The Novartis  Foundation for Sustainable Development, the philanthropic arm of Novartis, held  a symposium on Dec. 2, 2010, which focused on the progress and steps ahead required for achieving the 

United Nations (UN)  Millennium Development Goals (MDGs)

, a set of eight goals to help alleviate  poverty and improve economic and social development in the developing world.  The symposium continued the dialogue that started at the 

, which took place in New York in September 2010.  More than 500 representatives from nongovernmental organizations (NGOs), the private  sector, universities, and international organizations took part in the  symposium, according to a Dec. 16, 2010, Novartis press release.


The UN MDGs were adopted in 2000 by 189 UN member  states. The MDGs consist of eight major objectives,  targeted to be met by 2015, which require the participation of developed and  developing nations and entail time-bound targets for addressing extreme  poverty, hunger and disease, gender equality,  education, and  environmental sustainability.They also express basic human rights: the rights  of everyone to good health, education, and shelter. The eighth goal, to build a  global partnership for development, includes commitments in development  assistance, debt relief, trade, and access to technologies. Specifically, the MDGs are: eradicate extreme poverty and hunger; achieve universal primary education;  promote gender equality and empower women; reduce child mortality; improve  maternal health; combat HIV/AIDS, malaria, and other diseases; ensure  environmental sustainability; and develop a global partnership for development, The summit held in September 2010 reviewed the progress, assessed obstacles and  gaps, and discussed strategies and actions to help meet the MDGs by the target  date of 2015. 

At the Novartis symposium held in December 2010, Joseph Jimenez, CEO of Novartis,  stressed that the healthcare industry is committed to providing solutions to  global challenges. In the case of Novartis, specifically, this commitment is focused  on improving access to healthcare, which includes the donation of leprosy  drugs, the delivery of anti-malarial treatments at no profit as well as  

 neglected disease research.  He  also mentioned a pilot project in Tanzania to monitor stock levels of  antimalaria drugs in public-health facilities by using text messaging as a way to  prevent supply shortages and improve access to medicines. 

Novartis issued a report, “Achieving the UN  Development Goals: The Contribution of Novartis,” to outlined the efforts by  the company in achieving the MDGs, particularly as they relate to improving  access to healthcare, Novartis noted that through its access-to medicine programs,  valued at $1.5 billion, it has supplied medicines to people in  developing and developed nations. Approximately 94% of program beneficiaries  are malaria patients, which gain access to the company’s antimalaria drug,  Coartem, which consists of the active ingredients, artemether,  an artemisinin derivative, and lumefantrine. 

In addition to improving access to malaria  treatments, the company has access-to-medicines initiatives for treatments for  tuberculosis and liver fluke. In India, the company uses a social-business  model, Arogya Parivar, which aims to improve access through healthcare through  a network of community-health educators, mainly women, who help to promote  disease awareness among villagers. The program also engages rural practioners  to encourage compliance, and Novartis also makes select generic drugs and  over-the-counter medicines, particularly those that target child and maternal  health, available to rural pharmacies.  In addition, through the Novartis Institutes for Developing World Medical Research, the company conducts 

research for treatments for malaria,  tuberculosis, dengue fever, and diarrheal disease. 


 Other speakers at the  Novartis symposium addressed the progress and work needed to  achieve the UN MDGs. Jeffrey Sachs, director  of the Earth Institute at New York’s Columbia University and special advisor to  the UN Secretary-General, said the MDGs would be achievable only if the  governments that had adopted them 10 years ago honored their pledges. He  pointed out that wealthier countries, such as the US, Japan, and Switzerland, were  setting aside far less than the 0.7% of their economic output originally agreed  for development cooperation. Overall, he cited the need to improve investment in infrastructure, elementary schools, and secondary schools,  particularly for girls. In healthcare, he pointed to the importance of training healthcare workers, increasing emergency obstetric care, and committing more financial resources  for the Global Fund to Fight AIDS, Tuberculosis and Malaria. He also mentioned  the lack of money to fund climate adaptation and improve water supplies. 

Salim Abdulla, a  specialist in tropical medicines, and Flora L. Kessy, a social research scientist,  both from the Ifakara Health Institute in Tanzania, shared their  experiences in reducing child and maternal mortality. Due to improved health  services and ongoing education programs, Tanzania should succeed in halving  mortality in children under the age of five by 2015. However, success in  reducing maternal mortality has not been as great. Although trending downward,  the incidence of 450 deaths per 100,000 live births in Tanzania is more than  five times higher than the incidence of maternal mortality in European countries. They indicated that the large  number of home births without qualified help was the main reason for the slow  progress. In addition, Kessy pointed to successful approaches in improving access to healthcare, such as the use of microcredits to support women’s  groups, the establishment of small-scale, community-health funds, rapid diagnostic tests, and support for accredited drug-dispensing outlets. 

