The evening will feature two presentations on biologics:
Product and Process Design for Biologics
by Mihaela Simianu, PhD, Director Regulatory Compliance, Pharmatech Associates
All Things Considered: CMC and QMS Intersection in Process Development
by Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates
Dr. Simianu is an experienced executive leader in Bio-Pharmaceutical industry. She has diverse and deep expertise in development, commercialization and international manufacturing of complex bio-pharmaceuticals used in the treatment of multiple forms of cancer and diseases associated with endocrine, cardiovascular, neurological, and immunological disorders. She has successfully built new and flexible technical organizations, implemented improvements to development, quality and manufacturing systems, and has established technical and social capabilities that contributed to the success of multi-billion dollar organizations. In her role as Director of Regulatory Compliance at Pharmatech Associates she guides companies to apply a tailored "Compliance trough Science "approach to commercialization of complex therapeutic agents, balancing regulatory, compliance, and technical requirements with business needs. As a recognized international industry expert, Dr. Simianu has engaged in organizing numerous global events for the Parenteral Drug Association. She has spoken on many occasions on the application of science to quality and manufacturing practices.
Mr. Chatterjee has more than 30 years of experience in the pharmaceutical, biosciences, medical device/diagnostic and nutraceutical/dietary supplement industries. He has held senior management positions in operating companies for more than a decade and has successfully brought multiple drug and product platforms through the FDA regulated development process to market. He has successfully designed and implemented Quality, Engineering and Operations Management Systems for organizations in the US, Europe and Asia. Mr. Chatterjee holds multiple certifications including Lean Six Sigma Master Black Belt and is a Certified Lead Assessor. He has published over 80 articles and editorials throughout his career in peer reviewed journals. Mr. Chatterjee holds a BA in Biochemistry and a BS in Chemical Engineering from the University of California at San Diego.