Two fundamental cornerstones of the new bio/pharmaceutical business model are the end of the blockbuster product and the need to accumulate and conserve cash. These two realities have major implications for bio/pharmaceutical manufacturing strategies and technologies and create new challenges for CMOs.  

It is widely understood and accepted that the new products coming out of the bio/pharmaceutical pipeline will be sold in smaller volumes than the products introduced a generation ago (albeit at higher prices). This situation partly reflects the failure of bio/pharmaceutical R&D laboratories to come up with safe and effective drugs suitable for broad populations. More importantly, it also reflects the growing understanding of how drug effectiveness varies within patient groups, the ability to develop biomarkers to identify patients for whom new drugs will work best, and the expectation of regulatory authorities that new drugs will incorporate that knowledge into clinical regimens. The classic example is Roche's/Genentech's Herceptin (trastuzumab), which is highly effectively for the 20% or so of breast-cancer patients that test positive for expressing the HER-2 gene. 

The need to accumulate and conserve cash is driven by the imperative that bio/pharmaceutical companies in-license or acquire new development candidates and marketed products rather than depend solely on their in-house R&D operations. One prime target for improving cash position is inventories. Bio/pharmaceutical companies have traditionally held two to four times as much inventory relative to sales as have consumer-products companies. Turning inventories more frequently can release hundreds of millions of dollars in cash for the large bio/pharmaceutical companies. 

The implication of these two realities— smaller volumes and faster inventory turns—is that bio/pharmaceutical companies must manufacture smaller batches more frequently than they have traditionally. This new manufacturing imperative is triggering major changes in manufacturing practices, strategies, and technology. For instance, the CEO of GlaxoSmithKline (GSK) recently talked about how GSK is shortening its supply chain (thereby reducing inventory requirements) by moving manufacturing closer to where the products are being sold rather than concentrating production in very large scale but distant manufacturing sites. 

The new manufacturing paradigm will require facilities that are simultaneously smaller scale, more flexible, and lower cost and will mandate major changes in the design of facilities and equipment. Most of today's bio/pharmaceutical manufacturing facilities were designed 20 or more years ago to accommodate large-scale batch processing operations with separate suites each housing individual pieces of process equipment and complex material flows. Those facilities have very high fixed costs, and equipment often sits unutilized and requires long set-up times.  

Pharmaceutical equipment manufacturers and companies that develop advanced manufacturing technologies have been responding to the new manufacturing requirements for some time. The major advances already being used include:  

Higher-yielding expression and fermentation technologies that reduce the scale of biomanufacturing facilities

Manufacturing equipment for both API and dose manufacturing that incorporate disposable parts for components that come into contact with the product

Microreactors for small-molecule API manufacture, which replace large-scale batch processes with continuous processes conducted in a single, small piece of equipment

Continuous process finishing and dose manufacturing technologies, such as spray drying and equipment that can blend materials and extrude finished tablets

FDA-endorsed methodologies, such  as process analytical technology (PAT) and quality-by-design.

Some of these technologies and practices are not yet in widespread use or fully developed for commercial operation, but they are clearly making their way into the mainstream. For instance, Lonza announced in early February 2012 that it will build a "factory of the future" based on microreactor and continuous flow technology. Major bio/pharmaceutical companies are working with equipment suppliers and engineers to develop proprietary highly-automated and continuous manufacturing systems for their "factories of the future." 

The changing bio/pharmaceutical manufacturing requirements and technologies present a major challenge to CMOs. Much of the manufacturing capacity of the dose CMO industry is compromised of legacy facilities acquired in the past 10 years from global bio/pharmaceutical companies and embodies the large-scale, inflexible, and high-cost batch manufacturing processes that were dominant 20 years ago. As the manufacturing needs of the bio/pharmaceutical industry evolve in the next 5–10 years, CMOs risk being left behind with underutilized facilities that are unsuited for their potential clients' needs. 

Only a few CMOs can be considered innovators in manufacturing technology and practice despite the fact that manufacturing is only the thing they do. To a large degree, the CMO business forces them to focus on their clients' current and near-term needs. CMOs deal with a lot of older products and even with new products, their bio/pharmaceutical  company clients are unwilling to take on the risk of new manufacturing technologies unless they absolutely have to. CMO profit margins generally do not allow much room for investment in innovation, and most innovative technologies housed at CMOs have been developed and paid for by their clients. 

