Stephen Levine currently serves as Group Leader, Scientific Affairs, where he leads a team of formulation scientists and technicians in all aspects of their day to day activities.  Stephen has worked in the pharmaceutical and chemical industries over the past 16 years in the areas of quality control, specialty coating applications, solid and liquid dose development, litigation support, clinical supplies manufacturing, new product development, process optimization, and consulting.  He works with technically challenging formulations, including poorly soluble compounds, novel dosage forms, experimentally designed scale up, technical transfer problem solving, and as a troubleshooting consultant working to facilitate excellence in manufacturing.  Stephen continues to lead development strategy of alternate polymer and new coating systems for taste masking, sustained release, and enteric applications. Stephen has extensive experience with CMC Project Management, designing and presenting technical training programs (internal and external), producing technical publications, and Business Development activities. Prior to his current position, Stephen served as a Formulation Scientist during which time he gained  experience in a wide array of pre-formulation, granulation, tabletting, extrusion/spheronization, encapsulation, multi-particulate and API coatings, chewables, ODT tablets, and controlled release (tablet matrix and coatings), with specific expertise in taste masking, organic solvent coating, latex and pseudo-latex systems, hard capsule and softgel coatings, drug layering, and sugar coating, and cGMP documentation and clinical supplies manufacturing. Stephen has been a speaker for the AAPS, Excipientfest, and Interphex. He has had numerous technical publications and posters released in North America and Europe. Stephen holds a Bachelor of Science degree in Applied Human Anatomy and Physiology from Boston University’s Sargent College of Allied Health Professions. He also has a Master of Divinity degree from Westminster Theological Seminary.

Aaron Barkley holds a Bachelor of Science degree in Biology from Waynesburg College, and has been actively involved in the pharmaceutical industry for 12 years playing critical roles in the function and growth of two product development laboratories. His latest responsibilities include business and strategy development for all aspects of Emerson Resources’ business. Aaron has been with Emerson Resources, Inc. since its inception in 2000. Prior to his employment with Emerson, Aaron was employed by Monsanto Pharmaceutical Ingredients, and was responsible for new product development and generation of intellectual property for patents related to novel solid dose delivery systems and value-added ingredients. With Emerson Resources, Aaron has held positions including Formulation Scientist, Senior Formulation Scientist, R&D Group Leader, Contract Services Manager, and Business and Strategy Development. He has been involved in all phases of solid dose development and is experienced with a wide variety of equipment and manufacturing techniques for the production of instant and controlled release dosage forms. His work has led to the development and marketing of several novel delivery systems in the pharmaceutical, nutraceutical and food industries. Aaron has worked in all phases of product development, technical transfer, scale-up and manufacturing, and has gained valuable experience with process optimization and introduction of new and existing production technologies and practices. Aaron was responsible for the design, construction and validation of an 8000 ft2 contract manufacturing facility as well as the implementation of business and operational systems to establish ongoing contract manufacturing.

Aaron is a member of The American Association of Pharmaceutical Scientists, New Jersey Pharmaceutical Alliance of Science and Technology and the Philadelphia Pharmaceutical Forum.

Alexa Smith is the Global Regulatory Services Manager for Colorcon. She has been with Colorcon since June of 1997. In her current role, Alexa is primarily responsible supporting customer’s regulatory needs related to their use of Colorcon products. Alexa is also active in IPEC’s Excipient Qualification Working Group and was the Chair of their sub-committee working on Standardized Supplier Questionnaire Development. Currently, she is Co-Chair of their Quality Agreement Template sub-committee. She was recently selected to participate in USP’s Compendial Process Improvement Project Team, representing IPEC. In 2005, she was appointed as President of the Philadelphia Chapter of the Regulatory Affairs Professional Society (RAPS). Alexa is also active in the Regulatory Affairs Committee of the Council for Responsible Nutrition. She further holds a position as Adjunct Assistant Professor at Temple University. Alexa holds a M.S. in Quality Assurance and Regulatory Affairs from Temple University, a B.S. in Animal Sciences from Virginia Polytechnic Institute and State University and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.

Dale Carter is the Global Director of Quality for the JM Huber Engineer Materials Silica Business Unit. He is responsible for product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, India, Finland, and China. He represents JM Huber as a member of the International Pharmaceutical Excipient Council of the Americas where he is currently Chair. Dale received an MS in Chemistry from North Carolina State University and a BS in Chemistry from Davidson College. He is an ASQ Certified Quality Auditor. Prior to joining JM Huber Dale worked for Pfizer, The Coca-Cola Company, and Archer Daniels Midland Company.

