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Scientific Writing and Project Management in Biotechnology

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The book titled 'Scientific Writing Techniques and Project Management in Biotechnology' has been designed to provide a comprehensive basic text for medical and biotechnology students to make them conversant with molecular biology techniques, bioinformatics, art of planning and writing scientific research. The book has separate sections on survey of techniques in molecular biology; research and development of projects; management of projects and marketing of biotechnology inventions; and intellectual property and patenting.

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Ch-1

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TECHNIQUES IN

MOLECULAR BIOLOGY

INTRODUCTION

Amazing developments in biotechnology in late twentieth century include—decoding of human genome, cloning, gene therapy, progress in stem cell research and RNA interference.

Many earlier landmark discoveries that unveiled the mysteries of genetics and paved way for modern molecular biology. Beginning with Mendel’s experiments with garden peas published in 1866, suggesting concept of genes as discrete units of heredity. Morgan in

1910 revealed chromosomes as units of heredity and Avery in 1944 confirmed through bacterial studies that DNA carried genetic information with Watson Crick’s DNA double-helical model of DNA in 1953, Smith demonstrated that DNA can be cleaved by restriction enzymes. This facilitated the subsequent development of RECOMBINANT DNA

TECHNOLOGIES.

With construction of genetic map using restricting enzymes by Nathans, Southern

Blot was invented in 1975 to detect specific DNA sequences. This led to development of

DNA sequencing methodologies and first complete DNA sequence of bacteriophage was discovered. PCR (Polymerase Chain Reaction) was developed by Mullis and Coworkers in

 

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TECHNIQUES IN RECOMBINANT

DNA TECHNOLOGY

HUMAN GENOMIC PROJECT

Human Genomic Project deciphered 3 billion base pairs that make up the genetic code. In 1988, US National Research Council’s special committee formulated a 15-years human genome project, costing some $ 200 million a year. In September 1994, a genetic map with 1 cM resolution was accomplished and a physical map involving 52,000 sequencetagged sites (STSs) was completed in October 1998.

International Human Genome Sequencing Consortium consisting of investigators from 20 centres located in six countries—UK, US, Japan, France, Germany and China announced completion of a draft sequence in June 2000. The final sequence was accomplished in April 2003, with 99.99% sequence accuracy, with no gaps.

Human Genome

Of the total 3.2 Gb DNA of human genome, 2.9 Gb consists of, weakly staining generich enchromatic proteins, and only 1.1–1.4% sequence encodes proteins.

Estimated number of genes in human genome are between 26,000 and 31,000.

With the decoding of basic sequence, even more difficult task is elucidation of biological functions of these stretches of DNA.

 

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BIOINFORMATICS AND

COMPUTER APPLICATIONS

BIOINFORMATICS : INTRODUCTION

It is the science of using information to understand biology. It is conceptualizing biology in terms of molecules and applying informatics techniques (computer science, applied mathematics and statistics) to organize the information associated with these molecules. Bioinformatics and data mining are two latest areas of research involving computer-assisted management of data generated for biotechnology applications. The information generated in genomics is enormous and its interpretation requires the use of powerful computers and specific softwares.

Computer Network

The internet is a global network of computer networks that link government, academic and business institutions. Computer within the network are referred to as nodes and these communicate with each other by transferring data packets. Each computer or network mode has a unique address (IP address) by which it can be identified and can communicate with other nodes.

 

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SCIENTIFIC WRITING

Do not let me tell you how to write a paper, let me try to improve Your Writing!

SCIENTIFIC PAPER

What is a Scientific Paper

A scientific paper is not a technical report or term paper. It is a paper worth writing only if it has general implications for knowledge. One should think of his role as guiding future efforts of scholars since others will come after you with newer data and better models!

Need to Write Scientific Papers

Scientists are motivated for writing papers two ways namely, to understand the world and to get credit for it. In academic and public sectors, scientific papers are means of expansion of human knowledge. PUBLISH or PERISH should be the rule for scientists working as individuals professional survival: you do not publish, you are out.

Determinants of Quality of Scientific Paper

Nowadays, quality of a scientific paper is measured by citation index. It depends on:

(i) originality and importance of ideas.

(ii) effectiveness of communication to flag new ideas.

 

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Scientific Literature

information about nucleic acid and protein sequences, predicting protein structure, seeking research methodology and searching databases of genome program.

Title

Authors

Affiliation

Abstract

Background

Aim

Methods

Results

Discussion

Conclusion

(100–400 words)

Figure 5.1 Preparation of abstract for oral presentation.

Computer and Internet

By using computers one can greatly broaden it use to some of the following:

(i) Searching the biomedical literature for pertinent books and journal articles.

(ii) Accessing biological databases that provide nucleic acid and protein sequences and structures.

Once connected to internet, many programs are available as free ware, softwares are provided without charge by its creator.

Basic Facilities Available for Use on Internet for Researchers e-mail (electronic mail)

One can communicate by e-mail. Messages containing text, files, and graphics may be sent to anyone who has a computer with an internet link and e-mail address. Communications among scientists is now done primarily by e-mail. Also, one can join list server discussion groups such as USE NET.

 

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FUNDING AGENCIES

SCIENCE FUNDING ORGANIZATIONS

Biotechnology companies especially those profitable today, face a coming decade that may be even painful than the past decade was for global pharma, when many saw their valuations cut in half, not to mention all restructuring and management havoc. Most biotech companies achieved their success behind just one or two block busting drugs that are priced boldly and marketed aggressively. In spite of billions in R and D, large pharma have failed to produce much in the way of next round of innovations. It seems increasingly clear that once a biotechnology company reaches a certain size, it, like its large pharma counterparts, becomes unable to get much out of its heavy R&D spending.

