Biotechnology Themes

The term “Biotechnology”, according to the Cartagena Protocol on Biosafety (Ref.: The Cartagena Protocol on Biosafety,- http://bch.cbd.int/protocol) refers to any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for a specific use. Through modern biotechnology applications, persons skilled in the art can  take a single gene, which is a  specific nucleotide sequence from  a plant or animal cell or can  synthesize the gene  in the lab, and insert it in another plant or animal cell  or into a microorganism to give the transformed materials  a desired characteristic  emanating from the inserted gene. For example the transformed plants can resist specific pests or diseases; or the animals with specific genes cangrow  faster than the natural counter parts. Microorganisms can be transformed to produce specific proteins coded by the inserted gene; and the transformed cell lines can produce the right kind of glycosilated proteins which have for example have medical applications. The Cartagena Protocol on Biosafety is an international treaty for the transboundary movements of genetically modified substances across the countries and therefore, the definition of “Biotechnology” in this treaty is accepted globally.

Traditionally, humankind has used   techniques of fermentation for centuries to make bread, curd, cheese, beer and other fermented foods & drinks. Through traditional  plant and  animal  breeding techniques, for example crops  have been developed which produce higher yields of grain; animals have been produced with improved characteristics, for example higher milk-producing  cows etc.  SBPI shall not be dealing with such traditional biotechnologies.

SBPI shall arrange lectures in modern biotechnology. The areas would revolve around the use of techniques such Restriction enzymes ( DNA-cutting enzymes ) ;  DNA sequencing techniques and uses; DNA replication mechanisms; use of Polymerase Chain Reaction and amplification of DNA segments; detecting nucleic acids via Northern and Southern blotting  techniques; use of Computers for DNA sequence optimization and use; Enzyme Immobilization Techniques; Culturing of Animal Cells; Culturing of Plant Cells ;industrial liquid stage Batch and Continuous Fermentation  and Downstream Processing techniques; Solid-state Fermentation methods; and many other such modern techniques which are used  for producing goods and services in modern biotechnology for applications in Medicine, Agriculture ,Industry and Environment management. Students, semi-skilled and skilled individuals, academics, industrial employees working on the shop-floor or in other relevant areas, administrators, and general public having interest in biotechnology shall benefit from the deliberations. Individuals with a background in biology, zoology, botany, biochemistry, genetics, molecular biology, biotechnology, human physiology, microbiology, immunology, biophysics, biostatistics, chemistry, and chemical engineering and biochemical engineering shall be rewarded through  expansion of  their knowledge base.

Modern biotechnology establishments and companies are incessantly venturing into areas to serve the diseased and to save lives; to increase productivities in crops, vegetables, horticulture and animals and to improve the quality of food, feed and fodder; to safely harness biological materials from nature for the industry; and to preserve and improve the environment. The overall outlook is to make the world a more livable place irrespective of shifts in the regulatory landscape. Indian Government has promulgated environment protection laws and rules to ensure safe use of modern biotechnologies. The law requires continuous vigilance of the goods and services in modern biotechnology from research to applications and their safe disposal. At each stage, establishments are to comply with the relevant laws and procedures.

TheMinistry of Environment, Forests and Climate Change (MoEF&CC), Government of India has notified the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (Rules, 1989′) under the Environment (Protection) Act, 1986(EPA).In the context of EPA where the manufacture/ use/import/ export and storage of hazardous microorganisms are deliberated, the use of modern biotechnology, utilizing rDNA products and substances are embodied in the Sec. 6, Sec 8 and Sec 25 of the EPA.The Indian Ministry of Environment, Forest and Climate Change is the nodal agency for implementing Rules 1989.MoEF&CC is responsible for ensuring environmental safety and human health safety from the use of genetically modifies organisms(GMOs)/ Living Modified Organisms(LMOs).MoEF&CC is also the nodal agency for  the implementation of the Cartagena Protocol on Biosafety for the transboundary movement of LMOs.The Department of Biotechnology (DBT)is the nodal agency for all kinds of research in GMOs/LMOs and products thereof. DBT is also the nodal department for promoting biotechnology programs.Further, DBTprovides supports and services in all areas of implementation of biosafety regulations;provides services in biotech infrastructure development and generation of human resources in biotechnology. The Ministry of Agriculture deals with policies aimed at agricultural growth; monitoring of post-release performance of GM crops; and through its Indian Council of Agricultural Research (ICAR) is responsible for monitoring the agronomic benefits from GM crops.The Ministry of Healthand Family Welfare(MOEF&FW) deals with all policies including policies linked with protecting and monitoring human health from the use of GMOs and genetically modified substancesused in medicine. MOEF&FW is also responsible for Food Safety Standards for genetically modified foods and MOEF&FW operates through its Food Safety and Standards Authority.The Ministry of Commerce and Industries(MoC&I) is the nodal agency for implementing the notifications of the Directorate General of Foreign Trade (DGFT) for GMOs and LMOs and all foods containing GMOs /LMOs.The Central Board of Exciseand Customs, Department of Revenue, Ministry of Finance is responsible for the enforcement of regulations pertaining to the transboundary movement of GMOs/LMOs at the point of entry into/ exit from India.

