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VINE VOICEon July 26, 2009
Biologics Development: A Regulatory Overview, by Mark Mathieu is a 330 page book, containing 15 chapters. The paper is a off-white. There are about ten tables and flow charts, and reproductions of two forms, FDA Form 356h and the MedWatch form. This is a review of the second edition (but the currently available edition is still very short, around 350 pages).

Overall, the book is a walk-through that takes us along various rules in Title 21 of the CFR. The book is useful, in that it teaches a pharma or biotech employee things that management might not have time to teach. This book fills a niche, in that other books on clinical trials generally fail to disclose back and forth communications between the sponsor and FDA. But for the price charged for this book, the book does not go far enough. It is only an overview or introduction.

We learn that CBER has an office called OCTMA that provides guidance on how to go about filing an IND. We learn that the IND must be submitted using Form 1571, and that INDs include the Investigator's Brochure and Clinical Study Protocol (pages 64-66) to be used in the Phase I study, and that the CSP must be accompanied with the Consent Form. We learn that Institutional Review Board (IRB) approval is not needed for submitting an IND, but IRB approval is required before carrying out the actual study.

We learn that the Chemistry, Manufacturing, and Control Data (CMC) part of the IND includes drug substance, drug product, placebo (page 67), labels, and environmental analysis requirements sections, and that the Pharmacology & Toxicology Data section includes animal studies, in vitro studies, previous human experience, studies.

After an IND is approved, we learn that subsequent submissions include a revised IB, amendments to the CSP, information amendments, and IND safety reports (these report only AEs that are serious and unexpected, and must be submitted within 10 days after the sponsor's receipt (page 75).

Attention is devoted to the Clinical Hold and partial clinical hold (pages 72, 95, 99, 100, 105), to Informed Consent forms (pages 61, 145, 152-155), and to the label for the drug container and package insert (pages 170-172, 208, 223, 226, 280).

We learn how CBER is organized--its offices include Therapeutics (cytokines, cellular & gene therapies, hematologics, monoclonals), Vaccines, Blood Products, Office of Establishment Licensing & Product Surveillance, Office of Compliance, Office of Communication, and Office of Management. We learn about the time-line followed after submitting the IND, where the decision tree is to proceed (occurs automatically at 30 days after receipt of IND), to call the sponsor about minor deficiencies, or to impose a clinical hold.

An overview is provided of Phase I, Phase II, Phase III, and Phase IV clinical trials (page 107), and we learn about Expedited Development and Accelerated Approval. We are provided with a number of other concepts, but these are only named, and there are no examples (comparison group, multicenter trials, randomization, blinding, Data Safety Monitoring Committee, Endpoints and Surrogate Endpoints). It would have been nice to be provided with a disclosure of how these things are handled differently in oncology versus infectious diseases, but we're left in the dark.

We learn of the responsibilities of the Sponsor (selects investigators, ensures monitoring of trials, to ensure that requirements set forth by IRB and by Consent Forms are followed (page 145), to ensure that investigators understand the IB (page 145).

After the IND is filed, and after the clinical study is completed, a subsequent step is licensing. We are provided with the history of biologics approval, at least as it applies to licensing. We learn that the Establishment License Application (ELA) was implemented early (in 1902), because it was easy to monitor and control manufacturing steps, but that Product Licensing Application (PLA) came much later (in 1944), because it was not until this time that analytical methods became good enough to do quality control on the biologics product. We learn that in 1996, CBER combined the PLA and ELA, where the combination was called, BLA (BLA applies only to plasmids, peptides of 40 or fewer amino acids, monoclonals, and somatic cell therapy) (page 160, 233)

Examples and case histories would be a welcome addition to this book. For example, I would have liked to see a reproduction of a Consent Form, an example of a Synopsis from a Clinical Study Protocol, an example of an FDA Form 483 Warning Letter, a time-line of all milestone documents that are sent to the FDA with commentary disclosing what event triggers the submission of each of these documents, and information of additional FDA documents. I would like to see examples of an Information Request letter and an Advice letter (page 100). We are told of these letters but have no idea of their content.

We are told about INDs, BLAs, PLAs, ELAs, and CSPs, but certainly there are other major documents. Perhaps the following documents were not available at the time of the edition of the book being reviewed, but at the present time (2009), these other documents include a Fast Track Application, a Briefing Document, Statistical Analysis Plan, Change Control Form, and Special Protocol Assessment (SPA).

What is also missing is information about the European equivalent of the FDA, that is, European Medicines Agency (EMEA). I would have also liked to see two or three case histories, for example, disclosing conversations occurring during a pre-IND meeting. An excellent example of cases histories can be found in Data Monitoring in Clinical Trials: A Case Studies Approach by DeMets, et al. In my opinion, the DeMets book is a glorious, no holds barred, well-written treatise, on one aspect of clinical trials (data and safety monitoring committees). If Mark Mathieu's book was less expensive (in the range of $30-$40) it might deserve five stars.
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on February 16, 2014
I purchased this book for a class in Drug Development. I loved the class but didn't find the book very useful. It has no index which is strange and really decreases the utility of the book. I also noticed that the author would use lots of acronyms - par for the course in the research biz, I know - but he would often do it without using the full name prior to launching into the acronyms and because of the lack of index I would have to google to find the meanings of some of the acronyms. Again, if you're taking the course at Temple, it's an awesome course and a great chance to see drug development from start to finish and this book is fine...just not super user friendly.
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on March 30, 2016
This is a good book, but there are limitations. First, as other have mentioned, no index. Secondly, I bought this book for a class in the winter of 2016. This book was last edited in 2008 and much of it is outdated. 7 years is a long time in the field of regulatory affairs which is ever evolving. Finally, I found some sections within a chapter that were a repeat from other chapters. In summary, not a bad textbook, it just needs to be updated.
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on January 22, 2013
I'm doing regulatory intelligence for a client, and this book gave me a lot of great detail about drug development during all the stages, draft guidances and how they're used, etc (I'm about half way through now).

It would be pretty much perfect if it had an index. HUGE downside. I'm combating that by highlighting what I might want to find later and using sticky tabs, but with a textbook this big, it's very cumbersome to go back and find things. I would really like to go back and find out where draft guidances are referenced, but that's pretty near impossible. Never even thought to check if the book had one...I just assumed it would!
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on April 13, 2014
This is the first textbook that I have used that does NOT have an index at the end. Are you serious? If I have to research a certain topic, I have to use the glossary as a reference yet a certain topic could be discussed in various sections throughout the book so I cant find all the relevant info.
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on June 12, 2012
I purchased this book as a required textbook for a Drug Development class in a QA/Regulatory Affairs program. It's very nicely organized, well written and encompasses a lot of information about all the basics of Regulatory Affair. This is one of those textbooks that I will be keeping for useful reference.
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on June 10, 2011
Great book very easy explanation of FDA review and types of submissions involved in drug development process. basically contains top to bottom most information a regulatory person dealing with IND/NDA submission would need.
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on November 5, 2011
This book which I received was in a good condition and hence it was really joyful to read it. The content and format as well as simplicity of the language is also a plus point about the book!
Enjoy reading;
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on November 12, 2008
I bought this book for a Quality Control/ Regulatory Affairs course at Temple University. The book is really in-depth and covers everything from INDs to NDAs to drug approval in the EU and Japan. Recommended for anyone interested in learning more about the pharmaceutical regulatory process.
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on May 20, 2014
It is a good book of the new drug development processe. But it is a little expensive. I hope there will be a soft cover of this book, and make it light ,cost less.
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