BIOSIMILARS CONGRESS INDIA 2018

Speakers

Dr. Shubhadeep Sinha

Senior Vice President & Medical Director

Hetero Drugs

Dr. Shubhadeep Sinha currently is the Senior Vice President at Hetero and heading the department of Clinical Development & Medical Affairs (CD& MA) managing clinical development of biosimilars (including Rituximab, Bevacizumab, Adalimimab, Darbepoetin Alfa, Trastuzumab), global generics, NCEs (including Anti- HIV), global pharmacovigilance and medical affairs. Dr. Sinha has an extensive work experience spanning over 20 years with leading pharmaceutical organizations like Hetero, Dr. Reddy’s Laboratories, Glenmark Pharmaceuticals, Vimta Labs, Alquest LLC, Indigene Pharmaceuticals, Accenture and Organon ( Now Merck). He completed his MBBS from Seth GS Medical College and KEM hospital, Mumbai and MD pharmacology from TN Medical College and BYL Nair Charitable hospital, Diploma in Diabetes management from Apollo Hospitals, Executive Management Diploma from Indian Institute of Management (IIM), Calcutta and PG Diploma in Project Management and Planning from University of Hyderabad. Dr. Shubhadeep Sinha has to his credit 12 publications including 5 on biosimilars.

Sanjeev Gupta, Ph.D.

General Manager and Head- Advanced Biotech Lab (Biosimilar R&D)

Ipca Laboratories Ltd.

Dr. Sanjeev Gupta has obtained Ph.D. in Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as General Manager and Head, Advanced Biotech Lab (R&D-Biosimilar), Ipca Laboratories Ltd., Mumbai, India. Sanjeev Gupta has established a new state-of-the-art Biotech R&D facility for the development of mAb Biosimilar products. He is also actively involved in establishing single use Bio-manufacturing facility for Biosimilar commercial launch.

With 18 years of industrial experience he has been working on development of “Biosimilars” including monoclonal antibodies since 2000. His core expertise lies in the Molecular Biology, Cell Line, Upstream process development, Bio-analytical as well as GMP cell banking & characterization.

So far, he has developed and contributed for over ten recombinant molecules of which six Biosimilar products has been launched already in the Indian market and the rest are in the developmental or clinical phase, and are expected to be launched in near future.

During his professional tenure, he has worked at various position in reputed Indian biopharmaceuticals industries such as Zydus, Wockhardt, Panacea, Intas and Ipca Laboratories.

He presented his work in various national and international conferences such as IBC, Terrapin, IMAPAC, Biopharma, Selectbio and AMI.

Dr. Sanjeev Gupta has also published several Research articles, Book chapters, Magazines and Patent in lieu of the Biosimilar development.

Advisory Board Members

Ajaz Hussain, Ph.D.

President

National Institute for Pharmaceutical Technology and Education (NIPTE)

Dr Hussain trained at the Bombay College of Pharmacy and received an interdisciplinary doctoral degree from University of Cincinnati. He has more than 30 years of distinguished career in biopharmaceuticals in different capacities at academic institutions, at US FDA and in pharmaceutical industry. Major positions held by him include Deputy Director, Office of Pharmaceutical Science and served under the Senior Biomedical Research Service, Vice President and Global Head for Biopharmaceutical Development at Sandoz (a division of Novartis Corp.), Chief Scientific Officer at Philip Morris International (PMI) Switzerland and Chief Scientific Officer and President Biotechnology at Wockhardt Ltd. Among his most memorable peer recognitions are - FDA Scientific Achievement Awards, Fellow status in the American Association of Pharmaceutical Scientists and in Swiss Society of Pharmaceutical Sciences, Industrial Pharmacy Medal (International Pharmaceutical Federation); Scientific Achievement – Regulatory Science Award (AAPS); Dr. M. Venkateswarlu Memorial Lecture Award (Indian Pharmaceutical Association); Distinguished Alumni and Outstanding AlumniAwards from his alma mater, the University of Cincinnati. At Sandoz he was responsible for development and registration of Sandoz’s Biosimilarsand follow-on-protein portfolio. Dr. Ajaz Hussain ensured external communication and leadership to facilitate establishment of regulatory pathway for follow-on biologics. He also developed "Quality by Design" framework for biosimilar development to minimize development and regulatory risks.

