Speaker Biographies


Formulation Strategies for Improved Delivery of Biologics Conference 

Julia Rashba-Step, Ph.D., Senior Director, Novel Delivery Technologies, Pfizer, Inc. 

Julia is responsible for developing the strategy and managing the Novel Drug Delivery activities for Pfizer’s BioTherapeutics Pharmaceutical Sciences.  The position plays a major role in designing and supporting the BioTxDevelopment strategy and is a key driver for the life cycle management process for BioTx products.  In addition to developing the technologies for advanced delivery formulations, Julia also supports activities of novel device evaluation and development.

Prior to joining  Wyeth ( later acquired by Pfizer) organization, Julia worked at Epic Therapeutics, a wholly owned subsidiary of Baxter Healthcare Corporation as a Director of Research and Development and later as an Alliance Management Director.  In this role Julia was responsible for managing all technical and business aspects of collaborations with partners including out-licensing of proprietary PROMAXX technology.

Julia received her PhD in Biophysics from Russian Academy of Sciences, worked at Mount Sinai Hospital, NY and University of Southern California before transition in the industrial environment. Julia’s background is in formulation, delivery and process development of biologics. Julia’s expertise and interests are in multiple areas of advanced formulation and delivery such as sustained release, non invasive delivery, high concentration formulation, targeted delivery and innovative devices.

Julia is a member of multiple professional organizations including serving on the Advisory Board of Drug Delivery Partnerships, CRS Nominating Committee and mentoring group through HBA (Healthcare Business Woman Association).

Sujit K. Basu, Ph.D., Senior Director, Drug Product Development, Shire Human Genetic Therapies 

Sujit Basu joined Shire in 2012 and currently serves as Senior Director, Pharmaceutical Development. Dr. Basu has more than eighteen years of industry experience in pharmaceutical R&D, project management and cGMP manufacturing and is an inventor or author of more than 50 issued patents and patent applications and peer-reviewed publications. Before joining Shire, Dr. Basu was Vice President, Formulation at Dicerna Pharmaceuticals, responsible for nucleic acid formulation and delivery. Prior to that, Dr. Basu was Sr. Director, Formulation and project team leader at Altus Pharmaceuticals, responsible for developing drug products utilizing protein crystallization and formulation technologies and CMC team leader and staff scientist at Alkermes, responsible for developing inhalation and injectable drug products. Before coming to the USA he was a pharmaceutical manufacturing manager at Sarabhai Enterprises in Baroda, India, responsible for developing and commercial manufacturing of oral and injectable drug products.

Dr. Basu holds a B.S. in Pharmaceutical Technology and a M.S. in Pharmaceutical Engineering from Jadavpur University in Kolkata, India, a Ph.D. in Pharmaceutical Sciences from the University of Southern California, Los Angeles, and a Certificate in Management from Harvard University.

Nathan J. Alves, Ph.D., Post-Doctoral Research Fellow, Indiana University School of Medicine, Indiana

Nathan Alves is a Post-Doctoral Research Fellow at the Indiana University School of Medicine (IUSM) in the Emergency Medicine Department.  His current research interests are primarily in nanoparticle based pharmaceuticals for the clinical treatment of pulmonary embolism, blood clots in the lungs, in Dr. Jeffrey Kline’s lab.  Prior to joining IUSM in 2013, he received a PhD in Chemical and Biomolecular Engineering at the University of Notre Dame and MS and BS degrees in Biomedical Engineering from the University of Rochester in 2008 and 2007, respectively. The research he has conducted, while spanning many disciplines, is centered on the development of translational technologies, treatments and techniques that can be utilized to have a positive impact on people’s lives.  His graduate research was focused on how an underutilized, highly conserved binding domainlocated on the antibody variable fragment known as the nucleotide binding site (NBS) can be implemented to improve antibody purification, advance medical diagnostics, and to develop next generation antibody/nanoparticle based therapeutics.  Having major contributions to 4 patent pending antibody and nanoparticle based delivery technologieshe also received a 1st Tier Baxter Young Investigator award as an up-and-coming mind in science in 2013. 

Morten J. Maltesen, Ph.D., Project Manager, Biopharma Application Development, Novozymes Biopharma

Morten J. Maltesen joined Novozymes in 2010 as a Research Scientist. He earned his MSc in Engineering (specialized in Biotechnology) from the Technical University of Denmark combined with his PhD in Pharmaceutical Sciences from University of Copenhagen. In his current role as
Project manager, Dr. Maltesen works on slow-release formulations based on recombinant hyaluronic acid and on formulation and drug delivery of peptide based drugs. Before joining Novozymes Biopharma, Morten worked as a research scientist in early drug development.

