Tackling diseases of the developing world requires not only innovation in drug products, but also innovation in the organizational structures, training, and education to yield advances in R&D. Collaborative models, which bring together scientists from pharmaceutical companies, universities, and other research institutes, are important ways to marry external and internal activities, and several companies are advancing these approaches. 

In June 2011, external researchers from six medical research organizations began work in the GlaxoSmithKline (GSK) “open lab” in Spain as part of GSK’s experiment to stimulate collaboration in the search for new medicines against diseases of the developing world, such as malaria and drug-resistant tuberculosis (TB). In total, eight scientists from six organizations from four countries, including the United States and South Africa, will work on their own research projects in association with GSK scientists at the Tres Cantos research campus. The Tres Cantos Open Lab Foundation provides funding and support for scientists, academics, and institutions to develop and advance new ideas that could lead to new medicines to treat diseases of the developing world. The researchers are the first external researchers to take up the open-lab placements since GSK announced that it was seeking to be more collaborative in this area of research. 

GSK had first stated its intention to open the research campus outside of Madrid in 2010 with the plan of allowing GSK researchers to work more collaboratively with scientists from universities, not-for-profit partnerships, and other research institutes to address diseases of the developing world. The facility has made capacity available to independent researchers to allow them to work alongside approximately 120 GSK scientists and access their expertise and the facilities. 

Half of this first wave of research projects are being supported by the Tres Cantos Open Lab Foundation, through a £5-million ($8-million) donation in seed funding from GSK to support suitable research projects. Among the projects underway are research to identify and optimize compounds that could be tested in humans against multidrug-resistant TB, three separate projects for malaria, including one that investigates potential compounds from the GSK chemical library, and a new approach against the parasites that can cause leishmaniasis. The specific projects and partners are outlined below: 

• Themba Pharmaceuticals—A six-month project to identify potential new compounds for treating TB, specifically multidrug, extremely drug-resistant TB and co-infection with HIV-AIDS 

• The Barcelona Center for International Health Research—A two-year project to create a continuous laboratory-based supply of the 

• CICbioGUNE—An 18-month project to characterize the ubiquitylation profiles of cells infected by multiple drug-resistant TB and the malaria parasite 

• Durham University—A nine-month project to identify compounds that can inhibit a new target in kinetoplastid protozoan parasites 

• Weill Cornell Medical College—A 24-month project to identify compounds that can affect both drug-sensitive, multidrug-, and extensively drug-resistant TB in the nonreplicating phase 

• Imperial College London, Drug Discovery Center and The Wellcome Trust Sanger Institute—A two-month project aimed to identify calcium-dependent protein kinases inhibitors from the 13,500 compounds identified by GSK in 2010 as inhibiting 

Collaborative research models also are the focus of other companies’ efforts. For example, Sanofi recently formed several partnerships to advance research for diseases in the developing world. Earlier this year, the company formed a collaboration with the Drugs for Neglected Diseases initiative (DNDi), a nonprofit product-development partnership, for a three-year project for researching new treatments for nine neglected tropical diseases listed by the World Health Organization. The diseases are kinetoplastid diseases (i.e., leishmaniases, Chagas disease, and human African trypanosomiasis), helminth infections (i.e.,lymphatic filariasis, onchocerciasis, and soil-transmitted helminthiasis), and dracunculiasis, fascioliasis, and schistosomiasis. Under the agreement, Sanofi will initially bring molecules from its libraries into the partnership, and DNDi will collaborate in research activities on innovative molecular scaffolds. 

 Sanofi also partnered with the Medicines for Malaria Venture, a nonprofit public–private partnership, through an alliance agreement to research malaria treatments and agreed to the first research project agreement within the framework of the alliance. As part of an agreement, signed earlier this year, both parties will work together to identify, characterize, and optimize new candidate compounds to treat malaria and conduct early-development programs to demonstrate proof of concept. The three-year research project, “Orthology Malaria,” seeks to develop drug candidates from a sent of Sanofi compounds that have been selected for their potential activity against malaria parasites. 

And in June 2011,  Sanofi entered into a research collaboration with Weill Cornell Medical College  to identify new anti-infectives that shorten the course of TB treatment and provide therapies against drug-susceptible and drug-resistant strains of TB. Sanofi will prove 80,000 chemical compounds to Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of 

 Weill Cornell has obtained funding from the Bill and Melinda Gates Foundation for screening activities. Sanofi and Weill Cornell will jointly determine if any compounds screened through the collaboration should be optimized for potential development. 

Collaborative models also may involve building pharmaceutical scientific capacity. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), for example, facilitated setting up a Clinical Research Career Development program, which is coordinated by the UN Children’s Fund (UNICEF)–UN Development Program (UNDP)–World Bank–WHO Special Program for Research and Training in Tropical Diseases (1). The aim of the program is to provide practical clinical experience for promising researchers from low- and middle-income countries and encourage high-quality clinical R&D on medicines, vaccines, and diagnostics. After a 12-month fellowship with a research-based pharmaceutical company, the researchers return to their home countries and institutes to become a resource for R&D for infectious diseases. In 2009, 12 fellows were placed in training programs with seven IFPMA member companies: Eisai, GSK, Johnson & Johnson, Novartis, Pfizer, Roche, and Sanofi. This year, some of those companies are taking second fellows, and additional fellows are being placed with the IFPMA member companies of Astellas, Boehringer Ingelheim, Merck & Co., and Sigma-tau (1). 

