Bruce Johnson, Site Director, Dendreon
An accomplished leader, Bruce has more than 25 years of experience defining and implementing world-class manufacturing (biologics and biotech) strategies that support business success. As head of Dendreon’s West Coast Immunotherapy Manufacturing Facility (IMF), Bruce leads a high-performing team of 125 and is accountable for manufacturing operations at the 180,000 facility, which produces the world’s first autologous active cellular therapy (personalized medicine) for the treatment of advanced prostate cancer. Equally versed in clinical and commercial GMP environments, Bruce’s core competencies include: manufacturing, supply chain, engineering and facilities management. He also is technically skilled in the areas of protein fermentation / purification, sterilization, employee health & safety, and business continuity / risk management protocols.
Will Junker, Sr. Director Quality Engineering, Kite Pharma, Inc.
Will Junker is a biotechnology and pharmaceutical leader with a career spanning 33+ years. He started this career at Aventis in Frankfurt, Germany supporting their Insulin franchise for 15 years with process development, new facility design, process automation and all areas of validation. Upon migration to the US, Will managed computer validation for Baxter’s BioScience division in Southern California before moving to the East Coast. For over 12 years with MedImmune/AstraZeneca he served in various leadership roles like site validation, corporate validation, new facilities design, construction and CQV, process/facility automation and IT. At Kite since 2017, Will is building a global QE function to serve as technical core of quality and drive next generation quality concept introduction.
A member of ASQ, ISPE and PDA, he holds an advanced degree in Chemical Engineering from the University of Applied Sciences in Darmstadt, Germany.
Nadeem Sheikh, PhD, Vice President of Research & Manufacturing Sciences, Dendreon
Nadeem heads Research & Manufacturing Sciences (R&MS), which represents the biologic and scientific foundation for Dendreon. R&MS maintains the scientific integrity of Dendreon’s active cellular immunotherapy platform, furthering its development and generating and analyzing clinical data to strengthen the therapeutic understanding of PROVENGE: Analytical Sciences, Antigen Sciences, Biometrics, Clinical Affairs, Clinical Immunology, Process Sciences, and Process monitoring.
After working on therapeutic vaccine approaches for malaria and HIV, Nadeem joined Dendreon in 2004 as a scientist in the vaccine development group to work on sipuleucel-T, an innovative cell-based cancer immunotherapy for prostate cancer that would eventually become PROVENGE® (sipuleucel-T). He worked on CMC (chemistry, manufacturing and controls) aspects, a critically important process in drug development. Nadeem and the vaccine process team outlined the manufacturing steps and ensured control of the product every step of the way – from receipt of the cell collection (or leukapheresis) to final PROVENGE product. As a cellular immunologist, Nadeem has an extensive publication record in the immunology and mechanisms of action of adjuvants and vaccines; this knowledge has been applied to studies by R&MS demonstrating the immunological basis for the efficacy of sipuleucel-T.
Christina Yi, Chief Operations Officer, Dendreon
With more than 20 years of industry experience, Christina has a proven track record of success across various aspects of pharmaceutical operations. Leveraging modern operational approaches and data to deliver consistent, high-impact results, she has successfully brought innovative products to market through strategic planning, efficient process design and regulatory compliance. At Dendreon, Christina is responsible for manufacturing, quality, sourcing and procurement, technical operations, apheresis operations and project management.