Sabiruddin Mirza, Ph.D., Sr. Research Associate, School of Engineering & Applied Science, Harvard University

Sabiruddin Mirza is currently a Senior Research Fellow at the School of Engineering and Applied Sciences at Harvard University, Cambridge, MA, USA, and an Adjunct Professor at the University of Helsinki, Helsinki, Finland. Dr. Mirza received his M.S. degree in pharmaceutical chemistry from the Ukrainian Pharmaceutical Academy, Ukraine, in 1994 and began his professional career in the pharmaceutical industry as a production pharmacist. After several years in full-time industry, he escaped to academia and earned his Ph.D. degree in pharmaceutical technology from the University of Helsinki in 2007. His dissertation research has been awarded the 2008 American Association of Pharmaceutical Scientist’s Outstanding Graduate Research Award in Pharmaceutical Technologies. Dr. Mirza’s current research is focused on engineering of advanced nanosystems for drug delivery applications. In addition, his areas of expertise include pharmaceutical crystallization, cocrystallization and nanocrystallization, droplet-based microfluidics, and solid-state characterization, preformulation and formulation. Overall, his research has attracted around $550 000 in sustained funding from the Academy of Finland, private foundations, and industries. He is the author/coauthor of over 50 peer-reviewed articles and conference proceedings.

Tarun Mandal, Ph.D., McCaffrey/Norwood Endowed Professor of Pharmacy & Director, Center for Nanomedicine & Drug Delivery, College of Pharmacy, Xavier University of Louisiana  

Tarun K. Mandal, Ph.D. is an Endowed Professor at Xavier University College of Pharmacy. He is also Adjunct Professor at the UT at Memphis, UL at Monroe, and LSUHSC.  He is the founding Director of the Center for Nanomedicine and Drug Delivery and Co-Director of the Louisiana Vaccine Center. He is a member of the Scientific Advisory Board of Autoimmune Technologies. He has been elected as Fellow of the AAPS.His research focuses on the design and development of commercially viable formulations to improve the safety, efficacy, and patient compliance. Cutting-edge research in his laboratory has resulted in controlled release formulations of many therapeutic agents. He has published close to 200 original research papers, reviews, abstracts, and monographs and filed five patents. He received his B.S. degree in Pharmacy and M.S. and Ph.D. degree in Pharmaceutics/Industrial Pharmacy.

Russell G. Burge, Ph.D., Application Scientist, Freeslate, Inc. 
Russell Burge is an Application Scientist at Freeslate, Inc. He earned a Bachelor of Science degree in biochemistry from Arizona State University in Tempe. Russell obtained a Ph.D. in molecular biology and biochemistry from the Scripps Research Institute in La Jolla, California. After graduation, Russell received post-doctoral training at the University of Colorado in Boulder. During post-doctoral training, Russell worked on the biophysical characterization of RNA and DNA aptamers relevant to the biopharmaceutical industry. Russell’s industry experience includes working as a Scientist I at KBI Biopharma Inc., where he worked on more than a dozen biopharmaceutical development projects. 

Robert K. Prud’homme, Ph.D., Professor and Director Program in Engineering Biology, Department of Chemical & Biological Engineering, Princeton University 

Robert K. Prud'homme is a professor in the Department of Chemical and Biological Engineering at Princeton University and Director of the Engineering Biology Program. He received his BS at Stanford University and his PhD from the University of Wisconsin at Madison under Professor Bob Bird. He has served on the executive committees of the American Institute of Chemical Engineers Materials Science Division and the U.S. Society of Rheology and was the President of the U.S. Society of Rheology. He has served as the chair of the Technical Advisory Board for Material Science Research for Dow Chemical Company, which directs Dow’s materials research programs, and he was on the Board of Directors of Rheometric Scientific Inc., the leading manufacturer of rheological instrumentation. He also served on the Nanotechnology Scientific Advisory Committee for BASF, which provided guidance for future trends in nanotechnology for the company. His awards include the NSF Presidential Young Investigator Award, Princeton School of Engineering and Applied Science Outstanding Teaching Award, the Sydney Ross Lectureship at RPI, the Bird,Stewart and Lightfoot Lecturer at the University of Wisconsin, the Dinesh Shah lectureship at the University of Florida, and the Midland Macromolecular Institute Visiting Professor in Midland Michigan. He has been the organizer and Chair of the Gordon Conference on Ion Containing Polymers, and the Society of Petroleum Engineers Forum on Stimulation Fluid Rheology, in addition to organizing numerous sessions at AIChE, ACS, and SOR meetings. He directed the Princeton-University of Minnesota-Iowa State NSF NIRT Center on nanoparticle formation. His research interests include rheology and self-assembly of complex fluids. Systems of interest are biopolymer solutions and gels, surfactant mesophases, and polymer/surfactant mixtures. The goals of the studies are to understand how weak molecular-level interactions can be used to tune macroscopic bulk properties and phase behavior. Application of the work is directed at nanoparticle formation for the drug delivery, controlled release, targeting, and imaging.

