Bioscience Chapter Database :: 3635 Chapters Now Online

Chapter category:

Translational Medicine--a Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers

This chapter appears in the following book:

Pharmaceutical Biotechnology

Edited by: Carlos Alberto Guzmán and Giora Feuerstein
ISBN: TBA
» Get more information about this book at landesbioscience.com «

Chapter authors:
Mark Day, J. Lynn Rutkowski and Giora Feuerstein


[+] view image
The success rate of novel medical entities that are submitted for registration by the regulatory agencies and followed successful marketing has been stagnating for the past decade. Failure in efficacy and safety continue to be the prime hurdles and causes of failure. Translational medicine is a new function within the pharmaceutical industry R&D organization aimed to improve the predictability and success of drug discovery and development. Biomarkers are the essence of the translational medicine strategy focus on disease biomarker, patient selection, pharmacodynamic responses (efficacy and safety) target validation, compound‑target interaction). Successful deployment of biomarkers research, validation and implementation is adopted and embraced as key strategy to improved the drug discovery and development towards new medical entities.

Mark Day

J. Lynn Rutkowski

Giora Feuerstein
Wyeth Research

» Access chapter for $19



Additional chapters from this book:

Immune Interventions of Human Diseases through Toll-Like Receptors

Cevayir Coban, Ken J. Ishii and Shizuo Akira

Toll-like receptors (TLRs) are the immune sensors for infections, triggering robust innate immune activation followed by protective adaptive immunity against various infectious diseases. Recent eviden...

Virus‑Like Particles as a Vaccine Delivery System: Myths and Facts

Polly Roy and Rob Noad

Vaccines against viral disease have traditionally relied on attenuated virus strains or inactivation of infectious virus. Subunit vaccines based on viral proteins expressed in heterologous systems hav...

The Antigenome: From Protein Subunit Vaccines to Antibody Treatments of Bacterial Infections

Carmen Giefing, Eszter Nagy and Alexander von Gabain

New strategies are needed to master infectious diseases. The so-called “passive vaccination”, i.e., prevention and treatment with specific antibodies, has a proven record and potential in the manageme...

The Role of Nanobiotechnology in Drug Discovery

Kewal K. Jain

The potential applications of nanotechnology in life sciences, particularly nanobiotechnology, include those for drug discovery. This review shows how several of the nanotechnologies including nanopar...

Natural Products in Drug Discovery: Present Status and Perspectives

Gabriella Molinari

Natural products and their derivatives have been and continue to be rich sources for drug discovery. However, natural products are not drugs. They are produce in nature and through biological assays t...

Immune Modulators with Defined Molecular Targets: Cornerstone to Optimize Rational Vaccine Design

Thomas Ebensen and Carlos A. Guzmán

Vaccination remains the most valuable tool for preventing infectious diseases. However, the performance of many existing vaccines should be improved and there are diseases for which vaccines are still...

HSV as a Vector in Vaccine Development and Gene Therapy

Peggy Marconi, Rafaela Argnani, Alberto L. Epstein and Roberto Manservigi

The very deep knowledge acquired on the genetics and molecular biology of herpes simplex virus (HSV), major human pathogen whose lifestyle is based on a long-term dual interaction with the infected ho...

Conotoxin Venom Peptide Therapeutics

Richard J. Lewis

Venom peptides offer enormous opportunity for the discovery of peptide drug leads. This review focusses on the potential of cone snails that have developed arrays of small peptides as part of highly e...

Genome‑Based Vaccine Development: A Short Cut for the Future

Danilo Gomes Moriel, Maria Scarselli, Laura Serino, Marirosa Mora, Rino Rappuoli and Vega Masignani

Bacterial infectious diseases remain a major cause of deaths and disabilities in the world. Although conventional vaccinology approaches were successful in conferring protection against several diseas...

Applications of Bacterial Ghosts in Biomedicine

extra-please delete , extra-please delete and extra-please delete

Bacterial Ghosts (BG) are empty cell envelopes of Gram‑negative bacteria which have been produced by E‑mediated lysis. BG are devoid of cytoplasmic content and in combination with the expr...

Protein Pharmaceuticals: Discovery and Preclinical Development

Davinder S. Gill

Proteins are natural molecules that carry out important cellular functions within our bodies. Their precise role is crucial to the maintenance of good health. Malfunctioning proteins or those not prod...

New Strategies to Overcome the Drawbacks of Currently Available Flu Vaccines

Epifanio Fichera, Diana Felnerova, Robert Mischler, Jean-François Viret and Reinhard Glueck

Vaccination represents the most efficient tool to control morbidity and mortality resulting from influenza infections in humans. The currently licensed influenza vaccines provide good protection level...

Translational Medicine--a Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers

Mark Day, J. Lynn Rutkowski and Giora Feuerstein

The success rate of novel medical entities that are submitted for registration by the regulatory agencies and followed successful marketing has been stagnating for the past decade. Failure in efficacy...

Innovative Approaches to Develop Prophylactic and Therapeutic Vaccines against HIV/AIDS

Aurelio Cafaro, Iole Macchia , Maria Teresa Maggiorella, Fausto Titti and Barbara Ensoli

The acquired immunodeficiency syndrome (AIDS) emerged in the human population in the summer of 1981. According to the latest United Nations estimates, worldwide over 33 million people are infected wit...


SIGN IN

Email:


Password:


lost password?




[ Home | Authors | Editors | Custom Books | Chapter Reprints | Subscribe | Contact | Biotoons ]