The Association of Clinical Research Organizations (ACRO) testified before Congress last month to provide FDA with a number of suggestions to improve the drug-development process, highlighted by a call to appoint a chief innovation officer within the agency. ACRO’s recommendations were included in testimony presented by Executive Director Doug Peddicord, PhD, at a public hearing titled “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice.”

 “The current drug-development paradigm is unacceptable and unsustainable because too much time and too much money is spent producing too few new products,” said Peddicord, in a ACRO Apr. 20, 2012, press release. “CROs have a history of embracing innovative ideas, like electronic data capture and globalization, and stand willing and ready to work with sponsors and regulators to reduce the time and cost of drug development.” 

Peddicord expressed concern about the slow progress that has been made since the release of the FDA’s “Critical Path” whitepaper in 2004. He noted that while some FDA-supported efforts, such as the C-Path Institute and the Clinical Data Interchange Standards Consortium (CDISC), have had success developing tools to advance drug development, other efforts have fallen short. Notably, Peddicord singled-out the Clinical Trials Transformation Initiative (CTTI). The CTTI, which was launched by FDA, oversees specific projects to identify existing issues related to current practice, design models for improvement, and test new models and compare them to the existing system in an effort to modernize the clinical-trial process.

 “While CTTI is well-intentioned, it has not taken on projects that have the potential to be ‘transformative’,” said Peddicord, in the release. “Every effort at innovation that the FDA supports, directly or through the funding of public-private collaborations, should be measured against three objectives: does it make the drug development process faster, cheaper or more productive.” 

 ACRO made several specific recommendations for the FDA to consider, including the appointment of a chief innovation officer at the agency with broad authority to approve novel approaches to clinical trials. Several other organizations, led by the Biotechnology Industry Organization, have expressed support for this concept and it is expected to be included in the Prescription Drug User Fee Act reauthorization later this year, according to the ACRO release. 

• Incorporating more modern regulatory science into clinical trial design so that a sponsor can potentially generate the data necessary for product approval with fewer subjects 

• Simplifying the informed consent process so that the information provided to potential participants is more intelligible and meaningful • Testing, across therapeutic areas, the use of a single, central institutional review board on a country level to improve the quality of independent review 

• Approaches to risk-based oversight of sites/investigators by sponsors, including statistical and other sampling, remote and other technology-enabled monitoring 

• Expanding regulatory cooperation and information sharing for multiregional clinical trials to limit or eliminate duplicative audits, examinations and reviews. 

 “ACRO’s recommendations are by no means exhaustive but rather represent a starting point for the FDA to address widely-acknowledged areas of inefficiency,” said Peddicord. “But the agency must encourage and reward innovation because without proper assurances no organization will be willing to undertake the serious financial or operational risks associated with an unpredictable regulatory environment.” 

Articles

Contract Services

Clinical research organizations see reform in clinical-trial process, including the establishment of chief innovation officer at FDA.

CROs Urge for Modernization of Clinical Trials

The past 15 years has witnessed extreme and mounting cost pressures on the pharmaceutical industry.  This phenomenon has been driven by a host of changes, including:  

A saturated North American market where only a few new high-priced/high-margin drugs come to fruition

Longer and more costly regulatory cycle times with greater drug-failure rates

Advancing generic-drug competition and shorter patent life

Outdated cost structures still laden with excess capacity and high-wage/high-benefit employees (although the industry has done much to change this through plant sales and layoffs).

Few can argue that the golden years of the pharmaceutical industry with high-margin products and regular new blockbusters coming into the market to replace products going off patent is over. 

Although there is sales growth in exciting new global markets, these markets simply cannot command the high-priced drugs of the past. Granted, the potential exists for significantly increased sales volume over time, but the increased sales will be at a lower price and at lower margins.  

To counter these trends, Big Pharma has aggressively deployed network rationalization strategies, other restructuring, outsourcing, and reorganizing, which has resulted in massive layoffs. Reducing infrastructure and operational costs has become the new norm within the industry. Some doomsayers are even predicting the demise of Big Pharma in the decades to come as there will no longer be a financial model that is attractive to investors. Now that may sound a bit farfetched, but one thing is certain: every function and every person is being called upon and challenged to become lean, to cut cost, and to do more with less. 

I've written many times in the past that adopting best-practice procurement methods is a great way to reduce cost and to recover margin. My experience has shown that when the right sourcing strategies are deployed and the maximum amount of spend is truly competitively bid, the resulting savings can range from 10–30% of the starting baseline pricing of a company's total third-party purchases. Additionally, if a company is willing to focus on specifications, requirements, demand, and consumption, especially when buying indirect goods and services, significant incremental savings can be achieved on an ongoing basis.   