Kevin Constable, Director, Technology Development, Global Pharmaceutical Solutions, Terumo Medical Corporation 

Ian W. Hunter, Ph.D., Hatsopoulos Professor, Department of Mechanical Engineering, Mechanical Engineering, MIT  

Ian W. Hunter is a Chaired Professor (Hatsopoulos Professor) in the Department of Mechanical Engineering at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts where he heads the BioInstrumentation Laboratory.  Ian was born in New Zealand and had an early interest in science and instrumentation which continues to the present.  By the age of 10 he had published his first paper (a design of a miniaturized single transistor radio) and by 14 had built a fully functional gas liquid chromatograph (hydrogen flame ionization type) for chemical analysis.  After graduating from Auckland University with BSc, MSc and PhD degrees he did a Post-Doctoral Fellowship in the Department of Biomedical Engineering at McGill University, Canada.  He then joined the McGill University faculty and advanced to tenured Associate Professor in the Department of Biomedical Engineering.  In 1994 Ian moved his lab to the Department of Mechanical Engineering at MIT.

His main area of research is in bio-instrumentation.  As a result of his research, Ian has over 350 refereed publications.  He also invents instruments and devices based on this research.  This has led to over 150 issued and pending patents.  Ian’s inventions have been used by numerous companies and in addition he has founded or co-founded 22 companies.  His most recent company, Portal Instruments, is commercializing a very novel, high performance Lorentz force actuated needle-free drug delivery technology invented by Ian and developed in his BioInstrumentation Lab at MIT over a 10 year period.

William J. Lambert, Ph.D., Fellow, Drug Delivery and Device Development, MedImmune, Inc. 

Dr. Lambert heads the Innovative Drug Delivery Group at MedImmune, the biologics division of AstraZeneca.  His group assesses novel formulation- and device-based approaches to deliver drug and vaccine candidates.  Prior to MedImmune, he held various positions at the Upjohn Company, Pfizer, Eisai, and finally Pacira Pharmaceuticals, where he was Sr. VP of Pharmaceutical Development.  He is a member of the Advisory Boards of J. Pharm. Sci., AFPE, NIPTE, the Handbook of Pharmaceutical Excipients, and the USP Excipient Expert Committee.

Cindy Wu, Ph.D., Principal Scientist, Pharmaceutical Sciences, Allergan, Inc. 

Dr.  Wu is a Principal Scientist in the pharmaceutical group at Allergan, working on the development of ophthalmic formulations.   She received her B.S. in engineering from Swarthmore College and a Ph.D. in chemical engineering from Northwestern University.    Prior to joining Allergan, she worked as a scientist at Amgen on the development of parenteral formulations and drug delivery systems. 

Ashim K. Mitra, Ph.D., University of Missouri Curators’ Professor of Pharmacy, Division of Pharmaceutical Sciences, School of Pharmacy, University of Missouri-Kansas City 

Ashim K. Mitra received his Ph.D. in Pharmaceutical Chemistry in 1983 from the University of Kansas. He joined the University of Missouri-Kansas City in 1994 as Chairman of Pharmaceutical Sciences. He is also Vice Provost for Interdisciplinary Research, UM Curators’ Professor of Pharmacy, Co-Director, Vision Research Center UMKC School of Medicine. He has over 30 years of experience in the field of ocular drug delivery and disposition. He authored and co-authored over 300 refereed articles, editor of 6 books, 60 book chapters in the area of formulation development and ocular drug delivery, awarded 9 patents, and presented (along with his research group) well over 500 presentations/abstracts at national and international scientific meetings. This work has attracted over six million dollars in funding from government agencies such as the National Institutes of Health (NIH), Department of Defense (DOD) and pharmaceutical companies. He served as Co-chair, of the USP Council of Experts, General Chapter <771> Ophthalmic Preparations Expert Panel U.S. Pharmacopeia. In 2007, he was named one of two recipients for the ARVO/Pfizer Ophthalmic Translational Research Award for excellence in the areas of research and fundamental scientific discoveries, including concepts and novel technologies, leading to clinical evidence of diagnosis, prevention, or amelioration of the pathological eye and/or an understanding of the normal vision processes. He is a recipient of a numbers of research awards from NIH, AAPS, AACP, and numerous pharmaceutical organizations. He has served as a regular member of the National Institute of Health (NIH) Pharmacology & Toxicology Study Section and on the NIH Gene and Drug Delivery Study Section. He also serves on numerous scientific editorial boards. Dr. Mitra’s laboratory has been engaged in ocular drug delivery for nearly 30 years. Current efforts are directed to: (1) delineate mechanisms of transscleral permeation of both small and large molecules, (2) develop new strategies to deliver neuroprotective and antiproliferative agents from topical eye drops, (3) to design new biopolymers for long-term topical and subconjunctival administrations and finally, (4) delineate the expression of various transporters and receptor on the cornea, blood-retinal and blood aqueous barrier and utilize these cell absorptive mechanisms to deliver small and large molecule therapeutics.

