Paul L. Pluta is a pharmaceutical scientist with technical development, manufacturing, and management experience. He has been involved in nearly all phases of pharmaceutical development and manufacturing including R&D formulation and process development, dissolution, stability, regulatory, quality assurance / control, compliance, specifications, scale-up, technology transfer, technical support, and validation / qualification. In his time at Abbott he had numerous new product and supporting regulatory submissions, as well as, extensive product technical support experience. Additionally, his validation experience includes manufacturing process validation, cleaning validation and associated systems qualification including aseptic systems. He may be reached at firstname.lastname@example.org.
Bernard Hsu has nearly 10 years of experience in pharmaceutical product development at major pharmaceutical companies spanning all phases of development. Earlier in his career, his clinical training was in emergency medicine and toxicology. He is now Associate Director in Oncology Medical at Novartis. Most of Bernard's work now is in medical and scientific communications, both within the industry, and to the general public.
Alan M. Mancini, RPh., is a pharmacist with substantial experience with the formulation, process and package development, scale-up, technology transfer, validations and optimizations of pharmaceutical dosage forms on a global basis. He is an adjunct instructor in biopharmaceutics at the University of Illinois College of Pharmacy, Chicago, Illinois, USA. He may be contacted at email@example.com.
Richard Poska has more than 40 years of experience in pharmaceutical product development and regulatory affairs and is managing director at Flexo LLC, a CMC consulting firm. After earning a B.S. in Pharmaceutical Technology, his career focused on formulation and process development and manufacturing support for solid and liquid dosage forms – both new and existing products. This deep technical expertise provides a robust scientific foundation for his experience in preparation of global regulatory submissions, from pre-IND to post-approval product stage. Within his regulatory CMC experience, Richard has supported more than 10 legacy products and many new product candidates at all stages of the development lifecycle.