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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. 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.
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. The chapter covers typical GMP documents and important GxP requirements which will need to be verified.
This includes manufacturing-site specific documents and the process development and validation requirements. This includes approaches for evaluating preclinical studies as well as more specific information for toxicology and pharmacology work.
This section covers both general trial requirements as well as those specific to individual clinical phases. This includes determining market position, analysing potential competitors, and determining reimbursement options.
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.
The Biotech Trader Handbook
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THE BIOTECH TRADER HANDBOOK EBOOK DOWNLOAD