Eveline Herfkens, the former Minister for Development Cooperation  of the Netherlands and executive coordinator for the UN Millennium Development  Goals Campaign, shared her belief that governments, not charitable  institutions, were responsible for funding development. She stressed the importance of having governments of recipient countries decide  how to spend money as a means to create ownership and oblige good  governance by the recipient country. 

Klaus M. Leisinger, president and managing director of the Novartis  Foundation for Sustainable Development, discussed the cooperation between NGOs  and private companies. In recent years, he noted that relationships have improved significantly, and both parties have learned to think about the results achieved rather than  their individual contributions. In development cooperation as elsewhere, he said that one  should look at the return on invested funds, and payments should be linked to  the achievement of jointly agreed goals. He advised that NGOs use management  methods developed by the private sector. Looking into the future, he said that  multinational companies will be increasingly judged by the contribution they  are making to solve global problems. Amir  Dossal, who was responsible for the UN’s partnerships with private  donors, also emphasized the need for more cooperation between the private and public sectors. As an example, he reported that the privately funded UN Foundation currently supports more than 450 projects on  women’s and children’s health, climate change, and biodiversity protection.

Articles

CSR and Sustainability Forum

The Novartis Foundation for Sustainable Development held a symposium in December 2010 to continue dialogue on how the private and public sector can work together in achieving the UN Millennium Development Goals.

Novartis Participates in Achieving the UN Millennium Development Goals

The beginning of the new year is the time when many of us take stock of where we are and where we are headed. So, we will do the same and look at some of the key forces that we see driving and shaping the contract services industry, particularly those companies offering contract development and manufacturing services (CDMOs and CMOs). 

 Like the broader economy, the pharmaceutical services industry will continue to recover at a slow, steady pace, but a return to the halcyon days of the last decade is extremely unlikely. The good news is that many of the indicators are improving. Research and development (R&D) spending is growing, and financing from public equity markets and venture capitalists has improved. The large mergers and consequent integration efforts have been largely completed, and the global bio/pharmaceutical companies are again focused on pursuing compounds through their pipelines. 

Still, there is a great deal of uncertainty clouding the picture. The big restructuring efforts may be over for now, but bio/pharmaceutical companies continue to cull their pipelines to focus their efforts on the most promising therapeutic areas and candidates. Mid-size bio/pharmaceutical companies are doing the same thing, as witnessed by Biogen Idec's (Weston, MA) decision late last year to exit all therapeutic areas except neurology. Further, although external financing has improved, much of that is going to late-stage candidates, so the efforts of early-stage bio/pharmaceutical companies are still hampered. 

Other complicating factors include government efforts in all Western countries to reduce spending. These potential cuts could hurt bio/pharmaceutical profits and potentially hit heretofore sacred cows such as the National Institutes of Health, which underwrites a great deal of bio/pharmaceutical research in the US. 

The best news for the CDMO and CMO industry is that most major bio/pharmaceutical companies appear committed to outsourcing more of their development and manufacturing requirements. All of the companies have recognized the need to reduce fixed overhead costs and match spending to what is actually happening in their pipelines. So, while total R&D spending may grow at low single-digit rates, total outsourced spend should grow at a faster rate. 

 Although the outsourcing pie will increase in size, it certainly won't be divided up evenly. As the pharmaceutical industry restructures, so will the contract services industry that supports it, and industry consolidation will be a principal result. That restructuring is well underway in the clinical and preclinical development arenas, where the five largest firms already command nearly 50% of the market and are picking up share at a rapid pace. As discussed in past columns, the market leaders have succeeded by building a track record of dependable performance for their clients and broadening their offerings to meet the needs of their increasingly global clients. 

The same dynamic is taking place in the CDMO and CMO world, but at a slower pace. Outsourcing in this arena is slowed down by the considerable investment in manufacturing and laboratory assets that the global bio/pharmaceutical companies already have in place. Given the high costs of operating those facilities, companies are under pressure to keep them as highly utilized as possible. A growing number of global bio/pharmaceutical companies have even resorted to selling their excess capacity on the open market. Until the global companies are ready to face the considerable costs of closing down those underutilized facilities, the pace of outsourcing development and manufacturing activities other than packaging and laboratory services will be slow.  

 We see the formulations development and manufacturing segment engaging in a technology arms race in which competitors seek to broaden their formulation and processing "toolbox." The goal is to build a service offering that is comprehensive enough to serve a large share of a major client's needs and/or address the requirements of a broad swath of the industry's development pipeline. CMOs are rushing to add such capabilities as dry granulation, solubility enhancement, and handling of high-potency compounds, as well as bolstering their preformulation capabilities. In addition, CMOs are building their analytical capabilities for large molecules, reflecting the nature of the candidates in the pipeline. This drive to acquire drug-delivery, processing, and analytical technologies is crucial to the effort to fain "preferred supplier" status with the global bio/pharmaceutical companies, which favor suppliers with broad capabilities in their drive to reduce the number of supplier relationships they maintain. 