1. P. Van Arum, “IFPMA Outlines Global Health Initiatives,” online, 

Articles

CSR and Sustainability Forum

GlaxoSmithKline is among the companies building scientific capacity to address diseases in the developing world.

Building Pharmaceutical Scientific Capacity in the Developing World

Green chemistry is an important tool in improving reactions, which may for example, improve production economics through reduced energy requirements, lower solvent use, fewer byproducts, and less waste generation. In June 2011, the Presidential Green Chemistry Challenge Awards, an annual program by the US Environmental Protection Agency, was held to recognize advances in green chemistry

 Bruce H. Lipshutz, professor in the chemistry and biochemistry department at the University of California at Santa Barbara, was recognized for designing a second-generation surfactant, TPGS-750-M, which can be used in industrial processes to replace large amounts of organic solvents with small amounts of the surfactant nanodispersed in water only. TPGS-750-M is composed of tocopherol (i.e., vitamin E), succinic acid, and methoxy polyethylene glycol. TPGS-750-M forms nanomicelles in water that are lipophilic on the interior and hydrophilic on the exterior. A small amount of TPGS-750-M may be used to spontaneously form 50–100-nm diameter micelles in water to serve as nanoreactors.  The particle size of TPGS-750-M is engineered to facilitate organic reactions, such as cross-couplings. Reactants and catalysts dissolve in the micelles, resulting in high concentrations that lead to increased reaction rates at ambient temperature (1, 2).  

Several common organic reactions that are catalyzed by transition metals can take place within TPGS-750-M micelles in water at room temperature and in high isolated yields. These reactions include ruthenium-catalyzed olefin metatheses (Grubbs), palladium-catalyzed cross-couplings (Suzuki, Heck, and Sonogashira), unsymmetrical aminations, allylic aminations and silylations, and aryl borylations. The technology also offers the potential for palladium-catalyzed aromatic carbon–hydrogen bond activation for carbon–carbon bond formation at room temperature. In its awards recognition, EPA cited other advantages to the technology: straightforward product isolation; elimination of frothing and foaming commonly associated with other surfactants; efficient recycling of the surfactant after use; recovery of the insoluble product by extraction; and reuse of the aqueous surfactant with negligible loss of activity. Future generations of surfactants may include a catalyst tethered to a surfactant to provide both the reaction vessel (i.e., the inside of the micelle) and the catalyst to enable the reaction (1, 2).
 

. Eli Lilly submitted two entries to EPA’s Green Chemistry Presidential Challenge. The first involved the commercial production of LY2624803*H

, an investigational new drug candidate in Phase II clinical trials and a drug acquired by Lilly with its acquisition of Hypnion. The original synthesis was not amenable to large-scale manufacture and had several environmental and safety issues with the original chemistry. Among them were: dimethylformamide/sodium hydride in step one of the synthesis; methylene in various steps; a molten step with observed self-heating; an aldehyde purification that would be unsafe at increased scale; phosphoryl chloride in large excess; and chromatographic purification (1, 2).

The company made several improvements to the synthesis using flow processing. An efficient carbonylation replaced an inefficient oxidation catalyzed by tetramethyl pentahydropyridine oxide. Hydrogen replaced sodium triacetoxyborohydride in a reductive amination. Although both operations required high pressure (i.e., 1000 psi), which would be difficult to manage in a batch environment, both operations were amenable to flow processing (1, 2).

 Process mass intensity (PMI), a measure of the efficiency of a synthesis, was improved. PMI is the total mass of raw materials (including water) put into a process for every kilogram of product produced. The original route had a PMI of more than 1000 before chromatography. The new route has a net PMI of 59, representing a 94% reduction in PMI and a 96% reduction with chromatography. Lilly implemented its new route for LY262480*H

 on a pilot-plant scale in Indianapolis, Indiana, during 2009 and on a commercial scale in Kinsale, Ireland, during 2010, according to the EPA report. (1, 2). 


. Another entry from Eli Lilly involved the development of Grignard chemistry using a continuous stirred tank reactor. The Grignard reaction is applied to many industrial reactions, including producing intermediates for pharmaceutical compounds. Some commercial-scale problems with the reaction, however, are strongly exothermic activation and reaction steps, heterogeneous reactions with potential problems suspending and mixing the reaction mixture, and operational hazards posed by ethereal solvents, such as diethyl ether (1, 2).

