The second annual Women in the World Summit, held in New York, on Mar. 10–12, 2011, brought together leaders from business, government, and nongovernmental organizations (NGOs) to focus on the issues for improving the  economic, political, and social rights of women globally. The summit, which was organized by 

, generated a dialogue on the diversified approaches that can and are being used in various areas, including global health, business development, and individual economic advancement. 

In a keynote address at the summit on Mar. 11, US Secretary of State Hillary Rodman Clinton underscored the importance of advancing women’s roles and rights for  economic and social development domestically and abroad as part of the country’s overall foreign policy and security objectives. “We believe that women’s roles and rights are at the forefront of everything we should care about and need to be doing in our own lives and certainly in the life of our country,” she said. “But sometimes it’s good to be reminded why it’s important to have women and girls at the forefront of American foreign policy. And there is so much evidence of this. But I just want to, for the sake of laying the predicate and for any who are still wondering, a 2008 report commissioned by Goldman Sachs [which] found that educating girls and women leads to higher wages, a greater likelihood of working outside the home, and therefore having lower fertility, reduced maternal and child mortality, [and] better health and education outcomes.” 

Clinton noted that narrowing the gap in employment between men and women in emerging economies could raise incomes by as much as 14% by 2020 and  20% by 2030. “And the World Bank has documented that women tend to invest a much higher part of their earnings in their families and communities than men do,” she said. “They spread wealth.They create a positive impact on future development.” 

At the summit, Clinton announced that the US State Department has launched a new Women and Public Service initiative with five of the “Seven Sister” colleges of Barnard, Bryn Mawr, Mount Holyoke, Smith, and Wellesley. “Together, we will seek to promote the next generation of women leaders who will invest in their countries and communities, provide leadership for their governments and societies, and help change the way global solutions are developed,” she said. As a first step, the initiative will host a conference in the fall of 2011 to bring policymakers, public officials, academics, and “innovation thinkers around the world to build these new global partnerships, so that once we’ve brought attention to an issue or a leader, we will be able to continue to build and support the work that is being done,” she said. 

Illustrative of those partnerships in global health is a recently announced  project to improve maternal and child health in the developing world, which Clinton announced in Washington DC, in early March. The project, 

Saving Lives at Birth: A Grand Challenge for Development

, was launched to seek innovative prevention and treatment approaches for pregnant women and newborns in rural, low-resource settings. The project is a partnership between the US Agency for International Development (USAID), the government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, and the World Bank. These partners are providing nearly $14 million for this grant program's first round of funding and have a commitment of investing at least $50 million in projects during the next five years. 

“Healthy mothers and newborns are the foundation of healthy and prosperous societies," said Melinda Gates, co-chair of the Bill & Melinda Gates Foundation, in a Mar. 9, 2011, USAID press release. "We must partner to develop new technologies and seek new ways of delivering solutions to women and children who need them most. This initiative will speed up progress we're already making and will lead to new kinds of progress that we have yet to conceive." 

Gates also spoke at the Women in the World Summit to emphasize the importance of improving maternal and neonatal health and the role that the Bill & Melinda Gates Foundation is playing to advance that effort. “If you think about a child’s health, it’s related to the woman’s health,” she said in an interview with the broadcast journalist Charlie Rose at the summit. “If you want to lift a society, you have to lift up both of those things.”

According to estimates, more than 3 million newborns in the developing world die in their first month of life, a major and challenging concern. “We couldn’t solve that piece of the puzzle, that first 28 days,” she said. She explained that unlike deaths after a child is 28 days, which mostly can be prevented through vaccine development and delivery, reducing early deaths requires a range of approaches, including social and behavioral changes. Solutions include immediate and exclusive breastfeeding to improve a child’s immune system, skin-to-skin contact to keep babies warm, sterile blades to cut umbilical cords, and antibiotics for infections. 

The Bill & Melinda Gates Foundation  is investing to improve neonatal and maternal health. Its efforts include developing and delivering treatments to address the causes of deaths during pregnancy and childbirth, such as high-blood pressure, infection, uncontrolled bleeding, and obstructed labor. It also is seeking to improve access to healthcare, which may be impeded by cultural, financial, and societal reasons, as well as improve frontline workers' capabilities and performance as they are the first point of contact for delivering maternal and neonatal care. And the foundation is advocating for government funding and support to address the problem. 

In addition to government, private foundations, and nonprofit organizations, individuals play an important role in addressing global health concerns. The Women in the World Summit featured several panelists involved in individual or group projects. For example, Hawa Abdi, MD, founder of the Dr. Hawa Abdi Foundation and HA Village in Somalia, discussed how she founded and now runs a hospital and village in Somalia where more than 90,000 Somalis, many of them which are refugees, receive food and medical care. Amy G. Lehman MD, MBA, founder and executive director of the Lake Tanganyika Floating Health Clinic, discussed her efforts in addressing the problem of healthcare access for isolated communities in the Great Lakes region of Central Africa. And Ebby Elahi, MD, a surgeon and the director of Fifth Avenue Eye Associates in New York and an associate clinical professor of ophthalmology and global health at the Mount Sinai School of Medicine in New York, discussed his work as director of global health at the Virtue Foundation, an NGO that focuses on sustainable development through healthcare, education, and empowerment initiatives. 

Business partnerships and social entrepreneurs 

The Women in the World Summit further focused on ways in which industry is partnering with other companies, organizations, and individuals to build sustainable businesses in the developing world. Eva Walusimbi, an entrepreneur at Solar Sister, spoke of her work in Uganda. Solar Sister is an ExxonMobil partner and social enterprise that provides women with training and support to create solar microbusinesses, which build household income for women and provide light for their communities. Walusimbi sells solar lights and recruits other female entrepreneurs throughout Uganda. 

Diane von Furstenberg, chairman and founder of the fashion-design company bearing her name, participated in a panel discussion on partnering with women in building sustainable economic opportunities in developing countries and her support of and work with Vital Voices, a NGO that identifies, trains, and works with emerging women leaders and social entrepreneurs. Phelicia Dell, designer and CEO of VeVe Collections, described the importance of such partnerships in building her clothing line. She is a member of the Vital Voices chapter in Haiti and participated in the 2008 Vital Voices Summit in Argentina. In 2010, she won the Diane von Furstenberg handbag competition, which challenged designers from Haiti, Guatemala, Nigeria, and Cambodia to create a handbag reflective of their country’s local traditions and which served as a crucial starting point for building her business. 

Also speaking at that panel was Debbie Farah, founder and CEO of Bajalia International and Bajalia Trading Company, which helps women develop business and marketing skills to compete in an international market and become self sustaining. Another panelist was Rebecca Lolosoli, head of the Umoja Uaso Women’s Village in Kenya, who is head of a community that promotes human rights and economic development for women in that country. The women provide for their children and themselves through the sale of beaded jewelry and crafts and have established a sickness and disability fund, community center, and school. The work of Lilosoli, a Vital Voice member, and her community has been facilitated by Ms. von Furstenberg.  

The Vital Voices Global Partnership grew out of the US government's Vital Voices Democracy Initiative, which was established in 1997 by then-First Lady  Clinton and former Secretary of State Madeleine Albright after the United Nations Fourth World Conference on Women in Beijing to promote the advancement of women as a US foreign policy goal. The success of that meeting and subsequent conferences led to the creation of the Vital Voices Global Partnership as an NGO in 2000. Vital Voices has over 1000 partners, 

 experts, and leaders, including senior government, corporate, and NGO executives, who have trained and mentored more than 8000  women from more than 127 countries in Africa, Asia, Eurasia, Latin America, the Caribbean, and the Middle East. 