An example of the resulting margin improvement (i.e., recovery) from a best-practice procurement-transformation initiative is as follows. Take the case of a company that generates $20 billion in annual revenues and has total costs for third-party purchases (both direct materials and indirect goods and services) of $8 billion annually with gross margins of 33% (i.e., $6.67 billion). If a company reduced its costs by 10% (i.e., $800 million), its gross margin would increase to $7.47 billion, or a gross margin gain of 12%. If a company reduced the cost by 15%, the gross margin gain would be 18%. 

Based on this example, it is clear that a transformed procurement organization is a strong investment. It also should be noted that when done properly, the transformation can be accomplished at net cost post initial investment. Some organizations are even lowering the overall cost of procurement through the use of innovative technology and outsourcing strategies and are seeing a sharp rise in procurement's return on investment.  

With any improvement initiative, the secret to sustainability is to continue to improve and add new best practices as they become available. With that in mind, I offer some examples of what some organizations are beginning to do in this area, namely, recovery audits. Recovery audits are audits performed on past transactions to identify overpayments, recovering those overages, and putting safeguards in place to prevent recurrence. Recovery audits are becoming popular as a no-risk/low-risk method to recover overpayments associated with several areas in a company's business. The great thing about recovery audits are that there are many firms willing to perform the audit service and follow-up collections on a contingency fee basis (i.e., the firm will negotiate a split of the collected over payments). Recovery audits include payables audita, worker's compensation audita, telecommunications audita, and waste and recycling audits.  

Payables audits are probably the most common recovery audit being performed today. Auditors look for items, such as duplicate payments, invoicing errors, wrong price paid, and other incorrect payments. Many firms have reported up to 2% overpayment on the sample data being audited. As monies are found, companies typically expand the scope of the audit. 

The purpose of worker's compensation audits is to recover worker's compensation premium overcharges. Typically, the audit team will review the past five to seven years of insurance policies and premium calculations with the goal of finding errors and obtaining refunds. Various documents are reviewed, including final audit billing statements, experience-modification rating worksheet calculations, policy-declaration pages, auditor worksheets, loss-history summaries and claim reserves, and especially rating plans. Experience indicates that up to 70% of corporations will find that they have overpaid their carrier and will receive a refund as a result of this type of audit. 

Because the telecommunication industry has grown so complex and expensive, it is almost inevitable that waste and errors infiltrate the billing to an organization. The audit eliminates waste, corrects billing errors, and puts an organization in full control of future invoices. Auditors perform an in-depth analysis of local service, long-distance service, data lines and circuits, bandwidth usage, private lines, wireless service, teleconferencing services, equipment leases, and service contracts. Common issues that are addressed and corrected include hidden charges not on billing, overcharges versus contracted rates, incorrect long-distance carrier charges, duplicate charges, charges for unnecessary circuits, charges for services never ordered, and incorrect taxes and surcharges. History shows that corporations can lower their telecommunications bills by an average of 25% with the proper controls in place. 

Independent specialists will perform free comprehensive waste audits that examines every aspect of a company's current waste and recycling services. These audits include contract compliance, thereby right-sizing a company's waste output to ensure that a company's out-density is within its industry standards, margin pricing, and cubic-yard evaluation. Most companies are overserviced and incur expensive bills for frequently scheduled hauler pickups. The specialists also will uncover potential revenues for a company from a more organized and aggressive recycling effort. Specialists are compensated with recovered monies on a negotiated basis or from helping to implement the necessary changes. 

These are just a few examples. Recovery audits also are taking place for utilities, medical claims, merchant services (business-to-business transactions), sales and use tax recovery (for nonprofits), and property valuation, along with other areas where billing complexity exists. 

Recovery audits are important tools for a company to benefit from improved practices and having additional funds returned and should be considered. 

is CEO of Wildfire Commerce and strategic advisor for FedBid, tel. 215.327.5739, 

Outsourcing

Recovery audits and other past practices in procurement can improve the bottom line.

Ways to Recover Lost Margins

 magazine’s 2012 list of the 100 Best Corporate Citizens, a benchmark for socially responsible investors and other stakeholders.  Bristol-Myers Squibb has ranked among the top 10 companies each of the last four years and previously secured the number one ranking in 2009.  The 100 Best Corporate Citizens list ranks companies in the Russell 1000 using more than 350 data points in seven categories: environment, climate change, human rights, philanthropy, employee relations, finance, and governance. 

