changing the paradigm of drug development
Monday, July 25, 2011
Transparency featured at BioPharma Physicians blog
http://www.biopharmphysicians.com/crowd-sourcing-in-clinical-development/
Sunday, July 24, 2011
NIH on Crowdsourcing: The Art and Science of Open Innovation
This one day (July 18th 2011) event organized by the NIH is now available for viewing
http://videocast.nih.gov/PastEvents.asp
http://videocast.nih.gov/PastEvents.asp
Sunday, July 17, 2011
Open-source start-up Transparency LS lands seed funding
CHICAGO -- Open-source drug development upstart Transparency Life Sciences has "raised a small seed round" of funding. It's using the funds to build an Internet presence, says Tomasz Sablinski, head of clinical development at private equity concern Celtic Therapeutics, in an interview at the recent DIA show. Sablinski also is founder of TLS.
New co-founders include Marc Foster, a biotech IT entrepreneur and president at tech startup catalyst Foster & Roberts, and Larry Steinman of Stanford University's Beckman Center for Molecular Medicine.
The Internet presence will be a space for like-minded open-source drug developers to create and work on projects. Sablinski says he plans to officially launch TLS in the next few months with one drug development pilot project and then add subsequent projects. His goal is a "robust portfolio" by year's end.
Sablinski has been the chief champion of TLS, advocating not just open-source software but drug development as a whole. He questions whether drug development can be a viable business without using open source, and whether Big Pharma is capable of making the transition.
TLS is "more on the trajectory of a web-based company than a biotech. And I'm looking for similarly fast ROI by being transparent," Sablinski says. He adds that other companies have signed on with TLS and that several partnerships are in the works. Among these joiners are "traditional and nontraditional companies in biopharma drug development."
Read more: Open-source start-up TLS lands seed funding - FierceBiotechIT http://www.fiercebiotechit.com/story/open-source-start-tls-lands-seed-funding/2011-07-04#ixzz1SNkstZea
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New co-founders include Marc Foster, a biotech IT entrepreneur and president at tech startup catalyst Foster & Roberts, and Larry Steinman of Stanford University's Beckman Center for Molecular Medicine.
The Internet presence will be a space for like-minded open-source drug developers to create and work on projects. Sablinski says he plans to officially launch TLS in the next few months with one drug development pilot project and then add subsequent projects. His goal is a "robust portfolio" by year's end.
Sablinski has been the chief champion of TLS, advocating not just open-source software but drug development as a whole. He questions whether drug development can be a viable business without using open source, and whether Big Pharma is capable of making the transition.
TLS is "more on the trajectory of a web-based company than a biotech. And I'm looking for similarly fast ROI by being transparent," Sablinski says. He adds that other companies have signed on with TLS and that several partnerships are in the works. Among these joiners are "traditional and nontraditional companies in biopharma drug development."
Read more: Open-source start-up TLS lands seed funding - FierceBiotechIT http://www.fiercebiotechit.com/story/open-source-start-tls-lands-seed-funding/2011-07-04#ixzz1SNkstZea
Subscribe: http://www.fiercebiotechit.com/signup?sourceform=Viral-Tynt-FierceBiotechIT-FierceBiotechIT
Life Science Leaders article on Crowdsourcing Drug Development
This article (page 22) discusses the need of different models for clinical studies and features prominently the Transparency Life Sciences model.http://digital.lifescienceleadermag.com/link/lslead/2011/jul/1?s=0
“The obvious place to start is finding new clinical indications and
uses for generic drugs. We already know a lot about their modes of
actions and their safety profiles, and repurposing them for other indi-
cations has a higher probability of success than developing new or
novel drugs.”
Tomasz Sablinski, M.D., Ph.D., managing director at Celtic Therapeutics
“The obvious place to start is finding new clinical indications and
uses for generic drugs. We already know a lot about their modes of
actions and their safety profiles, and repurposing them for other indi-
cations has a higher probability of success than developing new or
novel drugs.”
Tomasz Sablinski, M.D., Ph.D., managing director at Celtic Therapeutics
Thursday, June 23, 2011
Pfizer's virtual trial: Open-source meets old pharma
Pfizer's virtual trial: Open-source meets old pharma
By gmiller
Created Jun 21 2011 - 12:02am
CHICAGO -- Drug giant Pfizer revealed more details of its all-electronic clinical trial [1] at the DIA's 47th annual show here, going to great lengths to acknowledge its partners in the endeavor and to credit collaboration for the achievements to date.
The news sounds big coming from a big pharma, especially given that the FDA is onboard. Pfizer's head of clinical innovation Craig Lipset took pains to appreciate the regulatory and Institutional Review Board input his project has received. And he acknowledged the contributions of partners Steven Cummings of Mytrus, which provided the front-end tech build-out of the investigator sites; Cameron Robertson, business development manager at Exco intouch, provider of the mobile e-diary equipment; Perceptive Informatics, for its back-end technology work; and the University of California investigational team.
