As the pharmaceutical industry begins a new year, 

 spoke with Bob Kanuga, executive director of the external manufacturing organization at Merck & Co. Inc.  (Whitehouse Station, NJ) and president of the Drug, Chemical and Associated Technologies Association (DCAT). The discussion spanned the dynamics shaping the pharmaceutical industry overall, key issues in sourcing and procurement, and the role of DCAT in facilitating the business relationships between pharmaceutical companies and their suppliers and the knowledge base common to both. DCAT is a business-networking association that is made up of representatives from companies that manufacture, distribute, or provide services to the pharmaceutical, chemical, and related industries, and sourcing and procurement professionals from the pharmaceutical industry and its suppliers. Kanuga became DCAT president in November 2010.

Pharmaceutical industry and supply chain dynamics


 “The pharmaceutical industry as a whole faces more challenges today than in the past, but those challenges are not insurmountable,” says Kanuga. Some of the challenges include patent expirations for innovator drugs, pricing pressures, and increasing research and development (R&D) productivity and enabling new product introductions.

As the industry responds to these challenges, it also faces a changing and increasingly complex supply chain. “Supply-chain integrity and security are of great importance,“ says Kanuga. “Pharmaceutical companies, as well as industry regulators, continue to raise their expectations that their suppliers can ensure product quality and the companies that provide products and services to these suppliers can do so as well.” 

At the same time, “the industry faces the need to broaden global access to life-saving medicines,” says Kanuga. This wider scope is reflected in the rising importance of emerging markets, the need for innovation in supply-chain management and logistics, as well as pharmaceutical industry participation in private and public partnerships and global health initiatives. Against this backdrop, specific supply-chain issues can surface, such as cold-chain management for vaccines and other temperature-sensitive drug products that need to be distributed to remote areas. 

These challenges underscore why the responsibilities of each entity involved at each point of the pharmaceutical supply chain must be specific, clear, and accountable. “As part of increasing transparency of the pharmaceutical supply chain, there is a greater need for first-hand knowledge and audits of upstream raw material manufacturers,” says Kanuga. “Each party in the supply chain has to own the integrity of its link in the supply chain.” 

Although the responsibility of quality of the pharmaceutical supply chain ultimately resides with the market authorization holder, Kanuga points to tools, such as consortium-based efforts, which can aid with supply-chain integrity and security. These consortiums can focus on compliance with good manufacturing practices, environmental performance, and overall business conduct and ethics. 

As examples, Kanuga mentions the Rx-360 Consortium, an international consortium consisting of pharmaceutical companies, suppliers, and industry associations, which is focusing on ensuring the quality of the pharmaceutical supply chain. Rx-360 is evaluating the utility and possible application of shared audits in balancing the logistical, time, and cost considerations with the need for risk mitigation when seeking to expand supply-chain surveillance of all suppliers in a given supply chain. 

Kanuga said the Pharmaceutical Supply Chain Initiative (PSCI) is another industry consortium involved in collective practices for the pharmaceutical supply chain. PSCI was formed in 2006 by a group of pharmaceutical companies to support responsible supply-chain practices of pharmaceutical industry suppliers, a crucial issue as drug companies elongate their supply chains geographically and increase their levels of external development and manufacturing. After launching in 2006, PSCI implemented the Pharmaceutical Industry Principles for Responsible Supply Chain Management in late 2007. These principles specify responsible business practices throughout the pharmaceutical industry's supply chain in areas such as ethics, labor, health, safety, and the environment, and related management systems. The activities of PSCI are facilitated by the Business for Social Responsibility, a corporate-social-responsibility association consisting of 250 member companies. The goal of PSCI is to apply the Responsible Supply Chain Management principles to achieve better social, economic, and environmental outcomes for all those involved in the pharmaceutical supply chain. One of the functions of PSCI is to help companies mitigate risk in supplier relations and supply-chain practices through a structured set of principles and an assessment program.

PSCI’s evaluation process includes environmental performance. As with other industries, the pharmaceutical industry has to evaluate its performance and opportunity in meeting broader goals of sustainability. “The supply chain plays a role in a company’s carbon footprint,” says Kanuga, pointing to several examples in which this may come into play. For example, sustainability may factor in the selection of an external manufacturer by considering how effectively the contract manufacturer can contribute to a pharmaceutical company’s sustainability goals by, for example, using green-chemistry approaches for process improvement for a given synthesis. 

