Eyal H. Barash
Barash Law LLC
Eyal Barash has over two decades of experience as a patent lawyer. Prior to starting Barash Law in 2009, he was chief patent counsel to SSCI, the world’s leader in solid-state chemistry. Before working for SSCI, Eyal practiced patent prosecution, litigation, and client counseling at a large intellectual property law firm in Washington, D.C. Barash attended Indiana University where he received undergraduate degrees in chemistry and history before making his way to California where he obtained a masters degree in physical chemistry from the University of California at Berkeley. His research at UC Berkeley was focused mainly on solid-state Nuclear Magnetic Resonance. Barash returned to the Midwest to attend Northwestern University where he obtained his law degree. He enjoys working with entrepreneurs and scientists and lectures frequently on how intellectual property, especially in the pharmaceutical arts, can be a business driver.
Ira Buckner, Ph.D.
Associate Professor School of Pharmacy and Graduate School of Pharmaceutical Sciences and Director, Duquesne Center for Pharmaceutical Technology, Duquesne University
Dr. Buckner earned his Ph.D. in Pharmaceutics under Dr. Dale Eric Wurster at the University of Iowa working on compression calorimetry. He has also spent time working in preformulation at Abbott Laboratories and Eli Lilly and Co. He has diverse scientific interests in the areas of solid-state and physical chemistry as they relate to pharmaceuticals. Ongoing projects in his laboratory focus on understanding the varied ways in which pharmaceutical solids respond to mechanical energy during processing.
Stephen Hoag, Ph.D.
Professor, Department of Pharmaceutical Sciences, Purdue University
Dr. Hoag received his B.S. in Biochemistry from the University of Wisconsin, Madison and a Ph.D. in Pharmaceutics from the University of Minnesota.
His research interests include developing systematic methods for formulating controlled and immediate release tablets and use of mathematical models to understand the mass transport processes in hydrogels.
Ajaz Hussain, Ph.D.
President, The National Institute for Pharmaceutical Technology & Education
Dr. Ajaz Hussain is the President of The National Institute for Pharmaecuetical Technology & Education. His background includes decades of experience in industry, US FDA, and in academic research and teaching to include a number of high-level corporate leadership positions. He has built teams to develop and launch several fist-in-class complex generic and biosimilar products, and contributed to advancing plant based vaccines and development of evidence necessary to demonstrate tobacco harm reduction. His career at US FDA spanned 10 years, where he served as the Deputy Director of the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER) and a “peer reviewed” Senior Biomedical Research position in the US Government Service.
Jeff Idle, Ph.D., FRSC, FRSB, FBPhS
Director and Endowed Professor, Arthur G. Zupko’s Systems Pharmacology and Pharmacogenomics, Long Island University
Dr. Jeffrey R. Idle received a BSc in Applied Chemistry and in Medicinal Chemistry from The Hatfield Polytechnic (now University of Hertfordshire). He then studied under Professor R. Tecwyn Williams, FRS, the founding father of drug metabolism, receiving his PhD from the University of London.
Some notable career achievements include: co-discovery of the first genetic polymorphism of cytochrome P450 (CYP2D6); founder of the journal Pharmacogenetics; and founder of a campus biotech company GenoType Ltd, the first company to provide genetic services to the pharmaceutical industry and the National Institutes of Health. Idle held a number of academic appointments before joining the LIU faculty in January 2018.
Idle is a Fellow of the Royal Society of Chemistry, the Royal Society of Biology, and the British Pharmacological Society. His research history spans drug metabolism, pharmacogenetics, metabolomics, and lipidomics, particularly as applied to medicine.
Athanas Koynov, PhD
Athanas holds an undergraduate degree in nuclear and particle physics from Sofia University (Bulgaria) and a PhD in chemical engineering from Rutgers University where he studied the mechanics of multi-phase flows and their impact on chemical and biological systems. His first exposure to pharmaceutical manufacturing was at the Engineering Research Center for Structured Organic Particulate Systems where he acted as the technical lead of the continuous manufacturing test bed.
After joining Merck in 2011, Athanas specialized in particle engineering and specialty dosage formulations. He currently leads the formulation efforts around long acting parenteral implants.
Tonglei Li, Ph.D.
Allen Chao Chair and Professor of Industrial and Physical Pharmacy, Purdue University
Dr. Li received a BS in Chemistry from Nankai University, China; his MS in Comp. Chemistry from Nankai University, China and an MS in Computer Science from Purdue University; and his PhD in Pharmaceutics from Purdue University.
