...The Business of Developing New Drugs for Cancer Larry Cephas Strayer University Developing new drugs for cancer and or any other medical purpose is a tedious, complex, expensive process. The process in developing new drugs involves numerous stages of trial and error. According to Mahajan and Gupta (2010) on average it can cost anywhere from US$ 802million to US$ 1billion dollars to successfully develop and market new drugs and, that process can take up to 12years with on average of only 8% of them ever hitting the market. From the beginning of civilization, people have been concerned regarding the quality and safety of medicines, which I do not fault anyone because, some medicines just do not work out to be very effected and good for the human body. My purpose of this white paper is to inform you and outline the various steps and procedures that goes into developing these new drugs for cancer, the economic issues people with face today, the special needs being served and the benefits of these new drugs and methods of how they are being developed, and finally based on my research the end result once these newly developed drugs reach the consumers. The Development of New Drugs The steps involved in developing new drugs for cancer patients are very complex (Figure 1). According to a fact sheet released by the California Biomedical Research Association there are several steps taken when developing a new drug. The first step involved is the preclinical research, in which scientist...
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...affected by it. There are many companies involved in the research and development of new drugs for the treatment of cancer patients, many of which hope to one day accomplish the ultimate goal of curing this atrocious disease. The process of developing the drugs that treat cancer is a long and meticulous one. In order for a new treatment to become available to patients, it must first go through a series of experiments. When a company wants to market a new drug to the public, it submits an NDA (New Drug Application) to the FDA for review. The company must prove through this application that the drug has been tested and is safe and effective (1.). But, even though it may pass as a safe drug to distribute, in the best interests of the developing company, it must also be economically cost effective. When developing a new treatment for cancer patients, some companies come across treatments that come from the hormones of animals. In cases like this, harvesting the animals for these hormones becomes an economic issue. How much will it cost to farm the animal? How can we harvest the hormone without seriously damaging the population? An example of how to solve this problem comes from the story of a drug developed for the treatment of Osteoporosis called calcitonin. Calcitonin is a hormone found in salmon; similar to one found in humans, that strengthens bones. But, likely because the company developing the...
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...The potential risk involved in bringing a new pharmaceutical drug to the market is huge. The actual timescale of the project is longer then a decade, and the success rate is around 1 in a 1000. In fact for every 1000 compounds that are produced only around 30 of these show any sort of promising result. Therefore introducing a new drug into the market does not simply involved one idea and one compound but in fact a complexed process of trial and error so to speak. After years of research on difference compounds have taken place the company can then progress to a stage know as the ‘preclinical stage’. This is where animals are tested upon and it is also the initial stage in the labs. The time scale varies from 3 and a half to four years and the main aim of this stage is to look at the biological activity of the compound and also to evaluate its safety. After the animal testing has been completed they company are not allowed to start testing on humans until their investigational new drug application (IND) has been approved. The company have to file a IND with the FDA, they do so to gain approval to start the next stage, which is on humans. The FDA has 30 days to disapprove. The investigation carried out looks at previous experiments and also information on the new study being evaluated i.e. how is conducting the study, where it is taking place etc. They also look at the chemical structure of the new drug and what its new purpose will be in the market. The next stage of testing...
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...biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Since 2001, the organization has researched, developed and experimentally tested a virus-killing drug called Brincidofovir. Subsequently learning of the existence of the drug, a family requested that the company donate the drug to treat their little boy who contracted a deadly virus after receiving a bone-marrow transplant. The company had distributed the drug during a three year testing period, but as the drug entered the final stages of the federal and drug administration (FDA) approval, the company ceased its compassionate care program. The establishment’s CEO reportedly claimed it has denied hundreds of requests because human testing guidelines mandate two control groups, one that takes the actual drug and the other that takes sugar pills, placing very ill people at-risk because the sugar pill is useless. As a result, the organization focused on getting the drug approved for widespread consumer use which entails denying interim requests for the drug, and presents an ethical dilemma for the company. Chimerix sought the research to find a solution to this ethical dilemma, gauging the social temperature of the people affected and risking the reputation of the organization at whole. Chimerix argued if the drug was made available to this one ill child, it could not ethically justify denying the drug to the hundreds of other ill individuals who...
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...to a large group of customers with a wide range of needs, such as businesses as a whole, men, women, households, or, in the broadest horizontal market, everyone. Documentum was founded in the summer of 1990 by database engineers Howard Shao and John Newton. Documentum leveraged Shao and Newton’s relational database knowledge with software systems dedicated to enterprise document management. Documentum software has the capacity to interface with many operating platforms and manages unstructured content such as technical procedure documents, medical records, financial, and inventory data. During the timeframe examined during the Harvard Business School case “Documentum, Inc.”, Documentum was in “Stage One – Growth” as they were a new industry that offered a superior buyer surplus compared with the available substitutes. This surplus was founded on innovative product features through the management of unstructured document information. Documentum was focused on automating the business processes of large enterprises. As a startup, they were required to bridge the trust gap of that enterprise. It has been noted that firms choosing to implement technology developed by fledgling companies are essentially sticking out their proverbial neck. Firms were required to front significant investment in capital and resources and the failure rates in such automation projects were very high (on the order of 15% - 50% depending on the project). Furthermore, Documentum...
