Social Entrepreneurship
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Social Entrepreneurship
Entrepreneurship Development
Social Entrepreneurship Defined
The work of a social entrepreneur. A social entrepreneur: Someone who recognizes a social problem and uses entrepreneurial principles to organize, create, and manage a venture to make social change. Whereas business entrepreneurs typically measure performance in profit and return, social entrepreneurs assess their success in terms of the impact they have on society. While social entrepreneurs often work through nonprofits and citizen groups, many work in the private and governmental sectors.
Social Entrepreneurship Defined
From the 1950s to the 1990s Michael Young was a leading promoter of social enterprise And in the 1980s was described by Professor Daniel Bell at Harvard as 'the world's most successful entrepreneur of social enterprises' because of His role in creating over 60 new organizations worldwide, including a series of Schools for Social Entrepreneurs in the UK.
Social Entrepreneurship Defined
A list of a few historically noteworthy people whose work exemplifies classic "social entrepreneurship" might include Florence Nightingale, founder of the first nursing school and developer of modern nursing practices, Robert Owen, founder of the cooperative movement and Vinoba Bhave, the founder of India's Land Gift Movement, etc.
A Face of Social Entrepreneurship
Mohd. Yunus Nobel 2K6 Awardee Founder, Grameen Bank, Bangladesh Father of Micro credit
Victoria Hale
She established her expertise in all stages of biopharmaceutical drug development at the USFDA, Center for Drug Evaluation and Research; and At Genentech, Inc., the world's first biotechnology company. An Adjunct Associate Professorship in Biopharmaceutical Sciences at the University of California, San Francisco (UCSF), An Advisor to the World Health Organization (WHO) for building ethical review capacity in the developing world, And has served as an expert reviewer to the National Institutes of Health (NIH) on the topic of biodiversity.
Victoria Hale
Ashoka Fellow by Ashoka for work in leading social innovation (2006), Executive of the Year by Esquire Magazine (2005), The Economist Innovation Award for Social and Economic Innovation (2005), and The Skoll Award for Social Entrepreneurship from the Skoll Foundation (2005). Named one of the “Most Outstanding Social Entrepreneurs” by the Schwab Foundation for Social Entrepreneurship in Switzerland (2004). In 2004, Dr. Hale and OneWorld Health were included in the Scientific American 50, the magazine’s annual list recognizing outstanding acts of leadership in science and technology.
Victoria Hale
A pharmaceutical scientist who became increasingly frustrated by the market forces dominating her industry. Although big pharmaceutical companies held patents for drugs capable of curing any number of infectious diseases, the drugs went undeveloped for a simple reason: The populations most in need of the drugs were unable to afford them. Driven by the exigency of generating financial profits for its shareholders, the pharmaceutical industry was focusing on creating and marketing drugs for diseases afflicting the well-off, living mostly in developed world markets, who could pay for them.
Victoria Hale
Hale became determined to challenge this stable equilibrium, which she saw as unjust and intolerable. OneWorld Health, the first nonprofit pharmaceutical company whose mission is to ensure that drugs targeting infectious diseases in the developing world get to the people who need them, regardless of their ability to pay for the drugs. Hale’s venture has now moved beyond the proof-ofconcept stage. It successfully developed, tested, and secured Indian government regulatory approval for its first drug, paromomycin, which provides a cost-effective cure for visceral leishmaniasis, a disease that kills more than 200,000 people each year.
Many Early Battles
Dr. Hale first set her sights on the drug after she attended a conference in Belgium in 1999, where Dr. Shyam Sundar, an expert on black fever, was railing against the world’s failure to fight the disease. “The tragedy, maybe even the crime, is that we have known that this drug is an effective treatment for kala azar since the 1960’s,” said Dr. Sundar, whose free clinic in Muzaffarpur was also a site for a trial by OneWorld Health. “We could do something, but we were choosing not to.”
Many Early Battles
After visiting Dr. Sundar’s clinic in 2000, Dr. Hale, (doing consulting work at the time), hired a law firm to help her get the tax exemption necessary to create a nonprofit drug company. The I.R.S. turned her down three times over 10 months, suspicious that her plan was a scheme by the drug industry to shelter profits. The tax agency challenged her to find an example of an existing charity that mirrored a for-profit business. “It took me five days, and then at dinner, it hit me: N.P.R. and public television,” she said. “They look an awful lot like for-profit radio and television, but they serve a different audience with programs that their for-profit counterparts don’t provide because they can’t profit from them.” Two weeks later, OneWorld Health received I.R.S. approval and set out to tackle black fever.
Many Early Battles
The immediate challenge was financing. Initially, survived on the largesse of. Hale and her husband, Dr. Ahvie Herskowitz. They put up $100,000, signed a $315,000 promissory note, used the ground floor of their house as offices, and worked without pay for two years. The Gates foundation, which at the time was primarily underwriting vaccines and other preventive strategies, eventually offered a grant of $4.2 million that grew to $47.2 million for the development of paromomycin. Dr. Hale also got help from others, including the Skoll Foundation, which has provided financing to underwrite salaries for new senior executives.