Given the elongation and increased complexity of the pharmaceutical supply chain, several key issues face pharmaceutical sourcing and procurement professionals in 2011, Kanuga said. “Active supplier management will continue to be crucial,” says Kanuga, as will “reliable and timely market intelligence to understand the supply chain and identify any possible disruptions to the supply chain.” Strategies for risk mitigation and effective risk management will continue to be important to minimize supply disruptions due to shortages, the financial solvency of suppliers, merger and acquisition activity, and the resulting consolidation in the supplier base. 


 As president of DCAT, Kanuga sees the association playing an important role in providing industry-relevant educational programs and business-development opportunities as member companies deal with the increasingly complex pharmaceutical supply chain. He said the educational programming during DCAT Week, which is held in mid-March each year, and the Sourcing Summit, which will be held in July 2011, are ways to share best practices and insights of specific concern to sourcing and procurement professionals in pharmaceutical companies and their suppliers. “In addition, DCAT gives employees of companies, such as mine, the chance to work with and benchmark with colleagues from all parts of the industry by volunteering on various committees and projects,” says Kanuga. “Membership in DCAT is a great value for all segments of our association.”

To reflect that broadening focus, DCAT expanded its educational programming to address topics relating to excipients, generic drugs, and biopharmaceuticals in 2010. For example, its educational programming during DCAT Week included programs on the integration of the business models between innovator-drug and generic-drug companies and the impact of mergers and acquisitions in the generic-drug industry. It also added programming to examine how the US Food and Drug Administration, the International Pharmaceutical Excipients Council, and the pharmaceutical industry are addressing the issue of excipient equivalence. To address the rising importance of biologic-based product development in the pharmaceutical industry, DCAT added a Biologics Forum to its slate of programs during DCAT Week in 2010. The program examined approaches for designing and implementing a successful supplier-management program in biologics manufacturing given the specialized economic, regulatory, and technical issues involved with biologic-based manufacturing. DCAT also held its first regional business development forum during DCAT Week in 2010, in which Ireland’s investment in the pharmaceutical industry was highlighted. 

In 2011, the educational programming during DCAT Week, which will be held Mar. 14–17, will continue to feature insight relating to the changing manufacturing and supply chain. At a business development forum, representatives from Pfizer (New York), Teva Pharmaceuticals (Jerusalem), Piramal Healthcare (Mumbai), and the management-consulting firm PRTM will offer perspectives on how issues such as globalization, healthcare reform, and other transformations in the pharmaceutical industry are affecting manufacturing networks and supply chains. DCAT will also provide an in-depth pharmaceutical/biopharmaceutical outlook from Wall Street and market analysts from Thomson Reuters, JP Morgan, and Deloitte Consulting. 

In another program, panelists from Pfizer, Abbott (Abbott Park, IL), Lonza (Basel, Switzerland), and Valsource (Downingtown, PA) will discuss the impact of the US Food and Drug Administration’s quality-by design initiative on the pharmaceutical supply chain. Also, Eli Lilly (Indianapolis, IN) will discuss approaches in selecting manufacturing partners in an era of increasing vendor consolidation. Panelists from Amgen (Thousand Oaks, CA) and Avantor Performance Materials (Phillipsburg, NJ) will examine various solutions, technologies, and collaborative approaches between customers and suppliers in ensuring supply-chain security and integrity. And a biologics forum will focus on trends and best practices for subcutaneous biologic drug-delivery systems with insight from FDA, Roche/Genentech (South San Francisco, CA), Amgen (Thousand Oaks, CA), and Becton Dickson (Franklin Lakes, NJ). 


 In his new role, Kanuga will head the association’s executive committee of the board of directors, which includes four officers­: president, senior vice-president, finance officer, and vice-president. The executive committee also consists of five segment vice-presidents: chemical; biotechnology; pharmaceutical; pharmaceutical services; and contract formulation, fill­–finish and packaging. The president serves a one-year term, which Kanuga began on Nov. 1, 2010. He succeeded Joe Principe, vice-president of global business development at Piramal Healthcare (Mumbai, India), who served as DCAT president in 2009 and 2010. 