 2012 Diversity Inc. Top 50 Companies for Diversity

 list. Lilly ranked 29th, an increase from its 2011 rating of 39. The list is an assessment of diversity management globally. To make the list, participating companies must have more than 1000 employees and demonstrate strength in key diversity areas: CEO commitment, human capital, corporate and organizational communications, and supplier diversity and show year-to-year progress in diversity initiatives. A total of 587 companies participated in the evaluation 

 reports that its rotavirus vaccine, Rotarix, will be introduced into a newly started national vaccination program in Ghana. This follows the finalization of an agreement that confirmed acceptance of the offer made by GSK to the GAVI Alliance in June 2011 to supply up to 132 million doses of Rotarix at a reduced price over five years. GSK will begin supplying the vaccine through UNICEF to countries in Africa. GSK has been a long-standing partner with the GAVI Alliance and continues to supply more than 70% of its total vaccine volumes to the least developed countries. Vaccination against rotavirus has so far been successfully introduced in five GAVI-eligible countries: Nicaragua, Honduras, Bolivia, Guyana, and Sudan. By securing a guaranteed supply of low-priced, high-quality vaccines, GSK’s commitment to supply up to 132 million doses of Rotarix will enable GAVI to expand rotavirus vaccination further with the aim to cover over 40 countries by 2015. 

 have formalized a collaboration to establish a new laboratory to accommodate the Center of Excellence for sustainable chemistry and to construct a carbon-neutral sustainable chemistry laboratory. This agreement represents progress on GSK’s green-chemistry commitment first announced in 2010. The GlaxoSmithKline Carbon Neutral Laboratory for Sustainable Chemistry will be based on the University’s Jubilee Campus, and its construction is being supported by a £12 million ($19 million) grant from GSK. The laboratory will be a Center of Excellence for sustainable chemistry and will focus on research that is of particular relevance to the pharmaceutical industry and which complements established expertise at the University of Nottingham. It will also deliver advanced undergraduate teaching and outreach to the wider scientific community. The center will serve as a global hub to catalyze new collaborations with other institutions and industry partners and will bring together UK academics, postgraduate and postdoctoral researchers, and GSK chemists for developing expertise in sustainable-chemical synthesis. The laboratory itself will be built from natural materials, and the energy required to run the laboratory will be met by renewable sources such as solar power and sustainable biofuel. Excess energy created by the building will provide enough carbon credits over 25 years to pay back the carbon used in its construction, according to GSK 

 a campaign to enable young adult women to map out their future plans and to provide some resources to help them get started. The campaign, debuting today on HerCampus.com, also encourages young adult women to consider how an unplanned pregnancy could impact her path and how family planning fits into her roadmap. 

 has also been named as a leader in the Maplecroft Climate Innovation Index (CII), which identifies global companies that demonstrate superior management, mitigation, and adaptation in climate innovation. Merck ranked 45th out of the top 100 global companies (and 17th among the top 100 US companies), out of a more than 300 companies that were reviewed. Merck placed third out of the 10 pharmaceutical companies that made the global ranking. The CII is based on public disclosures and direct engagement with companies. Maplecroft rated each company against more than 100 criteria, including technological innovation and new working practices to combat climate-change impacts, management of climate-related issues, adaption to physical climate-related risks, such as flooding or more extreme weather events throughout the supply chain, and the reduction of greenhouse-gas emissions. 

 reported that more than 25,000 employees across 54 countries are engaging in volunteer activities to benefit people in their local communities. The company reported the participation in line with its annual Community Partnership Day (CPD). Participation in the 2012 CPD activities increased 25% increase over the previous year, with more than 25,000 Novartis associates worldwide supporting a wide range of charitable causes. 

 reported a new global strategy aimed at reducing measles deaths and congenital rubella syndrome to zero. The announcement comes with the publication of new data that showed efforts to reduce measles deaths have resulted in a 74% reduction in global measles mortality, from an estimated 535,300 deaths in 2000 to 139,300 in 2010, largely due to increase immunization through vaccines. Since 2001, the Measles Initiative has supported developing countries to vaccinate over one billion children against measles. Now, in keeping with the new Global Measles and Rubella Strategic Plan to control and eventually eliminate measles and rubella, the initiative is called the Measles & Rubella Initiative. The new strategic plan presents a five-pronged strategy to cut global measles deaths by at least 95% by 2015 compared with 2000 levels and to achieve measles and rubella elimination in at least five WHO regions by 2020.  The strategies include high vaccination coverage monitoring spread of disease using laboratory-backed surveillance, outbreak preparedness and response and measles case management, communication and community engagement, and R&D. Under the new strategy, 62 countries currently not using rubella vaccine are encouraged to use their measles vaccination delivery system to introduce rubella vaccine into their national immunization schedule. The newly renamed Measles & Rubella Initiative has support from GAVI and is welcoming new partners, including the American Academy of Pediatrics, the International Pediatric Association, Lions Clubs International and the Sabin Vaccine Institute. 

