Integrating Protein Formulations with Parenteral and Alternative Administration Devices
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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.
Michael Gross, Ph.D., Owner and Principal Consultant, Chimera Consulting North America
Michael Gross, Ph.D., RAC is the President of Chimera Consulting North America LLC, a consultancy specializing in quality, regulatory affairs and technical development strategy for drugs, biologics, medical devices and in particular drug delivery systems and combination products. He is a former FDA reviewer and inspector. He has worked in the medical products industry for over thirty years in senior quality and regulatory affairs roles for pharmaceutical and medical device manufacturers. He plays an influential role providing an industrial perspective on the regulation of combination products.
Sesha Neervannan, Ph.D., Vice President, Pharmaceutical Development, Allergan, Inc.
Dr. Sesha Neervannan is currently Vice President of Pharmaceutical Development at Allergan. In his current role, he oversees the CMC activities related to developing the drug product from Discovery to Commercialization that includes material characterization, formulation, process engineering, device & packaging engineering, analytical development, and drug delivery research and development efforts. Prior to joining Allergan, Sesha held senior positions at Bristol-Myers Squibb and Amgen, in both a functional and team leadership role. Sesha has several research publications and patents and is a well recognized invited speaker at several national and international conferences. He serves on the Scientific Advisory Board for CHDI, as well as on the Editorial Advisory Board for the journal, Expert Opinion on Drug Delivery. He received his Ph.D. in Pharmaceutical Chemistry at the University of Kansas.
Edmond W. Israelski, Ph.D., Director, Human Factors, Combination Product Development, AbbVie
Ed Israelski is director of human factors at AbbVie, a biopharmaceutical company. He joined the company in 2001, where he leads a cross-company team to imbed best-practice human factors engineering HFE design methods into all of AbbVie’s products, to ensure safety and usability. He does this through hands-on design and evaluation of key new products, training internal resources, writing corporate policy and guidelines and facilitating the use of outside professional HFE resources.
Ed is past co-chair of the AAMI Human Factors Engineering committee, which develops HF standards for medical devices. He is also the convener for IEC and ISO Ergonomic groups in developing international HF medical devices standards. He is a certified human factors professional CHFP. He has authored fifteen book chapters and numerous articles in the area of human factors. Ed holds thirty patents. He is a fellow of the Human Factors and Ergonomics Society and a member of APA, UPA and previously the National Academy of Sciences Committee on Human-System Design Support for Changing Technology. He has served as a juror for the MDEA Medical Design Excellence Awards. He was selected by MDDI magazine as one of the 100 Notable People in the Medical Device industry in 2008. He is on the editorial board for the journal Human Factors and serves as a regular reviewer for several other scientific journals.
He has worked as a systems engineer, product manager, market researcher, industrial/organizational psychologist as well as a human factors engineer. He was technical manager of the human factors systems group at Lucent Technologies - Bell Labs, formerly AT&T. Later he was director of HF for SBC/Ameritech where his organization supported the design and evaluation of user interfaces for telecommunications products. In 2000, he became chief technology officer at Human Factors International, a user interface design and consulting firm in information technology. Ed is an adjunct instructor at Northwestern Univ and Virginia Tech and previously for New Jersey Institute of Technology. He received a B.S. in electrical engineering from NJIT, an M.S. in operations research from Columbia University and a Ph.D. in industrial and engineering psychology from Stevens Institute of Technology.
Brooks Boyd, Ph.D., Senior Director, Pharmaceutical Development, Zogenix, Inc.
Dr. Boyd is Sr. Director of Product Development at Zogenix. He is responsible for product development, including formulation, delivery system and non-clinical development. Dr. Boyd lead development of Sumavel® DosePro®, the first pre-filled, needle-free-injection drug product approved by the FDA, and is currently leading a number of product development programs at Zogenix. He is a Chemical Engineer by training, receiving his B.S. from UC Davis and Ph.D. UC Berkeley. Dr. Boyd has more than 15 publications, holds two issued patents, and has filed five other patent applications. He has been involved in pharmaceutical and delivery system research and development for over 20 years.
Amy M. Heintz, Ph.D., Senior Research Scientist, Battelle
Amy Heintz is a Senior Research Scientist at Battelle, the world’s largest independent research and development organization. She specializes in materials development, particularly in translating early stage research to products. She has assisted clients in North America, Asia, and Europe in markets including medical devices, drug delivery, and consumer products. She is leading an interdisciplinary team to develop formulation-device combinations to meet a rapidly expanding protein therapeutic market. Her research has led to development of several device prototypes that enable delivery of viscous or high volume therapies and that benefit from incorporating human factors. Her materials expertise has been applied to the study of structure-property relationships of protein formulations, concentrated protein solutions, and interaction of proteins with materials interfaces.
Samir Mitragotri, Ph.D., Professor, Chemical Engineering, Founding Director, Center for Bioengineering, University of California, Santa Barbara
Graham Reynolds, Vice President, Marketing and Innovation, West Pharmaceutical Services
Mr. Reynolds joined West in 1980 as a Polymer Technologist, and throughout his long career with West has held a range of positions with increasing responsibility. In his current role, Mr. Reynolds works within Delivery Systems organization, leading initiatives to market novel Delivery Systems and to develop strategies for future growth, including the acquisition and development of new technologies to enhance the West portfolio. His activities include work on key strategic areas involving injection devices, safety and administration systems, auto-injectors and prefillable syringes.
In 2005 Mr. Reynolds relocated to the US from Europe, where he was responsible for European Marketing, and led the integration of the acquired Medimop technologies into the organization. His experience within the core West business has been complemented by his past four years working in the field of devices and delivery systems. Mr. Reynolds holds a degree in Polymer Technology from Trowbridge College, UK.
David Cipolla, Ph.D., Senior Director, Pharmaceutical Sciences, Aradigm Corp.
David’s focus is the development of formulation and drug delivery technologies to support pharmaceutical product development. David leads the pharmaceutical sciences and intellectual property efforts at Aradigm Corp. (1996 to present), a specialty pharmaceutical company specializing in the development of inhalation treatments for severe respiratory disease. Aradigm’s lead product is an inhaled sustained release formulation of ciprofloxacin entering late-stage clinical development for bronchiectasis.
David is serving a second two-year term (2013-2015) as a Board Member for the International Society of Aerosols in Medicine (ISAM) and prior to that chaired the ISAM Regulatory Affairs Working Group (2009-2011). He also completed a two-year term (2006-2008) as Chair of IPAC-RS, an industry consortium. He is on the editorial board of the Journal of Aerosol Medicine and Pulmonary Drug Delivery (2008-present), the Inhalation Magazine (2008-present) and Pharmaceutical Patent Analyst (2012-present). He was one of the organizers for the 2009 ISAM conference in Monterey, CA.
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.
Diane J. Burgess, Ph.D., Board of Trustees Distinguished Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut
Dr. Burgess is Board of Trustees Distinguished Professor of Pharmaceutics, at the University of Connecticut. She has over 160 publications, over 420 research presentations at major scientific meetings, over 210 invited lectures, and has presented 15 keynote addresses. Her research efforts focus on gene and drug delivery: microspheres, emulsions, liposomes, hydrogels, as well as interfacial chemistry and implantable biosensors for glucose monitoring. Dr. Burgess was the 2010 President of the Controlled Release Society (CRS), the 2002 President of the American Association of Pharmaceutical Scientists (AAPS) and is an AAPS, CRS and an American Institute for Medical and Biological Engineering (AIBE) fellow. She is also an international fellow of the Association of Pharmaceutical Science and Technology Japan (APSTJ). Dr. Burgess is editor of the International Journal of Pharmaceutics and serves on the editorial boards of nine international journals. Among other prestigious awards, she is the 2011 recipient of the Nagai APSTJ International Woman Scientist Award. Dr. Burgess is an outstanding teacher and has twice been voted Teacher of the Year by her students. She designed and coordinates a summer Study Abroad Program for University of Connecticut pharmacy, premed and other science majors to go to China to learn about Traditional Chinese Medicine and immerse themselves in a different culture. Dr. Burgess has recently been appointed to the University of Connecticut Academic Vision Committee (a committee that will draft the next University of Connecticut academic plan 2014-2020).
Karthik Rajagopal, Ph.D., Scientist, Drug Delivery, Genentech, Inc.
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).
Brian Wilbur, Ph.D., Process Development Engineer, Biotherapeutics Pharmaceutical Research & Development, Pfizer, Inc.
William J. Lambert, Ph.D., Fellow, Drug Delivery and Device Development, MedImmune, Inc.
Dr. Lambert leads the Innovative Drug Delivery Group which identifies, evaluates and integrates leading edge device and drug delivery technologies with MedImmune molecules. Prior to MedImmune, he was Sr. VP of Pharmaceutical Development at Pacira Pharmaceuticals (formerly SkyePharma). He has held various positions in drug delivery and product development at Eisai Inc, Pfizer, and the Upjohn Company, and has contributed to the development and registration efforts of several marketed drugs.
Dr. Lambert received his B.S. in Pharmacy from the Univ. of Rhode Island followed by graduate studies in Pharmaceutics at the Univ. of Michigan and Utah. He is a member of the Advisory Boards of J. Pharm. Sci., NIPTE, Handbook of Pharmaceutical Excipients, USP Excipient Expert Committee, AFPE, and is past chair of the Pharm Tech Section of the AAPS.
John Zowtiak, Director, Device Development & Engineering, Johnson & Johnson
Michael D. Hooven, President and CEO, Enable Injections, LLC
Mike is the President and CEO of Enable Injections, LLC, a start-up company focusing on a unique technology for the injection of biologic drugs. He is the founder and a Director of AtriCure, Inc. (Nasdaq ATRC), the world leader in the surgical treatment of Atrial Fibrillation. Mike also holds Board positions at Minimally Invasive Devices, BioOhio and the Commercial Advisory Board at the University of Cincinnati. Mike was recently appointed by the Governor to the Third Frontier Advisory Board, a $2.3BB state funded initiative to accelerate high tech job creation in Ohio.
Mike has over 30 years of experience in the medical device industry in a broad variety of technical and clinical areas. He is the founder of five medical device companies and holds over 100 issued and pending US patents. Mike previously held positions as the Chairman and CEO of AtriCure, and the Founder and Chairman of Enable Medical, a surgical device manufacturer that was acquired in 2005. Mike was at Ethicon Endosurgery from 1988-2004, where he headed up all internal new product development. Mike held Engineering positions at Siemens/Pacesetter from 1986 to 1988, and at Cordis Corporation from 1981 to 1986. He earned a Bachelor of Science in Physics and a Master of Science in Mechanical Engineering from the University of Michigan.
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