Rami ElHayek, Ph.D., Research Manager, Research and Development, Ocular Therapeutix, Inc.

 Dr. El-Hayek holds a BS in chemistry from the Lebanese University in Beirut, a MS in Chemistry from UMASS Boston then completed his doctoral studies in Chemistry/ Sustainable Material Design at the Center for Green Chemistry at the University of Massachusetts Boston/Lowell in 2008.

Dr.  El-Hayek joined the Biomaterials and BioSurgery Group at Genzyme in Cambridge MA as part of the R&D group where he collaborated with some of the most experienced and skilled scientists in the art of Biomaterials, Tissue Engineering and Biosurgical design. Many biomedical applications were explored from Non Fouling Coatings for Implantable Devices and Drug Delivery Systems to Development of Matrices for Cellular Tissue Engineering and Tough Hydrogels as Orthopedic Implants for Meniscal Repair.
Currently facing some new challenges in the field of Ophthalmology at Ocular Therapeutix, a privately held company focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology to address unmet or underserved needs in ophthalmology and ophthalmic surgery. The company’s first product, Re-Sure® Ocular Bandage, approved in January 2014, is a synthetic ocular bandage designed and indicated for ophthalmic surgery. Ocular Therapeutix is also developing sustained drug delivery vehicles for the therapy and treatment of ophthalmic diseases. Ocular Therapeutix's vision is to address unmet needs in ophthalmology and ophthalmic surgery by developing first-of-a-kind therapeutic products.
 

Robert Kelley, Ph.D., Senior Scientist, Drug Delivery, Genentech, Inc. 

Dr. Robert F. Kelley earned a Ph.D. in Biochemistry from University of Iowa, with thesis work on protein folding in the lab of Dr. Earle Stellwagen, followed by postdoctoral training at Yale University with Dr. Fred Richards. Since joining Genentech, Bob has worked on a wide range of protein and antibody engineering projects with an emphasis on biophysical characterization of protein stability and protein-protein interactions. He is currently a Senior Scientist in the Drug Delivery Dept. at Genentech focusing on delivery of antibodies to the eye for treatment of ocular disease.

 

New Technologies for Biologics Delivery and Targeting Conference 

Omid Farokhzad, M.D., Associate Professor, Laboratory of Nanomedicine and Biomaterials, Department of Anesthesiology, Brigham and Women’s Hospital and Harvard Medical School  

Omid Farokhzad is an Associate Professor at Harvard Medical School (HMS) and a physician-scientist in the Department of Anesthesiology at Brigham and Women’s Hospital (BWH). He completed his post-graduate clinical and post-doctoral research trainings, respectively, at the BWH/HMS and MIT in the laboratory of Institute Professor Robert Langer. He received his M.D. and M.A. from Boston University School of Medicine. Dr. Farokhzad directs the Laboratory of Nanomedicine and Biomaterials at BWH, which he established in 2004. He is a faculty member of the Brigham Research Institute Cancer Research Center at BWH. He is additionally a member of the Dana Farber/Harvard Cancer Center Programs in Prostate Cancer and Cancer Cell Biology. He is a Research Affiliate in the Harvard-MIT Division of Health Sciences and Technology (HST). Dr. Farokhzad has extensive experience with the development of therapeutic nanoparticle technologies; most notably, he pioneered the high throughput combinatorial development and screening of multifunctional nanoparticles for medical applications. Dr. Farokhzad has authored approximately 95 papers and holds more then 125 issued/pending US and International patents. The technologies that Dr. Farokhzad has developed with collaborators at HMS, DFCI, Cornell and MIT have formed the basis for: 1) a new class of targeted nanoparticles for treatment of important human diseases including cancer and cardiovascular disease; 2) a new class of synthetic nanoparticle vaccines for prophylactic and therapeutic applications and 3) a new class of integrative combination nanomedicines for synergistic treatment of cancers, inflammation/pain, and infectious diseases. Dr. Farokhzad has delivered more than 110 invited talks including 85 at national and international conferences; several of which were keynote addresses. He has served as an ad hoc reviewer for over 30 international peer-reviewed journals including serving on the editorial board or advisory board of six journals including Nanomedicine, Theranostics, Drug Delivery, and ChemPlusChem. Dr. Farokhzad was elected to the College of the Fellows of the American Institute of Medical and biological Engineering. He was among the Nano50 winners by NASA Nanotech Briefs, which awards the most innovative people and design ideas that will revolutionize nanotechnology, and was among the 15 recipients across all industries to receive the All Star Distinguished Achievement Award from the Mass High Tech Journal for his contributions to the Life Sciences industry. He was an Ernst & Young Entrepreneur of the Year awardee for the Northeast Region. The Boston Globe selected him among the top innovators in Massachusetts. 