Looking ahead to 2011, Kanuga says the association will continue to build on the association’s strength in developing educational and networking opportunities for its members. “With the help of the organization’s key opinion leaders, our volunteer committee members are developing programs with relevant topics and current speakers that will be of interest to our members,” he says. “Also, we are in the process of identifying new venues and mediums to deliver this information in more convenient ways. In addition, we will continue to encourage nonmember companies who participate in our events to join our organization so that DCAT can continue to grow and be able to expand our offerings and business-development opportunities,” concludes Kanuga. 

Articles

Supply Chain

Pharmaceutical Technology discusses the key issues and trends facing the pharmaceutical supply chain with Bob Kanuga, executive director of the external manufacturing organization with Merck & Co. Inc. and president of the Drug, Chemical and Associated Technologies Association (DCAT).

DCAT President Discusses the Pharmaceutical Supply Chain

Market consolidation and the importance of size have been regular themes in 2010. A major deal in the early-development segment has once again underscored the primacy of these trends in the evolution of the pharmaceutical outsourcing sector.

The big deal is the 10-year services relationship between Covance (Princeton, NJ) and sanofi-aventis (Paris). The arrangement, which has a potential value of as much as $2.2 billion, has several key components. The key aspects are:

• Covance will acquire the research and development sites (R&D) of sanofi-aventis in Porcheville, France, and Alnwik, United Kingdom, for $25 million and maintain employment at those sites for 300 employees for at least five years

 • Covance will receive a five-year take-or-pay contract from sanofi-aventis worth at least $350 million for services to be provided from the two acquired facilities

 • Covance will receive from sanofi-aventis a 10-year, take-or-pay contract worth at least $850 million for additional services, including discovery, chemistry, Phase II–IV clinical research and postapproval services

 • Covance will be designated as the sole provider of central laboratory services to sanofi-aventis for a 10-year period, with potential business valued at up to $1 billion during the 10-year period.

The Porcheville and Alnwick sites host a variety of early-development activities, including drug metabolism, toxicology, and bioanalytical testing. The sites also have capabilities for CMC development, including early-phase small-molecule active pharmaceutical ingredient (API) development and manufacture, preformulation, formulation, and radiolabeling. 


The deal with sanofi-aventis is certainly a big one for Covance. In two to three years, when the deal fully kicks in, Covance could generate $200 million or more in revenue. That gain represents a sixfold increase in the revenues that Covance will generate from sanofi in 2010 and is equivalent to 10% of Covance's total revenue for all of 2010.

Moreover, the deal protects Covance's preclinical margins at the two acquired sites by guaranteeing $350 million of billings for the first five years. That guarantee is extremely important, as there is a glut in preclinical testing capacity, which has hurt pricing and forced preclinical contract research organizations (CROs) to operate facilities with high fixed costs at low levels of utilization. 

In fact, what has been particularly impressive in both the sanofi-aventis deal and the deal Covance struck two years ago with Eli Lilly (Indianapolis, IN) has been Covance's apparent ability to negotiate extremely favorable terms for itself. For one, it has been able to get very large take-or-pay or exclusivity agreements for relatively small initial outlays and very low risk. In good times, these arrangements often yield greater-than-guaranteed volumes, and in bad times they provide a degree of revenue certainty.

Covance has also used these deals to leverage the relationship beyond its core strengths in preclinical toxicology and central laboratory services to other R&D services where it is not necessarily a standout player, including Phase II–IV clinical research and other analytical services. In addition, the facility acquisitions have enabled Covance to gain valuable new capabilities, including API development and formulation capabilities in the sanofi-aventis deal. 


Covance's deals with sanofi-aventis and Eli Lilly are remarkable because of their large size and the broad scope of services they encompass. What does Covance bring to the table that is so convincing to its large pharmaceutical partners?

For one, Covance is probably the only CRO in the industry that has the scope of services and the scale of operations to offer such a comprehensive R&D package to a top-10 global pharmaceutical company. Other CROs can offer the combination of central laboratory and other clinical research services, and there are a few nonclinical CROs that can offer a comprehensive discovery/preclinical development package. However, no other CRO can offer a combined preclinical and clinical offering with such a large worldwide network of operations.

Further, we can assume that Covance has demonstrated a high level of operational prowess across its service offerings. Clients wouldn't be signing up for such large fixed commitments unless they were getting good performance from existing dealings with Covance and were convinced it could deliver. Finally, it has a strong balance sheet and a long record of profitability.