In another panel, Divya Keshav, owner of Krishna Printernational in New Delhi, India, a firm that manufacturers labels for multiple industries, spoke of her participation in the Goldman Sachs 10,000 Women program at the Indian  Business School, which helped her to develop her management skills for building and maintaining a successful business. 10,000 Women is a five-year, $100-million investment, started in 2008, by Goldman Sachs to provide 10,000 underserved women around the world with a business and management education. 10,000 Women operates through a network of more than 70 academic and nonprofit partners to develop locally relevant coursework for students and to improve the quality and capacity of business education. She was joined at the panel by Dina Habib Powell, president of the Goldman Sachs Foundation and managing director and global head of corporate engagement. The foundation seeks to foster economic growth and opportunity through programs offering business education, access to capital, mentors, and networks to small-business owners in the US and women entrepreneurs globally.

Zainab Salbi, founder and CEO of the nonprofit Women for Women International, discussed the work of her organization in helping women survivors of war and conflict move toward economic self-sufficiency with the organization’s programs of direct aid, rights education, job-skills training, and small-business development. It has distributed direct aid, microcredit loans, and other program services to nearly 300,000 women. The organization raises funding by connecting individual sponsors with women through small monthly contributions and other donations. 

The Women in the World Summit also featured leaders from government, including former US President and head of the William J. Clinton Foundation Bill Clinton, former Secretary of States Albright and Condoleezza Rice, Melanne Verveer, Ambassador at Large for Global Women’s Issues at the US State Department, and former Chilean president and now Under-Secretary General and Executive Director of  UN Women Michelle Bachelet. Bachelet was appointed to head the newly created UN body charged with promoting gender equality and women empowerment in 2010. Other summit participants included: Sheryl Sandberg, COO of Facebook; Susan Sobbott, president of American Express OPEN; Gabi Zedlmayer, vice-president of global social innovation at Hewlett-Packard; Ngozi Okonjo-Iweala, managing director of the World Bank; Judith Rodin, president of the Rockefeller Foundation; and Katy Bushkin Calvin, CEO of the United Nations Foundation.  

The Women in the World Summit was held in conjunction with the DVF Awards, sponsored by the Diller–von Furstenberg Family Foundation, and held at the United Nations on Mar. 11. Diane von Furstenberg established the DVF Awards in 2010  to recognize women for their leadership, courage, vision, and commitment in producing positive change. The DVF Awards provide recipients with the exposure and resources needed to extend their efforts on behalf of women’s causes. This year’s award winners were Elizabeth Smart for her dedication to child-abduction causes; Taryn Davis for her work with the American Widow Project, a project to help the widows of fallen US soldiers; Kakenya Ntaiya for creating the Kakenya Center for Excellence in her native Masaai village in Kenya; and Sohini Chakraborty for the Kolkata Sanved program, which teaches young women to gain self confidence through dance and cultural expression. 

For additional information on the Women in the World Summit, click 

Articles

CSR and Sustainability Forum

The Women in the World Summit, which was held in New York in March, focused on issues and solutions for improving the economic, political, and social rights of women globally, including a focus on global health initiatives.

Leaders from Business, Government and NGOs Advance Solutions for the Developing World

Realizing policy objectives in global health initiatives requires cooperation and innovation from the private sector, nongovernmental organizations (NGOs), and national governments. Technology transfer for pharmaceuticals and vaccines plays a crucial role in delivering healthcare solutions on a sustainable basis to low- and middle-income countries. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) recently issued a report, 

Technology Transfer: A Collaborative Approach to Improve Global Health

, to provide insight, best practices, and case studies from the pharmaceutical industry on how to use technology transfer as a vehicle to improve health outcomes in the developing world. 

In its report, IFPMA points out that technical transfer is essential for overall economic development for low- and middle-income countries as a way to accelerate the acquisition of knowledge, experience, and equipment related to advanced and innovative industrial products and processes. With regards to healthcare, technology transfer could be one innovative way to bridge the research and development (R&D) and access gap in low- and middle-income countries. In its report, IFPMA points to eight crucial factors for creating a favorable environment for pharmaceutical technical transfer as follows:

• A viable and accessible local market 

•  Political stability and good economic governance

• Strong intellectual property rights and effective enforcement

• Quality of the relationship between industry and government and the extent they are able to work together effectively for long periods of time. 

The importance of transferring technology for medicines is recognized in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Rights of the World Health Organization (WHO), whose implementation IFPMA is contributing to through issuing its report on technology transfer. Moreover, the IFPMA report points out that technology transfer is more than simply handing over technology. “The transfer of R&D pharmaceuticals is more than a question of bricks and mortar; or providing a toolbox." said the report. “It occurs through many channels, all of which result in improving the economic capabilities of the recipient.”  The United Nations identifies the following elements as part of technology-transfer package:

• Technoware, which from a pharmaceutical-industry perspective, would include the transfer of physical objects, such as equipment for use in research laboratories or production equipment for manufacturing pharmaceutical ingredients, formulation development, or manufacturing and packaging of finished drug products

• Humanware, which includes skills and human aspects of technology management and learning, such as a training course for researchers or physicians

• Infoware, which relates to techniques related to knowledge, information. and technology, inclusive of a technology license

• Orgaware, which involves the organizational and procedural knowledge needed to operate a given technology relating to a chemical or biological compound. 

Collaboration between Fiocruz and GlaxoSmithKline 

The IFPMA report details several examples of successful technology transfer in the pharmaceutical industry. One such example is a long-standing partnership between the Oswaldo Cruz Foundation (Fiocruz) in Rio de Janeiro, Brazil, and GlaxoSmithKline (GSK). Fiocruz was established in 1900 as the research arm of the Brazilian Ministry of Health with a goal to promote health and social development by spreading scientific knowledge. Today, Fiocruz performs basic and applied research, develops new technologies, and produces vaccines and medicines. The Immunobiological Technology Institute or Bio-Manguinhos unit of Fiocruz, which was established in 1976, develops and produces biopharmaceuticals, vaccines, and reagents for diagnostic kits. Fiocruz/Bio-Manguinhos manufactures approximately 10 million biopharmaceutical units per year (with capacity to triple this production), 7 million reactions for diagnostic kits, and 154 million doses of vaccines. 

“We use different strategies to make products in-house to be available for our population,” says Antonio de Pádua Barbosa, director of production of Fiocruz’s Bio-Manguinhos. “Besides our own innovation and development, we have partnerships with local and global organizations, and we use technology transfer to accelerate the viability of the products for the population.” 

 Bio-Manguinhos currently has 35 projects in development: 7 in bacterial vaccines, 14 in viral vaccines, 6 in biopharmaceuticals, and 8 in 

 diagnostics. “Most of the projects are in clinical development, “ says de Pádua Barbosa. “We have two bacterial-vaccines projects in Phase II, and three viral vaccine products in Phase II/III development,” he adds. 

Fiocruz currently has a partnership with GSK for developing a vaccine for Dengue fever. “It is a partnership involving scientists from both organizations, who from time to time, visit, discuss, and implement actions to achieve the goals of the projects,” he says. “The projects are currently in preclinical studies, and we intend to go to Phase I clinical development within a year.” 