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...Statement of accuracy/certification PI S Data Package/Records THS1 R1 TH THS2 PI R1 THS3 TH R2 TH PI S3 R1 TH R2 TH R3 TH PI S1 S1 S2 S1 S2 S1 S2 S3 Manufacturer Wholesaler Secondary Wholesaler Dispenser Trading partners pass product information and all prior transaction history upon each change of ownership. Electronic Pedigrees in California “Pedigree” means a record, in electronic form, containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, repackagers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution. Pedigree includes: MFR name / address & registration number, drug name, quantity, dosage form and strength, transaction date, invoice number, container size, number of containers, expiry, lot number. California Law – Main features • Unit – case level serialization – Inference = Aggregation by MFRs and anyone downstream opening a case. • ePedigree by change of title – Exception is drop shipments – “buyer” is excluded from pedigree • Certification – Correct information – Penalties...
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...211.22 Responsibilities of quality control unit. | (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. | | Sec. 211.25 Personnel qualifications. | (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations...
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...June 9-13, 2012 – Baltimore, Maryland 2012 ASHP Summer Meeting Management Case Study Submission and Format Guidelines Management Case Studies are 20-minute platform presentations followed by a 10-minute question and answer period. ASHP is seeking management case studies in specific topic areas: • Informatics • Leadership / Administration • Medication Safety • Clinical Conundrums This document will assist you in the preparation of your submission for a Management Case Study (MCS). The number of accepted management case studies will be limited and it is anticipated to be a highly competitive process. Each primary author is allowed only one submission. Due to ACPE Standards regarding active learning, a standard format will be required for final slide presentations which will utilize the learning objectives and self-assessment questions that you prepare for your submission. Thank you for your interest in presenting at the 2012 ASHP Summer Meeting! For assistance with preparing learning objectives and self-assessment questions, visit: http://www.ashp.org/menu/Education/OnlinePrograms.aspx and select ‘Education’ from the drop-down menu What is a Management Case Study? Introduction • The case study method was pioneered by the Harvard Business School in the early 1900s and still stands as a popular and effective teaching strategy in business education. • • The case method relies on information about people and events in a true-to-life situation that represents a problem to be analyzed...
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...Mabion seemed concerned with volume of pooled serum that they would need. They seemed hesitant to make small aliquots. 5) Due to the software used by Mabion, the calibrator curve will contain anchors calibrators. The LLOQ and ULOQ QCs will have a calibrator equivalent. 6) Interference by Hemolysis and Lipemia will be assessed. 7) Specificity will be assessed with recombinant CD20. 8) Mabion indicated that the serum samples from patients contained debris, they have been centrifuging them prior to preforming the MRD. I recommended handling the Cals and QCs the same way as the samples are being handled. I recommended setting the Calibrators, QCs, and samples in a 96 well plate, centrifuge the plate, and then transfer to a new plate prior to the MRD and loading onto the Gyros...
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...trials in Albania. You’ll be able to bring the drug to market faster and cheaper, which will be good for AH Biotech’s employees and investors and good for the millions of people who suffer from anxiety attacks. I don’t agree with this option because even it is good for AH biotech Company, but for those how are in Albania suffering from anxiety attacks will stop there free treatment and cannot afford after marketing the Drug and it will be difficult for them to buy it as they are poor people. 2. Do the clinical trials in the United States. Even though it will certainly be more expensive and time-consuming, you’ll feel as if you’re living up to the part of the Hippocratic Oath that instructed you to “prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.” In my view this is the best option for hassan, even though it is expensive to conduct the tests in the US, because the based clinical studies are far more stronger and in turn will give the company higher returns in the future, also the patients in the US can afford the treatment after the initial free doses are given by the investigators because of the insurance system in place. 3. Do the clinical trials in Albania, and if the drug is approved, use part of the profits to set up a compassionate use program in Albania, even though setting up a distribution system and training doctors to administer the drug, monitor patients for adverse effects, and...
