Immunotherapy – A Novel Facet of Modern Therapeutics

This book illustrates the significance and relevance of immunotherapy in modern-day therapeutics. Focusing on the application of immunotherapy in oncology, neurodegenerative and autoimmune diseases, it discusses the drug delivery systems, and pre-clinical and clinical methodologies for immunotherapy-based drugs.  It also comprehensively reviews various aspects of immunotherapy, such as regulatory affairs, quality control, safety, and pharmacovigilance. 


Further, the book discusses the in vitro validation of therapeutic strategies prior to patient application and management of immunotherapy-related side effects and presents case studies demonstrating the design and development (pre-clinical to clinical) of immunotherapy for various diseases. It also describes various design considerations and the scale-up synthesis of immunotherapeutics and screening methods. Lastly, it explores the important aspect of cost-effectiveness and rational immunotherapy strategies. 

Sujata P. Sawarkar is Professor and Head of Department, Pharmaceutics, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy, India. Before joining academics Dr. Sujata Sawarkar was associated with major pharmaceutical companies in India at managerial position, in the field of Research and Development, formulation development of conventional and novel dosage forms for regulated and domestic market. Several oral solid dosage forms and sterile products developed by her team have received approval in US and EU and have been commercialized. She has about total 22 years of research and teaching experience. Her research interests include Formulation Development of novel drug delivery and targeted systems based on nanotechnology for oral, ophthalmic, colonic and vaginal delivery, development of evaluation techniques for novel drug delivery systems, Translational research. Dr. Sujata Sawarkar has been Executive Member of Controlled Release Society (India Chapter) since 2014 and Secretary of Controlled Release Society (India Chapter) CRS IC for 2017-2019. She has been invited reviewer for Indian Drugs, AAPS PharmSciTech, International Journal of Nanomedicine Dove Press, Drug Design, Development and Therapy, Journal of Bioequivalence & Bioavailability, European Journal of Pharmaceutics and Biopharmaceutics and Journal of Cosmetic Dermatology . Dr. Sujata Sawarkar has received research project grants worth about 85 lakhs rupees (8.5 million INR i.e. about 1.19 million USD) from Industry and Government funding agency. She has presented about 50 research papers in national and international conferences like CRS Inc. and AAPS. She has several papers published in peer reviewed journals like AAPS PharmSciTech, International Journal of Pharmaceutics, Critical Reviews in Therapeutic Drug Carrier systems, Drug Development and Translational Research, Frontiers in Pharmacology , Expert Opinion on Drug Delivery. She has coauthored 5 book chapters and two books. Dr. Sujata Sawarkar has been awarded IDMA award for reviewer, Research and Industry Outcome by SVKM’s Dr. Bhanuben Nanavati College of Pharmacy in 2018 and 2020, Received Travel Grant from Controlled Release Society and All India Council of Technical Education for attending and presenting paper at 42nd and 46th Annual Meeting & Exposition of the Controlled Release Society in July 2015 and July 2019 respectively. She has several papers published in peer-reviewed journals like AAPS PharmSciTech, International Journal of Pharmaceutics. She has co-authored 2 book chapters and one book. 

Vandana S. Nikam is presently Associate Professor and Head of Department, Pharmacology, at STES’s Smt. Kashibai Navale College of Pharmacy, S. P. Pune University, India. Before her present association, she was a Post-Doctoral Fellow at Max Planck Institute for Heart and Lung Research, Bad Nauheim, Germany. Dr. Nikam has pursued her Master’s degree in Molecular Bioengineering from the Technical University of Graz, Austria and a Doctoral degree from School of Medicine, University of Giessen, Giessen, Germany. Dr. Nikam’s research interests and expertise include stem cells, tissue remodeling and regeneration , toxicology , understanding molecular and cellular biology of underlying diseases. She has received an honorarium from United Therapeutic , NC, USA, Fellowship award for Master of Science in Molecular Bioeng. (M.Sc.) from Technical University of Graz, Austria and received the scholarship from Afro- Asiatische Institute, Graz, Austria. She has several papers published in peer-reviewed journals like British Journal of Pharmacology, Eur Respir J, AAPS PharmSciTech, J Proteome Res, Am J Respir Cell Mol Biol and Pneumologie. She attended and presented her research work at several international conferences like American Thoracic Society Meeting (ATS ) 2006, 2009, Symposium of the Austrian Pharmacological Society (APHAR) 2004, European Respiratory Society (ERS) 2006, Austrian Academy of Sciences Proceedings 2008, American Association for Cancer Research (AACR) Annual Meeting, 2013. 

Shariq Syed is presently Interim Dean and Associate Professor at AIKTC School of Pharmacy and Advisor to Board, Medley Pharmaceuticals. Earlier, he has served as Senior Research Investigator, Bristol Myers-Squibb, USA (2007-2012). At Bristol Myer Squibb, he was part of Ipilimumab drug development team, and has collaborated with Dr. James Allison, immunologist and Nobel Laureate of the year 2018 . At Bristol Myer Squibb, he was responsible for all key aspects of Clinical Pharmacology in Oncology therapeutic area for large and small molecule drugs/ compounds, Co-lead Clinical Pharmacology development of Brivanib ®, a novel Kinase inhibitor for Liver cancer and contributed to NDA submission package of Yervoy ®, a breakthrough therapy in immune-oncology approved for skin cancer. Dr. Shariq’s research interest and expertise include Clinical Pharmacology, Pharmacokinetics, understanding drug exposure-response relationship (PK-PD) in early Proof of concept (POC) trials. He has received Pharma Ratan Young Achiever Award for his contribution tothe field of Immuno-oncology and award from Rho-Chi Honor society (Honor Society in Pharmaceutical Sciences). He is an invited reviewer of the European Journal of Drug Metabolism and Pharmacokinetics, Current Clinical Pharmacology. He is a member of American Association of Pharmaceutical Scientists, elected member of American College of Clinical Pharmacology, elected Member of American Society of Clinical Pharmacology and Therapeutics, a member of the Indian Society of Clinical Research. He has published several research articles in peer-reviewed international journals.