CMOs specializing in APIs went through a similar technology arms race 10 years ago. They learned that a broad technology offering was a necessary but not sufficient dimension for competitive success. Technology capabilities can often be duplicated, making it difficult for CMOs to differentiate themselves on that dimension alone. While CMOs expand their technical capabilities, they will need to maintain their focus on performance and serve a client base with increasingly global aspirations. 

.  It looks to us that the biggest challenge facing the CMO and CDMO industry is globalizing its offerings. Clinical research organizations (CROs) have moved aggressively to create a global footprint, and their ability to support international clinical trials is a big reason why the largest CROs such as Quintiles (Research Triangle Park, NC) and Icon Clinical Research (Dublin) have come to dominate the CRO industry. 

CMOs and CDMOs have been slow to attack the global development and manufacturing opportunity. Only a few Western API development and manufacturing companies, including Lonza (Basel), Aptuit (Greenwich, CT), and AMRI (Albany, NY), have made a major effort to establish their presence in emerging markets. In part, this slow pace reflects the relatively recent nature of the opportunity: demand within emerging markets for services such as formulation, manufacturing, and clinical packaging is following the growth of clinical trial activity in those countries. The slow response only reflects the fact establishing a presence in the emerging markets requires significant investment in key business assets, including facilities, senior management and technical staff, and knowledge about how to do business in those countries. 

Interestingly, the CDMOs and CMOs that have been most aggressive in growing their global network of operations have been those companies founded and headquartered in the emerging markets themselves, companies such as Piramal Pharma Solutions (Mumbai), WuXi AppTech (Shanghai), and Jubilant Life Sciences (Noida, Uttar Pradesh, India.) Understanding the next steps these companies will take to become truly large global players in the CMO and CDMO market is central to knowing where the industry is headed next. 

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

Outsourcing

CDMOs and CMOs face weak economic recovery, consolidation, and globalization.

What to Watch for in 2011

One year  following the devastating earthquake in Haiti, the pharmaceutical industry and  the business community continue to provide assistance to the country for its  relief and reconstruction projects. One recent project is a partnership between  Abbott and the humanitarian-relief organization Partners in Health for  nutritional food support. Also, at the World Economic Forum, held in late  January in Davos, Switzerland, participants outlined some of the private-sector  investment being made to help improve the economic situation in the country. 

 
 In  January 2011, Partners In Health (PIH) and Abbott and its philanthropic foundation, the Abbott Fund, announced a partnership to create  local solutions to the longstanding problem of severe malnutrition in Haiti. PIH  and Abbott plan to build a nutritional-food production facility that will allow  Haitians to produce locally sourced, high-quality nutritious food products. The  initiative also aims to empower local communities by creating local markets,  supporting local farms, and promoting economic development. The total value of  this multiyear initiative is estimated at more than $6.5 million,  including contributions from Abbott and the Abbott Fund, and the estimated  value of ongoing expert consulting provided by Abbott employees

"This ambitious partnership between PIH,  Abbott, and the Abbott Fund will help to address severe malnutrition in Haiti while also serving as an example of how partnerships can help to provide  economic empowerment for local communities," said Paul Farmer, cofounder  of PIH in an Abbott Jan.17, 2011, press release.”Abbott experts are working shoulder to  shoulder with Haitian farmers and community-health workers to create local,  sustainable solutions to treat malnutrition in children. By sharing the  collective expertise and resources of business, nonprofit organizations, and  civil society, we can help the people of Haiti build back better," he  said.

The new PIH nutritional production facility will be  located near PIH's main hospital in Cange in Haiti's central plateau region.  The facility initially will be focused on producing Nourimanba, PIH's  peanut-based, ready-to-use therapeutic food product, to treat severe childhood  malnutrition. In the future, the new facility also could be used to  develop and sell nonmedical nutritional foods, such as peanut butter, to  support the continued production and free distribution of Nourimanba by PIH.  The facility, which is expected to break ground in mid-2011 and begin  operations in early 2012, will be equipped with low-maintenance equipment  suited to operations in Haiti.

