...Introduction Drug development from initial discovery of a promising target to the final medication, is characterized by a high degree of scientific, regulatory and economic risk. Colossal amounts of time, effort, and money are invested in the research and development process to bring a new medicine to the market. In fact, it takes an average of 10 to 15 years to bring a drug from discovery to approval, and for every 5,000-10,000 compounds investigated; only one is approved and marketed. Figure 1: Current time-scale of drug approval processes. Studies have estimated that the cost of bringing a single new drug to market is in excess of US $800million., Other health economists estimate that the current cost of drug development is now between US$1.3 billion to $1.7 billion., However, an updated cost per NCE (New chemical entity) has been recently calculated taking annual inflation, toughening regulatory demands and the decline in success rates into account. It has been proposed that the earlier cost estimate of drug development of $802M has risen to the astronomical level of $3.9Bn after adjustment. In addition, it is important to note that this does not represent the entire cost as the expenditure for marketing is omitted from these figures. However, the costs have been questioned as it is claimed it is in the best interests of drug companies to overstate costs since they often lobby governments to loosen price regulations and increase patent protection. The surging...
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...The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities December 2007 Michael Steiner, CFP®, CPA David H. Bugen, CFP®, MBA Brian Kazanchy, CFP®, CFA, MBA William T. Knox IV, CFP®, CFA, JD Margaret V. Prentice, MBA Lauren Goldfarb Mark P. Hurley Steven E. Cortez Christine L. Boudreaux Benjamin J. Robins Yvonne N. Kanner Shehzad Sippy Adam L. Bartkoski Ana M. Avila RegentAtlantic Capital, LLC Michael Steiner is a Wealth Manager and Principal with RegentAtlantic Capital, LLC, and head of the firm’s Pharmaceutical Executive Services Group (PESG). David H. Bugen is a Wealth Manager and Principal, and Brian Kazanchy is a Wealth Manager. William T. Knox IV is a Wealth Manager and Principal. Margaret V. Prentice is the Chief Marketing Officer and Principal, and Lauren Goldfarb is the Business Development Coordinator. Fiduciary Network, LLC Mark P. Hurley is President and CEO of Fiduciary Network, LLC. Steven E. Cortez is Executive Vice President. Christine L. Boudreaux is Director of Adviser Communications, and Benjamin J. Robins is General Counsel. Yvonne N. Kanner is Executive Vice President and COO, and Shehzad Sippy is a Research Analyst. Adam L. Bartkoski is Director of Adviser Operations and Development, and Ana M. Avila is an Intern. © Copyright Fiduciary Network, LLC, 2007 This material is for your private information, and we are not soliciting any action based upon it. Opinions expressed are our current views only, at the...
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...facilities, and equipment distributors. The second group comprises companies that are primarily involved in the research, development, production, and marketing of biotechnology and pharmaceutical products. Business Overview: Healthcare companies currently shift their focus toward having more efficient management to drive profit higher. Significant regulatory changes, technological innovations, and financial pressures have influenced the need for health services to grow at a more aggressive rate. While monitoring the sector, it is easy to see that the average increase across the six industries has had a positive return of 1.54% over the past year, with the only lagging industries being Biotechnology (-0.76%) and Health Care Technology (-8.40%). Since the introduction of ObamaCare (or the Affordable Care Act) in 2010, insurance companies have taken advantage of those enlisted in the program by creating fewer opportunities to use “inside network” physicians and forcing patients to either forego treatment or take on the financial burden themselves. Estimates for 2016 show that insurance companies around the country are seeking premium rate increases of 20 percent to 40 percent or more, saying their new customers under ObamaCare turned out to be more sick than expected. Despite these circumstances, the overall sector is very strong, and other industries such as biotechnology and pharmaceuticals are still in a stage of rapid growth. For these reasons, we conclude that the Healthcare...