Since life science product life cycles are short, so companies should extract as much value from their products as possible and this is possible by R and D and careful planning and adequate knowledge of R and D funding and skill to draw funding help in survival of company.

 

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PREPARATION OF R & D

PROJECTS FOR FUNDING

ORGANIZATION OF RESEARCH PROJECT

1st step in research project is generation of research idea. This idea develops only after extensive reading and studying the relevant literature.

A research project usually begins in the form of a problem to be solved. For ease, this problem project should be divided into questions that may be answered by experimentation.

Key Questions for a Project

— What is the current state of knowledge in the area?

— What are the significant unknowns?

— What will be the possible outcome of project?

Basic Requirements for Project

— Knowledge of literature for design of experiment.

— Knowledge of techniques and laboratory procedures.

— Knowledge of relevant information of related parameter.

Core Capabilities Required in Field of Genomics

— Collection of comprehensive data set using technologically advanced laboratory tools.

— Searching for subtle relationships within them by using computationally sophisticated analytical methods.

CERTAIN CONSIDERATIONS

 

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BIOLOGICAL RESOURCE

CENTRES & BIORESOURCES

INTRODUCTION

“Biological resource centres BRCs are an essential part of the infrastructure underpinning life sciences and biotechnology. They consist of service providers and repositories of the living cells, genomes of organism, and information relating to heredity and the functions of biological systems. BRCs contain collections of culturable organisms (e.g., micro-organisms, plant, animal and human cells), replicable parts of these (e.g., genomes, plasmids, viruses, cDNAs), viable but not yet culturable organisms, cells and tissues, as well as databases containing molecular, physiological and structural information relevant to these collections and related bioinformatics”.

Human health

Environment

BRC

Agriculture

Biotechnology

R and D

Figure 8.1 Essential fields linked to BRC

(Definition based on the one adopted at the 1999 Tokyo Workshop on Biological

Resource Centres, where the concept of BRCs as an outgrowth of conventional pregenomics ex situ collections of biological materials was developed–and incorporating scientific developments since 1999.) BRCs must meet the high standards of quality and expertise demanded by the international community of scientists and industry for the delivery of biological information and materials. They must provide access to biological resources on which R&D in the life sciences and the advancement of biotechnology depends.

 

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CAPITAL INVESTMENT

COMMERCIAL POTENTIAL OF BIOTECHNOLOGY

Biotechnology has unlimited potential due to its capability to generate unlimited range of and useful products/services concerned with virtually every aspect of human existence. e.g., in mid-90s, over 130 biotechnologically derived pharmaceuticals aimed at everything from hemophilia to AIDS, and from anaemia to leukaemia, were under regulatory review in USA. The contribution of biotechnological products to global market is rising rapidly and is expected to increase from US $ 100 billion/year in 2000 to further higher.

Also, the biotechnology industry in India is growing rapidly in the wake of liberalization of the economy that fostered alliances between India companies and multinationals. The demand for biotechnological products in India has been estimated at around Rs. 55 billion

(US $ 1.85 billion) in 2000 and may double up by 2007 year end. The major share of this demand would be in the areas of human and animal health (72%), followed by that for industrial products (27%), agricultural sectors account for a very small portion (7%) of the demand.

 

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MARKETING STRATEGIES FOR

BIOTECHNOLOGICAL PRODUCTS

The key survival of pharmaceutical and biotechnology companies is to place successful products on the market place. Project managers are becoming an increasingly integral part of that strategy.

Biotechnology and pharmaceutical companies face constant challenges in the course of developing new pharmaceuticals or other products.

WHAT IS PROJECT MANAGEMENT

Project management is application of knowledge, skills, tools and techniques to a broad range of activities in order to meet the requirements of the particular project.

These results are defined in terms of four factors : cost, schedule, performance and scope.

Factors Affecting Project Management

Cost

budget allocated to the project.

Schedule

timeline for the project’s deliverables.

Scope

magnitude of the job.

Performance

how well the team members do their work.

Project management of a project in pharmaceutical companies.

It focusses on the following points:

1. Setting project goal.

2. Putting strategic plans into practice.

 

Ch-11

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INTELLECTUAL PROPERTY RIGHTS

CONCEPTS AND RELEVANCE

INTELLECTUAL PROPERTY (IP)

IP arises from an application of intellect and ingenuity and is usually in the form of an idea, concept, design, process etc. to generate a product ultimately. With emergence of modern technology, intellectual property is legal characterization and treatment of trade-related biotechnological processes and products.

Under biotechnology, important examples of intellectual property is processes and products that result from development of genetic engineering techniques (using restriction enzymes) to create recombinant DNA. These IPs can be copied and used by others, thereby reducing the benefits of original inventors.

The right of an individual to derive from intellectual property and to exclude others from doing so is referred to as INTELLECTUAL PROPERTY RIGHTS.

UTILITY PATENTS for genetic materials (both plants and animals) have been allowed in some countries so that patented material cannot be used for further breeding or cultivation (in case of seeds) without paying a fees to the patent holder.

 

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Scientific Writing Techniques and Project Management in Biotechnology

Trademarks

It can be either symbols or words that identify a particular process or product of a company.

Patents

For biotechnology, patents form most important part of intellectual property. Patent is a legal document that provides exclusive rights to the patent holder for implementing the invention commercially.

PATENT

Features of Patent

1. On the basis of the extent of claims of patent, patent holder can develop other products derived from their original invention.

2. Also, they can sell right to use their invention to their competitors for developing a product based on it.

3. Patent is a public document containing a detailed description of invention.

4. It also informs about nature and limits of invention, allowing people to start to continue working in a particular direction.

Patent decisions and law vary from country to country:

(i) In US, the duration of exclusion rights of a patent was 17 years after it was officially awarded.

 

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