"It's hardly Pfizer's technology," said Lipset, sounding less like a Big Pharma practitioner and more like an open source advocate. "We don't believe Pfizer owns this approach. We want to see greater uptake in the wider community." He said he believes the model can scale internally and perhaps eventually be used as modules in conventional studies in a form of "disruptive new medicine."
His words are strikingly similar to those of Tomasz Sablinski, head of clinical development at private equity concern Celtic Therapeutics, in a FierceBiotech IT interview [2] last February: "If you want to introduce disruptive [technology], you have to go out on your own," he said. "You can't do it from within." Sablinski in his spare time is launching Transparency Life Sciences, an open-source drug development enterprise.
Both Sablinski and Lipset acknowledge the great contribution to be made by telemedicine, with apps that are "growing at the speed of light" yet rarely used in pharma [Sablinski], and an "app store of tools from telemedicine, which can help expand health IT connectivity." [Lipset] sees the use of telemedicine apps in clinical trials as "a repurposing rather than inventing." On the innovation behind his project, Lipset says, "there are two approaches a company like Pfizer can take. One is private, to hide it. We took the more challenging way--with qualification, regulators, the IRB. They're all partners now."
Sablinski for the most part agrees with Lipset. But he has one quibble: "Pfizer concocted the trial in secrecy; the old way." He implies the drug giant worked on the effort for months internally before reaching out to others. To extrapolate what Pfizer did to a truly transparent model, the drugmaker would have spoken up earlier and said to the larger community of stakeholders, "we want to conduct an all-electronic trial. How do we design it?"
But he's not complaining. "For me, [the Pfizer project] is a godsend." If it succeeds, it validates his concept for the fledgling open-source Transparency Life Sciences. - George Miller (email [3])
The news sounds big coming from a big pharma, especially given that the FDA is onboard. Pfizer's head of clinical innovation Craig Lipset took pains to appreciate the regulatory and Institutional Review Board input his project has received. And he acknowledged the contributions of partners Steven Cummings of Mytrus, which provided the front-end tech build-out of the investigator sites; Cameron Robertson, business development manager at Exco intouch, provider of the mobile e-diary equipment; Perceptive Informatics, for its back-end technology work; and the University of California investigational team.
"It's hardly Pfizer's technology," said Lipset, sounding less like a Big Pharma practitioner and more like an open source advocate. "We don't believe Pfizer owns this approach. We want to see greater uptake in the wider community." He said he believes the model can scale internally and perhaps eventually be used as modules in conventional studies in a form of "disruptive new medicine."
His words are strikingly similar to those of Tomasz Sablinski, head of clinical development at private equity concern Celtic Therapeutics, in a FierceBiotech IT interview [2] last February: "If you want to introduce disruptive [technology], you have to go out on your own," he said. "You can't do it from within." Sablinski in his spare time is launching Transparency Life Sciences, an open-source drug development enterprise.
Both Sablinski and Lipset acknowledge the great contribution to be made by telemedicine, with apps that are "growing at the speed of light" yet rarely used in pharma [Sablinski], and an "app store of tools from telemedicine, which can help expand health IT connectivity." [Lipset] sees the use of telemedicine apps in clinical trials as "a repurposing rather than inventing." On the innovation behind his project, Lipset says, "there are two approaches a company like Pfizer can take. One is private, to hide it. We took the more challenging way--with qualification, regulators, the IRB. They're all partners now."
Sablinski for the most part agrees with Lipset. But he has one quibble: "Pfizer concocted the trial in secrecy; the old way." He implies the drug giant worked on the effort for months internally before reaching out to others. To extrapolate what Pfizer did to a truly transparent model, the drugmaker would have spoken up earlier and said to the larger community of stakeholders, "we want to conduct an all-electronic trial. How do we design it?"
But he's not complaining. "For me, [the Pfizer project] is a godsend." If it succeeds, it validates his concept for the fledgling open-source Transparency Life Sciences. - George Miller (email [3])
Source URL: http://www.
Monday, April 25, 2011
ALS Study Shows Social Media's Value as Research Tool
This article published in today's WSJ provides an important support for a new paradigm in clinical development. Although there were significant shortcomings, which would be obvious to anyone familiar with drug development process, the table at the end of the story is self explanatory. It does not take a financial guru to see what the advantage will be if you manage to save so much time and money in the process as this trial achieved, while introducing proper scientific scrutiny. This is what Transparency Life Sciences is about.
http://online.wsj.com/article/SB10001424052748704489604576283010994997034.html?mod=djemHL_t
http://online.wsj.com/article/SB10001424052748704489604576283010994997034.html?mod=djemHL_t
Tuesday, April 12, 2011
Open Source Biology Deserves a Shot
an interesting piece about even more interesting initiative...
http://www.xconomy.com/national/2011/04/11/open-source-biology-deserves-a-shot/
http://www.xconomy.com/national/2011/04/11/open-source-biology-deserves-a-shot/
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