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New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients (Anglais) Broché – 4 juin 2009


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During his 30-year career in pharmaceutical research and development, author Lawrence T. Friedhoff, MD, PhD, FACP has amassed an extraordinary record of industry accomplishments, most notably as the head of the teams that chose, developed, and brought two chemical compounds through regulatory approvals around the world. These new drugs are market “blockbusters,” each used by millions of patients and each generating well over $1 billion annual revenue worldwide. Dr. Friedhoff's first-hand knowledge of pharmaceutical R&D is extensive and comprehensive: he has held management positions at multi-national corporations developing novel drug compounds, small publicly-traded companies manufacturing generic drugs, start-up ventures, and academic-based research teams writing business plans to obtain venture capital. As an R&D head, he held primary responsibility for choosing drug candidates and preparing comprehensive plans for, as well as managing all phases of, their development, always with an eye towards fulfilling FDA (and often, European and Asian) drug requirements. He has also managed post-FDA-approval activities including collecting and analyzing adverse-event information from consumers, fielding inquiries from patients and healthcare providers, and marketing-related scientific studies. Although the press contains numerous reports of disastrous failed clinical trials, during Dr. Friedhoff's career none of the completed pivotal clinical trials for which he was fully responsible ever failed and all of his new drug applications (NDAs) submitted to the FDA were approved. Few industry professionals have been able match his achievements.


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Amazon.com: 13 commentaires
7 internautes sur 9 ont trouvé ce commentaire utile 
Superficial overview - largely uninformative 10 décembre 2010
Par psuvafn - Publié sur Amazon.com
Format: Broché Achat vérifié
Not worth the money - even at $9.99 for the Kindle. Merely reading the FDA website would give you 10x as much information. Very superficial - might be good for someone with absolutely no knowledge of FDA or drug process.

#1. Read "Inside the FDA" by Fran Hawthorne instead. #2. Familiarize yourself with the (free) FDA website. #3. Google research. #4 Personally attend an FDA Committee Meeting in the Metro DC area or attend online (free).
3 internautes sur 4 ont trouvé ce commentaire utile 
Insiders View 6 juillet 2009
Par Amazon Customer - Publié sur Amazon.com
Format: Broché
What an enjoyable read. I am a life science banker and I really enjoyed reading Dr. Friedhoff's book. Although I have been in the life science industry for over 17 years I was still able to learn a few things. Dr. Friedhoff's insights and clear outline of the drug development process really can benefit those who are new to drug development. I also liked the real-life examples which are pulled from the day's headlines. This should definitely be on the reading list for undergrads and business school students who are interested in drug development or life science banking.
1 internautes sur 1 ont trouvé ce commentaire utile 
Good for sales and management people as well as scientists 7 décembre 2013
Par David Jarvis - Publié sur Amazon.com
Format: Format Kindle
Excellent insiders guide to drug development and approval. Helpful for management and sales people who want to understand at a deeper level.
1 internautes sur 1 ont trouvé ce commentaire utile 
Great real life advice 14 janvier 2012
Par Edward A. Smith - Publié sur Amazon.com
Format: Broché Achat vérifié
Many books discussing drug development and FDA approval are theoretical, but in this book, Friedhoff gives us a "behind and scenes" view of how it's really done. The book is a fast read, but full of real-life experiences getting drugs approved. I'd advise anyone involved in drug development or investing to keep this book close by. I think a section on where and how to find drug development investors would be helpful. I give the book 5 stars.

Ed Smith
PBS-Bio
TGen
1 internautes sur 1 ont trouvé ce commentaire utile 
How not to lose money on clinical trials 1 novembre 2011
Par Behavioral Investors - Publié sur Amazon.com
Format: Broché
Including enough detail and commentary to be useful to physicians and biotech professionals but still very readable by the interested layman, Dr Friedhoff's book will be helpful for clinical researchers looking for actionable strategies to improve on the high cost, risk and failure rate common to most sponsored trials, as well as biotech value investors trying to handicap drug development efforts.

In addition to a basic overview of the drug development and approval process from phase I through post-marketing, the author walks us through several brief but relevant case studies and points out instructive examples of pitfalls arising from dysfunctional behavior patterns repeatedly demonstrated by biotech/pharma managements. For instance:

- ditching successful MD/PhD development leadership midstream for management-side MBAs with "marketing experience"
- including at-risk subpopulations who may be not tolerate the drug in phase I/II studies to assess potential toxicity, rather than voluntarily excluding them to avoid killing people and getting your study shut down
- getting approval for compassionate use, then finding physicians won't join phase III studies because it would now be unethical to prescribe placebo
- changing the formulation midstream without planning ahead to prove pharmacokinetic equivalence before studies continue
- spending heavily on head-to-head post-marketing comparisons against a competitor without considering the risks of proving inferiority (Mevacor anyone?)

Drawbacks include that the author repeatedly mentions how smart it would be to hire his consulting firm, and talks up his personal track record of "always being successful" in drug development projects; this is a little hard to swallow but not more so than the avoidable management missteps that Friedhoff accurately skewers. Recommended as a quick and worthwhile read.
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