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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

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September 21, 2012

Transcelerate: What Is It, Exactly?

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Posted by Derek

A list of big pharma companies have announced that they're setting up a joint venture, Trancelerate, to try to address common precompetitive drug development problems. But that covers a broad area, and this collaboration is more narrowly focused:

Members of TransCelerate have identified clinical study execution as the initiative's initial area of focus. Five projects have been selected by the group for funding and development, including: development of a shared user interface for investigator site portals; mutual recognition of study site qualification and training; development of risk-based site monitoring approach and standards; development of clinical data standards; and establishment of a comparator drug supply model.

Now, that paragraph is hard to get through, I have to say. I understand what they're getting at, and these are all worthy objectives, but I think it could be boiled down to saying "We're going to try not to duplicate each other's work so much when we're setting up clinical trials and finding places to run them. They cost so much already that it's silly for us all to spend money doing the same things that have to be done every time." And other than this, details are few. The initiative will be headquartered in Philadelphia, but that seems to be about it so far.

But this it won't get at the fundamental problems in drug research. Our clinical failure rate of around 90% has very little to do with the factors that Transcelerate is addressing - what they're trying to do is make that failure rate less of a financial burden. That's certainly worth taking on, in lieu of figuring out why our drugs crash and burn so often. That one is a much tougher problem, easily proven by the fact that there are billions of dollars waiting to be picked up for even partial solutions to it.

Comments (18) + TrackBacks (0) | Category: Clinical Trials | Drug Development


COMMENTS

1. lonelydatum on September 21, 2012 8:44 AM writes...

I don't know if it exists already, but I think a database of combinable tox data would be extremely helpful for understanding variability among various strains and breeds of animals in pre-clinical testing. GLP tox in normal control animals would be low hanging fruit, and might allow us to tease out subtle differences within strains, effects of transport, chow composition, country/supplier of origin, age, gender housing density, circadian effects vehicle composition, etc.. Basic stuff where larger datasets might help us make better pre-clinical decisions.

Sticking to control arms and GLP tox. would just be a first step to help work out the operational and data-handling kinks for tackling clinical and non-GLP pre-clinical data.

Bring on the flying pigs.

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2. Keith Robison on September 21, 2012 8:49 AM writes...

Not only does this new venture appear to be attempting to address cost of trials, but also time of execution -- by both shaving time off of setting trials up and shaving time off getting them closed & analyzed -- and in a business where adding just a month of sales to the patent clock is big dollars, that could be significant.

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3. luysii on September 21, 2012 9:29 AM writes...

"Our clinical failure rate of around 90% has very little to do with the factors that Transcelerate is addressing."

Exactly. The basic reason for the 90% failure rate is that we don't understand the system (living matter) that we're trying to alter with small molecules (drugs) well at all. For some 25 different ways in which we don't understand it see -- https://luysii.wordpress.com/category/aargh-big-pharma-sheds-chemists-why/

The title of the collection gives the main side effect of out lack of understanding -- the current horrible employment situation facing medicinal chemists today.

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4. DrSnowboard on September 21, 2012 10:33 AM writes...

Manufacturing style optimisation comes to clinical? Although standardising across external investigators may be new. I guess it makes it easier when the companies merge during the lifetime of a trial...

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5. Matthew Herper on September 21, 2012 12:44 PM writes...

In my conversations with them, they were really talking about brass tacks stuff -- training clinicians and running Web portals.

One potentially big thing is providing study drugs before they go to wholesale, so that when you compare to a competitor you get the drugs faster and don't have to pay the list price. That could actually move the needle, maybe.

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6. Hap on September 21, 2012 1:10 PM writes...

Could they be using it as a test of collaboration - to see how they can manage working together without compromising their IP, and to see how well the collaboration works for what it costs?

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7. Mucco on September 21, 2012 1:35 PM writes...

Check out this European initiative with similar aims: http://www.imi.europa.eu/

@1: There's a tox project: http://www.imi.europa.eu/content/etox

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8. KevinL on September 21, 2012 3:07 PM writes...

Does it seem a bit odd to anyone that TransCelerate will focus on the clinical side, yet the board is composed of the R&D heads of the ten companies?

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9. BigSky on September 21, 2012 4:12 PM writes...

Obviously, I don't know what the push behind this particular carpet-side initiative is but one of the biggest hurdles for most trials is access to patients. If all patients looking to enter a trial are screened through this 'initiative' it might benefit things by more than a tick or two.

If a potential enrollee-patient has X levels but also Y, and Y happens to be more valuable to one of the initiative's sponsors, maybe that patient can be routed to a Y trial rather than X. The way things operate now it's every clinical group for themselves trying to pick up and register enough patients to get numbers. So maybe this potentially collaborative method is the way of the future. Until the pipeline runs dry and Pharma doesn't need clinical departments anymore (see Medicinal Chemists).