Ashutosh Chilkoti, Ph.D., ThePilkington Professor of Biomedical Engineering, Director, Center for Biologically Inspired Materials and Materials Systems, Duke University  

Ashutosh Chilkoti received his B. Tech. in Chemical Engineering from the Indian Institute of Technology, Delhi in 1985, a Ph.D. in Chemical Engineering from the University of Washington in 1991, and was a post-doctoral fellow in the Department of Bioengineering at the University of Washington from 1992 to 1995. http://fds.duke.edu/db/pratt/BME/ashutosh.chilkoti He was appointed as an Asst. Prof. of Biomedical Engineering at Duke University in 1996, was promoted to Associate Professor in 2002 and to Professor in 2006. He currently holds the Theo Pilkington Chair in Biomedical Engineering and currently has appointments in three departments at Duke University: Biomedical Engineering, Mechanical Engineering and Materials Science, and Chemistry. Prof. Chilkoti was awarded the CAREER award from the NSF in 1998, the 3M non-tenured faculty award in 2002, and was awarded the Distinguished Research Award from the Pratt School of Engineering at Duke University in 2003 and in 2005. He was appointed Associate Director of the Center for Biologically Inspired Materials and Materials Systems at Duke University in 2002 and Director in 2007. His areas of research include Biomolecular Engineering with a focus on stimulus responsive biopolymers for protein purification and drug delivery, and Biointerface Science, with a focus on the development of advanced coatings for control of protein and cell adhesion for biosensors and biomaterials, bioinspired nanofabrication and plasmonic biosensors. http://www.chilkotilab.pratt.duke.edu/ He has co-authored over 175 publications, has been cited over 5600 times, has an H-index of 44, and has 25 patents awarded or in process. He is co-founder of a start-up company (Phase Biopharmaceuticals Inc.) that has raised over $35 million in venture capital funding, and he serves on the Scientific Advisory Board of another company, Asemblon. He serves on the Editorial Board of three journals: Journal of Biomedical Materials Research, Protein Engineering, Design and Selection, and Biointerphases and is a reviewer for over 20 journals.

Donald Cropek, Ph.D., Scientist, Construction Engineering Research Laboratory, Engineering Research and Development Center, U.S. Army Corps of Engineers 

Dr. Donald Cropek is the Director of the Environmental Chemistry Laboratory at the U.S. Army Corps of Engineers, ERDC-CERL, in Champaign, IL.  He has also initiated the Synthetic Biology Laboratory at CERL that takes advantage of his group’s expertise in microbiology, molecular and cell biology, and analytical chemistry.  He received his Ph.D. in Analytical Chemistry from the University of Illinois, Urbana-Champaign (UIUC).  Dr. Cropek is also affiliated with the Chemistry and Veterinarian Biosciences Departments at UIUC as well as with the Illinois Natural History Survey.  His experience began primarily to address short-term environmental and compliance issues at military installations, but has steadily moved to a focus on basic and applied research in biosensing.  His group comprises molecular and cell biologists, tissue engineers, microbiologists, polymer and analytical chemists, and civil engineers that study integrated microfluidic systems, tissue engineering, novel environmental sensor design, innovative selective molecular beacons, and advanced oxidative treatment methods for contaminants. 

Mansoor M. Amiji, Ph.D., Distinguished Professor and Chairman, Dept. of Pharmaceutical Sciences, School of Pharmacy, Northeastern University 

Dr. Amiji is currently the Distinguished Professor and Chairman of the Department of Pharmaceutical Sciences and Co-Director of Northeastern University Nanomedicine Education and Research Consortium (NERC) at Northeastern University in Boston, MA.  NERC oversees a doctoral training grant in Nanomedicine Science and Technology that was co-funded by the National Institutes of Health (NIH) and the National Science Foundation (NSF). Dr. Amiji received the BS degree in Pharmacy from Northeastern University in 1988 and a PhD in Pharmaceutical Sciences from Purdue University in 1992. 

His research is focused on development of biocompatible materials from natural and synthetic polymers, target-specific drug and gene delivery systems for cancer and infectious diseases, and nanotechnology applications for medical diagnosis, imaging, and therapy. His research has received over $15 million in sustained funding from the NIH, NSF, private foundations, and corporations.

Dr. Amiji teaches in the professional pharmacy program and in the graduate programs of Pharmaceutical Science, Biotechnology, and Nanomedicine. He has published four books and over 200 book chapters, peer-reviewed articles, and conference proceedings. He has received a number of awards including the NSTI Award for Outstanding Contributions towards the Advancement of Nanotechnology, Microtechnology, and Biotechnology in 2006 and the AAPS Fellowship and the AAPS Meritorious Manuscript Award in 2007.

Ramin Darvari, Ph.D., Principal Research Scientist II, Novel Delivery Technologies, Pfizer, Inc. 

