St. Xavier s College Autonomous. Mumbai. Syllabus. (June 2014 onwards) Contents. Syllabus for the following courses:

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St. Xavier s College Autonomous Mumbai Syllabus For 4 th Semester Courses in M.Sc in Biotechnology (June 2014 onwards) Contents Syllabus for the following courses: THEORY COURSES MS.BTS.4.01 DRUG DESIGNING & NANOTECHNOLOGY MS.BTS.4.02 ENTREPRENEURSHIP PRACTICAL COURSE MS.BTS.4.01PR RESEARCH METHODOLOGY MS.BTS.4.02 PR ENTREPRENEURSHIP EXTERNAL RESEARCH PROJECT (4 MONTHS) Page 1 of 8

SEMESTER 4 COURSE: MS. BTS. 4.01 Overall Learning Objective: DRUG DESIGNING AND NANOTECHNOLOGY 60 Lectures To gain an exposure to recent techniques in biopharmaceutical drug discovery To understand the applications of nanotechnology in medicine. Unit 1 Drug Development 15 Lectures Learning Objective: To understand the quantitative structure activity relationships of drug molecules To know the steps of drug discovery process 1. Steps involved in drug discovery, Production and characterisation, Preclinical studies and Validation studies 2. Computer aided drug designing and docking o General Principles of CADD o Types of drug designing o Ligand based molecular interactions o Structure based Drug designing o Examples of Ligand and structure based drug designing o Applications and importance of CADD Unit 2 Clinical Research 15 Lectures Learning objective: To understand the relevance of clinical research in drug discovery process 1. Introduction 2. Good clinical practice guidelines 3. Ethical aspects of clinical research 4. Clinical research methodologies and management 5. Regulatory requirements 6. Data management Page 2 of 8

Unit 3 Regulatory Affairs and Pharmacovigilance 15 Lectures Learning Objective: To understand the role of monitoring of drugs before and after release by regulatory authorities 1. ICH 2. FDA 3. Investigational New Drug Applications 4. Documents 5. Communication (Review period and approval period) 6. Classifications of Adverse Events 7. Scope of Drug Safety Problems 8. Drug Safety and FDA Unit 4 Nanotechnology in medicine 15 Lectures Learning objective: To study the concept of nanotechnology, synthesis of nanoparticles and its applications To understand the applications of emerging nanotechnology in treating diseases 1. Introduction to nanotechnology: o Introduction to nanotechnology and bio-nanotechnology o Important nano-particles / materials, bionanorobots/molecular motors nano motors and their uses (in brief) 2. Synthesis of nanoparticles: o Common Strategies for synthesis of nanomaterials with examples, (Biological methods for nanoparticle synthesis) o Characterization methods 3. Applications of nanotechnology: o Nanosensors, and Carbon nanotubes and their applications in biology o Medical nanotechnology Nano pharmaceuticals : Nanobiotechnology for drug discovery and drug delivery Nano-diagnostics : Nano particles for the detection and treatment of cancer, Nano arrays for molecular diagnostics, Nanoparticles for Molecular Diagnostics, nanobarcode Page 3 of 8

References: Role of nanotechnology in biological therapy, nano devices ain medicine and surgery Worldwide Development and Commercialization of Nanomedicine 1. Daan J. A. Crommelin, Robert D. Sindelar. (2002) Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists. Taylor & Francis. 2. Thomas M. Jacobsen, Albert I. Wertheimer. (2010) Modern Pharmaceutical Industry: A Primer. Jones & Bartlett Publishers. 3. Oliver Kayser, Rainer H. Müller. (2006) Pharmaceutical Biotechnology. John Wiley & Sons. 4. Gary Walsh. (2006) Biopharmaceuticals: Biochemistry and Biotechnology. John Wiley & Sons. 5. Tommy Liljefors, Povl Krogsgaard-Larsen, Ulf Madsen. (2010) Textbook of Drug Design and Discovery. 4 th Edition. CRC Press 6. Mansoor M. Amiji (Editor). (2006) Nanotechnology for Cancer Therapy. CRC Press. 7. Gabor, Hornyak, Joydeep Dutta, Harry F. Tibbas,(2009) Fundamentals of Nanotechnology, CRC Press 8. Kewal K. Jain (2008) The handbook of nanomedicine. Humana Press 9. Scott E. McNeil ( 2009), Nanoparticle therapeutics: a personal perspective, Wiley Interdisciplinary Reviews: Nanomedicine and Nanobiotechnology, Vol 1 Issue 3 Page 4 of 8