 Eli Lilly developed inherently safer Grignard chemistry using a continuous stirred tank reactor that allowed continuous formation of Grignard reagents with continuous coupling and quenching. This approach minimized hazards by operating at a small reaction volume, performed metal activation only once during each campaign, and used 2-methyltetrahydrofuran (MeTHF). MeTHF offers certain advantages, such as that it may be derived from renewable resources and may provide improved chemoselectivty and stereoselectivity compared with Grignard products using other ethereal solvents. The continuous approach provided reductions of 43% in metal use, 10% in Grignard reagent stoichiometry, and 30% in PMI (1, 2).

According to the EPA report, Lilly is using the continuous stirred tank reactor Grignard approach to produce two key materials: the penultimate intermediate of LY2216684*HCl, a norepinephrine reuptake inhibitor currently under clinical investigation, and for an intermediate for another drug under clinical development. Commercial production on a 22-L scale is under consideration (1, 2).

Presidential Green Chemistry Challenge Awards Program: Summary of 2011 Award Entries and Recipients

EPA's Presidential Green Chemistry Awards recognize developments in green chemistry, including those in pharmaceutical applications.

Advancing Green Chemistry in Pharmaceutical Applications

Pharmaceutical companies and their suppliers face an increasingly challenging operating environment, marked by industry-wide restructuring, slowing revenue growth, constrained profits, competition from companies in emerging markets, and uncertainty in overall macroeconomic conditions. In light of these issues, innovation, as a means of creating business value and generating growth, is crucial for pharmaceutical companies and suppliers alike. How to cultivate innovation, implement it, and sustain it was discussed at a recent educational program, the 

DCAT/ISM Sourcing Summit’ 11: Innovative Sourcing,

 which was organized and held by the Drug, Chemical, and Associated Technologies Association (DCAT) and its partner, the Pharma Forum and Chemical Group of the Institute of Supply Management (ISM). The program brought together pharmaceutical companies, contract service providers, and suppliers to share perspectives and approaches on how to achieve innovation overall and in sourcing and procurement in particular. 

“Innovation is not just an art, it is a science,” said Puneet Sapra, director of worldwide business development and innovation with Pfizer. From an overall business perspective, much like how the concept of quality became formalized through the adoption of specific frameworks, language, practices, and systems, the concept of innovation can be applied in similar systematic fashion, said Sapra. 

“Innovation is a process to generate creative solutions and implement them for business value,” said Sapra, pointing to three levels of innovation. At the first level, “Sustaining” innovation consists of incremental improvements in products or processes that can be delivered by existing resources. It involves meeting base-level commitments. Business-line functions can drive Sustaining innovation by using problem-solving approaches to reduce inefficiencies in existing processes, such as Lean Six Sigma, fish-bone analysis, and total quality management. 

“Transformative” innovation is the next level and involves expansionary improvements in products or process that can be delivered by existing resources and involves exceeding joint business targets, explains Sapra. Cross-functional teams can be used to create Transformative innovation through various ways, such as through a brand. An example outside the pharmaceutical industry is Virgin, a company founded by Sir Richard Branson, which creatively uses its brand in various businesses, such as mobile telephony, transportation, travel, financial services, media, music and fitness to create competitive advantage. 

Transformative innovation also can be driven by communities developed within an organization. The innovation communities use web platforms and consist of cross-functional employees that share ideas, information, and lessons learned. In this approach, leaders pose problems and opportunities for communities to tackle them in the form of challenges. Small teams can develop promising ideas by following a structured guided process. 

“Disruptive innovation” is the next level in the innovation spectrum. Disruptive innovation involves breakthrough business models that are delivered by new resources, processes, and economic formulas. “Disruptive innovation requires focus, collaboration, and new insights,” said Sapra. It involves identifying unmet needs, deciding strategic intent, creating an idea ecosystem, and devising business models. The idea ecosystem consists of not only internal participation across an organization, but also external participation from a variety of entities, such as suppliers, research institutes, contract service providers, joint-development partners, individual entrepreneurs, alliances, or trading partners. Within Pfizer, Sapra said innovation is a key focus of the company and building a sustaining culture of innovation requires “enabling business model innovation by sourcing and investing in transformational and disruptive ideas from inside and outside of the company.” 

The need to eliminate obstacles for innovation and create systematic approaches for fostering innovation was further emphasized by other speakers at the summit. “Seek input and listen to your partners, customers, and your target market,” added Donna Gruol, associate director of business development and alliance management at Teva Parenteral Medicines. “Develop a system that makes it easier to introduce and evaluate opportunities,” she said, emphasizing the need to provide prompt and honest feedback. Gruol offered that getting innovative ideas into the proper channels within large organizations can be part of the challenge, and in her view, establishing a corporate culture that embraces innovation is a critical success factor. “Encourage, acknowledge, and incentivize innovation thinking at all levels.” She further highlighted Teva’s own creation of TevaPartners, a web-based process open to the global community, to not only solicit innovative ideas from any possible interested source but as a means to ensure further consideration in a forum where it is not disruptive to the day-to-day goals and objectives of specific departments or divisions. Once the process is moving forward and the opportunity becomes a project of interest she advises, “Be flexible and creative in your deal structures, which may involve sharing the risk to share the reward.” 