CSR and Sustainability Forum

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

CSR and Sustainability in the News

Universal sustainability is an economic and social discipline that seeks to marry economic growth, competitiveness, and innovation with larger societal goals for economic, social, and environmental progress (1). By its nature, sustainability is interdisciplinary and requires the participation of industry, government, educational institutions, and nongovernmental organizations (NGOs). For the pharmaceutical industry and its stakeholders, sustainability plays a role not only in individual company activity, but also in collective efforts, such as in global health, where public, private, and public–private partnerships play a crucial role in advancing sustainable healthcare. 

 conducted a roundtable with Jane Griffiths, PhD and company group chair of Johnson & Johnson’s Janssen for Europe, the Middle East and Africa (EMEA), and Emma Waters, MD and specialty registrar at the Sustainable Development Unit (SDU) at the UK government’s National Health Service (NHS). Griffiths is responsible for the EMEA region of Janssen, the pharmaceutical division of Johnson & Johnson, and is also chair of the Johnson & Johnson Global Pharmaceuticals Sustainability Council.  In her position with the UK NHS, Waters is helping the SDU establish metrics for measuring sustainable development and to coordinate the SDU’s work with pharmaceutical companies to develop guidance for uniform carbon foot-printing of pharmaceuticals and medical devices.  Both Griffiths and Waters will be speakers at

 a conference addressing the goals and ways to achieve universal sustainability, which will be held June 21–22, 2012, in Dublin, Ireland. Griffiths and Waters are part of a specialized track on global health and sustainability. Other sessions at SustaiNext EU will address the interrelationships between sustainability and transportation, education, agriculture and food, and global society. 

SustaiNext EU is supported by the Sustainability Collaborative, a cross-functional coalition of representatives from industry, academia, government, and NGOs. The Sustainability Collaborative was created in 2009 to stimulate partnerships and connections between academia, business, government, nonprofits, and communities in pursuit of universal sustainability. It now has more than 800 participants, which include representatives from organizations, such as Dublin City University, Rutgers University, Drexel University, Advancing Sustainability in Higher Education, Johnson & Johnson, BD, SIMS, Sustainable Brands, Best Foot Forward, and Source 44. 

What role does sustainability play in addressing the goals of global health initiatives overall and with respect to specific objectives, such as increasing access to medicines? Can you offer examples from an industry perspective and/or from your own organization? 

As perhaps the highest profile social issue facing the pharmaceutical industry, it’s only natural that access to medicines is one of the most important elements in our sustainability strategy. A large percentage of the world’s population lives without access to basic medicines that can significantly reduce the impact of disease, improve the quality of life, and in some cases, save lives. A number of factors can affect access to medicines. In many areas, such as sub-Saharan Africa, the medical infrastructures are not well developed.  As a result, many other challenges still stand in the way even when we provide low-cost medicines, such as the ability to get the medicines registered for sale, the lack of a medical education infrastructure to help ensure proper use of medicines, efficient distribution of medicines, and even questionable business ethics. 

 We have a responsibility as a healthcare company to work with nongovernmental and governmental organizations to create better access to medicines. Licensing to local manufacturers is one pathway that has helped increase access, which we have done with some of our HIV/AIDS medicines.  In other cases, it may be through working with organizations, such as the TB Alliance, to help accelerate the development of our tuberculosis (TB) treatments to address the increase in drug-resistant strains of TB. 

 Another issue that crosses social and business lines is the cost of our current healthcare systems and the role we play as producers of healthcare products. Obviously, the cost of a product is only part of the total healthcare cost, but there is a lot of pressure on us to reduce cost. It’s inevitable that for a sustained healthcare system, the whole system needs to become more cost-effective, but on the other hand, there needs to be enough budget to continue to research and develop better and more effective products. In some cases, there might be other options than the use of healthcare products but that means a paradigm shift in society. We’ve been working with the NHS on assessing opportunities in the pathways of diseases, for example, Type 2 diabetes. We all know that obesity is a major cause of Type 2 diabetes, and that in many cases, lifestyle choices relate to obesity. Therefore, it’s interesting to see whether the healthcare industry can offer prevention rather than a cure, which obviously has a significant impact on the cost of healthcare. Such options, however, need a holistic approach, much in line with universal sustainability, including the food and transport industry. 

 It is known that climate change will have a significant negative impact on health (2).  However, it is also known that many strategies to reduce climate change also will have significant benefit to health (i.e., health co-benefits). For instance, enabling active transport, such as walking or cycling, will obviously have health benefits in addition to reducing greenhouse-gas (GHG) production. Low-carbon patient healthcare pathways and, when appropriate, community healthcare or telehealthcare also can improve health outcomes. Schemes, such as smoking cessation, which improve public health and reduce the need for patients to access healthcare, also will reduce carbon emissions. Finally, the World Health Organization and member states are committed to reducing health inequalities (3). However, it is recognized that climate change has the potential to increase health inequalities, both within countries and internationally (4). Therefore, climate- change mitigation is essential to help prevent increases in health inequalities. 