Many Early Battles
An initial, formal test of paromomycin, an antibiotic sold in some countries as an oral treatment for diarrhea and as a topical treatment for cutaneous leishmaniasis, which causes lesions, was done in the late 1980’s in Africa, two decades after it was identified as a simple, cheap, effective cure for black fever. Through a series of company mergers it was consigned to the corporate shelf and forgotten, ending up with the WHO, which lacked the money to develop it beyond the Phase II clinical trials. But negotiations with the WHO to hand over the data that would allow OneWorld Health to organize the Phase III clinical trials necessary for regulatory approval dragged on for almost two years.
Commerce came in the way
At the time, the W.H.O was developing another drug for black fever with Zentaris, a large pharmaceutical company, and the Indian government. That drug, miltefosine, has the advantage of being an oral treatment, while paromomycin is administered by injection. But miltefosine, an anticancer drug, also has drawbacks. In trials, it caused gastrointestinal problems in one-third of the patients. And patients must be strictly supervised to ensure that they take the full 21-day course of treatment. By contrast, paromomycin has shown almost no side effects in trials. Source: http://www.oneworldhealth.org/media/details.php?prID=152
Commerce came in the way
With a price of $100 to $200 a treatment, miltefosine is out of reach for most patients and government purchasing programs. Dr. T. K. Jha, a specialist in black fever who oversaw one of the OneWorld Health trials, said the W.H.O. wanted to make sure miltefosine made it onto the market before handing over its data on paromomycin. Dr. Robert G. Ridley, director of the W.H.O.’s special program for research and training in tropical diseases, disputed that. Dr. Ridley wrote in an e-mail message that the “time lag” had to do with getting financing from the Gates foundation and the process of negotiating an agreement with OneWorld Health. Source: http://www.oneworldhealth.org/media/details.php?prID=152
Non-profit vs. for-profit cousins
The subject of the commercial aspects of drugs is a difficult one for OneWorld Health, which is careful to avoid criticism of its for-profit cousins, as well as competition with them. But given the choice of paying more than $100 for Zentaris’s miltefosine or $10 for paromomycin, governments and most patients will no doubt choose the cheaper drug.
Still more difficulties
Distribution as the next hurdle. Getting paromomycin to remote villages at the end of pothole-pocked roads is difficult. Dr. Hale is trying to enlist a British nonprofit group, Riders for Health, to help. The group uses motorcycles to connect poor people to medical services. In Zimbabwe, for instance, it has taken pregnant women in need of Caesarean sections to hospitals. But first, the Bihar State government and India’s central government must create a system that encompasses diagnosing the disease, buying and administering the drug, keeping records and spraying to reduce the sand fly population.
Hale & Gates Foundation join
Hale’s goal falls directly in line with the Gates Foundation's mission to bring innovations in health and learning to the global community. Hale approached the Gates Foundation for funding in 2001. Her "risky new venture," according to the foundation, was predicated on unused intellectual property and creating innovative opportunities. Her premise was to resurrect expired drug patents and recycle abandoned research and development on drugs to treat tropical parasitic diseases such as malaria, diarrhea, Chagas and visceral leishmaniasis (Kala Azar or Black Fever) —deadly infectious diseases that disproportionately affect people in developing countries.
Victoria Hale
First, Hale has identified a stable but unjust equilibrium in the pharmaceutical industry; Second, she has seen and seized the opportunity to intervene, applying inspiration, creativity, direct action, and courage in launching a new venture to provide options for a disadvantaged population; and Third, she is demonstrating fortitude in proving the potential of her model with an early success. Time will tell whether Hale’s innovation inspires others to replicate her efforts, or whether the Institute for OneWorld Health itself achieves the scale necessary to bring about that permanent equilibrium shift. But the signs are promising.
Business Model – An Overview
Assemble an experienced and dedicated team of pharmaceutical scientists. Identify the most promising drug and vaccine candidates. Develop them into safe, effective and affordable medicines. Then partner with companies, non-profit hospitals and organizations in the developing world to conduct medical research on new cures, manufacture and distribute newly approved therapies that will impact the health of millions of people. Source: http://www.oneworldhealth.org/business/index.php
Business Model – An Overview
Extraordinary opportunities, inspired solutions
Business Model – An Overview
Challenge the assumption that pharmaceutical research and development is too expensive to create the new medicines that the developing world desperately needs. By partnering and collaborating with industry and researchers, by securing donated intellectual property, and by utilizing the scientific and manufacturing capacity of the developing world, OneWorld Health can deliver affordable, effective and appropriate new medicines where they are needed most.
Core Strengths of OneWorld Health
Core capacities lie in pharmaceutical product development. Scientific expertise extends from drug and vaccine lead identification and optimization to conducting clinical trials and securing regulatory approval of new medicines for patients in the developing world. Scientific efforts are guided by a mission that ensures their products are safe, effective and affordable for the populations they serve. In collaboration with hospitals in the US and abroad, it fills the huge gap in the development of new medicines – that is, bringing promising drug and vaccine research from the lab into the clinic and onto regulatory approval and manufacturing.
