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After discussing this case, students will be able to understand the challenges faced by social entrepreneurs in starting a health-tech start-up in Africa; create and evaluate lean business models of health-tech companies as a social enterprise; evaluate how health-tech start-ups were developing innovative business models and supply chain networks to make prescription drugs accessible and available in Africa; understand how inorganic growth strategies can help health-tech start-ups scale up; and evaluate what promises investors were seeing while investing in social enterprises in the health-care sector in Africa and what social wealth they were creating.

In August 2022, Gregory Rockson (Rockson), social entrepreneur and founder of for-profit health technology (health-tech) social enterprise in Ghana, mPharma, stated that he had plans to replicate the company’s business model, which provided people access to drugs and at affordable prices, to other African nations, beyond the company’s existing footprint. However, analysts pointed out that the fragmented drug supply chain and poor regulation in the health-care market across Africa could act as a challenge for mPharma to replicate its business model successfully across the African continent. People in Africa were forced to pay higher prices to buy life-saving drugs due to the continent’s fragmented drug supply chain. To add to their woes, pharmacies struggled to keep life-saving and life-sustaining medicines in stock. Often, patients traveled miles to a pharmacy only to find out that the drugs they needed were not in stock. In addition to this, the markets were flooded with counterfeit drugs. And the Covid-19 pandemic only exacerbated the situation. mPharma managed the prescription drug inventory for pharmacies and drug suppliers using its proprietary vendor management information system. By using the technology infrastructure it had built, the company connected patients, pharmacies and hospitals through a cloud-based software. The system enabled doctors to track in real-time which drugs were available and at which location, thus giving patients reliable access to medicines. Patients registering with mPharma with their prescriptions and medical history received an alert on their mobile phones notifying them where the drugs they needed were available. mPharma bought drugs from major drug manufacturers such as Novartis International AG, Pfizer Inc. (Pfizer) and Bayer AG, on behalf of the pharmacies. This enabled the pharmacies to save on the up-front costs of stocking the drugs, reduced supply constraints and ensured availability of drugs to consumers in these underserved markets. The company had a consignment model wherein member pharmacies had to pay only for what they sold. Most pharmacies forecast the number of drugs they needed and purchased them from mPharma at pre-agreed rates. The company took the inventory liability to prevent pharmacies from going out of stock. As mPharma used its purchasing power to buy drugs in large quantities from drug manufacturers and suppliers, it was able to help patients realize cost savings of 30% to 60% in the purchase of medicines. mPharma was focusing on achieving its ambitious goal of dominating the health-care market in Africa in future. However, analysts felt that the company would face challenges related to poor regulation in the health-care market, high prices of drugs and the fragmented pharmacy retail market in the continent.

This case is intended for use in MBA/MS level programs as part of a course on Social Entrepreneurship, Sustainability, Business Model Innovation, Disruptive Business Models, and Supply Chain Management in the Drug Industry.

Teaching notes are available for educators only.

CSS 3: Entrepreneurship.

In the 1960s thalidomide, a popular new drug considered to be safe and effective, was revealed to cause severe nerve damage and birth defects in newborn infants, prompting health officials to ban the use of the drug and tighten overall restrictions on new drugs and drug use. Twenty years later, after recognizing the positive effects of thalidomide when treating patients with leprosy and its potential role in the treatment of certain types of cancer and cases of HIV/AIDS, the Celgene corporation would be forced to contend with stringent FDA regulations, liability concerns, public skepticism, and poor mass media portrayal in order to secure the drug's approval.

To illustrate how regulators are subject to political pressure, which companies much recognize and consider when making business decisions.

The case tells the story of Synthroid from its development in 1958 as the first synthetic thyroxine molecule to its competition against generic equivalents in 2004. The case introduces students to the pharmaceutical industry, its practices, and some of the complexities of pricing and drug choice, with drug manufacturers, insurance companies, physicians, pharmacists, and patients all playing a role. It also provides a primer on hypothyroidism, its symptoms, and its treatment.

Because Synthroid was developed and introduced before FDA regulations and drug standards of identity were fully established, it was difficult for competitors to get their drugs certified as identical to Synthroid. Through a series of efforts with physicians, especially endocrinologists, Synthroid's owners were able to maintain the perception for forty-six years that Synthroid was uniquely effective. In 2004, however, the FDA declared several competitive products to be bioequivalent to Synthroid, which posed a significant challenge to its owner, Abbott Laboratories. Students are challenged to consider options to maintain the drug's unit volume, revenue, and/or profit in these difficult circumstances.

The case is written in two parts. The (A) case provides background on the history of the drug, the pharmaceutical industry and its marketing practices, and hypothyroidism and its treatment, and it concludes in 2004 as Abbott's marketers face the impending challenge of defending the Synthroid business against generic competition. The (B) case describes what Abbott actually did to maintain its share in the United States and outlines its strategy in India, a market without patent protection for pharmaceuticals.

