BIOSIMILARS CONGRESS INDIA 2017

Speakers 2016

Dr. Andrew Papas

Vice President of Regulatory Affairs, Pharma Biotech Consulting

NSF Health Science

Dr. Papas provides strategic leadership and regulatory guidance on global regulatory affairs, quality, compliance, and drug development programs. With over 38 years of industry and FDA experience, he brings to the table 28 years of experience in the FDA regulated pharmaceutical, biotechnology, and combination product industry plus 10 years managing R&D Analytical and Characterization laboratories for innovative chemistry-based imaging products. His areas of expertise and oversight includes US Regulatory Affairs, leading and authoring FDA submissions (IND, NDA, BLA, ANDA, 505 (B)(2), RFD, Orphan drug designation), biosimilar development, orphan drugs, CMC requirements, unique US combination product requirements, and GCP, GLP, GVP audits and remediation.

Dr. M.K. Sahib

Director Genomics and Biotechnology

Wockhardt

Rakesh Dixit, Ph.D., DABT

Vice President R & D Global Head, Biologics Safety Assessment

MedImmune Inc., USA (AstraZeneca Global Biologics)

Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohioof Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992.

In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology.

In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D since 2010, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings. Rakesh is one of the most invited speakers in the biotechnology industry.

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

Dr. Ashok Kumar

President – Centre for Research & Development

IPCA

Dr. Ashok Kumar carried out his Ph.D. work at CDRI, Lucknow under the supervision of Padmashree Dr.Nitya Nand. This was followed by Post-Doctoral studies with Prof. Sir John Cornforth, a Chemistry Nobel Laureate, at the University of Sussex, England from 1981-1984.

He started his carrier with Alchemie Research Centre at ICI, Bombay in 1985 and served Lupin before taking up the job with Ipca Laboratories Mumbai, in the year 2000 and is presently heading the Centre for Research & Development of Ipca, engaged in Chemical and Biotechnological R&D, New Drug Development and Intellectual Property Management in the capacity of President.

He is a co-author in more than 35 Papers published in peer reviewed International Journals, co-inventor in more than 100 patent applications filed, has presented scientific papers in many International Conferences in addition to delivering invited talks at various Institutions / Conferences on R&D Management, Idea Management, Innovations, Philosophy of New Drug Discovery & many more such topics.

Dr Ambrish Srivastava

Vice President Medical Affairs, Clinical Research and Regulatory

Alkem Labs

Dr Ambrish Srivastava working as Vice President- Medical Affairs, Clinical Research, Regulatory & Pharmacovigilance at Alkem.

MD in Clinical Pharmacology and worked as Asst Professor in Lady Harding Medical College, New Delhi before joining Pharmaceutical Industry.

Has more than 20 years of experience in Pharma worked in Indian and Multinational companies. He has been involved in clinical development of several New Drugs including New Chemical Entities (NCE) and Biologics in various therapy areas like Cardiology, Oncology, Neuropsychiatry, Diabetes, Immunology etc.

He underwent training in GCP at Indianapolis USA, and Clinical Quality Assurance from UK.

He has been guest speaker in National and International Conferences and visiting faculty at several Institutions.

He has about 50 publications in National and International Medical Journals. He is Life member of Indian Medical Association, Research Society in Research in Diabetes, Indian Society of Medical & Paediatric Oncology, and International Society of Pharmacovigilance.

Was awarded Vishisht Chikitsa Medal by Governor of AP in 1994 and Rashtriya Ratan Award by Governor of Gujarat in 2005 for working in community health.

Dr. Ranjan Chakrabarti

Vice President, Head – Global Biologics Lab operations

United States Pharmacopeia-India

Dr. Ranjan Chakrabarti is currently Vice President and Global Head of Biologics Lab Operations at United States Pharmacopeial Convention.

He has over 20 years of experience in Pharmaceutical and Biopharma industries. Before joining to Industry, he worked in Academics at SUNY, Buffalo and University of Massachusetts Medical Centre at USA and successfully coordinated research projects in Cancer Cell Biology and Diabetes. He has guided several Ph. D. students.

Before joining USP, Dr. Ranjan was leading the Biology Group at Dr. Reddy’s Drug discovery and also served at key management position in GVK Biosciences. He has worked with several National and International companies for discovery and development of both chemical and biological molecules.

