancer medicinal products was first adopted in 1996, and was revised in 2001, 2003 and 2005.

The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products.

EMA Updates Guideline for Anticancer Medicines

The pharmaceutical industry does not have a good reputation among patients and consumers.

		This may seem like an unfair situation given the fact that medicines produced by the pharmaceutical industry save millions of lives each year, but humans are far better at focusing on the bad things than the good, and recent recalls, controversial pricing policies and lawsuits have definitely given people reason to focus on the negative side of the pharmaceutical industry.

		According to a recently conducted global survey, the overall reputation of the pharma industry declined even more in 2012. The survey, conducted by 

, asked 600 patient groups from 56 countries about their views on the corporate reputation of the world’s top 29 pharma companies.

		The results show that pharma has some work to do to win back patient trust. Just 34% of the 600 respondents said that multinational pharma companies had an “Excellent” or “Good” reputation during 2012, down from 43% in a similar survey in 2011. Forty percent said the industry’s reputation had declined in 2012.

		Respondents indicated several reasons for the overall decline:

			perceived lack of transparency, especially in reporting results from clinical trials

			some drug prices are still unaffordable to many patients and payers, giving the general impression that profit comes before patients.

		Pharma is always going to struggle with its reputation. Drug development is expensive; far more expensive than many average patients and consumers will ever understand. As well as recouping the enormous costs of drugs that succeed, companies are also looking to make up for all the drugs that fail. In addition, the rise of the internet in the past few decades has sensationalised many pharma-related lawsuits, which will make patients more distrustful of the industry.

		However, surveys like this are useful because they show that the industry has to make an effort to improve its reputation. Six key indicators influencing corporate reputation that were examined n the survey were  patient-centredness, patient information, patient safety, useful products, transparency and integrity, so these represent good areas for companies seeking to boost their reputation to scrutinise.

		Ending on a positive note, the top pharma performers in 2012 in terms of their corporate reputation were Lundbeck, Gilead Sciences, Novartis, Janssen, Pfizer, Abbott, Novo Nordisk, Roche, Lily and GlaxoSmithKline

Pharma’s Reputation in Decline

In about 20 years and with a cost of around $10 billion. That’s the estimate given by researchers at the Beth Israel Deaconess Medical Center in the US who used quantitative modelling to forecast how much time and money would be required before pharmacogenomics could be expected to be used in clinical care.

		There has been a lot of hype about the potential of pharmacogenomics to transform medicine. Drug-related adverse events can cost healthcare systems tens of billions of dollars every year, but pharmacogenomics could alleviate this burden by enabling exact dosages to be chosen based on a patient’s individual genome. The problem, however, is that we have been hearing about this promise for years, but implementation has been slow.

		“If you look across medicine, you can see specific places here and there where genomics is really starting to change things, but it’s been hard to know how it all adds up in the big picture,” Ramy Arnaout, a founding member of the Genomic Medicine Initiative at Beth Israel Deaconess Medical Center, admitted in a 

		Arnaout and his colleagues developed a quantitative model to estimate the time and money needed before pharmacogenomics could realistically be used to help reduce the number of adverse outcomes that occur because of genetic differences between patients.

		Arnaout explained, “We know that preventable causes of these adverse outcomes - patients’ non-adherence, interactions between multiple drugs, and medical error, for example - account for only a fraction of the millions of adverse outcomes that patients experience each year. This leaves a significant number that are currently considered non-preventable and are thought to be caused by genomic variation.”

		As data for the model, the team chose eight associations involving six prescription drugs (clopidogrel, warfarin, escitalopram, carbamazepine, the nicotine-replacement patch and abacavir) and one drug class, the statin class of anticholesterol drugs.

		If the model proves to be accurate, we could start seeing some good indicators of early progress in the area of pharmacogenomics over the next five years or so. Or perhaps even sooner.

		This morning, for example, I read a piece on pharmacogenetics on the UK’s Guardian 

 about the possibility of using genetic testing to check whether children will respond appropriately to asthma treatments. While critics may complain that progress in personalised medicine and pharmacogenomics is slow, little by little, advances are still being made.

When Will Pharmacogenomics Live up to its Promise?

The PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals have announced a follow-on collaboration to advance the development of malaria vaccines and new vaccine delivery technologies. 

The companies will test whether combining genetically engineered DNA with electroporation, a new vaccine delivery technology, can induce a suitable immune response in humans to protect against malaria parasite infection.

Using controlled electrical impulses, electroporation creates temporary pores in a cell membrane that will allow for uptake of the synthetic DNA. The DNA instructions can then be used by the cell to produce proteins that mimic the presence of the malaria pathogen. Researchers hope the technology will induce an immune response that provides protection against malaria.

Dr. J. Joseph Kim, President and CEO of Inovio, said, in a statement, “Our synthetic vaccine platform has produced vaccine candidates against HPV, HIV, and influenza targets that have generated potent T cell immune responses observed in human clinical studies. Using the same platform technology, we have now generated encouraging data with preclinical testing of our malaria antigen plasmids.”Human clinical trials will begin in early 2014, where the vaccine technology will be tested in approximately 30 individuals. Volunteers will receive the vaccine and then be exposed to the malaria parasite to see whether infection is prevented. 

The PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals have announced a follow-on collaboration to advance the development of malaria vaccines and new vaccine delivery technologies.