Scientific Due Diligence

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Scientific Due Diligence

Author : Nathan Martinsberg
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781717537676
Total Pages : 182 pages
Book Rating : 4.5/5 (376 download)

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Book Synopsis Scientific Due Diligence by : Nathan Martinsberg

Download or read book Scientific Due Diligence written by Nathan Martinsberg and published by Createspace Independent Publishing Platform. This book was released on 2018-05-03 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many a blockbuster drug began in the mind of a single entrepreneur. From start-ups to spin-offs, there are no lack of options for a company or venture capitalist to license or invest into. But how can you know that this is the correct investment? The correct option to choose? The one which will lead to financial success and a nice end-of-year bonus? This is where scientific due diligence comes in, the independent, realistic and critical review of a potential technology. From early development data through to clinical study results, patents to competitor analysis, the due diligence process is essential for any investment decision. We have developed this handbook to guide investors and due diligence investigators through the minefield of scientific due diligence in the pharmaceutical world. It covers best-practice approaches, traps to avoid, and the most important areas to focus your limited time on. Investing in pharma? Then this is the book for you. --- Book contents --- The book has been divided into sections which cover the entire due diligence process. The first section covers the basics of due diligence: - Chapter 1 introduces due diligence investigations, including the attributes of good due diligence investigators, the basic rules to follow, and commonly-seen licensing approaches. - Chapter 2 covers the initial steps of assessment, including the preliminary screening for potential licenses and the secondary screen to identify true opportunities. - Chapter 3 shows the preparation for the on-site scientific due diligence investigation, including typical organisational tasks and team set-up. Next, the specific requirements for each area of expertise are covered in more depth: - Chapter 4 covers the investigation from the regulatory affairs perspective, including factors such as approval risk, regulatory planning, and useful special pathways. - Chapter 5 deals with quality, the assurance that the technology has been developed and manufactured to the required quality levels. The chapter covers typical GMP documents and important GxP requirements which will need to be verified. - Chapter 6 covers chemistry, manufacturing and control, the details of the product and the production process. This includes manufacturing-site specific documents and the process development and validation requirements. - Chapter 7 describes preclinical trials, the preliminary work prior to human testing. This includes approaches for evaluating preclinical studies as well as more specific information for toxicology and pharmacology work. - Chapter 8 involves clinical trials, the most important test of any new drug. This section covers both general trial requirements as well as those specific to individual clinical phases. - Chapter 9 deals with marketing, the ability to sell the new product. This includes determining market position, analysing potential competitors, and determining reimbursement options. - Chapter 10 describes the intellectual property factors which may be involved, covering both patenting and data exclusivity approaches to IP protection. - Chapter 11 finishes the scientific due diligence process by providing the final set of questions to ask prior to making the final recommendation. Finally the five appendices provide reference information which will help when conducting a due diligence investigation, from example checklists to work from through to advice for when you are being audited.

Venture Capital Due Diligence

Author : Justin J. Camp
Publisher : John Wiley & Sons
ISBN 13 : 9780471126508
Total Pages : 294 pages
Book Rating : 4.1/5 (265 download)

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Book Synopsis Venture Capital Due Diligence by : Justin J. Camp

Download or read book Venture Capital Due Diligence written by Justin J. Camp and published by John Wiley & Sons. This book was released on 2002-02-21 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due Diligence ist ein Prüfverfahren, mit dessen Hilfe Investoren die wirtschaftliche und finanzielle Situation des zu finanzierenden Unternehmens genau durchleuchten, um solide Investmententscheidungen zu treffen. "Venture Capital Due Diligence" ist ein praktischer Leitfaden zum Due Diligence Prozess. Er erläutert ausführlich das strenge Regelwerk dieses Prüfverfahrens und zeigt dem Leser, wie er diese Technik in der Praxis einsetzt, um damit Investmentchancen zu bewerten und die Rentabilität seiner Kapitalanlage (ROI - Return on Investment) einzuschätzen. Mit Tipps, Ratschlägen und Checklisten, die von den international erfolgreichsten Wagniskapitalgebern zusammengestellt wurden sowie einem Fragenkatalog, der die wichtigsten Kriterien des Due Diligence Prozesses beinhaltet. "Venture Capital Due Diligence" ist ein unentbehrlicher Ratgeber für alle Venture Capitalists, professionelle Investoren und Finanzgeber.