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10. Rick Wobbe on September 22, 2012 2:38 PM writes...

As Matt Herper pointed out in his blog post on this initiative, the point is to lower costs at the most expensive part of the process, not improve the success rate of finding effective drugs. Profit must grow and if you can't accomplish that by increasing the number of quality candidates going through the process, which we can't, you find ways to reduce the cost of what you do (e.g. lays offs, outsourcing to cheaper vendors, eliminating duplicated processes) and voila, productivity goes up. In this case, the idea is to burn the trash faster and cheaper, but, yes, it's still trash and it still stinks after a while.

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11. Network Pharmacology Blog on September 23, 2012 7:15 AM writes...

As Rick points out in his comment quoting Matthew Herper the initiative seems orientated to being more efficient and finder the failures more cheaply and quickly. Their overall problem relates to the quality of the input to clinical development and no amount of polishing of clinical development is going to solve this as it is a research issue.

We believe quality of candidates can be improved bringing huge paydays but it requires facing up to the scientific realities. The pathway and/or genetic observation basis of establishing mode of action for efficacy is too simplistic an approach for complex disease and the complexity of how biological function is actually derived.

To quote drugbaron 'Proteins are the stuff of life – responsible for every key process in every living cell. Nucleic acids, in all their diversity from DNA in chromosomes to regulatory microRNAs, exits only to create the right proteins in the right place at the right time.'

Until the realities of the complexities of the proteome are evaluated at the systems level then it looks like 'burn the trash faster and cheaper'.

Embrace the new tools that can analyse complex systems such as the proteome, establish key proteomic data (e.g. interaction, type of interaction) and evaluate compounds on a protein spectral basis - see Professor Andrew Hopkins at Dundee and the outcome will be very different.

The good news is the vanguard of these techniques are now showing real progress but whether it will filter through to big pharma in time to solve their problems is another question.

Interesting post.

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12. Rick Wobbe on September 23, 2012 8:49 AM writes...

#11, Network Pharmacology Blog, For those who haven't seen it yet, there's a pretty good discussion group on LinkedIn called the Phenotypic Drug Discovery SIG (a subgroup of the Society for Laboratory Automation and Screening) that's relevant. Methods and ideas for applying new tools (and resurrecting/repurposing old tools) NPB mentions to improve the quality of discovery research output (development candidates). Great discussions that may not be held often enough in the halls of pharma/biotech, or at least not with the same breadth of perspectives. It's run with great skill by another reader of this blog (i.e. not me), so it's a good opportunity for some cross-pollination in this particular area.

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13. celery on September 23, 2012 9:00 PM writes...

Funny, first thing that came to mind when I saw the name TransCelerate was a method for turning things into celery...

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14. Mark Lambrecht on October 11, 2012 4:44 AM writes...

Although this blog is usually of very high quality, I have to disagree with the opinion about TransCelerate in this post. The ability to standardize the way that clinical trials are executed, does not only lead to operational efficiencies, but can also feed back into the scientific learning process about the tested compound. For example, by standardizing clinical data gathered, clinicians and statisticians can compare different trials, and use them for further decisions about dosing, safety and compare to other drugs and therapies. This field is called model-based drug development. Also, by better training and execution of the trial at the clinical sites, feedback about efficacy and safety can be improved. So there is a feedback loop from clinical development into research that is easily forgotten. Researchers have to come up with the new compounds, but can learn a lot from the effects in the patients. By increasing the efficiency of a trial and designing optimized trials, perhaps even 1 or 2 compounds can be saved from failure - and that is something that can never be simulated or predicted in pre-clinical research and discovery setting.

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15. Mike Yelvigi on December 5, 2012 9:35 AM writes...

While the principle behind the goal is healthy one from a professional point, to make it happen and benefit from it needs good chemistry among participating partners.

Specially coming from drug development area, I have tried to smoothen the clinical comparator process, still it remains a dream.
But certainly worth trying.
Mike

Permalink to Comment

16. Mike Yelvigi on December 5, 2012 9:35 AM writes...

While the principle behind the goal is healthy one from a professional point, to make it happen and benefit from it needs good chemistry among participating partners.

Specially coming from drug development area, I have tried to smoothen the clinical comparator process, still it remains a dream.
But certainly worth trying.
Mike

Permalink to Comment

17. David Stark on May 7, 2013 3:25 PM writes...

I see that the most recent blog is from last year. Is anyone aware of any updates to what or how TranCelerate is doing? Thanks for your comments ahead of time.

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18. Alexa Foster on June 5, 2013 9:52 AM writes...

David, The TranCelerate website posted a paper on Risk Based Monitoring methodology on the website 2 days ago. It's worth a review.

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