To celebrate its 150th issue, the editors said they couldn't resist digging through the archives and rereading their best and boldest stories.
The Brand Called You (Issue 10 - September 1997)
Big companies understand the importance of brands. Today, in the Age of the Individual, you have to be your own brand. Here's what it takes to be the CEO of Me Inc.
Built to Flip (Issue 32 - March 2000)
A battle is under way for the new economy. Which side are you on?
What Should I Do With My Life (Issue 66 - January 2003)
The real meaning of success -- and how to find it.
The Wal-Mart You Don't Know (Issue 77 - December 2003)
The giant retailer's low prices often come with a high cost. Wal-Mart's relentless pressure can crush the companies it does business with and force them to send jobs overseas. Are we shopping our way straight to the unemployment line?
Change or Die (Issue 94 - May 2005)
All leadership comes down to this: changing people's behavior. Why is that so damn hard? Science offers some surprising new answers -- and ways to do better.
Is Your Boss a Psychopath? (Issue 96 - July 2005)
Odds are you've run across one of these characters in your career. They're glib, charming, manipulative, deceitful, ruthless -- and very, very destructive. And there may be lots of them in America's corner offices.
Why We Hate HR (Issue 97 - August 2005)
In a knowledge economy, companies with the best talent win. And finding, nurturing, and developing that talent should be one of the most important tasks in a corporation. So why does human resources do such a bad job -- and how can we fix it?
How Many Lightbulbs Does It Take to Change the World? One. And You're Looking at It. (Issue 108 - September 2006)
For years, compact fluorescent bulbs have promised dramatic energy savings--yet they remain a mere curiosity. That's about to change.
Hacker. Dropout. CEO (Issue 115 - May 2007)
When Mark Zuckerberg showed up in Palo Alto three years ago, he had no car, no house, and no job. Today, he's at the helm of a smokin'-hot social-networking site, Facebook, and turning down billion-dollar offers. Can this kid be for real?
Message in a Bottle (Issue 117 - July 2007)
Americans spent more money last year on bottled water than on ipods or movie tickets: $15 Billion. A journey into the economics--and psychology--of an unlikely business boom. And what it says about our culture of indulgence.
Tuesday, November 30, 2010
Thursday, November 25, 2010
My personal reflection of gratitude and appreciation on Thanksgiving
As we celebrate Thanksgiving, I’m reminded that we should aspire to express gratitude and appreciation year-round. Being truly grateful for what is already present in my life has certainly helped attract even more good.
And even as difficult and challenging situations arise, I try to be grateful for what I’m learning through them. It is often through these situations that I experience the most profound growth, learning to view each apparent obstacle as an opportunity to develop a new quality, strength, skill, insight or wisdom – and to be grateful for the lessons.
Earlier this year, I started keeping a "Gratitude and Acknowledgment" journal. It has proved to be a valuable tool in developing my awareness. My journal is not full of long and drawn out diary entries. Rather there are just short, simple lists of things I’m grateful for on a particular day. I even put in a few photos and clippings. It’s been good to look back through on tough days, too.
At our office each Friday afternoon, before going home for the weekend, we take a few minutes to review the week. We think about the week’s events. We select 3-5 people that we are most grateful for. There is no right or wrong; just whomever we are sincerely grateful for on that particular week. It may be the client who supported us, the supplier who gave us a kind word, the co-worker who helped us feel good about what we created. As we go around the room, I can feel the energy from gratitude and appreciation.
So especially on Thanksgiving, I’m taking a moment to acknowledge the changes that are occurring for our company and for me personally. I’m writing them down. I acknowledge the positive developments (and sometimes downright miracles) that can and do occur on a daily basis. They are happening all around me. So I notice them and honor them. I truly believe that my continued expressions of joy and gratitude will draw even greater joy, love, and abundance into my life.
Thanks especially for my family, my friends, my colleagues, and my clients who make my “journey” so gratifying.
And even as difficult and challenging situations arise, I try to be grateful for what I’m learning through them. It is often through these situations that I experience the most profound growth, learning to view each apparent obstacle as an opportunity to develop a new quality, strength, skill, insight or wisdom – and to be grateful for the lessons.
Earlier this year, I started keeping a "Gratitude and Acknowledgment" journal. It has proved to be a valuable tool in developing my awareness. My journal is not full of long and drawn out diary entries. Rather there are just short, simple lists of things I’m grateful for on a particular day. I even put in a few photos and clippings. It’s been good to look back through on tough days, too.
At our office each Friday afternoon, before going home for the weekend, we take a few minutes to review the week. We think about the week’s events. We select 3-5 people that we are most grateful for. There is no right or wrong; just whomever we are sincerely grateful for on that particular week. It may be the client who supported us, the supplier who gave us a kind word, the co-worker who helped us feel good about what we created. As we go around the room, I can feel the energy from gratitude and appreciation.
So especially on Thanksgiving, I’m taking a moment to acknowledge the changes that are occurring for our company and for me personally. I’m writing them down. I acknowledge the positive developments (and sometimes downright miracles) that can and do occur on a daily basis. They are happening all around me. So I notice them and honor them. I truly believe that my continued expressions of joy and gratitude will draw even greater joy, love, and abundance into my life.
Thanks especially for my family, my friends, my colleagues, and my clients who make my “journey” so gratifying.
Wednesday, November 24, 2010
3 Starbucks cups for the future?
Starbucks asked designers how they'd fix its cups. Here are FAST COMPANY's three favorite ideas from the 2010 betacup challenge.
Recyclable: KISS Cup
Australian designer Keith Orchard wanted to reduce waste while keeping the experience intact. His pulp paper-based cup is coated with palm-leaf-derived carnauba wax. "People aren't going to recycle if it's not easy," he says.
Reusable: CupUp
Inspired by children's toys, this inflatable thermal mug also has a bar code for loyalty programs. "Sustainable solutions must actively promote behavioral change," says Rae'ut Stern, one of CupUp's five Israeli designers.
Consumable: Cookie Cup
This wafer cup's edible heat- and liquid-resistant lining allows customers to dispose of their cup by eating it. "When you have a coffee, it's also an experience," Dutch designer Martijn van Loon says. As if those triple-mocha drinks didn't have enough calories.
Labels:
Starbucks
Tuesday, November 23, 2010
4 factors for nurturing "scenius"
Kevin Kelly, in his book What Technology Wants, shares a fascinating concept called scenius.
As defined, “scenius” stands for the intelligence and the intuition of a whole cultural scene. It is the communal form of the concept of the genius.
Kelly lists four factors that are important in nuturing scenius:
TEDxAmsterdam: Kevin Kelly from TEDxAmsterdam on Vimeo.
As defined, “scenius” stands for the intelligence and the intuition of a whole cultural scene. It is the communal form of the concept of the genius.
Kelly lists four factors that are important in nuturing scenius:
- Mutual appreciation -- Risky moves are applauded by the group, subtlety is appreciated, and friendly competition goads the shy. Scenius can be thought of as the best of peer pressure.
