Lectures

OPPORTUNITIES IN BIOTECHNOLOGY

By RAJESH JAIN

Some people like to tinker with gadgets. They take apart and repair watches or spend all day in the garage working on cars.

Biotechnologists tinker with living organisms. They use biochemistry and genetics to create new products for the agricultural, industrial, and. environmental industries. These products include vaccines, medicines, growth hormones for plants, and food additives.

AREAS OF BIOTECHNOLOGY

- Recombinant DNA

- Plant tissue culture and plant breeding

- DNA or Gene splicing

- Enzyme systems

- Mammalian cell culture

- Immunology

- Molecular biology

- Fermentation

CHANGE - RELEVANCE

Successful businesses hate change. People with great jobs hate change. But upstarts and entrepreneurs love change. There are always more competitors than market leaders, and there's a huge demand for change. More innovation! More competition! More change! It won't go away...

CHANGE - THE CHALLENGE

We work for companies that are organisms, living, breathing, changing organisms that interact with millions of other living, breathing, changing organisms. This is not business as usual. It's a new principle that is going to feel unnatural at first. We will need a new vocabulary just to discuss it.

REMEDY - THE EVOLUTION

Defined as inheritable modifications over many generations, evolution is the most powerful tool we have for dealing with change. Individuals and organisations can put this organic process to use by permitting change to occur.

DENYING EVOLUTION & IMPLICATIONS

The simple engine of evolution ... .inheritable changes in the species occurring over thousands of generations ... can produce extraordinary results. Charles Darwin felt that people have trouble visualizing anything that took place over the course of a hundred million years. These days, in a world where McDonald's aims to provide you with food in less than 60 seconds, it may be even harder for people to make the leap. Research is now at a turning point. Memetic evolution ... evolution caused by memes, or ideas for units of innovation ... is driving our research needs to change faster and faster. Penguins don't evolve on purpose. They don't have meetings about evolution. They don't debate the most effective routes for their future on the island either. Instead, evolution is built into their daily lives and embodied in their reprodtive cycle. And because evolution is automatic, it happens whether the penguins find time for it or not. The difference between a penguin and an organization is simple: While both have evolved to a point where they can succeed, the penguin continues to evolve whereas an organization usually does not.

YOUR TEST - TO CHANGE & EVOLVE Can you imagine these thoughts?

- Total vaccinations for all possible disease areas

- Only few days cure regime for tuberculosis

- Simplified treatment for the most complicated diseases.

- Vegetables to come from plants in the peeled form as housewives do not like to have trouble of peeling vegetables in the kitchen

- Instead of grains, atta direct from plants.

BIOMANUFACTURING OBJECTIVES

- Quality: Safe for humans and meets standards (GMP)

- Timeliness: Reproducible and First to market

- Quantity: Scalable and adequate productivity to meet market demand.

- Cost: Acceptable, predictable economies of scale.

THE CHALLENGE

Select clone, Cell banking and characterization. Process development and QC methods development. Prepare for Tox study. GMP manufacturing. CEO IND filing.

QUANTIFYING RISK

What is the cost of being wrong? Excess capacity: The estimated carrying cost of a facility operating at 50% capacity is $ 2-3 Million a month. Example: Synergen (Antril) Inadequate capacity: A 50% shortage is estimated to result in a 40-45 million dollar loss of operating profit. Example: Immunex (Enbrel)

TOO MANY CONTIGUOUS ACTIVITIES

- Pharmacology

- Timeliness . Assay Validation

- QA/QC . Phase I/II Clinical Protocol . FDA

- Previous Human Experience . Investigator vs Sponsor IND

- Sub contractors . Contractors

- Manufacturing . Pre-IND Meetings

- Orphan Drug Status . Record keeping

- Clinical trial agreements . Fast Track

- Drug formulation . Drug vialing

- Toxicology . Regulatory Issues

- Process Development Investigator Brochure

- Process Development

- Drug Stability . CMC

BIOTECH CAREER OPPORTUNITIES

From the present employee strength of 50,000, the number of jobs in the biotechnology sector is projected to increase by 10 lakh by 2012. Set to witness an IT-like revolution in the country, this field is now a hot career option for students. In fact, it is a happening career destination.

- Production - Model organisms in Drug Discovery & Development

- Research & Development

- Quality Control

- Quality Assurance

- Regulatory Affairs

- Intellectual Property Rights - Patents in Post Genomic Era

- Clinical Research

- Sales & Marketing - Product Management, Market Research, Training & Development, Sales Administration, Distribution streamlining

- Business Development - Domestic / International

- Financial Analyst

- Biostatistician

- Communication & Reporting - Specialization in Biotechnology - India Today, Business Standard, Economic Times.

PANACEA BIOTEC AT A GLANCE

One of India's leading research-based Health Management Company, Panacea Biotec is the second largest vaccine producer, and amongst top 50 Pharmaceutical companies in India. It is ranked third amongst all Biotechnologies companies in India by ABLE Survey, 2004. One of the only four companies in the world having WHO pre-qualification for the Oral Polio Vaccine. It has10 Global Drug Delivery Product Patents. It has established Brand Equity in Pediatric Vaccines, Pain and Diabetes Management, and Organ Transplantation. It has manufacturing facilities with WHO cGMP Certification, two state-of-the-art R&D Centers with over 300 highly qualified Scientists.

Current Vaccine Portfolio

- Poliomyelitis vaccine, live (oral)

- Monovalent poliomyelitis vaccne type 1 live (oral )

- Monovalent poliomyelitis vaccine type 3 live (oral )

- Enivac HB Hepatitis B vaccine ( Recombinant )

- Enivac HB SAFSY - prefilled device Hepatitis B Vaccine ( Recombinant )

- Evocac - 4 - Combination vaccine - DPT + Hepatitis B

- Easy Four - DPT + Hib

- Easy Five - DPT + Hep + HiB.