After analyzing the case students should be able to:

• Describe strategies that branded competitors can use to defend their business from lower-priced competition

• Understand the basics of pharmaceutical marketing and pricing, including the global challenge of defending branded drugs against generic equivalents

• Discuss ethical issues in the marketing of high-margin branded products that have lower-priced alternatives, especially in the healthcare industry

Describe strategies that branded competitors can use to defend their business from lower-priced competition

Understand the basics of pharmaceutical marketing and pricing, including the global challenge of defending branded drugs against generic equivalents

Discuss ethical issues in the marketing of high-margin branded products that have lower-priced alternatives, especially in the healthcare industry

Tom McKillop, CEO of AstraZeneca, faced the classic quandary of large pharmaceutical firms. The firm's patent for Prilosec (active ingredient omeprazole) was expiring. Severe cost-based competition from generic drug manufacturers was inevitable. Patent expirations were nothing new for the US$15.8 billion in revenues drug firm, but Prilosec was the firm's most successful drug franchise, with global sales of US$6.2 billion. How could the company innovate its way around the generic cost-based competition and avoid the drop in revenues associated with generic drug market entry? AstraZeneca had other follow-on drugs in the pipeline—namely Nexium, an improvement on the original Prilosec molecule. Additionally, the company had the opportunity to introduce its own version of generic omeprazole, hence becoming the first mover in the generic segment, and/or introduce an OTC version of omeprazole that might tap into other markets. Ideally, AstraZeneca would like to move brand-loyal Prilosec customers to Nexium. In this market, direct-to-consumer advertising has remarkable efficacy. Classical marketing challenges of pricing and promotion need to be resolved for the Nexium launch as well as possible product and place challenges for the generic or OTC opportunity. Which combination of marketing options will allow the firm to best sustain the value of the original omeprazole innovation?

The central objective of the case is to teach students how marketing variables can be used by first movers with diverse product portfolios to fend off severe price competition. These variables include pricing, promotion, product, and place (distribution) options as considered in the context of branded, generic, and OTC pharmaceutical market segments.

Pharmaceutical marketing, brand protection.

It could be used with the pharmaceutical marketing students and MBA students for analysing counterfeit medicines' menace in developing countries and positioning of a disruptive technology. The case could be used for marketing consultants, Brand managers and executive development programmes to explore issues such as protecting brands through technology, pharmaceutical packaging marketing, competitiveness of counterfeit drugs, global harmonisation.

Against the backdrop of rising menace of counterfeit drugs in developing countries, the case talks in particular about an innovative pharmaceutical packaging company. The company has developed a unique security technology called non-ClonableID™ which can enable products to be authenticated throughout the supply chain, thus protecting brands and preventing misuse. Despite a promising technology, it poses challenges regarding its adoption and commercial success.

Counterfeiting as an inevitable result of Globalization has become a global nuisance and has to be dealt at global level. Brand protection could be one of the lowest cost tools for pharmaceutical companies to restore public confidence in their products and themselves. While all methods for anti-counterfeiting are known to have short lives the menace still must be dealt with. For this, companies need to deploy anti-counterfeiting strategies that set up various layers of security.

Teaching note.

The case tells the story of Synthroid from its development in 1958 as the first synthetic thyroxine molecule to its competition against generic equivalents in 2004. The case introduces students to the pharmaceutical industry, its practices, and some of the complexities of pricing and drug choice, with drug manufacturers, insurance companies, physicians, pharmacists, and patients all playing a role. It also provides a primer on hypothyroidism, its symptoms, and its treatment.

Because Synthroid was developed and introduced before FDA regulations and drug standards of identity were fully established, it was difficult for competitors to get their drugs certified as identical to Synthroid. Through a series of efforts with physicians, especially endocrinologists, Synthroid's owners were able to maintain the perception for forty-six years that Synthroid was uniquely effective. In 2004, however, the FDA declared several competitive products to be bioequivalent to Synthroid, which posed a significant challenge to its owner, Abbott Laboratories. Students are challenged to consider options to maintain the drug's unit volume, revenue, and/or profit in these difficult circumstances.

The case is written in two parts. The (A) case provides background on the history of the drug, the pharmaceutical industry and its marketing practices, and hypothyroidism and its treatment, and it concludes in 2004 as Abbott's marketers face the impending challenge of defending the Synthroid business against generic competition. The (B) case describes what Abbott actually did to maintain its share in the United States and outlines its strategy in India, a market without patent protection for pharmaceuticals.

After analyzing the case students should be able to:

• Describe strategies that branded competitors can use to defend their business from lower-priced competition

• Understand the basics of pharmaceutical marketing and pricing, including the global challenge of defending branded drugs against generic equivalents

• Discuss ethical issues in the marketing of high-margin branded products that have lower-priced alternatives, especially in the healthcare industry

Describe strategies that branded competitors can use to defend their business from lower-priced competition

Understand the basics of pharmaceutical marketing and pricing, including the global challenge of defending branded drugs against generic equivalents

Discuss ethical issues in the marketing of high-margin branded products that have lower-priced alternatives, especially in the healthcare industry

The case offers a study of change management in the pharmaceutical industry in India.