 The new facility will be constructed by local  workers. Abbott experts in nutrition science, engineering, quality, and  manufacturing will join PIH staff in supporting all aspects of the project,  including design and construction of the facility, product quality and safety,  and expansion of production capabilities. When completed, the facility will be  able to employ up to 60 Haitians to handle production. The initiative also will  help expand agricultural development in the region by working with hundreds of  local farmers to source peanuts, the main ingredient in Nourimanba. Nourimanba  is a high-calorie, high-protein, fortified peanut-based paste that is ready to  eat by the patient and does not require mixing or refrigeration. PIH and Abbott experts will conduct training to build local capabilities  and develop the skills of local workers to ensure long-term sustainability.

"Severe childhood malnutrition is a complex  problem in Haiti that demands innovative, local solutions," said Katherine  Pickus, vice-president, the Abbott Fund, and divisional vice-president of global  citizenship and policy at Abbott, in the Abbott release. "As a longstanding  leader in strengthening local communities in Haiti, Partners in Health has  demonstrated a strong commitment to pioneering new approaches. Abbott and the  Abbott Fund look forward to working together with Partners In Health to build a  new nutrition production facility, train local staff, and empower local  communities to develop long-term solutions to malnutrition in Haiti."

The new initiative in Haiti is an extension of an  ongoing partnership between PIH, Abbott, and the Abbott Fund to expand access  to healthcare in developing countries. Projects are addressing critical  community needs in Haiti and countries in Africa, which also include establishing a  women's health clinic in Lascahobas, Haiti, and building a rural hospital in  Lisungwi, Malawi. Since 2007, Abbott and the Abbott Fund have provided  more than $48 million in grants and product donations to help address  health needs in Haiti, including maternal and child health, diabetes, HIV/AIDS  and malnutrition. In addition, Abbott and the Abbott Fund provided more than  $6 million to support relief efforts following the devastating earthquake  in January 2010. Most recently, Abbott has provided grant funding and donations  to help address the cholera outbreak in central Haiti.


 The  PIH-Abbott project is an example of ongoing private and public-private  partnerships focused at providing sustainable solutions to the social and development  concerns in Haiti. At the meeting of World Economic Forum, which was held Jan.  27–30, 2011, in Davos, Switzerland, public and private sector leaders pointed  to the potential of improved economic growth for Haiti. The World Economic  Forum is an independent international organization  committed to improving the state of the world by engaging business, political,  academic, and other leaders of society to shape global, regional, and industry  agendas.

The World Economic  Forum issued a report, 

Private Sector Development in Haiti:  Opportunities for Investment, Job Creation and Growth

,  in partnership with the World Bank, the Inter-American Development Bank (IDB)  and the International Finance Corporation (IFC). The full report is available 

 The report concluded that Haiti  can achieve growth in its gross domestic product (GDP) of 6–8% during the next  decade if the right public policies are put in place, the national and  international private sector becomes increasingly engaged, and support from the  international community is maintained. 

 “Despite  the challenges, Haiti possesses the economic fundamentals to experience  sustained growth. However, it cannot achieve it alone,” said Robert Greenhill, managing  director and chief business officer, World Economic Forum, in a Jan. 28, 2011,  World Economic Forum press release. “The private sector played an important and innovative role in  supporting humanitarian assistance to Haiti right after the earthquake, and now  it has an equally important role to play in helping Haiti achieve an  accelerated economic trajectory.”

 The report outlines opportunities for businesses  in Haiti and measures taken to encourage private-sector engagement, such as the  development of Special Economic Zones (SEZs). SEZS are areas identified by the  government as fast-track zones for commercial development to be equipped with  the infrastructure and regulatory framework to attract business. The World Bank  and IFC are actively engaged with the Haitian government to improve its  investment climate.

"The World Bank Group remains committed to  helping Haiti catalyze private investment and improve the business environment.  We are convinced that the private sector is essential for Haiti’s long-term  development, to create jobs and help the country break its dependence on  aid," said IFC’s Chief Executive Officer and Executive Vice-President Lars  Thunell, in the World Economic Forum release. "This joint report highlights the opportunities and challenges in  improving Haiti's investment climate, in particular business regulation, access  to basic infrastructure, logistic and financial services, and access to skills.  Multilateral banks, donors, the government of Haiti, and the private sector  should develop the framework that will address these challenges."

  The report outlines specific areas where the  private sector can become involved, highlighting opportunities in construction  and infrastructure development, agriculture, manufacturing, finance, tourism, and  energy. A specific example from the manufacturing sector is IDB’s recent  announcement of its support, along with the US government, of a $250-million deal  to develop an industrial park in northen Haiti that is expected to generate as  many as 65,000 jobs.

 “Haiti has countless needs, but what it  desperately requires to climb out of poverty is more jobs,” said IDB President  Luis Alberto Moreno, in the World Economic Forum release. “Our goal is to persuade several companies  from diverse industrial sectors to set up shop in the north, not only to boost  employment and economic activity outside of Port-au-Prince but also to change  common risk perceptions about Haiti, so that many more investors may follow  them.”

