The Funding of Biopharmaceutical Research and Development

The Funding of Biopharmaceutical Research and Development
Author: David R Williams
Publsiher: Elsevier
Total Pages: 284
Release: 2013-10-31
ISBN 10: 1908818387
ISBN 13: 9781908818386
Language: EN, FR, DE, ES & NL

The Funding of Biopharmaceutical Research and Development Book Review:

The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public. Presents a comprehensive view of the funding issues of R&D in this market sector, adopting a theory-to-practice approach A comprehensive and analytical review of the biopharmaceutical R&D literature and practice An overview of the various and competing/complementary theories of the firm and valuation methods as they apply to biopharmaceutical R&D

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology
Author: Institute of Medicine,Committee on Technological Innovation in Medicine
Publsiher: National Academies Press
Total Pages: 224
Release: 1991-02-01
ISBN 10: 030904491X
ISBN 13: 9780309044912
Language: EN, FR, DE, ES & NL

The Changing Economics of Medical Technology Book Review:

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policies--as well as the involvement of numerous government agencies--affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Strategies to Leverage Research Funding

Strategies to Leverage Research Funding
Author: Institute of Medicine,Board on Health Sciences Policy,Medical Follow-Up Agency,Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs
Publsiher: National Academies Press
Total Pages: 192
Release: 2004-11-27
ISBN 10: 0309092779
ISBN 13: 9780309092777
Language: EN, FR, DE, ES & NL

Strategies to Leverage Research Funding Book Review:

Since 1992 the Department of Defense (DOD), through the U.S. Army Medical Research and Material Command, has received congressionally earmarked appropriations for programs of biomedical research on prostate, breast, and ovarian cancer; neurofibromatosis; tuberous sclerosis; and other health problems. Appropriations for these Congressionally Directed Medical Research Programs are used to support peer reviewed extramural research project, training, and infrastructure grants. Congress has become concerned about funding increases for these programs given current demands on the military budget. At the request of Congress, the Institute of Medicine (IOM) examined possibilities of augmenting program funding from alternative sources. The resulting IOM book, Strategies to Leverage Research Funding: Guiding DOD's Peer Reviewed Medical Research Programs, focuses on nonfederal and private sector contributions that could extend the appropriated funds without biasing the peer review project selection process.

Outsourcing Biopharma R D to India

Outsourcing Biopharma R D to India
Author: P R Chowdhury
Publsiher: Elsevier
Total Pages: 130
Release: 2011-05-05
ISBN 10: 1908818018
ISBN 13: 9781908818010
Language: EN, FR, DE, ES & NL

Outsourcing Biopharma R D to India Book Review:

The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services
Publsiher: National Academies Press
Total Pages: 102
Release: 2020-01-27
ISBN 10: 0309498511
ISBN 13: 9780309498517
Language: EN, FR, DE, ES & NL

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access Book Review:

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

PAREXEL s Pharmaceutical R D Statistical Sourcebook

PAREXEL s Pharmaceutical R   D Statistical Sourcebook
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2005
ISBN 10:
ISBN 13: UOM:39015056546677
Language: EN, FR, DE, ES & NL

PAREXEL s Pharmaceutical R D Statistical Sourcebook Book Review:

Outsourcing Biopharma R D to India

Outsourcing Biopharma R D to India
Author: P R Chowdhury
Publsiher: Elsevier
Total Pages: 130
Release: 2011-05-05
ISBN 10: 1908818018
ISBN 13: 9781908818010
Language: EN, FR, DE, ES & NL

Outsourcing Biopharma R D to India Book Review:

The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
Author: J E Aguilar
Publsiher: Elsevier
Total Pages: 304
Release: 2013-09-30
ISBN 10: 1908818506
ISBN 13: 9781908818508
Language: EN, FR, DE, ES & NL

Formulation tools for Pharmaceutical Development Book Review:

A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software. Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicines Development of drugs and medicines using mathematical tools Compilation of expert system developed around the world

Computer Aided Applications in Pharmaceutical Technology

Computer Aided Applications in Pharmaceutical Technology
Author: Jelena Djuris
Publsiher: Elsevier
Total Pages: 300
Release: 2013-04-10
ISBN 10: 1908818328
ISBN 13: 9781908818324
Language: EN, FR, DE, ES & NL

Computer Aided Applications in Pharmaceutical Technology Book Review:

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

An Introduction to Pharmaceutical Sciences

An Introduction to Pharmaceutical Sciences
Author: Jiben Roy
Publsiher: Elsevier
Total Pages: 446
Release: 2011-07-25
ISBN 10: 1908818042
ISBN 13: 9781908818041
Language: EN, FR, DE, ES & NL

An Introduction to Pharmaceutical Sciences Book Review:

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences. This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry. A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

The Bullion

The Bullion
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1999
ISBN 10:
ISBN 13: STANFORD:36105121679521
Language: EN, FR, DE, ES & NL

The Bullion Book Review:

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publsiher: National Academies Press
Total Pages: 442
Release: 2011-04-03
ISBN 10: 0309158060
ISBN 13: 9780309158060
Language: EN, FR, DE, ES & NL

Rare Diseases and Orphan Products Book Review:

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Social Aspects of Drug Discovery Development and Commercialization

