About Gray's Global Medicines Development

"Dr Gray has done a masterful job of explaining each stage of the drug development process. This book will become an invaluable resource for anyone associated with drug development and commercialisation. It is crucial for early stage pharma and biotech companies to understand fully all the aspects of the drug development process and to maintain a commerical focus throughout the development process. It is refreshing to se a comprehensive drug development resource that starts with a market focus and advocates the development of target product profiles to help guide drug development plans. Dr Gray's book is easy to read and will help both business managers and researchers alike fill knowledge gaps in the drug development process and facilitate cross functional collaborations within drug development project teams. As a consultant working with early stage specialty pharma companies, Dr Gray's book provides a comprehensive overview that I can refernce when working with clients and use as a guide throughout the business planning process".                       

Thomas Marten, President Pharmacision LLC

 

"You wrote the best training book I have ever read".  

David Wang , Global Project Leader, Hoffmann-La Roche, US 

 

"This superb account of the subject succeeds in extracting the essentials while being of sufficient depth to make it suitable for a range of readers from science and business backgrounds, from beginners to those with prior knowledge in one area. The linkage to regulatory guidelines is of particular value, making this a unique learning tool. The clarity of the text reflects the teaching style of Dr Gray on the European Course of Pharmaceutical Medicine which has been highly valued over many years".                                                                                                                                                                                                     

Professor Fritz Buhler, MD, Professor of Pharmaceutical Medicine and Pathophysiology, University of Basel, former Head of Worldwide Clinical R&D at Roche, Basel, Switzerland

About Dr Gray's Teaching

"I would wholeheartedly recommend your course to professionals, being venture capitalists, business development personnel, program managers or scientists involved in drug discovery and development". 

Pascal Longchamp, VP Business Development, Evolva SA, Basel Switzerland
 

"I have now gone through the course and I have to say I found it very useful. I wish I had access to this course when I joined AZ nine years ago”.                                                                                                                                                                                   

Principal Scientist, AstraZeneca R&D

 

"It took me a long time to find the time to summarize the feedback we received on the Drug Development module but finally here it is. It is excellent, I have never seen such a positive result on any of the courses we held so far! This is for the most past your accomplishment and I would like to thank you!"

Barbara C. Peters, PhD, Training and Education, Clinical Trial Unit, University Hospital Basel, Switzerland

 

 


 

July 2017 Updated version of full case released

April 2017  Full Idea to Market Case - small molecule and monoclonal antibody-  released

September 2016  Graybook Spreadsheet Tools released

March 20 2016  EMA launches PRIME scheme to accelerate approval of priority medicines see this link 

September 3 2015 Integrated addendum ICH E6 (GCP guideline) inlcuded in Quicklinks

Jan 6 2015  EMA publishes article on  the adaptive pathways approach -  see this link

October 8 2014 EMA to publish clinical study reports underpinning approvals after January 1 2015 See this link.

September 8 2014 EMA publishes leaflet on EU regulation, see this link.

July 8 2014 Posting of clinical trial results in EudraCT mandatory from July 21 2014 - see this link.

June 6 2014 The European Medicines Agency has selected the first two medicines to be included in its adaptive licensing pilot project.

May 29 2014 Janet Woodcock, Director of FDA's CEDR, discusses accelerated approval procedures on the FDA voice blog and cites latest FDA guidance on this topic.