Unless CMOs become more forward-looking about their technology choices and investments, they risk losing out to new entrants and potential clients. The new technologies will often require less investment in facilities and utilities. Because they are smaller and more self-contained, more companies will be tempted to build their own facilities. Because they will operate more-or-less continuously and be highly automated, they will produce drugs less expensively than the older technologies.  

Today, the competitive challenges that CMOs seem most focused on are how to differentiate themselves from their many North American and European competitors while keeping a wary eye on producers in emerging markets. By not appreciating the changing manufacturing requirements of their clients and the related new technologies, they risk being made obsolete.   

This scenario bears a strong resemblance to what happened to Kodak, which recently filed for bankruptcy protection in the US. Because it was focused on preserving its cash cow—the film and photo processing business—the company viewed its primary competitive threats as coming from Fujifilm and other low-cost film manufacturers. As a result, it overlooked the emergence of digital photography, the new technology that ultimately undermined the company. CMOs could now be facing their Kodak moment. 

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

Articles

Outsourcing

The evolving bio/pharmaceutical business model poses risk for CMOs.

CMOs Face a Kodak Moment

UNICEF and UNFPA, the United Nations Population Fund, launched a high-level commission late last month to improve access to essential health supplies for women and children in the developing world. The Commission on Life-Saving Commodities for Women and Children is seen as important tool in realizing the UN Millennium Development Goals (MDGs), a set of antipoverty, which include reduction of maternal and children mortality. 

“Making sure that women and children have the medicines and other supplies they need is critical for our push to achieve the MDGs,” said Secretary-General Ban Ki-moon, in a Mar. 23, 2012, World Health Organization press release. “The Commission will tackle an overlooked but vital aspect of health systems and ensure that women and children are protected from preventable causes of death and disease.” 

President Goodluck Jonathan of Nigeria and Prime Minister Jens Stoltenberg of Norway will serve as founding cochairs of the Commission on Life-Saving Commodities for Women and Children, which will also include global stakeholders from the public, private, and civil-society sectors. UNICEF Executive Director Anthony Lake and UNFPA Executive Director Babatunde Osotimehin are vice-chairs of the Commission, which is part of the United Nations Secretary-General’s Every Woman Every Child movement to support achievement of the health-related MDGs. The Every Woman Every Child Initiative was launched by UN Secretary-General Ban Ki-moon during the United Nations Millennium Development Goals Summit in September 2010. 

“There is no doubt that lives can be saved by increasing access to affordable and effective medicines and health supplies. We must all make a difference and the time is now,” said President Jonathan of Nigeria in the release. 

“The day of birth is the most dangerous day in the life of a woman and her child,” said Prime Minister Stoltenberg. “The fact that women do not get the care they need during childbirth is the most brutal expression of discrimination against women. To prevent these tragic and unnecessary deaths is not only a humanitarian urgency of highest priority, but a key investment for social and economic development.” 

 The Commission will identify strategies for improving the delivery of essential health supplies, including strengthening local production capacities, promoting new technologies and products, strengthening regulatory frameworks, and enhancing innovative financing mechanisms at both the global and local levels. 

 The Commission will focus on high-impact health supplies that can reduce the main causes of child and maternal deaths, as well as innovations that can be scaled up, including mechanisms for price reduction and supplies stability. Key efforts include: reducing financial barriers to access through social-protection mechanisms, such as fee waivers, vouchers, and social insurance, and global financial mechanisms, such as pooled procurement; creating incentives for international and local manufacturers to produce and innovatively package overlooked supplies; identifying fast-track regulatory activities to accelerate registration and reduce registration fees for a special list of products to encourage a focus on quality medicines. The Commission also will advocate to build consensus around priority actions for increasing the availability, affordability, access, and rational use of overlooked health supplies that will prevent premature death and disease among children under five years old and women of childbearing age. 

CSR and Sustainability Forum

A new UN organization focuses on improving the delivery of essential health supplies, promoting new technologies and products, strengthening regulatory frameworks, and enhancing financing mechanisms.

