{"product_id":"scientific-due-diligence-nathan-martinsberg-9781717537676","title":"Scientific due diligence: A handbook for investigators and investors","description":"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. \u003cp\u003e\u003c\/p\u003eBut 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? \u003cp\u003e\u003c\/p\u003eThis 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. \u003cp\u003e\u003c\/p\u003eWe 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. \u003cp\u003e\u003c\/p\u003e\u003cb\u003eInvesting in pharma? Then this is the book for you.\u003c\/b\u003e \u003cp\u003e\u003c\/p\u003eThe book has been divided into sections which cover the entire due diligence process. \u003cp\u003e\u003c\/p\u003eThe first section covers the basics of due diligence: \u003cul\u003e\n\u003cli\u003eChapter 1 \u003cb\u003eintroduces \u003c\/b\u003edue diligence investigations, including the attributes of good due diligence investigators, the basic rules to follow, and commonly-seen licensing approaches.\u003c\/li\u003e\n\u003cli\u003eChapter 2 covers the \u003cb\u003einitial steps\u003c\/b\u003e of assessment, including the preliminary screening for potential licenses and the secondary screen to identify true opportunities.\u003c\/li\u003e\n\u003cli\u003eChapter 3 shows the \u003cb\u003epreparation \u003c\/b\u003efor the on-site scientific due diligence investigation, including typical organisational tasks and team set-up.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cbr\u003eNext, the specific requirements for each area of expertise are covered in more depth: \u003cul\u003e\n\u003cli\u003eChapter 4 covers the investigation from the \u003cb\u003eregulatory affairs\u003c\/b\u003e perspective, including factors such as approval risk, regulatory planning, and useful special pathways.\u003c\/li\u003e\n\u003cli\u003eChapter 5 deals with \u003cb\u003equality\u003c\/b\u003e, 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.\u003c\/li\u003e\n\u003cli\u003eChapter 6 covers \u003cb\u003echemistry, manufacturing and control\u003c\/b\u003e, the details of the product and the production process. This includes manufacturing-site specific documents and the process development and validation requirements.\u003c\/li\u003e\n\u003cli\u003eChapter 7 describes \u003cb\u003epreclinical \u003c\/b\u003etrials, 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.\u003c\/li\u003e\n\u003cli\u003eChapter 8 involves \u003cb\u003eclinical \u003c\/b\u003etrials, the most important test of any new drug. This section covers both general trial requirements as well as those specific to individual clinical phases.\u003c\/li\u003e\n\u003cli\u003eChapter 9 deals with \u003cb\u003emarketing\u003c\/b\u003e, the ability to sell the new product. This includes determining market position, analysing potential competitors, and determining reimbursement options.\u003c\/li\u003e\n\u003cli\u003eChapter 10 describes the\u003cb\u003e intellectual property\u003c\/b\u003e factors which may be involved, covering both patenting and data exclusivity approaches to IP protection.\u003c\/li\u003e\n\u003cli\u003eChapter 11 finishes the scientific due diligence process by providing the\u003cb\u003e final set of questions\u003c\/b\u003e to ask prior to making the final recommendation.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cbr\u003eFinally the five \u003cb\u003eappendices provide reference information\u003c\/b\u003e which will help when conducting a due diligence investigation, from example checklists to work from through to advice for when you are being audited.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Nathan Martinsberg\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1717537677\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781717537676\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Createspace Independent Publishing Platform\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/03\/2018\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 184\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.56lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.39d","brand":"Nathan Martinsberg","offers":[{"title":"Paperback","offer_id":43988000342271,"sku":"9781717537676","price":26.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_29c710a9-3e18-4ea4-8fe2-736be6b55faa.jpg?v=1683292061","url":"https:\/\/www.whiterainbookhouse.com\/products\/scientific-due-diligence-nathan-martinsberg-9781717537676","provider":"WR Book House","version":"1.0","type":"link"}