Dr. Arani Chatterjee

Senior Vice President, Clinical Research

Aurobindo Pharma Ltd.

Dr. Arani Chatterjee, MBBS, MPhil, PGCPM has completed his graduation from CMC, Vellore and post-graduation from NIMHANS, Bangalore. He has a Post Graduate Certificate in Management from IIM, Indore. With 20+ years of experience he served as Senior Vice President-Clinical Research at Biological E, Senior Vice President-Clinical Research at Panacea Biotec, Princpial Research Physician at Dr. Reddy’s Laboratories (Discovery Research) and Research Assistant at Rajiv Gandhi Centre for Biotechnology. He is a visiting faculty at University of Pune and Institute of Clinical Research, a member of Expert Committee for PG Diploma in Clinical Research at IGNOU, Academic Board of Studies, Institute of Clinical Research, Hindustan Institute of Medical Sciences & Research, Sharda University and National Committee on Biotechnology of CII. He has served as a WHO Adviser for the Global Polio Eradication Initiative. Dr. Chatterjee is a member of several Brighton Collaboration groups for vaccine safety. He has participated in WHO SAGE and GVSI meetings, pre-IND meetings with USFDA, scientific advice meetings with BfArM (Germany), ANVISA (Brazil), Medsafe (New Zealand), ALIMS (Serbia), expert group meetings on Indian GCP guidelines and Schedule Y, National Technology Advisory Group on Immunisation, Asia Pacific Dengue Prevention Board Meeting under the Pediatric Dengue Vaccine Initiative of International Vaccine Institute and Pneumococcal Vaccines at UNICEF. Dr. Arani Chatterjee has authored 22 papers in peer-reviewed journals and is a recipient of the 2012 Charles C. Shepard Award from CDC, Atlanta.

Dr. Sunit Maity

Director, Product Development

Zumutor Biologics

Dr. Sunit Maity is 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. At Max Planck Institute he was involved in the CNS development related project. In 2007, at Avesthagen 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. Dr. Sunit Maity has also developed platform technologies to improve functionalities of both Fab and Fc regions through innovative approaches and creating new molecules with synergistic effects.

Anjan Selz

Vice President – Head of Biosimilars

Lupin EMEA

In his current role, Mr. Anjan Selz is structuring the market facing organization for Biosimilars at Lupin EMEA 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. Mr. Selz was the co-founder and CEO of Finox Biotech in Switzerland, a first wave biosimilars venture recently acquired by Gedeon Richter of Hungary. Under his 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 he 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.

In between he worked as a Life Sciences technology commercialization manager in Australia and in parallel he successfully founded and developed a startup for live cell imaging reagents.

Mr. Anjan holds a Master of Arts from The Graduate Institute in Geneva / Switzerland where he focused on economics and international law. He complemented his education with post-graduate studies focusing on technology management and especially the management of life sciences ventures. Mr. Anjan Selz holds an executive MBA from the Swiss Federal Institute of Technology in Lausanne / Switzerland.

Speakers

Speakers

Dr. Shubhadeep Sinha

Senior Vice President & Medical Director

Hetero Drugs

Dr. Shubhadeep Sinha currently is the Senior Vice President at Hetero and heading the department of Clinical Development & Medical Affairs (CD& MA) managing clinical development of biosimilars (including Rituximab, Bevacizumab, Adalimimab, Darbepoetin Alfa, Trastuzumab), global generics, NCEs (including Anti- HIV), global pharmacovigilance and medical affairs. Dr. Sinha has an extensive work experience spanning over 20 years with leading pharmaceutical organizations like Hetero, Dr. Reddy’s Laboratories, Glenmark Pharmaceuticals, Vimta Labs, Alquest LLC, Indigene Pharmaceuticals, Accenture and Organon ( Now Merck). He completed his MBBS from Seth GS Medical College and KEM hospital, Mumbai and MD pharmacology from TN Medical College and BYL Nair Charitable hospital, Diploma in Diabetes management from Apollo Hospitals, Executive Management Diploma from Indian Institute of Management (IIM), Calcutta and PG Diploma in Project Management and Planning from University of Hyderabad. Dr. Shubhadeep Sinha has to his credit 12 publications including 5 on biosimilars.

Sanjeev Gupta, Ph.D.