The  project for developing a vaccine for Dengue fever is one of several partnerships that Fiocruz has with GSK. GSK and Fiocruz first partnered in 1998 to develop vaccines, and the organizations recently announced new projects. In November 2010, GSK and Fiocruz formed a R&D agreement to develop new medicines to treat diseases that disproportionately affect people in the developing world. Under the new collaboration, GSK and Fiocruz will share research and expertise for drugs to treat malaria, tuberculosis, and leishmaniasis, with initial research prioritized for drugs to treat Chagas disease and leishmaniasis. The partnership will enable scientists at Fiocruz and GSK’s Tres Cantos facility in Spain to openly share new research, ideas, and know-how. GSK’s Tres Cantos Medicines Development Campus is focused on discovering new medicines to address diseases of the developing world. In January 2010, GSK created the nonprofit Tres Cantos Open Lab Foundation with £5 million ($8 million) in seed funding. The Open Lab Foundation is designed to facilitate collaborations across academia and industry. 

GSK also partnered with Fiocruz  in 2009 to provide Fiocruz with access to the technology behind GSK’s 10-valent conjugate vaccine for pediatric pneumococcal disease, or Synflorix.  Under the agreement, GSK supplied Synflorix to Fiocruz until the technology transfer was completed. The vaccine was incorporated in Brazil’s national immunization program. Other strategic alliances between GSK and Fiocruz involve partnerships for several other vaccines, including vaccines against Haemophilus influenzae Type b, MMR (i.e., measles, mumps, and rubella), and rotavirus. 

Another example of successful technology transfer is through the Lilly MDR–TB Partnership, a public–private partnership set up in 2003 by Eli Lilly to address the problem of multidrug-resistant tuberculosis (MDR-TB) by increasing access to treatment and focusing global resources on prevention, diagnosis, and treatment of patients with MDR-TB. Eli Lilly set up the partnership with an initial investment of $135 million in cash in 2003. The MDR-TB Partnership seeks to offer a multidimensional program from drug supply to treatment and surveillance to community support. For drug supply, Eli Lilly is engaged in working with partners to produce the active pharmaceutical ingredient and finished drug product for two antibiotics, capreomycin and cycloserine. It has transferred the technology, expertise, formulas, and trademarks to manufacture these drugs to manufacturers in China, India, Russia, and South Africa to serve high-burden  MDR-TB areas. Eli Lilly also continues to supply antibiotics at concessionary prices to WHO-approved DOTS programs (Directly Observed Treatment, Short Course) for MDR-TB. These drugs are supplied through WHO’s global drug facility. 

“Technology transfer is one component to drug supply,” says Patricia Carlevaro, head of the international aid unit with Eli Lilly. “It also involves providing manufacturing expertise, related technical assistance, and human-resources to support the technology transfer.” 

In the case of the Lilly MDR–TB Partnership, Eli Lilly formed several strategic partnerships to meet an objective of increasing access to drugs to treat MDR-TB. For drug supply, it formed partnerships with several pharmaceutical manufacturing companies: Akorn (Lake Forest, Illinois), Aspen Pharmacare (Durban, South Africa), Hisun Pharmaceutical (Taizhou Zhejiang, China), Shasun Chemicals and Drugs (Chennai, India), SIA International (Moscow), and Vianex (Athens). Shasun is producing the API cycloserine, which is an oral drug, and Hisun is producing the API capreomycin, which is an injectable drug. Several manufacturers are producing the finished drug products: Hisun, Vianex, SIA International, Aspen, and Akorn. Purdue University in West Lafeyette, Indiana, is partnered with Eli Lilly to provide GMP training and related expertise to the partner companies in the MDR-TB Partnership. Also, Lilly also provides its partners staff for onsite technical assistance and training as well as financial support for facility upgrades as needed. 

 “In terms of a technology transfer strategy, our interest in these partnerships was to share Lilly’s specific and general manufacturing knowledge,” says Carlevaro. “We wanted to create self-sustaining centers of manufacturing excellence capable of providing additional products and employment. This involves supporting reliable generic-drug producers to ensure expanded multisource availability and to offer the manufacturing firms in the MDR-TB hot spots in China, India, Russia, and South Africa, the technology to produce the two second-line TB drugs.” 

 Carlevaro emphasizes that successful technology transfer relies on mutual trust and partnerships between the players and offers a mechanism to create sustainable drug supplies for developing-world markets. “It is a win–win situation for us and our partners,” she says. “We are able to share our technology for drugs that have reached the end of their product lifecycle for the innovator-drug company with companies or other partners that can manufacture and produce these drugs for the developing world.” She added that further facilitation of such arrangements can be helped through regulatory bodies as well by them allowing the mutual-recognition processes for drug approvals. “In the end, we are not just transferring manufacturing technology, but also other forms of acquired expertise: equipment, staff training, and quality.” 

Eli Lilly and GlaxoSmithKline are among several pharmaceutical companies using technology transfer as way to improve health outcomes in the developing world.

Technology Transfer in Global Health Initiatives

Of all the questions I get from contract services providers about industry trends and developments, the most commonly asked one focuses on the threat of competition from contract research organizations (CROs) and contract manufacturing organizations (CMOs) in India and China. Even when companies are not feeling immediate competitive heat, the long-term prospect of having to face off with low-cost emerging market competitors, especially those in India and China, is always a top-of-mind concern for CRO and CMO executives.  

To gauge just how big and immediate the threat of Asian competition is to Western service providers, I traveled to India in December 2010, where I attended CPhI India and visited several CROs and CMOs. My friend and colleague, Mak Jawadekar, known to many in the industry for his role in outsourcing activities at Pfizer, accompanied me and provided invaluable introductions and insights. 

This was my first opportunity to see the Indian pharmaceutical industry first hand, and I came away very impressed with the quality of the operations, the technology, and the entrepreneurial zeal of the industry leadership.  

Without question, what impressed me the most is the big bet the Indian pharmaceutical industry is making on the opportunity presented by the expiration of patents in the next few years. Most of the generic-drug companies I visited have 20–30 products in development for which they anticipate filing abbreviated new drug applications in the next several years. The US and European markets are major targets for their generic products, but these companies ship products all over the world and have significant sales in Africa, Latin America, and other Asian countries as well. 

The generic-drug companies are in high-gear and are investing in large state-of-the-art manufacturing and development facilities to meet the anticipated demand. One executive of a CMO of active pharmaceutical ingredients (APIs) I talked with cited a figure of an anticipated three-fold increase in unit volumes for generic APIs and formulations. The new manufacturing facilities that these generic-drug companies are building are impressive; facilities of 200,000 ft

  or more with state-of-the-art design and equipment are typical. In addition to the new facilities springing up around Hyderabad, the traditional center of the Indian pharmaceutical industry, large, new pharmaceutical clusters are being developed in areas, such as Vizag, a coastal city in Andhra Pradesh state, and Ahmedabad, in Gujarat. State governments are setting up special economic zones with subsidies and tax incentives to attract development to these centers. 

One of the most interesting characteristics of these facilities is the predominance of equipment made within India; the displays of the Indian equipment manufacturers at CPhI India were truly impressive. One brand new injectables facility we visited had vial washing and prep equipment made in India, fillers made in Europe, and a freeze dryer made in China. The availability of high-quality locally made manufacturing equipment is an important source of cost advantage for Indian manufacturers as it lowers their capital-investment requirements. 

