Slide 1 : September 30, 2005 Lan-Yang Ch’ang, Ph.D.
Institute of Biomedical Sciences
Academia Sinica
lychang@ibms.sinica.edu.tw Scientific Impacts to the Biotech Future
Slide 2 : Scientific Impacts to Human life Physics – Nuclear Engineering – Energy
Chemistry – Chemical Engineering – Synthetics
Mathematics – Computer Engineering – Information
Biology – Genetic Engineering – Therapeutics
-Genome Engineering – Synthetic Genomes Biotech Future? What & How?
Slide 3 : Human Genome Project (1990-2003) 3 billion letters of A, C, G or T 2001: Draft Sequence
2003: finished Sequence
~ 30,000 Genes US$ 3 billion !
Slide 4 : The scientific quest of life What is life? Why is life what it is? How do we know why life is what it is?
Slide 5 : Life on Mars? Life under the Sea? What makes us different genetically?
Slide 6 : Gene Number in Eukaryotes Human 32,000 2.9 Gb
Mustard Weeds 25,498 115 Mb
Fly 13,601 116 Mb
Worm 19,099 97 Mb
Yeast 5,800 12 Mb Species # of Genes Genome Size
Slide 7 : Bio-Complexity of Human Life Exon ~2%
Intron 24%
Intergenic 74% Geno-Complexity 3,000 Mb Genome
40,000 Human Genes
50% Repetitive Elements Pheno-Complexity DNA Methylation
Histone Acetylation Transcription
Activation or Silencing Protein Modifications
Complex Formation Functional Entity Protein Interactions Biochemical Cascade
Slide 8 : Biological Processes of Life Fertilization Fetal
Development Neonatal
Development Adolescence Maintenance
& Aging Gene Repertoire Energy & Metabolism Information Processing Communications Genetic Factors Environmental
Factors
Slide 9 : Gene mRNA Protein Structure Genome Transcriptome Proteome Bioinformatics SNPs Disease Gene Clinical Trials Lead Compound New Drug Chemical Library & HTS Optimization DNA Chip Protein Chip Peptide map Function Animal Model Haplotypes SNPs: single nucloetide polymorphisms
Slide 10 : Gene mRNA Protein Structure Genome Transcriptome Proteome SNP New Drug DNA Chip Protein Chip Protein Profiling Gene
Discovery mRNA Profiling Target
Discovery Drug
Discovery Modeling Lead Identification Virtual Screening Splicing Variants Isoforms & Modification Target Drug
Lead Dx
Slide 11 : Channels Consumers Healthcare
Providers Pipelines Research &
Development Drug
Development The Roadmap of Biotech Development
Slide 12 : 30,000 Genes Target HTS Drug Lead Preclinical Clinical Trial DRUG Disease Gene
Discovery New Paradigm in Drug Development Phase IV Phase I Phase II Phase III Genome Drug
Discovery Drug
Development US$ 1 billion
10 years
Slide 13 : Disease Management
Medical team
Clinical Diagnosis
Operation/Replacement
Physical/Chemical Treatment
Biotherapeutics Life Management
Individual Genetic Profiles
Individualized Medicine
Preventive Medicine Impacts of Biotechnology in the Future Century 20 Century 21 Quality of Living Quality of Life
Slide 14 : Bio-Century 21 Disease
Discovery Gene
Discovery Drug
Discovery Trauma
Infectious
Hereditary
Environmental Complex Diseases
Aging-related Diseases Disease Management Life Management New Diagnostics
New Therapeutics
Theranostics Individualized Healthcare
Predictive Medicine
Tissue Engineering
Slide 15 : Key Issues for the Biotech Future Changes in Population Dynamics
Effects of New Healthcare Policies
New Initiatives in Pipeline Development
Transformation in Industrial Leadership
