Importance of Biotechnology in Fuelling the National Economy

Sirimali Fernando

CEO / COSTI

Yes ! Robert Solow

1987 Nobel prize for Economics

In late1950’s/ 60’s proved that technological advances

arising out of R+D and innovation as a major

contributor to US economic growth – ‘The Theory of

Economic Growth’

Can Science Technology and Innovation fuel a National Economy ?

Wealth creation through R&D

Contract R&D

Create / value addition to products/ processes –

upscale and commercialize – sold in

the market with revenue generation

Knowledge through R&D generates Intellectual

property (IP) which is a traded

What are patents actually worth?

• The median value of the European patents (1993-

1997) was €300,000, with 10% of patent owners

reporting values of €10 million or more.

Study on Evaluation of the Knowledge Economy – What are Patents Actually Worth

(A survey of 9000 (of 20,000 ) patent owners who filed EPO patents between 1993 and 1997. )

Published by EU, 2005 26/09/2011 Sirimali Fernando 4

Technological revolutions (waves) - the basis for economic

development …..

26/09/2011 Sirimali Fernando 5

Industrial Revolution (late 18th and early 19th centuries)

Electronics Revolution (1960's)

ICT Revolution (1970’s)

Biotech Revolution (1980’s)

Nanotech (In 21 st Century)

In our life span

Modern biotechnology

Watson and Crick – 1953 Discovery of DNA

Cohen and Boyer – 1973 Recombinant DNA technique

Recombined ribosomal RNA genes from a toad (the African clawed toad Xenopus) into bacterial cells

Modern biotechnology industry

Genentech - founder of the modern biotech industry, formed in 1976 by Herbert Boyer and Robert Swanson, an entrepreneur (venture capitalist)

Genentech , the startup company, in 1978 produced human insulin in cloned bacteria and pilot production of recombinant human insulin began

• In 1980, Genentech made an initial public offering of stock – 1,000,000 shares at a price of $35 each and an hour later they rose to USD 88.

• It licensed the production method to Eli Lilly & Co.

• Humulin was approved by FDA in 1982 • Became one of the largest and most

successful biotech companies in the world • Company was sold to Roche in 2009

Enbrel

$5.867 X 108

Rituxan

$3.88 X 106

Kineret

Remicade

$5.46 X 108

Humira

$5.04X108

Cimzia

$7.94X108

Cancer therapeutics?

Discovery of TNF In 1986

Soluble TNF receptor

IL-1 inhibitors

Immune cell inhibitors

Anti-TNF monoclonal antibodies

2009 global pharmaceutical revenues for select drugs

Targeting TNF

TNF Research

Julia Lane and Stefano Bertuzzi , Science vol 331:11 February 2011

The Pay Back

The pay back …

• The US federal government funded the Human Genome Project at $3.8 billion, over 13-years (1990- 2003)

Human Genome Project

The scale of impact (in 2010) Drive $796 billion in economic activity; $244 billion in personal income; 310,000 jobs

(Quoting Fareed Zakaria from Washington Post of 20 June 2012)

Medical Biotechnology (Red Biotechnology)

Main areas

• Therapeutics

• Vaccines

• Diagnostics

• Bioengineered products

– cellular and tissue-engineered constructs

• stem cells, vascular and vein grafts

– Nano- biotechnology - Drug delivery systems

• nano-molecules and bio-molecules

• Biosensors, sensing using lasers, acoustics, MEMS

– Synthetic biology

• Fabrication of genes – ‘gene synthesis

New biotech breakthroughs

• Decay-Fighting Microbes (new engineered bacterial strain, called SMaRT), that cannot produce lactic acid; - prevent tooth decay - ONI BioPharma , USA

• Biological Pacemaker - pacemaker genes expressed in stem cells that are injected into damaged regions of the heart – successful results in dogs

• Nerve Regenerator – A NANOGEL - Injected as a liquid, the nanogel self-assembles into a scaffold of nanofibers. Peptides expressed in the fibers instruct stem cells to produce nerve cells. The scaffold, supports the growth of new axons