Contract development and services are a significant part of the business for these generic-drug companies—around 30% in some cases—but they are not the driver of their near-term growth strategies. Contract services are viewed as a way to leverage existing capacity, build relationships, and support a deepening scientific base. However, the focus of these companies is on the opportunities in generic drugs, and I don't see them becoming a disruptive force in the CMO industry in the foreseeable future. 

The big risk to the CMO industry is that the generic-drug companies may be building too much capacity as they each seek to cash in on the patent expirations. If this proves to be the case, we could see some Indian generic-drug  companies turn more aggressively to contract manufacturing to fill their underutilized facilities. Were this to happen, it could create pricing chaos in the CMO industry and put European and North American CMOs at a considerable disadvantage.  

In addition to the manufacturers, we also visited dedicated contract services companies offering discovery, API process development, and formulation-development services, along with clinical-scale manufacturing. These companies are largely targeting Western bio/pharmaceutical companies as their key clients, although they are finding clients within India as well. The impression left by these companies was decidedly mixed. Some reflected a high level of sophistication and understanding of what Western companies are looking for and expect, and others offered barebones facilities that generally wouldn't pass muster with prospective clients from major bio/pharmaceutical companies.  

The performance of these services-only companies varied by service offering. Those offering discovery and process development services appear to be doing quite well while those offering formulation development and early-stage clinical trial material (CTM) services are not as  robust. The global bio/pharmaceutical companies began turning to Indian and Chinese CROs for discovery and process chemistry services almost 10 years ago, and several of these companies have emerged as world-class service providers. We visited the Hyderabad campuses of two of industry leaders in chemistry outsourcing, GVK Bio and Aptuit, and came away impressed with the sophistication of their leadership and quality of their facilities and operations. 

The challenge for the formulation development companies seems to be two-fold: the local market for CTM is somewhat limited by the fact that bio/pharmaceutical companies cannot conduct first-in-man studies in India, and expenditures for early formulation-development services are so low at most Western companies these days that the expected cost savings from going to India are minimal. Near term, we think those companies are going to have to establish a laboratory presence in the Western markets to capture that early-phase business, with the intention that the products can be transitioned to Indian facilities as the products approach commercialization. Longer term, the formulation-development CROs will benefit as global bio/pharmaceutical companies establish more R&D operations in India and source more of their needs locally. 

My overall conclusion is that India is building a base for a strong local contract services industry in the coming years. The threat for Western contract development and manufacturing organizations (CDMOs) and CMOs is small in the near-term, but as global bio/pharmaceutical companies target this fast-growing market, Indian firms will be well-positioned to seize the opportunity. 

 is president of PharmSource Information Services, Inc., and publisher of 

Outsourcing

Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.

A First Hand Look at India's Pharma Services Sector

Growing public health initiatives, coupled with perpetual threats of pandemics and emerging infectious diseases, highlight the gaps in biopharmaceutical development capabilities, as well as access to medicines within the developing world (1, 2). The recent H1N1 pandemic also revealed the access inequity of the pandemic influenza vaccine between developed and developing nations.

To help fill this gap, developing nations have nurtured their local biotechnology industries to help grow existing and new biotechnology capacity. Just in the past 10 years, multinational (MNC) pharmaceutical companies have established a strong presence in BRICM (Brazil, Russia, India, China, and Mexico) countries through initiatives ranging from joint ventures with local manufacturers, to the building of captive research and development (R&D) centers, to the acquisition of local companies. 

Even with the biopharmaceutical industry’s increasing footprint, low- and middle- income countries (LICs and MICs) still face challenges in accessing medicines. For instance, BRICM countries represent 43% of the world population, but collectively account for only 1.8% of the global vaccine market (3, 4). Whereas US health expenditures per capita exceeds $7000 (as defined by purchasing power parity, PPP, international dollars), none of the BRICM countries’ expenditure exceeds $1000 (PPP) (5). This differential explains, in part, why many licensed vaccines are still unaffordable in developing and emerging countries, thus inhibiting access to essential treatment.

Aside from economic challenges, there are unique unmet medical needs typical for MICs and LICs that render biopharmaceuticals licensed in the Western world inadequate for the developing market. For some diseases, such as rotavirus and pneumococcal diseases, the distribution of disease serotypes in the developing world can differ from those in developed nations. There also are few effective medicines for prevention and sometimes only moderately effective existing therapies for neglected tropical diseases that are endemic to LICs (6). 

Table I outlines the market characteristics of biopharmaceutical products targeting underserved populations in developing countries. The models for providing access to biopharmaceuticals to underserved populations continue to undergo an interesting evolution. An emergence of private entities, state-owned enterprises, and public–private partnerships has led to innovative business models that address gaps in the development and commercialization of medicines for emerging and developing countries. Some examples are noted below.

Table I: Market    characteristics of biopharmaceutical products

testing underserved    populations in developing countries

Securing long-term contractual commitments from UNICEF or    PAHO requires WHO prequalification, a challenging task for local    biomanufacturing industry

Reliance on only local demand is risky due to dependence    on each country’s health policies and maturity of the supply chain.

Long, high-cost product-development cycle most often    culminates in low-price products. 

Limited incentives 
 for multinational corporations

Low profits coupled with high-risk, high-cost research and    development do not provide incentives for multinational corporations to    invest in the production and delivery of biopharmaceuticals addressing    neglected tropical diseases and country-specific serotypes of infectious    diseases.

State and product development partnership-supported    biotechnology companies are the key stakeholders in the developing world’s    biopharmaceutical research and development and manufacturing.

WHO is World Health Organization. PAHO is Pan American    Health Organization.

This approach involves free donation of medicines by MNCs through partnerships. One example is Merck & Co.’s Mectizan Donation Program (MDP) for the treatment of river blindness. MDP is still one of the largest ongoing medical donation programs in history, reaching more than 60 million people each year. The MDP is a partnership between public, private, and nongovernmental development organizations (7).

Transforming the marketplace from a low-volume, high-cost enterprise to a high-volume, low-cost business.

 The Clinton Foundation HIV AIDS Initiative (CHAI) has improved the demand side of the market through prevention and treatment programs and has provided technical assistance to develop procurement and supply-chain management practices. The initiative resulted in cumulative price reductions of 30% for second-line antiretrovirals and 60% for pediatric antiretrovirals to 70 countries and an increase of market size to more than two million people since 2002 (8). 

Emergence of state-owned and private manufacturers in developing countries. 

 In the last decade, a few prominent players in the developing countries’ biopharmaceutical sector have emerged (see Table II). Different business models were employed by these organizations. Some enterprises initially began as a manufacturing hub, growing through technology in-licensing, infrastructure development, or collaborations with MNCs into integrated R&D and manufacturing organizations. The Serum Institute of India is one of the most prominent vaccine manufacturers on this list: it is the fifth largest vaccine manufacturer by volume (after GlaxoSmithKline, sanofi-aventis, Merck & Co., and Novartis) and is one of the world's lowest-cost vaccine producers (7). 

Table II: Select    list of prominent private
 and state-owned vaccine manufacturers in developing countries. 