 The report also highlights examples of how  international businesses are actively engaged in mutually beneficial  partnerships designed to help grow Haiti’s economy. Under a public-private  partnership structured by the IFC, Haiti’s government and central bank, Banque  de la République d’Haiti, signed an agreement with Vietnam’s largest  mobile-telephone operator, Viettel, for $99 million. The agreement has led  Viettel to commit significant investments, including the construction of  Haiti’s first nationwide fiber optic backbone.

 Other examples of private-sector investment  include: the Coca-Cola Company’s Haiti Hope project, which was launched in  September 2010, with the goal of doubling the income of 25,000 Haitian mango  farmers over five years. It is a partnership between the Coca-Cola Company, IDB’s Multilateral Investment Fund, the United States Agency for  International Development, and TechnoServe, with the support of the Clinton- Bush Haiti Fund,  and other international and local organizations. 

 Other  examples include mobile-phone operators Voila and Digicel launching mobile-banking services in an effort to maximize resources of nongovernmental  organizations, bolster reconstruction efforts, and provide Haiti’s “unbanked”  population access to financial services. Alhough 85% of Haitian households have  access to a cell phone, there are only two banks for every 100,000 people in  the country. It is hoped that mobile-money products will enable Haitians to transfer money  domestically and internationally and complete commercial transactions  wirelessly, including using their cell phones to purchase food and nonfood  items from a network of affiliated merchants throughout the country. Voila,  Haiti-based Unibank, and the international aid agency Mercy Corps have joined  together to launch a mobile-banking service called T-Cash that offers  beneficiaries of Mercy Corps’s cash program the opportunity to receive and make  payments using their Voila phones. Digicel and Canada’s Scotiabank have  partnered to create Tcho Tcho Mobile, which offers mobile-banking services that  enable users to perform cash withdrawals, deposits, and transfers through their mobile phones.

 Another  project is from Swiss Re, one of the world’s largest reinsurers, which formed a  partnership with Caribbean Risk Managers Limited, Guy Carpenter Micro Risk  Solutions, and Haiti’s largest microfinance institution, Fonkoze, to design a micro-insurance scheme for  catastrophes in Haiti. The project will allow highly vulnerable Haitians to  protect themselves from natural disasters at a reasonable cost. Also, YY Haiti, an  initiative of the Grameen Creative Lab, the Yunus Center, and the software and  information-technology services company SAP intend to create the infrastructure  and provide the skills needed for social businesses in Haiti. YY Haiti is a  fund investing in social businesses in Haiti and also provides appropriate  business training. YY Haiti functions as a self-sustainable social business  that is financed through the management fees earned from the social businesses  in which it invests. Once the social businesses have returned their initial  investment, the fund reinvests this money into new social businesses. Initial  social business investments include a cocoa-processing plant and an eco-hotel  in Cap Haitien. Another 14 social businesses are currently in the due-diligence  process.

One year following the earthquake in Haiti, the pharmaceutical industry and private sector participate in efforts for long-term relief.

Pharmaceutical and Business Leaders Focus on Haiti

 have  implemented a pilot program at the hospital that is designed to safely divert from landfills a significant percentage of BD sharp waste, such as single-use  disposable medical devices, and use the recycled materials. One approach BD  is exploring to manage its disposable medical-device products is a cradle-to-cradle  program for every stage of a product's life cycle. The process entails recycling  waste materials and using them to manufacture new products rather than  permanently disposing of them in a landfill. Approximately 38,000 pounds of  sharp waste that might have been sent to a landfill will be recycled under the program with the hospital. Based on initial tests, BD believes that more than 70% of its overall sharps waste may ultimately be recovered and recycled for  use in new products. The pilot program, developed in collaboration with Waste  Management, a waste-management and recycling company, uses BD Sharps Containers  as aggregation points for the collection of sharp waste. Waste Management  collects filled sharp containers at the hospital, transports the material to a  nearby Waste Management facility, safely treats the waste to eliminate any  potential biohazard, and sends the treated material to a local recycling  company for raw-material recovery. BD then incorporates these post-hospital  recycled materials, along with recycled materials from other sources, into the  making of new BD Recykleen container products. BD plans to sell excess recycled  materials that cannot be used in BD products to other recyclers.

, a provider of plasma-protein  therapies and a subsidiary of  the Australian pharmaceutical company 

,  has contributed advocacy grants totaling approximately $100,000 to six patient organizations  through the Local Empowerment for Advocacy Development (LEAD) program. LEAD  grants support the grassroots advocacy efforts of organizations committed to  helping people who use plasma-derived or recombinant therapies to manage rare  and serious diseases. The following organizations were awarded CSL Behring LEAD  grants: the 

 to assist in  emergency-relief operations for the floods in Australia. In addition to the  donation of $200,000 to the Premier's Flood Relief Appeal, Dow Australia will  be working closely with its customers and industry to identify projects that  support long-term recovery in the region. 