A Non-Profit Model for Drug Development
OneWorld Health was founded to address the wide gulf between human need, scientific effort and the marketplace. Created a nonprofit model to achieve outcomes that would otherwise not be achievable. And to do so in a spirit of partnership and collaboration that capitalizes on the specific talents and resources that each participant can bring to this essential scientific endeavor.
A model that benefits industry and enhances their commitment to global health
Serves as a global development partner, taking responsibility for markets in the least developed countries (dual market opportunities). Obtains resources from private foundations and governments to fund the development costs of taking a new drug through to market in the developing world. Provides international regulatory expertise to increase the number of countries in which an important new drug is marketed. Provides a tax deduction for the projected future value of donated intellectual property such as licenses and patents [as a US 501(c)(3) nonprofit corporation]. Accepts responsibility for studying challenging patient subpopulations that would otherwise not be studied (e.g., infants and pregnant women). Creates a viable path for off-patent drugs which otherwise would not be pursued for any new uses.
A model that benefits academia as well as the government
University and government researchers produce exciting new leads for tropical infectious disease, only to be discouraged by the lack of outlets to advance their research into development. Provides the bridge between novel bench science and its conversion to applications for the developing world. Advocates to government and foundation funders in support of specific basic research that will later become new drug development projects. Advisors can advise academicians in translational science. A bridge between academia and industry, advocating for access to key industry resources, such as chemical libraries or specific assay reagents.
A model that benefits the developing world
The developing world is not only a beneficiary, but also a tremendous resource that is often disregarded in new drug development. Work with developing country partners in clinical trials, pharmaceutical manufacturing, and distribution of new medicines for neglected diseases. Advocates for increased funding for academic laboratories in the developing world and build capacity by training health care workers and scientists in clinical drug development through each of their projects. Actively transfer knowledge and technology to improve local efforts to address disease threats. All of this work simultaneously fosters new avenues of economic development.
A unique set of partnerships and investments
Pharmaceutical and biotechnology companies find an appealing outlet for idle intellectual property. Pharmaceutical scientists, drawn to a mission of saving lives and improving health worldwide, are eager to participate in groundbreaking and compassionate research and development. International health advocates including governments, nongovernment organizations (NGOs), hospitals in the US and abroad, welcome a powerful new ally for improving global health. And investors and donors recognize a strategic and pioneering investment in the health of millions of people.
Challenges Ahead
Navigating bureaucracies and garnering support from governments and international organizations can be challenging. Funding: To date, the Gates Foundation has been the largest donor to OneWorld Health, providing 96 percent of its funding. Other foundation contributors include Artemis, Chiron, Lehman Brothers, Pfizer, Vital Spark, Gap, Amgen, and Skoll (founded by Jeff Skoll, the first president of eBay). And the John D. and Catherine T. MacArthur Foundation awarded Ms. Hale an unrestricted, five-year $500,000 fellowship.
Challenges Ahead
Accountability: Gates’ Foundation brings attention to organizations like OneWorld Health by highlighting them as case studies on their website. Hale: “Open and frank about what we're learning from our grantmaking — what is working, and what isn't." Keeping public and private funders aware of their findings is helpful not only for current project accountability, but also for future grantmaking.
Hale to step down in 2K7 itself as CEO
To continue in her role as Chair of the Board of Directors and will focus on the long-term strategic direction and governance of the organization while pursuing broader engagement with industry and social entrepreneurs around global health.
Press Release: Sept. 27, 2007 on Oneworld.org
Distinguish Social Entrepreneurship from other socially valuable activities such as
Social Service Provision And Social Activism
Distinguish from other socially valuable activities
Social Service Provision
In this case, a courageous and committed individual identifies an unfortunate stable equilibrium – AIDS orphans in Africa, for example – and sets up a program to address it – for example, a school for the children to ensure that they are cared for and educated. The new school would certainly help the children it serves and may very well enable some of them to break free from poverty and transform their lives. But unless it is designed to achieve large scale or is so compelling as to launch legions of imitators and replicators, it is not likely to lead to a new superior equilibrium.
Distinguish from other socially valuable activities
Social Service Provision
These types of social service ventures never break out of their limited frame: Their impact remains constrained, their service area stays confined to a local population, and their scope is determined by whatever resources they are able to attract. These ventures are inherently vulnerable, which may mean disruption or loss of service to the populations they serve. Millions of such organizations exist around the world – well intended, noble in purpose, and frequently exemplary in execution – but they should not be confused with social entrepreneurship Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Distinguish from other socially valuable activities Social Service Provision
The difference isn’t in the initial entrepreneurial contexts or in many of the personal characteristics of the founders, but rather in the outcomes. Imagine that Andrew Carnegie had built only one library rather than conceiving the public library system that today serves untold millions of American citizens. Carnegie’s single library would have clearly benefited the community it served. But it was his vision of an entire system of libraries creating a permanent new equilibrium – one ensuring access to information and knowledge for all the nation’s citizens – that anchors his reputation as a social entrepreneur.
Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Distinguish from other socially valuable activities
Social Activism In this case, the motivator of the activity is the same – an unfortunate and stable equilibrium. And several aspects of the actor’s characteristics are the same – inspiration, creativity, courage, and fortitude. What is different is the nature of the actor’s action orientation. Instead of taking direct action, as the social entrepreneur would, the social activist attempts to create change through indirect action, by influencing others – governments, NGOs, consumers, workers, etc. – to take action. Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Distinguish from other socially valuable activities
Social Activism
Social activists may or may not create ventures or organizations to advance the changes they seek. Successful activism can yield substantial improvements to existing systems and even result in a new equilibrium, But the strategic nature of the action is distinct in its emphasis on influence rather than on direct action.
Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Reminds something!
Source: http://nssdc.gsfc.nasa.gov/planetary/lunar/apollo11.html
Edwin Aldrin: “We feel this stands as a symbol of the insatiable curiousity of all mankind to explore the unknown”. Neil Armstrong: “That's one small step for man, one giant leap for mankind”.
NASA mooned America! By R. Rene
Moon's surface has no moisture whatever. So why do we see boot prints where the astronauts have walked? You've walked in dry dirt and sand. It takes moisture to hold a print. NASA never put a man on the moon; that the whole Apollo saga was just a Hollywood-like production done with the help of the CIA. The surface of the moon is 243øF in the sun and for the two weeks of night. Our astronauts were just there in the daylight, so they were dealing with an environment that was around 250ø, with nowhere near enough power to run the cooling system needed to deal with that.
NASA mooned America! By R. Rene
Government has produced a $40 billion space opera. One photo in the book of Aldrin and Armstrong saluting the flag, where they claim the sun is at about 130, but Aldrin's photo was taken when the sun was at 26.4ø and Armstrong's was taken with the sun at 34.9ø, if one goes by the shadows they cast. Worse, the shadows are in two different directions, and the flag casts no shadow at all. And those who caused any problems were killed! Did the "accidents" which killed 11 astronauts in 1967 raise any questions in your mind? The Apollo mission data is still highly classified.
Forms of Social Engagement
In the real world
There are probably more hybrid models than pure forms. It is arguable that Yunus, for example, used social activism to accelerate and amplify the impact of Grameen Bank, a classic example of social entrepreneurship. By using a sequential hybrid – social entrepreneurship followed by social activism – Yunus turned microcredit into a global force for change. Other organizations are hybrids using both social entrepreneurship and social activism at the same time. Standards-setting or certification organizations are an example of this. Although the actions of the standards-setting organization itself do not create societal change – those who are encouraged or forced to abide by the standards take the actions that produce the actual societal change.
Kailash Satyarthi and RugMark: An example of Hybrid Model
Recognizing the inherent limitations of his work to rescue children enslaved in India’s rug-weaving trade, Satyarthi set his sights on the carpet-weaving industry. By creating the RugMark certification program and a public relations campaign designed to educate consumers who unwittingly perpetuate an unjust equilibrium, Satyarthi leveraged his effectiveness as a service provider by embracing the indirect strategy of the activist. Purchasing a carpet that has the RugMark label assures buyers that their carpet has been created without child slavery and under fair labor conditions. Educate enough of those prospective buyers, he reasoned, and one has a shot at transforming the entire carpet-weaving industry.
From Business Entrepreneurship to Social Entrepreneurship
Long shunned by economists, whose interests have gravitated toward market-based, price-driven models that submit more readily to data-driven interpretation, entrepreneurship has experienced something of a renaissance of interest in recent years. Building on the foundation laid by Schumpeter, William Baumol and a handful of other scholars have sought to restore the entrepreneur’s rightful place in “production and distribution” theory, demonstrating in that process the seminal (determining, influential, decisive) role of entrepreneurship. Social entrepreneurship, is as vital to the progress of societies as is entrepreneurship to the progress of economies, and it merits more rigorous, serious attention than it has attracted so far.
A social entrepreneur should be
Understood as someone who targets an unfortunate but stable equilibrium that causes the neglect, marginalization, or suffering of a segment of humanity; Who brings to bear on this situation his or her inspiration, direct action, creativity, courage, and fortitude; and Who aims for and ultimately affects the establishment of a new stable equilibrium that secures permanent benefit for the targeted group and society at large.
Our Time is Now: Young People Changing the World
The book contains the stories of more than thirty young people in over twenty countries who are taking action to contribute to their local and global communities. Spotlights the efforts of young leaders who are addressing a host of urgent global challenges: poverty, violence, racism, environmental destruction, and civic apathy, to name only a few. Challenge, adventure, serious work and creative fun. Strategies that help ensure the success of an initiative while reflecting on the rich personal rewards of giving back. Source: http://www.pearsonfoundation.org/IYF/ourtimeisnow//
Entrepreneurship Development
Social Entrepreneurship Defined
The work of a social entrepreneur. A social entrepreneur: Someone who recognizes a social problem and uses entrepreneurial principles to organize, create, and manage a venture to make social change. Whereas business entrepreneurs typically measure performance in profit and return, social entrepreneurs assess their success in terms of the impact they have on society. While social entrepreneurs often work through nonprofits and citizen groups, many work in the private and governmental sectors.
Social Entrepreneurship Defined
From the 1950s to the 1990s Michael Young was a leading promoter of social enterprise And in the 1980s was described by Professor Daniel Bell at Harvard as 'the world's most successful entrepreneur of social enterprises' because of His role in creating over 60 new organizations worldwide, including a series of Schools for Social Entrepreneurs in the UK.
Social Entrepreneurship Defined
A list of a few historically noteworthy people whose work exemplifies classic "social entrepreneurship" might include Florence Nightingale, founder of the first nursing school and developer of modern nursing practices, Robert Owen, founder of the cooperative movement and Vinoba Bhave, the founder of India's Land Gift Movement, etc.
A Face of Social Entrepreneurship
Mohd. Yunus Nobel 2K6 Awardee Founder, Grameen Bank, Bangladesh Father of Micro credit
Victoria Hale
She established her expertise in all stages of biopharmaceutical drug development at the USFDA, Center for Drug Evaluation and Research; and At Genentech, Inc., the world's first biotechnology company. An Adjunct Associate Professorship in Biopharmaceutical Sciences at the University of California, San Francisco (UCSF), An Advisor to the World Health Organization (WHO) for building ethical review capacity in the developing world, And has served as an expert reviewer to the National Institutes of Health (NIH) on the topic of biodiversity.
Victoria Hale
Ashoka Fellow by Ashoka for work in leading social innovation (2006), Executive of the Year by Esquire Magazine (2005), The Economist Innovation Award for Social and Economic Innovation (2005), and The Skoll Award for Social Entrepreneurship from the Skoll Foundation (2005). Named one of the “Most Outstanding Social Entrepreneurs” by the Schwab Foundation for Social Entrepreneurship in Switzerland (2004). In 2004, Dr. Hale and OneWorld Health were included in the Scientific American 50, the magazine’s annual list recognizing outstanding acts of leadership in science and technology.
Victoria Hale
A pharmaceutical scientist who became increasingly frustrated by the market forces dominating her industry. Although big pharmaceutical companies held patents for drugs capable of curing any number of infectious diseases, the drugs went undeveloped for a simple reason: The populations most in need of the drugs were unable to afford them. Driven by the exigency of generating financial profits for its shareholders, the pharmaceutical industry was focusing on creating and marketing drugs for diseases afflicting the well-off, living mostly in developed world markets, who could pay for them.
Victoria Hale
Hale became determined to challenge this stable equilibrium, which she saw as unjust and intolerable. OneWorld Health, the first nonprofit pharmaceutical company whose mission is to ensure that drugs targeting infectious diseases in the developing world get to the people who need them, regardless of their ability to pay for the drugs. Hale’s venture has now moved beyond the proof-ofconcept stage. It successfully developed, tested, and secured Indian government regulatory approval for its first drug, paromomycin, which provides a cost-effective cure for visceral leishmaniasis, a disease that kills more than 200,000 people each year.
Many Early Battles
Dr. Hale first set her sights on the drug after she attended a conference in Belgium in 1999, where Dr. Shyam Sundar, an expert on black fever, was railing against the world’s failure to fight the disease. “The tragedy, maybe even the crime, is that we have known that this drug is an effective treatment for kala azar since the 1960’s,” said Dr. Sundar, whose free clinic in Muzaffarpur was also a site for a trial by OneWorld Health. “We could do something, but we were choosing not to.”
Many Early Battles
After visiting Dr. Sundar’s clinic in 2000, Dr. Hale, (doing consulting work at the time), hired a law firm to help her get the tax exemption necessary to create a nonprofit drug company. The I.R.S. turned her down three times over 10 months, suspicious that her plan was a scheme by the drug industry to shelter profits. The tax agency challenged her to find an example of an existing charity that mirrored a for-profit business. “It took me five days, and then at dinner, it hit me: N.P.R. and public television,” she said. “They look an awful lot like for-profit radio and television, but they serve a different audience with programs that their for-profit counterparts don’t provide because they can’t profit from them.” Two weeks later, OneWorld Health received I.R.S. approval and set out to tackle black fever.
Many Early Battles
The immediate challenge was financing. Initially, survived on the largesse of. Hale and her husband, Dr. Ahvie Herskowitz. They put up $100,000, signed a $315,000 promissory note, used the ground floor of their house as offices, and worked without pay for two years. The Gates foundation, which at the time was primarily underwriting vaccines and other preventive strategies, eventually offered a grant of $4.2 million that grew to $47.2 million for the development of paromomycin. Dr. Hale also got help from others, including the Skoll Foundation, which has provided financing to underwrite salaries for new senior executives.