Marian Gindy, Ph.D., Director, Pharmaceutical Sciences, Merck Research Laboratories 

Marian earned her BS in Chemical Engineering from Rutgers University and PhD in Chemical and Biological Engineering from Princeton University.  She joined Merck in 2000 working in Chemical Engineering R&D where she was responsible for supporting the development and optimization of synthetic processes for the manufacturing of active pharmaceutical ingredients.  During her tenure, she was a key contributor and leader of multiple small molecule discovery and development programs.  She is currently a Director of Pharmaceutical Sciences, where she leads the formulation design and manufacturing process development of siRNA delivery vehicles to enable lead ID, optimization and early phase clinical development of siRNA therapeutics.

Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corp. 

Andrea Leone-Bay holds a Ph.D. in Organic Chemistry and has worked in the pharmaceutical industry for over 25 years. She has published 47 manuscripts in peer-reviewed journals and is an inventor on 87 issued U.S. patents. Her primary areas of expertise include chemistry and formulations research and development for oral and inhaled drug delivery.  In particular, Andrea is interested the development of formulation/device combination products for the oral inhalation delivery of peptides, proteins and small molecule drugs for diabetes, osteoporosis, asthma and COPD.  Andrea is currently Vice President of Pharmaceutical Research & Development at MannKind Corporation, where she and her staff are focused on the development of pulmonary drug delivery technologies.

Ajay K. Banga, Ph.D., Professor and Department Chair, Pharmaceutical Sciences, Endowed Chair in Transdermal Delivery Systems, College of Pharmacy, Mercer University 

Dr. Ajay K. Banga has a Ph.D. in pharmaceutical sciences from Rutgers University in NJ and currently is Professor and Chair in the Department of Pharmaceutical Sciences at the College of Pharmacy, Mercer University, Atlanta, GA. He also holds an Endowed Chair in transdermal delivery systems.  His transdermal delivery laboratory has been funded by several companies to explore non-traditional approaches for topical/transdermal drug delivery and he has over 275 publications and scientific abstracts in this area of research. Dr. Banga currently serves on the Editorial Board of 10 journals, as Associate Editor for one journal, and has served as the Editor-in-Chief for a drug delivery journal.  He has written three books in the areas of delivery of proteins and transdermal delivery. He is a Fellow of the American Association of Pharmaceutical Scientists.

Hayat Onyuksel, Ph.D., Professor of Pharmaceutics and Bioengineering, Department of Biopharmaceutical Sciences, College of Pharmacy, University of Illinois  

Dr. Hayat Onyuksel is currently Professor of Pharmaceutics and Bioengineering at the University of Illinois at Chicago (UIC), Department of Biopharmaceutical Sciences, College of Pharmacy. Her research interest is in the area of targeted drug delivery. She uses lipid-based nano carriers to develop nanomedicines with improved drug solubility, stability and safety. Applying her innovative targeted approach she has prepared several peptide nanomedicines and showed on animal models successful treatments of cancer and inflammatory diseases. Dr. Onyuksel has published more than 300 publications including scientific journal papers, conference proceedings, abstracts, and 9 issued patents.

She has received several prestigious awards including New Investigator Award from American Association of Colleges of Pharmacy, the UIC Inventor of the Year Award, the UIC Woman of the Year Award, UIC Graduate Mentoring Award, UIC University Scholar, and AAPS Lipid Based Drug Delivery Outstanding Researcher Award . She is a UIC University Scholar and AAPS fellow. Dr. Onyuksel has been serving in several NIH grant review panels more than two decades, she was a regular member of newly formed NIH Nano study session during 2009-2011. She was an associate editor of the Journal Nanomedicine: Nanotechnology, Biology, and Medicine between 2011-2013. She is currently on the Editorial Board of nine scientific journals related to nanotechnology and pharmaceutical sciences.

Maya Salnikova, Ph.D., Senior Scientist, Lead for Process and Product Development, Novartis Vaccines & Diagnostics, Inc.

Maya Salnikova Ph. D., is an expert in the product and process development, including novel drug delivery approaches for biologics, biosimilars and vaccine. Currently, she leads technical teams on Process and Product Development for novel vaccines at Novartis Vaccines and Diagnostics.  In past, Dr. Maya led formulation and drug product development of biologics, biosimilars and vaccines at Merck for 5 years.  At Macromolecule and Vaccine Stabilization Center (at University of Kansas) she contributed to biophysical characterization and development of Clostridium difficile vaccine as well as design for lyophilization platforms for growth hormone.  Having earned her Ph.D. in pharmaceutical science from University of Kansas, Dr. Salnikova has authored several patents, peer-reviewed scientific publications, review articles and book chapters. She has presented at several international conferences and chaired scientific workshops.

Reinhard Gabathuler, Ph.D., Chief Scientist, biOasis Technologies Inc. 