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...The Global Pharmaceutical Industry Case Analysis This case by Sarah Holland and Bernardo Bátiz-Lazostudies studies the evolution of the ethical pharmaceutical industry and analyses the various forces affecting the discovery, development, production, distribution and marketing of prescription drugs. The authors further analyses the critical issues of corporate social responsibility in the industry and the strategies being followed by major pharmaceutical companies and the challenges and opportunities for the future. This case bases its research to find evidence to support or disprove findings of a report published in the Gardiner by analysts at the investment bank of Dresdner Kleinwort Wasserstein which claimed that the world's major drugs companies are operating a business model that is unsustainable and rapidly running out of steam. On the surface however, the pharmaceuticals business seems like the epitome of a modern, mature industry that has found a comfortable way to make profits by the billion. According to the case large pharmaceuticals companies are currently facing the most challenging times since a decade. Even though the industry has made tremendous contributions to human well-being, its roles and actions are still criticized by the media and under constant scrutiny by national governments in their efforts to reduce expenditure in healthcare. Stringent laws and regulations have come in action which has made product approval, pricing and promotions costlier...
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...ANALYSIS OF SUPPLY CHAIN RISK MANAGEMENT IN THE GHANAIAN MANUFACTURING INDUSTRY: A CASE STUDY OF KAMA PHARMACEUTICAL MANUFACTURING COMPANY INTRODUCTION 1.0 Background of the Study According to Hendricks and Singhal (2005), there is increased awareness and recognition among managers, consultants and academicians that supply chain performance is increasingly important to business success. In other words, supply chain plays an important strategic role in the world economy and that firms are more dependent upon their supply chains networks in order to deliver value. Regrettably, there is also a point of vulnerability in the world economy which are subject to disruptions with significant consequences especially when the disruption comes suddenly, without warning, and with devastation. Handfield (2007) posit that the total set of risks to an organization is much broader. It includes hazard risk and operational risk. Hazard risks refer to weather disasters, equipment shutdown, or product liability, while operational risks include major disruptions such as theft, late supplier deliveries, and IT systems shutdowns and so on. For the purpose of this study, focus shall be placed on operational risk with specific focus on supply chain risk. Generally, supply chain operation is fundamental to the success of any organization. It is critical to a company’s ability to manage global operations, supply and demand volatility, the accelerated pace of new product and services introductions...
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...CRANEFIELD COLLEGE OF PROJECT AND PROGRAMME MANAGEMENT GROUP ASSIGNMENT FOR MODULE M1: Project Management: Leading, Creating, Implementing and Improving Please include the following declaration: “We hereby declare that this assignment is entirely our own work, and that it has not previously been submitted to any other Higher Education Institution. We also declare that all published and unpublished sources have been fully acknowledged and properly referenced. This includes figures, tables and exhibits. Where modified by us, this has also been indicated.” Print Name | Signature | ID Number | | | | | | | | | | | | | | | | Table of Contents 1. Executive Summary 2 1.1. Introduction 2 1.2. Anticipated Outcomes 2 1.3. Recommendation 3 2. PROBLEMS AND CAUSES 3 2.1 Problem Statement 3 2.2 Project Overview 4 2.3 Project Selection 4 2.4 Project Justification ...
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...question acts and deeds. The businesses AD23 drug has allegedly linked to deaths and now everything will need to be reviewed to determine validity. Ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examining whether PharmaCare violated any of the issues in question will be explored. Direct-to-consumer marketing (DTC), by drug companies is a strategy that will be argued either for or against in this paper. There are entities responsible for regulating compounding pharmacies under the current regulatory scheme. The actions that either of these entities or the Federal Drug Administration (FDA) could/should have taken will be explored along with whether PharmaCare could face any legal exposure surrounding its practices. The manner in which PharmaCare used the U.S law to protect its own intellectual property will be discussed, and if John the former employee has any claim as the true “inventor” of AD23. One real-world example of intellectual property theft will be examined and the effect to that company’s brand will be discussed. The issue surrounding John’s wife’s death and the other potential litigants against PharmaCare will be analyzed further as the result of AD23. Finally, both major arguments that John can make to claim that he is a whistleblower and the type of protections that should be afforded will be specified. Ethical Issues Marketing and advertising in the pharmaceutical business is a useful tool to assist in...
