Healthcare Biotechnology

A Practical Guide

Dimitris Dogramatzis

• Publisher: CRC Press
• Year: 2016
• Print ISBN:
  9780367452278
• Edition: 1
• eBook ISBN:
  9781439899359
• Topic: Business
• Subtopic: Management
• Index: Business

Foreseeing and planning for all of the possibilities and pitfalls involved in bringing a biotechnology innovation from inception to widespread therapeutic use takes strong managerial skills and a solid grounding in biopharmaceutical research and development procedures. Unfortunately there has been a dearth of resources for this aspect of the field.

I

The Healthcare Biotechnology Industry

CHAPTER 1

Bioeconomy

Biotechnology has created more than 200 new therapies and vaccines, including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders.

Source: Courtesy of Biotechnology Industry Association (BIO), Washington, DC, 2008.

HUMANS HAVE BEEN USING biotechnology to produce food and medicine since prehistoric times. Karl Ereky, a Hungarian engineer, suggested in 1919 the very term “biotechnology.” In 1953, James D. Watson and Francis Crick published a paper in Nature describing the double helix (1953), eventually receiving the Nobel Prize in Physiology in 1962 (http://nobelprize.org/nobel_prizes/medicine/laureates/1962/). And, in 1976, Robert A. Swanson and Herbert W. Boyer founded Genentech, eventually succeeding in launching the first biosynthetic insulin in 1982, in collaboration with Eli Lilly.

BIOTECHNOLOGY DEFINITIONS

The United Nations’ Convention on Biological Diversity (2009; http://www.cbd.int/convention/convention.shtml) defines biotechnology as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.” Similarly, the U.S.-based Biotechnology Industry Association (BIO; http://www.bio.org) defines it as “a collection of technologies that capitalize on the attributes of cells, such as their manufacturing capabilities, and put biological molecules, such as DNA and proteins, to work for us” (2008). Some of these “exotic” biotechnologies have been categorized by the Organization for Economic Cooperation and Development (OECD; http://www.oecd.org) in Table 1.1 (2005). Most of these terms will be further elaborated throughout this book.

TABLE 1.1 Which Are the Most Commonly Used Biotechnologies?

Source: OECD, Statistical Definition of Biotechnology, Paris, France, updated in 2005, http://www.oecd.org/document/42/0,3343,en_2649_34537_1933994_1_1_1_37437,00.html (accessed on January 27, 2010). With permission.

WHAT IS HEALTHCARE BIOTECHNOLOGY

Biotechnology is based on a thorough understanding of biological, biochemical, and genetic processes in humans and other species. These processes were greatly elaborated after the description of the double helix, and over the last 50 years have gradually produced a collection of technologies able to describe and, most importantly, influence cellular, molecular, and genetic phenomena. This influence has led to an explosion of scientific and commercial applications across several industrial sectors (see Figure 1.1), geometrically accelerating since the dawn of the twenty-first century, leading many experts to label it as the “biotechnology century.”

Red, Green, Blue, and White Biotechnologies

Today, there exist multiple commercial applications of biotechnology (biotech). More specifically, four different commercial sectors exist, each given its own corresponding coding color. In particular, healthcare biotech is color-coded red (from the red blood cells) and includes the biosynthetic production of medicines and vaccines, stem-cell research, DNA sequencing, and more. Agricultural (green) biotech includes biotransformation and biomediation. Marine (blue) biotech includes species preservation, viral genomics, etc. Industrial (white) biotech is involved, among other fields, with alternative energy sources. Finally, a fifth, interdisciplinary application, bioinformatics, is involved with sequence analyses, evolutionary biology, etc. For more commercial applications, see Table 1.2.

Healthcare (Red) Biotechnology

Of all the commercial applications mentioned above, healthcare biotechnology has had both a profound significance in saving, extending, and improving human lives, as well as significant commercial returns for the scientists and entrepreneurs involved.

By all accounts, it is the most important commercial stream mentioned above and will, from now on, be the focus of this book. Broadly speaking, healthcare biotech is about diagnosis, prevention, and treatment of disease. For diagnosis of disease, biotech has produced a series of new biomarkers, and the tools to measure them. It has also greatly reduced the sample volumes required, the diagnostic-related risks, and the waiting periods for results to be known. Furthermore, it has increased diagnostic portability, accuracy, sensitivity, and reproducibility.

FIGURE 1.1 Biotechnology applications.

TABLE 1.2 Which Are the Commercial Applications of Biotechnology Today?

Health Care (Red)	Agricultural (Green)	Marine (Blue)	Industrial (White)	Bioinformatics
Bionanotechnology	Biomediation	Marine pharmaceuticals	Alternative energy	Genome annotation
Bionics	Bioluminescence	Microbes	Oxidoreductase	Evolutionary biology
Cloning	Biotransformation	Pollutants	Food contamination testing	Protein structures
Cybernetics	New plant varieties	Species preservation	Microbial enzymes	Biodiversity
Diagnostics	Biopesticides	Viral genomics	Organic chemicals	Sequence analysis
DNA sequencing	Pathogen resistant crops		Mineral recovery	Cancer mutations
Enzymes	Improved livestock		Bioelectronics	Combinatorial chemistry
Gene therapy	Biofarming		Waste reduction	Nucleic acid amplification
Genetics	Veterinary therapeutics
Immune globulins	Veterinary diagnostics
Molecular energy	Veterinary vaccines
Monoclonal antibodies
Pharmacogenomics
Protein therapeutics
Stem cells
Tissue replacement
Toxins
Vaccines

Source: Author’s research.

For prevention of disease, genomics has led the way of identifying potential disease sufferers a...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Dedication
• Table of Contents
• Preface
• Author
• PART I The Healthcare Biotechnology Industry
• PART II Intellectual Property
• PART III Funding
• PART IV New Product
• PART V Marketing
• PART VI Running the Business
• Appendices
• INDEX