BIOTECHNOLOGY

“the exploitation of biological processes for industrial and other purposes, especially the genetic manipulation of microorganisms for the production of antibiotics, hormones, etc.”

Making of bread dates back to 30,000 years and modern bread making using yeasts came around 10,000 years ago. Making of bread is one of the simplest examples of fermentation biotechnology.

Human civilisation have employed biotechnology for ages

Other examples of age old biotech products

Curd Wine

Ancient greeks making wine.

6000BC was when yeast (Saccharomyces cerevisiae) was used by Sumerians for beer.

Selection of crops and livestock is also biotechnology

Biotechnology Timeline

Pre- 1800: Early applications and speculation

1800-1900: Significant advances in basic understanding

1900-1953: Genetics

1953- 1976: DNA research, science explodes

1977- present: modern biotechnology

Major contributions in mordernisation of biotechnology

Gregor Mendel Robert Koch Edward Jenner

Louis Pasteur Frederick Sanger Craig Venter

First mordern biotech product: the dawn of biotech, as we know it

1978: The cloning, expression and purification of recombinant insulin by Genentech

Nature Medicine 16, 146–149 (2010)

Genetically Modified Organisms – the edge of mordern biotechnology

Discovery of stem cells, 1981

Cloning

First GMO crop to be marketed

The FlavrSavr Tomato by Calgene, now Monsanto 1994

The tomato was made more resistant to rotting by adding an antisense gene which interferes with the production of the enzyme polygalacturonase. The enzyme normally degrades pectin in the cell walls and results in the softening of fruit which makes them more susceptible to being damaged by fungal infections.

Animals used for therapeutics

In 2006 that the European Medicines Evaluation Agency (EMEA) approved antithrombin, the first recombinant protein derived from the milk of transgenic goats.

Out of 312 therapeutic products obtained using living organisms had been introduced to the U.S. market by 2012, a total of 193 products were obtained using mammalian cell cultures.(Maksimenko et. al. Acta Naturae. 2013 Jan-Mar; 5(1): 33–46)

Opposition to GM crops

1. Doubt over origin of inserted foreign gene

2. Implication on safety. Eg., insect toxin gene coded (eg., in Btcotton) can be tranfered horizontally causing harmful pathogens and also can effect the fauna causing environmental and health issues. Following the introduction of Bt cotton in Northern China, non-target pests such as Mirid Bugs (Heteroptera: Miridae) have been becoming more abundant due to the reduction in conventional pesticides being sprayed. Bt cotton accounts for 93% of cotton grown in India. The state of Maharashtra has banned the sale and distribution of Bt cotton in 2012, in order to promote local Indian seeds, which demand less water, fertilizers and pesticide input.

3. Implication on human health post consumption

Not all GM crops have “negative foreign” elements

The Golden Rice Story

• Vitamin A deficiency is a major health problem• Causes blindness

• Influences severity of diarrhea, measles

• >100 million children suffer from the problem

• For many countries, the infrastructure doesn’t existto deliver vitamin pills

• Improved vitamin A content in widely consumed cropsan attractive alternative

-Carotene pathway in plants

IPP

Geranylgeranyl diphosphate

Phytoene

Lycopene

-carotene(vitamin A precursor)

Phytoene synthase

Phytoene desaturase

Lycopene-beta-cyclase

ξ-carotene desaturase

Problem:Rice lacks

these enzymes

NormalVitamin A

“Deficient”Rice

The Golden Rice Solution

IPP

Geranylgeranyl diphosphate

Phytoene

Lycopene

-carotene(vitamin A precursor)

Phytoene synthase

Phytoene desaturase

Lycopene-beta-cyclase

ξ-carotene desaturase

Daffodil gene

Single bacterial gene;performs both functions

Daffodil gene

-Carotene Pathway Genes Added

Vitamin APathway

is completeand functional

GoldenRice

The benefits of GMO in healthcareNeutraceuticals:

The Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have used food as medicine.Nutraceutical, a portmanteau of the words “nutrition” and “pharmaceutical”, was coined in 1989 by Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine.The term is applied to products that range from isolated nutrients, dietary supplements and herbal products, specific diets and processed foods such as cereals, soups, and beverages.Golden rice is an example of mordern technology in neutraceuticals.