UNICEF and PAHO    contracts, 
 WHO Prequalification

 A; rubella; measles; hepatitis B; measles and rubella (MR); measles, mumps,    and rubella (MMR).
 

diphtheria, pertussis, and tetanus (DPT); hepatitis B; measles; MMR; MR; tetanus
 

 BCG; Haemophilus influenzae type B (Hib); polio; combined DPT; tetanus;    pertussis; hepatitis B; Hib.

Pentavalent vaccine against DPT, hepatitis B, Hib,    pertussis, tetanus; oral cholera

DPT; recombinant hepatitis B; antisnake venom sera

: DPT;    tetanus
 No vaccines are WHO-prequalifed

Tetanus; BCG; hepatitis B; rabies, combined DPT, tetanus,    and pertussis

ChengDu Institute of 
 Biological Products (China)

Pneumococcal; Japanese encephalitis; BCG; typhoid;    combined DPT, tetanus, and pertussis.

* Acquired by sanofi-aventis in 2009.
 PAHO is Pan American Health Organization. WHO is World Health Organization
 Sources: UNICEF Contracts and Awards for Supplies and Logistics 2001 to 2010;    PAHO Contract 2003 to 2008; WHO Prequalified Vaccines; “Biotech in India:    Special Feature on India’s    Emerging Biotech Industry” insert, 

Even though there is currently an impressive list of biopharmaceutical manufacturers in developing nations, many are still challenged with obtaining prequalification from the World Health Organization (WHO) and securing contracts from large purchasers, such as UNICEF and the Pan American Health Organization. Less stringent local regulatory and quality assurance standards, coupled with bioprocessing challenges, such as the inability to gain access to best-in-class technology and development know-how are some of the factors contributing to these difficulties. 

 One prominent example of a MNC–public sector partnership undertaking an R&D effort tailored to the needs of developing world is the Hilleman Laboratories, a $147-million investment by Merck & Co. and Wellcome Trust, which was launched in India in 2009. The Hilleman Laboratories focuses on the development of affordable vaccines for low-income countries. Recently, Hilleman Laboratories announced a £90-million ($145-million) commitment to develop a new heat-resistant, affordable rotavirus vaccine using components of Merck’s existing rotavirus vaccines and formulation technology from Boston-based Medicine in Need (9). 

The public–private partnership model offers unique access to best-in-class commercial know-how for developing countries’ scientists and engineers and fills a need to translate discoveries into commercial products by establishing linkages among discovery, development, and delivery experts. This business model relies on the public–private partnership undertaking the product development from discovery through proof of concept, then having other public sponsors fund the rest of product development. The challenges are obvious: availability of sufficient public funding to enable development post-proof of concept and, most importantly, an interest from capable local manufacturers to complete technology development. For MNCs, such as Merck, this approach is an opportunity to contribute to the development of new medicines for underserved populations while advancing discovery and early development of dual-use platforms and new leads that could be further developed for commercial, high-profit indications. 

Creating biomanufacturing infrastructure 

The task of creating a reliable and efficient low-cost biomanufacturing base in developing and emerging countries is daunting, and several innovative approaches to addressing those challenges have been explored. Below are examples of some of the challenges and possible solutions. 

Need for capital investment to build and sustain a biomanufacturing base.

 There are several examples of how public financing can be used to build and sustain successful biomanufacturing capacity in developing countries. The state-owned Oswaldo Cruz Foundation (known as Fiocruz) in Brazil has leveraged state buying power to develop products through the in-licensing of technologies. Fiocruz also has forged some 20 public–private partnerships in recent years, both with domestic producers, such as Ache, and with MNCs, such as Novartis and sanofi-aventis, as well as with GlaxoSmithKline (GSK), with whom Fiocruz signed an agreement in 2009 to produce a 10-valent pneumococcal vaccine and develop vaccines against dengue, malaria and yellow fever (10). Another example is the PATH Malaria Vaccine Initiative strategic investment to create a cGMP-compliant dedicated malaria vaccine-manufacturing facility at Gennova Biopharmaceutical (India) to produce recombinant protein-based malaria vaccine candidates (11). 

New manufacturing capacity built through joint ventures (JVs). 

 The JV model presents an opportunity for both parties to have a tangible interest in the successful implementation and long-term sustainment of a new facility. One example of such a model is the long-term JV agreement between GSK and Jiangsu Walvax Biotech, resulting in a total investment of £41.2 million ($66.4 million) to develop and manufacture pediatric vaccines for use in China. The JV will build a new manufacturing facility for GSK’s pediatric vaccine Priorix in China, with both partners making investments and having an equity stake. 

Another example is the 2009 deal between Novavax, based in Rockville, Maryland, and Cadila Pharmaceuticals, based in India, to develop and commercialize the seasonal influenza and H1N1 pandemic vaccine in India. Through equity investment and service contracts with Novavax, Cadila gained access to a novel vaccine production platform and flexible biomanufacturing facility design. The construction of Cadilla’s new vaccine facility was completed in 2010. 

Access to bioprocessing technologies, expertise and know-how.

 Greater access to bioprocessing technologies will expedite the entry of new manufacturers into the market, which will ultimately drive product prices down and make drugs and vaccines more affordable for the developing and emerging world. Creating an environment where general bioprocessing platforms, standards, and quality controls can be openly discussed will be invaluable to address growing biopharmaceutical production needs. This task could be considered by the largest infectious-disease portfolio funders, such as the Bill and Melinda Gates Foundation, the the National Institute of Allergy and Infectious Diseases, National Institutes of Health, the Global Alliance for Vaccines and Immunization, and state governments. Through a structured  analysis of a holistic infectious disease portfolio, focusing on technology platforms, expression vectors, and product-delivery strategies, critical questions can be asked about building and maintaining capabilities (i.e., assay development and animal-model development) and infrastructure (process development and GMP manufacturing). This approach will enable an open dialogue and knowledge sharing about lessons learned from a diverse group of biopharmaceutical developers and manufacturers. 

The Developing Countries Vaccine Manufacturers Network is one example of a biopharmaceutical manufacturers’ forum with a mission to facilitate such an exchange of ideas and expertise. Another similar forum is the influenza vaccine hub established by WHO and the Netherlands Vaccine Institute to provide access to new manufacturing bioprocesses, technology platforms, and expression systems. The hub also provides guidance on alternative approaches to quality compliance for developing and emerging countries’ biopharmaceutical manufacturers (12). 

Great strides have been made to establish biopharmaceutical development and manufacturing capabilities in developing and emerging countries although significant barriers for new market entrants still exist. The collaborative nature of relationships between MNCs and emerging and developing countries’ biomanufacturers is critical for gaining access to new bioprocessing technologies and know-how. 

Innovative business models, such as JVs and public–private partnerships, are becoming the models of choice for growing the local biotechnology sector in developing nations. The management of technology transfer issues among discovery, early-development, and advanced-development stakeholders, including realistic assessments of funding and human capital needs, as well as timely planning, is becoming increasingly important. 

Public-sector funders and public–private partnerships will continue to play a pivotal role in advancing R&D and building new product development and manufacturing capabilities to address the unmet medical needs of the developing world. The well-considered and timely alignment of stakeholders along the healthcare value chain will ensure optimal market sizing/demand assessment, adequate financial planning, alignment of product development and commercialization capabilities, and finally, structured and agreed-upon procurement and distribution strategies, all of which are critical for the successful delivery of new medicines to developing and emerging countries. 