Dr Gabathuler obtained his PhD in Plant Biochemistry at the Université de Lausanne, Switzerland, in 1982. He completed postdoctoral studies at the University of Washington, Seattle, WA, USA. He became a research fellow at the Swiss Institute for Cancer Research (ISREC) in Lausanne and at the Ludwig Institute for Cancer Research at the Karolinska Institutet in Stockholm. In 1991, he joined the Biotechnology Laboratory of the University of British Columbia in Vancouver, Canada.

His research on new vector for delivery of therapeutics to the brain led to the creation of Synapse Technologies Inc., where he began as Director of Blood Brain Barrier Research, ultimately rising to the position of Vice President of Research. BioMarin Pharmaceutical Inc. later acquired the company, where Dr Gabathuler assumed the position of Vice President, Brain Research.

Dr Gabathuler joined AngioChem Inc. in 2004 as Chief Scientific Officer and is now the Chief Scientist of biOasis Technologies Inc. for the development of new peptide vector, Transcend, for the brain delivery of biologics. 

Scott Banta, Ph.D., Associate Professor, Department of Chemical Engineering, Columbia University 

Dr. Banta is Associate Professor of Chemical Engineering and director of the Protein and Metabolic Engineering Laboratory at Columbia University. His research thrusts are aimed at the engineering of novel proteins and peptides for a variety of important applications, including drug delivery, energy production, biosensing, bionanotechnology, and bioseparations.

Pankaj Karande, Ph.D., Assistant Professor, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute 

Prof. Karande joined the Chemical and Biological Engineering Department at Rensselaer in 2008. Before joining Rensselaer, Prof. Karande was a Postdoctoral Fellow in the Chemical Engineering Department and Center for Cancer Research at Massachusetts Institute of Technology. His postdoctoral research focused on targeted drug delivery to tumors using serum proteins such as albumin as drug carriers.  He obtained his Ph.D. from UC Santa Barbara in 2006 where his thesis work focused on the use of chemical enhancers for transdermal drug delivery. Prof. Karande has received several awards for his work including The Edison Award for best Product in Science and Medicine (2009), The Anna Fuller Fellowship in Molecular Oncology (2006-2007), Outstanding Pharmaceutical Paper by the Controlled Release Society (2005) and the Goldhirsh Brain Tumor Foundation Research Award (2010). Prof. Karande is an inventor on several patents in the area of Transdermal Formulation Discovery, Novel High Throughput Screening Platforms, and Drug Delivery Systems. He has also served as a scientific advisor to fqubed Inc., a soft materials innovation company (now part of Nuvo research).

Per-Ola Freskgard, Ph.D., Senior Leader and Vice Director, Neuroscience, Roche  

Per-Ola Freskgard is currently a Senior Leader in Neuroscience, Pharma Research and Early Development (pRED) ROCHE. He has a Ph.D. in Biochemistry and a post-doctoral visiting associate at California Institute of Technology, Chemical Engineering. 20 years of experience in big pharma and small biotech companies.He has authored or co-authored more than 60 peer reviewed international journals and patent applications in the fields of protein engineering, DNA encoding of small molecules, thrombosis and haemostasisand neuroscience.

 

SHORT COURSES

Pankaj Karande, Ph.D., Assistant Professor, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute 

Prof. Karande joined the Chemical and Biological Engineering Department at Rensselaer in 2008. Before joining Rensselaer, Prof. Karande was a Postdoctoral Fellow in the Chemical Engineering Department and Center for Cancer Research at Massachusetts Institute of Technology. His postdoctoral research focused on targeted drug delivery to tumors using serum proteins such as albumin as drug carriers.  He obtained his Ph.D. from UC Santa Barbara in 2006 where his thesis work focused on the use of chemical enhancers for transdermal drug delivery. Prof. Karande has received several awards for his work including The Edison Award for best Product in Science and Medicine (2009), The Anna Fuller Fellowship in Molecular Oncology (2006-2007), Outstanding Pharmaceutical Paper by the Controlled Release Society (2005) and the Goldhirsh Brain Tumor Foundation Research Award (2010). Prof. Karande is an inventor on several patents in the area of Transdermal Formulation Discovery, Novel High Throughput Screening Platforms, and Drug Delivery Systems. He has also served as a scientific advisor to fqubed Inc., a soft materials innovation company (now part of Nuvo research).

Christopher A. Rhodes, Ph.D., President, Christopher A. Rhodes & Associates LLC 

Dr. Rhodes is a pharmaceutical technologist with experience in combination product development including formulations and devices for pulmonary inhalation aerosol, nasal spray, transdermal patch, sustained release injection, and oral delivery systems for biopharmaceutical products and small molecules. 

