Biotechnology and Biopharmaceuticals Transforming Proteins and Genes into Drugs

Rodney Ho is a Milo Gibaldi Endowed Professor at the University of Washington School of Pharmacy in Seattle. He is founder and principal scientist of Impel NeuroPharma and Nova Theranostics, as well as a visiting professor at the School of Chemical Biology and Biotechnology at Peking University. Dr. Ho co-edited the first edition of "Biotechnology and Biopharmaceuticals", and has served in an editorial capacity for?numerous journals including J. of Pharmaceutical Sciences, Frontiers in Biosciences, and Open Journal: Clinical Medicine: Blood Disorders.

Chapter 2. Comparative Drug Developmental Path for Proteins and Genes versus Small
Molecule Therapeutics
1) Transforming new molecular entities to drug
2) Key differences between macromolecule and small chemical products
3) Current trends in drug development

Chapter 3. Biotechnology industry perspective on drug development
1) Introduction
2) The role of Orphan Drug Act and market exclusivity
3) Clinical leverage strategy
4) Therapeutic target considerations
5) Biosimilar or Biogeneric

Chapter 4. Biopharmaceutical technologies and processes in drug development
1) Application of biotechnologies in drug discovery and development
2) Large-scale up in production of recombinant proteins
3) Quality control and assurance

Chapter 5. Pharmacology, toxicology, therapeutic dosage formulations and
clinical responses
1) Clinical pharmacology and toxicology
2) Dosage form and route of administration
3) Drug concentration and therapeutic response

Chapter 6. Clinical trial and approval process
1) FDA review and approval process
2) Biologic license and new drug license
3) Preclinical and clinical testing requirement
4) Post approval monitoring
5) Globalization or harmonization of drug approval

Part II: Therapeutics based on Biotechnology-proteins and nucleic acids

Chapter 7. Hematopoietic growth and coagulation factors
1) Overview
2) Monographs

Chapter 8. Interferon and cytokines for anti-infective and cancer therapy
1) Overview of IFN in cancer therapy (expert commentary)
2) Overview of IFN in antiviral therapy (expert commentary)
3) Overview of IFN in multiple sclerosis
4) Monographs

Chapter 9. Hormones
1) Overview of growth hormones (expert commentary)
2) Monographs

Chapter 10. Enzymes
1) Overview of enzyme therapeutics
2) Monographs

Chapter 11. Antibodies and derivatives
1) Overview on antibody therapeutics
2) Monographs

Chapter 12. Vaccines
Overview Hu and Ho

Chapter 13. Nucleic acid based products
1) Overview of antisense and aptamers
2) Monographs

Chapter 14. Others (no overview)
Monographs

Part III: Future Directions

Chapter 15. Advanced drug delivery systems
1) Rationale and basic principles
2) Physiologic and mechanistic approach
3) Device based approaches
4) Molecular approaches

Chapter 16. Individualized and personalized medicine: Integration of pharmacokinetic and pharmacogenetic principles in drug therapy
1) Overview of factors governing inter-individual variations
2) Historical perspective on pharmacogenetics
3) Pharmacogenetcs: Drug metabolism and transport
4) Pharmacogenetics: Therapeutic response
5) Individualized gene-based medicine: A mixed blessing
6) Current and potential applications of pharmacogenetics and genomics
7) Summary

Chapter 17. Gene and cell therapy
1) Overview of gene and cell therapeutics
2) Delivery and expression of genes encoding for protein functions
3) Cell based therapeutics-stem cells and immune cell therapies

Chapter 18. Integration of discovery and development: The role of genomics and proteomics
1) Overview
2) Integration of discovery and development
3) Genomics: The first link between sequences and drug targets
4) Proteomics: From sequences to functions
5) Integrating proteomic and genomic tools to accelerate drug development
6) Summary

Chapter 19. Outcome research and Pharmacoeconomics in drug development and clinical use

Chapter 20. Summary and Future prosposects

Apendix I. Dosage form, Pharmacokinetics and Disposition Data

Appendix II. Molecular Characteristiocs and Therapeutic Use

Appendix III. Nomenclature of Biotechnology Products

Appendix IV. Synonyms of Trade, Common and Scientific Names

Appendix V. Other Information Tables

Index

Monographs Index

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