Sarwar Beg

Background

About Sarwar Beg

Acclaimed pharmaceutical scientist with over 14 years of academic and industry experience in oral drug product development, process optimization, scale up and tech. transfers, commercial manufacturing. • High level end-to-end support for phase appropriate oral solid dosage (OSD) drug product development early phase development supporting phase I, II and clinical trial batches manufacturing and supply, registration and commercial manufacturing, regulatory support for IND and NDA filing applications. • Thorough experience of implementing science and risk-based framework for developing the first-in-human and proof of concept formulation for clinical trial requirements, and planning for GMP scale-up batches for product registration and and commercial manufacturing. • Previously worked in generic drug product development for ANDA 505(j) applications through first-to-file approach, 505(b)(2) applications, devised strategies for patent non-infringement for para IV filing, discriminatory dissolution method establishment for complex generics. • Extensively worked on designing oral dosage forms for augmenting biopharmaceutical attributes of the difficult BCS Class II & IV drugs with special emphasis on self-nanoemulsifying systems, lipid nanoparticles, supersaturated systems (solid dispersions, inclusion complexes, coamorphous systems). • Worked extensively on the development of lipid and polymeric nanoparticles for chemotherapeutic drug delivery and site-trageting, experience in high-pressure homogenization, lyophilization, and product quality characterization using size, zeta potential, drug loading efficiency, drug payload analysis, in vitro drug release evaluation and data modeling. • Extensive work experience on ICH Q8, Q9, Q10 implementation using Quality by Design (QbD) paradigms like Quality Risk Management (QRM), Design of Experiments (DoE), and Multivariate Statistical analysis (PCA, PLS, Gauge R-R, cluster analysis) for the development of generic pharmaceutical products (solid/liquid orals, injectables, semisolids), nanostructured drug delivery systems, long-acting injectable preparations, solid-state pharmaceutical characterization. • Critical experience in mathematical modeling of drug release data, pharmacokinetic modeling including Physiological based pharmacokinetic (PBPK) Modeling, in vitro/in vivo correlations (IVIVC) and BCS-based Biowaiver establishment, and advanced statistical data analysis using computational modeling.