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High-Concentration Protein Formulations Speaker Biographies

Meera Agarkhed, Formulation Scientist, Imclone Systems Inc. 

Meera has M.S in Biochemistry and Biotechnology. She has over 10 years of industrial experience. Her experience/expertise include formulation development and analytical method development of monoclonal antibody drug products. Primary focus of her work is formulation development, from early to late phase development.

Ahmed Besheer, Ph.D., Research Fellow, Pharmaceutical Technology and Biopharmaceutics, Ludwig Maximilians University 

Dr. Besheer holds a B.Sc. in pharmacy, M.Sc. in polymer science and Ph.D. in Pharmaceutical Technology (MLU Halle, Germany). After doing a Postdoc at Merck Serono in Darmastadt, Germany, he moved to the department of Pharmaceutical Technology at Ludwig Maximilians University in Munich as a research fellow. He currently leads a research group focusing on protein formulation and delivery, and dealing with various topics such as: high concentration antibody solutions, polymer-protein conjugates and excipients for protein stabilization.

Elaheh Binabaji, Department of Chemical Engineering, The Pennsylvania State University 

Elaheh Binabaji is a Ph.D. student in the Department of Chemical Engineering at The Pennsylvania State University conducting research on the behavior of ultrafiltration systems for processing high concentration monoclonal antibody solutions in the lab of Andrew Zydney, Department Head and Walter L. Robb Family Endowed Chair in the Department of Chemical Engineering at The Pennsylvania State University.

Robin Bogner, Ph.D., Associate Professor of Pharmaceutics, School of Pharmacy, University of Connecticut 

Dr. Bogner is Associate Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science and a UConn Teaching Fellow. She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D from Rutgers University after which she joined the faculty of the University of Connecticut. Dr. Bogner's research interests are focused on solid dosage forms, both oral solids and parenteral lyophilized solids. Modeling the effect of variation on product quality and product performance is a recent area of interest. Dr. Bogner has served on a USP Expert Committee and various other leadership roles in AAPS and AACP. She is on the editorial boards of Pharmaceutical Research, Pharmaceutical Formulation and Quality, and Pharmaceutical Development and Technology where she is Editor for mini-reviews submitted to that journal.

Ravi Chari, Ph.D., Senior Scientist, Global Formulation Sciences Parenterals, Abbott 

Ravi Chari is a Senior Scientist in the Preformulation Group at Abbott Bioresearch Center in Worcester, MA. His primary work involves early discovery screening of biologics candidates for acceptable solubility, viscosity, and degradation profiles. He also supports later formulation development of API and Drug Product. His research interests include computer modeling of proteins to predict physicochemical properties.  

Yatin Gokarn, Ph.D., Head, Pharmaceutical Process and Technology Development, Genentech 

Yatin has over fourteen years of experience in the biopharmaceutical industry with tenures of increasing responsibilities at Pfizer, Amgen, and Genentech. He has broad exposure and expertise in parenteral and biopharmaceutical Drug Product development with direct experience spanning lead-candidate selection, EIH platform technologies, commercial formulation development, process development and tech transfers, multiple licensure applications, and life-cycle management of mature products. Presently, he is an Associate Director at Genentech and heads the Pharmaceutical Process and Technology Development department. Yatin is a biophysical chemist (M.S. & Ph.D., University of New Hampshire (UNH)) and a chemical engineer (B. Chem. Eng., ICT-Mumbai; M.S., UNH) by academic training.

Jennifer Litowski, Sr. Scientist, Drug Product Development, Amgen, Inc. 

Jennifer Litowski studied the design and folding of coiled-coils at the University of Alberta, receiving a Ph.D. in Biochemistry in 2003. She then held a post-doctoral position at Columbia University, where she studied the mechanochemical cycle of cytoplasmic dynein. In 2007, she joined the protein formulation group at Amgen, Inc. and she currently works in Seattle, WA.

Jennifer Maynard, Ph.D., Asst. Professor, Chemical Engineering, University of Texas at Austin 

Dr. Maynard received her undergraduate degree in human biology from Stanford University, followed by a Ph.D. in Chemical Engineering from the University of Texas at Austin, and post-doctoral studies as an NIH NRSA fellow in microbiology and immunology at Stanford University. An antibody she developed, which neutralizes a bacterial toxin, successfully completed Phase I and Phase II clinical trials, received fast-track status from the FDA under the guidance of its licensee, Elusys. Her lab is currently focused on design of antibodies and biologics to treat infectious disease.

Allen Minton, Ph.D., Senior Investigator, Physical Biochemistry, NIH 

This laboratory is engaged in theoretical and experimental studies of noncovalent interactions -- both attractive and repulsive -- between like and unlike biological macromolecules in solution and on surfaces. Novel experimental methods for the quantitative characterization of such interactions in solution, based upon the measurement and analysis of sedimentation equilibrium and light scattering, have been developed and are being developed. The effect of excluded volume ("macromolecular crowding") and surface interactions on the equilibria and kinetics of a variety of model reactions are studied experimentally and theoretically.