Dr. Ranjan is the Co-Inventor of 32 US Patents; published 56 papers in peer reviewed International Journals and presented 70 lectures in International and National Conferences.

Aniruddha Jamadar

Associate VP – Process Development

Stelis Biopharma

Dr. M.S. Ramakrishnan

Associate Vice President

Biocon

Dr. M.S. Ramakrishnan completed my PhD in Biochemistry from the University of Mysore in 1995. His Post Doctoral Research happened in University of Chicago between 1997 and 1999.

In both PhD and Post-Doc, he conducted Research in Yeast Biochemistry. His expertise lies in Protein Purification and Characterisation.

Dr. Ramakarishnan joined Biocon in 1999. In the six years since he joined Biocon he co-ordinated projects in Process Development of statins and immunosuppressants.

He has obtained training in manufacturing scale fermentation, analytical characterization of therapeutic biologics and in vitro cell based potency assays.

In the last ten years, he has been working on Process and Drug Development pathways for both novel and biosimilar monoclonal antibodies.

He has been focusing on disease indications in Cancer (Non-Hodgkin’s Lymphoma and Breast Cancer) and Auto-immune diseases (Rheumatoid Arthritis and Psoriasis).

Dr. Annappa Kamath

Portfolio Director

PAREXEL

Dr. Manish Sharma

Senior Medical Director

PAREXEL

Dr. Alok Sharma

Head Analytical Development

Lupin

Avani Ravin Mehta

Research Scientist II

CPL Biologicals Pvt. Ltd

Dr P. Babu

Associate Director

National Centre for Biological Sciences, CCAMP, Bangalore

Dr. Babu is currently the Associate Director of Glycomics and Glycoproteomics Unit in Mass spectrometry facility and Biologics Characterization Facility. He has established a range of capabilities and protocols for the structural analysis of complex carbohydrates (glycans) and biologics/biosimilar physicochemical characterization. These facilities are intended to serve academia and the growing biopharma (biosimilars, biobetters and antibodies, etc.) industry. He received his Master’s degree in chemical sciences and then obtained Ph.D from the Indian Institute of Science, Bangalore. Post-doctoral research was carried out at IISc, Bangalore, Imperial College London, UK (UKIERI Fellow) and University of Utah, Salt Lake City, USA. His research experience spans understanding the structure and functions of complex carbohydrates (glycans) under various biological contexts, including regeneration. For the structure elucidation of the glycans (N- and O-glycans, and glycolipids) and glycosaminoglycans he used tandem mass spectrometry techniques in conjunction with chemical, analytical and enzymatic methods.

Dr Ravi Krovidi

Head CharacterOmics

Enzene biosciences

Dr Ravi Krovidi holds a Ph D from Max Planck Institute, (Freiburg, Germany) where he focused on Orbitrap MS technology to understand Proteomics of red blood cellular differentiation programme and later worked for US Department of Energy , PNNL on diverse LC-MS based research applications. He has worked for leading MNC's including Thermo and Agilent in Application Manager and Global R & D/ Application Manger roles. As a General Manger he was instrumental in setting up a successful Panomics division at Lambda Therapeutics research Ltd delivering clinical research based solutions for regulatory submissions including DCGI, USFDA. He is currently heading "CharacterOmic"s at Enzene biosciences , Pune where his primary focus is to deploy Mass spectrometry based tools for Biosimilar evaluation both in R & D and clinical studies research arena.

Advisory Board Members and Speakers

Dr. Bhaswat S. Chakraborty

Senior VP Research & Development

Cadila Pharmaceuticals Ltd

Dr. Bhaswat S. Chakraborty graduated with a B.Pharm. (Hons.) from Banaras Hindu University and a PhD in Clinical PharmacologyfromUniversity of Saskatchewan, Canada.

Following his post doctoral fellowship and a brief spell of teaching at University of Saskatchewan, Saskatoon, Canada, Dr. Chakraborty joined the Health Protection Branch, Ministry of Health, Government of Canada(Canadian FDA)in Ottawa andserved as a Senior Clinical Reviewer and Acting Department Head of the Biopharmaceutics Evaluation Division. In this role, he has evaluated more than 300 ANDAs and 20 NDAs.

