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Archive for November, 2011

Published on Dowser on November 29, 2011.  Read the original article here:

Directed at budding social entrepreneurs, Social Enterprise Bootcamp, a recent two day workshop organized by students at Columbia, NYU and the School of Visual Arts, offered practical advice from an impressive array of speakers. Here are a few of the key take-aways:

A social enterprise can change the world, but only a part of it.

Greg van Kirk, founder of the New Development Solutions Group and of the micro-consignment model, told participants, “Social entrepreneurship is when people tell you you’re crazy, that your idea will never take off, but you decide it’s important enough to do anyway.” With a lofty vision, deep conviction for your cause, and solid execution capability, almost anything is possible. At the same time, however, the best social enterprises know their limits. No business can change everything, van Kirk said, and businesses that attempt to do too much will inevitably fail. Instead, he advised participants to pick what they want to influence and do it well.

Expect bumps along the way.

Starting a business, especially a social enterprise, is not easy. The speakers, many of whom were social entrepreneurs themselves, had no qualms about sharing their past and current obstacles in getting their businesses off the ground. Joanna Opot of TerraCycle, for instance, discussed the challenges all businesses face as they begin to scale up, and mentioned some ways her business is currently trying to overcome them. Joyce Meng of Givology advised participants to “keep it cheap” for as long as possible, so as to survive the unavoidable growing pains. “Do you really need an office in the early stages?” she asked. Or will it make your business more likely to sink if something goes wrong?

Do what you love.

Keynote speaker Jeffrey Hollender of Seventh Generation spoke to the importance of “doing what you love.” The process of opening a social enterprise is difficult, he said, and without a deep commitment to your cause, it will be easy to find exit opportunities. He also discussed the importance of developing a strong mission and set of values. In many cases, he said, these intangibles are more important and longer lasting than the product.

Design your business around your consumer.

Design thinking, or “human-centered design,” is important for almost any social enterprise. Jeff Chapin of IDEO explained how design thinking goes far beyond the aesthetics of a product or service, and often requires re-engineering entire business models and processes to focus on the consumer. He gave the audience examples from the water and sanitation world, where design thinkers made water filters, latrines, and mobile toilet systems with the consumer’s needs and preferences in mind.

Don’t undervalue your product/service.

It is common for social entrepreneurs, especially new ones, to undervalue the novelty of their offerings, and therefore undercharge for them. To illustrate this point, Opot of TerraCycle told participants her own story. “When we started making partnerships, we found that everyone was interested in partnering with us,” she said. It’s exciting in the beginning, Opot said, but after a point, she realized the real reason for the interest was that their prices were too low. “When we hiked up our prices, nobody even blinked,” she said.

Dot your i’s and cross your t’s.

Without basic logistical details in place, even social enterprises with rock star leaders and revolutionary business models can fail. To avoid this, some workshops focused on the legal, financial, and other backend processes needed to bring businesses to success. Speakers gave advice on how to register their businesses, how to forecast financials, how to engage good lawyers, and more.

Reflect.

One session asked participants to put everything away and spend the next forty-five minutes simply reflecting on what they had learned. Some rolled their eyes and left the session (“this isn’t what I paid money for!”), smartphones in hand, but I heard very good feedback from those who sat through it. “We’ve learned so much this weekend,” one participant told me, “and we never take time to just sit and consider what it all means.”

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Published in Forbes on November 22, 2011. Read the original article here

My last post discussed the reasons why neglected diseases have historically been neglected, the growing efforts to eradicate them, and why pharmaceutical companies should develop more drugs for them.

Unfortunately, the traditional economics of drug development are stacked against neglected diseases, which disproportionally affect the world’s poorest populations. Drug development is a costly and time-consuming process, and even if a pharmaceutical company did develop a viable drug for a neglected disease, they would have virtually no way of recouping their investment.

Luckily, there are many other ways the private sector can address neglected diseases (which are defined here as the seventeen neglected tropical diseases, malaria, and tuberculosis). I spent last week speaking with top officials from pharmaceutical companies, research groups, and intellectual property organizations to understand what the for-profit pharmaceutical industry can realistically do to push research forward on these diseases. All of the solutions presented below have, importantly, already been tested in the real world.