- Rapid exchange of tools and techniques -- As soon as something is invented, it is flaunted and then shared. Ideas flow quickly because they are flowing inside a common language and sensibility.
- Network effects of success -- When a record is broken, a hit happens, or breakthrough erupts, the success is claimed by the entire scene. This empowers the scene to further success.
- Local tolerance for the novelties -- The local "outside" does not push back too hard against the transgressions of the scene. The renegades and mavericks are protected by this buffer zone.
TEDxAmsterdam: Kevin Kelly from TEDxAmsterdam on Vimeo.
Labels:
scenius
Monday, November 22, 2010
MAGE (multiplex automated genetic engineering) technique developed from university research promises to speed up cellular mutations
Dr. George Church, a synthetic biologist and Harvard Medical School professor, says he can create living things faster than nature can, essentially speeding up evolution. And he says he can do it cheaply.
That intrigues us at STINSON Brand Innovation, and it’s another example of creative university discovery poised for development for broader biomedical use.
Most synthetic biologists laboriously tweak a genome one small piece at a time, then look at how the new cell behaves. Dr. Church, and fellow researchers Farren Isaacs and Harris Wang, have invented a technology known as multiplex automated genetic engineering, or MAGE, which makes the process much faster.
The table-top machine they created allows researchers to make 50 different genome alterations at nearly the same time. Combined with the mutations that occur as those cells go on and reproduce, MAGE can create billions of cellular mutations in a matter of days, essentially speeding up evolution. Scientists can then identify the most useful mutations.
Church’s team was able to genetically alter a common bacterium, E. coli, to produce lycopene, an antioxidant in tomatoes that may help fight cancer. Some of the altered bacteria produced five times the normal quantity of lycopene. The team spent just three days and $1,000 in supplies to produce the bacteria. Using old techniques, it would have taken months, says Church.
Church says his MAGE device will go on sale later this year for about $90,000. And at least a dozen companies, including DuPont and biotech startup Amyris, are considering purchasing it, says Wang.
Take a look at this quote from Church’s paper on MAGE:
Programming cells by multiplex genome engineering and accelerated evolution. Nature 460, 894-898 (13 August 2009).
“Here, we describe multiplex automated genome engineering (MAGE) for large-scale programming and evolution of cells. MAGE simultaneously targets many locations on the chromosome for modification in a single cell or across a population of cells, thus producing combinatorial genomic diversity. Because the process is cyclical and scalable, we constructed prototype devices that automate the MAGE technology to facilitate rapid and continuous generation of a diverse set of genetic changes (mismatches, insertions, deletions). We applied MAGE to optimize the 1-deoxy-d-xylulose-5-phosphate (DXP) biosynthesis pathway in Escherichia coli to overproduce the industrially important isoprenoid lycopene. Twenty-four genetic components in the DXP pathway were modified simultaneously using a complex pool of synthetic DNA, creating over 4.3 billion combinatorial genomic variants per day.”
That intrigues us at STINSON Brand Innovation, and it’s another example of creative university discovery poised for development for broader biomedical use.
Most synthetic biologists laboriously tweak a genome one small piece at a time, then look at how the new cell behaves. Dr. Church, and fellow researchers Farren Isaacs and Harris Wang, have invented a technology known as multiplex automated genetic engineering, or MAGE, which makes the process much faster.
The table-top machine they created allows researchers to make 50 different genome alterations at nearly the same time. Combined with the mutations that occur as those cells go on and reproduce, MAGE can create billions of cellular mutations in a matter of days, essentially speeding up evolution. Scientists can then identify the most useful mutations.
Church’s team was able to genetically alter a common bacterium, E. coli, to produce lycopene, an antioxidant in tomatoes that may help fight cancer. Some of the altered bacteria produced five times the normal quantity of lycopene. The team spent just three days and $1,000 in supplies to produce the bacteria. Using old techniques, it would have taken months, says Church.
Church says his MAGE device will go on sale later this year for about $90,000. And at least a dozen companies, including DuPont and biotech startup Amyris, are considering purchasing it, says Wang.
Take a look at this quote from Church’s paper on MAGE:
Programming cells by multiplex genome engineering and accelerated evolution. Nature 460, 894-898 (13 August 2009).
“Here, we describe multiplex automated genome engineering (MAGE) for large-scale programming and evolution of cells. MAGE simultaneously targets many locations on the chromosome for modification in a single cell or across a population of cells, thus producing combinatorial genomic diversity. Because the process is cyclical and scalable, we constructed prototype devices that automate the MAGE technology to facilitate rapid and continuous generation of a diverse set of genetic changes (mismatches, insertions, deletions). We applied MAGE to optimize the 1-deoxy-d-xylulose-5-phosphate (DXP) biosynthesis pathway in Escherichia coli to overproduce the industrially important isoprenoid lycopene. Twenty-four genetic components in the DXP pathway were modified simultaneously using a complex pool of synthetic DNA, creating over 4.3 billion combinatorial genomic variants per day.”
Labels:
MAGE
Friday, November 19, 2010
Is chief social media officer the "zaniest human resource innovation in memory"?
This new and trendy job is a two-step process at some companies:
- Scramble to hire social media officers.
- Figure out what it is, exactly, that social media officers do and how to measure it.
Labels:
social media
Thursday, November 18, 2010
4 healthcare innovations for a post-reform world
Achieving a political consensus on healthcare reform is not a prerequisite to instituting far-reaching institutional changes.
This viewpoint was expressed by Jill E. Sackman, PhD, senior consultant at Numerof & Associates in St. Louis, writing in a recent issue of BioPharm International.
Dr. Sackman notes that the department of Health and Human Services (HHS) continues to take action to achieve fiscal and quality objectives. The outline of where policy is headed is clearly discernable in the grants and pilot programs now being funded.
At Stinson Brand Innovation, we’re always on the lookout for opportunities for innovation in health, science, and technology – even those beyond the molecules and drug delivery systems.
So, I appreciate Dr. Sackman’s outline of steps being pursued to achieve better quality and reduce cost through:
The industry should be looking for ways to:
Dr. Sackman concludes her article with a call to action, “Leaders in the healthcare industry must think about the impact of these sweeping changes on their business now, and plan ways to assess risk and strengthen the economic and clinical value of their products in ways that ensure demand and optimal pricing.“
“Are you ready for life in a post–reform world?” she asks.
This viewpoint was expressed by Jill E. Sackman, PhD, senior consultant at Numerof & Associates in St. Louis, writing in a recent issue of BioPharm International.
Dr. Sackman notes that the department of Health and Human Services (HHS) continues to take action to achieve fiscal and quality objectives. The outline of where policy is headed is clearly discernable in the grants and pilot programs now being funded.
At Stinson Brand Innovation, we’re always on the lookout for opportunities for innovation in health, science, and technology – even those beyond the molecules and drug delivery systems.
So, I appreciate Dr. Sackman’s outline of steps being pursued to achieve better quality and reduce cost through:
- Aggressively implementing electronic medical records (EMR);
- Conducting comparative clinical effectiveness research (CER) to improve outcomes;
- Promoting more patient-centered primary healthcare delivery, particularly for disadvantaged populations; and
- Understanding the organizational and infrastructure changes needed to support improving quality and reducing costs.
