Delta Scan: The Future of Science and Technology, 2005-2055: Customisation of Drugs Through Biotechnology

Key Pages

Category:
Science and Technology

Domain:
Biology and Biotechnology

Keywords:
Biotechnology R&D, genetics - medicine, health care, disease, genotyping, pharmacogenetics, drug delivery

Outlook:
Chemical-based drug development is likely to be displaced by methods based on biotechnology, promising to make possible individualized drug formulas that are more efficacious than 'blockbuster drugs' in the treatment of disease.

Summary Analysis:
As biotechnology replaces chemistry as the primary mechanism for new drug development, the types of drugs being developed will change. Due mainly to the cost of drug development, chemistry based drug development has favoured 'blockbuster drugs' which serve large population segments in fighting widespread diseases. But the efficacy and tolerability of today's drugs is remarkably low: according to GlaxoSmithKline, 90% of today's drugs work for only 30% to 50% of the people for whom they are prescribed. Furthermore, adverse drug reactions account for a surprising number of hospitalizations and deaths: one analysis published in JAMA in 1998 found such reactions to be responsible for more than 2 million hospitalizations and 100,000 deaths in the US in one year. Biologics, or individualized medicines, could help change these figures and have a significant impact on health care.

The advances and benefits expected to accrue from individualized biologics are likely to be driven by single nucleotide polymorphism (SNP) mapping technologies, which could enable us to predict precisely which drugs individuals are most likely to respond to on the basis of their genetic make-up. These technologies should make precise customisation of drug formulas, treatment duration, and dosing for individuals possible. Drug development based on biotechnology is also likely to be far less expensive than that based on chemistry.

Implications:

Potential for earlier and more efficacious treatment of diseases
Decrease in the number of chemical-based drugs and increase in the number of biotech-based drugs sold, with uncertain consequences for the pharmaceutical industry
Potential for faster drug approval
Potential for more drugs to come to market, as drug trials that are abandoned today due to harmful consequences can continue in the future with at-risk patients excluded

Early Indicators:

Identification of a known susceptibility gene for Alzheimer's disease on chromosome 19 by using association analysis with SNPs
Current use of SNP mapping to identify adverse events from pharmacogenetics
Establishment of the International HapMap Project, built upon haplotype patterns, to shortcut SNP mapping

What to Watch:

SNP mapping technologies result in identification of susceptibility genes for migraine and psoriasis.

Parallels/Precedents:

Enablers/drivers:

Significant research into new drug delivery technologies, spurred by the challenge of delivering biologic medicines with their relatively large molecular structure
Reduction of the cost of genotyping by a factor of 4 or 5 to between $1,000 and $2,000

Leaders:

The SNP Consortium (a public/private collaboration that has to date discovered and characterized nearly 1.8 million SNPs) [link]
International Hap Map Project [link]
National Human Genome Research Institute (the work of Francis S. Collins)
University of Tokyo Human Genome Center (the work of Yusuke Nakamura, M.D.)
Riken Yokohama Institute, Japan [link]
GlaxoSmithKline (the work of Allen D. Roses)
Wellcome Trust Sanger Institute [link]
Genome Canada [link]
Chinese National Human Genome Center, Beijing [link]

Figures:

Sources:

Roses, Allen D. 2000 "Pharmacogenetics and the practice of medicine." Nature 405(6788):857-865.
"The Great Drugs Lottery." The Guardian, 9 December 2003.
Falcone, Linda Hull. "Pharmacogenetics: Where Will it Take Us?" Biotechnology Healthcare, July/August 2004.
Collins, Francis S., Eric D. Green, Alan E. Guttmacher, and Mark S. Guy. 2003. "A Vision for the Future of Genomics Research". Nature 422: 835-847.
"A Revolution in R&D: How Genomics and Genetics are Transforming the Biopharmaceutical Industry." Boston Consulting Group, 2001.
"Safer Medicines." November 2005. The Academy of Medical Sciences, UK [link]
HGM 2006, HUGO's 11th Human Genome Meeting, Finland [link]
Brain Science and Addiction - Genomics State of Science report [link]
"Drug Trial Horror -- the Official Interim Report." New Scientist. April 05 2006 [link]

At A Glance:
When:
11–20 Years

Where:
Global

How Fast:
Years

Likelihood:
High

Impact:
Medium-High

Controversy:
Medium

Related Outlooks:
"Evo-devo": [link]

About this outlook: An outlook is an internally consistent, plausible view of the future based on the best expertise available. It is not a prediction of the future. The AT-A-GLANCE ratings suggest the scope, scale, and uncertainty associated with this outlook. Each outlook is also a working document, with contributors adding comments and edits to improve the forecast over time. Please see the revision history for earlier versions.

