 made good on its promise to shake things up in its research and development divisions, announcing last Friday the launch of its revamped oncology R&D organization, which brings together discovery and development teams under one umbrella.

GSK hopes the merger will enable scientists and clinicians to communicate research quicker and move information easily between branches, thereby speeding up the time it takes to move a new treatment through the development process. 

“This is a deliberate attempt to blur the boundary of discovery and development,” said 

Perry Nisen, GSK senior vice president of cancer research

. “To have a dedicated unit liberates us to have talent and expertise exclusively around oncology.” 

The new oncology division will be tasked with finding new target areas to for developing treatments, running clinical trials, and boosting the development process to speed up the bevy of cancer drugs that are slowly making their way through its pipeline; these include Zunrisa, Tyverb, and MAGE-A3 ASCI.

GSK spent the last few years dicing its monolithic R&D divisions into smaller Centres for Excellence in Drug Discovery to bring more ownership and innovation to new drug design. 

 in its Health Blog that the new oncology unit seems to go against the idea of smaller is better. 

 on Tuesday that the large oncology division would be broken down into drug performance units. “DPUs are bite-sized units of people who are focused in key areas in an almost biopharm-like way, without having to be encumbered by democracy,” Nisen said.

The restructured oncology division is expected to suffer some layoffs as part of a 2 percent reduction in total R&D workforce announced in June. The group is also transitioning to one base of operations

“All partners [must] adjust themselves to deal with changes,” Nisen said. “We must get away from the insularity that everything has to be done internally. That has been a part of GSK’s strategy, particularly in India and China. I think that the concept of externalization and finding talent is part of the strategic agenda of all of the therapeutic areas.”

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Glaxo's cancer departments will be consolidated into one big division encompassing discovery, research, and trials. The move is expected to cost some jobs, but GSK hopes it will strengthen synergy within its R&D unit.

GSK Restructures Oncology Division

A new study of children receiving antipsychotic treatments for schizophrenia has caused a stir after it was revealed that patients taking second generation antipsychotics such as 

) were more prone to adverse reactions than children using older treatments. 

, was conducted to see if the efficacy of the new drugs in children and adolescents was comparable to their efficacy in adults. The investigators noted that not much pediatric data was available on newer drugs, and they wanted to compare the drugs to a treatment that had a fair amount of data-such as molindone. 

“At the time we started this study, there were essentially no data on children [for the drugs],” said lead investigator 

, a children’s psychiatrist and assistant professor at the University of North Carolina. “We had thought that there might be advantages in atypical versus traditional agents. However, most of the existing work was suppositions from adult work.” 

Children were randomized to receive a series of medications; if they didn’t respond to one medicine, their second line drug would be pre-established, so all the treatment could be double-blinded.

If children tolerated their regime at eight weeks, the treatment continued for a year to look at longer term side effects. “We really expected when we started the study that the two atypical agents-risperidone and olanzapine-would be much better tolerated and more efficacious than the molindone, though we did expect that the molindone would cause less weight gain,” Sikich said.

That was not the case, however. In the first eight weeks, there was no detectible difference in the efficacy of any of the medications, according to the report. They all reduced symptoms of hallucinations and delusions at the same speed, and worked on the same proportion of kids. The bad news is that none of the treatments worked in a large number of kids. Overall response rates at eight weeks were quite low; about 50 percent responded to molindone, 34 percent to olanzapine, and 46 percent to risperidone-though the differences may not have been significant, because a large percentage of the children had stopped taking their medications by that point.

“We weren’t surprised that olanzapine caused more weight gain-16 pounds average weight gain in the first eight weeks of the study-but we were surprised that olanzapine was associated in changes in LDL cholesterol and increases in insulin that may predispose to the development of diabetes,” Sikich said. Molindone was associated with more occurrences of restlessness. 

Olanzapine seemed to come out worst in the comparison. Sikich said that it might be difficult to recommend new starts on the that treatment for children with schizophrenia. “Right now, our practice parameters say that traditional antipsychotics shouldn’t be the first line of treatment, but I think this study raises some pretty serious questions about that,” Sikich said. 

Molindone has been off-patent for years, but no one has made a generic version. Lilly and Jansen donated the olanzapine and risperidone, respectively; they haven’t, however, reviewed the results or commented on the study. 

Asked if she would pull her patients off any of these treatments based on this study, Sikich was hesitant. “If you switch them off a treatment, it must be done slowly,” she said. “If someone tried five other treatments, and olanzapine was the only one working, I would leave them on it, even if they had significant side effects. If it was the first or second one, and they had significant side effects, I would switch them. But you have to individualize it. There is no ‘one answer’ for everyone.” 

A new study from the NIMH shows that next-generation treatments for schizophrenia might not be any better than older, first generation drugs-and in some cases might be worst.

Pharmaceutical Executive-09-17-2008

GSK Restructures Oncology Division

Older Antipsychotic Drug Found Safer than New Treatments