Dr. Li’s research interests include solid-state chemistry, formulation and drug delivery. He has a long-standing passion for molecular modeling, simulation, and ab initio methods. His recent focus has been on applying electronic calculation methods for describing intermolecular approaches. Combining experimental and computational approaches, his laboratory aims to understand crystal packing and discover molecular mechanisms of crystal growth and other phase transition behaviors. The ultimate goal is to predict physicochemical and mechanical properties and drug action kinetics in humans based on the molecular structure of a drug compound.
Xiuling Lu, Ph.D.
Associate Professor at the University of Connecticut, Associate Director of Center for Pharmaceutical Processing Research, University of Connecticut
Chair-Elect, The National Institute for Pharmaceutical Technology & Education faculty committee
Xiuling Lu, received her Ph.D. in Biochemical Engineering from the Chinese Academy of Sciences. During her postdoctoral training at the University of Kentucky, she received a prestigious Benedict Cassen Post-Doctoral Fellowship Award from the Education and Research Foundation for the Society of Nuclear Medicine in 2008. She was appointed as a Research Assistant Professor at the University of North Carolina at Chapel Hill from 2008 to 2011 prior to joining the School of Pharmacy at the University of Connecticut.
Dr. Lu’s research interests include nanoparticle-based drug delivery for improving therapeutic indices of anti-cancer agents, image-guided drug delivery for optimizing cancer diagnosis and therapy, and neutron-activatable nanoparticles for radiation therapy, formulation development processing and characterization. Her research is supported by NIH, American Cancer Society, NSF, FDA etc. Dr. Lu has published more than 60 peer-reviewed publications in high impact journals. The innovative research has resulted in two issued US patents and 4 PCT patent applications. Dr. Lu also received American Association of University Professors-UConn Excellence in Research and Creativity: Early Career Award in 2016.
Fernando J. Muzzio, Ph.D.
Distinguished Professor Chemical and Biochemical Engineering, Rutgers University
Dr. Muzzio’s professional career has focused on developing and applying systematic engineering methodologies for the design and optimization of pharmaceutical products and processes. His work has included the study of many manufacturing methods, including liquid mixing, powder blending, granulation, tableting, and coating. In the last 15 years, his focus gradually shifted to continuous processes. He started a research consortium on this topic in 2002, and expanded it in 2006 when the NSF ERC on Structured Organic Particulate Systems was funded. As director of this large center, he had an opportunity to learn how to manage a large research enterprise across multiple institutions and supported by many companies. The ERC succeeded in demonstrating the advantages of continuous manufacturing, which in the last five years has become a priority at the FDA, BARDA, and the pharmaceutical industry. During this same period, the center initiated a major Advanced Manufacturing partnership with Janssen pharmaceuticals, leading to the development of a continuous process for the anti-HIV medication Prezista, which was the first conversion from batch to continuous approved by FDA in April 2016. More recently, they launched an Advanced Manufacturing partnership with GSK.
Overall, through his work in pharmaceutical manufacturing, Dr. Muzzio has authored over 300 publications, with half of those related to continuous processes. This work also enabled him to assemble a very strong team of colleagues, post docs, and students, and to develop a very strong infrastructure dedicated to materials characterization, process development, and product testing.
Manuel Osorio, Ph.D.
Senior Scientist for Emerging Technologies and Medical Countermeasures, FDA/CBER
Manuel Osorio is currently the lead for the Advanced Manufacturing Technologies portfolio in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration. Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review in CBER. He received a BS degree from UCLA in Biochemistry and PhD degree in cellular immunology from the University of California at Santa Cruz.
Anil Patri, Ph.D.
Director, Nanotechnology Core Facility, Office of Scientific Coordination, FDA
Dr. Anil Kumar Patri received his Bachelor of Science degree in chemistry and biology from Osmania University, India. He obtained his Master of Science in organic chemistry from Aligarh Muslim University, India. He then worked as a lecturer in chemistry before moving to the U.S. and earning his Ph.D. in chemistry from the University of South Florida.