, an organization focused on environmental conservation, formed a collaboration to apply scientific  knowledge and experience to examine how Dow's operations rely on and affect  nature for the purpose of advancing the incorporation of the value of nature into business and to take action to protect the earth's  natural systems and the services they provide people for the benefit of  business and society. One of the major objectives of the collaboration is to  share tools, lessons learned, and results, publicly and through peer-review, so that other companies, scientists, and interested parties can test and apply  them. Dow and its foundation are committing $10 million to this collaboration  over the next five years. The Nature Conservancy will provide strategic,  science-based counsel and technical support to help answer questions about the  value and benefits of natural areas on or near where Dow works, such as the  benefits of a forest to ensuring clean water for towns and factories, and the role that natural wetlands and reefs play in preventing damage from storms. The collaboration will use scientific models, maps, and analysis for biodiversity  and ecosystem services, or the benefits  that nature provides for people, such as clean air, water, and food,  and apply  them to Dow's business decisions. It will inform Dow on setting new policies  and approaches in the areas of land and water management, siting  considerations, the benefits of natural resources on Dow lands and waterways,  and more explicit management of biodiversity. Scientists from both  organizations will implement and refine ecosystem services and biodiversity  assessment models, initially, on at least three Dow manufacturing sites.

, has granted multiple nonexclusive licenses to generic-drug manufacturers, including two Indian companies, 

 of South Africa to manufacture, market, and distribute the  investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents for  treating naïve HIV-1 infected adults.  The generic pharmaceutical  manufacturers in India will have rights to market the product in sub-Saharan  Africa (SSA), least-developed countries (LDCs), and India. Aspen will have  rights to market the product in SSA, including South Africa. Under the  agreement, the generic-drug manufacturers will be entitled to manufacture once-daily  25 mg TMC278 as a single-agent medicine and a fixed-dose combination  product. The project is part of the Johnson & Johnson Global Access &  Partnerships Program, which seeks to increase the availability of HIV medicines  to patients in need. The program also is  working through existing  agreements with generic-drug manufacturers Aspen as  well as 

 of India to broaden access to the medicines darunavir and etravirine in  SSA and LDCs and to darunavir in India.

 expanded its  renewable-energy portfolio by unveiling a wind turbine at P&G's pet-care  plant in Coevorden, The Netherlands by installing solar panels at its beauty and grooming plant in Cologne, Germany. The Coevorden turbine is the company's first  investment in wind energy and became operational in January 2011. The wind  power will supply approximately 17% of the plant's annual energy consumption.  The turbine is estimated to produce approximately 5500 megawatt hours of energy  per year, enough to power up to 1500 houses in The Netherlands.

 Additionally, P&G is planning to have solar panels installed atop one  of its plants in Cologne, Germany, with plans to extend solar installation to other sites in the  region. An estimated 796 megawatt hours of energy per year will be produced by  this initial installation, which is enough to power approximately 200 households in  Germany and contribute to a reduction of 544 metric tons of carbon dioxide per  year. Construction on the solar panels will begin in the spring of 2011 and is  expected to begin producing electricity in the summer of 2011. The Dutch and  German plants join other P&G sites in the US, Germany, and Mexico in  making  progress in renewable-energy use. 

 (Jordbro, Sweden), a contract development and  manufacturing organization, presented its annual International Environmental  Award for best environmental performance or environmental innovation in the  pharmaceutical and healthcare industries and academia to the 

  in  December 2010. The award was established in 2008. Past winners include  Apoteket, a  Swedish pharmaceutical association in 2008, and Klaus Kümmerer, professor at  Freiburg University in Germany. The Wellcome Trust Genome Campus was recognized for conducting several projects, including receiving ISO 14001  certification in 2009. For example, the organization's waste to landfill was reduced by 75%. Recipharm awarded Wellcome Trust Genome a monetary award  of SEK 30,000 ($4,400) in December 2010. 

, a new  multi-stakeholder organization, was launched in January 2011, with the goal of promoting  and improving sustainable and socially responsible business practices,  providing a space for cross-functional collaboration, and developing a  performance-based sustainability index. SAC is a coalition of industry, academia,  the investment community, and governmental and nongovernmental organizations (NGOs). Membership in SAC is open to industrial facilities, academic institutions,  governmental organizations, NGOs,  the investment community, and  trade associations. Members will be designated as alliance or participating  members, based upon their desire to set measurable goals and report upon them  publicly. Alliance members, generally academic institutions, government organizations, and  NGOs,  will support SAC, but will not set goals.  Participating members, generally industrial facilities, will set and report on  goals. Johnson & Johnson and Pfizer are among the founding members of SAC. 

