Editors
Thierry Oscar Edoh (Technical University of Munich/Germany)

Call for Chapters
Proposals Submission Deadline: March 22, 2019
Full Chapters Due: April 22, 2019
Submission Date: August 15, 2019

Introduction
Traditional Drug Development follows a well-defined paradigm in the national context. Bodies like the FDA (Food and Drug Administration) and CE (Communauté Européenne) oversee marketing approvals and product monitoring in afterward. The traditional paradigm, unfortunately, does not include the usage of digital technologies to support drug discovery and development processes. Though, an adjustment of the existing paradigm is, therefore, mandatory. This long ago already overdue enhancement will align the paradigm to fit the digital age and take advantage of it.
Although digital technologies have shown potential in contributing to transitioning to and supporting process automation, information gathering, and processing, the pharma industry does not yet fully adopt and include digital technologies in its processes. According to a recent study conducted by McKinsey, the pharma industry is slower in taking full advantages of using digital technologies in any research and development activities as well as manufacturing.
Since the topic is poorly investigated and very few research outcomes are published on it, there exists a need for an edited collection of research work on the topic, but also a set of discussion on the fundamentals, principles, and best practices of process digitalization in the industry field.

Objective
This handbook intends to investigate on one hand why the pharma industry and related fields are slow in adopting digital technologies, thus to understand the challenges and issues. On the other hand, it is important to analyze how to overcome any challenges and issues facing the discovery, development, and manufacturing process digitalization and to what extent modern digital technologies can contribute to improving drug development processes.
It, further, aims at providing relevant theoretical frameworks, the fundamentals, principles, and best practices of process digitalization, and the latest empirical research findings in the area.
The handbook is divided into five parts which present the fundamentals and principles of conventional drug development, the recent trends, and prominent cases of digitalization of drug discovery and development processes.
It will be written for professionals who want to improve their understanding of the strategic role of trust at different levels of information and knowledge society, that is, trust at the level of the global economy, of networks and organizations, of teams and work groups, of information systems and, finally, trust at the level of individuals as actors in the networked environments.

Target Audience
The target audience of this handbook will be composed of professionals, pharma industry, related sub-industry, and researchers working in the field of drug discovery and development. Moreover, this handbook will provide insights and support executives concerned with the digitalization of their discovery, development, and manufacturing processes.