Pharming:

“the process of producing medically useful products from genetically modified plants and animals.”Antitrypsin from goat milk is a classic example of Pharming.

Biotechnology is not just recombinant DNA technology

R&DHealthcare & Biomedical

Agriculture, Livestock and GMOFood processing

Fermentation technologyDrugs- pharmaceuticals

Bioinformatics – system biology, drug designing

Synthetic biologyEnvironmental Biotechnology

Biotechnology supporting industries; service industries

Biotech Boom – Did it happen? Or will it not?

Debunking myths about biotech venture capital

1. Returns in Life Science venture investing lag other venture capital sectors.

in the 2000’s, venture investing in the Life Sciences has outperformed venture investing in Tech. (Nature Biotechnology, July 2011)

Life Sciences Realized Returns (IRR) Dramatically Outperformed IT

Life Sciences Had A Lower Loss Rate and Higher Frequency of 5x+ Returns

Forbes, 22/5/2013

2. When biotech deals blow-up, they blow-up big

Adam’s Street Partners data also show that while over 30-years the aggregate biotech sector returns are similar to internet deals (~2x), the dollar-weighted loss ratio in biotech is significantly less: ~36% vs ~59%, respectively, over the past 30 years.

In English: biotech is far less lumpy than internet venture investing, far less dependent on the lottery ticket outlier.

3. Biotech takes far longer from inception to “exit” than other sectors

Debunking myths about biotech venture capital

4. The overall biotech venture capital funding environment is drying up

Debunking myths about biotech venture capital

Biotech scope in India

• Today, Indian biotech sector comprises of more than 280 companies and 180 bio-suppliers. Indian biotech industry is worth US$ 1.5 billion.

• Biotech Industry has 37.42% growth rate per annum Bioservices has reached US$ 160 million Bioagri sector has crossed US$ 130 million Biopharma has reached US$ 1billion

Bio Agri6.95%

Bio Pharma75.24 %

Bio Services8.95%

Bio-IT2.09 %

Composition of Indian biotech sector (2004-05)

Source:Biospectrum-ABLE Survey

Make in India initiative

Indian Players

MNCs scripting success in India

Genome Valley, Hyderabad

• Committed to facilitating business driven research & development• Spread across 200 acres and has over 30 R&D units functioning. • Prominent Companies: GVK Bio, Aptuit Laurus, Nectar Therapeutics, Dupont India

Pvt Ltd, etc.

Centre for Cellular and Molecular Biology Centre for DNA Fingerprinting and Diagnostics

International Crops Research Institute for the Semi-Arid Tropics Indian Institute of Chemical Technology

National Institute of Nutrition, Hyderabad Indian Immunologicals Limited

National Institute of Pharmaceutical Education and Research, Hyderabad Centre for Computational Natural Sciences and Bioinformatics, IIIT Hyderabad

TCS Bioinformatics Innovation Lab, Hyderabad Sir Ronald Ross Institute of Parasitology

Dr. Reddy's Institute of Life Sciences Indo American Cancer Hospital and Research Institute

Indian Institute of Biotechnology Directorate of Rice and Oil Seeds Research

Central Research Institute for Dry Land Agriculture Central Forensic Science Laboratory, Hyderabad

Central Institute of Medicinal and Aromatic Plants Central Food Technology Research Institute - Resource Center

L. V. Prasad Eye Institute Apollo Cell and Molecular Biology Research Center

National Institute of Animal Biotechnology National Academy of Agricultural Research Management

National Animal Resource Facility for Biomedical Research American Oncology Institute