, a cross-functional coalition of representatives from industry, academia,  government, and NGOs, will be held  March 22-23,  2011, at Drexel University in Philadelphia. SustaiNext is a two-year initiative  supported by the Sustainability Collaborative that was launched in December  2010 at Rutgers University in New Jersey. The goal of SustaiNext is to stimulate regional  partnering to help organizations, companies, and individuals to  integrate sustainability principles while realizing economic growth. In 2009,  the Sustainability Collaborative was created to help move the process by  stimulating partnerships across sectors by nurturing fresh connections between  academia, business, government, nonprofits, and communities. It now has more  than 500 participants. Participants in the Sustainability Collaborative network include representatives from business, which include representatives from companies, such as Johnson &  Johnson, Merck & Co., Eli Lilly, Amgen, Wal-Mart,  Kimberly Clark, Microsoft, DuPont, PepsiCo.,  7th Generation, Lockheed Martin, Saatchi & Saatchi, and Terra Cycle. Participants  in the Sustainability Collaborative network from academia include representatives from Drexel, Yale, Philadelphia  University, Catholic University of America, Bard College, Penn State,  University of Florida, Rutgers University, University of Maryland, and Ohio  State University. Participants in the Sustainability Collaborative network from NGOs include representatives from the  Environmental Defense Fund, National Science Foundation, Environmental Working  Group, Beyond Benign, Second Nature,  AASHE, and the Ecology Society of  America. Information about the Sustainability  Collaborative and the SustaiNext Summit on March 22–23 can be found 

, or for further information, contact Joanne Gere, at jgere@biosciencecollaborative or call 609-203-6852. 

US Chamber of Commerce's  Business Civic Leadership Center (BCLC

) has embarked on a year-long US  event series to improve the impact of corporate social involvement in local  communities. The event tour, called "Community Speaks," kicked off in  January 2011 in Los Angeles. One goal for the Community Speaks tour is to  understand and address the key developmental issues communities across the  United States are facing. The outcome of the tour is to provide a platform for  companies with specific geographic or social-investment interests to form  stronger partnerships, enhance local collaboration, and create more headway  through their corporate-citizenship commitments. Future cities on the Community  Speaks tour will be announced later this year.

Center for Policy on  Emerging Technologies (C-Pet)

 to examine the possible effects of  nanotechnology, biotechnology, and virtual technology on corporate social  responsibility (CSR). Through a number of focus forums, the “Emerging  Technology and the Future of CSR” series will convene futurists, scientific  writers, chief research and development officers, and leading CSR experts to  discuss how these technologies might change the business, environmental, and  political landscapes. The first forum entitled, "Ethical Concerns in  Biotechnology and Health Care Advances,"  was held Jan.14, 2011, in Washington, D.C.

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

Informex, the exhibition of contract manufacturers  of active pharmaceutical ingredients (APIs), pharmaceutical intermediates, and  fine chemicals, will be held Feb. 7-10 in Charlotte, North Carolina. As  the industry gathers next week, below is a roundup of key recent developments from suppliers. 

is investing in a new  high-containment facility in Queenborough, United Kingdom. The facility is  scheduled to be completed in May 2011. Aesica also is purchasing three manufacturing sites in Germany and Italy from the biopharmaceutical company UCB as announced in late 2010.  Aesica is acquiring sites in Monheim and Zwickau, Germany, as well as UCB’s  Pianezza, Italy site. The companies also formed a long-term supply agreement.

 is expanding its biocatalysis business with a  $4-million investment for discovering new biocatalytic platforms and for other  research areas. These areas include hyperactivation of biocatalysts to reduce  enzyme loadings, drivers for cofactor recycles, and resolving problems with  equilibriums. Almac also added a  dedicated late-stage customization suite to the company’s commercial  facilities. The addition is designed to assist orphan drug and niche product  launches in Europe.

 formed a research and licensing agreement with Genentech, part of the Roche Group, for a family of  antibacterial compounds discovered from AMRI's research of its natural-products  sample collection. Under the agreement, which was announced in January 2011, Genentech will receive an exclusive license to develop and  commercialize multiple potential products from AMRI's proprietary antibacterial program, and the companies will conduct research to identify antibacterial  agents. AMRI will receive an upfront license fee and research funding, milestone payments, and royalties on product sales.

 expanded  its current good manufacturing practice (CGMP) microbial contract fermentation  services at its facility in Charlottetown, Prince Edward Island, Canada. The  expansion doubled the company’s capacity to handle clinical-stage projects and was  scheduled to be completed in the fourth quarter of 2010.

