A Practical Guide to Drug Development in Academia: The SPARK Approach

by Daria Mochly-Rosen (Editor), Kevin Grimes (Editor)

"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."

188 pages, Paperback

First published November 30, 2013

Reviews

[Christina Xu · Rating 4 out of 5]

This book could probably serve as the syllabus to an Intro to Biotech Entrepreneurship / Drug Development course in college.

Paradoxically, this was a dense read, much like a textbook, but at the same time, barely scratches the surface in terms of what you need to actually know to start a biotech company. For now, while I’m just a curious reader, this book was more than sufficient in disseminating knowledge. I particularly like the “What surprised an academic?” blurbs interspersed between the chapters, infusing practical wisdom from a real founder into the theory.

[Chris Stivers · Rating 4 out of 5]

A great high-level overview to drug development emerging from academic pursuits. The book does not go into many “how-to” details but provides a general outline, which is appropriate for someone with no prior exposure to industry and/or the pharmaceutical world. For anyone at Stanford, this is a particularly valuable resource since many of the authors are advisors of the Stanford SPARK program.

[Jeanmarie · Rating 5 out of 5]

Not enough people are going to read this book, and it is a shame, because their good drugs are not going to go to market. But, hey, Academicians, hold on to that notion that you know everything.

[Brett · Rating 5 out of 5]

A fantastic high-level primer on the ins and outs of drug development, that will now be my go-to recommendation for academics interested in knowing what's involved. While it only touches lightly on every topic mentioned, it does so with enough detail that the interested party could easily seek out further sources, and it gives a rundown of the challenges faced at that particular stage. The only critique that I'd make is that it is heavily US-focussed, and at some points explicitly Stanford-focussed; given that it is essentially course notes from the SPARK program at Stanford this should come as no surprise, but for those outside the program you might find yourself skim-reading a chapter or two. As a window into the wild world of drug development, it's great.