This Covance-sanofi deal is impressive, but is it really strategic? It doesn't seem to be a game-changer for sanofi. After all, sanofi spends $6 billion per year on R&D. When Covance is billing sanofi $200 million or more per year, that level will only amount to about 3.5% of sanofi's total R&D spend and less than 10% of its preclinical and clinical expenditures. Furthermore, we can assume that much of the work now guaranteed to Covance has been outsourced to other CROs, so by itself, it probably means only a marginal increase in overall outsourcing activity. sanofi is benefitting from saving the financial and political costs of closing two redundant facilities and garners some potential contract-management savings by reducing the number of CROs it is working with in this area.

As a truly strategic deal, this one falls short of some others we have seen, notably those struck by Lonza (Basel, Switzerland) to provide biologics development and manufacturing services for Novartis (Basel) and GlaxoSmithKline (London). In both those cases, Lonza is effectively substituting its own expertise and facilities for its clients' capabilities and taking principal responsibility for some very strategic elements of its clients' pipelines. The Covance–sanofi deal doesn't seem to go that far.

Although the clinical research arena has seen more preferred-provider deals in recent years, it's not clear whether we will see many more of the size and scope of Covance's deals with sanofi and Lilly. There have been several proposals floated by major pharmaceutical companies, but most have come to naught. A big part of the problem has been that the pharmaceutical companies haven't been willing to guarantee a sufficient volume of work to the CRO to justify the cost and risk of acquiring the facility. It takes a serious corporate commitment and senior executive leadership to do a deal like this, and few major pharmaceutical companies seem to be there yet.

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, fax 703.383.4905,

Outsourcing

Covance's deal with sanofi-aventis demonstrates the power of scale and scope.

Winning Big

A recent analysis by the management-consulting firm PricewaterhouseCoopers (PwC) assessed the achievement and future success of countries in moving toward green economies. The report found that two emerging economies, Brazil and India, may outpace the efforts of developed nations in sustainability efforts.. 

The basis of PwC’s finding was the PwC Low Carbon Economy Index, which analyzes the G20 members (which includes 19 countries and the European Union) against a low- carbon economy model that combines both gross domestic product (GDP) and emissions growth rates. PwC’s Low Carbon Economy Index is based on carbon intensity (the ratio of emissions to GDP) against a fixed carbon budget that would meet greenhouse-gas stabilization targets outlined by the International Panel on Climate Change. A 50-year “carbon budget” was estimated for each nation, within an overall global carbon budget to meet the greenhouse gas stabilization targets outlined by the Intergovernmental Panel on Climate Change. 

PwC has estimated a country allocation of the global carbon budget for the G20 economies, which collectively make up over 80% of global carbon emissions, based on assumptions in several areas. These assumptions led to country-level projections of energy-related emissions, with some common features among countries but also some variations to reflect differing starting points, stages of economic development, and energy-resource endowments. The analysis assessed G20 achievements to date in reducing their carbon intensity levels, the ratio of emissions to GDP since 2000, and individual nations’ distances to go to meet their carbon-reduction targets to 2050. The report found that annual global decarbonization challenge to 2020 has almost doubled from 2% per annum in 2000 to 3.8% per annum to 2020. Overall, the analysis found that based on current trends in carbon intensity, the world will have used up an estimated global carbon budget for the first half of this century by 2034, 16 years ahead of schedule.

Brazil stood out as a good performer among developing countries that showed a pronounced decline in their carbon-reduction performances. A 5.4% reduction in carbon intensity meant that the country retained its top place in the PwC Low Carbon Challenge Index, measuring the level of decarbonization necessary per annum to 2050. The country has the least distance to go in terms of carbon-intensity reduction according to the PwC analysis, but this would still mean a 79% reduction by 2050. According to a Dec. 9, 2010, press release analyzing the results, Brazil experienced higher-than-forecasted economic growth while developing a stronger portfolio of renewable energy to  pave the way for further improvements in decarbonization. Within the G20, Brazil is also one of the closest to the 2050 low-carbon economy goal although challenges around deforestation and land use remain.

India also showed favorable results, according to the PwC release. The country has low-carbon emissions level per capita relative to other emerging economies, and so comes out relatively well when comparing carbon intensity among countries. However, facing a rapidly growing economy, both in terms of the economy and population, the Indian government has announced in 2009 a target of reducing its carbon intensity by 20–25% by 2020. For example, national missions have been developed to improve energy efficiency, scale up renewable energy, and transform land use and forestry practices, according to the PwC report.

