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Pharmaceutical Product Licensing

Pharmaceutical Product Licensing
Author: Brian R. Matthews
Publisher: CRC Press
Total Pages: 383
Release: 1991-05-31
Genre: Medical
ISBN: 113499494X

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Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.


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
Total Pages: 191
Release: 2016-05-06
Genre: Business & Economics
ISBN: 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.


Risk-sharing in the Pharmaceutical Industry

Risk-sharing in the Pharmaceutical Industry
Author: Gerrit Reepmeyer
Publisher: Springer Science & Business Media
Total Pages: 306
Release: 2006-02-25
Genre: Business & Economics
ISBN: 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.


Pharmaceutical Product Licensing

Pharmaceutical Product Licensing
Author: A. C. Cartwright
Publisher: CRC Press
Total Pages:
Release: 1991-05-31
Genre: Medical
ISBN: 9781134994922

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Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.


Determinants of Licensing Decisions

Determinants of Licensing Decisions
Author: Binu Thomas
Publisher:
Total Pages: 0
Release: 2019
Genre:
ISBN:

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There are several determinants that could have an effect on in-licensing decisions by a pharmaceutical or biotech firm. This work studies over 200 licensing deals involving big pharma companies in the period (2011 - 2015) and identifies different factors that could play a role in licensing deals, and classifies these determinants into direct determinants and indirect determinants. The direct determinants are defined as determinants that are directly attributable to the molecule. The direct determinants could be related to the indications, type of molecule, effectiveness, safety dose, presentation, shelf-life, treatment cost, target clinicians, availability, owner, stage of development, patent life, product differentiation, number of competitors offering similar product, or the probability of regulatory and technical success. The indirect determinants include the management, type of organization, size of organization, location of the company, quality of scientific publications, scientific advisory board, and current reputation in a certain therapeutic area, stage of deal, and type of license sought, valuation approach, or up-fronts sought. While direct determinants are widely believed to be directly related to the licensing decisions, we find the indirect determinants also play a significant role in these decisions. This paper studies the recent licensing deals and finds that both internal and indirect determinants need to be focused in licensing efforts.


Determinants of Licensing Deals in Pharmaceutical Industry

Determinants of Licensing Deals in Pharmaceutical Industry
Author: Binu Thomas
Publisher:
Total Pages: 0
Release: 2020
Genre:
ISBN:

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The drug discovery and development are very expensive, risky and time consuming. It requires several years and billions of dollars for developing a drug to the marketplace. Hence, smaller biotech companies seek to out-license or develop their drugs in collaboration with large pharmaceutical companies. On the other hand large pharmaceutical companies are constantly seeking new candidates to fill their product pipelines. From the perspective of a biotech company it is important to choose the licensing partner carefully as it takes several years of commitment and large investments to bring a new drug to the marketplace. However, recent analysis has shown that owing to the buoyant capital environment biotech companies have been able to raise capital and develop drugs to the marketplace. A sample of 101 pharmaceutical companies and 381 licensing deals that were announced in the period 2011-2015 were collected for quantitative analysis using Multilayer Perceptron technique and regression analysis. This study evaluated the five determinants including size of the company, pharmaceutical sales, number of employees, age of the company and pharmaceutical research and development expenditure that would have an effect on the licensing deal. The analysis of the data reveals that while seeking an out-licensing partner, a licensor preferred companies with R & D budget for expenditure and number of employees.


FTO (freedom to Operate) in the Pharmaceutical Industry

FTO (freedom to Operate) in the Pharmaceutical Industry
Author: Hirotaka Nonaka
Publisher: Nomos Verlagsgesellschaft
Total Pages: 0
Release: 2018
Genre: Drug development
ISBN: 9783848752218

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Key features of innovation in the pharmaceutical industry -- How to achieve freedom to operate (FTO) -- Dealing with adverse patents -- Structure and operation of FTO-licensing markets in the parmaceutical industry -- FTO-licensing between a venture business company for innovative drug development and a pharmaceutical company.


Licensing of Drug product for European Union

Licensing of Drug product for European Union
Author: Sandeep Narayan Patil, PMP
Publisher: Notion Press
Total Pages: 206
Release: 2021-05-25
Genre: Medical
ISBN: 1638736723

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This is the second book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book mainly discusses launch of drug products in EU market which are manufactured in countries like India or china by supplier manufacturer. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.