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Author: Gerrit Reepmeyer
Publisher: Springer Science & Business Media
ISBN: 379081668X
Category : Business & Economics
Languages : en
Pages : 306
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Book Description
The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.
Author: Gerrit Reepmeyer
Publisher: Springer Science & Business Media
ISBN: 379081668X
Category : Business & Economics
Languages : en
Pages : 306
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Book Description
The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.
Author: Youyang Gao
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Outsourcing risks problem for the new ethical drugs manufacturing and commercialization is one of the most challenging problems for the pharmaceutical firms due to the big uncertainty of the FDA testing result, fluctuating market performance, changing government and finance environment. Motivated by the need of the ethical drugs risks sharing in the pharmaceutical industry, we are introducing a finite period analysis based on three different types of contracts which distinguished by the level of risk sharing including price discount, quantity flexibility and forecasting methods. These contracts are short term contract, long term time flexible contract and long term time inflexible contract. In order to analyze the performances of risk sharing of those contracts, we use mathematical functions to express the price discount, quantity flexibility and the demand risk and put them into the model of total extra outsourcing cost. By successfully use the concept of the Leibnitz's Rule and newsvendor model, we successfully simplified the problem and classified the level of risk sharing for each contract, and also realized the complexity for those contracts. At the end of this thesis, we use a numerical analysis to give an introduction of how our model could be used in the contract selection. A quantitative solution is followed after that introduction and will select the best contract strategy under certain circumstance. The purpose of this thesis is to generate cost functions for the contracts, and help the firm to select the best contract strategy under different circumstances.
Author: Reza Mahjoub
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Many new and expensive drugs have been introduced in the past 10 years. However, at the time of introduction, the effectiveness of these drugs outside of clinical trials is often unknown. This creates a risk to third-party payers, as the outcome of these drugs in real-world practice is uncertain at the time of introduction. A pay-for-performance risk-sharing agreement is a type of contract that shares part of this risk with the manufacturer by linking the performance of a drug to the manufacturer's revenue. This dissertation consists of three essays to examine the performance of two types of pharmaceutical pay-for-performance risk-sharing agreements. In my first essay I examine the performance of a pay-for-performance risk-sharing agreement in which patients are assessed at some evaluation time to determine their response to the drug. The manufacturer rebates to the payer a proportion of the sales from all patients excluding the sales from those responding at the evaluation time. I model disease progression using a continuous time Markov chain with uncertain transition rates. I address the following questions regarding the performance of this agreement: What is the optimum evaluation time and under what conditions will the manufacturer make a profit? What is the distribution of the manufacturer's profit resulting from different sources of uncertainty? In the second essay I extend the model developed in the first essay to calculate the net monetary benefits of the payer and identify the conditions under which both parties have incentives to introduce the new drug. The third essay focuses on the analysis of a risk-sharing agreement in which patients are prescribed a drug only if their probability of response lies within a range of success probabilities. The payer determines this range such that the use of the drug is cost-effective. I generalize from the existing literature by allowing the rebate to be different from the price of the drug and incorporating two types of administrative costs. I seek to answer two important policy questions: First, under what conditions does the payer benefit from the agreement? Second, under what conditions does the agreement become welfare-improving?
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309268745
Category : Medical
Languages : en
Pages : 157
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Book Description
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.
Author: Ben Goldacre
Publisher: Macmillan
ISBN: 0865478066
Category : Business & Economics
Languages : en
Pages : 479
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Book Description
Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
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Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author: Hamid Mollah
Publisher: John Wiley & Sons
ISBN: 0470552344
Category : Science
Languages : en
Pages : 432
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Book Description
Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.
Author:
Publisher: DIANE Publishing
ISBN: 9780788104688
Category : Drugs
Languages : en
Pages : 380
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Book Description
Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.
Author: Stephen J. Mayall
Publisher: Elsevier
ISBN: 1908818271
Category : Medical
Languages : en
Pages : 435
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Book Description
Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle
