NATIONAL WORKSHOP ON

TECHNOLOGY UP-GRADATION &

PHARMACEUTICAL PROMOTION (29th & 30th July, 2016)

DEPARTMENT OF PHARMACEUTICALS Ministry of Chemicals and Fertilizers,

Government of India

Partners

INDIAN DRUG MANUFACTURERS’ ASSOCIATION SINCE 1961

ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA

REGIONAL OCCUPATIONAL HEALTH CENTRE (EASTERN)

Venue Auditorium, Regional Occupational Health Centre (Eastern), NIOH-ICMR,

Block DP, Sector V, Salt Lake, Kolkata, 700 091

Supported By

NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOLKATA

Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers,

Government of India KOLKATA

SOCIETY FOR ETHNOPHARMACOLOGY

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National Workshop on Technology Up-Gradation & Pharmaceutical Promotion

29th & 30th July 2016 About NIPER Kolkata National Institute of Pharmaceutical Education and Research (NIPER), Kolkata was created in 2007 under the aegis of Ministry of Chemicals & Fertilizers as a centre of excellence for higher education, research and development in pharmaceutical sciences. The institute was declared as an Institute of National importance by Government of India through Act of Parliament (NIPER Act 1998 & NIPER amendment Act 2007). At present the Institute is housed at Indian Institute of Chemical Biology (IICB), a premier Institute of the Council of Scientific & Industrial Research, India. The mentor Institute IICB is engaged in research on diseases and biological problems of global interest, employing sophisticated state-of-the-art technology in keeping with the rapid and unprecedented momentum that life science research has gained globally over the last 50 years. The scientific staff has expertise in a variety of areas including chemistry, biochemistry, cell biology, molecular biology, biotechnology, neurobiology, immunology, structural biology and bioinformatics, which promotes productive interdisciplinary interactions of the major laboratories in India. These interactive exercises initiated, right from its inception, multidisciplinary concerted efforts for conducting basic research on infectious diseases, specifically leishmaniasis and cholera, along with the development of technologies for the diagnosis, immunoprophylaxis, and chemotherapy of the diseases. Bioactive substances from natural sources and chemically synthesized new molecules are being explored as potential drugs.

Acknowledgment

Dear Colleagues, It's my great pleasure to acknowledge all the participated scientists,

eminent experts of pharmaceutical industries and academicians to the National Workshop on Technology Up-gradation and Pharmaceutical Promotion, organized by NIPER Kolkata under the aegis of the Pharmaceutical Promotion and Development Scheme (PPDS) of Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India. This is an attempt by NIPER, Kolkata to act as an interface to the pharmaceutical

industries and academic institutions and to create a platform that could help in the establishment of Industry-Academia partnership firmly to translate technologies and to appraise pharmaceutical promotion.

In this workshop, several themes and sub-themes are covered and several eminent experts from both reputed Academia and Industries in India delivered talks on wide-range of topics, under each theme fresh insights came into various fields of learning. It was indeed a great opportunity for all participants to connect with industrial experts and academic scientists. I hope that this National workshop has provided a platform to rise and address important challenges in the pharmaceutical industries as well academic sectors in integrating new technology for high-quality but cost-efficient pharmaceuticals from India to worldwide.

Regards, Dr. V. Ravichandiran Director, NIPER-Kolkata

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THEME OF THE WORKSHOP

Under the aegis of the Pharmaceutical Promotion and Development Scheme (PPDS), NIPER Kolkata with the support of Department of Pharmaceuticals is organizing Two Days National Workshop on Technology Up-gradation and Pharmaceutical Promotions (29th and 30th July, 2016) with the following objectives:

1. To establish an Industry-Academia partnership firmly to translate technologies developed through research by the industries.

2. To continuously monitor and understand the various challenges of pharmaceutical industries and to assist in their mitigation.

3. To apprise the national industries about the latest research developments in global pharmaceutical industries including newer technologies.

SUBTHEMES OF SESSIONS

Day 1: SESSION-I Day 1: SESSION–II Day 1: SESSION-III

Inaugural Address Keynote Address: Dr. A. V. Rama Rao Former Director, IICT, Hyderabad & MD, Avra Laboratories

Biotechnology Targeted Drug Delivery Nanotechnology Drug Discovery Multifunctional Nanomaterials

Hathi-to-Katoch Committee: Impact on Industry US-FDA/WHO, GMP-related Issues Import Dependence: Bulk Drug/Raw Materials Bio Similar Drugs Off-patented drugs

Day 1: SESSION-IV Day 2: SESSION-I Day 2: SESSION-II Day 2: SESSION-III

Natural Products Ayurvedic Formulations

Drug Discovery Bulk Drug (API) - Manufacture

Medical Devices Diagnostics Theranostics Patent-related

Final Reports Round-up Address Vote of Thanks

DAY 1 (29th July, 2016; Friday)

SESSION–I (10:30 - 11:30 A.M.)

INAUGURAL SESSION

Welcome address: Dr. V. Ravichandiran, Director, NIPER, Kolkata

Address

Dr. C. K. Pradhan, Scientist-E & Officer-in-Charge, ROHC(E), Kolkata

Mr. Deepnath Roy Choudhury, VP, IDMA East

Mr. Vivek Padgaonkar, Director – Project & Policy, OPPI

Dr. Subhash C. Mandal, President, IPA, Bengal Branch

Dr. C.M. Ghosh, Director, Directorate of Drugs Controller, WB

Inaugural address: Dr. A. V. Rama Rao, Former Director, CSIR-IICT, and MD, Avra Laboratories

Vote of Thanks: Dr. Kamal K. Datta, Academic Coordinator, NIPER, Kolkata

11:30 - 12:00 P.M. TEA BREAK

SESSION–II (12:00 - 01:30 P.M.)

RECENT TECHNOLOGICAL INNOVATIONS IN PHARMACEUTICAL INDUSTRIES

Chairperson: Dr. A. V. Rama Rao, Former Director, IICT, and MD, Avra Laboratories; Rapporteur: Dr. Kuldeep K. Roy, Assistant Professor, NIPER, Kolkata

Biopharmaceuticals: Quality & Regulatory Requirements. Dr. SriRam Akundi, Assistant Vice President, Biocon, Bangalore

Nanoscale Engineering for Drug Delivery. Dr. Arup Mukherjee, Pharm. & Fine Chem. Tech., Univ. of Calcutta, Kolkata

Biological API & New Technology Related to It. Prof. Rama S. Verma, Dept. of Biotechnology, IIT, Madras

Drug Discovery and Bioimaging. Dr. Sri Sivakumar, Assoc. Professor, Dept. of Chem. Engineering, IIT Kanpur

01:30 - 02:30 P.M. NETWORKING/LUNCH

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SESSION–III 02:30 - 04:00 P.M.

PHARMACEUTICAL PROMOTIONS: KEY POLICY-RELATED PHARMACEUTICAL CHALLENGES

Chairperson: Prof. Rama S. Verma, Dept. of Biotechnology, IIT, Madras; Rapporteur: Dr. V. Murugan, DST INSPIRE Faculty, NIPER Kolkata

Hathi-to-Katoch Committee: Impact on Industry. Dr. V. Ravichandiran, Director, NIPER Kolkata

Off-patented Drugs-Strategy for Pharmaceutical Promotions. Mr. Sarthak Ranade, Vice President – Mass Markets; Janssen India, Johnson & Johnson Private Limited, India

04:00 - 04:30 P.M. TEA BREAK

SESSION–IV 04:30 - 05:30 P.M.

NATURAL PRODUCTS SESSION

Chairperson: Dr. Syamal Roy, VC, Cooch Behar Panchanan Barma University, WB; Co-chairperson: Dr. S. Bandyopadhyay, Site Head, ASG Biochem Pvt. Ltd; Rapporteur: Dr. G. P. Pazhani, Assistant Professor, NIPER Kolkata

Product Development from Natural Resources: Industrial Perspectives. Prof. Pulok K. Mukherjee, Professor & Director, School of Natural Product Studies, Jadavpur University, Jadavpur

Modern Spectroscopic Techniques Driving Natural Products Research. Dr. P. Jaisankar, Chief Scientist & Head, Org. & Med. Chem., CSIR–IICB, Kolkata

Cultural Attention and Scientific Integration for Ayurvedic Formulations. Dr. V. Muruganandam, Director R&D, Natreon Inc., Kolkata

DAY 2 (30th July, 2016; Saturday)

SESSION–I 10:00 - 11:30 P.M.

PHARMACEUTICAL CHALLENGES

Chairperson: Dr. Siddhartha Roy, Director, Bose Institute, Kolkata; Co-chairperson: Dr. A. Chakraborti, Scientist-E, ROHC(E), Kolkata; Rapporteur: Dr. V. Murugan, DST Inspire Faculty, NIPER Kolkata

Quality Assurance: Challenges in Implementing New Technology. Mr. B. G. Chakrabarti, Senior Director & Head, QA, Dr. Reddy’s Lab, HYD

Challenges in the Field of Steroidal Bulk Drugs. Dr. S. Bandyopadhyay, Site Head, ASG Biochem Pvt. Ltd., Kolkata

Bioequivalence: Challenges and Solutions. Mr. Shrikrishna Pawar, Senior Manager, Clinical Development, Sanofi, Goa

Challenges for Biotech Enterprises and Large Scale Production of Recombinant Proteins. Mr. Jatin Vimal, Partner, Levim Biotech LLP, Chennai

11:30 - 12:00 P.M. TEA BREAK

SESSION–II 12:00-01:30 P.M.

ASSORTED SESSION

Chairperson: Mr. Vivek Padgaonkar, Director – Project & Policy, OPPI; Co-chairperson: Mr. B. G. Chakrabarti, Senior Director and Head, Quality Assurance, Dr. Reddy’s Laboratories, Hyderabad; Rapporteur: Dr. Jayeeta Bhaumik, Assistant Professor, NIPER Kolkata

Influence of Data Curation on Pharmaceutical Modeling. Prof. Kunal Roy, Professor, Dept. of Pharm. Technology, Jadavpur University, WB

Novel Therapeutic Targets for Inflammatory Disorders. Dr. S. Swarnakar, Sr. Principal Scientist & Head, Cancer Biology and Inflammatory Disorder, CSIR–IICB, Kolkata, WB

Nanomaterials for Drug Delivery and Medical Diagnostics. Dr. P. Sujatha Devi, Head, Sensors & Actuators Division, CSIR–CGCRI, & Adjunct Faculty, NIPER, Kolkata, WB

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Specificity in Small Molecule Interactions with Proteins: A Structure Based Computational Approach. Dr. Nakul C. Maiti, Senior Scientist, Structural Biology & Bioinformatics., CSIR-IICB, Kolkata, WB

Randomized Drug Trials and Ethical Issues. Dr. A. Chakrabarti, Scientist-E, ROHC(E)

Dey’s Medical, Kolkata Albert David Ltd., Kolkata East India Pharm. Works Ltd., Kolkata Dabur India Ltd., Kolkata

Dusap Pharmaceuticals, Kolkata Mr. T. Chakrabarti, SAC, NIPER, Kolkata Dr. Arul Pitchai, SAC, NIPER, Kolkata Stadmed Pvt. Ltd., Kolkata

01:30 - 02:30 P.M. NETWORKING/LUNCH

SESSION–III 02:30 - 03:30 P.M.

VALEDICTORY SESSION

Chairperson: Shri. Sudhansh Pant, IAS, Joint Secretary(Policy), Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India

Reports of Rapporteurs

Round-up Presentation. Dr. V. Ravichandiran, Director, NIPER, Kolkata

Address by Chairpersons

Vote of Thanks. Dr. Kamal K. Datta, Academic Coordinator, NIPER, Kolkata

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Keynotes of the sessions are mentioned below.

Day 1 (29th July 2016, Friday)

Session I: Inaugural address Dr. A. V. Rama Rao Former Director, CSIR-IICT, and MD, Avra Laboratories

The chief guest, Padma Shri and Padma Bhusan Dr. Rama Rao, delivered the inaugural address with background information on his earlier research career in CSIR-IICT, Hyderabad. The inspiration toward his new drug molecule design (for anti-depressant) or motivation of research project came through the need of simplified synthetic reaction steps in pharmaceutical industries. Another important research outcome of his career is development of anti-HIV molecule (AIDS treatment) and the socially important reason behind the research project were briefly narrated. Dr. Rama Rao highlighted the need of advanced technical skill developments in process chemistry and optimization of laboratory scales for the PhD program. As an academic consultant how Dr. Rama Rao excelled in his research project especially accomplishing sponsorship from pharmaceutical industries were presented. Dr. Rama Rao’s research activities in Harvard University, US, were also presented. Key simplified process chemistry developed during his research career for known molecules and commercialization, for the first time, through Indian Pharma industries were highlighted. His transformation from academic research to industrial entrepreneur was presented. Dr. Rama Rao also introduced the Avra Laboratories and its research capabilities. A keynote on the requirement of technologies leading to commercially successful products, processes and services, the relevant sustainable competitive advantages to Nation was emphasized as concluding remarks. Mr. Deepnath Roy Choudhury Vice President, Indian Drug Manufacturers’ Association (IDMA) East, MD, Strassenburg Pharm. Ltd., Kolkata

In the inaugural address, Mr. Deepnath briefly talked about the regulatory policies related to small-to-medium scale industries and public-private partnership. Further, he talked the requirement of better technology strategies, especially small industries, to sustain the global market competence. Key points on Indian pharma market toward export of API worldwide, industrial manpower and GMP guidelines were also discussed. He also highlighted the active role of NIPER-KOLKATA in bridging Industry-Academic partnership through conducting “National Workshop on Technology Up-Gradation and Pharmaceutical Promotion”.

Mr. Vivek Padgaonkar Director – Project & Policy, Organization of Pharmaceutical Producers of India (OPP), India

Mr. Vivek presented the active role of Indian Health care industries and role of NIPER as center of innovation for technology transfer to Industries. Also he emphasized the collaboration of NIPER-OPPI. Some of the technical advancements mentioned in the presentation are Electronic health record, M-Health, Telemedicine/ Tele health, Portal technology and remote monitoring technology.

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Photographs (Day 1, 29th July 2016)

Dr. A.V. Rama Rao Former Director CSIR-IICT

MD Avra Lab.

Dr. C.M. Ghosh Director, Directorate of

Drug Control, Govt. of West Bengal

Dr. K.K. Datta Academic Coordinator

NIPER-Kolkata

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Session II: Recent Technological Innovations in Pharmaceutical Industries

Topic: Biopharmaceuticals: Quality & Regulatory Requirements By Dr. SriRam Akundi, Asst. Vice President, Biocon, Ltd., Bengaluru

This talk highlighted the requirement of new manufacturing process for Biopharmaceuticals. Further, the operational domain for biopharmaceuticals from small molecules to complex systems, chemistry, manufacturing/operations, and controls (CMC); business models and return on investment and regulatory pathways were presented. Refinement in the regulatory CMC/Quality strategies and how to ensure compliance with regulatory requirements throughout the clinical development and post-approval process are discussed.

Topic: Nanoscale Engineering for Drug Delivery By Dr. Arup Mukherjee, Professor, Department of Pharmcetical & Fine Chemical Technology, University of Calcutta, Kolkata

Novel physicochemical properties of nanoparticles toward pharmacotherapy were introduced. Enhancement of drug solubility and functional properties of nanoformulation such as targeted delivery with modulated pharmacokinetics were emphasized. Relevant research results from laboratorial experiments were presented.

Topic: Biological API & New Technology Related to It By Dr. Rama S. Verma, Professor, Department of Biotechnology, IIT Madras

Dr. C.K. Pradhan Scientist-E & Officer-in-Charge ROHC(E), ICMR-NIOH, Kolkata

Dr. Siddartha Roy Director

Bose Institute, Kolkata

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In this talk the speaker introduced the pharmacological value of API which determines the structure and function of human body. Various developmental objects in the biological API such as cloning and expression of therapeutic proteins were detailed. Potential biosimilars derived from antibodies toward clinical functionalities were presented in video representation. Synthetic bio-degradable small/micro molecules and techniques involved in the processing of therapeutic antibodies or proteins for advanced clinical bioactivities were also explained with facet of API.

Nanoengineered Materials for Drug Delivery & Bioimaging Applications By Dr. Sri Sivakumar, Associate Professor, Department of Chemical Engineering, IIT Kanpur

Dr. Sivakumar highlighted the distinct size-dependent properties of nanoparticles toward biological and pharmaceutical applications, viz., bioimaging and therapy. Factors influencing the surface engineering on nanoparticles were discussed. Physical properties such as stability and inertness of the carbon and lanthanide based hybrid nanosystems were presented. Research results based on polydimethoxy siloxane and silica based hybrid composites and its drug delivery applications were discussed. Further applications of lanthanide based nanoparticles as MRI contrast agents were also covered.

Session III: Pharmaceutical Promotions: Key Policy-Related Pharmaceutical Challenges

Hathi-to-Katoch Committee: Impact on Industry By Dr. V. Ravichandiran, Director, NIPER Kolkata

In this presentation, Dr. Ravichandiran, presented the key recommendations concluded from Hathi committee report covering the various aspects of distribution of raw materials, small-to-medium scale industries, export-import statistics of important API, policy references and need of financial assistances from Government. Further, Dr. Ravichandiran highlighted the Katoch committee reports and viewpoints toward Make-in-India and sustainable global market growth of India. Importance of public-private partnership, innovations required in the modern technical fields such as nano-pharmaceuticals, medical theranostics, synthetic biology, bio-similars and novel functions of existing drug molecules such as amoxicillin and aspirin. Requirement of advanced infrastructure, high-quality with cost-efficient manufacturing process, radical up-gradation in technology, academia and industrial cooperation were also highlighted as the vision to be accomplished.

Off-patented Drugs-Strategy for Pharmaceutical Promotions.

Mr. Deepnath R. Choudhury VP, IDMA (East) &

MD, Strassenburg Pharm. Ltd.,

Dr. S.C. Mandal President

IPA, West Bengal Branch

Mr. Vivek Padgaonkar Director Project & Policy

OPPI

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By Mr. Sarthak Ranade, Vice President – Mass Markets; Janssen India, Johnson & Johnson Private Limited, India

In the talk, Mr. Ranade briefly discussed the cycle of innovation, importance of stakeholder mapping and understanding their needs to design appropriate strategy for promotion of off patented drugs. He also covered the various strategies deployed by pharmaceutical players with relevant examples.

Session IV: Natural Products Session

Product Development from Natural Resources: Industrial Perspectives. By Prof. Pulok K. Mukherjee, Professor & Director, School of Natural Product Studies, Jadavpur University, Jadavpur

Prof. Mukherjee briefly introduced the background on the discovery and development of drugs from natural resources with industrial elements and process workflow. Major aspects of industrial-academic collaboration toward product development, key examples of traditional Indian herbal medicines and its clinical values were compared, viz., hope of Ayurveda for Alzheimer’s disease, anti-oxidants, anti-aging formulations. He also presented the activities of Society for Ethnopharmacology, India for Globalizing Local Knowledge, Localizing Global Technology”.

Modern Spectroscopic Techniques Driving Natural Products Research. By Dr. P. Jaisankar, Chief Scientist & Head, Organic & Medicinal Chemistry, CSIR–IICB, Kolkata

In this talk, Dr. Jaisankar discussed the complex nature of natural product’s chemistry and its elucidation. Physical principles of spectroscopic techniques and mode of interpretation were presented. Important techniques such as HPLC and NMR methods like 1H, 13C, NOESY, COSY, ROESY and HSQC-NOESY were covered with examples.

Cultural Attention and Scientific Integration for Ayurvedic Formulations. By Dr. V. Muruganandam, Director R&D, Natreon Inc., Kolkata In this talk, Dr. Muruganandam reviewed contemporary approaches for bridging ayurveda with evidence-based medicine. Importance of integrating the scientific approaches in ayurvedic formulation for standardization was presented. Global export values of herbal formulations, problems associated with ayurvedic products such as cultivation and harvesting, processing, quality, pre-clinical and clinical data and efficacy were also discussed. Further, demand for softer techniques, full-spectrum quantification, safety, efficacy and clinical evidence data of ayurvedic medicinal research were briefly discussed.

Day 2 (30th July 2016, Saturday)

Session I: Pharmaceutical Challenges

Quality Assurance: Challenges in Implementing New Technology. By Mr. B.G. Chakrabarti, Senior Director & Head, QA, Dr. Reddy’s Lab, Hyderabad At first, Mr. Chakrabarti presented the various industrial challenges ranges from asymmetry of knowledge to approach and capital investment. In terms of regulatory aspect, change of management and industry partnership, especially existing single use technology were presented. As part of academic, curriculum and funding related topics were covered. Following, relevant responses exist and improvements required from industries and regulatory departments were addressed. For instance, holistic approach in identification of customer, right people-right leadership bond, encouragement in innovation/new technology and safety for transition of legacy

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system were presented. Academic responses such as how to reach the understanding of policies, building of IT and automation were also addressed.

Challenges in the Field of Steroidal Bulk Drugs. By Dr. S. Bandyopadhyay, Site Head, ASG Biochem Pvt. Ltd., Kolkata

In this talk, Dr. Bandyopadhyay introduced the clinical therapeutic value of steroidal drugs. Chemical structure of male/female hormones and its aspect as drugs were discussed. Key features like availability of natural resources/animal products, well known research chemistry and increased specificity of chiral compounds were presented. Chemical nature of steroids and biosynthesis from cholesterol were also presented. Challenges exist in the availability of basic raw materials; plant resources of relevant examples from India were briefly presented. Conversion reaction chemistry of specific steroidal drug molecules (viz., DHA to Testosterone, 19-Nor from 16-DPA, development of new generation of progestins) were highlighted. Further, need of new process technology, quality policy and quality manual (SOP), R&D in process development, modification, troubleshooting in-plant batches, scale-up as well as small manufacturing were reported.

Bioequivalence: Challenges and Solutions. By Mr. Shrikrishna Pawar, Senior Manager, Clinical Development, Sanofi, Goa

At first Mr. Pawar presented the background information on bioequivalence and its concepts. Factors influencing bioavailability such as pharmaceutical factors and patient related factors were listed. Challenges exist in the assessment methods classified under bioequivalence like pharmacokinetic endpoint studies, in vitro tests predictive of in vivo bioavailability, pharmacodynamic endpoint studies, comparative clinical trials and in vitro dissolution/drug release testing were presented. Further, bioequivalence study designs and its challenges and relevant modifications through comparative analysis on cross over vs parallel design were presented. Regulatory requirements on bioequivalence were also covered. Finally, challenges in generics business concerned to API salt, API polymorph, composition and technology were discussed.

Challenges for Biotech Enterprises and Large Scale Production of Recombinant Proteins. By Mr. Jatin Vimal, Partner, Levim Biotech LLP, Chennai

In this presentation, Mr. Vimal listed the clinical trial requirements and IP barriers in the biotech products. Capital investments costs, availability, affordability and age of the personalized medicines were pointed out. Further, drug interchangeability limitations for bio-similar were also discussed. Finally, requirements for the large-scale production of biopharmaceuticals related to clean facility designs, skilled manpower and timelines for material movement in commercialization have been summarized.

Dr. S. Bandyopadhyay Site Head, ASG Biochem Pvt. Ltd.,

Kolkata

Mr. B.G. Chakrabarti Senior Director & Head, QA, Dr. Reddy’s Lab, Hyderabad

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Session II: Assorted Session

Influence of Data Curation on Pharmaceutical Modeling. By Prof. Kunal Roy, Professor, Department of Pharmaceutical Technology, Jadavpur University, WB

In this session, Prof. Roy introduced the need of quality management in pharmaceutical chemical structure data. Value of pharmaceutical modeling using cheminformatics and QSAR were presented. Prof. Roy highlighted that curation of chemical and biological data will exclude the unreliable data sources. Further, he added that use of chemistry validation and standardization database (from RSC) and Knime workflows for Chemical and Biological data curation developed by his group at Jadavpur University could certainly provide valuable resource for data curation in pharmaceutical R&D.

Novel Therapeutic Targets for Inflammatory Disorders. By Dr. S. Swarnakar, Sr. Principal Scientist & Head, Cancer Biology & Inflammatory Disorder, CSIR–IICB, Kolkata, WB

In this talk, Dr. Swarnakar presented the basics of inflammatory responses. Following, effects of NSAIDs on prostaglandin and gastric ulcers were discussed. Key focus has been given to

Prof. Pulok K. Mukherjee Society of Ethnopharmacology

Mr. Vimal jatin Partner, Levim Biotech LLP, Chennai

Mr. Shrikrishna Pawar, Sr Manager, Clinical Development, Sanofi, Goa

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gastric ulcer causative factors and modern hypothesis. Important role of matrix metalloproteinase (MMP) family as biomarker in inflammatory disorders have been presented. Particularly, role of MMP-9 for alternative therapeutic design and role of MMP-13 in diabetes-induced ulcer were emphasized. At the end, Dr. Swarnakar discussed the various drug delivery system viz., anionic/cationic liposomes and polymer nanoparticles in anti-inflammatory therapy.

Nanomaterials for Drug Delivery and Medical Diagnostics. By Dr. P. Sujatha Devi, Head, Sensor & Actuator Division, CSIR-CGCRI, Adjunct Faculty, NIPER, Kolkata, WB

In this presentation, Dr. Sujatha presented the tunable physico-chemical properties of nanoparticles (NPs) and the challenges exist in the processing of the same for biomedical application. Key examples of nanoparticles presented are magnetic iron oxide nanosystem in drug delivery. Another area of interest discussed in the talk is medical diagnosis using functionalized nanoparticles. Metal oxide based sensors as non-invasive tool for identification of various diseases like diabetes and lung cancer markers were presented. Finally, the barriers exist in the development of product for commercial feasibility was also highlighted.

Specificity in Small Molecule Interactions with Proteins: A Structure Based Computational Approach. By Dr. Nakul C. Maiti, Senior Scientist, Structural Biology & Bioinformatics., CSIR-IICB, Kolkata, WB

Finding the right molecule for the right target is a challenge in drug discovery, herein, Dr. Maiti, presented the importance of computational approach in the screening of biological targets. Advancement of combinatorial chemistry and high throughput methods to screen the chemical

Dr. S. Swarnakar Sr. Principal Scientist & Head, Cancer Biology &

Inflammatory Disorder, CSIR–IICB, Kolkata

Prof. Kunal Roy Professor, Department of Pharmaceutical

Technology, Jadavpur University, WB

Dr. Nakul C. Maiti Senior Scientist, Structural Biology & Bioinformatics.,

CSIR-IICB, Kolkata, WB

Dr. P. Sujata Devi Head, Sensor & Actuator Division, CSIR-CGCRI,

Adjunct Faculty, NIPER, Kolkata, WB

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Dr. V. Ravichandiran Director, NIPER-Kolkata

space in search of the right molecule were also discussed. It has been shown that interactions driven by proteins and small molecules through nonspecific hydrophobic forces, covalent, hydrogen bonding, allosteric interactions and water bridges are important factors need to be explored for better drug design. Parameters to improve specificity (through molecular docking) of certain targets like MMP-9 with melatonine were presented.

Randomized Drug Trials and Ethical Issues. By Dr. A. Chakrabarti, Scientist-E, Regional Occupation Health Centre (East), ICMR-NIOH, Kolkata

In this talk, Dr. Chakrabarti reviewed the essential role of physician’s in health study (randomized double-blind study), exclusion criteria, primary endpoints and randomization schemes. Methodological issues in trials, phases of clinical trials, ethical standard-ignorance in trials and advantages of randomized trials were discussed.

Speaker’s Choice

In this session, representative from industries came forward and shared their opinion on the value of academic-industry cooperation especially improvement of skill development in man power at R&D and manufacturing units. For instance, representative from DUSAP pharmaceuticals came forward to share the importance of harmonized standard operation protocol in industrial set-up for standardization and production of high-quality pharmaceuticals.

Valedictory Session

Reports of Rapporteurs Overall summary or extracts of individual speaker’s topic delivered in two days of session were presented. Several key aspects from the speakers such as regulatory policies, skill developmental insights required in pharma industrial set-up as well academia, public-private partnership, emerging research topics, IP regulations, commercialization challenges and solutions were summarized.

Address by Chairpersons & Co-Chairpersons Comments/suggestions on reports of rapporteurs were requested from chairperson and co-chairperson for discussion. For instance, demands to industry from academic institution on joint-research venture possibilities, public-private partnership and research internship program for students were discussed. Industrial experts and students were also expressed the view and opinion on curriculum development in the NIPER’s M.S./PhD (Pharm.) program.

Round-Up Presentation By Dr. V. Ravichandiran, Director, NIPER-Kolkata

In this section, Dr. Ravichandiran provided snap shot of overall content of the workshop starting from describing the value of Hathi-to-Katoch committee reports, present status and value of generic export from Indian pharma sectors to worldwide. Key points observed from eminent speakers of academic institutions such as IIT Madras, IIT Kanpur, CSIR-IICB, CSIR-CGCRI, ROHC(E) (ICMR-NIOH), Jadavpur University and University of Calcutta. Further, resources persons from IDMA(East), OPPI, Dr. Reddy’s Lab, Biocon, Sanofi, ASG Biochem Pvt. Ltd., Janssen India Johnson & Johnson Pvt. Lt., Natreon Inc., Kolkata and Levim Biotech were recollected and discussed.

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Dr. Kamal K. Datta Academic Coordinator, NIPER-Kolkata

Vote of Thanks By Dr. Kamal K. Datta, Academic Coordinator, NIPER-Kolkata As the National Workshop convener, Dr. Datta delivered the official vote of thanks.

Important Observations and Conclusions Technologies leading to commercially successful products, processes and services, and the

relevant sustainable competitive advantages were emphasized. Regulatory policies for pharma industry should be harmonized so that the quality assurance

standard protocols are uniformly followed in all the drug manufacturing units and manufactured drugs are of uniform standard quality.

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The workshop provided a very useful platform to connect with industrial experts and academic scientists. Important challenges in the pharmaceutical industries as well academic sectors in integrating new technologies for high-quality and cost-efficient pharmaceuticals from India to worldwide

Requirement of new manufacturing process for biopharmaceuticals, operational domain for biopharmaceuticals from small molecules to complex systems, refinement in the regulatory CMC/Quality strategies and modalities to ensure compliance with regulatory requirements were recommended.

Novel physicochemical properties of nano-particles towards pharmacotherapy were highlighted. Enhancement of drug solubility and functional properties of nano-formulation such as targeted drug delivery with modulated pharmacokinetics were emphasized.

Pharmacological value of generics was discussed. Potential biosimilar-derived from antibodies were presented and synthetic bio-degradable small/micro molecules and techniques involved in the processing of therapeutic antibodies or proteins for advanced clinical bioactivities were recommended.

Distinct size-dependent properties of nanoparticles towards biological and pharmaceutical applications, viz., bioimaging and therapy; physical properties such as stability and inertness of the carbon and lanthanide based hybrid nanosystems were presented. Applications of lanthanide-based nanoparticles as MRI contrast agents were also brought to the focus.

Key recommendations of Hathi committee and thereafter that of Katoch committee reports were presented. Make-in-India and sustainable global market growth of India, importance of public-private partnership, innovations required in the modern technical fields such as nano-pharmaceuticals, medical theranostics, synthetic biology, bio-similars, requirement of advanced infrastructure, high-quality with cost-efficient manufacturing process, radical up-gradation in technology, academia and industrial cooperation were the focus of discussion. Small-to-medium scale entrepreneurship should be promoted.

The cycle of innovation, importance of stakeholder mapping and understanding their needs were discussed. Designing appropriate strategy for promotion of off-patented drugs was recommended.

Background on the discovery and development of drugs from natural resources with industrial elements and process work flow were discussed. Key examples of traditional Indian herbal medicines and its clinical values were compared, viz., hope of Ayurveda for Alzheimer’s disease, anti-oxidants, anti-aging formulations. Activities of Society for Ethnopharmacology, India for globalizing local knowledge and localizing global technology were highlighted.

The complex nature of natural product’s chemistry was explained. Important techniques such as HPLC and NMR methods like 1H, 13C, NOESY, COSY, ROESY and HSQC-NOESY were highlighted.

Contemporary approaches for bridging Ayurveda with evidence-based medicine were reviewed. Importance of integrating the scientific approaches in Ayurvedic formulation for standardization was presented. Global export values of herbal formulations, problems associated with Ayurvedic products such as cultivation and harvesting, processing, quality, pre-clinical and clinical data and efficacy were also discussed. Further, demand for softer techniques, full-spectrum quantification, safety, efficacy and clinical evidence data of Ayurvedic medicinal research were presented.

Various industrial challenges ranges from asymmetry of knowledge to approach and capital investment. Holistic approach in identification of customer, right people-right leadership bond, encouragement in innovation/new technology and safety for transition of legacy system were presented.

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The clinical therapeutic value of steroidal drugs was discussed. Chemical structure of male/female hormones and its aspect as drugs were discussed. Challenges existing in the availability of basic raw materials; Conversion reaction chemistry of specific steroidal drug molecules (viz., DHA to Testosterone, 19-Nor from 16-DPA, development of new generation of progestins) were highlighted. Further, need of new process technology, quality policy and quality manual (SOP), R&D in process development, modification, troubleshooting in-plant batches, scale-up as well as small manufacturing were focused.

The background information on bioequivalence and its concepts., challenges that exist in the assessment methods classified under bioequivalence like pharmacokinetic endpoint studies, in vitro tests predictive of in vivo bioavailability, pharmacodynamic endpoint studies, comparative clinical trials and in vitro dissolution/drug release testing were presented.

The clinical trial requirements and IP barriers in the biotech products were discussed. Capital investments costs, availability, affordability and age of the personalized medicines were pointed out. Further, drug interchangeability limitations for bio-similar were also discussed. Finally, requirements for the large-scale production of biopharmaceuticals related to clean facility designs, skilled manpower and timelines for material movement in commercialization were brought into focus.

The need of quality management in pharmaceutical chemical structure data was discussed. Value of pharmaceutical modeling using cheminformatics and QSAR were presented. Curation of chemical and biological data will exclude the unreliable data sources.

The basics of inflammatory responses following effects of NSAIDs on prostaglandin and gastric ulcers were discussed. Key focus has been given to gastric ulcer causative factors and modern hypothesis. Important role of matrix metalloproteinase (MMP) family as biomarker in inflammatory disorders have been presented. Particularly, role of MMP-9 for alternative therapeutic design and role of MMP-13 in diabetes-induced ulcer were emphasized.

The tunable physico-chemical properties of nanoparticles and the challenges that exist in the processing of the same for biomedical application were discussed. Another area of interest discussed in the talk is medical diagnosis using functionalized nanoparticles. Metal oxide based sensors as non-invasive tool for identification of various diseases like diabetes and lung cancer markers were presented. Finally, the barriers that exist in the development of product for commercial feasibility were also highlighted.

Finding the right molecule for the right target is a challenge in drug discovery. Dr. Maiti, presented the importance of computational approach in the screening of biological targets. Parameters to improve specificity (through molecular docking) of certain targets like MMP-9 with melatonin were presented.

The essential steps in clinical trials exclusion criteria, primary endpoints and randomization schemes. Methodological issues in trials, phases of clinical trials, ethical standard-ignorance in trials and advantages of randomized trials were discussed.

DUSAP pharmaceuticals shared the importance of harmonized standard operation protocol in industrial set-up for standardization and production of high-quality pharmaceuticals.

IDMA and OPPI agreed to extend and utilize the platform Industry-Academia partnership firmly to translate technologies developed through research by the industries.

To continuously monitor and understand the various challenges of pharmaceutical industries in the eastern region of the country and to assist in their mitigation a committee could be established drawing scientists from CSIR -IICB and CGCRI, DST - BOSE Institute, ICMR–NIOH, IIT Madras and Kanpur, Jadavpur University, Calcutta University under the leadership of NIPER-Kolkata to apprise the industries about the latest research developments in global pharmaceutical industries including newer technologies.

Contact Details National Institute of Pharmaceutical Education & Research (NIPER), At CSIR-IICB Campus, 4, Raja S. C. Mullick Road, Jadavpur, Kolkata

700032, West Bengal, India, Email: info@niperkolkata.edu.in