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Pharmas, Gov’t Team to Study If Stem Cells Can Serve ADME-Tox Function in Rx Libraries

A group of US and UK drug makers and a government agency last week launched an initiative to explore whether stem cells can serve ADME/Tox functions in compound libraries, and provide guidance and funding for stem cell research in the UK.
The initiative, dubbed Stem Cells for Safer Medicines (SC4SM), is organized as an independent, non-profit company, and has issued a call for proposals from potential research partners interested in developing techniques to use stem cells for ADME/Tox testing.
SC4SM is the first public-private partnership on human embryonic stem cells and marks the pharmaceutical industry’s first foray into the field of hESC research. AstraZeneca, GlaxoSmithKline, and Roche have each committed an initial £100,000 ($204,000) towards SC4SM, while the UK Department of Health, which initiated the project, will provide £750,000.
The consortium is led by the Association for the British Pharmaceutical Industry, and is also supported by the UK Department for Innovation, Universities, and Skills; the Scottish government; the Medical Research Council; and the Biotechnology and Biological Sciences Research Council.         
Philip Wright, CEO of SC4SM and director of science and technology at the ABPI, told CBA News this week that although Glaxo, AstraZeneca, and Roche are the three founding pharmaceutical members of the consortium, the group is “in discussions with other pharmaceutical companies, and will be looking to have others join SC4SM during the first year.”
Wright mentioned that opportunities exist for companies to participate on a project-by-project basis, although they will only have access to the projects that they are directly involved in. He declined to elaborate further.
The launch of SC4SM is the first step in a five-year, £10 million initiative to develop stem cell technology for use in predictive toxicology assessment testing. The initiative is divided into a one-year pilot phase followed by a four-year main phase.
The pilot phase seeks to address particular scientific hurdles in the differentiation of truly indicative hepatocytes from existing stem cell lines in relation to safety assessment, Wright said. The first year will also allow the consortium to build networks among the scientific experts in the companies and academia.
The pilot phase will run to late 2008 or early 2009, depending upon how quickly research programs can be initiated, Richard Ley, head of media relations for the ABPI, wrote in an e-mail to CBA News.
SC4SM plans to fund five projects over the next year aimed at differentiating hESCs into hepatocytes. Many companies are making progress in terms of deriving hepatocyte-like cells, according to Wright.
“But from the companies’ point of view, quite a chasm still exists between what those hepatocyte-like cells actually do and the proteins that they express, as compared to actual hepatocytes,” he said.      
The consortium feels that creating a protocol which can consistently derive stem cells with an improved set of expressed markers is an important issue, said Wright. “We want to make the protocol for that derivation as useful as possible because we want to be able to use it on a number of different cell lines.”
For example, Wright said that the consortium would like to derive cardiovascular cells and is also interested in looking at central nervous system cells.
Buiding an SAB
“We are also spending time in the first year mapping out a five-year scientific plan,” Wright said. An independent scientific advisory board chaired by Glyn Stacey, the head of the UK Stem Cell Bank and director of the National Institute of Biological Standards and Controls, will oversee the drafting of the scientific plan.
“The board’s key role is to help us assess the quality of the scientific proposals that come in,” said Wright. “We will also be using a broader peer review panel as is commonly used in the assessment of academic research proposals.” 
The names of those on the scientific board cannot be released without their permission, Wright said, but the board comprises a UK stem cell scientist and stem cell scientists from other parts of the world, particularly Europe. “In addition, we have safety and toxicology assessment scientists from pharmaceutical companies, and academic toxicologists as well,” he said.
In all, 15 people serve on the scientific advisory board, including representatives from the UK Research Council, so it is well “in tune with the work that is going on elsewhere in the UK,” said Wright.  
The consortium will also establish an independent ethical advisory board early next year to audit and review the policy and advise the consortium’s membership, Wright said. At that time, the number of people who will serve on the board will be determined.
“The model that we will probably be using is the one that is used for the UK Stem Cell Bank and other initiatives that have gone on in the UK, so we would probably be looking at between eight and 10 people, with a mix of lay members and a certain number of UK ethics experts,” Wright said. He said the ethics committee would meet as often as necessary.  
”The key thing for us, and the reason that we are establishing the ethics advisory board in 2008, is that we already have the ethics policy in place for the pilot phase, and what we would be asking the ethics board to review in the first year would be the five-year scientific policy as it develops,” said Wright.
Wright added that during discussions about setting up SC4SM, its founders decided to adopt pharmaceutical companies’ policies on the use of stem cells in research. According to Wright, many pharmaceutical companies have conducted internal consultations and used their own advisory boards.   
“We distilled the consensus from the policies and also brought in that of the UK government,” said Wright. He said that SC4SM is not going to be deriving these cell lines during the first year, because it does not believe there is a scientific need to do that. “We are going to adopt a very similar ethical framework that would be adopted, for example, in terms of informed consent in clinical studies,” he explained.
In this instance, those stem cell lines must be derived from donated eggs that have been contributed from unused in vitro fertilization treatments. And there must be full disclosure and no inducements for donation to occur, Wright said.
“So perhaps we are not as open as the UK government’s position as a whole, but we are more progressive and open than the current federal policy in the US,” he said.
First on the Pharm
The role of the SC4SM’s pharmaceutical partners is to provide funding and guidance, said Thomas Sueta, global head of public relations and communication for R&D functions at AstraZeneca.