A clear cut understanding of all the steps in the regulation of GMOs/LMOs provides smooth activities at all the establishments dealing with modern biotechnology products and processes.SBPI can assist in various aspects of regulations requiring compliance for the user establishments.

In biotechnology research, often the output may have potentialfor commercial applications. The researchers may not have the foresight of ensuring fructification of the potential for applications. The mission of impacting society through their research can be accomplished through commercialization. For an efficient and effective technology transfer, certain elements need to be taken into consideration which among others include perception, conceptions, inception and interpretation of technology, technological activities including transfer issues, communication channels, factors affecting transfer and models of transfer. Good technologies sell themselves without much effort but at the initial stage all the inventions do not have the hallmark of potential technologies. Initially, specialized knowledge may not appear to have technological values. Experts skilled in the art can more comfortably foresee the value of specialized knowledge and can advise the researchers to protect such knowledge so as to enable the transfer of such knowledge to the potential recipients. This is different from the material transfer model, where something tangible is already in sight. Even in technology  transfer models for material-transfer, in  the accompanying documents, several elements such as  adequate description of the invention with proper SOPs,blueprints and  application-methods need to be adequately  elaborated so as to  enable effective  transfer.  Specialized knowledge is required beyond the lab expertise for this. There is also a need for liasoning work between the industry and the academia.

Modern biotechnology products can emanate from the applications of techniques of genetic engineering in microorganisms, animal and plant cells and tissues;use of novel bioprocess engineering anddownstream processing techniques; biotransformation processes; autologous stem cells and somatic cells based transformations/transplantations;synthetic biology processes; and antigen/antibody based as well as nucleotide sequence based / amplified  technology- based  processes  for diagnosis/ prognosis. The products would include diverse range of rDNA products including living substances;stem cell based as well as autologous transformation-based products; RNA Interface-based products; bio-chips; diagnostics; and many more. These would have use in medicines; in agriculture; in industry; and in environment management/abatement issues. Facilitation of various phages of Clinical trials for products in medical biotechnology area is also another segment requiring specialized expertise.

In multiple such areas the SBPI experts would be able to assist the potential beneficiaries, which include the biotech research institutions on the one hand and the industry, regulators, funding institutions and banks on the other hand.

***Some key tips

Converting an idea into a project is an art. It is an instrument that effectively conveys to a donor what the prospective recipient has in mind. Quite often the success in getting a project funded lies in meeting the requirements of a funding agency.In other words it is a case of matching interests. It also helps very much if one understands the process required to be followed to see the project move successfully through the various stages.

Before one puts an idea into a proposal it is essential to study the scientific landscape in order to identify the gaps and see how one’s proposal is going to fill a distinct gap or answer an unanswered scientific question. Quite often fundable proposals or ideas do not get funded simply because the concept has not been articulated clearly.

Scientific excellence and strong credentials of the investigators are key selling points. The other essential elements are understanding the requirements of the donor ie if an area identified is a priority of the donor agency and importantly fund availability. It is necessary to incubate the idea and fine tune the concept before preparing a submission. Rushing into submitting a proposal is not wise as it reduces the quality of the submission. Visiting the website of a donor and having a look at a sample of projects fundedwould give a sense of the level at which a proposal has to be pitched. If one could get in touch with a successful applicant it would help a lot. It must be realized that most agencies use a process of competitive grant funding where there is obviously an unwritten rule that the best proposals and the best articulated proposals have a greater chance of success. During a competitive process when there are more proposals that can be accommodated, the less articulated ones get edged out by the ones presented with more clarity and where the concept is easily conveyed to the evaluators.

The thumb rule is that all sections in the prescribed format must be filled in. Care must be taken to note the instructions given with regard to word count, details of outputs and outcomes required. In technology development/commercialization projects unlike pure R&D, the aspect of commercialization should be clearly brought out. One should also see the freedom to operate that is available when employing technologies that have been commercialized/patented. It would also be useful to understand the transition from research leads to translational research and commercialization.