General Manager and Head- Advanced Biotech Lab (Biosimilar R&D)

Ipca Laboratories Ltd.

Dr. Sanjeev Gupta has obtained Ph.D. in Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as General Manager and Head, Advanced Biotech Lab (R&D-Biosimilar), Ipca Laboratories Ltd., Mumbai, India. Sanjeev Gupta has established a new state-of-the-art Biotech R&D facility for the development of mAb Biosimilar products. He is also actively involved in establishing single use Bio-manufacturing facility for Biosimilar commercial launch.

With 18 years of industrial experience he has been working on development of “Biosimilars” including monoclonal antibodies since 2000. His core expertise lies in the Molecular Biology, Cell Line, Upstream process development, Bio-analytical as well as GMP cell banking & characterization.

So far, he has developed and contributed for over ten recombinant molecules of which six Biosimilar products has been launched already in the Indian market and the rest are in the developmental or clinical phase, and are expected to be launched in near future.

During his professional tenure, he has worked at various position in reputed Indian biopharmaceuticals industries such as Zydus, Wockhardt, Panacea, Intas and Ipca Laboratories.

He presented his work in various national and international conferences such as IBC, Terrapin, IMAPAC, Biopharma, Selectbio and AMI.

Dr. Sanjeev Gupta has also published several Research articles, Book chapters, Magazines and Patent in lieu of the Biosimilar development.

Advisory Board Members

Ajaz Hussain, Ph.D.

President

National Institute for Pharmaceutical Technology and Education (NIPTE)

Dr Hussain trained at the Bombay College of Pharmacy and received an interdisciplinary doctoral degree from University of Cincinnati. He has more than 30 years of distinguished career in biopharmaceuticals in different capacities at academic institutions, at US FDA and in pharmaceutical industry. Major positions held by him include Deputy Director, Office of Pharmaceutical Science and served under the Senior Biomedical Research Service, Vice President and Global Head for Biopharmaceutical Development at Sandoz (a division of Novartis Corp.), Chief Scientific Officer at Philip Morris International (PMI) Switzerland and Chief Scientific Officer and President Biotechnology at Wockhardt Ltd. Among his most memorable peer recognitions are - FDA Scientific Achievement Awards, Fellow status in the American Association of Pharmaceutical Scientists and in Swiss Society of Pharmaceutical Sciences, Industrial Pharmacy Medal (International Pharmaceutical Federation); Scientific Achievement – Regulatory Science Award (AAPS); Dr. M. Venkateswarlu Memorial Lecture Award (Indian Pharmaceutical Association); Distinguished Alumni and Outstanding AlumniAwards from his alma mater, the University of Cincinnati. At Sandoz he was responsible for development and registration of Sandoz’s Biosimilarsand follow-on-protein portfolio. Dr. Ajaz Hussain ensured external communication and leadership to facilitate establishment of regulatory pathway for follow-on biologics. He also developed "Quality by Design" framework for biosimilar development to minimize development and regulatory risks.

Dr. Arani Chatterjee

Senior Vice President, Clinical Research

Aurobindo Pharma Ltd.

Dr. Arani Chatterjee, MBBS, MPhil, PGCPM has completed his graduation from CMC, Vellore and post-graduation from NIMHANS, Bangalore. He has a Post Graduate Certificate in Management from IIM, Indore. With 20+ years of experience he served as Senior Vice President-Clinical Research at Biological E, Senior Vice President-Clinical Research at Panacea Biotec, Princpial Research Physician at Dr. Reddy’s Laboratories (Discovery Research) and Research Assistant at Rajiv Gandhi Centre for Biotechnology. He is a visiting faculty at University of Pune and Institute of Clinical Research, a member of Expert Committee for PG Diploma in Clinical Research at IGNOU, Academic Board of Studies, Institute of Clinical Research, Hindustan Institute of Medical Sciences & Research, Sharda University and National Committee on Biotechnology of CII. He has served as a WHO Adviser for the Global Polio Eradication Initiative. Dr. Chatterjee is a member of several Brighton Collaboration groups for vaccine safety. He has participated in WHO SAGE and GVSI meetings, pre-IND meetings with USFDA, scientific advice meetings with BfArM (Germany), ANVISA (Brazil), Medsafe (New Zealand), ALIMS (Serbia), expert group meetings on Indian GCP guidelines and Schedule Y, National Technology Advisory Group on Immunisation, Asia Pacific Dengue Prevention Board Meeting under the Pediatric Dengue Vaccine Initiative of International Vaccine Institute and Pneumococcal Vaccines at UNICEF. Dr. Arani Chatterjee has authored 22 papers in peer-reviewed journals and is a recipient of the 2012 Charles C. Shepard Award from CDC, Atlanta.

