Real World Drug Discovery: A Chemist’s Guide to Biotech and Pharmaceutical Research Kindle Edition

Real World Drug Discovery: A Chemist’s Guide to Biotech and Pharmaceutical Research Kindle Edition
Author: Visit ‘s Robert M. Rydzewski Page ID: B003FK5PYI

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File Size: 5410 KBPrint Length: 600 pagesPublisher: Elsevier Science; 1 edition (July 7, 2010)Publication Date: July 7, 2010 Sold by:  Digital Services, Inc. Language: EnglishID: B003FK5PYIText-to-Speech: Enabled X-Ray: Not Enabled Word Wise: Not EnabledLending: Not Enabled Enhanced Typesetting: Not Enabled Best Sellers Rank: #735,889 Paid in Kindle Store (See Top 100 Paid in Kindle Store) #42 in Kindle Store > Kindle eBooks > Nonfiction > Science > Chemistry > Industrial & Technical #57 in Kindle Store > Kindle eBooks > Medical eBooks > Special Topics > Biotechnology #123 in Kindle Store > Kindle eBooks > Nonfiction > Science > Chemistry > Organic
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.
Drug discovery and development is a complex, highly multidisciplinary endeavor in which practitioners have to have knowledge about a disparate range of topics, from chemistry and biology to outsourcing, patent laws and business aspects. It is not physically possible for any one person to have detailed knowledge about all these areas. What is therefore necessary is a book that provides bite-sized chunks about the most relevant aspects of the science, art and commerce of drug discovery and development that will keep scientists, technologists, lawyers and businessmen up to date with the essentials.

Rydzewski’s Real World Drug Discovery admirably fills this void. In clear, comprehensive and sometimes witty prose he describes the most essential aspects of the field. He begins with the basics of drug development, including a history of the industry and the challenges that it had to face along the way. Then, in a series of chapters the author leads the reader through a remarkable range of topics. A sampling of examples makes the impressive diversity of scientific, business and legal topics clear; patent law, Hatch-Waxman and Bayh-Dole acts, generics, outsourcing and patent busting, high-throughput screening, stereochemical aspects, mouse knockouts and RNA interference, process research and manufacturing, gene arrays and pharmacogenomics, biotechnology, pharmacokinetics and metabolism, side-effects, structure-based drug design and computational modeling, FDA rules, mergers and acquisitions, project management and leadership and statistics and trends. And in spite of such broad coverage, Rydzewski pays a remarkable amount of attention to detail.
Overall, this is a very good and very well written book. Any aspiring chemist thinking of entering into the world of pharmaceutical and biotechnology R&D should get this book – it covers a lot of ground that will otherwise take 2-3 years to learn … the hard way.

The first third of the book is focused on the big picture of the current landscape, from the evolving role of big pharma to the struggles of biotech companies.

The second third of the book covers more tactical aspects like project teams and how work in corporations is conducted under projects (for which the new chemist will likely be lucky to only be involved in one or two at once).

The last third of the book tackles specific chemistry issues associated with drug discovery. It should be noted that all of this is in the discovery or "fundamental" research stage (e.g., before clinical trials) – so there is no mention of regulatory compliance or quality systems needs.

Every so often, the author has put in small summary boxes of key topics to drive home his details – this is very helpful and something that I wish more authors would do, especially when writing about complex, interrelated topics.

The minor drawbacks that I found in this book that kept it from being 5 stars for me:

Throughout, there is significant emphasis on the increIDgly successful role of academia in drug development, but zero discussion of some of the more recent innovations such as NRDO (no research, development only) companies. As a result, I walked away wondering if this book was a call to come help industry develop new drugs inside of industry or as a member of academia.

Also missing was a discussion of the various state efforts throughout the U.S.
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