Sign Risk-sharing Contract with Contract Manufacturing Organizations in Pharmaceutical Industry
Sign Risk-sharing Contract with Contract Manufacturing Organizations in Pharmaceutical Industry

Author: Youyang Gao

Publisher:

Published: 2014

Total Pages:

ISBN-13:

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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.

Contract Manufacturing of Medicines
Contract Manufacturing of Medicines

Author: Magdalena Krekora

Publisher: Kluwer Law International B.V.

Published: 2008-01-01

Total Pages: 462

ISBN-13: 9041126422

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Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and• definition of and‘medicineand’ in different jurisdictions; and• categories of medicines; and• manufacturing and importation regulation in numerous jurisdictions worldwide; and• inspection regimes; and• good manufacturing practice (GMP); and• marketing authorization; and• manufacturing documentation; and• complaints and product recall; and• liability insurance; and• protection of trade secrets; and• data exclusivity and data protection; and• deficiencies and delays; and and• recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.

Modeling Pharmaceutical Risk-Sharing Agreements
Modeling Pharmaceutical Risk-Sharing Agreements

Author: Reza Mahjoub

Publisher:

Published: 2014

Total Pages:

ISBN-13:

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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?

Risk-sharing in the Pharmaceutical Industry
Risk-sharing in the Pharmaceutical Industry

Author: Gerrit Reepmeyer

Publisher: Springer Science & Business Media

Published: 2006-02-25

Total Pages: 306

ISBN-13: 379081668X

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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.

Making Medicines Affordable
Making Medicines Affordable

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-03-01

Total Pages: 235

ISBN-13: 0309468086

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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.

Conflict of Interest in Medical Research, Education, and Practice
Conflict of Interest in Medical Research, Education, and Practice

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-09-16

Total Pages: 436

ISBN-13: 0309145449

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Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Wiley Pathways Health Care Economics
Wiley Pathways Health Care Economics

Author: Thomas E. Getzen

Publisher: John Wiley & Sons

Published: 2007-01-22

Total Pages: 390

ISBN-13: 0471790761

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Becoming a manager of a health care organization requires a broad understanding of the field. This includes a strong grasp of the economics involved in the daily operation of the organization. Providing an accessible introduction to important economic concepts in the field, this book will help readers gain the knowledge to run an organization. Getzen breaks down difficult topics while explaining the importance of economics in the function of the health care system.

Continuous Manufacturing of Pharmaceuticals
Continuous Manufacturing of Pharmaceuticals

Author: Peter Kleinebudde

Publisher: John Wiley & Sons

Published: 2017-09-05

Total Pages: 645

ISBN-13: 1119001323

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A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

PBMs
PBMs

Author: Sheila Shulman

Publisher: CRC Press

Published: 1998-06-18

Total Pages: 216

ISBN-13: 9780789005120

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PBMs: Reshaping the Pharmaceutical Distribution Network provides HMOs and other third-party payers with information on the new and increasingly important role of pharmaceutical benefit companies (PBMs) in the health care industry. From this text, you will learn how PBMs can maintain and deliver a quality, cost-effective drug benefit plan to your company while achieving the anticipated market share for the product. PBMs: Reshaping the Pharmaceutical Distribution Network offers you suggestions on how to choose which PBM service is correct for your business, such as what qualifications to look for in a PBM, as well as what questions you should ask a respective company. This text also offers ways on how your company can benefit from becoming a client and may make your business more competitive in the pharmaceutical industry. PBMs: Reshaping the Pharmaceutical Distribution Network also informs you about the controversies that have arisen concerning the new position of PBMs in the industry. Through research and evaluation, this text addresses these issues from many different perspectives and gives you insight into other topics concerning PBMs, including: operating methods that PBMs currently rely on for designing and overseeing a drug benefit plan how the Food and Drug Administration currently views the role of PBMs and why they are contemplating regulatory intervention alerting PBMs, pharmacies, pharmaceutical companies, and managed care organizations to new legal issues involving fraud and abuse affecting pharmacy benefit management and pharmaceutical manufacturers reasons why retail drug chains and pharmacist organizations oppose recent industry developments regarding PBMs whether or not PBMs reflect a move toward greater centralized decisionmaking in the health care systemIn addition, PBMs: Reshaping the Pharmaceutical Distribution Network offers pharmaceutical companies, health care providers, and managed care organizations several suggestions for further research, which may make your business or your business relationships more efficient and productive in the future. If you or your company are considering the services of a pharmacy benefit management, PBMs: Reshaping the Pharmaceutical Distribution Network will guide you in choosing a company that helps you deliver the most cost-effective and efficient pharmaceutical benefits to customers.