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...9-604-101 REV: JUNE 20, 2006 GARY PISANO LEE FLEMING Vertex Pharmaceuticals: R&D Portfolio Management (A) EEEddduuucccaaatttiiiooonnnaaalll mmmaaattteeerrriiiaaalll sssuuuppppppllliiieeeddd bbbyyy TTThhheee CCCaaassseee CCCeeennntttrrreee CCCooopppyyyrrriiiggghhhttt eeennncccooodddeeeddd AAA777666HHHMMM---JJJUUUJJJ999KKK---PPPJJJMMMNNN999III OOOrrrdddeeerrr rrreeefffeeerrreeennnccceee FFF222555222999888333 I’ve never made a bad decision. I’ve just had bad data. — Joshua Boger, CEO and Founder of Vertex Pharmaceuticals Like many New Englanders on this bright October morning in 2003, Josh Boger, CEO of Vertex Pharmaceuticals, had been up until 2:00 a.m. the previous evening watching the Boston Red Sox playoff game. The game, predictably, ended in a heartbreaking loss for the Red Sox, but Boger’s lingering disappointment (and regret over staying up so late) quickly faded as he strode down the halls of the Cambridge, Massachusetts company he had founded 15 years earlier. Vertex had four promising drugs in various stages of clinical development, and Boger was excited by the possibilities: “The portfolio is playing out exactly as we hoped. We’ve got a stream of revenues from our partnered project that will help fund our development costs. There are multiple paths for us to become profitable. We’re in a position to choose.” While the company had revenue from various corporate partnerships and roughly $600...
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...the Best Managers of 2003, Business Week. Arthur Levinson, a molecular biologist turned CEO, joined Genentech, a research-oriented biotechnology company, just before the company went public in 1980. Herapidly rose through the ranks to become president and CEO by 1995. Hiscommitment to basic research and his motivation to create a company that was also able to turn a profit made Genentech a model company for the biotechnology industry and a recognized leader in selected pharmaceutical markets. Levinson relied on his scientific instincts as he manipulated Genentech, a relatively small company, to a leadership position among the highly competitive pharmaceutical giants. The leadership instincts possessed by Levinson: He used to follow a Transformational leadership style. He was a person with great enthusiasm and energy which he wanted to inject in his organization. He had a vision and a passion to achieve those targets. He started with developing a vision, a view of the future that will excite and convert potential followers. He wanted to shed the company’s status of a scrappy start up to become a consistently profitable powerhouse. if Levinson pulls off this transition , it will be the strongest...
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...CASE TEACHING NOTES The Global Pharmaceutical Industry Sarah Holland (Manchester Business School) and Bernardo Bátiz-Lazo (London South Bank University) 1. Introduction The case describes how the prescription pharmaceutical industry has changed since its modern beginnings in the early 1950s. The various forces affecting the competitive environment of the industry are discussed in terms of origins, immediate past and immediate future (2004 onwards). As a result, the note provides insights into the evolution of barriers to enter and exit the industry for prescription pharmaceuticals, while aiming to help students to recognise how to set boundaries for an industry. This is a detailed industry note on the “ethical” pharmaceutical industry which provides an opportunity to analyse key success factors of major players. The note centres on a descriptive overview of the predominant issues in the three major Triad market areas: the US, Europe and Japan (although major issues in emerging markets are also mentioned). The note covers the overall industry environment with in-depth discussion of the driving forces in the industry such as globalisation (in particular global regulatory issues, changing world demographics and worldwide pricing disparities); development of new technology; the importance of time to market; and amalgamations. The case also examines issues around corporate social responsibility. 2. Position of the Case The pharmaceutical industry case study lends itself...
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...armed forces. Growth In 1996 Yunnan Baiyao Limited Co. and three other producers were integrated into Yunnan Baiyao Group Co. through joint shareholding. China became member of the WTO, which increased the competition landscape. In 2002 , Baiyao Da Yao Fang Ltd (a drugstore chain) was established and Wuding Planting Base was established to carry out the forward vertical integration. Industry players are adjusting to open market and multinationals were coming into play. Many of YB products had reached maturity and growth potential was limited in current state. To respond to current challenges YB established a series of strategies “one core and four growth areas”. The “one core” would focus on the YB headquarters and the three companies it had acquired, as well as the sales network. Symptoms In order to depict the problem for YB there were three issues. Firstly, it is evident YB has a growth issue. Many of YB's products have reached or were reaching maturity. Secondly, there is a competition and global problem where the Chinese market was open to Global competition in 2002 because of their entrance to WTO. Thus, several diversified and vertically integrated companies had the opportunity to enter the industry. YB must "grow bigger through integration and diversification or they would...
