Lesson Overview
The learner will gain a foundational understanding of:
- The technology and processes for discovering and developing biotech products
- Immunotherapy using monoclonal antibodies on the market or under development
- The development of a monoclonal antibody from target identification through clinical trials to market using case examples (“bench to bedside” denosumab in post-menopausal osteoporosis & oncology)
Online Lessons
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What is Biotechnology? This brief module describes the key events in the evolution of biotechnology and its application to produce useful products, encompassing a broad overview of the processes, science and strategies in drug development.
Monoclonal antibodies are biotech’s most versatile therapeutic agents. Here we discuss immunotherapy and the use of mAbs. What they are, how they are created, how they have their therapeutic effect and what applications they have now and will have in the future of clinical practice.
The full development of a monoclonal antibody as a therapeutic using denosumab as a case study. This module covers the medical needs for a new agent, then the efforts that were made to understand the biology underlying that disease and to develop an agent that could affect that biological process. Then, we will look at how the safety and efficacy of the antibody was established, what regulatory steps led to gain approval, and finally where this antibody may go in the future.
Interactive iBook for iPad
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Recommended Readings
Carter PJ.
Potent antibody therapeutics by design.
Nat Rev Immunol. 6:343-57, 2006.
Brennan FR, Morton LD, Spindeldreher S, Kiessling A, Allenspach R, Hey A, Muller PY, Frings W, Sims J.
Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies.
MAbs. 2:233-55, 2010.
Hansel TT, Kropshofer H, Singer T, Mitchell JA, George AJ.
The safety and side effects of monoclonal antibodies.
Nat Rev Drug Discov. 9:325-38, 2010
Lacey DL, Boyle WJ, Simonet WS, Paul J. Kostenuik PJ, Dougall WC, Sullivan JK, San Martin J, Dansey R
Bench to bedside: elucidation of the OPG–RANK–RANKL pathway and the development of denosumab
Nature Reviews Drug Discovery 11:401-419, 2012
Additional readings are provided within the references to each module. These are available as downloadable Workbooks (PDF transcripts) for each module in the course.
Acknowledgements
This module has been kindly provided by Amgen in the framework of the Innovative Medicines Initiative (IMI) PharmaTrain project. It has been created by the following experts:
Dr D Ian Haynes MB ChB, FFPM - Following an initial clinical background in obstetrics and gynaecology, Ian has worked in the pharmaceutical industry for the last 13 years. In this time he has worked in country and regional roles in oncology drug clinical development, medical affairs and market access. Since 2009, he has worked in Amgen as the international medical lead for the Amgen molecule, denosumab, and its applications within oncology.
Margaret Harmon PhD - The modules were produced with the expert writing and multimedia development capabilities of a team at ScienceMedia, led by Margaret Harmon, Program Director. Margaret has a PhD in Biology from the University of California at Los Angeles. She conducted post-doctoral work in the department of Pharmacology at UT Southwestern Medical Center at Dallas. Her research experience includes the Green Center for Reproductive Biology Sciences, and the Howard Hughes Medical Institute. Margaret has extensive teaching experience in physiology and cell biology. Her success as a teacher was recognized by the UCLA Board of Regents in the form of a Distinguished Teaching Award. At ScienceMedia, Margaret leads a team of doctorate-level scientific and medical writers and individually contributes instructional design to eLearning curriculum development.
It has been reviewed by the following experts:
Jean-Marie Boeynaems - Jean-Marie Boeynaems graduated from the medical school of the Université Libre de Bruxelles (ULB), where he later obtained a PhD degree in biochemistry and pharmacology. Following a post-doctoral stay at the department of pharmacology of Vanderbilt University, Nashville, he became professor of pharmacology at ULB. He was later appointed as director of the clinical pathology laboratories of Erasme academic hospital. He is a member of the Belgian Royal Academy of Medicine. His research has been devoted to the study of the P2Y receptors of extracellular nucleotides. In 1992 he founded in Brussels the PHARMED programme in pharmaceutical medicine/medicines development sciences, now recognized as Centre of Excellence in the framework of the European PharmaTrain project.
Marc de Longueville - Marc de Longueville graduated as M.D. from the Université Catholique de Louvain, Belgium. He is a member of the Faculty of Pharmaceutical Medicine and of the Belgian College of Pharmaceutical Medicine. After 8 years as medical advisor at Novartis, he moved to UCB where he is currently Medical Director Inflammation.
William Finlay - William Finlay, PhD, is Director of the Protein Discovery and Optimisation Group (PDOG), Global Biologic Therapeutics, in Pfizer. The PDOG is responsible for the discovery and molecular engineering of novel protein therapeutics for use in indications across all Pfizer Research Units and disease indications. Prior to joining Pfizer, William Finlay carried out postdoctoral research in recombinant protein engineering at several institutes, including the Centre for Biologics Evaluation and Research, FDA, National Institutes of Health.
Sandor Kerpel-Fronius - Professor Sandor Kerpel-Fronius, M.D., D.Sc. graduated from the Semmelweis University of Budapest, Hungary. He has board examinations in Clinical Laboratory Sciences and Clinical Pharmacology. First he worked in brain research, later in the development of oncologic agents in several institutes of Hungary, Sweden, USA and Holland. Subsequently he joined the pharmaceutical industry in Germany. Presently he teaches clinical pharmacology at the Semmelweis University.