UN Launches Commission on Life-Saving Commodities for Women and Children

 the philanthropic arm of Baxter, reported combined charitable giving of more than $80 million in 2011. Key figures include: $47 million from donations of Baxter products through donor partners and the company's US patient-assistance programs; $29 million from Baxter's businesses and facilities to address critical local needs in more than 42 countries; and $4 million from The Baxter International Foundation, including grants to increase access to healthcare worldwide, prize programs that recognize excellence in community service and healthcare research, a scholarship program that contributes to the education of Baxter employees’ children, and support of employees' philanthropic efforts through the Foundation's Dollars for Doers and Matching Gifts programs. 

 has launched the fourth annual Dow Sustainability Innovation Student Challenge Award (SISCA) program and has expanded it to include nine new strategic universities. Developed in conjunction with Dow’s 2015 Sustainability Goals, SISCA drives collaboration and advancement in social and environmental responsibility by asking students to solve significant world challenges through sustainable solutions. 

 has launched a new multidisciplinary apprenticeship scheme for 16–24 year olds for positions at the company’s UK manufacturing, R&D, and corporate sites. The scheme will begin in August this year, and GSK will take on 40 apprentices in the first intake. The company has historically taken on a number of engineering apprentices; however, this new integrated scheme will offer IT, R&D, laboratory technician, manufacturing, supply-chain management, and artwork-design opportunities. The full list of sites offering apprenticeships is Barnard Castle, GSK House (London), Irvine, Maidenhead, Montrose, Slough, Ulverston, Ware, and Worthing. Apprenticeships will last between two and four years depending on the discipline. All roles will consist of a combination of on-the-job training and study modules.

 have launched a three-year, $1.5-million partnership to increase access to safe water and reduce the impact of water-borne disease among impoverished communities in Andhra Pradesh, India. Safe Water Network is a not-for-profit organization committed to developing locally owned and operated water-purification systems that achieve lasting health impact. The initiative will add a dozen sites to Safe Water Network's existing field projects in Andhra Pradesh, which already provide nearly 40,000 people access to clean water. The additional sites will provide safe water access to another 20,000–30,000 people. Each phase of the initiative will be documented, including the data on health outcomes. Key findings will be shared with the water and sanitation sector as well as other organizations to help raise awareness to address the global water crisis. Merck and Safe Water Network are also exploring employee volunteer opportunities as part of the partnership in the areas of health, behavior change, and quality assurance. 

 have developed a cancer cell-line encyclopedia that catalogues the genetic and molecular profiles of almost 1000 human cancer cell lines used in drug R&D. Results of the collaboration allow scientists to use this information to improve cancer clinical-trial design and further cancer research. The genetic and molecular profiling data from the cell lines is freely available to the scientific community on the Broad Institute’s website 

 have inaugurated a second Phelophepa Healthcare Train. The Phelophepa train is a clinic on rails with 18 coaches that provides healthcare in remote rural areas of South Africa. With this launch, the two trains will effectively double the capacity of the program to reach people in remote regions of South Africa who otherwise have little access to healthcare. 

 group, a global provider of corporate responsibility auditing and consulting services, has launched a Corrective and Preventive Action (CAPA) System to help manage and track improvements in manufacturing processes and responsible workplace systems throughout the supply chain. The CAPA System is an online workflow-management tool that helps companies communicate workplace improvements to their business partners, educate staff and suppliers about workplace systems, track and document the closure of audit findings, and streamline management of the corrective action process. 

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

Achieving a good return on assets through manufacturing-capacity utilization is an ongoing challenge for bio/pharmaceutical companies. Pharmaceutical companies need manufacturing capacity on hand to produce commercial products and also to launch new products as they come through their drug-development pipelines. The inherent uncertainty of drug development, however, makes it difficult to balance the need for timely access to manufacturing capacity with the interest of avoiding underutilizing capacity and a resulting reduction on a return on assets. This balancing act is particularly challenging with biologics manufacturing because the capital costs for manufacturing capacity are higher than traditional small-molecule drug-substance manufacturing. A long-term manufacturing capacity-sharing arrangement by Merck & Co. and MedImmune LLC, the biologics arm of AstraZeneca, established in September 2011, demonstrates a potential solution for the capacity challenges increasingly being faced by bio/pharmaceutical companies. 