Asian Institute of Gastroenterology Owaisi Center for Liver Research and diagnostics

Global Centers of Excellence in R & D

Shantha Biotech- A Case Study of Industry-R&D Institute Partnership

Founder: Dr. KI Varaprasad ReddyElectronics Engineer by profession

Developed with CCMB

Vaccine Industry

Major Markets

Global vaccine leaders

The Indian Market

Vaccines currently under development by Indian companies

Bioinformatics and its importance

The human genome project would not have been possible without bioinformatics

“The dominant players in the $900 billion global pharmaceutical industry are at a crucial juncture, because within the next three to four years, drugs worth $150 billion in revenue, will go off patent. At the same time, new drug creation has become prohibitively expensive, costing, on an average, more than US$ 1 billion to take a drug from concept and R&D through clinical trial and FDA approval, before it can be put into the market.” (From Infosys)

In healthcare and disease researchPersonalised medicine

Drug discovery

Research Areas: Computational Finance and Risk | Computational Life Sciences | e-Security | Business Systems and CyberneticsThe research groups in Hyderabad work on:Biomedical text-mining for enhanced healthcareHuman genome analysisComputational structural biology Drug development e-Security: Advanced encryption methods, Enterprise digital rights management, Digital watermarking and traitor tracingRisk and Finance: Quantitative and computational methods for risk management in financial and non financial applications with special emphasis on pricing, hedging, Monte-Carlo simulations and stochastic optimization

Offering:Bio-Suite™Bio-Appliance platformTCS PubMed eXplorer (TPX)Genome Commons Navigator - A comprehensive tool for Genome Annotation andInterpretationQuantlator- A comprehensive tool for pricing and hedging of derivativesVideo Mudra – Digital watermarking tool for videoseDRM – enterprise DRM for office documents

TCS Innovation Labs – Hyderabad

The Bioethical Challenge

Is Biotechnology Morally Acceptable?

Two Kinds of Ethical Arguments Used to Evaluate Concerns Over Biotechnology

• Intrinsic objections say the process of biotechnology is objectionable in itself

• Extrinsic objections say the possible consequences of some biotech applications are objectionable, but others may be acceptable

Ethical, Social and Legal Implications: Agricultural Biotechnology

• Is it against “nature”? Risks vs benefits?– Relative lack of religious objections.– Transgenics intrinsically harmful to the environment?

Environmental biosafety concerns.– Harmful to consumers? Health biosafety concerns.

• Gap between haves and have-nots increased.– Intellectual property system in favour of already developed

countries (eg. gene patents). – Production system in favour of the already efficient.

Ethical, Social and Legal Implications:Cloning

• Is it ethical to use embryonic stem cells? In what circumstances?

• Is it ethical to clone spare organs? From oneself? From another individual?

• Is it ethical to clone human beings? Under what circumstances?

• The legal status of a human clone?

Ethical, Social and Legal Implications:Intellectual Property Rights

• Should genes be patentable?• Who own the genes (biological materials)?• Who has the right to use the genes?• Special considerations for developing countries/poor

communities who cannot afford the treatment (eg. compare with AIDS drugs).

• Role of government:– Oversees development and capability strengthening in both

technical and social, ethical issues in biotechnology and life sciences.

– Set up regulations and laws as necesssary, making sure of having a healthy balance.

• Role of civil societies (NGOs)– Help to make the public understand issues in various aspects,

not just lobby on single issues.• Role of education/research institutes

– Acquire knowledge and understanding on issues interfacing between technology and society.

– Help to generate healthy debates among various stakeholders and the public.

Future Directions: Towards Good Governance in Biotechnology

The Biotech Boom might not have happened, but it still is steadily on rise and an attractive career option.

There has been a steady increase in number of jobs in companies.

In academics, government has increased fellowships by more than 50%A Junior Research Fellow will get INR 25,000+HRAA PostDoctoral Fellow will get INR 35,000+HRA

Thank you