Social Aspects of Drug Discovery  Development and Commercialization
Author: Odilia Osakwe,Syed A.A. Rizvi
Publsiher: Academic Press
Total Pages: 324
Release: 2016-02-18
ISBN 10: 0128024976
ISBN 13: 9780128024973
Language: EN, FR, DE, ES & NL

Social Aspects of Drug Discovery Development and Commercialization Book Review:

Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society. Organized in a sequence of interrelated theories and principles that provide the foundation for increased understanding of the relevant social aspects Includes analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development Provides a global perspective with examples from developed areas, such as the US, Japan, Canada and Europe, as well as faster-growing and emerging economies including Brazil, Russia, India, and China Serves as an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
Author: Anonim
Publsiher: John Wiley & Sons
Total Pages: 744
Release: 2013-09-19
ISBN 10: 1118659988
ISBN 13: 9781118659984
Language: EN, FR, DE, ES & NL

Biotechnology and Biopharmaceuticals Book Review:

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

PAREXEL s Bio pharmaceutical R D Statistical Sourcebook

PAREXEL s Bio pharmaceutical R   D Statistical Sourcebook
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2006
ISBN 10:
ISBN 13: UOM:39015064922456
Language: EN, FR, DE, ES & NL

PAREXEL s Bio pharmaceutical R D Statistical Sourcebook Book Review:

Re inventing Drug Development

Re inventing Drug Development
Author: Jeffrey S. Handen
Publsiher: CRC Press
Total Pages: 152
Release: 2014-10-28
ISBN 10: 1466579986
ISBN 13: 9781466579989
Language: EN, FR, DE, ES & NL

Re inventing Drug Development Book Review:

The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation. The most successful products are losing patent protection, and pipelines have been unable to fill the gap. This book explores the evolving definition of innovation in therapeutic product development and begins to examine its effects on the life sciences R&D industry. Historically, scientific innovation alone was sufficient to maintain ROI and deliver on unmet medical needs. However, with many forces now conspiring to increase pressures on the commoditization of drug development, industry support for truly novel, often high-risk development has eroded. This calls for a drastic redefinition of what "innovation" is. While innovation in the pharmaceutical R&D industry has historically been applied to major advances in therapy and unmet medical needs, we now need to see innovation increasingly defined in terms of financial, marketing (e.g. branded generics and emerging markets), pharmacoeconomic, and operational innovation. In this book, contributors drawn from the executive ranks of clinical development practitioners and stakeholders—from biopharmaceutical companies, clinical research organizations, academia, the financial community, and the patient perspective—have all come together to provide their expertise and visions. Their goal is to start a dialogue about ways to radically improve therapeutics development and get more and better medicines to the patients who need them, as fast as possible, in the most cost-efficient manner.

Financing Vaccines in the 21st Century

Financing Vaccines in the 21st Century
Author: Institute of Medicine,Board on Health Care Services,Committee on the Evaluation of Vaccine Purchase Financing in the United States
Publsiher: National Academies Press
Total Pages: 264
Release: 2003-12-10
ISBN 10: 9780309133258
ISBN 13: 0309133254
Language: EN, FR, DE, ES & NL

Financing Vaccines in the 21st Century Book Review:

The national immunization system has achieved high levels of immunization, particularly for children. However, this system faces difficult challenges for the future. Significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations. These disparities result, in part, from fragmented publicâ€"private financing in which a large number of children and adults face limited access to immunization services. Access for adults lags well behind that of children, and rates of immunizations for those who are especially vulnerable because of chronic health conditions such as diabetes or heart and lung disease, remain low. Financing Vaccines in the 21st Century: Assuring Access and Availability addresses these challenges by proposing new strategies for assuring access to vaccines and sustaining the supply of current and future vaccines. The book recommends changes to the Advisory Committee on Immunization Practices (ACIP)-the entity that currently recommends vaccines-and calls for a series of public meetings, a post-implementation evaluation study, and development of a research agenda to facilitate implementation of the plan.

Health at a Glance 2019 OECD Indicators

Health at a Glance 2019 OECD Indicators
Author: OECD
Publsiher: OECD Publishing
Total Pages: 220
Release: 2019-11-07
ISBN 10: 9264807667
ISBN 13: 9789264807662
Language: EN, FR, DE, ES & NL

Health at a Glance 2019 OECD Indicators Book Review:

Health at a Glance compares key indicators for population health and health system performance across OECD members, candidate and partner countries. It highlights how countries differ in terms of the health status and health-seeking behaviour of their citizens; access to and quality of health care; and the resources available for health. Analysis is based on the latest comparable data across 80 indicators, with data coming from official national statistics, unless otherwise stated.

Making Medicines Affordable

Making Medicines Affordable
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies
Publsiher: National Academies Press
Total Pages: 234
Release: 2018-03-01
ISBN 10: 0309468086
ISBN 13: 9780309468084
Language: EN, FR, DE, ES & NL

Making Medicines Affordable Book Review:

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.

Value Creation in the Pharmaceutical Industry

Value Creation in the Pharmaceutical Industry
Author: Alexander Schuhmacher,Markus Hinder,Oliver Gassmann
Publsiher: John Wiley & Sons
Total Pages: 508
Release: 2016-04-11
ISBN 10: 3527339132
ISBN 13: 9783527339136
Language: EN, FR, DE, ES & NL

Value Creation in the Pharmaceutical Industry Book Review:

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.