Many Early Battles
An initial, formal test of paromomycin, an antibiotic sold in some countries as an oral treatment for diarrhea and as a topical treatment for cutaneous leishmaniasis, which causes lesions, was done in the late 1980’s in Africa, two decades after it was identified as a simple, cheap, effective cure for black fever. Through a series of company mergers it was consigned to the corporate shelf and forgotten, ending up with the WHO, which lacked the money to develop it beyond the Phase II clinical trials. But negotiations with the WHO to hand over the data that would allow OneWorld Health to organize the Phase III clinical trials necessary for regulatory approval dragged on for almost two years.
Commerce came in the way
At the time, the W.H.O was developing another drug for black fever with Zentaris, a large pharmaceutical company, and the Indian government. That drug, miltefosine, has the advantage of being an oral treatment, while paromomycin is administered by injection. But miltefosine, an anticancer drug, also has drawbacks. In trials, it caused gastrointestinal problems in one-third of the patients. And patients must be strictly supervised to ensure that they take the full 21-day course of treatment. By contrast, paromomycin has shown almost no side effects in trials. Source: http://www.oneworldhealth.org/media/details.php?prID=152
Commerce came in the way
With a price of $100 to $200 a treatment, miltefosine is out of reach for most patients and government purchasing programs. Dr. T. K. Jha, a specialist in black fever who oversaw one of the OneWorld Health trials, said the W.H.O. wanted to make sure miltefosine made it onto the market before handing over its data on paromomycin. Dr. Robert G. Ridley, director of the W.H.O.’s special program for research and training in tropical diseases, disputed that. Dr. Ridley wrote in an e-mail message that the “time lag” had to do with getting financing from the Gates foundation and the process of negotiating an agreement with OneWorld Health. Source: http://www.oneworldhealth.org/media/details.php?prID=152
Non-profit vs. for-profit cousins
The subject of the commercial aspects of drugs is a difficult one for OneWorld Health, which is careful to avoid criticism of its for-profit cousins, as well as competition with them. But given the choice of paying more than $100 for Zentaris’s miltefosine or $10 for paromomycin, governments and most patients will no doubt choose the cheaper drug.
Still more difficulties
Distribution as the next hurdle. Getting paromomycin to remote villages at the end of pothole-pocked roads is difficult. Dr. Hale is trying to enlist a British nonprofit group, Riders for Health, to help. The group uses motorcycles to connect poor people to medical services. In Zimbabwe, for instance, it has taken pregnant women in need of Caesarean sections to hospitals. But first, the Bihar State government and India’s central government must create a system that encompasses diagnosing the disease, buying and administering the drug, keeping records and spraying to reduce the sand fly population.
Hale & Gates Foundation join
Hale’s goal falls directly in line with the Gates Foundation's mission to bring innovations in health and learning to the global community. Hale approached the Gates Foundation for funding in 2001. Her "risky new venture," according to the foundation, was predicated on unused intellectual property and creating innovative opportunities. Her premise was to resurrect expired drug patents and recycle abandoned research and development on drugs to treat tropical parasitic diseases such as malaria, diarrhea, Chagas and visceral leishmaniasis (Kala Azar or Black Fever) —deadly infectious diseases that disproportionately affect people in developing countries.
Victoria Hale
First, Hale has identified a stable but unjust equilibrium in the pharmaceutical industry; Second, she has seen and seized the opportunity to intervene, applying inspiration, creativity, direct action, and courage in launching a new venture to provide options for a disadvantaged population; and Third, she is demonstrating fortitude in proving the potential of her model with an early success. Time will tell whether Hale’s innovation inspires others to replicate her efforts, or whether the Institute for OneWorld Health itself achieves the scale necessary to bring about that permanent equilibrium shift. But the signs are promising.
Business Model – An Overview
Assemble an experienced and dedicated team of pharmaceutical scientists. Identify the most promising drug and vaccine candidates. Develop them into safe, effective and affordable medicines. Then partner with companies, non-profit hospitals and organizations in the developing world to conduct medical research on new cures, manufacture and distribute newly approved therapies that will impact the health of millions of people. Source: http://www.oneworldhealth.org/business/index.php
Business Model – An Overview
Extraordinary opportunities, inspired solutions
Business Model – An Overview
Challenge the assumption that pharmaceutical research and development is too expensive to create the new medicines that the developing world desperately needs. By partnering and collaborating with industry and researchers, by securing donated intellectual property, and by utilizing the scientific and manufacturing capacity of the developing world, OneWorld Health can deliver affordable, effective and appropriate new medicines where they are needed most.
Core Strengths of OneWorld Health
Core capacities lie in pharmaceutical product development. Scientific expertise extends from drug and vaccine lead identification and optimization to conducting clinical trials and securing regulatory approval of new medicines for patients in the developing world. Scientific efforts are guided by a mission that ensures their products are safe, effective and affordable for the populations they serve. In collaboration with hospitals in the US and abroad, it fills the huge gap in the development of new medicines – that is, bringing promising drug and vaccine research from the lab into the clinic and onto regulatory approval and manufacturing.