Changing fundamentals for biologics manufacturing

The impetus for the companies’ manufacturing capacity-sharing agreement reflected larger trends in biopharmaceutical manufacturing. In the 1990s, many large pharmaceutical companies began building biologics manufacturing capacity in anticipation of advancing biologic-based drug candidates. At the same time, certain CMOs began to emerge to fill capacity requirements. As these changes occurred, during the 2000s, technology gains also started to significantly improve upstream yields, explained Michael Kamarck, president of Merck BioVentures. Kamarck spoke at the Drug, Chemical, and Associated Technologies Association (DCAT) Business Development Forum, 

Successfully Partnering PharmaceuticalManufacturing Throughout Product Lifecycle

, which was held in mid-March in New York.  Proprietary fermentation technology, for example, improved yields at the beginning of the decade from 0.5 to 1 g/L to 1–3 g/L in 2002, to 3–5 g/L in 2004 to 10 g/L in 2007. The confluence of increased manufacturing capacity that resulted from both improved technology and recently constructed greenfield biologic-based manufacturing facilities resulted in overcapacity on an industry level. “This evolution brought us to another chapter in biomanufacturing,” said Kamarck, pointing to strategic collaborations as a way to manage the capacity overflow and biomanufacturing needs. 

The genesis of the Merck–MedImmune collaboration

The fundamental changes in biomanufacturing trends came into play with the biologics manufacturing capacity-sharing arrangement made by Merck and MedImmune in September 2011. 

 In 2007, AstraZeneca completed the acquisition of MedImmune, which became the biologics arm of AstraZeneca, incorporating the MedImmune assets, legacy AstraZeneca biologics assets, and Cambridge Antibody Technology, which AstraZeneca had acquired in 2006.  A key manufacturing asset for MedImmune, which is headquartered in Gaithersburg, Maryland, is the company’s large-scale monoclonal antibody (mAb) manufacturing facility in Frederick, Maryland. Prior to its acquisition by AstraZeneca, in 2005, MedImmune committed to support 500 kilograms of production per year through the addition of two 15,000-L bioreactors, which would replace an original 2 x 2500 L plant. The additional capacity was intended to meet the mid-range product demand of MedImmune through 2013. In acquiring MedImmune in 2007, AstraZeneca further authorized an additional 500 kilograms of capacity to include a total of four 15,000-L bioreactor trains at the new Frederick facility.

When the MedImmune product for which the initial capacity was intended did not proceed through clinical development, MedImmune realized that existing products would not fill the site. The combination of a pipeline-delivery gap and the subsequent improvement in titres or grams-per-liter yields required an alternative solution to fill capacity. “This became the genesis of the concept for sharing capacity or selling it directly,” explained Andrew D. Skibo, executive vice-president of operations at MedImmune, who also spoke at the DCAT Business Development Forum. The business case for developing an alternative approach to utilizing capacity was clear, he said. Contrary to the original plan, the plant would not be fully utilized by MedImmune’s own pipeline until at least 2022 based on a three- to five-year delay in product commercialization and dramatically improved titres. In addition to the underutilization of the facility, the associated staff at the facility would be in standby status. “The skilled and trained staff was the highest value asset of concern,” said Skibo. “We wanted to retain key employees by getting them working in their area of expertise.”

With the motivation of covering operating expenses of staff and depreciation for the manufacturing assets, which was estimated at $100 million per year, the business case for developing a partnership for sharing capacity was made. In evaluating a potential partner, Skibo outlined that certain criteria came into play. The ideal situation would involve one or two partners with large-volume needs specific to needing capacity for mammalian cell culture (i.e., Chinese hamster ovary). The arrangement would require joint capacity planning in a long-term deal (i.e., 10 to 15 years).  In an arrangement, MedImmune capacity needs would prevail, and reciprocity with capacity in other areas, such as microbial bulk capacity, high-capacity mAb filling, and live-virus filling would also be part of any agreement. “This criteria would preclude a strictly CMO-type agreement from working,” explained Skibo. “This type of arrangement would require the right people and people ‘chemistry.’ It is more than a financial agreement; both parties would have ‘skin in the game,’” he said. 