Dr. Patri moved to the National Cancer Institute’s Nanotechnology Characterization Laboratory (NCL) in 2005. There he established the Physico-Chemical Characterization Facility and served as deputy director and principal scientist. In a decade-long tenure at NCL, he worked on clinical translation of promising cancer nanomedicines and also oversaw the preclinical assessment of over 85 projects with proof-of-principle efficacy for cancer with a multidisciplinary research team. He was a guest researcher at the National Institute of Standards and Technology (NIST) from 2006-2014 and co-led the development of the first “Nanosized Gold Reference Material Standards” with NIST colleagues.
Dr. Patri was recruited to direct the NCTR staff and research conducted by the NCTR/Office of Regulatory Affairs (ORA) Nanotechnology Core Facility (NanoCore) and was appointed Chair of the Nanotechnology Task Force in the FDA’s Office of the Commissioner. He serves on the National Nanotechnology Initiative’s (NNI) Nanoscale Science, Engineering, and Technology Subcommittee and the Nanotechnology Environmental and Health Implications (NEHI) Interagency Working Group of the NNI.
Gintaras V. (Rex) Reklaitis, Ph.D.
Courtesy Professor of Industrial and Physical Pharmacy Edward W. Comings Professor of Chemical Engineering, Purdue University
Reklaitis received his BS from Illinois Institute of Technology, his MS from Stanford University and a PhD from Stanford University.
Dr. Reklaitis specializes in the areas of process systems engineering, computer aided process operations, batch process design, and scheduling and analysis. His research involves the application of computing and systems technology to support the design and operation of processing systems. A long term goal is to create a framework for and demonstrate the feasibility of fully computer integrated chemical manufacturing. Areas of recent emphasis are investigation of approaches to support batch and semi-continuous operations as well as methodology for plant- and enterprise-wide planning and optimization.
Michael Repka, PhD
Chair of Pharmaceutics and Drug Delivery, Director of the Pii Center for Pharmaceutical Technology, Distinguished Professor of Pharmaceutics and Drug Delivery,University of Mississippi
Dr. Repka’s research interests include “trans” systems, including transmucosal, trans-nail and transdermal drug delivery systems. Many of these systems are directed toward the delivery of poorly soluble drugs via hot-melt extrusion techniques. Polymeric drug delivery design and stabilization of conventional and novel drug delivery systems for natural product compounds such as THC, is a continued focus of research.
Jason Rodriquez, Ph.D.
Laboratory Branch Chief, St. Louis, MO, US FDA
Jason Rodriguez is a Laboratory Chief for Branch I at the FDA Division of Pharmaceutical Analysis in St. Louis, MO. He joined FDA in 2009 and has a Ph.D. in Chemistry from the University of Illinois Urbana-Champaign. As a Laboratory Chief at DPA, he leads a team of analysts that works on pharmaceutical science and research projects including dissolution, chromatography, inhalation, transdermal and mass spectrometry.
Dr. Rodriguez also has extensive experience in rapid spectroscopic screening techniques using Raman and near infrared technologies. The work of his team has spanned the areas of improving raw material identification, counterfeit medicine detection and screening of stockpiled medical countermeasures.
Susan Rosencrance, Ph.D.
Director, OPQ’s Office of Lifecycle Drug Products (OLDP), FDA
Dr. Susan Rosencrance currently serves as Director for the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality (OPQ). In this capacity, she directs procedures and processes for evaluating and assessing drug product quality during the lifecycle of both brand name and generic drug products. Prior to joining the FDA, Susan worked at Merck in Rahway, New Jersey. She joined the Office of Generic Drugs (OGD) in 1991 and spent the majority of her tenure in CDER working on generic drug products. She held various roles within OGD including senior chemistry reviewer, team leader, deputy division director, and OGD Deputy Director for Chemistry.
Aliasger Salem, Ph.D.
Bighley Chair and Professor of Pharmaceutical Sciences and Head of the Division of Pharmaceutics and Translational Therapeutics, University of Iowa, College of Pharmacy
Dr. Salem received his BSc in Applied Chemistry from Aston University, U.K., and a PhD in Pharmaceutical Sciences from University of Nottingham, U.K. He completed his postdoctoral Fellowship (Medicine) at Johns Hopkins University.
His research interests are primarily focused on self-assembling systems, the rational design of novel drug and gene delivery systems and on the development of sophisticated scaffolds for tissue-specific regeneration. In tissue engineering, Dr. Salem’s laboratory applies microfabrication techniques to novel biomaterials to provide spatial control over tissue formation and to integrate minimally invasive scaffold delivery strategies. In drug/gene delivery, he is currently exploring the synergistic application of degradable particle technology, CpG oligonucleotides and heat shock proteins for generating sustained immunotherapeutic responses against cancer.