A Non-Profit Model for Drug Development
OneWorld Health was founded to address the wide gulf between human need, scientific effort and the marketplace. Created a nonprofit model to achieve outcomes that would otherwise not be achievable. And to do so in a spirit of partnership and collaboration that capitalizes on the specific talents and resources that each participant can bring to this essential scientific endeavor.
A model that benefits industry and enhances their commitment to global health
Serves as a global development partner, taking responsibility for markets in the least developed countries (dual market opportunities). Obtains resources from private foundations and governments to fund the development costs of taking a new drug through to market in the developing world. Provides international regulatory expertise to increase the number of countries in which an important new drug is marketed. Provides a tax deduction for the projected future value of donated intellectual property such as licenses and patents [as a US 501(c)(3) nonprofit corporation]. Accepts responsibility for studying challenging patient subpopulations that would otherwise not be studied (e.g., infants and pregnant women). Creates a viable path for off-patent drugs which otherwise would not be pursued for any new uses.
A model that benefits academia as well as the government
University and government researchers produce exciting new leads for tropical infectious disease, only to be discouraged by the lack of outlets to advance their research into development. Provides the bridge between novel bench science and its conversion to applications for the developing world. Advocates to government and foundation funders in support of specific basic research that will later become new drug development projects. Advisors can advise academicians in translational science. A bridge between academia and industry, advocating for access to key industry resources, such as chemical libraries or specific assay reagents.
A model that benefits the developing world
The developing world is not only a beneficiary, but also a tremendous resource that is often disregarded in new drug development. Work with developing country partners in clinical trials, pharmaceutical manufacturing, and distribution of new medicines for neglected diseases. Advocates for increased funding for academic laboratories in the developing world and build capacity by training health care workers and scientists in clinical drug development through each of their projects. Actively transfer knowledge and technology to improve local efforts to address disease threats. All of this work simultaneously fosters new avenues of economic development.
A unique set of partnerships and investments
Pharmaceutical and biotechnology companies find an appealing outlet for idle intellectual property. Pharmaceutical scientists, drawn to a mission of saving lives and improving health worldwide, are eager to participate in groundbreaking and compassionate research and development. International health advocates including governments, nongovernment organizations (NGOs), hospitals in the US and abroad, welcome a powerful new ally for improving global health. And investors and donors recognize a strategic and pioneering investment in the health of millions of people.
Challenges Ahead
Navigating bureaucracies and garnering support from governments and international organizations can be challenging. Funding: To date, the Gates Foundation has been the largest donor to OneWorld Health, providing 96 percent of its funding. Other foundation contributors include Artemis, Chiron, Lehman Brothers, Pfizer, Vital Spark, Gap, Amgen, and Skoll (founded by Jeff Skoll, the first president of eBay). And the John D. and Catherine T. MacArthur Foundation awarded Ms. Hale an unrestricted, five-year $500,000 fellowship.
Challenges Ahead
Accountability: Gates’ Foundation brings attention to organizations like OneWorld Health by highlighting them as case studies on their website. Hale: “Open and frank about what we're learning from our grantmaking — what is working, and what isn't." Keeping public and private funders aware of their findings is helpful not only for current project accountability, but also for future grantmaking.
Hale to step down in 2K7 itself as CEO
To continue in her role as Chair of the Board of Directors and will focus on the long-term strategic direction and governance of the organization while pursuing broader engagement with industry and social entrepreneurs around global health.
Press Release: Sept. 27, 2007 on Oneworld.org
Distinguish Social Entrepreneurship from other socially valuable activities such as
Social Service Provision And Social Activism
Distinguish from other socially valuable activities
Social Service Provision
In this case, a courageous and committed individual identifies an unfortunate stable equilibrium – AIDS orphans in Africa, for example – and sets up a program to address it – for example, a school for the children to ensure that they are cared for and educated. The new school would certainly help the children it serves and may very well enable some of them to break free from poverty and transform their lives. But unless it is designed to achieve large scale or is so compelling as to launch legions of imitators and replicators, it is not likely to lead to a new superior equilibrium.
Distinguish from other socially valuable activities
Social Service Provision
These types of social service ventures never break out of their limited frame: Their impact remains constrained, their service area stays confined to a local population, and their scope is determined by whatever resources they are able to attract. These ventures are inherently vulnerable, which may mean disruption or loss of service to the populations they serve. Millions of such organizations exist around the world – well intended, noble in purpose, and frequently exemplary in execution – but they should not be confused with social entrepreneurship Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Distinguish from other socially valuable activities Social Service Provision
The difference isn’t in the initial entrepreneurial contexts or in many of the personal characteristics of the founders, but rather in the outcomes. Imagine that Andrew Carnegie had built only one library rather than conceiving the public library system that today serves untold millions of American citizens. Carnegie’s single library would have clearly benefited the community it served. But it was his vision of an entire system of libraries creating a permanent new equilibrium – one ensuring access to information and knowledge for all the nation’s citizens – that anchors his reputation as a social entrepreneur.
Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Distinguish from other socially valuable activities
Social Activism In this case, the motivator of the activity is the same – an unfortunate and stable equilibrium. And several aspects of the actor’s characteristics are the same – inspiration, creativity, courage, and fortitude. What is different is the nature of the actor’s action orientation. Instead of taking direct action, as the social entrepreneur would, the social activist attempts to create change through indirect action, by influencing others – governments, NGOs, consumers, workers, etc. – to take action. Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Distinguish from other socially valuable activities
Social Activism
Social activists may or may not create ventures or organizations to advance the changes they seek. Successful activism can yield substantial improvements to existing systems and even result in a new equilibrium, But the strategic nature of the action is distinct in its emphasis on influence rather than on direct action.
Source: Stanford Social Innovation Review, Spring 2007 (p.37)
Reminds something!
Source: http://nssdc.gsfc.nasa.gov/planetary/lunar/apollo11.html
Edwin Aldrin: “We feel this stands as a symbol of the insatiable curiousity of all mankind to explore the unknown”. Neil Armstrong: “That's one small step for man, one giant leap for mankind”.
NASA mooned America! By R. Rene
Moon's surface has no moisture whatever. So why do we see boot prints where the astronauts have walked? You've walked in dry dirt and sand. It takes moisture to hold a print. NASA never put a man on the moon; that the whole Apollo saga was just a Hollywood-like production done with the help of the CIA. The surface of the moon is 243øF in the sun and for the two weeks of night. Our astronauts were just there in the daylight, so they were dealing with an environment that was around 250ø, with nowhere near enough power to run the cooling system needed to deal with that.
NASA mooned America! By R. Rene
Government has produced a $40 billion space opera. One photo in the book of Aldrin and Armstrong saluting the flag, where they claim the sun is at about 130, but Aldrin's photo was taken when the sun was at 26.4ø and Armstrong's was taken with the sun at 34.9ø, if one goes by the shadows they cast. Worse, the shadows are in two different directions, and the flag casts no shadow at all. And those who caused any problems were killed! Did the "accidents" which killed 11 astronauts in 1967 raise any questions in your mind? The Apollo mission data is still highly classified.
Forms of Social Engagement
In the real world
There are probably more hybrid models than pure forms. It is arguable that Yunus, for example, used social activism to accelerate and amplify the impact of Grameen Bank, a classic example of social entrepreneurship. By using a sequential hybrid – social entrepreneurship followed by social activism – Yunus turned microcredit into a global force for change. Other organizations are hybrids using both social entrepreneurship and social activism at the same time. Standards-setting or certification organizations are an example of this. Although the actions of the standards-setting organization itself do not create societal change – those who are encouraged or forced to abide by the standards take the actions that produce the actual societal change.
Kailash Satyarthi and RugMark: An example of Hybrid Model
Recognizing the inherent limitations of his work to rescue children enslaved in India’s rug-weaving trade, Satyarthi set his sights on the carpet-weaving industry. By creating the RugMark certification program and a public relations campaign designed to educate consumers who unwittingly perpetuate an unjust equilibrium, Satyarthi leveraged his effectiveness as a service provider by embracing the indirect strategy of the activist. Purchasing a carpet that has the RugMark label assures buyers that their carpet has been created without child slavery and under fair labor conditions. Educate enough of those prospective buyers, he reasoned, and one has a shot at transforming the entire carpet-weaving industry.
From Business Entrepreneurship to Social Entrepreneurship
Long shunned by economists, whose interests have gravitated toward market-based, price-driven models that submit more readily to data-driven interpretation, entrepreneurship has experienced something of a renaissance of interest in recent years. Building on the foundation laid by Schumpeter, William Baumol and a handful of other scholars have sought to restore the entrepreneur’s rightful place in “production and distribution” theory, demonstrating in that process the seminal (determining, influential, decisive) role of entrepreneurship. Social entrepreneurship, is as vital to the progress of societies as is entrepreneurship to the progress of economies, and it merits more rigorous, serious attention than it has attracted so far.
A social entrepreneur should be
Understood as someone who targets an unfortunate but stable equilibrium that causes the neglect, marginalization, or suffering of a segment of humanity; Who brings to bear on this situation his or her inspiration, direct action, creativity, courage, and fortitude; and Who aims for and ultimately affects the establishment of a new stable equilibrium that secures permanent benefit for the targeted group and society at large.
Our Time is Now: Young People Changing the World
The book contains the stories of more than thirty young people in over twenty countries who are taking action to contribute to their local and global communities. Spotlights the efforts of young leaders who are addressing a host of urgent global challenges: poverty, violence, racism, environmental destruction, and civic apathy, to name only a few. Challenge, adventure, serious work and creative fun. Strategies that help ensure the success of an initiative while reflecting on the rich personal rewards of giving back. Source: http://www.pearsonfoundation.org/IYF/ourtimeisnow//
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