Clinical Pharmacology & Biopharmaceutics
Open Access

Biography

Irfan A. Mohammed is a CMC Development Scientist/ Leader with comprehensive experience in ideating, designing, developing, and scaling innovative and complex drug development programs ranging from oral solids to sterile dosage forms (Injectables and Ophthalmics) from pre-clinical stage to commercialization. Irfan A. Mohammed has led the development of drug products in various disease spaces, such as, oncology, hematology, neurology, ophthalmology, hospital, and critical care medicine, including rare diseases. He is an inventor/ co-inventor on 30+ patents awarded/ pending in the US and rest of the world (ROW).

Currently serving as an  Associate Director, CMC Development Leader at Alexion Pharmaceuticals, his work focuses on leading global Chemistry, Manufacturing and Controls (CMC) development teams, such as, drug substance, drug product , analytical sciences, device, clinical manufacturing, clinical supply chain, regulatory CMC and quality management teams to advance innovative therapies for rare diseases from R&D to clinics. His experience includes leading drug product design and development (pre-formulation and formulation), manufacturing science and technology (MS&T), such as, manufacturing process development, characterization, verification, validation, and formulation/fill/finish operations), regulatory CMC and compliance. His research experience encompasses both academia and industry focused on developing robust drug product formulation and process strategies for new molecular entities and already approved drug substances, primarily within sterile dosage forms, such as, injectables and ophthalmic drug products, including aqueous, non-aqueous, lyophilized, suspensions, emulsions formulations, pre-filled syringes/ combination products, blow fill seal (BFS) and infusion bags. His work aims to develop drug products to improve the overall quality of life in patients, adding value to the patients, healthcare providers and the healthcare system.  

Irfan is passionate to contribute and add value to the overall healthcare ecosystem, beginning from drug development to healthcare delivery and health outcomes leveraging new and innovative approaches, such as, digital applications in drug development and healthcare.

Irfan A. Mohammed is also currently pursuing his Doctorate Degree in Pharmaceutics from Philadelphia College of Pharmacy, University of Sciences, where his research work focuses on developing long acting injectables drug delivery systems. He obtained his Master’s degree in Pharmaceutics and Industrial Pharmacy from Long Island University, Brooklyn, NY, where his research work focused on development, characterization and understanding the process variables in the preparation of stable polymeric nanoparticles using wet media milling to improve the drug delivery of an antifungal agent through topical/transdermal and oral solid dosage forms utilizing and comparing regular form of drug, nanoparticles and solid dispersion technologies. He graduated with a Bachelor’s degree in Pharmacy from Jawaharlal Nehru Technological University, Hyderabad, India

Research Interest

Pharmaceutics, Chemistry, Manufacturing and Controls, Advance Medicine, Analytical Sciences