Anna Schwendeman, Ph.D.
Associate Professor of Pharmaceutical Sciences, University of Michigan
Schwendeman spent 12 years in pharmaceutical industry at Cerenis Therapeutics (Fierce 15 biotech), Pfizer, and Esperion Therapeutics. She was involved in discovery and translation of several HDL therapies to Phase II clinical trials. Her efforts led to development of a kilo-scale recombinant Apolipoprotein A-I process and highly homogeneous and safe HDL particles for the largest-to-date Phase II sHDL clinical trial (>500 patients). She successfully submitted FDA INDs for six different products including nanoparticles, liposome, proteins, peptides and small molecules. Schwendeman’s long-term research goal is to design highly potent and safe synthetic high-density lipoprotein (HDL) nanomedicines for treatment of atherosclerosis.
Michael Tarlov, Ph.D.
Chief, Biomolecular Measurement Division, NIST
Michael J. Tarlov is the Chief of the Biomolecular Measurement Division of the Material Measurement Laboratory at the National Institute of Standards and Technology in Gaithersburg, Maryland. The Division has over 100 staff members performs research in biological separations, mass spectrometry, mass spectral libraries, NMR, nucleic acid and protein structure determination, biological particle characterization, and the development of nucleic acid and protein reference materials. He also directs the NIST Biomanufacturing Program, an effort involving more than 30 scientists from 6 NIST Divisions, that is developing measurement science and standards to support the development, manufacturing, and regulatory approval of biologic medicines.
Katherine Tyner, Ph.D.
Associate Director for Science (acting), Office of Pharmaceutical Quality, CDER/FDA
Dr. Katherine Tyner is the Associate Director of Science in the Immediate Office of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). As Associate Director, Dr. Tyner leads the OPQ Science Staff in coordinating the intersection between science, review, and policy in OPQ as well as facilitating interactions between other CDER offices and FDA Centers. She received her PhD in Chemistry from Cornell University and joined the Food and Drug Administration in 2007 as a chemist specializing in nanotechnology. While at the FDA, Dr. Tyner has investigated the quality, safety, and efficacy of complex drug products including drug products containing nanomaterials, and she currently leads the CDER nanotechnology working group and is active in other CDER and FDA nanotechnology initiatives. Dr. Tyner is the author of multiple book chapters and journal articles concerning the appropriate characterization and biological impact of nanoparticle therapeutics and other complex products.
Zachary Warnken, Ph.D.
University of Texas at Austin
Zachary Warnken is a recent PhD graduate from the University of Texas at Austin College of Pharmacy Molecular Pharmaceutics and Drug Delivery Division where he is currently a research scholar. Zachary completed his PhD as part of a combined PharmD/PhD program, receiving his PharmD in 2014 and his PhD in 2018. Currently, Zach’s research involved nasal drug delivery, repurposing drugs for unmet medical needs, poorly water-soluble drugs and abuse-deterrent transdermal drug delivery. Zachary Warnken also served as AAPS PharmSciTech Social Media Editor for the journal to help improve the way we keep up with pertinent information in our field of study.
Senior Staff Fellow, Office of Testing and Research/Office of Pharmaceutical Quality, CDER
Dr. Xiaoming Xu is a principle investigator in the CDER/OPQ lab, leading multiple research areas such as complex ophthalmics, nanomaterial formulations, evaluation of abuse deterrent opioids. He also leads a particle characterization lab in OPQ and provides hands-on trainings to reviewers on various topics, including concept of particle size and measurement. Dr. Xu is a member of the CDER Nanotechnology Working Group and is co-leading the Nanotechnology Reviewer Network at CDER. Dr. Xu is also an editorial board member of the International Journal of Pharmaceutics.
Bruce Yu, Ph.D.
Professor of Pharmaceutical Sciences, University of Maryland
Dr. Yu received a B.S. in Biochemistry from Peking University and Ph.D. in Biophysics from Johns Hopkins University. His postdoctoral training was in NMR spectroscopy at SUNY Buffalo and peptide chemistry at the University of Alberta. Dr. Yu received the Kimmel Scholar Award for his work on imaging agent development in 2004 and the Presidential Early Career Awards for Scientists for Engineers for his work on biomaterials in 2005. He holds several issued patents for dendrimer synthesis, biomaterials engineering and noninvasive analytical technologies.