The Gray Book e-text covers all aspects of development from preclinical through clinical development to marketing. There are 18 sections, each covering one major area as shown below. An additional short section describes a "perfect case" to illustrate the overall process.

1. AN OUTLINE OF THE DEVELOPMENT PROCESS
2. DISCOVERY OF NEW MEDICINES
3. DEVELOPMENT OF MEDICINES: PLANNING
4. NON-CLINICAL SAFETY TESTING
5. PHARMACEUTICAL DEVELOPMENT/MANUFACTURING
6. REGULATORY ISSUES part 1(GUIDELINES/IND/IMPD/JAPAN/MEETINGS)
7. INTRODUCTION TO CLINICAL RESEARCH, GOOD CLINICAL PRACTICE
8. STATISTICS AND DATA MANAGEMENT
9. DRUG SAFETY, PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
10. INTRODUCTION TO PHARMACOKINETICS, POPULATION PK, DRUG-DRUG INTERACTIONS AND SPECIAL POPULATIONS
11. PHASE I STUDIES
12. PHASE IIA STUDIES
13. PHASE IIB and PHASE III STUDIES
14. REGULATORY ISSUES Part 2: Filing for approval (MAA/NDA Filings)
15. PHARMACOECONOMICS
16. PATENTS
17. PROJECT VALUATION
18. MARKETING, INFORMATION, PROMOTION AND EDUCATION

The core e-text is hyperlinked to key regulatory guidelines. It is regularly updated.

A Synopsis of the text is available in English, German, French, Japanese and Chinese

A Quicklinks section provides rapid guideline access

The Toolkit  contains Excel based templates to assist in the following activities:

-Target product profile, target label and core profile development

- Issue identification and management

- Key activity and action plan documentation

- Cost planning

- Development scenario building

- Go/no-go decision tracking

- Competitor documentation

- Sales forecasting

- NPV calculation

- Project upside identification

- Recruitment tracking

Internet-based courses using the e-text and tools are available as introductory and full versions, teh latter with hands-on case studies to give full appreciation of all key development activities at a practical level - see Courses for more information.

Courses

The introductory course using the e-text supplemented with slides, self-assessment questions and case studies are available (see courses and contact admin@graybook.net).

The unique idea to market course uses the e-text and e-tools including cost spreadsheets  with Gantt charts to follow the development of a new mediciane from concept and discovery to marketing

The Author

Julian Gray is a physician working in medicines development for 25 years internationally. He is the author of the e-book Gray's Global Medicines Development (formerly Gray's Drug Development), updated annually and hyperlinked to regulatory guidelines. He studied medicine in the UK , obtaining a BA with first class honours from Oxford University in 1978 and MBBS from the University of London in 1981. He subsequently undertook training in internal medicine, clinicalpharmacology and neurology obtaining the Membership of the Royal College of Physicians (UK) in 1984 and a D.Phil (PhD) in neuropharmacology from Oxford University in 1988.

In 1988 he took up a position of medical expert at Sandoz in Basel, developing drugs in the neurology area including the early

 

 

 

 

 

 

 

clinical studies of Exelon in Alzheimer's disease. In 1992 he took up the position of International Clinical Leader at Hoffmann La Roche in Basel, leading the development of clinical projects globally. He gained experience also in business aspects during this time through an attachment in the strategic marketing and business development department, completing a thesis on financial and strategic aspects of codevelopment and obtaining an MBA with distinction from Oxford Brookes University. He subsequent left to become Vice President of Clinical R&D at Praecis Pharmaceuticals in Cambridge Massachusetts to work on an early stage project in Alzheimer's disease. In 2000 he took up the role of head of CNS clinical area at Eisai, based in London, leading early and late stage clinical projects globally. Since 2004 he has worked as a consultant to the industry on development, taking a leading role in CNS projects on a day to day basis on behalf of companies internationally. He has also started a virtual development group, Neuroglobe Ltd, to facilitate the development of special CNS projects of high medical value which might not otherwise happen.

He previously established a successful  course  for the MRCP examination, which ran for 10 years in Guildford UK and been a longstanding member of the teaching faculty of the European Course in Pharmaceutical Medicine at the University of Basel, and has participated in its sister courses, ACDRS at UCSF in the US and CCDRS at the Peking University Medical School in China. He is the principal teacher of the Drug Development module of the Clinical Trial Professional Course at the University of Basel.The work to produce Gray's Global Medicines Development, commenced in 2006, along with the production of a popular one-day, film-based course showing 15 experts developing a drug from lab to market.   

 

 

 

 

 

 

 

 

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.