 How does sustainability factor into the pharmaceutical supply chain?  Where do you see areas of greatest impact, such as in green-manufacturing processes for pharmaceutical products, green procurement practices for pharmaceutical ingredients or products, or distribution activity? Can you offer examples from an industry perspective and/or from your own organization? 

With healthcare spend accounting for anywhere from 6 to 16% of GDP [gross domestic product] in developed countries, it follows that healthcare has a very large associated environmental footprint. Our largest customers, (e.g., government accounts and large hospital networks), where the environmental impact can be seen at a macro level, are starting to take notice of that environmental footprint and are reaching out to their suppliers to help them minimize waste, save energy, eliminate toxics, and reduce water consumption. The benefits spread beyond the environment as they can save them money as well. We need to continue to develop greener products that are more environmentally friendly, not only for our customers but all along their value chain. 

 For J&J, we have a product stewardship program known as Earthwards that guides and assists development teams in each of the sectors to deliver greener products.  For pharmaceuticals, developing greener products begins with having a full understanding of what happens to our pharmaceuticals once they enter the environment; incorporating green-chemistry principles into our chemical synthesis and processing; leaning our packaging and incorporating more sustainable packaging materials; and ensuring that our suppliers also take great care to minimize their impacts to the environment and the communities in which they are located. 

While we expect that we will have chemical-based pharmaceuticals with us for some time, in the longer term, we believe the move to biologic-based treatments will address many of the concerns around chemicals in the environment.  However, biologics have their own set of environmental effects, such as significant water use and cold-chain distribution, which we need to address over time. We are confident, however, that overall we are moving into a period where healthcare products will have less of an impact on the environment. 

 It is known that globally, pharmaceuticals contribute a large proportion of healthcare GHG emissions. For instance, research carried out by the NHS Sustainable Development Unit (SDU) found that in 2010, an estimated 22% of the National Health Service (NHS) for England’s GHG emissions were attributable to pharmaceuticals (5). It is essential that healthcare providers take action to reduce their carbon emissions, and the UK’s NHS has committed to an ambition of reducing its carbon dioxide (CO

) equivalent emissions by 80% by 2050. Due to the significant proportion of GHG emissions that are attributable to pharmaceuticals, it is obviously essential that the all parts of the pharmaceutical supply-chain and end-of-use factors are considered when reducing GHG emissions. However, for many pharmaceutical products, there is only limited data available regarding their complete life-cycle CO

 equivalent footprint. For this reason, the NHS SDU is currently working with industry partners, international health providers, and an environmental consultancy firm to develop uniform international guidance to aid in the development of CO

 equivalent foot-printing for the complete life cycle of pharmaceuticals. It is hoped that the resulting guidance will highlight to the pharmaceutical industry and healthcare providers areas of high GHG emissions and allow them to work together to reduce carbon emissions. 

From your perspective, where do you see the greatest progress to date in achieving sustainability with respects to the pharmaceutical industry and/or global and national health policy? Looking ahead five to 10 years, what might be some future goals or aspirations in this area?

The greatest progress to date is the ongoing discussion around this topic. This might seem strange, but the fact that all the stakeholders in our industry are now actively engaged with identifying and discussing opportunities to make healthcare more sustainable has moved it away from being a ‘flavor of the day’ to a embedded part of our strategies. Obviously, there were immediate steps that we were able to take, such as making our processes more lean and reducing waste and energy use, in some cases quite dramatically. 

 In the longer term, say 10 years from now, I think technological advances, such as the continued development of early diagnostic technologies and chronic disease intervention, personalized medicine, telemedicine, and preventive therapies, such as next-generation vaccines, all stand to help reduce the footprint of care while increasing the quality of care.  However, healthcare companies, systems, and governments that can commercialize prevention, that is, getting patients to really place a value on their health and preserve it, will be the most successful going forward.  Elimination of preventable diseases, especially chronic and disabling diseases, really should be our goal, and we really can’t afford not to achieve that goal. 

Currently, multisectorial collaborations, such as the international collaboration to create uniform carbon foot-printing guidance already described, and collaborations between industry and healthcare providers to create low-carbon patient-care pathways are making important contributions toward the ambition to reduce pharmaceutical related GHG emissions. Ultimately, the SDU envisages that sustainable healthcare will involve a move toward a service-based model of healthcare where providers support the system through providing services around fewer products rather than the current more product-based system. 