Chan Harjivan (charjivan@prtm.com) is a partner and Diana Elkis (delkis@prtm.com) is a principal, both in the Global Public Health practice at the global management consulting firm PRTM. 

This article is Part II of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. 

 , which focused on drug development, appeared in the March 2011 issue of 

, which focused on distribution and administration, appeared in the May 2011 issue of 

Global Immunization Vision and Strategy 2006–2015 

The Millennium Development Goals Report 2010 

The Vaccines Market Outlook to 2014: Competitive Landscape, Pipeline Analysis, Growth Opportunities and Market Forecasts 

Fact Sheet: Merck Mectizan Donation Program, River Blindness 

(Whitehouse Station, NJ).8. Clinton Foundation, 

9. “Hilleman Lab to Invest about Rs 650 CR to Develop Vaccines,” 

10. A. Jack, “Brazil’s Prescription for Pharma,” 

11. “Gennova Biopharmaceuticals Collaborates with PATH MVI,” 

12. J. Hendricks and C. Boog, “Influenza Technology Hub, a WHO Vaccinology Center of Excellence,” presented at the WHO Technology Transfer Workshop, Bilthoven, The Netherlands (Nov. 30–Dec. 1, 2010), 

This article, which focuses on manufacturing and drug access, is Part II of a three-part series on biopharmaceutical issues in public health, government, and developing world markets.

Manufacturing and Access in Public Health, Government, and Developing World Markets

Keeping pace with the changing market, regulatory, and technical requirements of the fine and custom chemical sector is an important consideration for bio/pharmaceutical companies and their suppliers. Key issues relating to the supply, sourcing, and manufacture of fine and custom chemicals will be addressed at a symposium at Chemspec USA, an exhibition of fine, custom, and specialty chemicals producers, which will be held May 3–5, 2011, in Philadelphia. The full-day symposium will be held May 3, beginning at 9:30 AM, and will feature industry experts discussing the trends and issues facing the fine, custom, and specialty chemical sectors. Additionally Rx-360, the international pharmaceutical supply chain consortium, will hold an open meeting along Chemspec USA on May 5, and a full-day conference on formulation science and technology will be held on May 4. 

The symposium at Chemspec USA will open with a plenary session with presentations by leading CEOs in the fine, custom, and specialty chemical sectors. Speaking at this session will be Joe Carleone, CEO of AMPAC, parent company to AMPAC Fine Chemicals, Craig Rogerson, CEO of Chemtura, and Jerome Peribere, CEO of Dow Advanced Materials. Reflecting the increased emphasis on biopharmaceutical development and other biochemical-based development, the symposium also will feature a session on biotechnology and bio-based chemicals. Speakers from Lonza Bioscience, Rennovia (a company specializing in catalyst technology for producing renewable bio-based chemicals) as well as representatives from the biotechnology organizations, BioNJ, Pennsylvania Bio, the Delaware Bioscience Association, and MichBio, will offer input. 

The future of the chemical enterprise for life-science markets (pharmaceutical and crop protection) and overall chemical markets also will be examined. Moderating the panel will be Magid Abou-Gharbia, PhD, former senior vice-president of Wyeth and current head of chemical and screening processes with Temple University, School of Pharmacy, as dean for research, professor of medicinal chemistry, and director of the Moulder Center for Drug Discovery Research. Panelists offering input on the future of the chemical enterprise include the following; Paul Anderson, PhD, former president of the American Chemical Society and former senior vice-president for chemical and physical sciences at DuPont–Merck Pharmaceuticals; John LaMattina, PhD, former senior vice-president at Pfizer and former president of Pfizer Global Research & Development and now a director of Human Genome Sciences as well as a senior partner at PureTech Ventures; and Pat Confalone, PhD, vice-president of global R&D for DuPont Crop Protection. 

Financial factors influencing the market for fine, custom, and specialty chemicals will be discussed as well. Peter Young, CEO of Young & Partners, will discuss merger and acquisition activity and related trends. Also, financial analysts from Venture Well, CMEA Capital, Forge Partners, Commons Capital, and Angel Fund, will examine trends in venture capital and related issues. 

The key trends in supply-chain management will be examined by Cathy Budd, supply chain director of Dow Builing Solutions, and Paul Brouillard, director of global accounts for Spectrum Chemicals and Laboratory Products. Also Guy Villax, CEO of Hovione and board member of the European Fine Chemicals Group and the Rx-360 Consortium will examine key regulatory issues in the fine-chemicals supply chain. 

The symposium also will feature a panel discussion on green chemistry. Panelists include: Martha Murray, director of EH&S at AMPAC Fine Chemicals; John Warner, president  and chief technology officer for the Warner Babcock Institute for Green Chemistry; Catherine Hunt, Ph.D, R&D director of innovation sourcing and sustainable technology at Dow Chemical; Michael Lefenfeld, president and CEO of SiGNa Chemistry; and R.P. (Skip) Volante, vice-president and global leader process chemistry at Merck Research Laboratories. 

 Details of the Chemspec USA symposium may be found 

Also, the Rx-360 Consortium will hold an open meeting at Chemspec USA. Rx-360, incorporated in 2009, aims to develop and implement a global quality system to help members ensure product quality and authenticity throughout their supply chains to enhance drug safety. Guy Villax, CEO of Hovione and Rx-360 board moderator, will moderate the meeting. Panelists include current Rx-360 chair, Lynne Byers of GlaxoSmithKline, and representatives from Amgen, AstraZeneca, and Baxter, who will provide a review of Rx-360 initiatives. Rick Friedman, director of the Division of Manufacturing and Product Quality, Office of Compliance, the Center for Drug Evaluation and Research at FDA, will provide FDA's view on the supply chain, including how Rx-360-type initiatives contribute to a safer supply chain and help support the meeting of regulatory obligations. 

Details of the Rx-360 Consortium meeting may be found 

Also, on May 4, the Chemistry Innovation Knowledge Transfer Network, based in Manchester, UK, will host a full-day of seminars and workshops on the latest in formulation science and technology. Presentations from specialists in their fields will explore the importance of formulation, new business challenges/opportunities, and approaches to collaboration and open innovation.  There will also be a showcase of the latest technologies and associated research and development expertise and also several facilitated sessions to stimulate ongoing international collaborations.  Presentations will examine related work in pharmaceuticals, cosmetics, food, home and personal-care products, coatings, inks, and dyes. Panelists include representatives from Procter & Gamble, Dow Chemical, AkzoNobel, Reckitt Benckiser, and academia.

Details of the Formulation Science and Technology Day may be found 

Supply Chain

Chemspec USA, which will be held in early May, in Philadelphia, addresses the key issues affecting the manufacturing and supply of fine chemicals.

Navigating the Supply Chain in Fine Chemicals

Shifting fundamentals in the innovator-drug market are helping to drive change in the generic-drug market. Despite strong opportunity presented in the near term by a wave of patent expirations, the generic-drug industry has its own set of challenges and opportunities. Generic-drug companies face increased competition not only within the sector, but from newer entrants, including from the pharmaceutical majors and emerging-market players. In response, generic-drug companies have been consolidating and partnering to build economies of scale, improve their access to emerging markets, and build their technological expertise in select sectors, such as follow-on biologics (FOBs). These issues also are influencing the composition and direction of the supply base of generic active pharmaceutical ingredient (APIs) manufacturers. 