Thereafter, he was the Director of Biopharmaceutics at Biovail Corporation International, Toronto. Till date, he has designed and investigated ~860 BE/Phase I and 82 higher Phase Clinical Studies for the FDA, TPP, EU and other Agencies.

Recipient of many prestigious research grants, Dr. Chakraborty is currently the Senior Vice President of Research & Development at Cadila Pharmaceuticals Ltd., Ahmedabad. He is also an author and co-author of more than 118 scientific papers and abstracts in refereed international journals.

An eminent speaker, Dr. Chakraborty is an Honorary Professor and External Examiner to a few universities; editorial board member of four international journals; reviewer of many professional & biomedical journals, and also on the board of several Institutes and Universities in India and USA in various capacities. He has supervised 24 Masters and 5 PhD students. He is also the former Chair of Pharma & Healthcare Panel of Confederation of Indian Industries (CII), Gujarat and a current Member of National CII Committee on International Trade Policy and Exports.

Dr. Narendra Chirmule

Senior Vice President, Head of Research and Development

Biocon

Narendra is the Sr. VP & Head of Research and Development at Biocon. With over 23 years of experience in Immunology, he has held senior leadership positions at Amgen and Merck, in the US, in the departments of Clinical Immunology overseeing drug development in regulated laboratories. He is an expert in the area of immune responses to biologics and vaccines.

Narendra completed his post-doctoral training at Cornell University Medical College, New York and has teaching and research experience as Assistant Director at the Human Gene Therapy Group of University of Pennsylvania. He is an advisor to the Filovirus consortium and a reviewer on the HIV vaccine study section for the National Institutes of Health. He is also an academician conducting Biotech educational seminars and has published extensively (more than 100) on the topics of immunogenicity prediction and assessment, predictive toxicology and quality-by-design.

Narendra is a MS (Zoology, Animal Physiology) and Ph.D.in Applied Biology from the University of Mumbai

Anjan Selz

Vice President - Head of Biosimilars EMEA

Lupin Atlantis Holdings SA

In his current role, Anjan is structuring the market facing organization for Biosimilars at Lupin Europe and implementing the processes necessary to access the market with this new product portfolio.
He has substantial experience in driving technology and commercialization projects in the Life Sciences area and especially in the biosimilars. Anjan was the co-founder and CEO of Finox Biotech in Switzerland, a first wave biosimilars venture recently acquired by Gedeon Richter of Hungary. Under Anjan’s guidance the start-up company successfully developed a biosimilar from TPP through to EMA approval and into Phase-III in the US.
In a previous role Anjan got also exposure to the full development and commercialization cycle of medical devices, as Head of Industrial Development with the Swiss based device company Ypsomed. Anjan holds a Master of Arts from The Graduate Institute in Geneva / Switzerland where he focus Anjan Selz is Vice President – Head of Biosimilars EMEA, at Lupin Europe.
In his current role, Anjan is structuring the market facing organization for Biosimilars at Lupin Europe and implementing the processes necessary to access the market with this new product portfolio.
He has substantial experience in driving technology and commercialization projects in the Life Sciences area and especially in the biosimilars. Anjan was the co-founder and CEO of Finox Biotech in Switzerland, a first wave biosimilars venture recently acquired by Gedeon Richter of Hungary. Under Anjan’s guidance the start-up company successfully developed a biosimilar from TPP through to EMA approval and into Phase-III in the US.

Dr. A. K. S. Bhujanga Rao

President of R & D and Technical

Natco Pharma

Dr. Akshaya S. Odak

Head – Regulatory -Biotechnology Division

Lupin limited

Akshaya S. Odak is currently Head – Regulatory ‐Biotechnology Division of Lupin limited based in Pune, Maharashtra. Prior to that, he was looking after the regulatory function for the registration of Biotechnology products of Wockhardt Limited, Aurangabad. During regulatory tenure, worked primarily on biosimilars and has a vast experience of regulatory dossier filing and product approval in India and more than 70 countries; clinical trial applications in EU, Japan and US. He has also faced regulatory audits from different agencies viz., US FDA, EU, ANVISA, GCC and other countries. He has an industrial experience of 24 years and has also worked for companies like Hoechst Ltd., and Ranbaxy Laboratories Ltd. His prior experience included development and production of Biologics. He has done his Master’s, M.Phil., and Ph.D. from Jiwaji university, Gwalior.

Dr.Sunit Maity

Director Product Development

Zumutor Biologics

Dr. Sunit was trained as Developmental/Cardiovascular Biologists in Leuven, Belgium where he received his PhD. He worked in industry (Mermaid Pharmaceuticals, Hamburg Germany) for three years where he was involved in target identification using model system. He has spent time at Max Planck Institute where he was involved in the CNS development related project. After coming back to India in 2007, he joined Avesthagen where he headed the biosimilar group. He was responsible for development of biologics including recombinant protein and monoclonal antibodies using mammalian expression system. He is associated with Zumutor Biologics since its inception and currently works as director of Product Development team. Zumutor is heavily invested to develop novel monoclonal antibody drugs in the Immune-Oncology segment that is driven by patient requirement for more effective drugs with reduced side effects. Antibody Fab region imparts recognition of target tumor antigens and the Fc region directs patients’ immune system to kill the tumor cells. We have also developed platform technologies to improve functionalities of both Fab and Fc regions through innovative approaches and creating new molecules with synergistic effects.

Cecil Nick

Vice President (Technical), Integrated Product Development,

PAREXEL Consulting

Since joining PAREXEL in February 2001 Cecil has applied his extensive scientific, drug development and regulatory experience in supporting clients with clinical development plans and regulatory strategies for EU, US and global approval. In the last five years alone he has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft plans which are effective, highly efficient and achievable.
Work Experience
Regulatory affairs and clinical development professional for over 30 years with focus on biological medicines. Cecil Nick has particular expertise in monoclonals and biosimilars, having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agencies in the EU, US, Canada, Australia, Mexico, Brazil and supported 6 submissions in the EU and US. He has also participated extensively in Industry and International meetings on the subject. Additionally, Cecil Nick has extensive experience in orphan drugs and in numerous therapeutic areas including, but not limited to, oncology, inflammatory disease, diabetes, growth and hematology
Prior to joining PAREXEL, Cecil served as Regulatory Manager at Novo Nordisk Ltd., working on the development and registration of biotechnological products and NCE’s. In addition he has knowledge of health economic assessments. Cecil is a Fellow of TOPRA and has been a guest lecture at Cardiff University MSc in Clinical Research and Greenwich University MSc in Pharmaceutical Sciences courses and Biotech Module leader for the TOPRA MSc course. He was on the editorial panel of SCRIP Clinical Research and has authored many articles on regulatory and clinical development issues.
Education
Mr. Nick received his BSc (Hons) in Biochemistry from the University of Cape Town.

Dr. Richard L. Easton

Technical Director- Structural Analysis

BioPharmaSpec Ltd

Richard obtained his PhD in glycoprotein structural characterization using mass spectrometry from Imperial College of Science, Technology and Medicine. He subsequently spent several years there as a postdoctoral research scientist working in the field of glycoprotein structural characterization with emphasis on glycan elucidation. The projects he was involved in required detailed structural analysis of glycoproteins derived from animal, plant and fungal systems, very frequently expressing unusual glycosylation profiles. He moved to GlaxoSmithKline for a short time where he was head of mass spectrometry for the toxicoproteomics and safety assessment group. Richard joined M-Scan Limited (now part of SGS Life Sciences) in 2003 as a biochemist and became the Team Leader for Carbohydrate Analysis before being appointed Principal Scientist. In 2016, Richard joined BioPharmaSpec as Technical Director for Structural Analysis and is responsible for management of all aspects of carbohydrate and glycoprotein characterization at the primary structure level.