“We believe this is a unique opportunity to participate in such a consortium.”

AstraZeneca is participating on both the governing board of SC4SM and the scientific advisory board, Sueta said. The company has one representative on the governing board, Tim Hammond, who is a vice president of safety assessment in the company’s UK organization. It also has two other people on the scientific advisory board who are part of its safety-assessment group.
According to Sueta, their role on the board is to serve as experts in safety assessment during the drug-development process and contribute scientific and academic expertise.
For example, one of the people on the scientific board who actually participated in the launch, Ian Cotgreave, is AstraZeneca’s head of molecular toxicology and a researcher and professor at Karolinska Institute in Sweden, Sueta said. 
“The great thing is that all the programs that received funding have an opportunity to complement each other and make sure that we have really good, predictive processes and ways of seeing safety signals early on, so that the are no surprises by the time you take a drug into clinical trials,” said Sueta.
Pauline Page, director of science communications for GSK, told CBA News in an e-mail that like other members of the consortium, GSK will benefit from the opportunity to influence the direction of the work.
For instance, the company participates in early drug-safety screening, which aims to create standards for tools that assess the human safety of potential new drugs. It will also share scientific expertise and knowledge as part of the SC4SM network; disseminate risk in what is a significant research and technology challenge; and develop the ability to rapidly adopt stem cell technologies for use in toxicologic assessment during drug discovery.

”We believe that the consortium has excellent representation from government, academia, and industry, and secure funding as well,” Page wrote. “This will accelerate the program and establish a rich resource beyond what each body could achieve alone.”

Equally important, the consortium could help the pharmaceutical industry overcome the current restrictions on the supply of normal cells, Claudia Schmitt, a Roche spokesperson wrote in an e-mail to CBA News. “We believe this is a unique opportunity to participate in such a consortium,” she said.
Non-consortium members agree that the initiative will encourage the use of stem cells for toxicology assessment.     
“I think it’s a very valuable, albeit small, financial step that will support stem cell research in the UK,” said Peter Mountford, CEO and president of Stem Cell Sciences.
He said that although the funding commitments might seem small, it will significantly advance programs that are already underway. However, the amount of funding will need to increase proportionately to the growing return from the initial investments, Mountford said.     
“The initiative reinforces the UK's strengths in hESC and tissue engineering research within academia and among subject matter experts, the highly permissive but tightly regulated environment, and the strong public support for stem cell research,” Anna Krassowska, research manager of the UK Stem Cell Initiative, wrote in an e-mail to CBA News.
She added that a collaborative approach using these strengths combined with the expertise and technology pull from industry can only facilitate progress in the field of stem cell research in the UK.

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