APIs

Increased competition, the rising role of emerging markets, and targeted opportunities in niche segments are factors influencing the generic-drug market and related supply base.

The Changing Players and Supply Base for Generic Drugs

, through its philanthropic foundation the 

, is providing $3 million to support relief efforts in response to the earthquake and tsunami in Japan. The Abbott Fund donation is being made to the Japanese Red Cross through the American Red Cross and the relief organization AmeriCares. 

 will donate $1 million to Japanese disaster-relief efforts. Amgen and the Amgen Foundation will distribute the funds to Direct Relief International and International Medical Corps to support  basic needs and health services. 

California State University, East Bay (CSUEB)

 to create the Center for STEM Education on CSUEB Hayward campus. The center will focus on enhancing and coordinating existing STEM (science, technology, engineering, and mathematics) education activities at CSUEB to give the university a greater role in regional and national STEM education issues. The new grant, to be administered over three years, will establish the Bayer Executive Directorship for the center and allow the school to begin teacher development in STEM education and to advance student academic achievement. The center will become the focal point of regional efforts to build on and expand sustainable models, such as Biotech Partners and MESA (Mathematics, Engineering, Science Achievement), two education and job training programs. It also will expand a pipeline of K–12 students motivated and prepared to pursue college degrees in STEM disciplines or math and science teacher education. 

has awarded a $750,000-grant to the educational nonprofit organization ASSET (Achieving Student Success Through Excellence in Teaching) to establish the Bayer Professional Development Academy at ASSET and support the creation of new regional professional development centers and satellite sites in Pennsylvania. The new Bayer grant supports ASSET's Investing in Innovation grant program that is designed to scale up the organization's reach and impact on K–8 teachers and students. It will allow for a growing number of teachers in southwest Pennsylvania and in high-need urban and rural areas to receive more and higher level teacher training in ASSET's K–8 standards-aligned STEM education program. 

, the philanthropic arm of Baxter, announced their combined 2010 charitable giving of nearly $80 million and employee volunteering of more than 163,000 hours. Most of those hours were civic engagement, such as organizing food drives and building homes through Habitat for Humanity, and local education needs, such as mentoring students in science education and teaching through Junior Achievement. For financial aid, the support was focused on increasing access to healthcare, contributions to developing nations, and other global programs. The company donated $48.1 million in Baxter products through donor partners and the company's US patient assistance programs and $27.2 million from Baxter's businesses and facilities to address local needs in more than 37 countries. 

 Baxter also noted its efforts to reduce its carbon footrpint in product transport. The company participates in the US Environmental Protection Agency's SmartWay program as both a carrier partner and a shipper partner. SmartWay is a partnership between EPA and industry to help reduce air pollution and greenhouse-gas emissions through cleaner and more fuel-efficient transportation options. Baxter became a SmartWay Carrier Partner in 2009 with its US renal truck fleet and was accepted into the SmartWay Partnership as a shipper in January 2011. In other supply-chain efforts, in March 2011, Baxter was recognized as a Tier III Partner in the US Customs–Trade Partnership Against Terrorism (C-TPAT) program. C-TPAT is a joint US government–business initiative that builds cooperative relationships to enhance security throughout the import supply chain. 

With start-up funding and hands-on support provided by several partners, including Baxter, Chicago's first charter health-science career academy, the Instituto Health Sciences Career Academy (IHSCA), broke ground on Feb. 18, 2011, and is slated to open in late 2011. The school will provide up to 600 mostly Latino students with an opportunity to receive a college-preparatory math and science education that will enable them to enter healthcare careers. 

, a medical-technology company, is donating $325,000 to assist in relief efforts for victims of the earthquake and tsunami in Japan. BD will distribute these funds among the nonprofit disaster relief and humanitarian aid organizations AmeriCares, the American Red Cross, Direct Relief International, Heart to Heart International, Project HOPE, Save the Children, the US Fund for UNICEF, World Vision, and the Give2Asia Japan Earthquake and Tsunami Fund. BD is currently working with these nonprofit organizations to assess the country's needs for healthcare products and will respond accordingly when the assessments are complete. Additionally, the company will match donations from its associates worldwide to the US Fund for UNICEF and the American Red Cross, up to a total of $50,000. This match is in addition to BD's traditional Matching Gift Program, which matches donations from US associates to eligible nonprofit organizations. 

 awarded a Positive Charge grant to the American College of Physicians (ACP) Foundation to support ACP Foundation’s HIV workforce-capacity-building initiative. ACP Foundation’s initiative seeks to address the US HIV medical workforce shortage and increase healthcare-capacity building and skill- transfer support programs to help benefit people living with HIV and AIDS in areas of high unmet need. The Positive Charge grant to the ACP Foundation totals $2.93 million over three years and is the second major Bristol-Myers Squibb Positive Charge grant focused on expanding access to HIV care and treatment in the US. 

 has awarded four new grants to help improve awareness, prevention, and care of hepatitis B and hepatitis C in China and India. The grants total nearly $1 million and bring the foundation’s commitment to reducing hepatitis-related health disparities in Asia to $8 million over the past three years. 

 has joined EPA’s SmartWay Transport Partnership, which brings together major freight shippers, trucking and distribution companies, and trade associations, to reduce emissions and improve environmental programs. 

 is investing $100 million in projects to reduce energy usage and greenhouse-gas emissions. The $100-million in investment capital will be awarded to Dow business units and manufacturing sites that present projects with the greatest impact in several key performance areas, including reductions in energy use and greenhouse emissions and accelerated cost savings. To date, Dow business units have submitted around 60 projects, with a net present value totalling more than $500 million, nearly 8 trillion BTUs of energy savings, and a reduction of over 400,000 metric tons of carbon dioxide emissions. 

 also is donating up to $6 million in humanitarian aid in response to the earthquake and subsequent tsunami that struck Japan in March. The company will donate $2 million to the City of Soma Community Rescue Fund, up to $3 million to the Soma region in Dow product, technology, and financial resources for long-term rebuilding, and is developing a plan to offer employees a matching grant opportunity of up to $1 million. 

 has launched its new global service program, Connecting Hearts Abroad. Through the program, the company is sending 200 Lilly ambassadors to assist people and communities that  lack basic resources and to gain a deeper, more intimate understanding of different cultures and see firsthand the problems and opportunities associated with improving human health in developing areas. The first of 200 Lilly Ambassadors started their two-week assignments in New Delhi, India, on April 2, 2011. The program will send ambassadors to 38 countries in Latin America, Asia, and Africa and provide support in healthcare, caregiving of the eldery, children, and the disabled, teaching, and community development. Lilly is partnering with  Cross-Cultural Solutions, an international not-for-profit organization that operates short-term volunteer programs in 12 countries. 

 issued its corporate responsibility report last month. GSK announced a new environment strategy, which included the objective that the company’s operations become carbon neutral by 2050. This target means there will be no net greenhouse gas emissions from manufacturing, distribution, use and disposal of products and the sourcing of raw materials. The company has interim targets to reduce its overall carbon footprint by 10% by 2015 and 25% by 2020, reduce its operational water consumption by 20% by 2015, and reduce waste to landfill from operations by 25% by 2015 and to zero by 2020. The company estimates that it will save £100 million ($161 million) per year 2020 through reduced energy, materials and distribution costs. 