Using those criteria, MedImmune selected Merck & Co. as its partner. The companies formed a 15-year manufacturing capacity-sharing agreement in September 2011 with Merck utilizing MedImmune’s Frederick, Maryland, facility for Merck bulk product manufacturing.The companies also are exploring the suitability of Merck’s facilities in the production of microbial-based compounds in MedImmune’s pipeline, and other potential manufacturing opportunities where business strategies intersect. Manufacturing began in the fourth quarter of 2011. The arrangement provides benefits to both parties. For MedImmune, the arrangement provides long-range utilization of excess capacity at the company’s Frederick facility while maintaining sufficient capacity for MedImmune’s own products. For Merck, the arrangement provides flexible and rapid access to capacity for the company’s maturing biologics pipeline, which includes biosimilar candidates. 

 Skibo points out that the deal represents a new model in pharmaceutical manufacturing, one based on “co-opetition,” a mindset that contains both cooperation and competition (1). A key consideration of a “co-opetition” model is that the players in the game of business include customers, suppliers, competitors as well as those that provide complementary rather than competing products and services. In the case of Merck and MedImmune, although both companies provide pharmaceutical products, there is no direct competition in the service being shared, namely biologics manufacturing capacity. The deal is structured to provide MedImmune and Merck a balance of lot cost versus production risk allocation that in combination is uniquely different than a typical CMO arrangement.  Lot cost is based upon MedImmune’s own internal fully absorbed lot production costs.  The risk associated with lot production reflects a traditional CMO assignment of risk.   Merck pays for any additional specialized resources and/or capital expansion upgrades as needed. The initial focus is on cell-based compounds for which Merck develops the process and analytics through medium scale, so any future changes are limited to fit and manufacturing needs only. MedImmune can provide large-scale technology transfer out of the Frederick facility as needed and can decline to work on any specific project. 

Since Merck and MedImmune announced their manufacturing-capacity arrangement, several other companies have partnered in biosimilars in a co-opetition-like or strategic partnership model. In February 2012, Biogen Idec and Samsung formed a joint venture, Samsung Bioepis to develop, manufacture, and market biosimilars in keeping with their agreement announced in December 2011. Under the agreement, Samsung is contributing $255 million of the $300 million for an 85% stake, and Biogen Idec is contributing $45 million for a 15% stake in the joint venture. The joint venture, which will be based in Korea, will contract with Biogen Idec and Samsung Biologics for technical development and manufacturing services. Samsung Biologics is a Samsung business formed in April 2011 to specialize in biopharmaceutical manufacturing. The joint venture will not pursue biosimilars of Biogen Idec's proprietary products. 

Amgen and Watson Pharmaceuticals formed a collaboration in December 2011to develop and commercialize, on a worldwide basis, several oncology antibody biosimilars. Under the agreement, Amgen will assume primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.  Watson will contribute up to $400 million in codevelopment costs over the course of development, including the provision of development support, and will share product-development risks. In addition, Watson will contribute its expertise in the commercialization and marketing of products in specialty and generic-drug markets. The collaboration products are expected to be sold under a joint Amgen/Watson label.  Watson will initially receive royalties and sales milestones from product revenues. The collaboration will not pursue biosimilars of Amgen's proprietary products. 

Baxter and Momenta Pharmaceuticals also formed collaboration in December 2011 to develop and commercialize biosimilars. Baxter will provide its clinical- development and biologic manufacturing expertise while Momenta will provide its expertise in high-resolution analytics, characterization, and product and process development.

In looking ahead, Skibo observed, “Partnering to minimize investment risk will become commonplace in the future. It easier to justify a $600 million to $800 million investment when there is more than one pipeline to support, in addition to in-licensing, biosimilars, and novel products.”

Biologics

The manufacturing capacity-sharing model in biologics between Merck & Co. and MedImmune LLC ushers in a new paradigm of co-opetition.

Manufacturing Capacity-Sharing Model: Merck & Co. and MedImmune LLC

Last month, the Indian patent authorities ruled that Bayer must grant a compulsory license to the generic-drug manufacturer Natco for Bayer’s anticancer therapy Nexavar (sorafenib), a drug to treat advanced kidney and liver cancer.  The judgment represents the first time the Indian Controller General of Patents, Designs and Trademarks has granted a compulsory license to a generic-drug manufacturer (1).