Without further ado, here are – in no particular order – the top five ways Big Pharma can address neglected diseases.

1) Create cross-sectoral research partnerships for neglected diseases
Though pharmaceutical companies have generally shied away from independently developing drugs for neglected diseases, several are open to creating drugs with partners. Just this past Thursday, Novartis and collaborators, including Scripps Research Institute and Swiss Tropical and Public Health Institute, discovered a new dual-acting class of anti-malarial compounds. “It was a multi-disciplinary, multi-continental effort,” said Paul Herrling, head of corporate research at Novartis. “Each partner brought unique knowledge and skills needed to obtain the common goal.”

Other pharmaceutical companies have also created partnerships for neglected diseases. Sanofi has, for instance, partnered with non-profit drug developer DNDi to develop medicines for up to nine NTDs. GSK has similar partnerships with foundations including Medicines for Malaria and the Global Alliance for TB Drug Development. In most cases, the partnerships are funded through a combination of sources, including the private sector, government, and other donors.

Partnerships for neglected diseases appear to be on the rise across the pharmaceutical industry. The International Federation of Pharmaceutical Manufacturers and Association (IFPMA) found that partnerships for neglected diseases have increased five-fold from 2005, and that today, 80 percent of neglected disease research efforts are done through collaborations. Mario Ottiglio, Associate Director of Public Affairs and Global Health Policy at IFPMA, said, “[Partnerships are] basically a very pragmatic solution to address market failure in neglected diseases. Pharmaceutical companies bring adequate resources, while academia and government bring the epidemiological context.”

This does not mean, of course, that every research partnership is guaranteed to succeed. Scientifically speaking, neglected diseases are quite complicated and few efforts will yield positive results. Robert Sebbag, Vice President of Access to Medicines at Sanofi, also discussed how strong relationships are crucial to the success of a partnership. “Each partner has to respect and trust each other,” he said. “They must also have a common objective.” Without those fundamentals, he said, everyone will assume the worst in each other and the fruits of collaboration will be lost.

2) Join patent pools for neglected diseases.
Patent pools are created when two or more companies agree to cross-license certain products or technologies. Recognizing the need for shared progress in neglected diseases, the World Intellectual Property Organization (WIPO) and BIO Ventures for Global Health recently created a patent pool, WIPO Re:search, for neglected diseases. In addition to maintaining a searchable database of relevant intellectual property, it will also facilitate new research partnerships.

“Most pharmaceutical companies have some form of CSR programs. They also have intellectual property. This is basically an effort to put those two things together,” said Francis Gurry, Director General of WIPO.

Since it was only created this year, the potential of a patent pool is yet to be seen. However, Gurry has high hopes. “In the best case scenario,” he said, “[WIPO Re:search] will help create partnerships between public and private entities… which over a five or ten year period will create good candidates for products.”

Many pharmaceutical companies have responded positively to the effort, and seem generally willing to share intellectual property related to these unprofitable disease areas. Sebbag from Sanofi believes it is a “very good step forward” in neglected disease research, and a GSK spokesperson said the program was “a natural evolution” of existing efforts in the field.

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Published in Forbes on November 9, 2011. Read the original article here.

What do schistosomiasis, cysticercosis, and lymphatic filariasis have in common?

Besides verging on the unpronounceable, they are all classified as neglected tropical diseases (NTDs). NTDs are a set of diseases – seventeen, by the World Health Organization’s count – that collectively affect over a billion people, but have historically received little attention. The most common NTDs, including those listed above, are caused by parasitic worms or protozoa. Others, such as leprosy and trachoma, are the result of bacterial or viral infections.

Though caused by a range of pathogens, NTDs share some important characteristics. First, many are diseases of rural poverty. Most neglected diseases affect the poor in the developing world, particularly in Africa and Asia, but some have also been found in “pockets of poverty” in the United States. For instance, hundreds of thousands of Americans, most of whom are Hispanic immigrants, suffer from Chagas disease. Second, most NTDs cause bodily impairment and disability (i.e., they have high morbidity) but are not very lethal (i.e., they have low mortality). Some result in blindness, others in unseemly swelling, and still others in impaired cognitive development. Most patients do not die, but the morbidity often hinders wage-earning capacity, thereby creating a vicious cycle of poverty.