GSK also outlined is progress and goals for improving access to medicines in the developing world. In July 2010, GSK created a specific Developing Countries and Market Access (DCMA) business unit dedicated to increasing patient access to GSK medicines while expanding the company’s presence and helping it build a sustainable business in developing countries. The unit’s success is judged on profits and its contribution to increasing access to medicines. These efforts include a commitment to reduce prices of GSK patented medicines in least developed countries to no more than 25% of their price in the United Kingdom (or in France for products not sold in the UK). The company also repeated its pledge to price is malaria vaccine candidate, now in late-stage development, at affordable levels. GSK has committed to price the vaccine at a level that covers costs and generates a small return of around 5% which it will reinvest in the development of future vaccines for malaria or other products for diseases of the developing world. Also, ViiV Healthcare, a HIV company established by GSK and Pfizer, extended its policy on voluntary licenses in 2010. Voluntary licenses are granted by patent holders to allow generic-drug  companies to manufacture and sell their products.  ViiV Healthcare has now granted 11 voluntary licenses for its antiviral drugs to treat HIV/AIDS. 

Overall, GSK reported charitable contributions of £222 million ($358 million) in 2010, an increase of 36% over the previous year. The £222 million represents £147 million ($237 million) in product donations, £53 million ($85 million) in cash donations, £18 million ($29 million) in management costs, and £4 million ($6 million) for in-kind donations. 

For relief efforts for the earthquake and tsunami in Japan GSK is donating £1.5 ($2.4 million) to the Japanese Red Cross to support the immediate efforts to supply clean water, blankets, and food supplies. The company also is donating cold medicines and oral care products worth £600,000 ($967,000). 

Additionally,GSK reported in February 2011 of the incorporation of Synflorix, its pneumococcal vaccine, into the Kenyan national immunization program.  Kenya is the first African country to receive pneumococcal vaccines through the financing mechanism known as the Advance Market Commitment (AMC), which is designed to bring discounted vaccines to developed countries. GSK’s Synflorix is the first vaccine to be rolled out in Africa under the AMC framework and provides protection against 10 strains of the pneumococcus bacteria that are responsible for the large majority of pneumococcal disease in Kenya and worldwide. Sierra Leone also is introducing pneumococcal vaccines through the AMC in Africa, and Yemen is doing the same in the Middle East. Certain countries in Latin America are also eligible to receive pneumococcal vaccines through the AMC.  Nicaragua began vaccinating children in late 2010, and Guyana is introducing vaccines this year.  In total, the Global Alliance for Vaccines and Immunization anticipates that more than 40 developing countries will receive pneumococcal vaccines through the AMC by 2015. In March 2010,GSK and Pfizer signed 10-year contracts through the AMC to provide up to 300 million doses each of their pneumococcal vaccines at an approximate reduction of 90% of the cost in developed markets. 

 has received a 2011 EPA Energy Star Sustained Excellence Award for the company’s energy-management program, including Energy Star designations for six manufacturing sites and the two corporate office buildings at the company's headquarters campus. The company has established a greenhouse-gas reduction goal of 10% by 2015 from a 2009 baseline. Three  Merck manufacturing sites (Stonewall, Virginia; Wilson, North Carolina;, and Barceloneta, Puerto Rico)  received the Energy Star Challenge for Industry for reducing energy use by more than 10% during the previous three years. Three additional manufacturing sites (Cleveland, Tennesse; Elkhorn, Nebraska; and Las Piedras, Puerto Rico) earned an Energy Star award for ranking in the top 25% of pharmaceutical plant-energy performance nationwide, and Merck's headquarters in Whitehouse Station, New Jersey, qualified for the Energy Star label for the third time. 

reported on its  Triple Bottom Line business principle, balancing economic, social, and environmental decisions, in China. A study, conducted by Novo Nordisk in collaboration with Accenture, confirms the relationship between Novo Nordisk's market-entry strategy, including physician training, patient education, local production, and the value created for Novo Nordisk and Chinese society by reducing the personal and economic burden of diabetes. Conducted in 2010, the study highlights Novo Nordisk's training of 220,000 physicians and 280,000 people with diabetes as a driver of shared value. The study also details Novo Nordisk's initiatives to reduce carbon dioxide emissions through a production facility in Tianjin, China, which achieved a 20% reduction in carbon dioxide, energy, and waste compared with the company’s current best-in-class production facility in Brazil. The production facility will make better use of localized suppliers and reduce product-distribution distances, saving 25,000 tons of carbon dioxide from 2012 to 2018, according to the company. 

 signed a new agreement to donate $25 million, extending its decade-long partnership with the World Health Organization for another five years, to control neglected tropical diseases, including African sleeping sickness. Including the additional $25 million donation, the company’s total contribution amounts to $75 million.  This new donation includes medicines and funding for professional training, disease-awareness campaigns, logistics, and infrastructure. 

 has contributed JYP 300 million ($3.6 million) in cash to aid emergency relief for the earthquake in Japan. In addition to the cash donation, Takeda is planning the donation of pharmaceutical products. 

Guiding Principles for Business and Human Rights 

 late last month. The Guiding Principles provide for the first time a global standard for preventing and addressing the risk of adverse human-rights impacts linked to business activity, according to the UN. The UN Human Rights Council will consider formal endorsement of the text at its June 2011 session. The Guiding Principles are the product of six years of research and consultations, led by the Secretary-General's Special Representative for Business and Human Rights, Harvard professor John Ruggie, and which included input from governments, companies, business associations, civil society, affected individuals and groups, and investors. The Guiding Principles outline what steps states should take to foster business respect for human rights,  provide a blueprint for companies for understanding and showing that they respect human rights and for reducing their risk of causing or contributing to human rights harm, and constitute a set of benchmarks for stakeholders to assess business respect for human rights. 

Towards Universal Access to Diagnosis and Treatment of MDR-TB and XDR-TB by 2015

, to address the progress and work needed to be done to combat multidrug-resistant tuberculosis (MDR–TB). WHO estimates there will be more than 2 million new cases of MDR-TB between 2011 and 2015. Programs financed by theGlobal Fund to Fight AIDS, Tuberculosis and Malaria and that follow WHO treatment standards are expected to diagnose and treat about 250,000 people for MDR-TB by 2015. It is anticipated that the Global Fund will provide 84% of all international investments in TB in 2011. However, both domestic and international resources need to be scaled up to cope with MDR-TB and to continue progress in the fight against TB, according to the Global Fund. 

 issued its first-ever list of priority medicines for maternal and child health. The top 30 priority list was compiled by experts in maternal and child health and medicines, who analyzed the WHO Model List of Essential Medicines and the latest WHO treatment guidelines to establish which medicines would save the most lives.The drugs on the priority medicines list for mothers and children are all included in the current version of the WHO Model List of Essential Medicines, which is reviewed every two years by the Expert Committee on the Selection and Use of Essential Medicines. The committee, which met in Accra, Ghana, in late March, also is reviewing and considering 16 applications for the addition of a new medicine to the model list, seven applications for the addition of a new formulation, and nine applications for the deletion of a medicine from the list. The committee also discussed several policy items. These items include the role of clinical pharmacologists in relation to improving use of medicines, new strategies and directions for improving the rational use of medicines, a draft document on how to develop a national essential medicines list, and a proposal on missing essential medicines for the treatment of HIV in adults and children. 

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.