Dreams and Due Diligence

Author : Joe Sornberger
Publisher : University of Toronto Press
ISBN 13 : 1442694130
Total Pages : 185 pages
Book Rating : 4.4/5 (426 download)

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Book Synopsis Dreams and Due Diligence by : Joe Sornberger

Download or read book Dreams and Due Diligence written by Joe Sornberger and published by University of Toronto Press. This book was released on 2011-10-05 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: In proving the existence of stem cells, Ernest Armstrong McCulloch and James Edgar Till formed the most important partnership in Canadian medical research since Frederick Banting and Charles Best, the discoverers of insulin. Together, Till and McCulloch instructed, influenced, and inspired successive generations of researchers who have used their findings to make huge advances against disease. Thousands of people who would have died from leukemia and immunological disorders now owe their lives to therapies developed from their discoveries. Despite their accomplishments, Till and McCulloch remain largely unknown, and until now, their story has remained untold. Dreams and Due Diligence vividly chronicles the work of two researchers who made medical history – two men who possessed exactly the right complementary talents to achieve greatness and win nearly every award available in medical research. Bringing their legacy to life for the first time, Joe Sornberger provides a dramatic account of the development of stem cell research, one of today's most ground-breaking medical scientific fields.

Due Diligence Handbook

Author : Linda S Spedding
Publisher : Elsevier
ISBN 13 : 0750686219
Total Pages : 749 pages
Book Rating : 4.7/5 (56 download)

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Book Synopsis Due Diligence Handbook by : Linda S Spedding

Download or read book Due Diligence Handbook written by Linda S Spedding and published by Elsevier. This book was released on 2009 with total page 749 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Due Diligence Handbook provides business directors with a practical and authoritative guidance to minimising financial and legal risks, as well as risks to reputation. The book brings together practical information on relevant legislation, regulations, codes and best practice guidance in one volume." "The book provides clear guidance and case studies to help understand the complexity of due diligence issues, and to demonstrate the detailed work that is necessary to ensure that the benefits of an acquisition can be realised and that there are no unexpected problems."--BOOK JACKET.

Due Diligence and Corporate Governance

Author : Linda S Spedding
Publisher : Elsevier
ISBN 13 : 9780754526223
Total Pages : 542 pages
Book Rating : 4.5/5 (262 download)

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Book Synopsis Due Diligence and Corporate Governance by : Linda S Spedding

Download or read book Due Diligence and Corporate Governance written by Linda S Spedding and published by Elsevier. This book was released on 2005-03-07 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical title covers broadly the subject of due diligence - used to provide a framework for helping businesses avoid reputational, environmental and social hazards. Straightforward and clearly written, Due Diligence and Corporate Governance is a unique title which covers all aspects of new due diligence in one book. Taking a risk-based approach, this essential reference book for company secretaries, directors and managers, includes checklists to monitor risk management, explains best practice illustrated with practical examples and diagrams, and explains in a user-friendly way exactly how to get it right. LexisNexis UK and CIMA Publishing are offering CIMA members a discount on this product. Please go to www. lexisnexis. co. uk/cimapublishing to see if you qualify and to order.

Technology Due Diligence: Best Practices for Chief Information Officers, Venture Capitalists, and Technology Vendors

Author : Andriole, Stephen J.
Publisher : IGI Global
ISBN 13 : 1605660191
Total Pages : 422 pages
Book Rating : 4.6/5 (56 download)

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Book Synopsis Technology Due Diligence: Best Practices for Chief Information Officers, Venture Capitalists, and Technology Vendors by : Andriole, Stephen J.

Download or read book Technology Due Diligence: Best Practices for Chief Information Officers, Venture Capitalists, and Technology Vendors written by Andriole, Stephen J. and published by IGI Global. This book was released on 2008-08-31 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due diligence conducted around technology decisions is complex. Done correctly, it has the power to enable outstanding positive outcomes; done poorly, it can wreak havoc on organizations, corporate cultures, and markets. Technology Due Diligence: Best Practices for Chief Information Officers, Venture Capitalists, and Technology Vendors develops a due diligence framework for anyone resolving technology decisions intended to help their business achieve positive results. This essential book contains actual case studies that incorporate the due diligence methodology to assist chief information officers, venture capitalists, and technology vendors who wrestle with technology acquisitions challenges on a daily basis.

Preserving the Promise

Author : Scott Dessain
Publisher : Academic Press
ISBN 13 : 0128092092
Total Pages : 277 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Preserving the Promise by : Scott Dessain

