- Addressing the state of the biopharmaceutical industry today: Which emerging trend will see the most growth?
- Embracing modular automation, PAT and continuous processing to increase agility, flexibility and improve efficiencies
- People and technology: How are these forces working together to grow and mature our industry?
- IoT- how will cloud based data, data analytics and data integrity evolve compliance and quality towards continuous improvement
- How will these technologies affect patient and product needs towards more individualized therapies?
Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and corporate manufacturing where she oversaw supply chain, contract manufacturing, global distribution, manufacturing technologies, and operations risk management. She also headed up Amgen’s Fremont, California, manufacturing facility (AFR). Before heading up the AFR facility, Moore was a director in chemistry, manufacturing and controls regulatory affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the process development organization. Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England.
Rohini Deshpande is the VP Process Development of Amgen. She joined Amgen in 1997 as a scientist in R&D. At present, she is Vice President Process Development and Head of Attribute Sciences. Attribute Sciences is a multi-modality global group across six Amgen sites. The scope spans preclinical to commercial. Previously, Rohini was Executive Director of Drug Substance group for Amgen Thousand Oaks. Her team developed production cell lines and processes for many Amgen biologics products. Prior to her 20 years at Amgen, Rohini did her post-doctoral work in antibody structure function at UCLA, before that she worked as a post-doctoral fellow establishing a Yeast two hybrid system at University of Michigan, Ann Arbor, and prior to that she did her Ph.D. in Biology with an emphasis on Immuno endocrinology at SUNY Binghamton.
Christie Bielinski is the Vice President of Product Quality Management of Janssen Pharmaceuticals. She leads a world-wide organization of quality professionals accountable for the development, manufacture and launch of pharmaceutical products across the Janssen therapeutic areas. The scope of her responsibilities include assuring that the quality requirements are built into the product in early and late-stage development, that proactive identification of ‘critical to quality attributes’ are identified, and that the associated risk is quantified so that defects can be prevented during the entire lifecycle of the product. In her 11-year career with Johnson & Johnson, Christie has held positions in both the Medical Device and Pharmaceutical segments and has had responsibility for marketed products that span a diverse portfolio of Pharmaceuticals, Biologics, Devices and Combination Products. Her responsibilities during this tenure have included new product development and lifecycle management, supplier quality, validations/site qualifications, laboratories, quality operations and network optimization.
Craig Beasley is the Vice President of Manufacturing Operations at Juno Therapeutics, a clinical-stage cell immunotherapy company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Prior to joining Juno Therapeutics, Craig worked at Biogen for sixteen years in roles of increasing responsibility in process engineering, manufacturing, supply chain, site operations, and financial planning functions. Craig has a BS in Chemical Engineering from Purdue University.