The industry should be looking for ways to:
- link physician payment to high-quality care at lower cost,
- connect payment bonuses to hospitals that improve patient results, and
- impose penalties on institutions that don't meet the mark.
Dr. Sackman concludes her article with a call to action, “Leaders in the healthcare industry must think about the impact of these sweeping changes on their business now, and plan ways to assess risk and strengthen the economic and clinical value of their products in ways that ensure demand and optimal pricing.“
“Are you ready for life in a post–reform world?” she asks.
Tuesday, November 16, 2010
Another Asian “tiger” to watch: Singapore
Much has been written about China’s potential in life science and pharmaceutical sectors. This is a positive trend, for sure, but has been hampered by quality control concerns.
Many are looking beyond China to another Asian tiger: Singapore.
Singapore's economy grew at an annualized rate of 26 percent in the first half of this year, a blistering pace that may moderate for the full year to 15 percent, the top-of-the-range estimate for many economists. Still that should be enough to overtake China as Asia's fastest-growing economy this year.
A long-standing policy to lure pharmaceutical factories to Singapore with tax breaks, special R&D facilities, and worker training has paid off spectacularly.
Pfizer, Sanofi-aventis, Roche, and other pharma leaders have picked Singapore as a key operations base for Asia because they need facilities that can pass rigorous inspections by regulators and produce huge volumes of pharmaceuticals. GlaxoSmithKline has also expanded in Singapore this year.
When I was at an Asia-Pacific managers’ meeting earlier this year, I met with the Singapore sales and marketing team to get their first-hand impression of the upside potential. They are well-positioned to take full advantage of the opportunities this market offers. And we at Stinson Brand Innovation are pleased to be supporting them.
Many are looking beyond China to another Asian tiger: Singapore.
Singapore's economy grew at an annualized rate of 26 percent in the first half of this year, a blistering pace that may moderate for the full year to 15 percent, the top-of-the-range estimate for many economists. Still that should be enough to overtake China as Asia's fastest-growing economy this year.
A long-standing policy to lure pharmaceutical factories to Singapore with tax breaks, special R&D facilities, and worker training has paid off spectacularly.
Pfizer, Sanofi-aventis, Roche, and other pharma leaders have picked Singapore as a key operations base for Asia because they need facilities that can pass rigorous inspections by regulators and produce huge volumes of pharmaceuticals. GlaxoSmithKline has also expanded in Singapore this year.
When I was at an Asia-Pacific managers’ meeting earlier this year, I met with the Singapore sales and marketing team to get their first-hand impression of the upside potential. They are well-positioned to take full advantage of the opportunities this market offers. And we at Stinson Brand Innovation are pleased to be supporting them.
Labels:
Singapore
Monday, November 15, 2010
5 steps in putting the World Community Grid to work
Last week, I shared how Stanley Watowich, a biochemist at the University of Texas Medical Branch in Galveston, is using IBM's World Community Grid (WCG) – to model in algorithms what happens between a small molecule and a protein related to dengue fever, West Nile virus, and hepatitis C.
His virtual experiments analyze millions of possibilities in months, as opposed to more time-consuming and expensive wet-lab experiments that might examine only hundreds.
Here are more details on how it works:
DESIGN
Stanley Watowich of the University of Texas Medical Branch in Galveston develops algorithms for a virtual experiment to test how more than 3 million molecules interact with 12 proteins related to dengue fever.
TEST
Grid supervisor Viktors Berstis, in Beaverton, Oregon, and his IBM team around the country fine-tune Watowich's code to make sure it will run safely and reliably on tens of thousands of different machines. Once it's approved, the grid team puts it in the work queue.
ASSIGN
When there's space on the grid, Berstis's group uploads the program and corresponding data to the main servers in Toronto. The grid automatically assigns pieces of the project to thousands of available machines, based on each one's computing power.
COMPUTE
Whenever the program senses that a volunteer's computer is idle, even for a moment, it borrows 60% of the computing power and begins crunching numbers in the background; each time the software resumes, it picks up where it left off.
REPORT
When any one computer's work is done, the grid transmits the results to the servers in Toronto. Once all of Watowich's calculations are complete, WCG sends the results to his servers in Galveston, where his team looks for the most promising drug candidates to test further.
Click here to learn more about the WCG project – and even how to join the effort.
His virtual experiments analyze millions of possibilities in months, as opposed to more time-consuming and expensive wet-lab experiments that might examine only hundreds.
Here are more details on how it works:
DESIGN
Stanley Watowich of the University of Texas Medical Branch in Galveston develops algorithms for a virtual experiment to test how more than 3 million molecules interact with 12 proteins related to dengue fever.
TEST
Grid supervisor Viktors Berstis, in Beaverton, Oregon, and his IBM team around the country fine-tune Watowich's code to make sure it will run safely and reliably on tens of thousands of different machines. Once it's approved, the grid team puts it in the work queue.
ASSIGN
When there's space on the grid, Berstis's group uploads the program and corresponding data to the main servers in Toronto. The grid automatically assigns pieces of the project to thousands of available machines, based on each one's computing power.
COMPUTE
Whenever the program senses that a volunteer's computer is idle, even for a moment, it borrows 60% of the computing power and begins crunching numbers in the background; each time the software resumes, it picks up where it left off.
REPORT
When any one computer's work is done, the grid transmits the results to the servers in Toronto. Once all of Watowich's calculations are complete, WCG sends the results to his servers in Galveston, where his team looks for the most promising drug candidates to test further.
Click here to learn more about the WCG project – and even how to join the effort.
Friday, November 12, 2010
4 examples of how pharma hopes to save big using stem cells to test drugs for dangerous side effects long before costly human trials are needed
Discovering late in the game that a promising new drug has side effects in humans is a frustrating and expensive pitfall for pharmaceutical companies. That kind of setback sends scientists back to the lab—or even prompts a company to shut down a multimillion-dollar drug development program.
Researchers at many companies – big and small – hope to use human tissue created from stem cells to reduce such mishaps, according to BusinessWeek.
For years, stem cells have been hailed as potential treatments for Parkinson's disease, spinal cord injuries, and diabetes. Even though these may be years away, pharma has begun using the cells to help identify potentially dangerous side effects of drugs in development before they undergo expensive human trials.
(The stem cells being employed by drugmakers don't come from embryos, thereby avoiding an ethical and political controversy that's dogged the technology. Instead they were created using a method that allows scientists to transform ordinary skin cells into another type of stem cell known as induced pluripotent stem, or IPS, cells as versatile as embryonic cells.)