The case is designed for undergraduate and postgraduate students to examine strategic decisionmaking in the context of mergers and acquisitions (M&As), firm capabilities and management practices. In particular, it has important pedagogical lessons for businesses eager to start operations in emerging countries. Students learn to recognize the unique nature of the pharmaceutical market and the factors affecting the demand and supply of drugs, including the economics of generics. The case can be discussed in one class session of approximately one-and-a-half to two hours duration.

In 2012, the pharmaceutical industry in India was undergoing dynamic changes. There was keen interest among MNC pharmaceutical giants to buy up Indian generic manufacturing companies since their revenues were drying up with the impending patent expirations of many blockbuster brand name drugs. Japan's Daiichi Sankyo's had taken over the largest Indian pharmaceutical company, Ranbaxy Laboratories, known for its heritage of process innovations and market leadership. However, after the acquisition, Ranbaxy slipped to third position in the domestic market and was facing multiple problems including net losses and falling share prices, cultural differences in management practices, recall of drugs from foreign markets and a US FDA ban on its manufacturing plants. Further, Ranbaxy had always been viewed as a national champion and a customer-friendly company but drug prices had increased after the merger causing problems of affordability. The new CEO of Ranbaxy was facing a dilemma: how to regain the company's position as the market leader. Students are asked to advise the CEO of Ranbaxy how to tackle the challenges arising from the integration of an Indian company with a Japanese company. More specifically, the case focuses on M&A as a strategy for growth and also touches on issues related to competition, regulation, innovation and corporate governance.

The case discusses the different motives behind the deal for Daiichi Sankyo and Ranbaxy and why it was a strategic move by both the alliance partners. The case also raises issues of corporate governance for the management of Ranbaxy and the need for a proactive corporate social responsibility (CSR) strategy. The case provides students with the opportunity to develop their analytical skills in a real-life setting and apply theoretical concepts to the consideration of the various issues raised by the acquisition deal.

Teaching notes are available; please consult your librarian for access.

This case, developed from a wide variety of publicly available information, presents ethical and economic issues arising from the development, marketing, and pricing of a biotech drug. Genentech developed TPA, the first genetically engineered drug that could be used in clot-dissolving therapy for heart attack, and marketed it as Activase. Public outrage focused on the disparity between the drug's $10 direct manufacturing cost and what Genentech charged for its drug. Activase/TPA was priced at $2200 a dose, raising immediate concerns about its affordability and therefore availability to those who needed it. Additional issues arise from other events, including concern over related-party relationships between the company and organizations which researched and recommended TPA, as well as aggressive marketing of TPA to physicians and the company's refusal to participate in an international drug study to compare TPA with competitor drugs.

Case information was mainly acquired through interviews with Richard Gammans, chief operating officer. Dr Gammans was a visiting professor at Fayetteville State University for a year, and two of the case authors developed personal friendships with Richard. Interviews were conducted over a two-year period as the accelerator got started. In addition, one author conducted a team-building session with the management team and one of the bio-startup researchers. An interview was also conducted with Clayton Duncan, chief executive officer, to gain his agreement with developing the case.

The Accele website included a write-up on each of the pharmaceutical startup companies. The write-up included a company summary, description of the science (disease and cure), the size of the market, results from testing, regulatory considerations and intellectual property. A literature review was conducted as the basis for the information on the pharmaceutical industry.

This case is about a biopharmaceutical accelerator founded in 2011 by two senior executives with experience in both large pharmaceutical companies and running biotech startup companies. The founders were successful in raising capital to start their first venture capital fund which they used to invest in four biotech startups. All four startups were working in very different disease areas. For example, one developed a drug to help with hearing loss that the department of defense was funding. Another of the startups discovered drug candidates that attack antibiotic-resistant bacteria. Biopharmaceutical accelerators were relatively new. They differed from business incubators because they invest in the startups and provide operational support, but the degree of support provided varies across accelerators. The Accele BioPharma accelerator operated in virtual, network type of organization, and Accele BioPharma provided primary strategic and operational management for the startups. The challenge in this case is to identify how the leaders managed the virtual network, and what additional resources were needed so that the management team could expand their ability to assist startups to get drugs approved by the food and drug administration.

This case is suitable recommended for undergraduate/graduate strategy, undergraduate/graduate organizational behavior, entrepreneurship and health-care management courses.

The pandemic induced lockdown lead to supply and manufacturing disruptions that were swiftly dealt with by the Indian Pharma Industry through successful industry-government collaboration. By May 2020 production was back to normal and exports were higher than the same period in May 2019. The case deals with the processes that enabled this to happen, the policy responses and the changes that happened in the period from March 2020 to August 2020.