Dr. Sunit Maity

Director, Product Development

Zumutor Biologics

Dr. Sunit Maity is 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. At Max Planck Institute he was involved in the CNS development related project. In 2007, at Avesthagen 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. Dr. Sunit Maity has also developed platform technologies to improve functionalities of both Fab and Fc regions through innovative approaches and creating new molecules with synergistic effects.

Anjan Selz

Vice President – Head of Biosimilars

Lupin EMEA

In his current role, Mr. Anjan Selz is structuring the market facing organization for Biosimilars at Lupin EMEA 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. Mr. Selz was the co-founder and CEO of Finox Biotech in Switzerland, a first wave biosimilars venture recently acquired by Gedeon Richter of Hungary. Under his 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 he 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.

In between he worked as a Life Sciences technology commercialization manager in Australia and in parallel he successfully founded and developed a startup for live cell imaging reagents.

Mr. Anjan holds a Master of Arts from The Graduate Institute in Geneva / Switzerland where he focused on economics and international law. He complemented his education with post-graduate studies focusing on technology management and especially the management of life sciences ventures. Mr. Anjan Selz holds an executive MBA from the Swiss Federal Institute of Technology in Lausanne / Switzerland.

Speakers

Dr. Shubhadeep Sinha

Senior Vice President & Medical Director

Hetero Drugs

Dr. Shubhadeep Sinha currently is the Senior Vice President at Hetero and heading the department of Clinical Development & Medical Affairs (CD& MA) managing clinical development of biosimilars (including Rituximab, Bevacizumab, Adalimimab, Darbepoetin Alfa, Trastuzumab), global generics, NCEs (including Anti- HIV), global pharmacovigilance and medical affairs. Dr. Sinha has an extensive work experience spanning over 20 years with leading pharmaceutical organizations like Hetero, Dr. Reddy’s Laboratories, Glenmark Pharmaceuticals, Vimta Labs, Alquest LLC, Indigene Pharmaceuticals, Accenture and Organon ( Now Merck). He completed his MBBS from Seth GS Medical College and KEM hospital, Mumbai and MD pharmacology from TN Medical College and BYL Nair Charitable hospital, Diploma in Diabetes management from Apollo Hospitals, Executive Management Diploma from Indian Institute of Management (IIM), Calcutta and PG Diploma in Project Management and Planning from University of Hyderabad. Dr. Shubhadeep Sinha has to his credit 12 publications including 5 on biosimilars.

Sanjeev Gupta, Ph.D.

General Manager and Head- Advanced Biotech Lab (Biosimilar R&D)

Ipca Laboratories Ltd.

Dr. Sanjeev Gupta has obtained Ph.D. in Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as General Manager and Head, Advanced Biotech Lab (R&D-Biosimilar), Ipca Laboratories Ltd., Mumbai, India. Sanjeev Gupta has established a new state-of-the-art Biotech R&D facility for the development of mAb Biosimilar products. He is also actively involved in establishing single use Bio-manufacturing facility for Biosimilar commercial launch.

With 18 years of industrial experience he has been working on development of “Biosimilars” including monoclonal antibodies since 2000. His core expertise lies in the Molecular Biology, Cell Line, Upstream process development, Bio-analytical as well as GMP cell banking & characterization.

So far, he has developed and contributed for over ten recombinant molecules of which six Biosimilar products has been launched already in the Indian market and the rest are in the developmental or clinical phase, and are expected to be launched in near future.

During his professional tenure, he has worked at various position in reputed Indian biopharmaceuticals industries such as Zydus, Wockhardt, Panacea, Intas and Ipca Laboratories.

He presented his work in various national and international conferences such as IBC, Terrapin, IMAPAC, Biopharma, Selectbio and AMI.

Dr. Sanjeev Gupta has also published several Research articles, Book chapters, Magazines and Patent in lieu of the Biosimilar development.