Here are four views of company approaches to R&D with stem cells:
1. Roche
Earlier this year, Roche scientists used heart tissue made from stem cells to test an antiviral drug it had abandoned two years earlier because it caused irregular heartbeats in rodents and rabbits. The same adverse effects were seen in the lab using the stem cell-generated heart cells. The finding is important to drug researchers because it showed that human tissue grown from stem cells can mimic the body's reaction to medicines, helping spot side effects early. And that matters greatly in an industry that can spend upward of $4 billion to produce a new drug. Had stem-cell-derived heart tissue been available two years ago, Roche could have pulled the plug earlier on its antiviral drug, saving millions, says Kyle Kolaja, Roche's global head of predictive toxicology screens and emerging technologies.
2. iPierian
A drug study in mice alone can cost about $3 million, says Michael C. Venuti, chief executive officer at iPierian, which is developing drugs using stem cells. iPierian is making cells from people with heart disorders, diabetes, and neurological ailments to develop drugs that threat these disorders. Founded by venture capitalists at Kleiner Perkins Caufield & Byers in Menlo Park, Calif., the company was built on the work of Shinya Yamanaka of Kyoto University in Japan, who turned skin cells into IPS cells back in 2006. It has since raised $60 million including money most recently from the venture arms of Google, Glaxo, and Biogen Idec. IPierian has made IPS cells from the skin of children with spinal muscular atrophy, a deadly muscle-wasting condition. Morphing the stem cells into neurons that carry the disease, they've identified drug candidates that may help motor neurons to survive, said Venuti, iPierian's CEO. The company also used the neurons to test 15 drugs that previously failed in clinical trials, said Corey Goodman, iPierian's chairman. The signs of failure were evident in each case, he said. "IPS technology gives you the opportunity to screen out a lot of things that are going to fail," said Goodman, who formerly was head of Pfizer's biotechnology unit. "That saves money, emotion, and testing."
3. Glaxo
A drug that's found to cause cardiac damage only after it has advanced to large, late-stage human studies might cost a company $1 billion or more, says Jason Gardner, a Glaxo vice-president who heads its stem cell drug performance unit. "There is a real need to more accurately model human physiology," he says.
4. Cellular Dynamics International
This company was founded in 2004 by James Thomson, the University of Wisconsin scientist who first isolated human embryonic stem cells in 1998, made the heart cells used by Roche and also being tested by Glaxo and Pfizer. Cellular Dynamics International is now producing more than 7 billion heart cells a month made from skin and blood, says Robert Palay, CDI's chief executive. Next year, the company plans to start selling liver and nerve cells as well. "Others are talking about the promise of stem cells, we are delivering today," Palay says. Cellular Dynamics is backed by $70 million from private equity groups including Sam Zell's Equity Group Investments and Palay's Tactics II Stem Cell Partners.
Researchers at many companies – big and small – hope to use human tissue created from stem cells to reduce such mishaps, according to BusinessWeek.
For years, stem cells have been hailed as potential treatments for Parkinson's disease, spinal cord injuries, and diabetes. Even though these may be years away, pharma has begun using the cells to help identify potentially dangerous side effects of drugs in development before they undergo expensive human trials.
(The stem cells being employed by drugmakers don't come from embryos, thereby avoiding an ethical and political controversy that's dogged the technology. Instead they were created using a method that allows scientists to transform ordinary skin cells into another type of stem cell known as induced pluripotent stem, or IPS, cells as versatile as embryonic cells.)
Here are four views of company approaches to R&D with stem cells:
1. Roche
Earlier this year, Roche scientists used heart tissue made from stem cells to test an antiviral drug it had abandoned two years earlier because it caused irregular heartbeats in rodents and rabbits. The same adverse effects were seen in the lab using the stem cell-generated heart cells. The finding is important to drug researchers because it showed that human tissue grown from stem cells can mimic the body's reaction to medicines, helping spot side effects early. And that matters greatly in an industry that can spend upward of $4 billion to produce a new drug. Had stem-cell-derived heart tissue been available two years ago, Roche could have pulled the plug earlier on its antiviral drug, saving millions, says Kyle Kolaja, Roche's global head of predictive toxicology screens and emerging technologies.
2. iPierian
A drug study in mice alone can cost about $3 million, says Michael C. Venuti, chief executive officer at iPierian, which is developing drugs using stem cells. iPierian is making cells from people with heart disorders, diabetes, and neurological ailments to develop drugs that threat these disorders. Founded by venture capitalists at Kleiner Perkins Caufield & Byers in Menlo Park, Calif., the company was built on the work of Shinya Yamanaka of Kyoto University in Japan, who turned skin cells into IPS cells back in 2006. It has since raised $60 million including money most recently from the venture arms of Google, Glaxo, and Biogen Idec. IPierian has made IPS cells from the skin of children with spinal muscular atrophy, a deadly muscle-wasting condition. Morphing the stem cells into neurons that carry the disease, they've identified drug candidates that may help motor neurons to survive, said Venuti, iPierian's CEO. The company also used the neurons to test 15 drugs that previously failed in clinical trials, said Corey Goodman, iPierian's chairman. The signs of failure were evident in each case, he said. "IPS technology gives you the opportunity to screen out a lot of things that are going to fail," said Goodman, who formerly was head of Pfizer's biotechnology unit. "That saves money, emotion, and testing."
3. Glaxo
A drug that's found to cause cardiac damage only after it has advanced to large, late-stage human studies might cost a company $1 billion or more, says Jason Gardner, a Glaxo vice-president who heads its stem cell drug performance unit. "There is a real need to more accurately model human physiology," he says.
4. Cellular Dynamics International
This company was founded in 2004 by James Thomson, the University of Wisconsin scientist who first isolated human embryonic stem cells in 1998, made the heart cells used by Roche and also being tested by Glaxo and Pfizer. Cellular Dynamics International is now producing more than 7 billion heart cells a month made from skin and blood, says Robert Palay, CDI's chief executive. Next year, the company plans to start selling liver and nerve cells as well. "Others are talking about the promise of stem cells, we are delivering today," Palay says. Cellular Dynamics is backed by $70 million from private equity groups including Sam Zell's Equity Group Investments and Palay's Tactics II Stem Cell Partners.
Labels:
stem cells
Wednesday, November 10, 2010
“Contagious” ideas that universities could benefit by catching from health care
While higher education and health care share some important characteristics and problems, many hospitals and clinics have achieved more thorough reforms than have colleges and universities.
This is the conclusion of an article from Trusteeship, the journal of the Association of Governing Boards of Universities and Colleges.
“I firmly believe that higher education can find valuable ideas in health care—ideas that validate what some universities are already doing, and ideas that are less familiar but may have potential for universities,” writes Ellen Chaffee.
Chaffee is an AGB senior fellow and director of AGB ’s Lumina Foundation project on Governance for Student Success. She is president emerita of Valley City State University and past president of Mayville State University, the Association for Institutional Research, and the Association for the Study of Higher Education. She also chairs the board of trustees of the MeritCare Health System in
Fargo, ND. (Click here to go to her webpage. )
She believes that governance of many hospitals and clinics has become more strategic, with board discussions focusing less exclusively on budget and finance and more on aligning resources to achieve well-defined goals, including improvements in quality.
Chaffee offers details on the comparison.
