National Workshop on “Potential Biotechnology Programmes using Bioresources of NE regions” DBT-NECAB Workshop Assam Agricultural University, Jorhat September 13 -14 , 2019 1
Dr. P.M. Bulakh Former Dean, B.J. Medical College And Sassoon General Hospital, Pune. Director, Board Of College And University Development, Bharati Vidyapeeth Deemed To Be University. 2
Bioprospecting practice in the pharmaceutical industry • Bioprospecting is the process of discovery and commercialization of new products based on biological resources. • These resources or compounds can be important for and useful in many fields, including pharmaceuticals, agriculture, bioremediation, and nanotechnology, among others. 3
Bioprospecting practice in the pharmaceutical industry (Contd…) • Between 1981-2010, one third of all small molecule new chemical entities approved by the U.S. Food and Drug Administration (FDA) were either natural products or compounds derived from natural products. • Despite indigenous knowledge being intuitively helpful, bioprospecting has only recently begun to incorporate such knowledge in focusing screening efforts for bioactive compounds. 4
Need of bioprospecting • The underlying aim of bio prospecting is to find new resources and products from nature that can be used by humans. • Improving human health, through both medicine and better nutrition are key focal areas. • It plays a dominant role in discovering leads for drug development, since existing/known compounds for developing drugs for human use are limited. 5
Need of bioprospecting • A study showed that between 1983 and 2003, almost two thirds of anti-cancer agents being investigated as drug candidates were derived from natural products. • Other related sectors, such as crop plant biotechnology, screen natural resources for useful traits, such as disease resistance. 6
Approach to drug developed • A different approach has been developed to make use of the structural diversity of isolated natural products: in silico drug discovery or virtual screening. • In this, the chemical structures and physico-chemical properties of compounds are gathered in a computerised database that can be searched to find matches either to complement the three-dimensional structure of a drug target or the chemical features of a compound with the desired 7 activity.
Drug development protocol 8 R Janna, Q Cassandra, I Gazi. The Four-Sided Triangle of Ethics in Bioprospecting: Pharmaceutical Business, International Politics, Socio-Environmental Responsibility and the Importance of Local Stakeholders. Ethnobiology and Conservation, 2012
Bioprospecting programmes : Examples from India • CSIR Coordinated Programme on Drug Discovery (1996) • Dept. of Biotechnology – Bioprospecting and Molecular Taxonomy Programme (1998) • New Millennium Indian Technology Leadership Initiative (NMITLI) – Planning Commission/CSIR (2002) 9
Bioprospecting : Major Areas Chemical prospecting Gene prospecting • Drug & • Genetic engineering Pharmaceuticals • Crop developmnet • Pesticides • Fermentation • Cosmetics • Cell culture • Food additives • Other industrially valuable products Bionic prospecting • Designs • Sensor technologies • Architecture • Bioengineering • Bio-modeling 10
Bioprospecting : Major Areas 11 • P. Pushpangadan. National Botanical Research Institute, Lucknow, IUCN South Asia Regional Training Programme on Bioprospecting, Access and Benefit Sharing, NBRI, 10-12, January 2005
Ocimum sanctum: ( Holy Tulsi)
Actions of O.santum ❑ Antimicrobial, ❑ Insecticidal ❑ Antispasmodic, ❑ Mosquito repellent ❑ Bactericide, carminative, ❑ Antiinflammatory ❑ Biological activity ❑ Wound healing ❑ Luteolin anthelmintic, ❑ Antidiabetic ❑ Hepatoprotective, ❑ Antipyretic ❑ Antiviral, ❑ Antimelanoma ❑ Larvicidal – ❑ Rediaoprotective ❑ Antinociceptive, ❑ Antioxident ❑ Anti-fungal, ❑ Anticancer ❑ Antiaflatoxigenic, ❑ Anthelmintic ❑ Anti-diarrheic, ❑ Anticandidal ❑ Amylase inhibitory ❑ Hypolipaemic
Research Methodology 14
Types of research * Applied research * Clinical trials 15
Scientific Advisory Committee Chairperson – Outsider. ( Professor/ Scientist from National Institute) Subject Experts ◦ Internal ◦ External Statistician Member Secretary 16
