E-mail: rbookman@miami.edu
Mailing Address: | Street Address: 1400 N.W. 10th Avenue Medical Campus, LC: R64 |
Mailing Address: | Street Address: 1400 N.W. 10th Avenue Medical Campus, LC: R64 |
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The Pharmaceutical Development Section (PDS) is a corps of 20 chemists, pharmacists, pharmacokineticists and technicians who make investigational agents for many of the 1,500 clinical research studies running at any given moment at the NIH's Clinical Center. It is not a drug-discovery group, but rather a team of experts who churn out custom-made pills, vaccines, intravenous drugs and capsules, and even ointments and creams, for NIH investigators when the investigational agents they need aren't available.
Twenty-first century technology and government-mandated manufacturing standards have outpaced the equipment and capacities of the group's old, 743-square-metre workspace. But, if all goes according to schedule, in early June it will move seamlessly into a new, $12-million, 1,115-square-meter drug-making facility--a warren of rooms seven years in the planning that is tailor-made for the group's purposes.
The PDS's new digs are a reservoir of state-of-the-art machinery and minus 80 ÂșC freezers; high-efficiency particulate-absorbing filters populate the ceiling; and highly purified watercirculates through stainless-steel pipes that cost over $1,000 per meter. There are meticulous controls on air temperature, humidity and pressure. The facility's layout and structural materials are geared to maximum cleanliness--right down to the easily-scoured, porous epoxy floors."
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Minger, an American, has been in charge of stem cell biology at Guy’s Hospital and King’s College London since moving to the UK in 1996.
As well as being one of the top researchers into human embryonic stem cells in Britain - his lab has derived several hESC lines including ones with genetic mutations for cystic fibrosis and Huntington’s disease - Minger has been a fearless public advocate of stem cell science.
The relatively science-friendly legislative and regulatory framework for embryo research that has emerged in the UK owes something to Minger’s communications skills. He is one of the most open and media-friendly scientists I have come across, in any field.
“Leading GE Healthcare’s Cell Technologies research and development will allow me to bring many years of academic research in the stem cell field to bear in a commercial environment,” he says. “This is an opportunity for me to play a leading role in the realization of the emerging potential of stem cell technology in drug discovery and therapy, and to help grow a strategic business for GE Healthcare.”
“This area of science has had very little public discussion, though it has been scientifically very important and has led to some important medical advances,” says Martin Bobrow, the Cambridge University medical geneticist who will lead the study.
Animals containing human material - mostly transgenic mice with genes of human origin - are used routinely in laboratories world-wide. They have enabled researchers to make groundbreaking advances in understanding the causes and devising treatments of disease.
However, increasingly powerful methods for introducing human material into animals, including new stem cell technologies and ways to transfer many genes together, will present new opportunities and significant regulatory and ethical challenges in the future.
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Could the cash piles of big pharma be mobilised in a more efficient way for the public good?
There is another way to fund the development of new treatments. Many innovative ideas that have changed society have arisen from the combination of curiosity and academic freedom found in universities. This is where small amounts of funding can produce big results. In recent years, university research has been exploited by industry to produce new drugs, such as blood clot-busting "tissue plasminogen activator", courtesy of the Catholic University of Leuven (KUL) in Belgium.
Now, while big pharma has so much money it doesn't know what to do with it, universities are being starved of resources and research funding has decreased in real terms. At the same time, university research strategy is under-organised and there is ignorance of how to exploit intellectual property and utilise patents. Nevertheless, the potential of universities is enormous.
Sadly, because of intense competition for limited funds, academic scientists are now driven to perform predictable low-risk science in small packets that will give quick results in time for the next grant application. The end result is that we have a plethora of small groups with strong leaders that act independently, fragmenting effort. At the same time, little translational research is being performed, even though politicians pay endless lip service to the idea.
The way forward is obvious: inject the money into university research. Experience tells us this can have major benefits. "There is another way to fund the development of new treatments." http://www.newscientist.com/article/mg20427295.500-big-banks-big-pharma-big-problems.html