Al Gallo, sourcing director and category lead for clinical technologies and supply management services with Johnson & Johnson (J&J) Pharma R&D, outlined an approach taken by J&J with its suppliers in holding an innovation and sustainability summit as a means of generating actionable innovation ideas. The dialogue at this forum was two-fold, with J&J generating awareness of its business needs and sustainability objectives for which the company was seeking innovative solutions. After identifying these needs, J&J communicated them to the suppliers and contract service providers assembled at the forum, who were placed in various breakout sessions, which served as the vehicle for idea generation. The innovation ideas were ranked, scored, and aligned with unmet needs. From this process, more than 30 projects were identified, making the forum a useful process for all parties involved. 

 Offering a perspective from a contract service provider, Andreas Stolle, head of the pharma business line for Saltigo, a subsidiary of the specialty-chemicals company Lanxess, pointed out that innovation can be developed and created at different levels, such as scientific/technology innovation and business-process innovation. To foster scientific/technology innovation, Stolle spoke of the need to create customer–supplier relationships through open communication and an alignment of objectives to build a level of trust that allows innovation to be generated and flow from both the customer and supplier. To achieve business-process innovation, Stolle pointed to possible areas of innovation in the supply chain, procurement, and outsourcing that affect key drivers in these functions, such as cost, efficiency, reduced complexity, and timelines, as well as by looking to other industries to adapt solutions that can be applied to the pharmaceutical value chain. 

Oscar–Werner Reif, executive vice-president of R&D, managing director, and member of the board of directors with Sartorius Stedim Biotech, also pointed to barriers that may arise in the innovation process. In offering an overall perspective, he said that true innovation is often disruptive for user organizations and competing industries and may be opposed by internal technical and business process organizations. It is for that reason that he emphasized the importance of top management support and involvement with dedicated teams for successful implementation of innovative projects, processes, and other ideas. 

 Paul Sidhu, vice-president of marketing and strategy at DSM Pharmaceutical Products, echoed the need for management engagement and support for innovation and for developing structured approaches to cultivate and reward innovation. “Innovation requires internal mobilization,” he said.  “In the right model, management endorses and promotes innovation, and innovative ideas get responded to consistently in a timely fashion,” he said. “Innovation becomes a recurring topic in internal and external communication. Innovative behavior is recognized and innovation effort is rewarded. Success stories, which are directly or indirectly, entirely or partially, attributed to innovation are communicated.” 

In the case of DSM, Sidhu points to some examples in innovation, such as in biocatalysis and microreactor technology in pharmaceutical chemical development and manufacturing solutions. In biologic drug-substance manufacturing, he pointed to innovation in upstream biologics processing for yield improvement and downstream improvements in purification to eliminate the bottlenecks that may occur as upstream processing yields improve. 

Sidhu comments that these higher upstream yields and downstream efficiencies lead to further innovation by providing a step-change in biopharmaceutical production through the use of disposable equipment with lower costs and smaller footprints to enable a small, yet highly productive, facility with only a small fraction of the capital requirement. As a case in point, DSM is building a new mammalian-cell biologics manufacturing facility in Brisbane, Australia. This facility is scheduled to come on line in 2013 and incorporates the company’s improvements in upstream and downstream processing technologies. In 2010, DSM formed a partnership with the Australian governments (Queensland state government and the Commonwealth of Australia) to design, build, and operate the facility with 100% government funding. 

Sourcing

Pharmaceutical companies and their suppliers share approaches for innovation in sourcing and procurement.

Strategies for Innovation in Pharmaceutical Sourcing and Procurement

Pharmaceutical companies and their suppliers are faced with an ever-increasing complex and global supply chain.  As companies are tasked with ensuring product integrity and supply-chain security, they also are confronting evolving expectations in customer–supplier relationships and changing regulatory requirements. To gain a perspective on these issues, Xavier University will be hosting the 

in partnership with FDA in Cincinnati, Ohio, Oct. 2–5, 2011. The conference was developed through a collaborative effort of pharmaceutical companies, contract organizations, and FDA regulators as a means of engendering critical thinking, understanding, and continuous improvement in drug development, manufacturing, and the related supply chain. 

in October is the second time that Xavier University and FDA will be holding the conference, which was first held in 2010. “We saw a need to have a meaningful dialogue among pharmaceutical companies, contract manufacturers, suppliers, and regulators to address the challenges that the industry faces in the global supply chain,” says Marla Phillips, director at Xavier University and formerly head of quality operations of the Wilson, North Carolina, facility of Merck & Co.  To that end, the conference features panelists from FDA, pharmaceutical companies, suppliers, contract manufacturers, and other industry experts. 

