Robert Dream is an industry leader with more than 29 years’ experience, including 15 years of executive leadership experience, in the consumer product, pharmaceutical, biotechnology, and life sciences industries. He has led projects, improved processes, and scaled up products through operational excellence strategies and technology knowledge and know how. He is business oriented and has a functional knowledge of manufacturing, operations, regulatory compliance and regulatory affairs (assisting on CMCs and BLAs), risk mitigation and risk management. He is experienced in biotechnological and biological products manufacturing (including Continuous Biomanufacturing, ATMPs/Cell & Gene Therapies), with extensive hands-on, senior managerial and executive experience at world-leading organizations. He is a registered professional engineer and an active member of ISPE and PDA. He is a member of the Pharmaceutical Processing Editorial Advisory Board, the Pharmaceutical Manufacturing Editorial Advisory Board, Pharmaceutical Technology Editorial advisory Board, Pharmaceutical Engineering Committee, and the INTERPHEX Advisory Council. He is a graduate of the Illinois Institute of Technology (BS and MS) and Drexel University (PhD).
The 2022 Planning Committee is delighted to welcome attendance and registration for the fast-approaching ISPE Biotechnology Conference, taking place 28-30 June in Boston, Massachusetts and virtually.
This article revisits the concept of phased engineering, procurement, and construction (EPC) and updates it with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects. Enhancing the relationship between phases of a project, advanced planning, and more formal management of...
Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) would, in principle, be even more justified for both quality and business gains. This article briefly reviews continuous...
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and regulatory hurdles in the life cycle of a process analytical technology application—including model...