Dr. Ecevit Bilgili
Dr. Ecevit Bilgili is a professor, master teacher, and associate chair of the Chemical and Materials Engineering department at NJIT. His Particle Engineering and Pharmaceutical Nanotechnology Lab has been conducting research in designing formulations and processes for high-value-added products like pharmaceuticals with enhanced functionalities.
His research interests center on the development of a fundamental understanding of the mechanisms involved during the formation of drug nanoparticles via top-down and bottom-up approaches, nanocomposite microparticles, and amorphous solid dispersions. Prior to this academic position, Dr. Bilgili worked as Principal Development Engineer within R&D and Pharmaceutical Commercialization Technology Department at Merck & Co., Inc. during 2004–2009.
Dr. Bilgili is a well-recognized member of the Particle Technology Community. He served as an elected Executive Committee Member of the Particle Technology Forum of AIChE. He also served as the Chair & Vice-Chair of AIChE Area3a: Particle Production and Characterization. Dr. Bilgili authored about 100 peer-reviewed journal articles, 5 U.S. patents, and several invention disclosures. He delivered 120+ national/international conference presentations and 30+ invited talks. Dr. Bilgili serves as an Associate Executive Editor of Advanced Powder Technology, an Editor of Pharmaceutics and Powders journals, and an Editorial Advisory Board member of Pharmaceutical Research. He is a recipient of numerous Excellence in Teaching Awards from NJIT and the George Klinzing Best PhD Thesis in Particle Technology Award from the AICHE. In 2022, he was elected as a Fellow of AIChE.
Dragan Djordjevic
Dragan has been at Takeda since March 2020 and is currently leading the modeling group in Cambridge, MA. He has previously worked at Seven Bridges, delivering solutions for genomic and phenotypic analysis at scale, as well as front-end web development at multiple companies after leaving Belgrade with two Master's degrees, in Fine Art and Mechanical Engineering.
Connor Gallagher
Connor Gallagher has been a Process Engineer at GlaxoSmithKline since 2021. Born and raised in Havertown, Pennsylvania, he attended the University of Pennsylvania, receiving an undergraduate degree in chemical and biomolecular engineering in 2020. At GSK, Connor has been extensively involved in developing and deploying statistical process control models across both small and large molecule modalities at manufacturing sites in the United States and United Kingdom.
Bob Yule
Bob Yule is the head of the new US Engineering and Modeling group at Sanofi Cambridge Crossing. Bob is a Chemical Engineer with 40 years of experience. He started with Dupont in manufacturing and moved to R&D early in his career. He provided leadership building process engineering groups at Dupont Merck, BMS, Abbott and GSK. Before joining Sanofi, he led Global and Early Development modeling groups at GSK working on Drug Substance and Drug Product process and product development. He has partnered externally on industry, academic and government funded collaborations to advance simulation and Industry 4.0 (Digital Design). Bob’s passion is to accelerate develop and increase process understanding using simulation. This includes establishing efficient material sparing and data intensive workflows integrated with a comprehensive data infrastructure.
Ben Smith
Ben has been at Amgen since 2013, working in the applied modeling and simulation engineering team. He is currently working in process-economic and facility-fit evaluations for new manufacturing platforms and supporting automation of process modeling through digitization of process parameters and lifecycle management, as well as working as a sustainability lead in the team.
Ben Stevens
Ben Stevens is a Director of CMC Policy and Advocacy at GSK and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam where he led the clinical regulatory CMC development of vutrisiran prefilled syringe in over 30 countries, and the initial US NDA and EU MAA submissions. Before Ben joined Alnylam, he was a Principal Consultant at PAREXEL and an acting Branch Chief in the Office of New Drug Products (ONDP) at the FDA. At FDA, Ben worked closely with several key policy groups (OPPQ, ORP), partnered with CDRH on matters related to combination product review, and was a government liaison to USP. Before FDA, Ben spent seven years in medicinal chemistry R&D at Pfizer and Merck. Ben has broad regulatory CMC experience in small molecules, peptides, oligonucleotides, botanicals, and combination products, with recent focus CMC policy and advocacy for biologics and CGT at GSK. He received a Ph. D. in Chemistry from the University of Pittsburgh, a M.P.H. from the Johns Hopkins and is a co-author of over 30 publications and patents.
Michaela Schütz