On the regulatory front, Deborah Autor, FDA deputy commissioner for global regulatory operations and policy, will provide the keynote address by examining the newly released report:  “Pathway to Global Product Safety and Quality,” and collaborative approaches between regulators and industry. Richard Andrews, operations manager within the GMP/GDP Inspectorate at the Medicines and Healthcare Regulatory Products Agency (MHRA), Michael Levy, director of the Office of Drug Security, Integrity and Recalls at the Office of Compliance at the Center for Drug Evaluation and Research (CDER) at FDA, and Jair Calixto, manager of good practices and audits with the Association of the Pharmaceutical Industry in Sao Paulo State (SINDUSFARMA) will offer perspectives on global regulatory expectations and the initiatives and challenges in global outsourcing and supply-chain security. In another session, Levy also will provide an update on FDA’s Drug Integrity and Security Program. Kathleen Culver, field investigator and drug pre-approval manager in the Cincinnati District at FDA, and MHRA’s Andews will offer insight into trends in inspection findings and enforcement action. Rick Friedman, director of drug manufacturing and product quality with FDA’s CDER, has been invited to join Steve Niedelman, lead quality system and compliance consultant with King & Spalding and formerly FDA’s deputy associate commissioner for regulatory affairs and formerly FDA’s chief operating officer of the Office of Regulatory Affairs, to discuss supplier-qualification programs and related approaches in risk management. 

 The conference also will feature panels examining quality by design and audits. Several speakers will offer insight into how to operationalize quality by design (QbD). The panelists offering QbD perspectives include: Eric Ahuja, director of analytical chemistry development and supply at Merck & Co.; John Lepore, senior director of chemical process development and commercialization of global pharmaceutical commercialization at Merck; Stephen Closs, director of global technical affairs at Patheon; and Chris Watts, partner of consulting at NNE Pharmaplan. Another panel will discuss best practices in audits. Participating in the panel are: Janeen Skutnik, director at Pfizer responsible for developing the company’s position on quality and CMC; Vicky Stoakes, president of the consultancy IntegRx; Christopher Smith, vice-president of quality assurance and regulatory affairs at AAIPharma; and Bob Coleman, senior compliance expert of pharmaceuticals at IHL Consulting. 

Integrating best practices in supply-chain management in early-stage drug development is an effective way to ensure that quality, cost, and delivery of product is achieved throughout product development and commercialization. Offering insight into this area are: Edward Kobeliski, formerly vice-president of global API manufacturing for Pfizer Global Research and Development; Patrick Crowley, formerly vice-president of GlaxoSmithKline; and Hedley Rees, managing partner at Biotech PharmaFlow. And John Curran, distinguished scientist at Merck & Co., will provide case-study analysis of end–to–end planning for successful product launch. 

Other industry experts will offer insight into global supply-chain practices. Brian Johnson, senior director of supply-chain security at Pfizer, will provide case-study analysis of effective processes to manage global and complex supply chains. Mary Foster, vice-president of quality at Catalent Pharma Solutions and 

 guideline author, will discuss good storage and distribution practices, including 

 Effective supply-chain management relies on successfully working with contract manufacturers and other suppliers, and several speakers will offer insight into the outsourced relationship. Andrew Cox, chairman of the advisory board for the International Institute for Advanced Purchasing and Supply, will offer insight into strategic sourcing from a pharmaceutical supply perspective. Javaid M. Cheema, president of the consultancy Lean-O-Pex, will provide case-study analysis and best practices in determining the total cost of ownership in product development and manufacturing.  James Ryan, associate in the technology transactions group of the London office of Morrison and Foerster, will offer insight into the development of commercial contracts. Alan Minsk, partner and practice leader of the food and drug practice team at the law firm Arnall Golden Gregory will discuss how best to develop and monitor functional quality agreements. And Andrew McNicoll, senior director of global quality compliance at Patheon, will provide insight into performance metrics. 

In addition to the conference, which will be held Oct. 3 to Oct. 5, two supplemental workshops will be held Oct. 5 to Oct. 7. International Pharmaceutical Excipient Auditing (IPEA) will hold workshops on excipient GMP auditing on Oct. 5, 6, and 7. Another workshop relating to documentation practices and legal ramifications will be held on Oct. 5. 

The Global Outsourcing Conference is one of two pharmaceutical-related conferences held by Xavier University and FDA. MedCon, which was held in May 2011, focuses on the strategic and regulatory issues affecting the medical-device industry. A third conference, focusing on best practices in supply-chain management across various sectors, food, drug, medical device, aerospace, and automotive is under consideration. 

Details of the Global  Outsourcing Conference may be found 

Supply Chain

Xavier University, in partnership with FDA, will hold a conference in October to focus on the changing regulatory, business, and operational issues affecting the global pharmaceutical supply chain.

Industry Experts Focus on Ways to Best Manage the Global Pharmaceutical Supply Chain

Global health solutions involve a myriad of ways to improve access to medicines and healthcare services in the developing world. This need is particularly important in maternal and children’s health, where the health of mothers and children are linked, and raising the bar in healthcare benefits not only them but also the community at large. 

 One recent important initiative to improve maternal and child health in the developing world is a public–private project, 

Saving Lives at Birth: A Grand Challenge for Development,

 which was launched in March 2011 to seek innovative prevention and treatment approaches for pregnant women and newborns in rural, low-resource settings. The project is a partnership between the US Agency for International Development (USAID), the government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, and the World Bank. These partners are providing nearly $14 million for this grant program's first round of funding and have a commitment of investing at least $50 million in projects during the next five years. 

