Customer Reviews

New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients

5 star:		(6)
4 star:		(2)
3 star:		(0)
2 star:		(0)
1 star:		(1)

 

 

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.

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

I was pleased to find this book about the pharma industry that is neither a standard dry textbook nor a sensational expose motivated by an axe-grinder. The author's achievements here was to provide a thorough description of the processes and people involved in new (branded) drug development while sharing his experiences and insights about obtaining FDA approvals. The anecdotes were entertaining and informative and a brief foray into investing in the health sector was thoughtful. Overall, accessbile and well-written.

New Jersey Bill

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.

As a lay person, I found this book to be clear and concise without a lot of unnecessary filler. Other material I've read on such a topic often required a level of knowledge only held by a scientist. A good job was done by this author in getting to the point in a way that could be better understood. I especially liked the personal anecdotes which injected personality into a sterile topic. The stated goal in the book of appealing to a broader audience was definitely achieved!

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).

I great read. It gave a great overview of the drug development process from a Reg Affairs point of view. It provided starting points and in some cases advise for someone who wnats to become an expert. I've been part of new drug development teams and this book provided me with insignt on what goes on up and down the process stream. I loved the book.

I feel very excited to find this book. In fact, I view this book as one of the best text books for pharmaceutical industry professionals. It is really in-depth and covers every essential aspect in the new drug development process in a clear and systematic way. Dr. Friedhoff is so skillful in writing that the maze of new drug development and FDA guidelines become so easy to understand and you do not have to be experienced personnel to understand the whole picture. Another thing I appreciate most is that Dr. Friedhoff shares his 30-year professional experience in this book. He not only provides down-to-the-earth but very important information, he also gave us tools to achieve new drug approval. I found all the messages from the book are invaluable. I highly recommend this book.

I have spent my career in pharma business as a financial manager of R&D budgets and cost management (ranging from multinational corporations to start-up companies). I found this book to offer a thorough, understandable summary of how to efficiently negotiate the FDA's New Drug Approval (NDA) process. Dr. Friedhoff clearly does not accept the prevailing wisdom that it should cost a billion dollars to get a new drug approved, and his assertion that many companies have lost the core competency of efficient drug development is becoming increasingly accepted by the financial community.

His discussion of the business covers issues that I have not seen discussed elsewhere; for example how GAAP accounting actually distorts the true nature of a pharmaceutical company's asset and can lead to a sub-optimal investment allocation. He also presents a clear discussion of the strengths and limitations of the current system of evaluating drug safety prior to marketing, as well as a glimpse into the future of the industry, areas of particular importance to investors.

I consider this a must-read for any pharmaceutical company investor, prospective employee, government official or patient interested in the reality of how drugs are actually developed and approved and how pharma companies really work from an "insider's" perspective. I particularly enjoyed his personal anecdotes and case studies. I'm sure that despite its slim size (it doesn't purport to be a tome on pharmaceuticals, indexed and footnoted), health industry professionals would also benefit from its information and advice.