International Conference and Expo on Parenterals & Injectables August 17-19, 2015 Chicago, USA

Maik W. Jornitz, President of G-CON Manufacturing Inc., is a distinguished industry leader with close to 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. He is a member of the PDA Science Advisory Board, Marketing Advisory Baord and Audit Committee, as well as an advisory board member of Artemes Technologies, Biotechnology Industry Council and multiple science trade journals. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland

Jornitz has published multiple books, book chapters and over 100 scientific papers.

Mahesh Chaubal is a Vice President at Product Quality at Baxter Healthcare

Product Quality

Carsten Worsøe has a background in analytical chemistry and graduated from University of Copenhagen in 1998. Since then he has been employed at Novo Nordisk as a principal scientist in an analytical R&D department at Novo Nordisk. During his 16 years at Novo Nordisk, his main responsibility has been to develop analytical methods for Leachables and Extractables (L&E) test procedures of new container closure systems and devices under development.

Leachables and Extractables (L&E) test procedures

Ms. Paskiet has over twenty years of experience in packaging analysis. She has served as a project advisor in support of qualification studies associated with drug containment systems for regulatory filings. Her current responsibilities include coordination of study plans for technical support of packaging components and R&D. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is serving a five year term on the United States Pharmacopeia (USP) Packaging, Storage and Distribution Expert Committee and a co-recipient of the USP award for Innovative Response to a Public Health Challenge. She is Chair of the PQRI Parenteral and Ophthalmic Drug Product (PODP) Leachables and Extractables Working Group and a faculty member of the PDA Training Institute. as well as author/co-author of papers on the subject of pharmaceutical packaging.

Packaging, Storage and Distribution

Dr. Timothy Lee has approximately 15 years of experience in biopharmaceutical science and manufacturing with a proven track record in management of multi-disciplinary teams in product development and transfer of processes to manufacturing and CMO. He has worked as a process development scientist performing upstream bacterial and mammalian media optimization, protein recovery and purification before moving into manufacturing operations. Dr. Lee was at Allergan serving as Director of Process Sciences leading a team of 20 people in biologics development. He is involved in developing process from early to late phase clinical manufacturing. Prior, Dr. Lee worked at Sanofi Pasteur, LTD where he served in a wide variety of roles including: Director, Industrial Performance; Deputy Director, Bulk Manufacturing; and Sr. Development Scientist, Bioprocessing R&D. Dr. Lee is currently an Adjunct Professor at Rutgers University in Bioprocessing and Quality Assurance, speaks annually at industry conferences and is well published in peer reviewed journals, biotechnology books and served as editorial board member of the journal bioprocessing & Biotechniques & Journal of Vaccines & Vaccination. He holds a Ph.D. in Biochemical Engineering.

Protein recovery and purification

Gulay Yelken Demirel has degree in Department of Chemistry from University of Gazi (Ankara, Turkey) followed by a master degree at Medicinal and Pharmaceutical Chemistry (faculty of pharmacy) from same university. She is also a Turkish Patent Attorney. She has nine years experience in R&D department of generic pharmaceutical companies. She worked as formulation scientist at the Pharmaceutical Technology Department of Nobel Pharmaceuticals. She gained experience in pre-formulation and formulation studies, new combination and techniques for formulation development studies, process validation, scale-up, bio-equivalance batches preparation, drug product dossier preparing with main focus on generic drugs. Presently, She owns the R&D Project Group Executive position at Sanovel Pharmaceuticals with development and validation of stability indicated analytical methods, stability tests, in-vitro studies of bio-equivalence batches, OTC and herbal drugs formulations, parenteral dosage forms, patent applications in addition to her skills mentioned before. She has also studied on parenteral projects for different market applications.She has several published papers in the academic areas and over 35 patents&patent applications in the industrial areas on pharmaceutical dosage forms.

Formulation development studies, process validation, scale-up, bio-equivalance batches preparation, drug product dossier preparing with main focus on generic drugs.

Li Shi is a CEO at Shanghai Zerun Biotechnology Co .,Ltd.

Biotechnology

Doctor Pharmacist, graduated in technological pharmacy, quality control and management. Currently Sterility Assurance Expert and formerly Head of Performance and Pharmaceutical Support in Merial, Toulouse, France. Provide a corporate support on sterility and aseptic processes to Merial sites. Used to work in or with the pharmaceutical industry for 15 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.

Published a number of papers in peer-reviewed journals relating to cleanroom activities or aseptic practices and also presented/moderated at various industry forums in Europe and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA...)

Xiaodong Feng is Vice President of Admissions at California Northstate University College of Pharmacy

Pharmaceutical Industry

Duc P. Do, Ph.D. is an associate professor of pharmaceutical sciences (pharmaceutics) at Chicago State University College of Pharmacy (CSU-COP). Prior to joining CSU-COP, he was an assistant professor of pharmaceutical sciences at Lake Erie College of Osteopathic Medicine (LECOM), School of Pharmacy. Dr. Do has received awards in recognition of his teaching, research and service.

Pharmaceutics

Esma S. Yolcu is a Associate Director at University of Louisville School of Medicine.

Pharmaceutical Industry

Nesrine M. Hegazi working at National Research Center

Pharmaceutical Industry