...University of Maryland Case Study Analysis Eli Lilly: Developing Cymbalta Case Study AMBA 650 Section 1131 Kelvin Harris January 24, 2012 Executive Summary Eli Lilly and Company resounding success was the arrival of Prozac in 1988. By mid-1988, a new anti-depressant team was formed to find and develop a drug that would be the successor to Prozac. The strategic issues and problems they faced were developing a new drug to replace Prozac, meeting the company budget constraints to perform clinical trials, and finally launch the new drug by mid-2001. The analysis and evaluation revealed that the pharmaceutical industry is changing fast and it usually takes a long time and millions of dollars to develop a new drug. The recommendation for Eli Lilly is to take the lead in developing the new drug Cymbalta, invest a stable share of the company revenue, seek the FDA approval for the development of Cymbalta before going to market, and not change their market plan from the FDA approved Cymbalta dosage of 20 mg twice daily. Introduction Eli Lilly and Company was founded by Colonel Eli Lilly, Lilly’s namesake, in 1876 when he purchased a laboratory on Pearl Street in Indianapolis, Indiana. Eli Lilly was a pharmacist who had served in the Union Army during the Civil War. The company success included creating the process for applying gelatin-coating to pills for easier swallowing and the introduction of Iletin which was the first mass-produced insulin. Iletin...
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...Introduction Clinical trials, for any pharmaceutical company are significant, as they serve as the back bone in Research and development of new medicines and their standardization for the advantage of human population. In developed countries the conduct of clinical trials in more transparent and heavily regulated. However, the conduct of clinical trials in India come with lot of risks, as a lot of people are uneducated, no rules of compliance by the government. India was considered as the economical and feasible place to conduct these clinical trials, as the laws pertaining for the same were not stringent. Clinical Trials: A clinical trial is a scientific investigation to evaluate the effect of new drugs or vaccines other than health interventions, by administering these to human volunteers. They are generally bio medical or health-related research studies in human beings that follow a pre-defined protocol. In 2005 amendments were made on Drugs and Cosmetics Act, 1945, which allowed big companies to start their clinical trials in India. After that, there are number of incidents resulting in death of people participating in such clinical trials, particularly women, aged and even mentally challenged people, across the country. Due to this, the Drugs and Cosmetics Act Amendment Bill 2013 was brought forth in order to strengthen the drug regulatory system and create a central authority for managing drug and medical device approval. The non-conducive climate for clinical trials within...
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...changes in regulatory requirements for clinical trials pose considerable challenges for the clinical research community. The clinical research Quality Assurance (QA) profession as a whole has not historically utilised quality management tools, and QA professionals may have little to no formal training in continuous improvement methods, to be aware of their value in assessing and improving the impact and value of the QA department to any organisation. This article will present Deming’s 14 Principles for Management, paraphrasing them to demonstrate how easily they can apply to the clinical trial project management, Contract Research Organisation (CRO) and clinical department management. Deming’s 14 Principles Dr. William Edwards Deming is known as the father of the Japanese post-war industrial revival and was regarded by many as the leading quality guru in the United States. Deming created 14 Principles for Management that summarised his business philosophy. The principles became a basis for transformation of industry. The 14 principles apply anywhere, from small organisations to large ones, to the service industry as well as to manufacturing. They apply to any division within a company. 2. Adopt the New Philosophy Management should actually adopt the ‘quality philosophy’, rather than merely expect the workforce to do so. When the new clinical trial project is thoroughly planned and the quality matters are carefully embedded into it by the study management, while creating the atmosphere...