1. R.L. Lattimer, “Universal Sustainability: The Economy and Competitiveness 2012,” 

Rio Political Declaration on Social Determinants of Health 

(Rio de Janeiro, Brazil, Oct. 21, 2011). 

(NHS Sustainable Development Unit, 2012). 

Industry leaders share their perspectives on how the pharmaceutical industry is and can further advance sustainability.

The Marriage of Global Health and Sustainability

Last month, GlaxoSmithKline (GSK) released its 2011 corporate social responsibility report, which included the company’s progress and goals for environmental improvement. The company estimates its carbon footprint across its value chain to be 14 million metric tons of carbon dioxide. It is implementing an environmental sustainability strategy across the value chain from raw materials to product disposal. The strategy focuses on carbon dioxide and other emissions that contribute to climate change, water use, waste reduction, and environmental stewardship. By 2050, the company is aiming to have a carbon-neutral value chain. 

• Reduced greenhouse gas emissions from its facilities by 5.3%; its overall carbon dioxide impact rose slightly due to increased production volumes 

• Reduced water use by 6.9% and waste sent to landfill by 25% with 30 sites now sending zero waste

• Developing a product carbon-footprint approach that will be used with individual products to identify carbon hotspots and measures to reduce them 

• Continued to pilot a take-back scheme for used inhalers in the United States and United Kingdom to reduce waste and greenhouse-gas emissions 

• Recycled its own waste polyethylene terephthalate (PET) plastic to make new Ribena bottles (Ribena is an uncarbonated soft drink by GSK)

• Received an “‘A” rating for performance and scored 93% on disclosure in the Carbon Disclosure Project assessment 

• Had its first office building certified as gold under the Leadership in Energy and Environmental Design (LEED) environmental-rating system 

• Published a report, with partners, exploring the impact of climate change on health. 

In reducing its carbon-dioxide-equivalents from its facilities by 5.3% in 2011, GSK’s main focus has been on energy-efficiency activities, where it saw a 7.2% decrease in carbon-dioxode-equivalent emissions. This reduction has been offset by increases in its manufacturing and production volume. Production-related carbon-dioxide-equivalent emissions increased 5.4%, and transport emissions increased 8.4%. The combined total reduction in facilities and transport emissions was 2.6%. 

Combined heat and power (CHP) generation also is playing a growing role in decreasing the company’s carbon emissions. In 2011, GSK installed five CHP units, bringing the total to 16 operating units across 10 sites. For example, its manufacturing site in Irvine, Scotland, has reduced greenhouse-gas emissions by 12% during the past three years.  The site makes the active ingredient for for the antibiotic Augmentin in an energy-intensive process, and the company aims to secure its energy supplies from renewable sources by installing wind power. The first turbine should be operating early in 2013, with two to follow subject to planning approvals. Together, they will deliver annual savings of 8000 metric tons of carbon-dioxide equivalents. 

 The company also approved a £15 million ($24 million) project to convert waste to heat at its plant in Singapore, with estimated annual savings of  7700 metric tons of carbon-dioxide-equivalents from 2014. In 2011, the vaccine site at Sainte-Foy in Quebec supported renewable energy and energy reduction projects. Over the past four years, it has supported over 800 projects that have saved approximately 170,000 metric tons of carbon-dioxide equivalents. 

 Also, its factories in India for Horlicks (a malted milk drink made by GSK) uses coal to generate energy, which creates approximately 72,000 metric tons of carbon-dioxide-equivalent emissions per year, or approximately 5% of the total for GSK’s operations. In 2011, sites began trials to switch from burning coal exclusively to blending it with waste biomass. The company tested several options, such as rice husk, pellets made from waste wood, sawdust, grain straw, cotton straw, and ground nut shells. If further trials in 2012 prove successful, GSK plans to blend up to 30% waste biomass at all three sites, thereby avoiding 19,800 metric tons of emissions per year. In the longer term, the company aims for 100% waste biomass for steam generation and investment in combined heat and power technology to generate its  own electricity. 

 Other measures involved eliminating chlorofluorocarbon gases from its products (completed in 2010), which has substantially reduced inhaler emissions from 24 million metric tons of carbon dioxide-equivalents in 1998 to less than five million metric tons. Although progressing in this field, the company notes that its replacement propellant is still a greenhouse gas and seeks to reduce this further by such means as supplying dry-powder inhalers where appropriate. 

Unlike carbon emissions whose impacts are global, water use has local and global impacts and needs to take into account all users of a watershed as well as seasonality and water quality. GSK is active in the UN CEO Water Mandate, under which it cosponsors work to develop disclosure guidelines. These guidelines will help companies to measure andcommunicate performance more effectively. A eventual goal is to develop a water-footprint approach similar to the greenhouse-gas protocol. 