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...future commercialization path for Lilly’s new, potential blockbuster drug, Evista®, which had received FDA approval on December 9, 1997, for the prevention of post-menopausal osteoporosis. Evista®, generically known as raloxifene hydrochloride, would be entering the estrogen replacement market, a market that had worldwide sales in excess of $1 billion in 1997.[1] Of even wider significance was the fact that in initial trials, Evista® appeared to lower the incidence of breast cancer and reduced total LDL in post-menopausal women without the negative side effect profiles of currently available estrogen replacement therapies. The potential of this new therapeutic and its impact on Lilly could be enormous. Some analysts predicted that Evista® might become a $1B drug for the company.[2] With this in mind, Watanabe knew that the decision on how best to commercialize Evista® would have a profound effect on Lilly’s well-being. Should Lilly follow its traditional approach to commercialization? Or should Lilly follow a course more in line with the development approach adopted for Evista® in early 1995, which would require the organization to transform its heavyweight product development team into a focused product (commercialization) team? In a senior management meeting later in the day, Watanabe would have to make a recommendation. Company Background Eli Lilly and Company was incorporated in 1901 to pursue the drug manufacturing business founded in Indianapolis...
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...Implementation 28-30 References 31 Executive Summary A Customer’s Hope Eli Lilly and Company is on a mission that benefits millions of people every day by helping them live longer and fuller lives. They provide their customers with answers that matter—life saving and enhancing medicines. They carry out this mission by discovering, developing, and marketing pharmaceutical therapies. Many of the pharmaceutical products Lilly brings to market are first-in-class, providing customers a therapeutic relief that did not exist. An example of this is their newly FDA-cleared drug, Xigris™, which helps thousands of people every day by treating the potentially fatal condition of sepsis. The Lilly research team persevered over two decades to bring Xigris™ to fruition, even when over ten other companies failed to produce a viable drug remedy for sepsis (Eli Lilly Annual Report 2001). This dedication truly exemplifies Lilly’s commitment to their customers and transcends into all their efforts. Eli Lilly continues to be a successful pharmaceutical company, while other pharmaceutical companies have seen their success erode, because of the strategies they employ. Lilly has focused on building partnerships rather than acquisitions and continually reinvests the highest percentage of their sales revenue into research and development. Both of these actions allow them to expand their reach in research and development providing them with one of the strongest pipelines...
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...their products for generations. Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products in the industry. Their products touch the lives of nearly a billion people every day. Their operating companies around the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets. With approximately 120,000 employees working in more than 250 companies in 57 countries, Johnson & Johnson has the skills and resources to tackle the world’s most pressing health issues. Few companies have the consistent track record of public trust, annual sales increases, double-digit earnings increases, and steady dividend increases of Johnson & Johnson. Working together across various business segments, Johnson & Johnson believe that they can accelerate growth through a dedicated focus on the intersection of existing capabilities, customer need, and emerging trends. Because of their wide-ranging technological expertise and global presence, cross-business collaborations provide an enormous opportunity to address unmet health care needs and to enhance competitive advantage for their Family of Companies. Success in these markets requires an understanding of local cultures derived only from local experience. By sourcing top business and technology employment candidates for positions in their home countries, we can build organizations, facilities, and product marketing systems that respond to local needs. One of America's...
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...9-707-441 REV: MARCH 30, 2010 TARUN KHANNA KRISHNA PALEPU CLAUDINE MADRAS Teva Pharmaceutical Industries, Ltd In Israel we have a 1970s song based on a poem from 1953 by Amir Gilboa about Theodor Herzl.1 It has a line in it about Herzl: “Suddenly a man rises in the morning, feels he is a people, and starts walking.” That is exactly what Hurvitz did. Suddenly he woke up in the morning, feels he is a giant world class company, and starts walking. No one, aside from Herzl, has accomplished anything as remotely as impressive in this country as Hurvitz. It was impossible, a million to one odds at best, and he still did it. He woke up one morning and started walking. — Ori Hershkovitz, equity analyst at Tel Aviv-based Leader & Company The markets had not been kind to Teva Pharmaceutical during the first half of 2006. The stock had plunged nearly 30% from January 1 to June 30, erasing billions of dollars from the company’s market capitalization. Even good news, such as reports in July of Teva’s wildly successful introduction of generic Zocor—the largest blockbuster drug ever to go off-patent—had failed to boost the stock significantly. Since nearly every retirement fund and mutual fund in Israel invested in Teva, this drop had been felt throughout the population, in effect amounting to every Israeli family losing NIS 3000, or $675.1 Teva was more than the world’s leading producer of generic pharmaceuticals (see Exhibit 1 for financials). It represented the gold standard of business in...
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