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...INTRODUCTION Pharmaceuticals industry has a key role in manufacturing and developing new vaccines and drugs with an objective to improve life and prevention of diseases. Pharmaceutical industry have involvement in research and development, dealing in research and generation of new drugs, bulk manufacturing involving production of already existed drugs and in marketing. In spite of the fact that pharmaceutical industry is subjected to high risk and challenging business conditions as compared to any other industry. It has made tremendous contribution in improving global health. (IFPMA, 2012) “ Pharmaceutical industry spends more on research and development, relative to its sales revenue, than almost any other industry in the United States. According to various estimates, the industries’ real spending on drug R&D has grown between threefold and six fold over the past 25 years and that rise has been closely matched by growth in drug sales”(CBO, 2006). The research and development based pharmaceutical industries invest billions of dollars for development of a single drug and on an average the annual spending by the pharmaceutical industry is five times greater than that of the aerospace and defense industries, 4.5 times more than that of the chemicals industry, and 2.5 times more than that of the software and computer services industry”(IFPMA, 2012). IMPACT ON GLOBAL HEALTH & ECONOMY Pharmaceuticals research and drugs showed a remarkable performance in...
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...Diabetes and the Older Adult Christine McDermott Metro State University of Denver DIABETES AND THE OLDER ADULT General description of the Gerontological care issue The ageing population is unusually increasing in the history of humanity. With increase in number of the older persons, there is a decline in that of the younger people and it is estimated that by 2050 the percentage of the older persons would have increase by 10% from the current 15% (Cisneros & Hickie, 2012). These changes come with major challenges not only to the health sector, but also to the pension and welfare system in both the first and second world countries. Diabetes mostly among the old people is continuously being diagnosed in an epidemic magnitude. It is estimated to affect 592 million people in 2035 compared to 382 million people in 2013 (Guariguata et. al 2012). Type 2 diabetes is mainly more prevalent in the ageing population compared to type one diabetes, which affects mostly the going thus creating burden to the society as the sick mostly depend on the society. China is the leading country with the largest number of people with diabetes, followed by India, the United States, brazil and Mexico in the fifth position. These statistics bring about a considerable concern for the national healthcare system which come with various challenges in provision of focused diabetes management to the ageing population. This problem becomes complex by the different modalities of managing diabetic patients in...
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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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...The author’s intention is to identify an aspect of clinical practice which lends itself to change at a micro level. The definition of a micro-change is an intervention of change aimed at the individual or the way small teams work. The micro-level change is not to be confused with a service change (Walsh, 2009). When considering a change in practice we need to firstly understand why we need to make a change? Secondly when making a change, we need to justify a decision. This can be achieved by exploring the components which encompass decision making within nursing practice. Cullum et al (2007) identifies four requirements:-Clinical experience, valid researched evidence, available resources and lastly but no less important the patient preferences and experiences. The area of clinical practice to be studied is within a community district nursing team consisting of 7 qualified nurses and 3 health care assistants. The location is situated within a seaside town with a large population of over 65 year olds. Through clinical experience, the author has found a flaw in quality of care when nursing staff are using the overview assessment document which has been adapted from the single assessment process produced by the Department of Health (DOH, 2002). When assessing nutrition there is a series of six questions and an asterisk to consider the “Malnutrition Universal Screening Tool” (MUST, 2003) however experience in practice would suggest the tool (MUST, 2003) isn't used and a local...
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...Strategic Management Case study C: GSK, a merger too far? Answer 1: 1. By using Five Force Framework, assess the threat of rivalry and threat of entry in the pharmaceutical industry: Threats of rivalry. When we talk about threats of rivalry we should mention not only the rivalry at the industry but also at the product market level. Industry level The pharmaceutical industry has become increasingly concentrated during last 20 years. Guided by absence of proper R&D facilities, gradual expiry of patents and other reasons, there has been a number of mergers and acquisitions in the industry within last 20 years. This trend is currently shaping the internal rivalry among companies. The major reasons for that are opportunistic financial operations and the creation of synergy. It is worth mentioning that some companies would prefer to merge than to experience hostile takeover. Product market level: The two-tier structure has to be taken into account: patented original brands vs. generics. Original compete mostly on non-price benefits, especially as long as they are patent protected, whereas generic drug are generally driven by price competition. The threats of entry. The threats of entry into the pharmaceutical industry are extremely high. Still, it is considered to be very attractive for the new comers. As an evidence for that, 21 pharmaceuticals are featured in the Fortune 500 companies in return on sales. The pharmaceutical industry has big barriers to prevent new comers from...