 On a company basis, GSK also continues site-level action to improve water use with a 6.9% reduction in 2011. The company has developed a “water kaizen” rapid improvement process to identify more efficient ways to use water. It piloted this approach at its Worthing and Maidenhead sites in England and identified potential savings of more than 25%. Examples of projects implemented include fitting aerators to taps, decommissioning redundant equipment, optimizing service water flows, and fitting trigger guns to water hoses. Both sites are investigating other opportunities identified in the kaizen process, such as whether high-grade wastewater from one part of the plant could be used elsewhere instead of using additional potable water in its supply chain.

GSK’s total waste (hazardous and nonhazardous) fell by 1.2% and volumes to landfill were down by 25.5% in 2011. A total of 30 sites now send zero waste to landfill.  Some examples of waste-reduction and reuse projects included using panelling from its refrigerated vaccines shipping packaging as insulation material for the construction industry. Reusing these materials reduces waste by 64 metric tons per year that previously went to landfill. Another innovation in 2011 led to its own waste PET plastic being used to make bottles for Ribena. Previously, waste contractors disposed of approximately 700 metric tons of PET packaging trays used to deliver components to GSK’s  sites at Ware, UK, and Evreux, France. The material is being recycled to create new Ribena bottles saving approximately more than 3000 metric tons of carbon-dioxide-equivalent emissions per year. Other examples of reducing packaging waste in 2011 include converting from glass to plastic bottles for Horlicks, reducing packaging material on consumer healthcare products, and converting from blister packs to film wrapping for its nasal spray Flixotide. GSK estimates these measures will avoid more than 10,000 metric tons of carbon-dioxide equivalents per  year.

In its sustainability report, GSK also noted certain practices to help meet its environmental profile. For example, a green packaging guide helps designers to avoid waste and choose the most sustainable option and includes sustainability-assessment tools covering energy and water use as well as the carbon footprint of packaging materials and transport. A carbon tracker collects data to monitor progress in the use of materials for its new pharmaceutical products. The average mass efficiency of the new primary processes transferred to manufacturing in 2011 was 2.2%, compared to its 2015 target of 2.5%. The company aims to increase the mass efficiency of products transferred to manufacturing to 3% by 2015 through measures such as solvent recovery. 

 In 2011, the company created a new R&D group working on second-generation product development to improve the sustainability profile of the R&D and manufacturingportfolio of projects through the product life cycle. GSK also continued its collaboration with the GSK-Singapore Partnership for Green and Sustainable Manufacturing. Its R&D groups have also worked with other industry partners to create a €20 million ($32 million) Sustainable Chemistry partnership with academia through the European Innovative Medicines Initiative, which begins work in 2012. GSK is also part of the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable, where it collaborates with other pharmaceutical companies on green chemistry and engineering in the pharmaceutical industry. 

The company provides progress made in 2011 and future environmental objectives.

GlaxoSmithKline Outlines Its Sustainability Goals

Late last month, the Obama Administration released the National Bioeconomy Blueprint. The report outlines steps that federal agencies will take to drive the bioeconomy—economic activity driven by research and innovation in the biosciences—and details ongoing efforts across the federal government to realize this goal. A key part of these efforts are ways to improve innovation, development, and regulation of pharmaceuticals. 

In 2010, the Obama Administration included in its science and technology priorities as part of federal agency budget submissions a priority for federal agencies to “support research to establish the foundations for a 21st century bioeconomy.” In September 2011, President Obama announced that his Administration would release a National Bioeconomy. Modeled after the Administration’s 2011 Blueprint for a Secure Energy Future, the 2012 National Bioeconomy Blueprint has two purposes: to lay out strategic objectives that will help realize the full potential of the US bioeconomy and to highlight early achievements toward those objectives. 

 The report recognizes the importance of biotechnology not only in healthcare but in other sectors. “The bioeconomy emerged as an Administration priority because of its tremendous potential for growth and job creation as well as the many other societal benefits it offers,” says the report.” A more robust bioeconomy can enable Americans to live longer and healthier lives, develop new sources of bioenergy, address key environmental challenges, transform manufacturing processes, and increase the productivity and scope of the agricultural sector while generating new industries and occupational opportunities.” 

 The Bioeconomy Blueprint outlines five strategic imperatives: support R&D investments; facilitate the transition of bioinventions from research laboratories to market, including an increased focus on translational and regulatory sciences; reduce barriers to increase the speed of regulatory processes; update training programs and align academic institution incentives with student training for national workforce needs; and identify and support opportunities for the development of public–private partnerships and precompetitive collaborations. 

