Biosimilars Regulatory, Clinical, and Biopharmaceutical Development

Hiten Gutka PhD., is an Associate Director Formulation Development at Oncobiologics Inc. where he works on biosimilar drug product development. He worked on formulation and stabilization of novel insulin analogues at Thermalin Diabetes LLC. He did a co-op at Medimmune LLC, in the Formulation and Drug Product Development group. Hiten got his PhD in Pharmacognosy (Pharmaceutical Biotechnology track) from University of Illinois at Chicago (UIC), College of Pharmacy. Dr. Gutka worked at Biocon, USV and Reliance Biopharmaceuticals in India, on analytical and pharmaceutical development of biosimilar Insulins and other biosimilars including cytokines and hormones. He got his Bachelors in Pharmaceutical Sciences from University of Mumbai, India and Masters in Pharmaceutical Sciences from University Institute of Chemical Technology, Mumbai, India. Hiten is a member of the American Association of Pharmaceutical Sciences (AAPS). He serves on the editorial board of the journal mAbs.

Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at MedImmune. He has participated in industry initiatives related to Quality by Design, analytical method development and validation, and sterile drug product bioburden testing. He has 23 years of experience in drug discovery, pre-clinical and clinical study design and analysis, translational sciences, biopharmaceutical development, manufacturing, and regulatory submissions. He has authored 5 statistical books and published 14 book chapters and more than 90 papers. He received his Bachelor’s and Master’s degrees in Applied Mathematics from Peking University, and Ph.D. in Statistics from the University of Pittsburgh.

Shefali Kakar PhD., is an Executive Director, Global Head Respiratory, in the Novartis Pharmacokinetic Sciences group.  She is responsible for overseeing all aspects of pharmacokinetics sciences (ADME, PK/PD, and clinical pharmacology) for the respiratory portfolio ranging from early discovery to full development.  Dr. Kakar has over 15 years of industrial experience and has been involved in discovery and development of over 40 small molecules and protein therapeutics, including biosimilars.  Prior to joining Novartis, Dr. Kakar worked at Pfizer and also served as an Adjunct faculty at the Brown University.  She received her PhD in Pharmacology from University of Michigan.