Ravishankar Kasturi

Vice President - Manufacturing operations and Process Development

Reliance Life Sciences

Amarnath Chatterjee

General Manager, Head-ADD

Stelis Biopharma; a Strides-Shasun enterprise

Dr. Annu Uppal

Global Demo Lead and Manager Application Support for Biopharma applications

SCIEX

  • Has been working with  SCIEX since Jan 2009 (LabIndia that time)
  • Scientific professional with strong expertise in the development and implementation of LC-MS based applications for the qualitative and quantitative analysis of protein/peptide based therapeutics.
  • Global Demo Lead and Manager Application Support for Biopharma applications, SCIEX  (Jan 2014-Present)
    Application Support Scientist, SCIEX (Jan 2011-Dec 2013)
    Application Support Specialist, Applied Biosystems (Life technologies/LabIndia Instruments Pvt Ltd), Gurgaon, India (Jun 2009-Dec 2012)
    Senior Research Associate, Applied Biosystems (Life technologies/LabIndia Instruments Pvt Ltd), Gurgaon, India (Jan 2009-Jun 2009)
  • Postdoctoral Fellow: (Dec 2004-Mar 2006), School of Life Sciences, JNU, New Delhi, India).
  • PhD in Biotechnology from the Indian Institute of Toxicology Research, Lucknow. (Sept 1998-Apr 2004)
    Thesis Work: Molecular Mechanism of Tumor Suppression by Diallyl Sulfide in Experimental Carcinogenesis using various intervention targets viz. induction of apoptosis, restoration of tumor suppressor gene (p53) and inhibition of oncogene activation (H-ras).
  • More than 25 research papers and book chapters published in peer reviewed journals.

Speakers 2016

Dr. Andrew Papas

Vice President of Regulatory Affairs, Pharma Biotech Consulting

NSF Health Science

Dr. Papas provides strategic leadership and regulatory guidance on global regulatory affairs, quality, compliance, and drug development programs. With over 38 years of industry and FDA experience, he brings to the table 28 years of experience in the FDA regulated pharmaceutical, biotechnology, and combination product industry plus 10 years managing R&D Analytical and Characterization laboratories for innovative chemistry-based imaging products. His areas of expertise and oversight includes US Regulatory Affairs, leading and authoring FDA submissions (IND, NDA, BLA, ANDA, 505 (B)(2), RFD, Orphan drug designation), biosimilar development, orphan drugs, CMC requirements, unique US combination product requirements, and GCP, GLP, GVP audits and remediation.

Dr. M.K. Sahib

Director Genomics and Biotechnology

Wockhardt

Rakesh Dixit, Ph.D., DABT

Vice President R & D Global Head, Biologics Safety Assessment

MedImmune Inc., USA (AstraZeneca Global Biologics)

Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohioof Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992.

In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology.

In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D since 2010, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings. Rakesh is one of the most invited speakers in the biotechnology industry.

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

Dr. Ashok Kumar

President – Centre for Research & Development

IPCA

Dr. Ashok Kumar carried out his Ph.D. work at CDRI, Lucknow under the supervision of Padmashree Dr.Nitya Nand. This was followed by Post-Doctoral studies with Prof. Sir John Cornforth, a Chemistry Nobel Laureate, at the University of Sussex, England from 1981-1984.

He started his carrier with Alchemie Research Centre at ICI, Bombay in 1985 and served Lupin before taking up the job with Ipca Laboratories Mumbai, in the year 2000 and is presently heading the Centre for Research & Development of Ipca, engaged in Chemical and Biotechnological R&D, New Drug Development and Intellectual Property Management in the capacity of President.

He is a co-author in more than 35 Papers published in peer reviewed International Journals, co-inventor in more than 100 patent applications filed, has presented scientific papers in many International Conferences in addition to delivering invited talks at various Institutions / Conferences on R&D Management, Idea Management, Innovations, Philosophy of New Drug Discovery & many more such topics.

Dr Ambrish Srivastava

Vice President Medical Affairs, Clinical Research and Regulatory

Alkem Labs

Dr Ambrish Srivastava working as Vice President- Medical Affairs, Clinical Research, Regulatory & Pharmacovigilance at Alkem.

MD in Clinical Pharmacology and worked as Asst Professor in Lady Harding Medical College, New Delhi before joining Pharmaceutical Industry.

Has more than 20 years of experience in Pharma worked in Indian and Multinational companies. He has been involved in clinical development of several New Drugs including New Chemical Entities (NCE) and Biologics in various therapy areas like Cardiology, Oncology, Neuropsychiatry, Diabetes, Immunology etc.

He underwent training in GCP at Indianapolis USA, and Clinical Quality Assurance from UK.

He has been guest speaker in National and International Conferences and visiting faculty at several Institutions.

He has about 50 publications in National and International Medical Journals. He is Life member of Indian Medical Association, Research Society in Research in Diabetes, Indian Society of Medical & Paediatric Oncology, and International Society of Pharmacovigilance.