Download or read book Preserving the Promise written by Scott Dessain and published by Academic Press. This book was released on 2016-10-05 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preserving the Promise: Improving the Culture of Biotech Investment critically examines why most biotech startups fail, as they emerge from universities into an ecosystem that inhibits rather than encourages innovation. This "Valley of Death" squanders our public investments in medical research and with them, the promise of longer and healthier lives. The authors explicate the Translation Gap faced by early stage biotech companies, the result of problematic technology transfer and investment practices, and provide specific prescriptions for improving translation of important discoveries into safe and effective therapies. In Preserving the Promise, Dessain and Fishman build on their collective experience as company founders, healthcare investor (Fishman) and physician/scientist (Dessain). The book offers a forward-looking, critical analysis of "conventional wisdom" that encumbers commercialization practices. It exposes the self-defeating habits of drug development in the Valley of Death, that waste money and extinguish innovative technologies through distorted financial incentives. - Explains why translation of biotech discovery into medicine succeeds so infrequently that it's been dubbed the Valley of Death - Uncovers specific decision-making strategies that more effectively align incentives, improving clinical and financial outcomes for investors, inventor/entrepreneurs, and patients - Examines the critical, early stages of commercialization, where technology transfer offices and Angels act as gatekeepers to development, and where tension between short-term financial and long-term clinical aspirations sinks important technologies - Deconstructs the forces driving biotech, recasts them in a proven conceptual framework, and offers practical guidance for making the system better

Due Diligence

Author : William J. Gole
Publisher : John Wiley & Sons
ISBN 13 : 0470375906
Total Pages : 304 pages
Book Rating : 4.4/5 (73 download)

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Book Synopsis Due Diligence by : William J. Gole

Download or read book Due Diligence written by William J. Gole and published by John Wiley & Sons. This book was released on 2009-08-03 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: This nuts-and-bolts guide examines all aspects of an M&A due diligence--from coming to the decision to acquire a company, to who should be on the due diligence team, to the actual process and the final report and post-closing follow up. It advocates a focus on both risk mitigation and shareholder value creation, and emphasizes a holistic approach that spans from planning to post-acquisition integration. The tentative contents is: (1) Introduction; (2) Planning for value creation: growth strategy; (3) Engagement and pursuit; (4) Preparing for due diligence; (5) Validation of value: performing due diligence; (6) Assessment of due diligence results; (7) Optimizing value: post diligence negotiation; (8) Extracting value: post-transaction integration.

Hedge Fund Due Diligence

Author : Randy Shain
Publisher : John Wiley & Sons
ISBN 13 : 1118039246
Total Pages : 348 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Hedge Fund Due Diligence by : Randy Shain

Download or read book Hedge Fund Due Diligence written by Randy Shain and published by John Wiley & Sons. This book was released on 2010-12-16 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hedge Fund Due Diligence provides a step-by-step methodology that will allow you to recognize and avoid questionable hedge funds before its too late. Based on a framework that hedge fund investigative expert Randy Shain has refined over the course of his successful career, this book offers an overview of due diligence into hedge fund management, how information on managers can be obtained, and why this information is essential to your investment endeavors.

OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas Third Edition

Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264252479
Total Pages : 122 pages
Book Rating : 4.2/5 (642 download)

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Book Synopsis OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas Third Edition by : OECD

Download or read book OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas Third Edition written by OECD and published by OECD Publishing. This book was released on 2016-04-06 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication provides step-by-step management recommendations endorsed by governments for global responsible supply chains of all minerals, in order for companies to respect human rights and avoid contributing to conflict through their mineral or metal purchasing decisions and practices.

Due Diligence

Author : David Roodman
Publisher : CGD Books
ISBN 13 : 1933286539
Total Pages : 388 pages
Book Rating : 4.9/5 (332 download)

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Book Synopsis Due Diligence by : David Roodman

Download or read book Due Diligence written by David Roodman and published by CGD Books. This book was released on 2012 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: The idea that small loans can help poor families build businesses and exit poverty has blossomed into a global movement. The concept has captured the public imagination, drawn in billions of dollars, reached millions of customers, and garnered a Nobel Prize. Radical in its suggestion that the poor are creditworthy and conservative in its insistence on individual accountability, the idea has expanded beyond credit into savings, insurance, and money transfers, earning the name microfinance. But is it the boon so many think it is? Readers of David Roodman's openbook blog will immediately recognize his thorough, straightforward, and trenchant analysis. Due Diligence, written entirely in public with input from readers, probes the truth about microfinance to guide governments, foundations, investors, and private citizens who support financial services for poor people. In particular, it explains the need to deemphasize microcredit in favor of other financial services for the poor.