University leaders dealing with scarce resources often believe they need to cut academic programs based on high cost or questionable mission relevance. By contrast, cutting services in this way is not on the agenda of many financially stressed health-care systems. The ability to identify more subtle but equally effective cost savings is one of the major benefits of systematic quality improvement.
For example, some health systems assign nurses to work closely with individual patients who have chronic diseases to fine-tune their treatment and promote their compliance with medical advice. This may seem like added expense, but it often lowers costs due to early intervention and increased compliance. MeritCare Health System partnered with Blue Cross Blue Shield of North Dakota in a pilot project to explore this approach with diabetes patients. In one year, the program saved over $330,000.
Chaffee also proposes that universities could benefit from revisiting the “continuous quality improvement” approach, which sectors of health care now use to pursue evidence-based, systematic improvements. Moreover, evidence-based medicine has become a requirement for hospital accreditation, using metrics from the government and other outside groups. Higher-education performance metrics on student learning tend to come from institutions themselves.
As a firm who has worked with universities and serves medical clients, we at Stinson Brand Innovation have seen that higher education can find potentially valuable ideas from health care.
This is the conclusion of an article from Trusteeship, the journal of the Association of Governing Boards of Universities and Colleges.
“I firmly believe that higher education can find valuable ideas in health care—ideas that validate what some universities are already doing, and ideas that are less familiar but may have potential for universities,” writes Ellen Chaffee.
Chaffee is an AGB senior fellow and director of AGB ’s Lumina Foundation project on Governance for Student Success. She is president emerita of Valley City State University and past president of Mayville State University, the Association for Institutional Research, and the Association for the Study of Higher Education. She also chairs the board of trustees of the MeritCare Health System in
Fargo, ND. (Click here to go to her webpage. )
She believes that governance of many hospitals and clinics has become more strategic, with board discussions focusing less exclusively on budget and finance and more on aligning resources to achieve well-defined goals, including improvements in quality.
Chaffee offers details on the comparison.
University leaders dealing with scarce resources often believe they need to cut academic programs based on high cost or questionable mission relevance. By contrast, cutting services in this way is not on the agenda of many financially stressed health-care systems. The ability to identify more subtle but equally effective cost savings is one of the major benefits of systematic quality improvement.
For example, some health systems assign nurses to work closely with individual patients who have chronic diseases to fine-tune their treatment and promote their compliance with medical advice. This may seem like added expense, but it often lowers costs due to early intervention and increased compliance. MeritCare Health System partnered with Blue Cross Blue Shield of North Dakota in a pilot project to explore this approach with diabetes patients. In one year, the program saved over $330,000.
Chaffee also proposes that universities could benefit from revisiting the “continuous quality improvement” approach, which sectors of health care now use to pursue evidence-based, systematic improvements. Moreover, evidence-based medicine has become a requirement for hospital accreditation, using metrics from the government and other outside groups. Higher-education performance metrics on student learning tend to come from institutions themselves.
As a firm who has worked with universities and serves medical clients, we at Stinson Brand Innovation have seen that higher education can find potentially valuable ideas from health care.
Tuesday, November 09, 2010
3 steps to building your health advocacy skills
“Inspiration and ideas come from a wide variety of sources,” says Suzanne Ross of the Aerie Company. I appreciate Suzanne’s ability to integrate new thoughts and make the strategy + communications + leadership link to elevate performance.
Recently, Suzanne’s newsletter featured an article on Health Literacy, and I asked her if I could share it with friends of Stinson Brand Innovation.
=============================
As health care reform brings millions more people into the system over the next several years, there has never been such an urgent and dramatic need to advocate for yourself, your family and the people you love at the doctor’s office and in the hospital.
The successful champions will be those with a solid health literacy foundation – often described as an individual’s ability to read, understand and use healthcare information to make decisions and follow instructions for treatment. While it seems pretty straightforward, the complexities of chronic conditions, varied therapeutic approaches and an enormous array of drug options, let alone insurance and financial issues, require today’s patients and consumers to be prepared for even more responsibility and accountability for their health.
Health Literacy awareness draws increased attention on the importance of access to accurate, understandable health information and promoting good health. It has been well documented that limited health literacy has a direct link to worse health outcomes and higher costs, something we can ill afford today.
Among many resources available to promote greater consumer understanding of health, particularly navigating the system, is “The Empowered Patient” by CNN senior medical correspondent Elizabeth Cohen. The book is an outgrowth a career reporting on healthcare, her Empowered Patient column for CNN.com and personal and family experience as patients. Cohen takes a be-prepared-like-a-Boy Scout approach offering advice, patient stories, resources and check lists on getting the right diagnosis and plan for the best medical care, dealing with your insurance company, how to maximize prescriptions, ultimately informing patients of their vital role in creating a smarter, safer health care system.
The basic principles for becoming a personal advocate ring true for the business environment as well, whether responding to a crisis or promoting a new point of view on issues critical to your company or industry. To help pave the way to define and resolve problems, focus on advocacy skills that enable you to:
You can contact Suzanne Ross at www.aeriecompany.com.
Recently, Suzanne’s newsletter featured an article on Health Literacy, and I asked her if I could share it with friends of Stinson Brand Innovation.
=============================
As health care reform brings millions more people into the system over the next several years, there has never been such an urgent and dramatic need to advocate for yourself, your family and the people you love at the doctor’s office and in the hospital.
The successful champions will be those with a solid health literacy foundation – often described as an individual’s ability to read, understand and use healthcare information to make decisions and follow instructions for treatment. While it seems pretty straightforward, the complexities of chronic conditions, varied therapeutic approaches and an enormous array of drug options, let alone insurance and financial issues, require today’s patients and consumers to be prepared for even more responsibility and accountability for their health.
Health Literacy awareness draws increased attention on the importance of access to accurate, understandable health information and promoting good health. It has been well documented that limited health literacy has a direct link to worse health outcomes and higher costs, something we can ill afford today.
Among many resources available to promote greater consumer understanding of health, particularly navigating the system, is “The Empowered Patient” by CNN senior medical correspondent Elizabeth Cohen. The book is an outgrowth a career reporting on healthcare, her Empowered Patient column for CNN.com and personal and family experience as patients. Cohen takes a be-prepared-like-a-Boy Scout approach offering advice, patient stories, resources and check lists on getting the right diagnosis and plan for the best medical care, dealing with your insurance company, how to maximize prescriptions, ultimately informing patients of their vital role in creating a smarter, safer health care system.
The basic principles for becoming a personal advocate ring true for the business environment as well, whether responding to a crisis or promoting a new point of view on issues critical to your company or industry. To help pave the way to define and resolve problems, focus on advocacy skills that enable you to:
- Be prepared – do your research to support your position, keep organized records that outline all details and have a plan for success
- Be clear – articulate a clear, specific definition of the problem that distinguishes major issues from incidental details and always be listening to ensure you understand any response you receive
- Be engaged – adopt a lifelong learning mindset so you are receptive and can question new information and options while remaining polite and persistent
You can contact Suzanne Ross at www.aeriecompany.com.