In its ruling, Indian patent authorities asserted that compulsory licensing, when a government allows a party other than the patent owner to produce a patented product or process without the consent of the patent owner, is permissible under  Indian patent law, patent laws of certain other nations, and  the World Trade Organization’s  (WHO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It acknowledged, however, that this case by which the applicant, Natco, sought a compulsory licensing under Indian patent law, was the first time such a case has been considered. 

In its ruling, Indian patent authorities noted that Bayer launched the drug worldwide in 2006, received regulatory authority to import and market the drug in India in 2008 and launched the product in 2009 in India. Natco, a generic-drug manufacturer based in Hyderabad, India, developed a process to manufacture the drug. It received approval for manufacturing the drug in bulk and marketing the drug in tablets from the Drug Controller General of India in April 2011. In its ruling, the Indian Controller General of Patents, Designs and Trademarks said that Natco had sought a voluntary license from Bayer to manufacture and sell the drug in India, but that had not materialized. Natco had sought to sell the drug for 8800 rupees ($178) for a month’s supply of a generic version of the drug compared with the 284,428 rupees ($5698) for a month’s supply sold by Bayer. 

In its decision, the Indian patent authorities asserted that a compulsory license may be granted if an invention is not available to the public at “reasonably affordable price.” The limited use of the drug in India, a delay by Bayer in bringing the drug to market in India, the lack of affordability of the drug to the public, the absence of local manufacture of the drug in India, and limited imports of the drug by Bayer into India were factors in the controller’s ruling that Bayer had not adequately “worked the invention” on a commercial level. Bayer had countered by asserting that price should reflect development costs not the public’s ability to pay for the drug. It further noted that a generic version of the drug is now being sold by the generic-drug manufacturer Cipla, an action that is the subject of a patent-infringement case between the two companies, which has impeded its ability to market the drug in India. 

Under the granting of the compulsory license, Natco must pay Bayer 6% of the net sales of the drug and sell it for 8800 rupees ($178) for a month’s supply of 120 tablets. Natco also must manufacture the drug at its own manufacturing facility and not outsource the production of the drug, and the drug must only be sold in India.

The Pharmaceutical Research and Manufacturers of America (PhRMA) weighed in on the issue of compulsory licensing. Although not specifically commenting on the specifics of the case, the association stated it did not favor the use of compulsory licenses. 

“While India has not routinely issued compulsory licenses (CL), PhRMA believes it is not an appropriate tool even if granting CLs may be a legal option,” said PhRMA President and CEO John Castellani, in a Mar. 14, 2012, statements. “Assessments of particular compulsory licensing policies and decisions need to be made on a case-by-case basis, taking into account a number of factors. Legitimate health emergencies that require making exceptions to intellectual property rights can and should be accommodated under the international framework, but only after exhausting all other efforts and under extraordinary circumstances.” 

PhRMA said it will not address the specifics of this case, but did offer a perspective on intellectual property rights. “One aspect that is particularly troublesome is the contention that ‘working’ a patent requires a company to manufacture within India. It is our firm belief that this is fully at odds with India’s TRIPS commitment (as well as its broader WTO obligations), and distorts what was intended as a public health exception into an industrial policy,” said Castellani, in the statement.

PhRMA also stressed the industry supports increasing access to medicines, but is against the use of compulsory licensing to achieve that objective. “The research-based pharmaceutical industry fully supports the objective of improving access to innovative medicines; however, CLs cannot solve India’s larger problems regarding access to medicines and healthcare. If countries begin to routinely use CLs, we could see a ‘race to the bottom’ in which governments in the developing world walk away from their responsibility to support research and innovation in public health. In the absence of the investment made by our members, and the resulting research and development, there would be no generic medicines for the world’s patients. The responsibility to promote development of new drugs lies with all countries, not solely those in the developed world.” 

1. G. Anand and R. Ahmed,  “Bayer Loses Drug Ruling in India,” 

APIs

The decision by the Indian patent authorities to issue a compulsory license for a generic version of a Bayer anticancer drug engenders debate.

PTSM: Pharmaceutical Technology Sourcing and Management-04-04-2012

CMOs Face a Kodak Moment

UN Launches Commission on Life-Saving Commodities for Women and Children

CSR and Sustainability in the News

Manufacturing Capacity-Sharing Model: Merck & Co. and MedImmune LLC

Pharmaceutical Industry Faces Compulsory Licensing in India