In laying out a plan to increase R&D investment, the report emphasizes the need to increase coordination of federal bioeconomy-related research activities to improve the efficiency and effectiveness of R&D investments. The report also emphasizes the importance of multiagency collaborations for emerging foundational technologies, such as synthetic biology, biology-related information technologies, and proteomics and the integration of disciplines. The report says that the Administration will prioritize additional multidisciplinary efforts in physics, chemistry, engineering, computer sciences, and mathematics, to support the bioeconomy. The report also calls for federal agencies to further explore the use of new or modified funding mechanisms in and across agencies to stimulate the discovery of new bioinventions with potential to grow the bioeconomy. 

 In facilitating the transition of bioinventions from research laboratory to market, the report emphasized an increased focus on entrepreneurship, translational sciences, regulatory science, and technology transfer, including strategic, coordinated investments in translational and regulatory sciences to accelerate progress. To capitalize on the promise of the newly reauthorized Small Business Innovation Research (SBIR) program, the report said that federal agencies should evaluate and update SBIR programs. Some relevant objectives include reducing application response times, hiring/training program staff to enhance relevant in-house experience, and increasing the use of industry experts as peer reviewers to evaluate industry proposals. The report also stressed the importance of enhancing entrepreneurship at universities and using federal procurement to encourage the development of biobased products. 

The blueprint calls for regulatory reform by reducing barriers, increasing the speed and predictability of regulatory processes, and reducing costs while protecting human and environmental health. When an emerging technology enters the regulatory process, federal agencies are asked to have a robust framework that identifies lead agency responsibilities, clarifies supporting agency roles, and delivers timely, specific guidance for applicants. The report also calls for stakeholder collaborations to identify needs and reduce impediments. 

The report also calls for updating training programs and aligning academic institution incentives with student training for national workforce needs. At the K-12 and undergraduate levels, the report cites progress in developing approaches to improve science, technology, engineering, and mathematics (STEM) education and increasing the number and diversity of STEM students. The report points to the Educate to Innovate campaign, launched in 2009, to move American students from the middle to the top of international rankings in STEM achievements over the next decade. The report says that by building upon and expanding these efforts, particularly with regard to graduate-level training enhancements, would help to align academic institution incentives with training for future workforce needs. 

The blueprint also calls for increased partnerships between employers and educational institutions, including incentives for academic institutions to enhance entrepreneurship and restructure training programs. Following reengineering of training programs, the report says that agencies should consider convening industry stakeholders from various sectors to assess the success of training programs to meet the needs of employers.

The report also calls for identify and supporting opportunities for the development of public–private partnerships and precompetitive collaborations—where competitors pool resources, knowledge, and expertise to learn from successes and failures. “Many companies do not invest in early ideas because they are unlikely to pay off immediately. This is one place where the government can play a crucial role,” says the report. Moving forward, the report emphasizes that federal agencies provide incentives for public–private partnerships and precompetitive collaborations. 


In laying out a blueprint, the report also identifies areas of progress, including those relating to pharmaceuticals and biomedical innovation. One area cited by the report is the need to improve the information technology infrastructure of FDA and the access to this information to “transform FDA archives into a driver of discovery and development,” says the report. It notes that FDA currently houses one of the largest known repositories of clinical data, including safety, efficacy, and performance information, and an increasing amount of postmarket safety surveillance data. Integrating and analyzing these data, with appropriate patient privacy protections, is one way to advance biomedical research, notes the report. The report points to FDA efforts to rebuild its information technology and data analytic capabilities and establishing “science enclaves”— virtually networked IT environments where multidisciplinary teams can work together to analyze large sets of data extracted from the FDA data resources while complying with applicable law concerning proprietary information and patient privacy. The enclaves can also be used to design new software that should enhance the quality, efficiency, and accuracy of FDA regulatory reviews. 

 Other projects cited by the report are the recent launch of Intramural Center for Regenerative Medicine (CRM) at the National Institutes of Health (NIH) to support induced pluripotent cell technology. NIH CRM and its partners are exploring the development of iPS cell therapies to treat blood-related diseases, such as leukemia and metabolic diseases, including lysosomal storage diseases that affect children. In addition, researchers will investigate whether iPS cells can be used to develop blood products that could help meet the demand for blood transfusions during medical emergencies and surgeries. NIH also recently embarked on a major effort to use iPS technology to advance research into neurodegenerative diseases. That effort already has developed and made widely available neural cell lines for Parkinson’s disease, amyotrophic lateral sclerosis, and Huntington’s disease. 

Also, the NIH’s newest center, the National Center for Advancing Translational Sciences (NCATS), recently teamed up with Eli Lilly to create a step-by-step playbook to help researchers from all sectors translate their basic findings into potential treatments for patients. The Assay Guidance Manual will be available as a free e-book in early May. 

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