Labels:
health advocacy
Monday, November 08, 2010
3 university programs using WCG to accelerate research
How could you make supporting medical research more gratifying than writing a check?
One initiative is including volunteers in a greater part of the scientific journey toward a life-changing solution.
Meet a new breed of innovator: a citizen researcher.
On IBM's World Community Grid (WCG), there is an unprecedented effort to deploy ordinary people's idle computers to create a free, open-source lab for researchers around the globe.
Since the tech giant launched the nearly $2-million-a-year project in November 2004, more than half a million people in 218 countries have volunteered some 1.5 million laptops and desktops. Massive computational research is broken down into discrete problems and distributed across a vast network. In raw computing power, the grid is comparable to a top-10 supercomputer. The average PC would take more than 328,000 years to complete the grid's calculations so far.
Three university research programs were featured in Fast Company in relation the project.
One initiative is including volunteers in a greater part of the scientific journey toward a life-changing solution.
Meet a new breed of innovator: a citizen researcher.
On IBM's World Community Grid (WCG), there is an unprecedented effort to deploy ordinary people's idle computers to create a free, open-source lab for researchers around the globe.
Since the tech giant launched the nearly $2-million-a-year project in November 2004, more than half a million people in 218 countries have volunteered some 1.5 million laptops and desktops. Massive computational research is broken down into discrete problems and distributed across a vast network. In raw computing power, the grid is comparable to a top-10 supercomputer. The average PC would take more than 328,000 years to complete the grid's calculations so far.
Three university research programs were featured in Fast Company in relation the project.
- Researcher Alán Aspuru-Guzik, an assistant professor of chemistry at Harvard, says WCG "gives you the opportunity to do something nobody else has done. Something disruptive."
- Scientists at the University of Washington are using WCG to compile a comprehensive map of rice proteins, which could help developing countries grow more nutritious, higher-yield crops.
- Stanley Watowich, a biochemist at the University of Texas Medical Branch in Galveston, uses WCG to model in algorithms what happens between a small molecule and a protein related to dengue fever, West Nile virus, and hepatitis C. His virtual experiments analyze millions of possibilities in months, as opposed to more time-consuming and expensive wet-lab experiments that might examine only hundreds. The first stage winnowed the molecules to several thousand that plug into binding sites on a dozen proteins, like puzzle pieces, says Watowich. The second stage narrows the field again, evaluating the binding energy of those candidates and the proteins, a highly complex computation that's practical only on a large grid. The idea is to reserve lab time for the molecules with the greatest chance of becoming effective drugs. "This has the potential to be a game-changing approach," says Watowich. Without WCG, he couldn't have pursued this path. "We've worked with supercomputers before," he says, "but there's no way we could say, 'We'd like half your supercomputer for the next six months. Would that be a problem?' " Watowich conducted experiments on a 1,000-computer test grid of his own, but even a network that small took six months to get up and running and proved demanding to maintain. "Now," he says, "IBM does the heavy lifting."
Friday, November 05, 2010
$4 billion-a-year market for drug-coated stents gets a disappearing act from Abbott
Abbott’s experimental heart stent, a scaffold-like device the size of the spring in a ballpoint pen, was inserted into the first patient in March 2006 and inflated under pressure to prop open the passage, which had been clogged by fatty plaque. Unlike metal stents, Abbott’s is made of polylactic acid and designed to dissolve within two years after implant.
If studies confirm the device helps arteries and disappears without causing clots or other risks linked to metal models, the product may take the lead in the $4 billion-a-year market for drug-coated stents, as it would be safer for patients, said John Capek, Abbott Park, Illinois-based Abbott’s executive vice president of medical devices.
The dissolving stent is designed to confer the benefits of existing devices without leaving behind the “metal spider,” the image that appears during an X-ray of a patient whose coronary arteries are fully stented. Current stents don’t shrink and expand with the artery’s natural movement. The metal devices can trigger deadly clots, and may interfere with future tests and surgeries, Capek said.
There haven’t been any cases of clots in people getting Abbott’s bioresorbable stent, Capek said. Data on 45 patients, who were followed for nine months after treatment, were presented at the Transcatheter Cardiovascular Therapeutics meeting in Washington Sept. 21-25.
Abbott’s approach is part of an evolution, said Patrick Serruys, chief of interventional cardiology at Erasmus Medical Center in Rotterdam, who has been a pioneer of the technology. Doctors first cleared clogged arteries with a balloon, inflating it inside a blockage to allow blood to flow. The arteries often snapped shut or reclogged, leading researchers to craft metal tubes that were left behind to prop open the vessels.
Abbott’s main competitors in the stent market are in the early stages of evaluating dissolving devices. Most of their work is in places such as the leg where the larger size of an absorbable stent isn’t a problem.
Here’s what BusinessWeek reported on the competition.
Boston Scientific
While Natick, Massachusetts-based Boston Scientific is working on bioresorbable stents for leg and heart arteries, the company’s emphasis in research is something else: metal devices with coatings that dissipate over time, said Keith Dawkins, chief medical officer for the cardiology, rhythm and vascular group.
“There is very little evidence that the long-term presence of a metal scaffold is detrimental,” J&J’s Rogers said. “There are millions and millions of patients with metal scaffolds in their arteries and are doing fine.”
Reva Medical
Founded in 1998, Reva is working on a stent that starts to resorb after 90 days. The company redesigned its prototype after patients who received it in a 2007 study needed repeat treatment. Reva, whose investors have included Boston Scientific and Medtronic, aims to start another trial by next year. Now closely held, the company plans a public sale of securities to be traded in Australia, according to a regulatory filing on Aug. 13.
Biotronik
Biotronik’s bioresorbable drug-coated metal stent, made from magnesium and dubbed Dreams, was implanted in its first patient in August, in Germany, said Sandy Hathaway, a company spokeswoman. Biotronik, founded in 1963 by the developers of a heart pacemaker, is closely held.
Medtronic
"The legs, where the arteries run close to the surface of the skin, present anatomical dynamics that may warrant this kind of biomaterials innovation," says Sean Salmon, general manager of Medtronic's coronary and peripheral division. "The clinical need to reduce pain and amputations remains largely unmet."
Johnson & Johnson
At New Brunswick, New Jersey-based Johnson & Johnson, officials say they aren’t sure how much promise there is in dissolving stents.
“For coronary stents, there is an incredible premium on stent performance,” said Campbell Rogers, chief scientific officer for J&J’s Cordis unit. “You need a Ferrari. The bioresorbable stent is a larger, bulkier stent. The likelihood of it being a significant advance for patients and clinicians in coronary use is not great.”
If studies confirm the device helps arteries and disappears without causing clots or other risks linked to metal models, the product may take the lead in the $4 billion-a-year market for drug-coated stents, as it would be safer for patients, said John Capek, Abbott Park, Illinois-based Abbott’s executive vice president of medical devices.
The dissolving stent is designed to confer the benefits of existing devices without leaving behind the “metal spider,” the image that appears during an X-ray of a patient whose coronary arteries are fully stented. Current stents don’t shrink and expand with the artery’s natural movement. The metal devices can trigger deadly clots, and may interfere with future tests and surgeries, Capek said.