 “The climate change agenda has started to shift, from global political cooperation to national economic competition, and from a focus on cost sharing to a focus on value creation,” said Leo Johnson, partner in the PwC sustainability and climate change practice in the PwC release.” What a number of countries have woken up to is the potential for low carbon growth, and the risks to economic competitiveness of falling behind.”

To meet climate goals by 2050, on an overall global basis, countries need to emit around one-tenth of carbon emissions for every unit of GDP currently produced at today’s levels. Certain countries, such as Brazil, are ahead of that goal; for example, Brazil needs to cut its emission by only one-fifth of current levels. Overall in 2009, the G20 reduced its total carbon emissions by 1.3% compared to 1.8% growth in 2008. This means global carbon intensity has fallen by 0.7%, a fraction of the 3.5% reduction per annum required to 2020, according to the PwC analysis. The estimated global carbon budget in the report implies that annual emissions of global total greenhouse gases will need to fall to below 20 gigatonnes of carbon dioxide equivalent by 2050, half the global annual emissions today, while sustaining a global economy nearly four times larger and global population one and a half times bigger. By 2050, for every unit of GDP produced, the world economy can only emit one tenth of the carbon emissions compared to today. It is estimated that, in order to have a likely and cost-effective chance of pegging temperatures to 2 degrees Celsius or below over the course of the 21st century, global emissions will need to have peaked within the next 10 years and be around 44 gigatonnes of carbon dioxide equivalent by 2020.

CSR and Sustainability Forum

An assessment of the progress and needed activity to achieve global sustainability goals shows Brazil and India leading G20 economies.

The Race to Sustainability

The Amgen Foundation, the philanthropic arm of 

a community of action of social entrepreneurs announced three winners for the Patients, Choices, Empowerment competition. Each winner received a $10,000-cash prize and was selected by the public for their innovative solutions to empower and elevate patients' voices to improve health outcomes. Out of 10 finalists, the entries receiving the most votes in the Changemakers.com competition were: CureTogether— Crowdsourced Patient Experience, which uses quanitative data to help patients make more informed choices about their healthcare; Educating Tuberculosis Patients for Excellent Results, a program to remove the stigma around tuberculosis and to encourage support and treatment; and SMS Now! A Life Depends on It, a program that uses the mobile technology and the Internet to connect volunteer blood donors  with patients. 

 renewed their partnership to advance math and science education in America's underserved public schools. Under the partnership, the Amgen Foundation pledged $1.8 million to increase the number of math and science graduates who join Teach For America's teaching corps by 2013. This new grant brings the total support from the Amgen Foundation to more than $7 million since 2004. The Amgen Foundation is Teach For America's Founding National Math and Science Partner. Each year, the Amgen Foundation supports 100 new Amgen Fellows, selected from the top incoming Teach For America corps members with undergraduate degrees in math or science. These fellows each receive a $1000-signing bonus and are eligible for additional financial support for classroom resources or professional development. 

 (Deerfield, IL) reported on Dec. 15, 2010, that they have teamed to deliver additional intravenous (IV) solutions to Haiti as part of the ongoing effort to stem the cholera outbreak. Baxter has donated  IV solutions, including lactated ringers and dextrose, and sets used to administer the solutions to help meet the hydration needs of people affected by waterborne bacteria. Baxter's previous  philanthropic giving in response to the January 2010 earthquake in Haiti included grants from Baxter and The Baxter International Foundation to support immediate, acute-care, and longer-term needs of the region with a focus on health-related efforts, as well as shipments of more than 330,000 units of  IV solutions, antibiotics, and other drugs through AmeriCares and Direct Relief International. 

 Science@Work education program recently hosted interactive science workshops by Baxter scientists to help Chicago-area high school students experience the science behind healthcare careers. Baxter's Science@Work program is a multiyear partnership launched in 2008 with the Chicago Public Schools to support teacher training and student development in healthcare and biotechnology. The day featured interactive laboratory demonstrations and exercises to help students understand the varying factors considered when engineering a medical device.

 also reported that it ranked first in the healthcare category in 

 second annual Green Rankings and fifteenth in the overall list. The rankings assess a company's environmental footprint, policies, and strategies to manage that footprint and reputation among environmental experts. The quality of each company's environmental reporting, policies, programs, and initiatives are measured, including 700 metrics, such as emission of key greenhouse gases, water use, and solid-waste disposal. 

