The Effects of Licensing and Equity Financing Cycles on Pharmaceutical Development

The Effects of Licensing and Equity Financing Cycles on Pharmaceutical Development

Author: Jonathan Douglas Alspaugh

Publisher:

Published: 2010

Total Pages: 50

ISBN-13:

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The purpose of this paper is to examine the interactions between licensing status, equity issuance cycles, and drug development success at the small pharmaceutical companies that originate these development projects. Specifically, this paper is aimed at identifying how financing alternatives available to small pharmaceutical companies influence development success and firm behavior. The hypotheses developed and tested in this paper are as follows: H 1: Pharmaceutical development projects that are licensed are more likely to advance to the next stage in the clinical development process. H2: A licensed pharmaceutical development projects' likelihood of advancing to the next stage of the clinical development process will depend on the amount of equity issuance during the period in which the project was licensed. H3: Pharmaceutical development projects that are licensed during periods of low equity issuance are more likely to advance to the next stage in the clinical development process than projects that were not licensed or were licensed but not in a low equity issuance period. H4: Pharmaceutical development projects that originate at firms that have multiple projects in development at the beginning of a particular clinical trial stage are less likely to advance from phase I to phase II, but more likely to advance in later stages. H5: Pharmaceutical development projects that originate at firms that have previously launched a project in the market are more likely to be launched in the market. The results of a logistic regression analysis suggest that drugs licensed in periods of lowest equity issuance exhibit a higher rate of advancement from phase II to phase III. The relationship between advancement and amount of equity issuance at the time of licensing suggests that the lower the equity issuance in the licensing period the more likely the drug will advance. These results point to the possible existence of a "lemons" phenomenon in the market for pharmaceutical development projects. However, a different interpretation of the results suggests that large pharmaceutical company licensees are superior evaluators of quality and are perhaps more selective and opportunistically license higher quality drugs when equity issuance is low and licensors have no other financing options. Both interpretations point to the issue of information asymmetry as a central theme to this work.


Research and Development in the Pharmaceutical Industry (A CBO Study)

Research and Development in the Pharmaceutical Industry (A CBO Study)

Author: Congressional Budget Office

Publisher: Lulu.com

Published: 2013-06-09

Total Pages: 65

ISBN-13: 1304121445

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Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...


Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1990-02-01

Total Pages: 241

ISBN-13: 0309042860

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The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.


Alzheimer's Disease Drug Development

Alzheimer's Disease Drug Development

Author: Jeffrey Cummings

Publisher: Cambridge University Press

Published: 2022-03-31

Total Pages: 575

ISBN-13: 1108838669

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Provides a definitive overview of the complex ecosystem facilitating Alzheimer's Disease drug research and development. Demonstrates a drug's journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.


Economic Dimensions of Personalized and Precision Medicine

Economic Dimensions of Personalized and Precision Medicine

Author: Ernst R. Berndt

Publisher: University of Chicago Press

Published: 2019-04-22

Total Pages: 361

ISBN-13: 022661123X

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Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement of PPM is a challenge in traditional clinical, reimbursement, and regulatory landscapes because it is costly to develop and introduces a wide range of scientific, clinical, ethical, and socioeconomic issues. PPM raises a multitude of economic issues, including how information on accurate diagnosis and treatment success will be disseminated and who will bear the cost; changes to physician training to incorporate genetics, probability and statistics, and economic considerations; questions about whether the benefits of PPM will be confined to developed countries or will diffuse to emerging economies with less developed health care systems; the effects of patient heterogeneity on cost-effectiveness analysis; and opportunities for PPM’s growth beyond treatment of acute illness, such as prevention and reversal of chronic conditions. This volume explores the intersection of the scientific, clinical, and economic factors affecting the development of PPM, including its effects on the drug pipeline, on reimbursement of PPM diagnostics and treatments, and on funding of the requisite underlying research; and it examines recent empirical applications of PPM.


Licensing, Selling and Finance in the Pharmaceutical and Healthcare Industries

Licensing, Selling and Finance in the Pharmaceutical and Healthcare Industries

Author: Martin Austin

Publisher: Routledge

Published: 2016-05-06

Total Pages: 191

ISBN-13: 1317105311

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Licensing, Selling and Finance in the Pharmaceutical and Healthcare Industries is an assessment of the turbulent state of pharmaceutical and biotechnology markets as we enter the second decade of the 21st Century. At the same time, the book offers a cautionary evaluation of the future financing of innovation in terms of what's gone wrong and how to succeed in the future. Martin Austin explores the challenge that the pharmaceutical (and related) industries face in terms of balancing short term, cost containment and expenditure control in areas such as internal research and development; whilst embracing in-licensing and the acquisition of innovative therapies to counteract their impending portfolio weaknesses in the mid to longer term. The first part of the book provides an engaging and convincing perspective on the context in which the industry currently finds itself; the second part is a pragmatic guide to commercialising your intellectual property; including how to recognise and value what you have as well as the new ways of working that you will need to adopt when negotiating, collaborating and contracting in partnership and alliance with others. Commentators have described in great detail the cocktail of commercial, clinical and social issues that threaten to overwhelm the pharmaceutical industry; Martin Austin's book offers a very distinctive perspective on these issues and their solution.


Sharing Clinical Trial Data

Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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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.


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.


From Breakthrough to Blockbuster

From Breakthrough to Blockbuster

Author: Donald L. Drakeman

Publisher: Oxford University Press

Published: 2022-02-14

Total Pages: 241

ISBN-13: 0197626300

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Financial Times Business Top Title March 2022 How could a large collection of small companies, most with fewer than 50 employees, rise to compete with Big Pharma, one of the world's most breathtakingly expensive and highly regulated industries? Beginning in the 1970s, several scientific breakthroughs promised to transform the creation of new medicines. As investors sought to capitalize on these Nobel Prize-winning discoveries, the biotech industry grew to thousands of small companies around the world. Each sought to emulate what the major pharmaceutical companies had been doing for a century or more, but without the advantages of scale, scope, experience, and massive resources. Biotech companies have met the challenge by creating nearly 40% more of the most important treatments for previously unmet medical needs. Moreover, they have done so with much lower overall costs. From Breakthrough to Blockbuster: The Business of Biotechnology focuses on both the companies themselves and the broader biotech ecosystem that supports them. It paints a portrait of the crucial roles played by academic research, venture capital, contract research organizations, the capital markets, and pharmaceutical companies, demonstrating how a supportive environment enabled the entrepreneurial biotech industry to create novel medicines with unprecedented efficiency. In doing so, it also offers insights for any industry seeking to innovate in uncertain and ambiguous conditions.


Rare Diseases and Orphan Products

Rare Diseases and Orphan Products

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-04-03

Total Pages: 442

ISBN-13: 0309158060

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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.