These and other characteristics have unfortunately led to neglected tropical diseases being, well, a bit neglected. Since most policymakers live in urban centers, geographically separated from the rural areas with high NTD prevalence, there has traditionally been limited awareness of NTDs. Similarly, because NTDs cause more disability than death, they have historically flown under the radar of many public health efforts. Perhaps most importantly, the populations NTDs disproportionately affect have little money to spend on medicine, resulting in what Peter Hotez, President of the Sabin Vaccine Institute, calls “the business plan from hell.”

How can we change this status quo? What needs to happen for the pharmaceutical industry, academic researchers, and other key players begin investing more seriously in diseases that debilitate over a billion people?

To some extent, the status quo has already begun to change. It has not yet changed nearly enough, and there is ample room for the pharmaceutical industry to invest more in NTDs, but it is important to acknowledge how far the fight against neglected diseases has come.

The term “neglected tropical diseases” was only coined in 2005; before that, each unpronounceable disease fought its own uphill battle with limited success. WHO Director-General Margaret Chan explained in 2007 the benefits of having a catch-all term: “When these diseases are viewed together, we gain critical mass. We get a better grip on the scale of the economic and social consequences as well as the health burdens. Arguments for giving these diseases higher priority become more powerful, more persuasive.”

Since the term was coined, there has been considerable activity in the neglected disease space from governments, donors, pharmaceutical companies, and nonprofits alike. The US government, the UK government, and the Bill & Melinda Gates Foundation have collectively pledged or spent over $200 million on NTD prevention and treatment by 2013. Pharmaceutical companies have donated billions of doses of drugs to various NTD control programs. Some, such as GSK and Merck, have also entered “patent pools” to allow cross-licensing of NTD innovations. The Global Network for Neglected Tropical Diseases has engaged in NTD advocacy and on-the-ground coordination efforts. They also run a frequently updated blog, End the Neglect, that discusses NTD news and reminds readers that “just 50 cents” will provide a year’s worth of treatment against several NTDs.

There has also been a marked increase in NTD product development. The nonprofit pharmaceutical company OneWorld Health, which is partly funded through the Gates Foundation, conducts R&D for drugs against kala-azar (visceral leishmaniasis) and hookworm. It also ties up with for-profit pharmaceutical companies, such as Sanofi-Aventis and Anacor, to develop and manufacture some of their medicines. “Pharmaceutical companies have become more interested in NTDs than they were five to ten years ago,” said Richard Chin, CEO of OneWorld Health. “They would have sent us to their PR department before, but now they send us to their research department.”

Chin noted how their for-profit partners have invested significant time and money into the partnerships: they put their scientists on NTD projects at their expense and allowed OneWorld Health to manufacture drugs in their facilities. Many other product development partnerships (PDPs) for NTDs, such as PATH and the Sabin Vaccine Institute, seem to function along similar lines.

These developments are impressive, especially given the short time frame, but there is still a long way to go. This is perhaps most evident in the product development space. Hotez believes the pharmaceutical industry is “generally doing very well” in donating drugs, manufacturing space, and time to NTDs, but says most have invested relatively little in developing NTD drugs and vaccines themselves. Direct pharmaceutical investment has greatly helped the fight against the “big three diseases” (that is, HIV/AIDS, tuberculosis, and malaria): most recently, GSK invested in a malaria vaccine that is in final rounds of a large-scale clinical trial. Similarly, pharmaceutical companies can invest in drugs and vaccines that spur improvements in NTD morbidity rates.

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Published in Huffington Post on November 1, 2011. Read the article here or below

On November 8, Mississippi voters will be faced with the following yes-or-no question regarding their state constitution: “Should the term ‘person’ be defined to include every human being from the moment of fertilization, cloning, or the functional equivalent thereof?”

If a majority votes “no” on the measure, known as Initiative 26 or the personhood amendment, reproductive rights in the nation’s most conservative state would essentially remain unchanged. Mississippi’s one abortion clinic would continue operating, women would continue having access to a suite of contraceptive measures, the state’s three doctors who do in vitro fertilization (IVF) would continue following standards generally accepted in medical circles, and unborn fetuses would continue having fewer legal rights than fully formed humans.