, a biocatalysis company, expanded its line of Codex panels with the introduction of Codex screening kits. The screening kits  consists of 24 enzymes, which represent two commonly used enzyme classes:  ketoreductases and transaminases. In January 2011, Codexis and DSM Pharmaceutical Products, the custom-manufacturing organization of Royal DSM, formed an enzyme supply agreement. The agreement grants DSM rights to use Codexis’ custom biocatalysts and services and secures supply of Codexis enzymes for commercialization of pharmaceutical manufacturing routes developed by DSM’’s InnoSyn route-scouting services.

, the  custom manufacturing organization of 

, formed a license  agreement with the German biotechnology company c-LEcta GmbH, an industrial biotechnology company, for proprietary  screening technology. The agreement, which was announced in December 2010, grants DSM rights to c-LEcta’s proprietary  alcohol dehydrogenases for enzyme screening programs and development of  sustainable manufacturing routes for manufacturing of APIS and intermediates. 

Royal DSM also reported  in December 2010 that 

 formed a joint venture (JV) with the Chinese chemical company 

. As  part of the JV agreement, Sinochem will take a 50% equity interest in DSM  Anti-Infectives for EUR 210 million ($275.7 million) on a cash and debt-free  basis. The JV will be headquartered in Hong Kong, and all 2000 DSM  Anti-Infectives employees will be part of the new entity. The parties  anticipate the closing to take place in the second quarter of 2011.

, the contract-manufacturing arm of the  Finnish pharmaceutical company Orion, is investing EUR 5 million ($7 million) in its plant in Oulu,  Finland, to expand its capabilities in high-potency manufacturing. The company  conducted a SafeBridge precertification inspection in the third quarter of  2010. The expansion is expected to be operational in early 2012.

 formed an  agreement to provide peptide manufacturing and development services. CPRI adds  geographic diversity to Lonza's existing facilities in Braine-l'Alleud  (Belgium), Visp (Switzerland), Nansha (China), and Kouřim (Czech Republic).  CPRI’s offering includes milligram- to multi-gram-scale custom synthesis, a  variety of catalog products, as well as consulting services and technical  support.

 to provide early-phase chemistry and kilogram-laboratory  manufacturing services for small molecules. Dalton offers contract chemistry  research, contract analytical services, and chemical synthesis up to CGMP  kilogram-scale as well as small-scale fill-finish activities at its site in  Toronto, Canada.

, developed and launched a  recombinant source of sodium hyaluronate, which is not derived from animal-based  raw materials. Sodium hyaluronate is traditionally derived from rooster combs  or from strains of 

 bacteria, which may potentially result in safety risks from animal proteins,  viruses, or endotoxins, according to the company. Novozymes uses fermentation  for producing 

 sodium  hyaluronate. The product is used in drug formulations and may be used in drug-delivery systems, including nanocarriers, micelles, cross-linked  hyaluronic acid molecules, hydrogels, powders, minipellets, implants, sponges,  films, and conjugates. Novozymes is constructing a new CGMP facility for its 

-based hyaluronic acid in  Tianjin, China. The facility will make pharmaceutical-grade products.  Large-scale GMP production is planned for the first quarter of 2011.

, the  contract- manufacturing arm of Piramal  Healthcare, completed the latest phase of its investment program to  increase production capacity for antibody drug conjugates at its facility in  Grangemouth, Scotland. The expansion supports the GMP production for the  planned launch of a new cancer treatment by an undisclosed US-based biotechnology  company in 2011.

 is investing EUR 15 million ($21 million) in a new  manufacturing facility in the United States for its biomedical polymers. The  company’s biopolymers business includes lactide-based polymers such as  polylactic acid and lactide/glycolide copolymers. The company currently  manufactures biopolymers at its facility in The Netherlands. Construction of  the US-based facility will begin in 2011 and is expected to be completed by the  end of 2011.

 completed its expansion of its high-potency  fermentation capabilities at its facility in Jerusalem. Production was  scheduled to begin in October 2010.

 is considering setting up capacities for  manufacturing highly potent APIs at its facilities in Leverkusen, Germany, and  Redmond, Washington, according to an Aug. 24, 2010, press release. In October 2010,  Saltigo also reported that it will jointly develop processes for the synthesis  of APIs and intermediates with Reuter Chemische Apparatebau (RCA). RCA produces chiral substances.

Contract Manufacturing

As the industry prepares for Informex, the trade show of custom and batch manufacturers in Charlotte, North Carolina, a roundup of key recent developments.

PTSM: Pharmaceutical Technology Sourcing and Management-02-02-2011

Novartis Participates in Achieving the UN Millennium Development Goals

What to Watch for in 2011

Pharmaceutical and Business Leaders Focus on Haiti

CSR and Sustainability Forum

Contract Manufacturers Gear up for Informex 2011