Saving Lives at Birth: A Grand Challenge for Development

 is seeking new technologies, new service-delivery models, and other approaches to improve healthcare services at the time of birth. The call elicited more than 600 submission on a global basis, and in late July 2011, 77 finalists participated in the final stage of the competition, which involved displaying their ideas in an open marketplace and establishing connections with a community of innovators. Of the 77 finalists, 19 nominees for awards were recognized for the most promising solutions to address the causes of maternal and newborn deaths in the developing world. 

“We have a tremendous opportunity to take advantage of all of the changes that are occurring in the world today and put them to work on behalf of development,” said US Secretary of State Hillary Clinton, who spoke at an event in Washington DC, in late July to recognize the nominees. “We know that it’s moving so quickly. There is no way to keep up with the fast-paced global innovation contest that is happening on products and goods and services, but we can do our part to make sure that we harness all of that scientific and technological capacity on behalf of the poor and the needy,” she said. “So in reaching out to the global community, NGOs, international partners, and working with likeminded governments and foundations and other institutions, we have established this program of Grand Challenges. And few challenges are as persistent or heartbreaking as the health of mothers and children because we are well aware that the single most critical window for maternal and child health occurs from the onset of labor to 48 hours after childbirth,” noted Clinton.  

 In making her comments, Clinton pointed to the extent of the problem in maternal and child mortality, but also to some positive signs of improvement. She noted on a global basis in 2011, one woman dies every two minutes during childbirth. A woman in sub Saharan Africa is 136 times more likely to die in childbirth than one in a developed country. In 2009, 2.6 million children were stillborn, and one million newborns die every year in the two days after birth, according to the World Health Organization. “We know this can be impacted when pregnant women have access to adequate nutrition and prenatal care, lifesaving medicines, [and] skilled health workers when they do give birth,” said Clinton, pointing to recent progress. From 1990 to 2008, the global maternal mortality rate dropped by 34%, and in certain countries, the decline was greater, such as in Bangladesh, where it declined by 40%, and in Nepal, where it dropped 50%. 

To reduce maternal and child deaths, Clinton pointed to several factors. “We identified three major barriers to saving lives at birth,” said Clinton. “First, a lack of medical technologies appropriate for the community or clinic settings. Second, a shortage of trained, equipped caregivers in positions to help. And third, a lack of demand; too many mothers still don’t know about the care they need and where and how they can find it.” 

Clinton pointed to solutions, such as advances in drug delivery, which can make a difference in reducing deaths at childbirth. She cited the potential benefit of switching from injectable drug delivery, which requires sterile equipment, trained medical personnel, and a cold chain, to aerosol-spray drug delivery through disposable devices. To mitigate mother-to-child transmission of HIV/AIDS, she noted the importance of increasing access to medicines to newborns within the first 24 hours of life. Since such medication is typically available only through clinics, which may not be accessible, she cited work by researchers in developing a pouch containing medicines that can be carried by mothers for months and used at the time of birth to deliver need medication. 

 The resourcefulness of such approaches was a key part of the 

 Saving Lives at Birth: A Grand Challenge for Development. 

 The 19 nominees for awards from the challenge are as follows: 

• Operative Experience (Elkton, MD) for its simulation-based training for emergency C-sections 

• Healthpoint Services  (Secunderabad, India) to apply low-cost health and information technologies at the community and clinic level for integrated maternal and neonatal health delivery in rural India 

• Program for Appropriate Technology in Health (Seattle, WA) to increase accessibility to less invasive lung support equipment for neonates in low-resource settings 

• Baylor College of Medicine (Houston, TX ) for primary prevention of periodontal disease in relation to preterm birth in Malawi 

• Moi University School of Medicine (Eldoret, Kenya) for improving community-based accountability for maternal and newborn health 

• Monash University (Clayton, Australia) for an alternative means of delivering oxytocin to women in resource-poor countries 

• Jhpiego Corp. (Baltimore, MD) for development of an e-partogram 

• Duke University (Durham, NC) for its innovation to reduce mother-to-child transmission of HIV 

• Zoe Alexander (Nairobi, Kenya) for a novel mobile application 

• University of British Colombia (Vancouver, Canada) for an innovative phone oximeter 

• Save the Children Federation (Westport, CT) for an human energy-powered fetal heart rate monitor and phone-based mortality audit 

• Population Council (New York, NY) for a mobile clinical-assessment service, Baby Monitor 

• Johns Hopkins University (Baltimore, MD) for an easy-to-use identification system for early and late preterm infants 

• WHO (Geneva, Switzerland) for a low-cost instrument for assisted vaginal delivery 

• Diagnostics for All (Cambridge, MA) for low-cost, point-of-care microfluidic diagnostics 

 • Partners for Development (Silver Spring, MD) for a reliable, market-driven emergency transport solution for pregnant women 

• Hospital for Sick Children (Toronto, Canada) for an approach to supply micronutrients to pregnant women 

• Fincon (Islamabad, Pakistan) for a microhealth franchise system 

• William Marsh Rice University (Houston, TX) for a low-cost, bubble continuous positive airway pressure system. 