Challenges in Business Intelligence
Emergence of New Competitions
Slide 16 : 1970 1980 1990 2000 Recombinant DNA
Hybridoma
DNA Sequencing Blotting
RFLP/STRP
Transgenic/KO
PCR HGP Genome Sequencing
Genotyping – SNP
Combinatorial Chemistry
High-throughput Screening
DNA Microarray
Protein Chip
Bioinformatics
RNAi IHMP Technology Development for Life Sciences
Slide 17 : Mabs in the Cancer Pipeline 2001: $ 1.3 B
2003: $ 3.0 B
2004: $ 4.3 B
2008: $12.8 B ~600 anticancer drugs in development
>130 are Mab products
~13% of the cancer therapeutic market
Annual growth of 60% since 2002
More FDA approvals
Slide 18 : US FDA Approved Mab Drugs (I) Rituxan (Genentech)
11/’97 for non-Hodgekin’s lymphoma
US market: Genentech and Biogen Idec
EU approval: 06/’98
EU market by Roche as MabThera
Herceptin (Genentech)
09/’98 for metastatic breast cancer HER2
EU approval: 08/’00
EU market by Roche
Slide 19 : US FDA Approved Mab Drugs (II) Campath (Ilex Oncology)
05/’01 for chronic lymphocytic leukemia
US market: Berlex Lab
EU approval: 07/’01
EU market by Schering as Mabcampath
Bexxar (Corixa)
06/’03 for non-Hodgekin’s lymphoma
US market: GSK
EU market by Amersham Health
Panorex (Centocor)
1st Mab drug approved in 1995
For advanced colorectal cancer
Only available in Germany by GSK
Slide 20 : Erbitux (ImClone)
02/’04 for metastatic colorectal cancer
US market: Bristol-Myers-Squibb; $84 M in Q3/04
Switzerland approval: 12/’03
EU market by Merck; $30 M in Q3/04
Avastin (Genentech)
02/’04 for metastatic colorectal cancer
Worldwide market: Roche, Chugai US FDA Approved Mab Drugs (III)
Slide 21 : Current Market of Mab Drugs 2003 (>US$4 billion)
Genentech (61%): Rituxan & Herceptin
Roche (33%): MabThera (Rituxan in EU)
Berlex (2%): Campath
Others: Bexxar (Corixa) & Panorex (Centocor) 2004
Erbitux (ImClone)
US market: BMS; $84 M in Q3
EU market by Merck; $30 M in Q3
Avastin (Genentech)
Worldwide market: Genentech Roche, Chugai
Slide 22 : Biotech Industry: New Revolution Every biotech company wants to be a pharmaceutical company,
while the existing pharmas are heavily invested in biotech R/D. Platform Technology -- Tools
Discovery –- Gene to Drug
Bioinformatics – Knowledge Discovery
CMO/CRO – Manufacturing & Clinical Trials AgriBiotech: Plant and Animal Genomics
Nutriceuticals: Nutrigenomics
Cosmeceuticals: Nutrigenomics
BioPharmaceuticals: Pharmacogenomics
Slide 23 : VC Investment in Biotech: Jan.-Feb.,2005 USA Canada UK US$ 198.6 M US$ 14.6 M US$ 4.3 M 10 companies 2 companies 1 company US$ 384.4 M 19 companies Switzerland Germany US$ 60.5 M US$ 14.6 M 2 companies 2 companies France Italy US$ 42.9 M US$ 36 M 1 company 1 company TOTAL
Slide 24 : Biotech Deals: Jan.-Feb.,2005 1. Buyout: 6 deals for US$1,453.4 M 2. Merge & Acquisition: 5 deals 3. Licensing: 2 deals 4. Collaboration: 6 deals 6. Co-promotion: 1 deal
Slide 25 : Biotech Industry: Where do we go?
Slide 26 : 1970 1980 1990 2000 Recombinant DNA
Hybridoma
DNA Sequencing Blotting
RFLP/STRP
Transgenic/KO
PCR HGP Genome Sequencing
Genotyping – SNP
Combinatorial Chemistry
High-throughput Screening
DNA Microarray
Protein Chip
Bioinformatics
RNAi IHMP Technology Development for Life Sciences Biopharmaceutics
Immunotherapy Molecular Dx Genomics
Proteomics
Bioinformatics
RNAi
CRO/CMO