David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments. He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. His previous position at Colorcon was Director of Quality Assurance and Quality Control. He has been at Colorcon since 1977. Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT). Mr. Schoneker is the past Chairman of IPEC Americas (2007-2008) where he is actively involved with the development of Excipient GMP and Qualification related guidelines to improve Global Supply Chain Security. Mr. Schoneker is a frequent speaker at ExcipientFest.

Linda Herzog is Director, Technical Sales & Marketing for Pharmaceutical and Food Ingredients at Asahi Kasei America, Inc. She has worked in the excipients and pharmaceutical industry for 10 years, formerly as Sales Director and General Manager for an excipients distributor. Linda has been an enthusiastic supporter and advocate of excipient good manufacturing and distribution practices and was a member of the group who authored IPEC’s Excipient Pedigree Position Paper in 2007. She gives talks in the US and Europe on excipient supply chain integrity and security, especially as they relate to distributors and other non-manufacturing suppliers. Linda serves on the IPEC excipients Good Manufacturing Practices committee and the USP Expert Panel for General Chapter <1197> Good Distribution Practices for Bulk Pharmaceutical Excipients. She holds a BA in Chemistry from the College of the Holy Cross and an MBA in Marketing and Finance from the University of Connecticut.

Mr. David Klug – Senior Manager, Supplier Audit – sanofi-aventis: David Klug has been with sanofi-a ventis since 1995. In his current role, David is responsible for GMP compliance audits of suppliers of materials used in U.S. marketed products. He currently serves on the IPEC Americas' Executive Committee and as Chair for the Excipient Qualification committee, which is completing a revision to the IPEC Certificate of Analysis Guide. David has participated in development of numerous IPEC guides, including Qualification of Excipients for Use in Pharmaceuticals; 2008, IPEC Excipient Information Package (EIP): Template and User Guide, 2009 and The IPEC Quality Agreement Guide and Template, 2009. Formerly employed by Mallinckrodt, David holds an MS degree in Chemistry from the University of Missouri - Columbia. This is his first year speaking at ExcipientFest.

Pending.

David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments. He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. His previous position at Colorcon was Director of Quality Assurance and Quality Control. He has been at Colorcon since 1977. Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT). Mr. Schoneker is the past Chairman of IPEC Americas (2007-2008) where he is actively involved with the development of Excipient GMP and Qualification related guidelines to improve Global Supply Chain Security. Mr. Schoneker is a frequent speaker at ExcipientFest.

Ms. Sheehan is Director of Excipients in the Documentary Standards Division, United States Pharmacopeia, Rockville, MD. In her current role, she is responsible for development and update of excipient monographs and related chapters, and participates in the Pharmacopeial Discussion Group’s compendial harmonization of excipient monographs and excipient chapters. Ms. Sheehan is active in AAPS and RAPS. She was a member on the Product Quality Research Institute, Excipient Working Group from 2006-2007 and was co-author of the group’s two published articles that appeared in Pharmaceutical Technology , “PQRI survey of Pharmaceutical Excipient testing and Control strategies used by excipient manufacturers, excipient distributors and drug product manufacturers”, and “PQRI Joint Position Paper on Pharmaceutical Excipient testing and Control strategies”. Ms. Sheehan is a graduate of University College Cork, Ireland. She holds a B.Sc. Degree from University College Cork, Ireland. She holds an M.S. Bioscience Regulatory Affairs from Johns Hopkins University, USA. This is her third time speaking at ExcipientFest.

Irwin Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in quality assurance for API, medical device and drug products. He was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) where he spent 17 of his 22 years leading the Quality Unit responsible for excipients, API, and medical devices. He has worked for over 18 years with the International Pharmaceutical Excipients Council (IPEC) developing guidance documents for excipient GMP compliance. In addition to working as a consultant to the industry, he is the VP and Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc (IPEA). He began consulting as an expert consultant hired by pharmaceutical firms under FDA Consent Decree. Recent consulting includes pharmaceutical firms where he assesses conformance to site requirements and GMP gap assessments of excipient manufacturers. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed IPEA auditor training programs for hourly and supervisory personnel. He is establishing IPEA as an accredited organization to issue certification to excipient GMP in conformance with ANSI requirements.

Laura Scattergood is the Film Coating Manager of North America at Colorcon. In her 15 years with Colorcon, she has held positions in both the New Product Development Group as well as the Global Technical Support Group. In these roles, she has provided technical support for film-coating processes and solid oral dose formulation using immediate and modified release technologies supplied by Colorcon. In her career at Colorcon, Laura has focused on delayed and sustained release coating process applications in addition to immediate release coating applications. Laura has authored several posters exhibited at the American Association of Pharmaceutical Scientists national meetings. Laura received her Bachelors Degree in Biology and Environmental Science from Dickinson College.

Pending.