Real World Drug Discovery: A Chemist's Guide to Biotech and Pharmaceutical Research

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Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a basic understanding must somehow be obtained. Even the more experienced scientist can find it frustratingly difficult to get an overview of the many factors involved in modern drug discovery and often only after years of exploring does a whole and integrated picture emerge in the mind of the researcher.
Real World Drug Discovery: A Chemist� s Guide to Biotech and Pharmaceutical Research presents this kind of map of the landscape of drug discovery. In a single, readable volume it outlines processes and explains essential concepts and terms for the recent science graduate wondering what to expect in pharma or biotech, the medicinal chemist seeking a broader and more timely understanding of the industry, or the contractor or collaborator whose understanding of the commercial drug discovery process could increase the value of his contribution to it.

Key Features:
- Interviews with well-known experts in many of the fields involved, giving insightful comments from authorities on many of the sub-disciplines important to cutting edge drug discovery.
- Helpful suggestions gleaned from years of experience in biotech and pharma, which represents a repository drug discovery "lore" not previously available in any book.
- "Periodic Table of Drugs" listing current top-selling drugs arranged by target and laid out so that structural similarities and differences are plain and clear, with regular updates available at the book's website.
- Extensive use of diagrams to illustrate concepts like biotech startup models, preteomic profiling for target identification, Gantt charts for project planning, etc.

Real World Drug Discovery: A Chemist's Guide to Biotech and Pharmaceutical Research Review

REAL WORLD DRUG DISCOVERY by Robert Rydzewski is a glitzy 515 page book, on glossy paper, with hundreds of figures and graphs, many in color, disclosing structures of organic chemicals, time courses of metabolism, enzyme kinetics, and economics. Where the discussion concerns a specific organic chemical, e.g., used as a drug, we find a picture of it on the same page. In this way, the author is an excellent communicator. The book is attractive because the writing is slightly informal, and yet the book is highly factual and reliable.

At first, we are provided with a short history of organic chemistry, biotechnology, and genomics (pages 1-13). We then learn about pharmaceutical economics (pages 13-47). We learn the cost of bringing a new drug to market, and that this particular number has been calculated to be one of a number of million dollars, depending on how it is calculated (page 14). We learn of the Hatch-Waxman Act, and how it has encouraged generic manufacturers to unfairly challenge patents held by pharma companies (page 22). We learn about pitfalls facing pharma, namely, market withdrawals, adverse events, blackbox warnings, and competition from generics. We also learn how pharma reduces competition from generics, by creating your own generic, negotiating with insurance companies, and providing over-the-counter status (page 24). We learn various reasons why biologicals don't go generic.

CONTRACT RESEARCH ORGANIZATIONS (CROs). We learn about CROs, which let a startup hit the ground running (without having to buy lab equipment or to hire personnel), but that the disadvantage of CROs is often that they may be just a pair of hands (page 76-79).

PERSONALIZED MEDICINE. We learn that "personalized medicine" takes into an account biological variability that modifies how a drug works in vivo, in terms of efficacy and adverse events. We learn that this variability can result from variability in Cyt. P-450, from constitutively activated BCR-AB2 tyrosine kinase, thiopurine methyltransferase, transporters such as p-glycoprotein. We learn that alterations in these genes can change certain drugs (the drugs are identified for us), and we learn about genetic tests used to test for alterations of these genes (pages 88-105).

PATENT LAW. We learn that the two most important things are NOVELTY and PRIORITY (page 114), that lab notebooks need to be co-signed and that the dates are used to establish diligence (a legal term relevant to 35 USC 102(g) and Interference Proceedings), that the European Patent Office does NOT have a 1-year grace period where the inventor can publish his work without fear of invalidating his patent, and the concept of BLOCKING PATENTS (page 120). We learn that Europe has a first-to-file system (not a first to invent system) for establishing priority, and that notebook dates are used for Interference Proceedings. (An oversight is that the author failed to mention that a sale, or offer to sale (even if secret), can be just as invalidating as a publication.) We learn that proper notebook-keeping procedure entails NOT jotting down notes, such as "this invention was OBVIOUS to us," because this can backfire against the patentee during litigation. (One might also note that the issue of utility COMMONLY occurs in patent applications claiming new genes) (page 123). We are told about several patent searching tools, but there are others that weren't mentioned, such as espacenet and PUBLIC PAIR. The author is careful to tell us that prophetic embodiments in patents should never be described in the past tense (the present or future tense is the safe way to do it). We learn about material transfer agreements (MTAs), often between a company making a compound that a university wishing to do research on it (page 136).

CLINICAL TRIALS. We learn that the time line from Phase 0 (PK studies in humans), Phase I, Phase II, Phase III, and about occasional use of a document called a Target Product Profile, which is used as a reference point, and updated, during these studies. We learn about the IND, NDA, and IRB. We learn how FDA responds to these documents (page 147). But I wish another few more pages could be devoted to the time-line of preparing and filing an IND, NDA, Investigator's Brochure, and Briefing Document. For more info on FDA documents, I recommend M. Mathieu's BIOLOGICS DEVELOPMENT:A REGULATORY OVERVIEW, or FUNDAMENTALS OF CLINICAL TRIALS by Friedman.

PROJECT MANAGEMENT. We learn about the project team leader, meetings, performance evaluations, and Gannt charts (pages 151-174). We learn about the "two boss syndrome" where an employee can have two different bosses (page 157). Various problems can arise from this situation, in this reviewer's experience. First, Boss A can give an instruction that conflicts with what Boss B wants. The second problem is that Boss A is the "official boss" but is technically incompetent, and is incapable of understanding the technical aspects or process aspects of the employee's work, while Boss B is highly competent both in terms of technology and process.

CHOOSING DRUG TARGETS. Chapter 5 concerns choosing drug targets, and the influence of these things on making the choice: (1) Identity of target already accepted/established by the scientific and medical community, (2) Patents owned by competitors that cover the target, (3) Availability of mouse models. The other side of the coin is the drug, not the target, and we learn about these classes of drugs: antisense; siRNA; antibodies; intrabodies; aptamers; small molecules (page 175-195). We also learn about effective drugs where the target was unknown or remains unknown, e.g., aspirin, isoniazid, FK506 (pages 200-207).

SCREENING AND TESTING CANDIDATE DRUGS. The heart of this book occurs in pages 218-468, as here we learn techniques for screening for and testing drug candidates. For example, we learn of identifying lead compounds by titrating enzymes (p. 218) or cell-based assays (p. 223), by binding assays conducted with fluorescence polarization (p. 224) or bead-binding assays (p. 226), artifacts due to autofluorescence or to quenching (p. 229), artifacts in bacterial inhibition assays due to non-specific detergent effects (p. 230), the question of whether to screen pure drug candidates or mixtures of drug candidates (p. 233), the issue of whether to test one (or a plurality) of drug condentrations (p. 237), and the question of false positives vs. false negatives (p. 239). We are then treated to a primer of enzyme kinetics as it related to inhibitors (p. 280-289, 299-307), and we find an interesting detour into the question of whether a drug candidate can "look" like a drug (p. 290-293).

REAL WORLD DRUG DISCOVERY discloses a wide variety of intriguing topics. While the writing is lively, e.g., by sometimes referring to Greek legends, the book is different from typical journalism, in that the writing is trustworthy and accurate. An introductory book can take two approaches: (1) Delve deeply into selected topics that serve as milestones for a given topic, or (2) Provide a shallow overview that touches on all the relevant topics (where every available topic is covered by one sentence). This book takes the first approach, and I am glad of this. FIVE STARS.

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