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...To locate your exam number, go to www.hamline.edu and follow the steps below. A graphic guide to locating your exam number is attached to these instructions. Click on Logins in the header. Go to Piperline Log in to the secure area Enter your Student ID and PIN Click Student Services Click Registration Click Student Detail Schedule Select the appropriate term from the drop down menu Exam Numbers are listed below Total Credit Hours at the top of the page 2. Confirm that you are using and have typed the correct exam number on your exam document. 3. You may download the exam from the course TWEN site any time after 12:01 a.m. on Monday, April 29, 2013. All exams must be submitted within 72 hours of download. But, in any case, all exams must be submitted by the end of the final exam period, i.e. by 11:59 p.m. on Monday, May 13, 2013. Therefore, you will want to download your exam no later than 11:59 p.m. on Friday, May 10, 2013, to ensure that you have the full allowed 72 hours to complete your exam. 4. Write your answers to BOTH parts of the exam in a word processor. Save your document as a single PDF file before uploading to TWEN. Use your exam number as the name for the PDF file. Instructions Specific to This Examination GENERAL INSTRUCTIONS:...
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...improving Quality and Value in the U.S. Health Care System August 2009 Preamble The Bipartisan Policy Center (BPC) is a public policy advocacy organization founded by former U.S. Senate Majority Leaders Howard Baker, Tom Daschle, Bob Dole, and George Mitchell. Its mission is to develop and promote solutions that can attract the public support and political momentum to achieve real progress. The BPC acts as an incubator for policy efforts that engage top political figures, advocates, academics, and business leaders in the art of principled compromise. This report is part of a series commissioned by the BPC to advance the substantive work of the Leaders’ Project on the State of American Health Care. It is intended to explore policy trade-offs and analyze the major decisions involved in improving health care delivery, and discuss them in the broader context of health reform. It does not necessarily reflect the views or opinions of Senators Baker, Daschle, and Dole or the BPC’s Board of Directors. The Leaders’ Project was launched in March 2008. Co-Directed by Mark B. McClellan and Chris Jennings, its mission is (1) to create a bipartisan plan for health reform that can be used to transform the U.S. health care system, and (2) to demonstrate that health reform is an achievable political reality. Over the course of the project, Senators Baker, Daschle, and Dole hosted public policy forums across the country, and orchestrated a targeted outreach campaign to...
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...to take off those extra pounds. With diets, I am miserable because I am starving all the time, and none of the weight-loss pills seem to work. I might lose a couple pounds, but I never reach my weightloss goals and I usually end up gaining more back. I would give anything to lose this extra 20 pounds, so that I can live a longer, happier life.” — Tamara Jinkens: focus group participant, age 42 Barbara Printup, senior director of marketing for Cambridge Sciences Pharmaceuticals (CSP), listened as overweight focus group participants recounted their lifelong struggles with weight loss. Printup had just been placed in charge of the upcoming U.S. product launch of CSP’s newest prescription drug, Metabical (pronounced Meh-tuh-bye-cal). In clinical trials, Metabical proved to be safe and effective in stimulating weight loss for moderately overweight individuals. CSP was an international health care company with a focus on developing, manufacturing, and marketing products that treat metabolic disorders, gastrointestinal diseases, immune deficiencies, as well as other chronic and acute medical conditions. The company captured over $25 billion in sales in 2007. Printup had over 20 years of experience marketing prescription drugs for CSP. She had led six new drug campaigns and had just concluded work on Zimistat, CSP’s most successful product launch to date. Final FDA approval for Metabical was expected in the coming year, and the product launch was scheduled for January 2009. It was now...