COURSE: MS. BTS. 4.02 ENTREPRENEURSHIP AND RESEARCH METHODOLOGY Overall learning objective: 60 Lectures To Understand the commercial potential of research and business in Biotechnology Unit 1 Management principles 15 Lectures Objective: To provide students from a non-management orientation with a brief idea on the various functions in an organization, the role of various departments and how they function together in the creation of a successful and profitable company. 1. Organizational Structure o Various Departments and the Roles they play 2. Marketing Management: o Understanding the role of marketing in Organizations o Customer Satisfaction and its importance o Marketing Research and its importance o Brief Introduction to Buying Behaviour o Understanding the Micro Environment (Strengths and Weaknesses vis-à-vis your company and its competition) o Understanding the Macro Environment (Opportunities and Threats PEST Analysis) o Brief Introduction to Demand Forecasting o Market Segmentation and Target Markets o 5P s (Product, Price, Place, Promotion, People) 3. Finance Management o Understanding the role of finance in Organizations o Functions of a Finance Manager, Accountants, etc. o Financial Statements o Cash Flow o Taxes o Interest Rates Page 5 of 8

o Risk and Rate of Return o Break-even analysis 4. Human Resource Management o Understanding the role of a HR Manager in Organizations o HR Planning, Resourcing and Retention o Training and development o Performance Management o Grievance handling o Labour Laws and its importance 5. Other functions : o Operations o Research & Development o Administration Unit 2 Entrepreneurship 15 Lectures Objective: To make students aware of entrepreneurship and motivate them to identify opportunities and dispel any fears they may have even in considering the same through Case Studies and talks by Entrepreneurs. 1. Entrepreneurship o Meaning of entrepreneur o Advantages and Disadvantages of being and Entrepreneur o Function of an entrepreneur o Types of entrepreneur o Evolution of entrepreneurship in India o Factors affecting development of entrepreneurship o Stages in entrepreneurial process o Role of entrepreneurs in economic development entrepreneurship in India. o Case Studies of Entrepreneurs (Good and Bad) o Visit and Lectures by Entrepreneurs 2. Women Entrepreneur : Page 6 of 8

o Case Studies of Successful Women Entrepreneurs o Challenges faced by Women Entrepreneurs o Govt. Policy on Women Entrepreneurs 3. Micro Small & Medium Enterprises (MSME) o Role and Importance in Economic Development, o Impact of Liberalization, Privatization and Globalization on MSME, o Effect of WTO/GATT, PEST Analysis w.r.t. India 4. Sources of Finance o Sources of Finance available o How to prepare a business Plan o What do financiers look for in a business plan o Institutional Support-Different Schemes, TECKSOK, KIADB, KSSIDC, KSIMC, DIC single window Agency SISI, NSIC, SIDBI, KSFC o Case Studies Unit 3 Business of Biotechnology 15 Lectures Learning objective: To understand the commercial applications and the current market status of biotechnology and related areas like pharmaceutical and diagnostics. 1. Process Economics: Cost estimates, Process design, Design Exercise, Capital Costs estimates, Operating costs estimates. 2. Biotechnology companies, their care and nurturing 3. Investment in Biotechnology: seed investment, private investors, Venture capitalists, Corporate Partners, Grants. 4. Management in Biotechnology 5. Growth of Biotechnology industry in India Page 7 of 8

Unit 4 Introduction to research methodology 15 Lectures Learning objective: To understand the basis of research methodology 1. Meaning, objective and types of research 2. Research approaches, Research Process and Criteria for Good Research 3. Research problem: definition, techniques involved, illustration 4. Research design : meaning, Important Concepts and basic Principles of Experimental Designs 5. Research and grant proposal writing: significance and mechanics. Reference books: 1. Dynamics of Entrepreneurial Development & Management Vasant Desai Himalaya Publishing House 2. Entrepreneurship Development small Business Enterprises Poornima M Charanthmath Pearson Education 2005 3. Entrepreneurship Development S S Khanka. S Chand & Co 4. Basic Biotechnology, Colin Ratledge and Bjorn Kristiansen, Cambridge University Press- 2 nd Ed,2001 5. C.R. Kothari, Research methodology: methods and techniques, 2 nd edition, New Age International Publishers, 2004 6. James Morris, A students guide to writing in the life sciences, The President and Fellows of Harvard University, 2007 PRACTICALS Overall learning objective: To train the students in different aspects of scientific research and entrepreneurship. 4.01PR: Research methodology 4.02 PR: Entrepreneurship EXTERNAL RESEARCH PROJECT FOR 4 MONTHS WITH DISSERTATION Page 8 of 8