The AMA Handbook of Due Diligence

Author : William M. CRILLY
Publisher : AMACOM Div American Mgmt Assn
ISBN 13 : 0814413854
Total Pages : 843 pages
Book Rating : 4.8/5 (144 download)

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Book Synopsis The AMA Handbook of Due Diligence by : William M. CRILLY

Download or read book The AMA Handbook of Due Diligence written by William M. CRILLY and published by AMACOM Div American Mgmt Assn. This book was released on 2010-04-28 with total page 843 pages. Available in PDF, EPUB and Kindle. Book excerpt: The AMA Handbook of Due Diligence is the most complete guide available on how to properly perform a due diligence investigation — and radically improve the success rate of a pending corporate merger or acquisition. The new edition of this long-trusted resource includes a CD-ROM packed with almost 400 customizable forms and templates for recording and analyzing every possible operational or financial activity at any organization. Extensively revised and updated, the book reflects significant changes in the financial landscape such as the Sarbanes-Oxley Act. There are specialized sections on joint ventures, franchises, and outsourcing, as well as new legal memo and form requirements, including data room index, preliminary diligence memorandum, and the Hart-Scott-Rodino questionnaire. Thorough and easy to use, this essential resource will ensure that every “t” is crossed, every “i” dotted...and no mistakes left out on the table.

A Biotech Manager's Handbook

Author : M O'Neill
Publisher : Elsevier
ISBN 13 : 1908818158
Total Pages : 414 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis A Biotech Manager's Handbook by : M O'Neill

Download or read book A Biotech Manager's Handbook written by M O'Neill and published by Elsevier. This book was released on 2012-05-02 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. - No other 'how to' manual exists for this sector - Written by a range of expert professionals in each area, all in one book - Is the only 'bench to bedside' book covering the whole spectrum of development

Due Diligence

Author : Peter Howson
Publisher : Taylor & Francis
ISBN 13 : 1317147588
Total Pages : 299 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis Due Diligence by : Peter Howson

Download or read book Due Diligence written by Peter Howson and published by Taylor & Francis. This book was released on 2017-07-05 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: How can you be sure you are buying the company you think you are? Are you sure it is as good as the seller says? How can you be certain unexpected costs and obligations will not suddenly appear once you are the owner and responsible for them? How best can you arm yourself for the negotiations? Have you worked out precisely what you are going to do with it once it is yours? How do you set the priorities for change to recoup the premium you have paid for it? The answer to all these questions, and many more, lies with effective due diligence. Due diligence is one of the most important but least well understood aspects of the acquisition process. It is not, as many believe, a chore to be left to the accountants and lawyers. To get the best from it, due diligence has to be properly planned and professionally managed. This book is a comprehensive manual on getting due diligence right. It is a uniquely comprehensive guide, covering all aspects of the process from financial, legal and commercial due diligence right through to environmental and intellectual property due diligence. There are also useful chapters on working with advisers and managing due diligence projects. It also includes a number of checklists to help ensure that the right questions are asked.

The Pharmagellan Guide to Biotech Forecasting and Valuation

Author : Frank S. David
Publisher : Pharmagellan, LLC
ISBN 13 : 9780998407500
Total Pages : 138 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis The Pharmagellan Guide to Biotech Forecasting and Valuation by : Frank S. David

Download or read book The Pharmagellan Guide to Biotech Forecasting and Valuation written by Frank S. David and published by Pharmagellan, LLC. This book was released on 2017-01-06 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you're a biotech executive, investor, deal maker, entrepreneur, or adviser-or aspire to be one-then you need to know how to build and analyze forecasts and valuation models of R&D-stage drugs. The Pharmagellan Guide is a comprehensive, thoroughly referenced handbook for early-stage biopharma assets and companies.

Due Diligence Obligations in International Human Rights Law

Author : Maria Monnheimer
Publisher : Cambridge University Press
ISBN 13 : 1108899307
Total Pages : 353 pages
Book Rating : 4.1/5 (88 download)

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Book Synopsis Due Diligence Obligations in International Human Rights Law by : Maria Monnheimer

Download or read book Due Diligence Obligations in International Human Rights Law written by Maria Monnheimer and published by Cambridge University Press. This book was released on 2021-02-18 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the importance of non-State actors ever increasing, the traditional State-centric approach of international law is being put to the test. In particular, significant accountability lacunae have emerged in the field of human rights protection. To address these challenges, this book makes a case for extraterritorial due diligence obligations of States in international human rights law. It traces back how due diligence obligations evolved on the international plane and develops a general analytical framework making the broad and vague notion of due diligence more approachable. The framework is applied to different fields of international law which provides guidance on how due diligence obligations can be better conceptualized. Drawing inspiration from these developments, the book analyses how extraterritorial human rights due diligence obligations could operate in practice and foster global human rights protection.

Business Development for the Biotechnology and Pharmaceutical Industry

Author : Martin Austin
Publisher : CRC Press
ISBN 13 : 1317170598
Total Pages : 202 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis Business Development for the Biotechnology and Pharmaceutical Industry by : Martin Austin

Download or read book Business Development for the Biotechnology and Pharmaceutical Industry written by Martin Austin and published by CRC Press. This book was released on 2016-04-08 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.