Baxter also led the healthcare products subsector of the Maplecroft Climate Innovation Indexes (CII), created in collaboration with Bloomberg, for performance in climate-related innovation and carbon management in the US. Baxter ranked twenty-first among the Maplecroft CII Leaders, composed of the 100 top performers in the total benchmark of 339 companies that engage in public climate-related programs. Also, two Baxter facilities in the United Kingdom achieved certification for improving carbon efficiency. Baxter's Thetford and Liverpool manufacturing facilities earned the "Carbon Trust Standard" from the Carbon Trust, an independent company that works with businesses to cut carbon emissions. 

 launched the 2011 Reyataz “Fight HIV Your Way” contest; Reyataz (atazanavir sulfate) is BMS’s drug to treat HIV/AIDS. The contest aims to raise awareness about HIV/AIDS among the general public and inspire people affected by the disease. Now in its third year, the 2011 Reyataz “Fight HIV Your Way” will accept entries through February 28, 2011 by individuals touched by HIV and AIDS, who are asked to share their stories as a photo and essay through www.fightHIVyourway.com or to mail in their entries. BMS will announce ten first-place winners in July 2011. These winning entries will be the inspiration for a new dance by the Alvin Ailey American Dance Theater, and the work will have its world premiere during Ailey’s New York City Center season in December 2011 and be performed across the country as part of a 2012 national tour. 

 are evaluating an approach that targets a novel part of a major surface protein on the malaria parasite. 

 (CSP) has been recognized as a potential target in the development of vaccines focused on the earlier stages of malaria infection. The researchers are focusing on a new approach that targets a region of CSP important to a critical function of the protein. By blocking this function, it is hoped that invasion of the parasite into the liver, an essential step in causing malaria disease, can be prevented. The researchers hope that they can improve the way sub-unit vaccines are designed by strategically targeting this critical protein function. Although this vaccine approach is being tested primarily for use in children younger than one year of age, it could be used to help prevent disease in all populations vulnerable to 

, the most deadly species of the parasite, and could potentially be adapted to prevent 

 as well, according to Merck. Approximately 40% of the world’s population lives at risk of contracting malaria caused by 

 (Basel, Switzerland) held a symposium of the Novartis Foundation for Sustainable Development in early December to discuss the current state, progress, and road ahead in achieving the United Nation’s Millennium Development Goals (MDGs), a set of antipoverty and development objectives. The symposium continues the dialogue started at the Millennium Summit in New York in September 2010, where the UN reviewed progress and looked ahead to the five years remaining for realizing the MDGs. The aim of the Novartis Foundation symposium was to come up with specific proposals in support of achieving these goals. 

 (Bagsvaerd, Denmark) organized and sponsored the MENA [Middle East and Northern Africa] Diabetes Leadership Forum, which was held  Dec. 12 and 13 in Dubai, United Arab Emirates (UAE). Twenty-two countries from MENA and five international organizations agreed on the "Dubai Declaration on Diabetes and Chronic Non-Communicable Diseases in the Middle East and Northern Africa Region." It is estimated that 26.6 million people in MENA countries are afflicted with diabetes, and that number is expected to double to 517 million people by 2030. The Dubai Declaration is focused on three key issues:

All MENA countries must be represented and take an active role in the Moscow June 2011 United Nations International Conference on Non-Communicable Diseases and the New York September 2011 UN Summit on Non-Communicable Diseases. 

A commitment to provide comprehensive care to people with diabetes, including encouraging them to lead a normal life.

Introducing preventive measures such as healthier living, which slows the progression of diabetes and its related non-communicable diseases.

The forum was supported by the Dubai Health Authority, the Health Authority of Abu Dhabi, the World Health Organization, the International Diabetes Federation, the Emirates Diabetes Society, the Gulf Group for the Study of Diabetes, the MENA Health Policy Forum, the Steno Diabetes Center, the Joslin Diabetes Center, the Imperial College London, and the Sheikh Hamdan bin Rashid Al Maktoum Award for Medical Sciences.

 also voiced its support for the Draft Guiding Principles presented by Professor John Ruggie, Special Representative to the UN Secretary General. The Ruggie's Guiding Principles elaborate and clarify for companies, states, and other stakeholders how they can put into practice their respective roles in the UN Protect, Respect and Remedy' Framework, a framework for human rights that outlines the role of states to protect human rights, the responsibility of business to respect these rights, and the obligation for both to ensure appropriate mechanisms for remedy in cases of infringement. As a founding member of the Global Business Initiative on Human Rights, Novo Nordisk has played an role in consultations leading up to the draft and will provide comments during the open hearing period. Feedback on the Draft Guiding Principles remains open until Jan. 31, 2011. 

