Evgenyi Shalaev, Ph.D., AAPS Fellow, is an executive director in Biological Products Development, Allergan, California, USA, and an adjunct professor in the Department of Pharmaceutics, University of Minnesota. He held the Royal Society Fellowship in Pafra Biopreservation and the University of Cambridge, UK, post-doctoral research appointments at the University of Wisconsin-Madison and Cornell University, and worked at the Institute of Carbon (Russia), Institute of Molecular Biology (Russia), and Pfizer Inc. (USA). Dr Shalaev’s research interests include: amorphous solids; phase transitions in aqueous systems; stability of pharmaceuticals; freeze-drying. He has published over a hundred peer-reviewed papers, book chapters, and patent applications.

Tai-Hsi Fan is an associate professor in the Department of Mechanical Engineering at University of Connecticut. He received his PhD in Mechanical Engineering from Georgia Tech and was a postdoctoral fellow at Max-Planck-Institute for Polymer Research in Germany before joining UConn. His research interests are in theoretical analysis and computation of multiphase flows, phase transition dynamics, and thermal manufacturing processes.

Alexander Tambovzev, received Ph.D. in refrigeration technology in technical university of Dresden in 2008 with a focus on modeling of dynamic processes. He was working in research and development area of refrigeration systems for commercial and industrial applications. Currently he is a project engineering and development group leader at Optima pharma, Germany. The area of his responsibility is leading the project engineering of the freeze dryers as well as the R&D effort in the freeze dryer technology.

Evgenyi Shalaev, Ph.D., AAPS Fellow, is an executive director in Biological Products Development, Allergan, California, USA, and an adjunct professor in the Department of Pharmaceutics, University of Minnesota. He held the Royal Society Fellowship in Pafra Biopreservation and the University of Cambridge, UK, post-doctoral research appointments at the University of Wisconsin-Madison and Cornell University, and worked at the Institute of Carbon (Russia), Institute of Molecular Biology (Russia), and Pfizer Inc. (USA). Dr Shalaev’s research interests include: amorphous solids; phase transitions in aqueous systems; stability of pharmaceuticals; freeze-drying. He has published over a hundred peer-reviewed papers, book chapters, and patent applications.

Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG BioTech Group in Europe and Steering Committee Member of the ISPE SPP (Sterile Product Processing) CoP. Furthermore Mr. Denk founded the PDA Expert Group about Cleaning and Cross Contamination Requirements for Biopharmaceutical Products and published this topic as PDA Paper. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

Fawziya Ali is a Scientist at Pfizer working in the Pharmaceutical Research and Development Group. She has 5 years of experience supporting formulation and process development of early and late stage liquid and lyophilized biologics and is actively engaged in the assessment of new technologies. Fawziya Ali graduated with a BS in Chemical and Biological Engineering from MIT.

Ekneet did her PhD in Pharmaceutics from University of Connecticut in Powder flow behavior for different unit operations and pursued her Postdoc at University of Connecticut with Dr. Michael Pikal. Currently, Ekneet is an Ass. Principal Scientist in Manufacturing Science & Technology division at Pfizer. In her present role she supports Lyophilization cycle optimization/troubleshooting, Scale-up and commercial products transfer activities, Commercial products investigation, Lyophilizer characterization & mathematical modeling.

Bernhardt L. Trout is the Raymond F. Baddour, ScD, (1949) Professor of Chemical Engineering at MIT. His research focuses on the development of advanced manufacturing processes and rational tools for liquid and lyo formulation and product design. In 2007, with several colleagues from MIT, he set up the Novartis-MIT Center for Continuous Manufacturing, a $85 million partnership with the objective of transforming pharmaceutical manufacturing. He has recently collaborated with Roberto Pisano of the Polytechnic University of Turin on continuous lyophilization, the subject of this talk. In addition, he is Co-Chair of the International Symposium on Continuous Manufacturing of Pharmaceuticals. He has published over 200 papers and has 22 patents issued or pending.

Justin Stanbro is an Associate Principal Scientist at Merck., where he has worked for 16 years. He received a B.S. in Biomedical Engineering from Rutgers University and an M.S. in Chemical Engineering from Lehigh University. For eight years, Justin supported the upstream and downstream clinical manufacture of both vaccines and therapeutic proteins. For the last six years, Justin has been evaluating new technologies in the Vaccine Drug Product Development Group, including Microwave Vacuum Drying as an alternative to Lyophilization and other novel drying approaches.

Dr. Ehab Moussa received his PhD in Pharmaceutics from Purdue University where he focused on the lyophilization and spray drying of proteins. He is currently a senior scientist in drug product development at AbbVie Inc. where he is responsible for the formulation and process development of parenteral products (Small molecules and biotherapeutics). His current research focuses on lyophilization process modeling and scale-up, and freeze-thaw process development.