Agro biotech (Green Biotech) • Tissue culture and micropropagation

• Molecular breeding or marker assisted selection

• Genetic engineering and GM crops

• Molecular Diagnostic Tools

• Bio-herbicides, pesticides

• Improved shelf life, disease resistance (stress resistance, herbicide resistance, pest resistance)

• Resistance to non-biological stresses like drought, high soil salinity and nitrogen starvation

Genetically modified Crops

• In 2012, a total of 17.3 million farmers planted biotech crops in 28 countries

Industrial or White Biotechnology

• Use renewable resources – Living organisms,

organic materials, or chemical components of living organisms (eg.enzymes)

• Produce chemicals, materials and energy

• Novel enzymes, microorganisms, biocatalysts

• Microbial genomics and bioinformatics (systems biology)

• Metabolic engineering and modeling

• Improved designs for bio-catalytic processes, fermentation, downstream processing

Current or emerging biotech areas

• Convergence of biotech with nanotechnology and ICT • Synthetic Biology • Advanced instrumentation

– Sensing devices: detection and sensing of single cells; biomarkers; environmental and toxic chemicals

– Separation technologies: improvements and variations to classical techniques such as electrophoresis and chromatography; mass spectrometry; cell separations; DNA sequencing, microfluidics; nanotechnology

– Micro/nanofabrication: devices and systems for use in biological research or diagnostics.

– High throughput assay systems for the identification of small molecule ligands, drugs or other effectors of biological activity

Biotech industry - Funding trends in emerging economies

VC in not the major source of funding in emerging economies

Source of Biotech Funding in BRICS

Governments, MNC and local companies US $

Venture Capital US $

14 b 100-150m

VC Funding for biotech pharma industry

Worldwide average

In China

10% 2%

Indian Biotech Industry (INR billions): 2002-2013

15% growth Export (2 b US$) Domestic (1.9 b US$) Among exports: BioPharma (65 %) BioServices (32 %)

Bio-pharma - vaccines, therapeutics and diagnostics Bio Services - contract research and manufacturing services (CRAMS) and clinical research services

National Biotechnology Policy

• Adopted as a National Policy in 2010

Policy Objective 1 Harness Biotechnology for socio-economic

development

Enhancing opportunities for local industries through biotechnology

• Agriculture – Promoting food production

• Health – well being of the people through health care

• Value added Industry- promotion of industrial biotechnology

• Energy – promotion of bio-energy and sustainable use of biodiversity

• Environment – promote

clean energy

• Directed, multi- disciplinary, multi-sectoral research programmes

• Public –Private partnership

• Techno-entrepreneurship Initiative

Policy Objective 2 Provide legal, regulatory and economic

Framework

• National policy on human genetic material and data for Sri Lanka - – Final draft - Ministry of Health

• National Biosafety Framework – Final draft - Ministry of Enviornment

Policy Objective 3 Establish an Apex Body for Biotechnology

• Establishing a National Biotechnology Council to plan, coordinate, monitor and evaluate all activities related to biotechnology including facilitating and supporting bio-industries while ensuring safe and ethical practices

• The Senior Minister for Scientific Affairs has established a Coordinating Secretariat for Science, Technology Innovation (COSTI)

• National Biotechnology Council has been set up under that.

Policy Objective 4 Building human resources and establishing Centers of

Excellence in Biotechnology and Biotechnology Parks

• Hayley's Biotech

• CIC Biotech

• Ceylinco Biotech

• Serendib Horticulture Technologies Pvt Ltd

• Bio Power Pvt Ltd

• Ceygen Biotech

17 B.Sc. Special degree programmes in biotechnology in Universities of CMB, PDN, SJP, KLN, JFN,MTW, RHN, WMB

7 Postgraduate Masters degree programmes

92 papers in mol biology/ biotechnology published in indexed journals in 2012

Top 10 Sri Lankan Institutions for Biochemistry, Genetics and Molecular Biology 2008-2012

A National Virtual

Ecosystem to enable Biotech

Innovations

Research

Technology

Commercialization