 (New York) reported on Dec. 12, 2010, that Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) was introduced into the first childhood-immunization program for pneumococcal disease in the developing world under the auspices of the

 when Nicaragua launched its program in December 2010. The AMC is a program that involves private–public partnerships to help make newer vaccines available on a sustainable, affordable, and accelerated basis to the least developed countries. In March 2010, Pfizer entered into a 10-year agreement to provide Prevenar 13 to infants and young children in the world's poorest countries under the terms of the AMC for pneumococcal disease.

 (P&G, Cincinnati, OH) reports that its Auburn, Maine, site became the first P&G manufacturing plant in North America to achieve zero waste to landfill. The feminine-care facility worked with employees and suppliers to implement a process that uses 100% of its waste. A majority, more than 60%,  is recycled or reused, while the remainder is converted to energy. Auburn is the ninth P&G global manufacturing plant to achieve zero waste to landfill. P&Go has a goal to achieve less than 0.5% disposed manufacturing waste by 2020.

 (WEC), a global nonprofit, nonadvocacy organization dedicated to advancing environmentally sustainable business strategies and solutions, announced the election of new officers and a new member to its board of directors and approved an updated strategic plan. Jeff Seabright, vice-president for environment and water resources at 

 (Atlanta), was elected WEC's new chairman of the board, succeeding Wayne S. Balta, vice-president of corporate environmental affairs and product safety at IBM. Other officer appointments included Peter Schnurrenberger, head of group safety, health and environmental protection at 

 (Basel) as vice-chair; Mary K. Armstrong, corporate vice-president of environment, health and safety at 

 (Seattle) as vice-chair; and Paul Hagen, principal at 

 as secretary-treasurer of the board. All officer appointments are one-year terms.

The WEC board also approved an updated strategic plan that will expand the organization's core focus areas to include business solutions to climate adaptation; the integration of biodiversity protection into business strategy and operations; water conservation and efficiency and how business initiatives can be leveraged to assist communities in obtaining potable water supplies; and enhancing the importance of social responsibility issues in business value creation. These focus areas will complement WEC's active programs in green supply-chain management, learning and competency development, and the promotion of business excellence, according to WEC.

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

Creating practical and economically sustainable solutions to meet climate-change objectives was a major theme of two conferences held in late November and December in Cancún, Mexico. The first, the United Nations Climate Change Conference held Nov. 29 to Dec. 10, 2010, was the 16th conference of the 194 parties of the United Nations Framework Convention on Climate Change (UNFCCC) and the sixth meeting of the 192 parties to the 

. Coincident to the UN conferences was the first-ever World Climate Summit, which is an open and collaborative global 10-year framework designed to help businesses, investors, and governments accelerate solutions to climate change. 


 Approximately 15,000 participants, including government delegates from the 194 parties to the UNFCC and representatives from business and industry attended the United Nations Climate Change Conference. At the conference, the 194 parties to the UNFCCC adopted the 

, a set of decisions to direct governments more firmly on the path to a low-emissions future and enhanced action on climate change in the developing world. “Governments have given a clear signal that they are headed toward a low-emissions future together, they have agreed to be accountable to each other for the actions they take to get there, and they have set it out in a way which encourage countries to be more ambitious over time,” said UNFCCC Executive Secretary Christina Figueres, in a Dec. 11, UN press release. 

Industrialized-country targets are officially recognized under the multilateral process. These countries are to develop low-carbon development plans and strategies and assess how best to meet them, including through market mechanisms, and to report their inventories annually.

Developing countries’ actions to reduce emissions are officially recognized under the multilateral process. A registry is to be established to record and match developing-country mitigation actions to finance and technology support from industrialized countries. Developing countries are to publish progress reports every two years.

 agreed to continue negotiations with the aim of completing their work and ensuring there is no gap between the first and second commitment periods of the treaty. 

’s Clean Development Mechanisms were strengthened to drive more major investments and technology into environmentally sound and sustainable emission-reduction projects in the developing world. 