“So we have lots of great ideas that are here, and to the 600 entrants all over the world and to the 77 finalists and the eventual winners, my message is the same: Please keep going with these ideas. There were so many great ideas,” said Clinton. “We will try to help you figure out ways to make them scalable, sustainable, deliverable interventions. And this is the kind of creative approach toward enhancing development that I think is in the best interests of the people whom we are hoping to serve, but it’s also necessary in these times of great budgetary strains on all governments, not just my own, so that we can deliver higher impact in way that will keep our publics continuing to support this very important work,” she said. 

The US Agency for International Development, the government of Norway, the Bill and Melinda Gates Foundation, Grand Challenges Canada, and The World Bank partner to bring innovative solutions to improve maternal and children’s health in the developing world.

Improving the Delivery of Maternal and Children's Healthcare Services

For several years, Big Pharma has been cutting programs and reducing headcount as a result of mergers and acquisitions and overall cost-cutting efforts. According to industry estimates, approximately 50,000 pharmaceutical industry employees lost their jobs in 2010, and 300,000 have been let go in the past 10 years (1). Many reasons are behind these cuts: a decline in traditional research and development productivity, tougher regulatory hurdles, a plethora of government and formulary pricing controls, and significant patent expiry of major blockbuster drugs. 

Now, more than two years after the economic meltdown, the industry understands that prosperity is not around the corner. What many call the "New Normal," characterized by slower growth, tighter credit markets, a more conservative approach, less money available for investment, and tighter financial regulations, has become the new operating reality. 

It doesn't have to be all doom and gloom, however. Even in the best-run organizations, there is an untapped source of cash from what I like to call "creating your own stimulus by buying items and services better." In many companies, the cost of purchased items and services (i.e., the money paid to suppliers) is equal to between 30–70% of total company revenue. In the pharmaceutical industry, this cost is typically between 30 and 50%. What I've come to understand is that regardless of how good or how bad a company is at buying products and services, there is still plenty of cash to extract from its costs. Three methods—spend segmentation, better specifications, and online reverse marketplaces—can improve results. 

. By not applying the appropriate sourcing strategy, a company may pay between 10% and as high as 70% more for products and services, based on my experience. This differential exists because of the strategy or lack of strategy that is in place for a certain purchase. Figure 1 identifies four types of supplier relationships by such attributes as ease of buying, supply-market competitiveness, uniqueness, and strategic importance. A buyer's strategy needs to be in the right quadrant to ensure that a company is paying the right price, producing the right total cost, and getting the best value associated with a particular product or service.  

Figure 1: Spend segmentation categories based on customerâsupplier relationships. (FIGURE 1 IS COURTESY OF THE AUTHOR) 

For example, if a company is making a purchase where the supplier maintains the power in the relationship (i.e., the "critical" quadrant), the buyer is paying an absolute premium. Typically, less than 10% of a company's spend will be designated as "critical," according to my experience. Companies with poor purchasing practices, however, often allow suppliers to act as if they were a natural monopoly. A purchaser should review its spending to move supplier relationships from the "critical" quadrant to "strategic" or better yet to "leverage" positions (see Figure 1). My experience suggests that on average, only 20% of spend is truly "strategic," and most of what is purchased can be highly leveraged among multiple suppliers.  

. Many factors determine how much to pay for a good or service. In simple terms, supply is what is available, and demand is how much is being requested. Consumption is how much is being used at what rate, and specification is what constitutes a product or service. The interactions of these variables are the main drivers of price paid.   

Once spending is properly segmented  per Figure 1, four focal points determine  the price paid. A company's strategy affects its ability to pay less, to use less, to use something else, or not to use at all. Take a close look at specifications and carefully review the requirements. In many cases, a company will find individual requirements that are "over spec'd" or not needed at all, which lead to significant and unnecessary costs. Additionally, consumption can often be reduced by making the user community aware of the total costs involved and by policies that control overall usage, particularly for indirect items and services.   

. Think about how a company buys. It is probably one of the following scenarios. The simplest is calling the supplier and accepting the price being quoted. Then there is the "haggle" method, same as the first method, but with some pressure applied to get a lower price. Then more sophistication with the "competitive bid policy," in which the buyer typically gets three bids before making a selection. Another method is to do additional negotiation after getting the three bids, an interesting approach, but it still may fall short in securing the best possible terms.   

A reverse auction, a transparent and dynamic bidding model, is different. All sellers are bidding on the exact same item or service. When using this method, the buyer must have good specifications or requirement documents available to all sellers as opposed to the haphazard way requirements are given using some of the other traditional methods. Because the buying event has great transparency, sellers can see if their pricing leads or lags. The buyer does not have to select the lowest bidder and may weigh other factors in the purchasing decision. Reverse auctions drive pricing to what the market will bear at any given time against various seller independent variables.  