Michael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut 

Dr. Pikal is currently Professor and Distinguished Chair in Pharmaceutical Technology at the University of Connecticut. He received his Ph.D. in physical chemistry (1966) from Iowa State University and was a Postdoctoral Research Fellow with the Lawrence Livermore Laboratory(1966-1967). Prior to joining Lilly Research Laboratories in 1972, he was assistant professor of chemistry at the University of Tennessee (1967-1972). His current research activities include the solid state chemistry of pharmaceuticals, particularly the stability of amorphous materials, characterization of solids by calorimetry, and the science and technology of freeze drying with a focus on optimization of formulation and process for labile proteins. Dr. Pikal is a member of the ACS and AAPS. He was the recipient of the Ebert Prize (1977) and the PDA's "best paper of the year" award (1989). He received the Eli Lilly & Co. "Presidents Award" in 1996. Dr. Pikal was the Busse Lecturer (University of Wisconsin, 1983) and the Enz Lecturer (University of Kansas, 1998). Dr. Pikal is a Fellow of the AAPS, and received the AAPS Research Achievement Award in Pharmaceutical Technologies in 2001, and the Criofarma award in Freeze Drying in 2006. Dr. Pikal is the 2009 recipient of the AAPS Distinguished Scientist Award.

Venkatramana Rao, Ph.D., Associate Director, Drug Product Science and Technology, Bristol-Myers Squibb 

Dr. Rao is currently working as Associate Director in Drug Product Science & Technology within R&D Division of Bristol-Myers Squibb. He received his B.Tech. in Chemical Engineering from Osmania University, India, M.S. in Chemical Engineering and Ph.D. in Pharmaceutical Chemistry with honors from The University of Kansas. Since joining BMS R&D in 2000, he has held positions of increasing responsibility in design, development and technology-transfer of clinical and commercial products. In his current role, he leads a sterile products group that is responsible for designing, developing and transferring biologics & small molecule drug products to clinical & commercial manufacturing sites. Dr. Rao is credited with more than 20 manuscripts, 2 book chapters, 5 patents and has made numerous external presentations and invited lectures. He is currently serving on the 2010-2015 USP Excipients Expert Committee.

Yu Tang, Ph.D., Investigator, Integrated Biologics Profiling, Novartis 

Yu Tang is currently an Investigator in the Integrated Biologics Profiling Unit of Novartis. She received her Ph.D. in the field of controlled delivery of biologics from North Dakota State University in 2008. Prior to joining Novartis, she served as a scientist in the late stage formulation development in Seattle Genetics for more than a year. Her current research focuses on Developability Assessment of Biologics using a high-throughput formulation platform.

Serguei Tchessalov, Ph.D., Associate Research Fellow , Pharmaceutical Sciences, BioTx R&D, Pfizer 

Dr. Serguei Tchessalov is a Principal Scientist at Pfizer Pharmaceutical R&D (Andover, MA). He received his Ph.D. from Institute of Applied Biochemistry (Moscow) on development of novel methods for formulation and process control during lyophilization. For the past 20 years (in Russia and US) he was working on formulation and lyophilization process development of bacterial and viral vaccines, proteins and different biological materials. His current research is focused on lyophilization process scale up as well as processing of parenteral dosage forms (filtration, filling, freezing/thawing and etc).

Sandeep Yadav, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech Inc. 

Sandeep Yadav is a Post-Doctoral fellow with Steven J. Shire at Late Stage Product Development, Genentech Inc. with responsibility for devising novel strategies to address viscosity and stability issues associated with high concentration formulation development, and has authored and co-authored several publications concerning viscosity, self-association/aggregation and stabilization techniques in peer-reviewed journals. Sandeep holds a PhD degree in Pharmaceutics from University of Connecticut, MS in Pharmaceutics (Drug Delivery) and BS in Pharmaceutical Sciences from University of Delhi.

Andrew Zydney, Ph.D., Department Head and Walter L. Robb Family Endowed Chair , Department of Chemical Engineering, The Pennsylvania State University; Editor-in-Chief, Journal of Membrane Science 

Andrew Zydney is Department Head and Walter L. Robb Family Endowed Chair in the Department of Chemical Engineering at The Pennsylvania State University. Dr. Zydney is also Editor-in-Chief of the Journal of Membrane Science and on the Editorial Boards of several chemical engineering and bioprocessing journals. Dr. Zydney is a Fellow of the American Institute of Chemical Engineers and the American Institute of Medical and Biological Engineers. He has an active research program in membrane separations and downstream processing and has published more than 170 papers in these fields.

Vikas Sharma, Ph.D., Sr. Scientist and Group Leader, Early Stage Pharmaceutical Development, Genentech 

Vikas Sharma is currently a Group Leader and Sr. Scientist in the Early Stage Pharmaceutical Development department at Genentech, South San Francisco, CA. He received his Ph.D. from the University of Connecticut in Pharmaceutical Sciences and completed a postdoctoral fellowship at MIT prior to joining Genentech in 2006. His current responsibilities at Genentech include formulation development of antibodies and related biologics to support pre-clinical and early clinical studies. He is also involved in the molecule assessment program to screen antibodies for clinical development and his research interests entail understanding antibody behavior at high concentration from a molecular properties point of view.



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