 Parties launched a set of initiatives and institutions to protect the vulnerable from climate change and to deploy the money and technology that developing countries need to plan and build their own sustainable futures. 

 A total of $30 billion in fast-start finance from industrialized countries to support climate action in the developing world up to 2012 and the intention to raise $100 billion in long-term funds by 2020 was included in the decisions. The first fast-start finance reports to the UNFCCC secretariat are due in May 2011. 

 In the field of climate finance, a process to design a Green Climate Fund under the Conference of the Parties, with a 24-member board with equal representation from developed and developing countries, was established. 

 was established to allow better planning and implementation of adaptation projects in developing countries through increased financial and technical support, including a clear process for continuing work on loss and damage. 

 Governments agreed to boost action to curb emissions from deforestation and forest degradation in developing countries with technological and financial support. 

 Parties established a technology mechanism with a Technology Executive Committee and Climate Technology Center and Network to increase technology cooperation to support action on adaptation and mitigation. 

If all the targets and actions of the agreement are fully implemented, UN estimates show they could deliver 60% of the emission reduction needed to stay below a recognized standard of a two-degree in average temperatures, although staying below this temperature rise does not guarantee survival of the most vulnerable people, according to a Dec. 20, 2010 UN press release. “All countries, but particularly industrialized nations, need to deepen their emission-reduction efforts and to do so quickly, said Figueres in the Dec. 20 release. Following the UN Climate Change Conference in Copenhagen in 2009, developed countries announced pledges totaling $28 billion.

The next meeting of the Conference of Parties of the UNFCCC is scheduled to take place Nov. 28 through Dec. 9, 2011, in South Africa. 


 A key part of countries in achieving climate-change goals is to develop the financing and technology needed to meet these objectives. As part of that effort, the World Climate Summit was held Dec. 4–5, 2010, in Cancún. The global platform was deigned to assist governments, companies, and investors build bottom-up solutions to meet 2020 climate-change targets. Founding partners of the World Climate Summit included: 

 Dow Jones, The Prince of Wales Corporate Leaders Group, The Climate Group, UN Global Compact, Bright Green, United Nations Environment Program Finance Initiative, the Carbon Disclosure Project, the World Bank, the International Finance Corporation,  the Club of Beijing, Local Governments for Sustainability, Sir Richard Bransons Carbon War Room, and the support of the Mexican Government Trade and Investment Promotion Agency ProMexico. More than 800 delegates and 140 business leaders attended the summit. The following initiatives were announced at the conference:

 The launch of the Gigaton Awards, which recognized  the efforts of six companies reducing carbon emissions: Reckitt Beckinser, Nike, 3M, Vodafone, GDF Suez, and Suzlon.

 Overseas Private Investment Corporation (an independent US agency) will provide at least $300 million in financing for new private-equity investment funds that could ultimately invest more than $1 billion in renewable resources projects in emerging markets, thereby representing one of the largest initiatives by the US government to support the international effort to mitigate climate change.

 The Carbon War Room (a nonprofit organization for climate change founded by Richard Branson, CEO and chairman of the Virgin Group) announced the first-ever universal energy index for the shipping industry

 Avoided Deforestation Partners (a nonprofit network for thought leadership and action on deforestation) announced a fully approved Voluntary Carbon Standard methodology for avoided deforestation that will enable immediate flow of capital to projects that reduce deforestation rates

 GreenTEK venture announced a $150-million Mexico Fund dedicated to climate change mitigation

 The Prince of Wales Leadership Group on Climate Change, which brings togethers business leaders from the United Kingdom and European Union, reported that 350 companies signed the 

 a platform for businesses to work together for climate change

 The World Climate Initiative was launched and led by Casas GEO,  a voluntary code of conduct for reductions of greenhouse-as emissions, integration of sustainability into core strategy, and leadership to drive change for global companies

 SwissInso launched KRYSTALL, a new solar-powered autonomous system that can bring clean water supply to remote regions of the world

 Philips launched their “Livable Cities” programs with local governments to provide energy efficiency and lighting in all cities around the world.

The World Climate Summit also announced its 2011 program, a set of high-level roundtables and summits in Brussels; Xian and Beijing, China; and New York and Washington. The next World Climate Summit will be held in Durban, South Africa Dec. 3–4, 2011.

Representatives from the United Nations, governments, businesses, and nonprofit groups met in Cancún, Mexico, to move forward international efforts for meeting climate-change goals.

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