Until recently, the technology required to conduct reverse auctions was costly, required considerable employee training, and presented certain internal and some external barriers for implementation. These barriers, however, are eroding. The premier reverse auction marketplace, FedBid, used by the federal government for 10 years, is now available for commercial use and offers a procurement model for commodity products and basic services. The marketplace has over 50,000 qualified suppliers. More than 50,000 "buys" were conducted in 2010 with savings ranging between 5 and greater than 50%. There is no cost to the buyer for using the technology,  which is web-browser-based. The winning seller pays a modest 3% transaction fee and is billed by the marketplace operator 60 days after the buying award is made. If the product is not currently in the marketplace, the marketplace operator will at, no charge, find the right sellers and even train a company's existing suppliers so they can compete on a regular basis in the marketplace. Reverse auctions can be good for buyers and sellers. Buyers save money, and sellers gain more opportunities to win business. Reserve auctions, along with the other sourcing practices discussed, are potential drivers for value creation.   

is CEO of Wildfire Commerce, and senior advisor for A.T. Kearney Procurement and Analytic Solution

1. E. Teichert, "Top 10 Pharma Layoffs for 2010,"

Outsourcing

Better strategies and practices in sourcing and procurement can contribute to the bottom line.

Offsetting Budget Cuts

 reports that it plans to develop two new formulations of its HIV medicines, Kaletra (lopinavir/ritonavir) and Norvir (ritonavir). The company is currently investigating a new powder formulation of Norvir as well as a co-formulation of three HIV medicines: lopinavir, ritonavir and 3TC (lamivudine). The Norvir powder formulation is intended to make it easier to store the medicine. The investigational fixed-dose combination of lopinavir, ritonavir, and 3TC could reduce the daily number of tablets a patient takes of the fixed-dose combination. If developed and approved, the fixed-dose combination would be designed to be taken with one additional anti-HIV medicine. Abbott is developing the new formulations with the goal to make a contribution to the World Health Organization’s Treatment 2.0 strategy. This strategy includes providing treatment options to make the most of the resources available in those developing countries that carry the heaviest HIV burden.

 for a week-long curriculum program using the pharmaceutical R&D process to teach teachers and their students about science, mathematics, and societal issues. Seventeen teachers from 14 high schools and middle schools in New Jersey and New York participated in the program, which was held in July at the Bristol-Myers Squibb Center for Science Teaching and Learning at Rider University in Lawrenceville, New Jersey.

, a nonprofit organization that helps individuals and corporate donors contribute directly to grassroots charitable organizations, to offer Lilly employees a customized Lilly Global Giving website, where employees may choose from multiple projects in line with the Lily’s corporate social responsibility goals in health, hunger, education, and the environment.  Employees who donate $25 or more to projects featured on the website will have their donations automatically matched by the Lilly Foundation, the company’s philanthropic arm.

 has made a charitable contribution to the 

 to enable the foundations’ expansion of patient-service programs, including case management and copay relief for patients, to support a new fund for patients with nonsquamous non-small-cell lung cancer.

 a five-year strategic roadmap for its citizenship and sustainability priorities. The plan includes the company’s efforts in global health initiatives and sustainability efforts, including its goals for reducing carbon-dioxide emissions, water usage, waste disposal, and product-stewardship efforts.

In other news, J&J is sponsoring a swim relay across the English Channel as part of a fundraising effort for the 

 The program is supported by Animas, a J&J company providing diabetes-management products. Also, 

 a division of J&J’s Janssen Products, is launching an initiative to encourage HIV testing, and the 

Johnson & Johnson Campaign for Nursing’s Future 

, a multiyear, $50-million initiative to support nurses and nursing education, is sponsoring an Amazing Nurses national contest to recognize contributions by individuals in the field of nursing.

 reported on three patient-focused programs to support the hepatitis C community.They included a concert program as part of an awareness campaign launched by Merck and the 

 a free hepatitis C testing and educational program launched in select major league baseball parks, and a grant to the World Hepatitis Alliance, an organization engaged in preventing the spread of viral hepatitis.

 has been awarded an exclusive contract by the National Laboratory Health Laboratory Services in South Africa for the support of the Early Infant Diagnosis program, an infant-testing initiative that seeks to identify HIV-infected children during the first months of life.

 also is collaborating with the Salzburg Festival, a music festival annually held in Austria, to bring students of the sciences, arts, and music to discuss creativity in the sciences and arts. The study week, which first took place in 2007, encourages students to share in discovering concepts of creativity and innovation in science, music, and the arts.

 has entered into a research collaboration with 

 to identify new anti-infectives that aim to shorten the course of treatment of tuberculosis (TB) and provide therapies against drug-susceptible and drug-resistant strains of TB.  Sanofi will prove 80,000 chemical compounds to Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of 

 Weill Cornell has obtained funding from the Bill and Melinda Gates Foundation for screening activities. Sanofi and Weill Cornell will jointly determine whether any compounds screened through the collaboration should be optimized for potential development.

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