There haven’t been any cases of clots in people getting Abbott’s bioresorbable stent, Capek said. Data on 45 patients, who were followed for nine months after treatment, were presented at the Transcatheter Cardiovascular Therapeutics meeting in Washington Sept. 21-25.
Abbott’s approach is part of an evolution, said Patrick Serruys, chief of interventional cardiology at Erasmus Medical Center in Rotterdam, who has been a pioneer of the technology. Doctors first cleared clogged arteries with a balloon, inflating it inside a blockage to allow blood to flow. The arteries often snapped shut or reclogged, leading researchers to craft metal tubes that were left behind to prop open the vessels.
Abbott’s main competitors in the stent market are in the early stages of evaluating dissolving devices. Most of their work is in places such as the leg where the larger size of an absorbable stent isn’t a problem.
Here’s what BusinessWeek reported on the competition.
Boston Scientific
While Natick, Massachusetts-based Boston Scientific is working on bioresorbable stents for leg and heart arteries, the company’s emphasis in research is something else: metal devices with coatings that dissipate over time, said Keith Dawkins, chief medical officer for the cardiology, rhythm and vascular group.
“There is very little evidence that the long-term presence of a metal scaffold is detrimental,” J&J’s Rogers said. “There are millions and millions of patients with metal scaffolds in their arteries and are doing fine.”
Reva Medical
Founded in 1998, Reva is working on a stent that starts to resorb after 90 days. The company redesigned its prototype after patients who received it in a 2007 study needed repeat treatment. Reva, whose investors have included Boston Scientific and Medtronic, aims to start another trial by next year. Now closely held, the company plans a public sale of securities to be traded in Australia, according to a regulatory filing on Aug. 13.
Biotronik
Biotronik’s bioresorbable drug-coated metal stent, made from magnesium and dubbed Dreams, was implanted in its first patient in August, in Germany, said Sandy Hathaway, a company spokeswoman. Biotronik, founded in 1963 by the developers of a heart pacemaker, is closely held.
Medtronic
"The legs, where the arteries run close to the surface of the skin, present anatomical dynamics that may warrant this kind of biomaterials innovation," says Sean Salmon, general manager of Medtronic's coronary and peripheral division. "The clinical need to reduce pain and amputations remains largely unmet."
Johnson & Johnson
At New Brunswick, New Jersey-based Johnson & Johnson, officials say they aren’t sure how much promise there is in dissolving stents.
“For coronary stents, there is an incredible premium on stent performance,” said Campbell Rogers, chief scientific officer for J&J’s Cordis unit. “You need a Ferrari. The bioresorbable stent is a larger, bulkier stent. The likelihood of it being a significant advance for patients and clinicians in coronary use is not great.”
Thursday, November 04, 2010
8 steps to document your brand’s persona in a social media style guide
These days, it seems as if brands are transforming so rapidly – often on a whim of based on a social media concept. So, consider way to adapt the proven tool of “brand style guide” to guide the way the brand socializes in all mediums. Print. TV. Experiences. And of course, digitally.
In a recent issue of Advertising Age, guest contributor Brian Solis suggested eight steps to reflecting on your brand and laying the foundation for a new, more socially inspired and relevant corporate culture and value system.
In a recent issue of Advertising Age, guest contributor Brian Solis suggested eight steps to reflecting on your brand and laying the foundation for a new, more socially inspired and relevant corporate culture and value system.
- Core Values: The audience, surrounding environment, and the circumstances in which we are summoned contribute to our disposition and character. At the beginning, we need to form a common center of gravity to support the orbiting characteristics that support our mission and purpose. Essentially, we need to specify what we stand for and weave it into all we do.
- Brand Pillars: Pillars are the support objects that serve as the foundation to sustain and fortify the brand. It is these pillars that establish the principal, central themes that convey our uniqueness and value, fortified through the social objects we develop and distribute.
- Promise: The pledge that paves the way to brand meaning and direction is the brand promise. It should answer a simple, yet powerful question: What is our mission and how does it introduce value to those who align with our purpose?
- Aspirations: No brand is an island, nor is it inanimate. As such, the attributes we define today must continually evolve. Our aspirations are representative of the stature and mission we seek today and over time. This is how we compete for the future.
- Brand Characteristics: Defining the brand characteristics will help us establish the traits we wish to associate with the brand represented through our actions, words and overall behavior.
- Opportunities: As we complete this exercise, the identification of the attributes that are not embodied allows us to find a path to greater relevance. It's a combination of who we are and what we offer today and also the opportunities that emerge that allow us to connect to those seeking solutions we had yet to identify.
- Culture: The brand team must examine the culture of the company, not only what it is today, but ultimately how it should embody our aspirations so that it is readily identifiable in social media. People need something they can align with, and it is our culture that serves as the magnet to our purpose and aspirations. We are all in this together.
- Personality: It is crucial that we contemplate, review and designate the elements that we wish the brand to illustrate and represent. This final step is to identify and bring to life the personality and character of the brand through conversations, social objects and stories. If the brand was a person, how would it appear? How would it sound? How would it interact with others? How would others describe it?
- Here are a few elements proposed for a social-media style guide.
- What the brand represents in the social web
- Its characteristics
- Brand personality traits
- The voice of the brand
- Attributes and voice necessary at the representative level
- Procedures and guidelines for representation, accountability and workflow
- Metrics for quantifying activity and the intended results
Tuesday, November 02, 2010
6 top blog posts of the last 3 months
Every now and then, I look back to see what some of the favorite blogs have been. And I try to review what we’re posting to learn what readers like might be interested in.
Here are a few top entries of the last three months:
10/19
Pharmaceutical Executive called biosimilars “this decade’s most disruptive technology.” I wrote about 4 building blocks for a biosimilars strategy.
9/17
Patient access was the leading messaging focus for the majority of 2009’s best-selling prescription drugs. And I connected you to a PharmaVoxx analysis of promotional activity for the top 20 pharmaceutical brands by revenue.
9/1
I considered the implications of “open innovation” on our mission at Stinson Brand to accelerate the adoption of new medical treatments. It’s worth going back to watch the video with MIT Professor Eric von Hippel.
8/27
I shared 2 words to improve your margin: raise price. Read the review of The Art of Pricing by Rafi Mohammed.
8/12
I recalled flying on a late night flight from LAX to SFO. Also on the plane was David Gergen, CNN senior political analyst and advisor to 4 US Presidents. You always imagine what you’d talk about sitting next to someone like Mr. Gergen (or if he’d just sleep on the plane, like I do).
7/10
I featured a great illustration of Noggin – a beautifully named brain protein that acts as a BMP antagonist. Exercise, says Dr. Jack Kessler, through a complex interplay with Noggin and BMP, helps to ensure that neuronal stem cells stay lively and new brain cells are born.
What would you like to see more of in our blog? Write to me and offer your suggestions. Everyone who does will receive a complimentary e-book.
