Dr. Atul Dubey
Title: Director of Continuous Manufacturing at the United States Pharmacopeial Convention
Company: United States Pharmacopeia
Education: Ph.D., degree in Mechanical Engineering
Dr. Atul Dubey is the Director of Continuous Manufacturing (CM) at the United States Pharmacopeial Convention, headquartered in Rockville, MD, USA. At USP his interest is in supporting the industry produce quality medicines using continuous manufacturing. To this end he is involved in the development of training curriculum for industry as well as regulators to bring the technological awareness about CM.
After earning his Ph.D. degree in Mechanical Engineering, Dr. Dubey carried out research in pharmaceutical manufacturing processes using modeling and simulation to understand and optimize unit operations such as continuous mixing, granulation and pan coating. He has authored several journal articles and book chapters in the domain.
After his stint at the C-SOPS (Rutgers University) he moved to India where he worked as a consultant to pharmaceutical companies, as well as a Sr. Scientist in the Aditya Birla Group in India. With a strong interest in academic research, he is interested in applied R&D towards development of guidelines and standards for continuous manufacturing.
Lucy L. Botros, M.S.
Title: Scientific Liaison, General Chapters
Company: United States Pharmacopeia
Education: M.S. and B.S. in Chemistry from the McGill University, Montreal, Canada
As a Scientific Liaison with the General Chapters group of The United States Pharmacopeial Convention, Ms. Botros is responsible for supporting USP Expert Committees and associated Expert Panels in the development and revision of USP-NF general chapters related to chemical and physical analysis of pharmaceutical drug substances and drug products. Ms. Botros is also responsible for the development of new standards in Pharmaceutical Continuous Manufacturing.
Before joining the General Chapters group of USP, Ms. Botros was responsible for the development and validation of analytical procedures published in the USP-NF, Dietary Supplements Compendium, and Food Chemicals Codex, ensuring the quality, safety, and benefit of medicines and foods. Analytical procedures she and her team developed included identification and quantitation by spectroscopic (Mid-IR, Raman, NIR) and chromatographic (LC) methods. In addition, she provided chemometrics support for the analysis of spectral data.
Prior to joining USP, Ms. Botros worked as a Research Scientist at Molecular Biometrics Inc. (New Haven, CT), a start-up medical device company developing a spectroscopic method for the non-invasive assessment of gamete viability in in vitro fertilization treatments. There she gained experience in instrumental design and advanced chemometric model development and validation.
Dr. Fernando J. Muzzio
Title: Director of Engineering Research Center on Structured Organic Particulate Systems (C-SOPS)
Company: Department of Chemical and Biochemical Engineering at Rutgers University in New Jersey
Education: Ph.D., Univ. of Mass. at Amherst, Chemical Engineering
For the last 27 years, pharmaceutical product and process design has been Professor Muzzio’s main research and educational focus. His research interests comprise continuous manufacturing, pharmaceutical formulation, powder mixing, powder flow, segregation, compression, mixing and flow of liquids and suspensions, capsule filling, tablet dissolution, and tablet coating. He is a frequent lecturer at FDA events, and from 2012-2015 he was a voting member of the FDA committee on Pharmaceutical Sciences and Clinical Pharmacology.
Prof. Muzzio is the director of the NSF Engineering Research Center on Structured Organic Particulate Systems (C-SOPS), an entity created in 2006 to bring together a cross-disciplinary team of researchers from major universities to work closely with industry leaders and regulatory authorities to improve the way pharmaceuticals, foods and agriculture products are manufactured. C-SOPS focuses on advancing the scientific foundation for the optimal design of SOPS with advanced functionality while developing the methodologies for their active control and manufacturing.
Dr. Gerardo Callegari
Title: Associate Research Professor at C-SOPS
Company: Department of Mechanical and Aerospace Engineering, Rutgers University in New Jersey
Education: Ph.D. Universidad de Buenos Aires, Argentina
Gerardo Callegari is an Associate Research Professor at C-SOPS and the Department of Mechanical and Aerospace Engineering at Rutgers University. In the last years he has been working on characterizing manufacturing processes and materials in diverse areas related to the direct compaction of powders including pharmaceutical products. His work was focused on developing methodologies to identify failure modes and critical processing parameters of continuous direct compaction lines, advancing predictive methodologies for pharmaceutical tablet quality attributes, building up relations between material properties, process parameters and product properties and developing. Dr Callegari has led several projects funded by FDA, NSF and companies as a principal/co-principal investigator.
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Dr. Ravendra Singh
Title: Research Assistant Professor at Engineering Research C-SOPS
Company: Department of Chemical and Biochemical Engineering, Rutgers University in New Jersey
Education: Ph.D. Technical University of Denmark
Dr. Ravendra Singh is Research Assistant Professor at C-SOPS, Department of Chemical and Biochemical Engineering, Rutgers University, NJ, USA. He is the recipient of prestigious EFCE Excellence Award from European Federation of Chemical Engineering. His research focus is pharmaceutical systems engineering (PSE) including process modelling and control. He developed the control system of continuous pharmaceutical manufacturing process. He has extensive experience of giving lectures, workshops, and hands on training to pharmaceutical companies and regulators. He is leading projects funded by FDA and pharmaceutical companies as a principal/co-principal investigator. He has published more than 63 papers, written 12 book chapters, edited pharmaceutical system engineering book published by Elsevier and presented at over 100 conferences.
Dr. James Scicolone
Title: Research Professor at Engineering Research C-SOPS
Company: Chemical and Biochemical Engineering Department, Rutgers University in New Jersey
Education: Ph.D. in Materials Science and Engineering, New Jersey Institute of Technology
James Scicolone is currently an Assistant Research Professor in the Chemical and Biochemical Engineering Department at Rutgers University in New Jersey, USA. He received his PhD in Materials Science and Engineering and has been working on correlating material properties to performance in unit operation and manufacturability in the continuous pharmaceutical line. He has managed a number of projects associated with the US Army, pharmaceutical companies, and food companies. His recent work has focused on assessing quality performance in continuous manufacturing as well as correlating material properties to loss-in-weight feeder performance.
Dr. Andres Roman
Title: Postdoctoral Associate at the Engineering Research C-SOPS
Company: Chemical and Biochemical Engineering Department, Rutgers University in New Jersey
Education: Ph.D. in Applied Chemistry, University of Puerto Rico, Mayaguez
Andres Roman has a Ph.D. in Applied Chemistry. He is a Postdoctoral Associate at the Chemical and Biochemical Engineering Department. Over the last six years, he developed and implemented PAT methodologies for real-time measurements of API concentration, powder density and dissolution
Dr. Sonia Modarres Razavi
Title: Postdoctoral Associate at the NSF Engineering Research (C-SOPS)
Company: Chemical and Biomedical Engineering Department, Rutgers University in New Jersey
Education: Ph.D. in Mechanical and Aerospace Engineering from Rutgers University
Sonia Modarres Razavi is currently a Postdoctoral Associate at the NSF Engineering Research Center on Structured Organic Particulate Systems (C-SOPS). She has a PhD in Mechanical and Aerospace Engineering from Rutgers University. Her main area of research is on powder characterization, powder compaction, and pharmaceutical tablet characterization. Her recent work focuses on understanding the impact of material properties and process settings on the final product.
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