Developability of Biotherapeutics ─ Computational Approaches

Several computational methodologies and biophysical techniques are being adapted and examples of successful designs are beginning to emerge. Simultaneously, there is a growing awareness of improving clinical trial designs using statistical and mathematical modeling to prevent unnecessary drug candidate failures. This book details the applications of computational and molecular modeling techniques towards affordable biopharmaceutical drug development at both pre-clinical and clinical stages.

Sandeep Kumar, PhD, is a senior principal scientist at Pfizer, Inc. in the Biotherapeutics Pharmaceutical Sciences group, working on computational modeling and developability risk assessments of a wide variety of biotherapeutic drug candidates, including monoclonal antibodies, antibody-based therapeutics, fusion proteins, vaccines, and antibody–drug conjugates. He earned his PhD in computational biophysics from the Molecular Biophysics Unit of the Indian Institute of Science, Bangalore. He has more than 15 years of experience in computational protein sciences. He has contributed more than 60 research papers, review articles, and book chapters; delivered more than 40 invited talks; chaired sessions of several conferences; won several fellowships and awards, including the 2014 Ebert Prize; and mentored several graduate students and postdoctoral scientists.

Satish Kumar Singh, PhD, is a research fellow at Pfizer, Inc. in the Biotherapeutics Pharmaceutical Sciences group, and an adjunct professor of the Department of Physical Pharmaceutical Chemistry at Uppsala University in Sweden. His responsibilities include leading formulation, product, and process development activities for biologics and therapeutic vaccines. He earned his PhD in chemical engineering from Kansas State University. He has more than 25 years of industrial experience and has published more than 50 peer-reviewed articles with emphasis on the colloidal and physical chemistry of macromolecules. He also holds four patents. He is involved in several professional groups through the American Association of Pharmaceutical Scientists and the USP, was chair of the Protein Aggregation and Immunogenicity Focus group, and is a frequently invited speaker at various conferences and symposia.