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...capital given the large costs and lengthy time to develop drugs? - New product process: Merck is real fast in marketing drugs, as it develops cross-functional teams and starts marketing early in the development process only - through the new process development Merck is able to stand out in the crowd of pharma company, as its giving a specialized and patented medicine which a patient ccant get from any other pharma company. Besides this, the company manufactures certain hightly critical patented drugs. This helps it to capture the untapped market od such drugs. - Through the late 80's to early 90's, Merck was able to boast profits and sales through biochemistry drugs that were seen as breakthrough drugs in this new market. With this sudden boom competitors started to take notice and emulate Merck's business model. This success also brought up a number of questions within Merck as a company; mainly how was Merck going to keep up with its numbers and keep pumping new drugs into the market. By assessing some strengths, weaknesses, opportunities and threats (SWOT Analysis) of the firm itself and offering some recommendations of how Merck may be able to conquer this challenge, you will be able to conclude that the success of Merck as a company relies heavily on its management and how they adapt the business model that is already in place to that of the ever-changing pharmaceutical industry. - This success of Merck's novelty drugs not only reaffirmed Merck's reputation in the market...
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...content such as technical procedure documents, medical records, financial, and inventory data. During the timeframe examined during the Harvard Business School case “Documentum, Inc.”, Documentum was in “Stage One – Growth” as they were a new industry that offered a superior buyer surplus compared with the available substitutes. This surplus was founded on innovative product features through the management of unstructured document information. Documentum was focused on automating the business processes of large enterprises. As a startup, they were required to bridge the trust gap of that enterprise. It has been noted that firms choosing to implement technology developed by fledgling companies are essentially sticking out their proverbial neck. Firms were required to front significant investment in capital and resources and the failure rates in such automation projects were very high (on the order of 15% - 50% depending on the project). Furthermore, Documentum faced challenges related to their financial viability, product development and testing resources, and their execution experience. Documentum’s primary cost driver was research and development in an amount relating to 328% of sales percentage for 1992. While working on the New Drug Application processing system, Documentum was forced to extend its products core functionality and their system integrator spent several hundred hours customizing the Documentum software in order for it to meet the customer demands. ...
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...or by information storage or retrieval systems, without prior written permission from the Publisher. All rights reserved. Not for commercial use or unauthorized distribution Downloaded from content.healthaffairs.org by Health Affairs on February 29, 2016 at UNIV OF CALIFORNIA Intellectual Property & Innovation By Henry G. Grabowski, Joseph A. DiMasi, and Genia Long 10.1377/hlthaff.2014.1047 HEALTH AFFAIRS 34, NO. 2 (2015): 302–310 ©2015 Project HOPE— The People-to-People Health Foundation, Inc. doi: Henry G. Grabowski (grabow@ econ.duke.edu) is a professor of economics at Duke University, in Durham, North Carolina. Joseph A. DiMasi is director of economic analysis at the Tufts Center for the Study of Drug Development, Tufts University, in...
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...PLIVA, Inc. v. Mensing Doctors prescribed both Gladys Mensing and Julie Demahy the drug Reglan. They each had their prescriptions filled with the generic equivalent of the name brand drug. After long-term use of this generic drug, Mensing and Demahy developed severe neurologic disorders. The women separately sued Pliva and Actavis, the generic drug manufacturers, making state law failure-to-warn claims, alleging that the drug’s warning label failed to adequately warn them of the risks. Pliva and Actavis argue that the federal Food, Drug, and Cosmetic Act, along with Food and Drug Administration regulations that govern the entire drug approval and labeling process, preempt Mensing and Demahy’s state law claims because it was impossible for Pliva and Actavis to comply with both federal and state law. The companies argue that they could not provide additional warnings beyond what the brand manufacturer provided on its label. In deciding this case, the Supreme Court will ultimately have to weigh the costs born by generic drug manufacturers and the public against the benefits of incentivizing manufacturers to create safer drugs with more complete warnings. After taking metaclopramide for several years, both respondents developed tardive dyskinesia and sued the manufacturers of the medication that they took. The suits were based on failure-to-warn theories under state law. The defendant manufacturers in both cases argued that federal statutes and FDA regulations...
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...Merck was founded in 1668 2. Globl drug manufacture in the world 3. Merck’s significant investment in internal research and development (R&D) was a strategic advantage with which few companies could compete 4. Merck’s recent $41 billion “reverse-merger” with Schering-Plough represented a significant step away from a closed R&D model toward a more open innovation strategy. Merck is a global research-driven company that discovers, develops, manufactures, and markets a broad range of innovative products to improve human and animal health. 5. They call The Harvard Pharma, because By 1950, five Merck researchers had won Nobel prizes for their contributions to medicine. Head scientists were successful in the recruitment and retention of superior research personnel because Merck maintained an academic, university-like atmosphere in which scientists were given freedom to explore their personal research interests. 6. Fosamax drugs revention of osteoporosis 7. Recall drugs vioxx 8. The joining of these two former rivals in March 2009 was seen as a necessary step toward diversification and increased economies of scale, propelled by imminent patent expirations and increasing pressure from shareholders, government, and customers to control costs. 9. The deal was structured as a “reverse-merger” to permit SP to bypass a change-of-control clause in a drug partnership it had with Johnson & Johnson (J&J). SP and J&J shared the rights to the blockbuster drugs Remicade and Simponi, 10. Merck...
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