Recommended Topics
Each chapter should provide a series of
• Questions and
• Solutions
Part I: Fundamentals, Principles, and Limitations of the conventional Drug Development Paradigm
This part of the handbook aims at presenting the fundamentals of conventional drug discovery and development process in low-, Middle- and high-income countries and give insight into the particularities of each part of the world. Additionally, it is worth discussing the limitation, challenges of these conventional paradigms in stating the problem as well as the deeper causes. Finally, this part of the handbook should show why the conventional drug discovery and development should move to the next step and thus enter the digital age.
• Fundamentals and Principles of Traditional Drug Development Paradigm
• Challenges facing Traditional Drug Development Around the World
• Drug Development Processes, Methodologies, and Paradigm: Low- and Middle-Income Countries Versus High-Income Countries
• Pre-clinical and Clinical Research and Challenges
• Clinical Testing and Related Ethical Challenges and Transparency Issues
• Drug and Medical Device Review
• Therapy and/or Diagnosis Development: Process and Paradigm
• Personalized Medicine Paradigm
• Etc.
Part II: Recent Trends in Drug Development and the Digital Curve
The first part of the handbook would present the “WHY” the conventional drug development process and paradigm should enter the digital age. This part aims at presenting the recent trends in the drug development around the world and especially pointing out the prominent role of the Information and Communication Technology in the entire process. It will be interesting to state some perspective for the future of drug development.
• Data and Information-Driven Drug Discovery and Development
• Medical Devices as Drug: Recent Trends
• Blockchain for More Transparency in Clinical Trials
• Blockchain for Secure All Along the Value Chain (from Discovery to Approval)
• Digital Technology based Drug and Medical Devices Reviews
• Internet of Things Enabled Asset and Ingredient Traceability
• Digital as the main Data Source for biomolecular platforms
• Digital Technology and Personalized Medicine from genetical and integrative Aspects (ex. Personalized medicine, from genomics, proteomics, and epigenetics, etc.)
• Digital Drug Development: Promises and Pitfalls
• Knowledge transfer
• Inter-organizational communication
• Knowledge-centric best practices
• Information security
• Knowledge creation
• Knowledge representation
• Organizational learning Management and Information systems
• Etc.
Part III: Digital Networking Technologies and Modern Drug Development
Networking Technologies, as well as infrastructure, are playing an important role in the digital age since they are underpinning the digital processes for example data transmission, data storage or publishing. Many technologies are available and used for precise purposes.
This part of the handbook aims at investigating generations of wired and wireless communication technologies and underpinning infrastructures that are involved in drug developing processes.
This part should focus on networking technologies and infrastructures in Low- and Middle-Income countries as well as in High-Income countries and on which benefits drug discovery, development, and manufacturing can take from them in each context and which challenges are facing.
Fiber optics, LTE, and 4G mobile communication are not available everywhere on the globe. Though, it is, therefore, worth getting insight into the impacts of the available technologies on drug development.
• Modern Network Infrastructure for Drug Development
• Network and Telecommunication in Drug Development in Low- and Middle-Income Countries
• Network and Telecommunication in Drug Development in High-Income Countries
• Network related Quality of Service
• User Experience (QoE)
• The global network
• Etc.
Part IV: Regulatory Drug Affairs and Marketing Authorization: Tradition and Trends in the Digital Age
Regulatory Drug Affairs and Marketing Authorization are intended to secure and prevent the patient from any health damage.
Regulators like FDA (USA) and CE (Europe) are regularly monitor released and marketed drugs and can recall some in the case of damage.
This part should discuss the marketing authorization process in the digital age, present some significant trends, and compare conventional processes with recent or trending ones. It is worth discussing here:
• Traditional Regulatory Drug Affairs Process and Paradigm (around the world)
• Common Regulatory Uncertainty in the Pharma Industry
• Common Pre- and Post-Market Safety Monitoring
• Digital Technology Supported Drug Regulatory Affairs and Marketing Authorization
• Blockchain and Regulatory Drug Affairs
• Internet of Things Enabled Drugs Monitoring
• Artificial Intelligence in the Marketing Authorization Processes
• Digital Technology and Drug Approval Flexibility and Process Interaction
• Towards an End of Off-Label-Use Through Flexible Drug Approval and Marketing?
• User-Data-Driven Flexible Marketing Approval
• Trust Model in the Regulatory
Part V: Cases of Drug Development Processes Using Digital Technologies
This part of the handbook should discuss some concrete drug development projects that entirely are being supported by digital processes. The contributions are requested to point the digital aspects and their beneficial aspects.
• Prominent cases

Submission Procedure
Researchers and practitioners are invited to submit on or before March 22, 2019, a chapter proposal of 1,000 to 2,000 words clearly explaining the mission and concerns of his or her proposed chapter. Authors will be notified by April 1, 2019, about the status of their proposals and sent chapter guidelines. Full chapters are expected to be submitted by April 22, 2019, and all interested authors must consult the guidelines for manuscript submissions at http://www.igi-global.com/publish/contributor-resources/before-you-write/ prior to submission. All submitted chapters will be reviewed on a double-blind review basis. Contributors may also be requested to serve as reviewers for this project.
Note: There are no submission or acceptance fees for manuscripts submitted to this book publication, Handbook of Research on Drug Discovery and Development in the Digital Age. All manuscripts are accepted based on a double-blind peer review editorial process.
All proposals should be submitted through the eEditorial Discovery®TM online submission manager.

Publisher
This book is scheduled to be published by IGI Global (formerly Idea Group Inc.), publisher of the "Information Science Reference" (formerly Idea Group Reference), "Medical Information Science Reference," "Business Science Reference," and "Engineering Science Reference" imprints. For additional information regarding the publisher, please visit www.igi-global.com. This publication is anticipated to be released in 2019.

Important Dates
March 22, 2019: Proposal Submission Deadline
April 1, 2019: Notification of Acceptance
April 22, 2019: Full Chapter Submission
June 20, 2019: Review Results Returned
August 1, 2019: Final Acceptance Notification
August 15, 2019: Final Chapter Submission

Inquiries
Thierry Edoh
oscar.edoh@gmail.com

Propose a chapter for this book