On the other hand, if a majority votes “yes,” as it seems poised to do, Mississippians’ reproductive rights would drastically change. It may also fuel personhood movements in several other states, including Michigan, Florida, and Ohio.

The most publicized difference is with abortion, which would be considered murder and effectively banned — without exceptions for rape, incest, or when the woman’s health is compromised but not at immediate risk of death. OB-GYN doctor and “Yes on 26” advisory board member Freda Bush said in a press conference, “Women who have borne a child conceived in rape testify that the baby is a blessing, rather than have an abortion, which essentially continues the assault. Adoption is always a loving option.”

Limiting abortions is a popular idea in Mississippi, which has a thriving anti-abortion movement and a prominent Christian majority. Perhaps as a result, much of YesOn26’s advocacy appears designed to appeal to this audience. One YesOn26 commercial reminds Mississippians, in a manner similar to many pro-life campaigns, “No matter how small, every human life has infinite value.” Another shows the audience a 24-week-old fetus named “Lyza Kate Freeman.” Local newscasters have also highlighted the abortion element of the amendment, telling viewers, “[Initiative 26] would make abortions illegal, which is what’s at the heart of this debate.”

These segments do not, however, tell the full story. The implications of personhood — that is, of granting a fertilized egg legal rights — go far beyond limiting abortion. Regardless of one’s stance on abortion, personhood is an extreme measure that pushes against many commonly accepted reproductive and human rights.

With full legal rights, destroyed eggs are essentially treated as murder victims. This is why abortion is illegal under personhood. This is also why personhood would outlaw all contraceptives that interfere with the implantation of fertilized eggs — including intrauterine devices (IUDs), some forms of the birth control pill, and the “morning-after pill,” which YesOn26 proponents call “human pesticide.” Personhood would also prohibit scientists from destroying embryos they create in laboratories, a process often necessary during in vitro fertilization and in types of scientific research.

Personhood would also change how doctors treat women undergoing difficult pregnancies. On its website, YesOn26 advocates write, “Under personhood, a doctor would be required to save both lives if possible; but in the hard cases where the baby is unviable, the doctor would save the life of the mother.” However, doctors often have to make judgment calls on when either life is in danger, and when they should begin prioritizing the mother over the unborn baby. This is particularly true in ectopic pregnancies, a complication in which the fertilized egg implants outside the womb. Under personhood, some doctors may become wary of prioritizing the mother’s health, fearing legal ramifications if they “murder” the unborn fetus in the process.

Perhaps most worryingly, personhood may begin to criminally implicate some women for having stillbirths and miscarriages. Though YesOn26 insists personhood will not prosecute women for having miscarriages, this trend has already begun in some states, including Mississippi. Rennie Gibbs, who had a stillbirth in 2006 when she was 15, was charged with “depraved-heart murder” after prosecutors discovered she had a cocaine habit. The charge carries a mandatory life sentence.

In an extreme case, personhood could be even used to justify legal measures that most would otherwise consider preposterous. For instance, according to a recent New York Times editorial, a zygote under personhood may “be eligible to inherit money or be counted when drawing voting districts by population.” Given how many laws use the terms “person” and “people,” the editorial argued, the implications of personhood could be endless.

Within Mississippi, some groups have been trying to distinguish between the pro-life movement and Initiative 26. A grassroots organization called Parents Against MS 26, which claims to take no position on elective abortion, has been spreading its belief that “there are many valid reasons for pro-life AND pro-choice Mississippians to vote No on 26.” In addition to providing FAQs on ectopic pregnancies and IVF, the site offers several personal stories and guest bloggers. For instance, Reverend Todd Owen Watson wrote, “It would be nice if the changing of one or two words in a state constitution would solve all of our concerns about life, its sanctity, and its meaning, but this ill-written and ill-advised amendment might destroy more life than it saves because of its… heavy-handed impact across all aspects of our daily existence.”

Freda Bush hopes the personhood amendment will restore a “culture of life” in the United States. “It’s unfortunate,” she said, “that for the last forty years, the pre-born person has been marginalized and made legally irrelevant.” Sadly, by granting equivalent legal rights to fertilized eggs, the personhood amendment may tip the scales and begin prioritizing the zygote over the post-born person. Personhood is not a simply change in nomenclature; its consequences are perverse, many of them reaching well beyond abortion.

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