Ethics Committee IEC (Independent Ethics Committee) IRB – Institutional Review Board Constitution ❖ Chairperson (Preferably outside the Institution) ❖ Member Secretary (Within the Institution) ❖ 1-2 Basic Med. Scientists ❖ 1-2 Clinicians ❖ One legal expert / retired judge ❖ One Social Scientist / NGO ❖ One Philosopher ❖ Lay person from Community eg. Housewife 17
Nuremberg Code “Voluntary consent of the human subject is absolutely essential” • Human experiments must be based on prior animal experiments • Anticipated results should justify the experiments • Only qualified scientists should conduct research • Physical and mental suffering should be avoided • There should be no expectation of death or disabling injury from an experiment
Members of Animal Ethics Committee ❖ CPCSEA ( Committee for the purpose of control and supervision of experiments on animals) ❖ This is a committee formulated by Government of India to control experiments on animals 19
Members of Animal Ethics Committee contd … ❖ Members of ethics committee are – Nominated by CPCSEA: Main nominee – Scientist from outside the institute – Socially aware member ( Generally having knowledge about animals) – Nominated from institute : 4 or 5 members – Scientist in charge of animal house – Chairman nominated from amongst the people (Generally Principal) – Scientist from other speciality – Veterinary Doctor – Member Secretary 20
Regulatory Authorities ❖ Indian /council of Medical Research ❖ State Government ❖ Central Government ❖ Data Safety Monitoring Board. 21
DSMB Composition • Clinical Medicine experts • Biostatistician, Bioethics • Pharmacologists • Pt. Advocate, community representative • Chairman – previous experience in monitoring • Ex officio – member secretary, no voting rights.
Functions of DSMB Initial Meeting 1) Protocol approved by IRB 2) CRF & DM Plans 3) Informed consent forms, Protocol design – capture all efficacy and safety.
Types of research * Applied research * Clinical trials 24
Animal Models ❖ Alloxan Induced Diabetes Mellitus Antidiabetic drugs (catalin), Medicinal plants ❖ Cholesterol Induced Atherosclerosis statins, Garlic, Onion, Vitamin C, Aspirin ❖ Glucose Induced Cataract in Goat lenses. Medicinal Plants : Amala, Bael, Jamun and Garlic ❖ Steroids Induced cataracts in goat lenses. Metabolites – Uric acid, Bilirubin, certain amino acids having antioxidant properties. ❖ UV and IR Radiation Induced Cataract : Goat lenses were exposed to UV and IR Radiation. 25
Effect of Medicinal Plants on Lens Enzymes in Experimental Diabetic Cataract by Arti Hajarnavis Under The Guidance of Dr. P.M. Bulakh Department of Biochemistry BVDUMC, Pune.
Cataract ❖ Cataract – opacification of lens of eye is a leading cause of visual impairment. ❖ Accounts for 51 % of global blindness. ❖ Cataractogenesis -is more pronounced and accelerated in diabetic individuals ❖ Is one of the earliest secondary complications of Diabetes mellitus. ❖ Risk of cataract advances with duration and severity of diabetes. 27
Treatment of cataract ❖ A definite pharmacological therapy for cataract is not yet available. ❖ Surgical removal of cataractous lens is the only respite to cataract patients. 28
Mechanism of Cataractogenesis In view of this, researchers have proposed a ‘multi target’ strategic approach for a possible prevention / delay of diabetic cataractogenesis • Multiple mechanisms have been proposed in the development of diabetic cataract. • This could be achieved by • Three important and probable using substances which could mechanisms are:- act as – – Antiglycation agents - Non enzymatic glycation of lens proteins – Antioxidants and - Oxidative stress and – Aldose reductase inhibitors - Increased polyol pathway in hyperglycemia. 29
Medicinal Plants ❖ Phytochemicals from various plants have been found to have such multiple beneficial effects in diabetes and its complications. ❖ India has a rich heritage of ancient traditional systems of medicine . ❖ Various indigenous plants are used in Ayurveda for the treatment of diabetes and cataract . 30
Sample Collection ❖ Goat eyeballs were obtained from the slaughter house and were transported to the laboratory in an ice-box. Lenses were removed from the eyeballs by intracapsular lens extraction method. ❖ The weight of the lenses was recorded and lenses were then carefully placed on sterile petri dishes with a dark colored nylon net. ❖ The lenses were incubated in tissue culture medium (TC-199) by “Lens Organ Culture Technique” for 72 hours. 31
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