Madhushree Gokhale got her Ph.D in Pharmaceutics from the University of Iowa in the area of chemical kinetics and drug degradation. She is currently an Associate Director at Bristol Myers Squibb, NJ in the Drug Product Science and Technology Group. She has over 13 years of experience and leads a group in the formulation/process development space working with biologics and small molecule parenteral product development. Prior to her current role she also has extensive experience with oral small molecule product development. She is also an active member of AAPS.

Lauren joined the Sanofi R&D Lyophilization Center of Excellence within the Global Biological Drug Product Development (BioDPD) team in May 2019. Lauren recently defended her doctorate in Pharmaceutical Sciences at the University of Connecticut, where she was advised by Dr. Robin Bogner. For her dissertation research, she developed a Raman spectroscopic method to detect secondary and tertiary structural changes in proteins in the solid state. The goal was development of a structural analysis tool for use in formulation development, process development and stability studies. Prior to UConn, Lauren spent 15 years in the pharmaceutical industry as a chemist working in various areas, including development of analytical methods and medical devices, as well as, formulation and process development for lyophilized protein drug products.

Evgenyi Shalaev, Ph.D., AAPS Fellow, is an executive director in Biological Products Development, Allergan, California, USA, and an adjunct professor in the Department of Pharmaceutics, University of Minnesota. He held the Royal Society Fellowship in Pafra Biopreservation and the University of Cambridge, UK, post-doctoral research appointments at the University of Wisconsin-Madison and Cornell University, and worked at the Institute of Carbon (Russia), Institute of Molecular Biology (Russia), and Pfizer Inc. (USA). Dr Shalaev’s research interests include: amorphous solids; phase transitions in aqueous systems; stability of pharmaceuticals; freeze-drying. He has published over a hundred peer-reviewed papers, book chapters, and patent applications.

Mr. Swapnil Pansare is Principle Scientist at Bristol-Myers Squibb and in his current role, he is Drug Product (DP) tech transfer lead interfacing with R&D and internal sites or CMO’s for new & commercialized product development teams. Swapnil has 10 years of experience in DP manufacturing, fill-finish, scale & tech transfer and Formulation development. He is a key member of Parenteral MS & T group, currently supporting tech transfer of commercial products to commercial sites. In his previous role, Mr. Pansare was responsible for lyophilization process optimization, scale-up & tech transfer for freeze-dried products. He has received his MS in pharmaceutical sciences from Northeastern University.

Fabrice Schlegel, Ph.D., is a mechanical engineer relying on first principles to understand and solve engineering problems, especially those involving fluid flow, heat transfer and mass transport. Fabrice has a Masters in applied mathematics and scientific computing from the MATMECA Engineering School (Bordeaux, France) and a Masters and Ph.D. in Mechanical Engineering from MIT. Before Joining Amgen, Fabrice was an applications engineer and team leader at COMSOL Inc, the multiphysics simulation software company.
As part of the Digital Integration and Predictive Technologies (DIPT) team at Amgen, he drives the development and deployment of computational models across the product lifecycle, to achieve the best patient experience. Fabrice has managed and completed several key projects with process development, spanning the spectrum of the drug substance, drug product, device and development supply chain verticals.
 

Chakradhar Padala, Ph.D. is a Director in Amgen Process Development, with more than 11 years of experience in drug product process design, scale-up, and tech transfers to manufacturing sites. He led a number of Amgen products from early stage through commercial filing and has authored multiple regulatory filings. As part of process development, he now leads a team of engineers & scientists responsible for developing and integrating next generation technologies into drug product manufacturing plants. He is also a Lyophilization subject matter expert at Amgen, and is a member of industry consortia, working on establishing best practices.

Chakradhar received his Ph.D. in Chemical & Biological Engineering from Rensselaer Polytechnic Institute (NY), working on understanding the interaction of proteins with lipid bilayer systems. He has published seven research publications in peer reviewed journals, scientific book chapters, and presented at many scientific conferences.
 

Pouya Tavousi is currently an Assistant Professor at the Central Connecticut State University. He received his Bachelor’s degree in Aerospace Engineering in 2010 from Sharif University of Technology in Tehran, Iran. He then moved to US and received his PhD in Mechanical Engineering in 2016 from the University of Connecticut. Throughout his research career, he has focused on the development of state-of-the-art algorithmic approaches for addressing one of the most challenging science problems, namely characterization and understanding the behavior of nanoscale biological systems as well as design, fabrication and manipulation of such systems. He has developed new techniques and computational and physical tools for studying nanosystems and the related manufacturing processes.

Charlie (Xiaolin) Tang is a Director in Formulation Development at Regeneron Pharmaceuticals Inc. He received his Ph.D. in pharmaceutics from University of Connecticut, specialized in freeze drying technology. He is the co-inventor of “Smart Freeze-Dryer” (with Dr. Michael Pikal and Steven Nail). His current research interests are in early and late phase protein formulation development for liquid & lyophilized drug products, lyophilization process development and technical transfer to manufacture sites.