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...pharmaceutical division of XYZ, one of the world’s leading companies in the life science sector, convenes yearly in August to review the composition of the research and development (R&D) project portfolio. It also meets on a monthly basis to monitor the project portfolio and make decisions regarding new developments. According to John Smith, “The PMB is an important decision making body because it shapes the future of the company by determining its product pipeline”. The PMB members include the CEO of XYZ, the CEO of XYZ Pharma, the heads of the different business units, the heads of Development, Research, Global Marketing and Strategic Planning, the regional heads for the US, Europe and Japan and the functional managers for Regulation, Clinical, Licensing, Technical Research and Development, and Patents. The portfolio group, led by John Smith, had analysed the project portfolio carefully and had highlighted several potential threats that required action. According to John, “There will be an indepth discussion of which projects will be allocated additional resources, and at expense of which other projects this will be”. The Pharmaceutical Industry The lion share of the pharmaceutical market is captured by approximately hundred manufacturers, which account for more than 90% of global sales. Exhibit 1 contains the top twenty pharmaceutical companies ranked by sales. Since the mid-1980s, the...
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...pharmaceutical division of XYZ, one of the world’s leading companies in the life science sector, convenes yearly in August to review the composition of the research and development (R&D) project portfolio. It also meets on a monthly basis to monitor the project portfolio and make decisions regarding new developments. According to John Smith, “The PMB is an important decision making body because it shapes the future of the company by determining its product pipeline”. The PMB members include the CEO of XYZ, the CEO of XYZ Pharma, the heads of the different business units, the heads of Development, Research, Global Marketing and Strategic Planning, the regional heads for the US, Europe and Japan and the functional managers for Regulation, Clinical, Licensing, Technical Research and Development, and Patents. The portfolio group, led by John Smith, had analysed the project portfolio carefully and had highlighted several potential threats that required action. According to John, “There will be an indepth discussion of which projects will be allocated additional resources, and at expense of which other projects this will be”. The Pharmaceutical Industry The lion share of the pharmaceutical market is captured by approximately hundred manufacturers, which account for more than 90% of global sales. Exhibit 1 contains the top twenty pharmaceutical companies ranked by sales. Since...
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...pharmaceutical division of XYZ, one of the world’s leading companies in the life science sector, convenes yearly in August to review the composition of the research and development (R&D) project portfolio. It also meets on a monthly basis to monitor the project portfolio and make decisions regarding new developments. According to John Smith, “The PMB is an important decision making body because it shapes the future of the company by determining its product pipeline”. The PMB members include the CEO of XYZ, the CEO of XYZ Pharma, the heads of the different business units, the heads of Development, Research, Global Marketing and Strategic Planning, the regional heads for the US, Europe and Japan and the functional managers for Regulation, Clinical, Licensing, Technical Research and Development, and Patents. The portfolio group, led by John Smith, had analysed the project portfolio carefully and had highlighted several potential threats that required action. According to John, “There will be an indepth discussion of which projects will be allocated additional resources, and at expense of which other projects this will be”. The Pharmaceutical Industry The lion share of the pharmaceutical market is captured by approximately hundred manufacturers, which account for more than 90% of global sales. Exhibit 1 contains the top twenty pharmaceutical companies ranked by sales. Since the mid-1980s, the...
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...Pharmaceuticals and Life Sciences Global pharma looks to India: Prospects for growth Table of contents Introduction 03 Background 04 A fast growing economy An expanding pharmaceutical market Government-provided healthcare improving, but private healthcare dominates Domestic market overview 09 Background Consolidation underway, despite challenges Contract manufacturing Vaccines Over the counter market holds significant potential Reaching the untapped rural market Growing Research & Development 15 Overview Clinical trials Biotech and biosimilars on track for growth Other growth areas Bioinformatics 20 Stem cell research Medical devices Global Pharma’s evolving business models and options in India 23 Background Export-oriented business (Contract Research and Manufacturing Services) Licensing Franchising Joint ventures Wholly-owned subsidiaries Practical concerns 27 Infrastructure Tax environment Counterfeiting Intellectual property Conclusion 30 Related reading: Pharma 2020 31 References 32 Acronyms 38 Introduction The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate...
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