Was awarded Vishisht Chikitsa Medal by Governor of AP in 1994 and Rashtriya Ratan Award by Governor of Gujarat in 2005 for working in community health.

Dr. Ranjan Chakrabarti

Vice President, Head – Global Biologics Lab operations

United States Pharmacopeia-India

Dr. Ranjan Chakrabarti is currently Vice President and Global Head of Biologics Lab Operations at United States Pharmacopeial Convention.

He has over 20 years of experience in Pharmaceutical and Biopharma industries. Before joining to Industry, he worked in Academics at SUNY, Buffalo and University of Massachusetts Medical Centre at USA and successfully coordinated research projects in Cancer Cell Biology and Diabetes. He has guided several Ph. D. students.

Before joining USP, Dr. Ranjan was leading the Biology Group at Dr. Reddy’s Drug discovery and also served at key management position in GVK Biosciences. He has worked with several National and International companies for discovery and development of both chemical and biological molecules.

Dr. Ranjan is the Co-Inventor of 32 US Patents; published 56 papers in peer reviewed International Journals and presented 70 lectures in International and National Conferences.

Aniruddha Jamadar

Associate VP – Process Development

Stelis Biopharma

Dr. M.S. Ramakrishnan

Associate Vice President

Biocon

Dr. M.S. Ramakrishnan completed my PhD in Biochemistry from the University of Mysore in 1995. His Post Doctoral Research happened in University of Chicago between 1997 and 1999.

In both PhD and Post-Doc, he conducted Research in Yeast Biochemistry. His expertise lies in Protein Purification and Characterisation.

Dr. Ramakarishnan joined Biocon in 1999. In the six years since he joined Biocon he co-ordinated projects in Process Development of statins and immunosuppressants.

He has obtained training in manufacturing scale fermentation, analytical characterization of therapeutic biologics and in vitro cell based potency assays.

In the last ten years, he has been working on Process and Drug Development pathways for both novel and biosimilar monoclonal antibodies.

He has been focusing on disease indications in Cancer (Non-Hodgkin’s Lymphoma and Breast Cancer) and Auto-immune diseases (Rheumatoid Arthritis and Psoriasis).

Dr. Annappa Kamath

Portfolio Director

PAREXEL

Dr. Manish Sharma

Senior Medical Director

PAREXEL

Dr. Alok Sharma

Head Analytical Development

Lupin

Avani Ravin Mehta

Research Scientist II

CPL Biologicals Pvt. Ltd

Dr P. Babu

Associate Director

National Centre for Biological Sciences, CCAMP, Bangalore

Dr. Babu is currently the Associate Director of Glycomics and Glycoproteomics Unit in Mass spectrometry facility and Biologics Characterization Facility. He has established a range of capabilities and protocols for the structural analysis of complex carbohydrates (glycans) and biologics/biosimilar physicochemical characterization. These facilities are intended to serve academia and the growing biopharma (biosimilars, biobetters and antibodies, etc.) industry. He received his Master’s degree in chemical sciences and then obtained Ph.D from the Indian Institute of Science, Bangalore. Post-doctoral research was carried out at IISc, Bangalore, Imperial College London, UK (UKIERI Fellow) and University of Utah, Salt Lake City, USA. His research experience spans understanding the structure and functions of complex carbohydrates (glycans) under various biological contexts, including regeneration. For the structure elucidation of the glycans (N- and O-glycans, and glycolipids) and glycosaminoglycans he used tandem mass spectrometry techniques in conjunction with chemical, analytical and enzymatic methods.

Dr Ravi Krovidi

Head CharacterOmics

Enzene biosciences

Dr Ravi Krovidi holds a Ph D from Max Planck Institute, (Freiburg, Germany) where he focused on Orbitrap MS technology to understand Proteomics of red blood cellular differentiation programme and later worked for US Department of Energy , PNNL on diverse LC-MS based research applications. He has worked for leading MNC's including Thermo and Agilent in Application Manager and Global R & D/ Application Manger roles. As a General Manger he was instrumental in setting up a successful Panomics division at Lambda Therapeutics research Ltd delivering clinical research based solutions for regulatory submissions including DCGI, USFDA. He is currently heading "CharacterOmic"s at Enzene biosciences , Pune where his primary focus is to deploy Mass spectrometry based tools for Biosimilar evaluation both in R & D and clinical studies research arena.