Translating Molecules into Medicines : Cross-Functional Integration at the Drug Discovery-Development Interface / edited by Shobha N. Bhattachar, John S. Morrison, Daniel R. Mudra, David M. Bender.

Format:

Book

Contributor:

Bhattachar, Shobha N., editor.

Morrison, John S., editor.

Mudra, Daniel R., editor.

Bender, David M., editor.

SpringerLink (Online service)

Series:

AAPS advances in the pharmaceutical sciences series 2210-7371 ; 25.

AAPS Advances in the Pharmaceutical Sciences Series, 2210-7371 ; 25

Language:

English

Subjects (All):

Medicine.

Pharmaceutical technology.

Biomedicine.

Local Subjects:

Biomedicine.

Physical Description:

1 online resource.

Contained In:

Springer eBooks

Place of Publication:

Cham : Springer International Publishing : Imprint: Springer, 2017.

System Details:

text file PDF

Summary:

Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field. The authors of each chapter address the paradox between the molecular understanding of diseases, drug discovery, and drug development. Laying out the detailed trends from various fields, different chapters are dedicated to target engagement, toxicological safety assessments, and the compelling relationship of optimizing early clinical studies with design strategies. The book also highlights the importance of balancing the three pillars: sufficient efficacy, acceptable safety and appropriate pharmacokinetics, all of which are crucial to successful efforts in discovery and development. With discussions regarding the combined approaches of molecular research, personalized medicine, pre-clinical and clinical development, as well as targeted therapies-this compendium is a flexible fit, perfect for professionals in the pharmaceutical industry and related academic fields.

Contents:

Pharmaceutical Industry Performance

Scope: productivity, success rates and costs

Competitive landscape and regulatory requirements across different geographies. Drivers for increased efficiency, innovative approaches, and outlook for the next decade

Unmet needs, major therapeutic areas of R&D focus and investment

New Product Planning: Scope: General overview of patient profiles from different therapeutic areas, competitive intelligence, standard of care considerations, and impact of this information on the definition of NCE and product attributes and timelines

Discovery Chemistry and Technologies: Scope: The druggable chemistry space, current targets of interest, new discovery technologies to define the binding pockets and compound attributes for a druggable target

Challenges, examples of innovation and success

Chemistry (Authors: TBD)

Biology, genomics, target validation

In silico tools

Early Discovery: Target of Interest through Lead: Scope: Effective and dynamic cross-functional collaboration between in vitro biology, chemistry, pharmacology, ADME, preformulation and toxicology to achieve Druggable Leads

Application of in silico, in vitro and in vivo tools and translational approaches and strategies for integrated assessment and creation of druggable and developable lead scaffolds and assessing affinity and druggability at the scaffold level

FBDD, druggable scaffolds, hit screening and making compounds

Integrated assessment of Lead readiness, SRA

Lead Optimization: Scope: Effective and dynamic cross-functional collaboration between in vitro biology, chemistry, pharmacology, ADME, preformulation and toxicology to achieve target engagement with a druggable candidate

Candidate Selection

Application of in silico, in vitro and in vivo tools and translational approaches and strategies for integrated assessment and identification of druggable and developable Clinical Candidate(s) with line of sight for clinical development

Include description of tools, examples of application/case studies

Developability including formulations and bio-relevant dissolution

Chemistry scale up

Early Clinical Development: Scope: Strategies for clinical trial study designs in the context of different therapeutic areas, clinical formulations, safety margins, biomarkers, tailored therapeutics, PK/PD modeling, controlled release formulations

John Morrison working out the details of this section

Alternative Drug Delivery: Scope: non-oral formulations based on patient/caregiver/marketing considerations

Design, definition of compound attributes and development

Regulatory aspects

Industry Academia Collaboration

Outlook for the Future.

Other Format:

Printed edition:

ISBN:

9783319500423

Access Restriction:

Restricted for use by site license.