Dr. Rhodes has been responsible for product development including drug delivery R&D, formulation and process development, clinical supply and manufacturing, analytical and bioanalytical chemistry in companies including SKS Ocular, Amylin Pharmaceuticals, Guilford Pharmaceuticals, and Mannkind Pharmaceuticals.Currently, Dr. Rhodes is President and Founder of a consulting practice providing interim management, R&D support, portfolio strategy, and due diligence to biopharmaceutical, drug delivery, device, and specialty pharmaceutical companies in combination product development and integration with commercial strategy and life cycle plans.

Dr. Rhodes earned his Doctorate degree in physical organic chemistry from UCLA and completed his training with a Post Doctoral position at Yale University.  He has a Bachelors degree in chemistry from New York University.

Frank Tagliaferri, Ph.D., Vice President, R&D, 4P Therapeutics  

Frank Tagliaferri is currently Vice President of Research & Development at 4P Therapeutics in Norcross, GA working on the development and commercialization of novel drug delivery products.  He received his Bachelor’s degree from Franklin&MarshallCollege in 1987 and his Ph.D. in Chemistry from Universityof Virginia in 1992. He was a post-doctoral fellow at University of Tennessee, Knoxville from 1992-1995.  As Director of Drug Delivery at GeneMedicine (later Valentis) from 1995-2001 his focus was on the development of delivery systems for both DNA and proteins. He later served as Director of Delivery and Preclinical Development at Napro Pharmaceuticals (later Tapestry) from 2001-2003 where he worked on a variety of cell and oligonucleotide therapeutics.  He was at Altea Therapeutics in Atlanta, GA from 2003 to 2011 where he most recently served as Vice President of R&D. While at Altea he helped to develop the PassPort® System for the transdermal delivery of small molecules and biologics.  His research interests include the design, characterization, and development of novel delivery systems and drug/device combination products for biologics and other complex molecules. 

Christopher M. Olsen, Ph.D., Senior Scientist, CMC Analytical Chemistry, Alcon Laboratories, Inc., a Division of Novartis 

Dr. Christopher Olsen is a Senior Scientist in the CMC Analytical Chemistry group at Alcon Labs (a Novartis company), completed his undergraduate studies in physics and chemistry from the University of Nebraska-Omaha (B.S. in Chemistry, 2000), and received his Ph.D. in Pharmaceutical Sciences from the University of Nebraska Medical Center in 2008 with a focus on the biophysical characterization of unique nucleic acid structures.  Dr. Olsen completed his postdoctoral fellowship in 2010 studying the formulation and bio physical characterization of biopharmaceuticals at the Macromolecule and Vaccine Stabilization Center at the University of Kansas.  He continued as a permanent staff member and research associate of the Center until 2012, and in early 2012 moved to Alcon to join the biologics group where he continues to work as an analytical chemist in the biologics division and as a CMC Team lead for a biopharmaceutical product.

Dr. Olsen’s experiences include the formulation and biophysical characterization of over 15 biopharmaceuticals ranging from small peptides to mAbs at both low and high concentration, vaccines, live attenuated viruses, G-quadruplexes, and siRNAs for an assortment of small and large pharmaceutical companies.  He has also worked with the development, design and testing of new temperature dependent, automated and high throughput instrumentation for a variety of techniques including Calorimetry, Spectroscopy, and Fluorometry.  His work at Alcon involves the development, performance and validation of bio-analytical assays in a GMP environment; supports exploratory, toxicology, and clinical stability studies; writes and reviews briefing documents, IND and CTA Amendments; works closely with CROs and CMOs for Phase III commercial drug supply; is an active member of 5-6 CMC sub teams within Alcon and is the CMC Team lead for one of the active biopharmaceutical projects.

Nicholas J. Darton, Ph.D., Platform Manager, Arecor Ltd.

Nicholas Darton is responsible for managing and developing new formulation technologies. He has a strong background in the research and development of novel platform technologies in industry and academia. He is currently responsible for R&D activities in new platform development areas and technical IP support in the field of stabilisation of biologics with a key focus on rheology. He had developed a new chromatography platform based on extruded plastic microcapillary films for single-step antibody purification, as a Research Associate at the Department of Chemical Engineering and Biotechnology, University of Cambridge. He has tested this new chromatography platform in close collaboration with Medimmune, Cobra Biologics, Paraytec and Lonza, gaining three BBRSC-BRIC prizes 2010-2012. Dr. Darton is also an Inventor of a new drug-delivery platform using magnetic nanoparticles to deliver linked therapeutics by MRI in 2008 as a Research Associate, Department of Chemical Engineering, University of Cambridge. He was awarded a Ph.D. in Biochemistry at the University of Cambridge in 2003 for Wellcome Trust Prize funded research into a peptide-loop phage display vaccine platform technology. He is a member of the Royal Society of Chemistry/Society of Chemical Industry’s Joint Colloids Committee and an Associate Member of Institute of Chemical Engineers.

 


 


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