Thanks for following us.
Here are a few top entries of the last three months:
10/19
Pharmaceutical Executive called biosimilars “this decade’s most disruptive technology.” I wrote about 4 building blocks for a biosimilars strategy.
9/17
Patient access was the leading messaging focus for the majority of 2009’s best-selling prescription drugs. And I connected you to a PharmaVoxx analysis of promotional activity for the top 20 pharmaceutical brands by revenue.
9/1
I considered the implications of “open innovation” on our mission at Stinson Brand to accelerate the adoption of new medical treatments. It’s worth going back to watch the video with MIT Professor Eric von Hippel.
8/27
I shared 2 words to improve your margin: raise price. Read the review of The Art of Pricing by Rafi Mohammed.
8/12
I recalled flying on a late night flight from LAX to SFO. Also on the plane was David Gergen, CNN senior political analyst and advisor to 4 US Presidents. You always imagine what you’d talk about sitting next to someone like Mr. Gergen (or if he’d just sleep on the plane, like I do).
7/10
I featured a great illustration of Noggin – a beautifully named brain protein that acts as a BMP antagonist. Exercise, says Dr. Jack Kessler, through a complex interplay with Noggin and BMP, helps to ensure that neuronal stem cells stay lively and new brain cells are born.
What would you like to see more of in our blog? Write to me and offer your suggestions. Everyone who does will receive a complimentary e-book.
Thanks for following us.
Monday, November 01, 2010
An accelerated path to proof-of-concept in drug development – new innovations in Phase I and IIa clinical trial designs
A recent issue of R&D Directions highlights the need for contract research organizations to truly differentiate their services for a pharma client base that, given various circumstances, has become increasingly selective.
For the clinical outsourcing provider, that means coming up with inventive and lasting solutions to help speed up drug development, while lessening the cost burden for sponsors. One area where CROs are putting that responsibility to the test is in early-stage development, particularly around smoothing the patches between first-in-human and proof-of concept studies, an admitted stumbling block for drugmakers now much more under gun to generate go/no-go decisions on their products sooner.
Early-stage CRO Cetero Research, for example, recently proclaimed success in using an innovative accelerated proof-of-concept design approach in Phase I and II trials. By combining single ascending dose, multiple ascending dose, and preliminary food effect trials into one study, Cetero says it cut study times by 50% and reduced costs by more than 10%.
The all-in-one design paid off in a recent allergy study Cetero conducted for a major pharmaceutical company. The program went from first patient, first visit, to top-line proof-of-concept results in just 16 weeks, instead of the 32-week average to run the trials separately, according to Cetero executives. In an accelerated proof-of-concept study for an obesity treatment, the time to top-line results was 12 weeks.
An editor of R&D Directions recently spoke with Cetero’s president of clinical operations, Graham Wood, Ph.D.
Accelerated POC studies sound difficult to pull off on the surface, so he explained how this approach works. “What the accelerated proof of concept allows us to do is to take all those studies from your first-in-human study all the way to your first proof-of-concept study and put them together,” says Dr. Wood. “In some examples, it’s going to be four studies put together; it could be five studies, it could be three. It really depends on the products. Each time the design is going to be different, because in each therapeutic area and each product, we’re going to have to approach it a little bit differently.”
Dr. Wood says the key overriding protocol is really the adaptive protocol. “So, as you go, you learn from what happened in Phase I of the protocol and you apply it to what you do in parts B, C, and D. It’s really learning as you go. The key last step is establishing that proof of concept to show, is this compound going to have success when it goes out into patients?” he says.
One of the keys in speed is the use electronic case report forms for these studies. Dr. Wood says, “Our staff enters the information into the report forms and sponsors can actually review them remotely on the Web. They can, as the data is coming in from the different groups, start looking at it right away to help them make decisions. These are adaptive designs – you are going to maybe change your dose, change different things about it before you go to the next [stage]. The sooner you can look at the data, the better informed your decision is. The electronic case report forms help us tremendously in doing that without affecting quality at all. It’s still QC’d, it still goes through the queries. It just gives that kind of instant access that the sponsors need.”
For research sponsors who clearly want to establish POC earlier in development, this approach to Phase I and II trials may be one avenue to consider. And beyond that, trying to add biomarkers for first-in-human studies and really get as much data as possible out of those. The ideal scenario is when you have a good validated biomarker, or you can go into patients with a really sound model to assess the symptoms.
For the clinical outsourcing provider, that means coming up with inventive and lasting solutions to help speed up drug development, while lessening the cost burden for sponsors. One area where CROs are putting that responsibility to the test is in early-stage development, particularly around smoothing the patches between first-in-human and proof-of concept studies, an admitted stumbling block for drugmakers now much more under gun to generate go/no-go decisions on their products sooner.
Early-stage CRO Cetero Research, for example, recently proclaimed success in using an innovative accelerated proof-of-concept design approach in Phase I and II trials. By combining single ascending dose, multiple ascending dose, and preliminary food effect trials into one study, Cetero says it cut study times by 50% and reduced costs by more than 10%.
The all-in-one design paid off in a recent allergy study Cetero conducted for a major pharmaceutical company. The program went from first patient, first visit, to top-line proof-of-concept results in just 16 weeks, instead of the 32-week average to run the trials separately, according to Cetero executives. In an accelerated proof-of-concept study for an obesity treatment, the time to top-line results was 12 weeks.
An editor of R&D Directions recently spoke with Cetero’s president of clinical operations, Graham Wood, Ph.D.
Accelerated POC studies sound difficult to pull off on the surface, so he explained how this approach works. “What the accelerated proof of concept allows us to do is to take all those studies from your first-in-human study all the way to your first proof-of-concept study and put them together,” says Dr. Wood. “In some examples, it’s going to be four studies put together; it could be five studies, it could be three. It really depends on the products. Each time the design is going to be different, because in each therapeutic area and each product, we’re going to have to approach it a little bit differently.”
Dr. Wood says the key overriding protocol is really the adaptive protocol. “So, as you go, you learn from what happened in Phase I of the protocol and you apply it to what you do in parts B, C, and D. It’s really learning as you go. The key last step is establishing that proof of concept to show, is this compound going to have success when it goes out into patients?” he says.
One of the keys in speed is the use electronic case report forms for these studies. Dr. Wood says, “Our staff enters the information into the report forms and sponsors can actually review them remotely on the Web. They can, as the data is coming in from the different groups, start looking at it right away to help them make decisions. These are adaptive designs – you are going to maybe change your dose, change different things about it before you go to the next [stage]. The sooner you can look at the data, the better informed your decision is. The electronic case report forms help us tremendously in doing that without affecting quality at all. It’s still QC’d, it still goes through the queries. It just gives that kind of instant access that the sponsors need.”
For research sponsors who clearly want to establish POC earlier in development, this approach to Phase I and II trials may be one avenue to consider. And beyond that, trying to add biomarkers for first-in-human studies and really get as much data as possible out of those. The ideal scenario is when you have a good validated biomarker, or you can go into patients with a really sound model to assess the symptoms.
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