It would be a good exercise to start looking at the websites of the Department of Biotechnology (DBT) http://dbtindia.gov.in/ and the Department of Science of Technology (DST) https://dst.gov.in/ and fill up the grant application form while refining the science concept for which funding is sought.

*** the trajectory

Public-private partnershipsfor developing technologies inmodern biotechnology is constrained because of several factors. Important among these are grey areas in intellectual property arrangements, requirement of complex regulatory capacity compliance,lack of adequate numbers of skilled personnel and scientific resources and high R&D costs. By modulating some of these factors, it would be possible to develop new and contemporary, coactive and complementary PPP for India to move forward towards progress, enabling the exploiting of benefits of modern biotechnology at large by the country.

Convergence of the Public and Private sectors for undertaking research in critical areas of biotechnology to address needs of technology developmentand commercialization is a recent phenomenon. The close association of the public and private sector resulting in game changers like the Silicon Valley has been possible because of the careful nurturing of such association and creating a congenial ecosystem in which Public Private Partnership(PPP)activities thrive. Many countries have tried replicating the Silicon Valley with varying levels of success. The coming together of the public and private sectors in India has opened up immense opportunities and created a multiplier effect in R&D funding. Decades ago there used to be a near ‘blood brain barrier’ type situation between the private and public domains, with cross funding and cooperation in R&D quite unheard of.

The launchofNIMITLIhttps://www.csir.res.in/collaborations/nmitli ,  the funding by  Department of Biotechnology (DBT) http://dbtindia.gov.in/  and the Department of Science of Technology (DST) https://dst.gov.in/ have provided new windows for public private partnership. Mention should be made of the BIRAC https://birac.nic.in/  as a novel platform for public private partnerships with the various tailor made programmes such as SBIRI https://birac.nic.in/desc_new.php?id=217 embedded within BIRAC.

The entrepreneurial scientists should look at opportunities for setting up incubators on their own or in partnership with other companies. Through government funding, a number of incubators have been set up invarious universities. The scheme of bio-nest  https://birac.nic.in/bionest.php under the BIRAC umbrella is a good model to be considered. Individual entrepreneurs can explore opportunities where they can hire space for incubation of ideas.

There are success emanating from the initiatives of the Ministry of Science and Technology and others. The details of these should be sourced from the respective websites. In the sector of biotechnology there are notable opportunities in the sub sectors of agriculture, medicine, industrial application and devices. There is a huge potential in bio-medical devices since about 90 % of devices used in India are imported. Cross cutting sectors like nano technology will see emerging new applications.

*** a few snippets

As the dictum goes information is power and the earlier the information is available, the greater the power to leverage and put oneself in an advantageous position. Modern Science & Technology are driven endlessly by knowledge generation. Number crunching game operations seem to be increasingly emerging as the underpinning of biological sciences. Mathematical models and algorithms are continuing to define and redefine our understanding of biology. We are living in exciting times.

The Technology Information and Forecasting and Assessment Council (TIFAC) https://tifac.org.in//once headed by Dr. Kalam addressed the emerging scenario in India and came out with a monumental collection of reports that helped set the course for development in various sectors. Vision setting and forecasting has become an integral part of the planning process of most organizations.  The National Science Foundation of the US is a great engine that drives technology development and watching its website would give a sense of the emerging scenario.

As someone said..the only thing predictable about S&T  is that it is unpredictable !

Despite the breathtaking and fast moving developments that sometimes catch us off guard we need to engage in technology assessment and forecasting to the extent possible. Think tanks are an integral part of many institutions but they do not always address the complexities in the emerging scenario and the viability of available technologies. Many institutions need to go back to their drawing boards and involve potential end users early on in the R&D process. This would ensure that technologies developed are relevant and do not remain on the shelf.

The National Research Developmental Corporation  (NRDC)   http://www.nrdcindia.com/ of the Council of Scientific and Industrial Research  https://www.csir.res.in/  and the Biotech Consortium India Limited (BCIL) http://bcil.nic.in/  a company promoted by the Department of Biotechnology and financial institutions for commercialization of biotechnologies are useful windows for technology watch.

Modern biotechnology industry shows the incredible discoveriesthat human kind has benefitted from. The world is becoming a better place to live because of new discoveries for diagnosis and treatment, cure for many dreaded microbial diseases, certain bodily dysfunctions, chronic diseases and certain cancers.

SBPI can assist in the collection, compilation and dissemination of information on global developments in modern biotechnology including identification on new inventions and developments in industries.

***some other useful windows for technology watch are:

http://dbtindia.gov.in/

https://dst.gov.in/technology-watch-foresighting