Category:	Science and Technology
Domain:	Biology and Biotechnology
Keywords:	Biotechnology R&D, genetics - medicine, health care, disease, genotyping, pharmacogenetics, drug delivery
Outlook:	Chemical-based drug development is likely to be displaced by methods based on biotechnology, promising to make possible individualized drug formulas that are more efficacious than 'blockbuster drugs' in the treatment of disease.
Summary Analysis:	As biotechnology replaces chemistry as the primary mechanism for new drug development, the types of drugs being developed will change. Due mainly to the cost of drug development, chemistry based drug development has favoured 'blockbuster drugs' which serve large population segments in fighting widespread diseases. But the efficacy and tolerability of today's drugs is remarkably low: according to GlaxoSmithKline, 90% of today's drugs work for only 30% to 50% of the people for whom they are prescribed. Furthermore, adverse drug reactions account for a surprising number of hospitalizations and deaths: one analysis published in JAMA in 1998 found such reactions to be responsible for more than 2 million hospitalizations and 100,000 deaths in the US in one year. Biologics, or individualized medicines, could help change these figures and have a significant impact on health care. The advances and benefits expected to accrue from individualized biologics are likely to be driven by single nucleotide polymorphism (SNP) mapping technologies, which could enable us to predict precisely which drugs individuals are most likely to respond to on the basis of their genetic make-up. These technologies should make precise customisation of drug formulas, treatment duration, and dosing for individuals possible. Drug development based on biotechnology is also likely to be far less expensive than that based on chemistry.

	Implications:	Potential for earlier and more efficacious treatment of diseases Decrease in the number of chemical-based drugs and increase in the number of biotech-based drugs sold, with uncertain consequences for the pharmaceutical industry Potential for faster drug approval Potential for more drugs to come to market, as drug trials that are abandoned today due to harmful consequences can continue in the future with at-risk patients excluded
	Early Indicators:	Identification of a known susceptibility gene for Alzheimer's disease on chromosome 19 by using association analysis with SNPs Current use of SNP mapping to identify adverse events from pharmacogenetics Establishment of the International HapMap Project, built upon haplotype patterns, to shortcut SNP mapping
	What to Watch:	SNP mapping technologies result in identification of susceptibility genes for migraine and psoriasis.
	Parallels/Precedents:
	Enablers/drivers:	Significant research into new drug delivery technologies, spurred by the challenge of delivering biologic medicines with their relatively large molecular structure Reduction of the cost of genotyping by a factor of 4 or 5 to between $1,000 and $2,000
	Leaders:	The SNP Consortium (a public/private collaboration that has to date discovered and characterized nearly 1.8 million SNPs) [link] International Hap Map Project [link] National Human Genome Research Institute (the work of Francis S. Collins) University of Tokyo Human Genome Center (the work of Yusuke Nakamura, M.D.) Riken Yokohama Institute, Japan [link] GlaxoSmithKline (the work of Allen D. Roses) Wellcome Trust Sanger Institute [link] Genome Canada [link] Chinese National Human Genome Center, Beijing [link]
	Figures:
	Sources:	Roses, Allen D. 2000 "Pharmacogenetics and the practice of medicine." Nature 405(6788):857-865. "The Great Drugs Lottery." The Guardian, 9 December 2003. Falcone, Linda Hull. "Pharmacogenetics: Where Will it Take Us?" Biotechnology Healthcare, July/August 2004. Collins, Francis S., Eric D. Green, Alan E. Guttmacher, and Mark S. Guy. 2003. "A Vision for the Future of Genomics Research". Nature 422: 835-847. "A Revolution in R&D: How Genomics and Genetics are Transforming the Biopharmaceutical Industry." Boston Consulting Group, 2001. "Safer Medicines." November 2005. The Academy of Medical Sciences, UK [link] HGM 2006, HUGO's 11th Human Genome Meeting, Finland [link] Brain Science and Addiction - Genomics State of Science report [link] "Drug Trial Horror -- the Official Interim Report." New Scientist. April 05 2006 [link]

At A Glance:	When:	11–20 Years
	Where:	Global
	How Fast:	Years
	Likelihood:	High
	Impact:	Medium-High
	Controversy:	Medium