Industry Experts Will Focus on Educational Sessions for May 1-3 Event
The organizers of INTERPHEX have announced the selection of the event's 2012 Advisory Board, the volunteer panel of industry experts whose insights play a strong role in determining the event's conference programs and direction. INTERPHEX 2012 will be held May 1-3 at the Javits Convention Center in New York City.
The 2012 Board members' combined experience represents the spectrum of pharmaceutical and biopharmaceutical manufacturing, and will be instrumental in developing the 2012 INTERPHEX Conference Program. They will be joined this year by Russ Somma, Ph.D., President of SommaTech and a long-time pharmaceutical industry expert, who is consulting with INTERPHEX on restructuring the conference programming. Dr. Somma has also joined the volunteer board.
The 2012 Advisory Board members are:
Dilip Ashtekar, Ph.D., Senior Director, Quality Control, Gilead Sciences. Dr. Ashtekar has 28 years of combined experience in R&D, Quality Assurance, sterility assurance, aseptic manufacturing, risk assessment, and Contamination Control in biotechnology, pharmaceutical, and vaccine industries. He has held positions at Amgen Inc., Medimmune, Watson-Schein Pharmaceutical, Jensia-Sicor Inc, Advance Tissue Science and Ciba-Geigy, and is the author of several patents and anti-infective related publications. He also serves on several Parenteral Drug Association (PDA) Task Forces.
E. Morrey Atkinson, Ph.D., Chief Scientific Officer, Vice President of Research and Development, Vice President of Drug Substance Manufacturing, Cook Pharmica. Dr. Atkinson's experience includes publications and patents on biologics process development, focusing on upstream, downstream, viral safety, analytical, and Quality by Design (QbD). He has also worked with Eli Lilly, Geron and Targeted Genetics.
E.J. Brandreth, Vice President, Quality and Regulatory Affairs, Althea Technologies. Mr. Brandreth brings more than 25 years experience in the biotechnology and pharmaceutical industries. Prior to Althea he has worked with Favrille, BioMarin Pharmaceuticals and IDEC Pharmaceuticals. He has authored PDA Technical Reports and chairs the PDA Biotech Advisory Board.
John, Gilroy, P.E., Senior Vice President and Principal, Integrated Project Services (IPS). Mr. Gilroy brings more than 25 years of diverse Engineering, Procurement, and Construction Management (EPCM) experience providing project management and mechanical services to the pharmaceutical, semi-conductor, petrochemical, and commercial sectors. His experience includes design engineering from concept through implementation and overall project execution.
Michelle M. Gonzalez, P.E., BioPharm Engineering Consultant. Ms. Gonzales has extensive experience in facilities engineering, process systems design and construction project management, holding technical positions in mechanical and process engineering with Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, Amgen and others. She has helped develop a number of ISPE baseline and good practice guides, the ISPE Glossary of Applied Terminology for the Pharmaceutical Industry.
Timothy P. Howard, C.P.I.P., P.E. Vice President and Company Officer, Commissioning Agents. Mr. Howard is responsible for the Commissioning and Validation services business unit, including internal quality system maintenance and implementation, hiring, training, professional development and oversight of all major projects. He also serves as a Director on the ISPE international board of directors.
M.J. Kimmel, Principal, MJK Solutions. Mr. Kimmel has more than 30 years experience in pharmaceutical engineering and facility operation and maintenance. Prior to joining the engineering consulting firm he held positions with Cephalon, Wyeth Pharmaceuticals and ICI Americas (now Astra Zeneca). He is a member of the ISPE Body of Knowledge Task Team, the Facility of the Year Committee, and the East Coast Resource Committee.
Albert Manigo-Bey, Jr., Senior Strategic Sourcing Manager, Watson Pharmaceuticals. Mr. Manigo-Bey has more than 13 years' experience in procuring process manufacturing and facility equipment, sourcing both engineering and construction services. He has also worked with Genzyme and Amgen.
Sanjay Patel, Senior Director, Global Materials Management, Shire Pharmaceuticals. Mr. Patel leads planning, external manufacturing, and distribution teams of virtual supply in specialty pharmaceuticals. He has more than 20 years' experience in a number of roles, including facilities, manufacturing support, procurement and planning.
Richard Poska, R.Ph., Director, Regulatory Affairs, Abbott Pharmaceutical Products Group. Mr. Poska has 20 years of technical experience, including solid dosage form research, production troubleshooting, process improvement and support, harmonization of excipients and processing, and statistics application for manufacturing controls. He has also worked with Searle Laboratories and The Upjohn Company, and chaired the Scale-Up and Post-Approval Changes (SUPAC) Equipment Equivalents Steering Committee for ISPE, which won the National Performance Review Hammer Award.
Jaspreet Singh Sidhu, Ph. D., Vice President Business Development and Pharmaceutical Biology, Molecular Epidemiology, Inc. Dr. Sidhu joined Molecular Epidemiology in 2004, following positions as Principal Scientist and Laboratory Research Director, Senior Research Scientist, and Visiting Scientist at the University of Washington. He is a member of the PDA and a former member of ISPE and RAPS.
Scott Rudge, Ph.D. Chief Operating Officer, RMC Pharmaceutical Solutions. Dr. Rudge is a founder, COO, Chairman and Principal Consultant with RMC Pharmaceutical Solutions, a privately held consultancy in manufacturing and quality in the pharmaceutical, biotechnology, medical device and nutraceutical industries. He also serves as Senior Vice President of Product Development for Bradmer Pharmaceuticals, which develops targeted radiolabeled antibodies to treat glioblastoma multiforme. He was previously with FeRx Inc., Amylin, Synergen, and the National Institute of Standards and Technology.
Russ S. Somma, Ph.D., President, SommaTech LLC. Dr. Somma has more than 30 years of experience in pharmaceutical production, dosage form development, manufacturing scale up, technology transfer and project management. He previously worked at Novartis and as an investigator trainer and liaison for the FDA. He is considered an expert in technology transfer and QbD, and authored SUPAC equipment guidelines for the FDA and Certified Pharmaceutical Industry Professional (CPIP) guidelines for ISPE. The FDA has honored him for his SUPAC-related work, and he has received ISPE's Max Seales Yonker award and the Hammer Award from the National Partnership for Reinventing Government.
Robert J. Timko, R.P.H., Ph. D., Director, Chemistry, Manufacturing and Controls (CMC) Group, Global Regulatory Affairs, AstraZeneca LP. Dr. Timko has more than 30 years of pharmaceutical industry experience in product development, manufacturing and regulatory affairs. He is a member of a number of professional organizations, holds several formulation patents, has written journal articles and made presentations on formulation and process development and optimization, equipment instrumentation and regulatory affairs.
Chad Wachter, Senior Manager, BTG. Mr. Wachter has more than 19 years experience in nearly all dosage forms, including engineering, construction, commissioning and qualification, industrial operations (commercialization), design, GMP, quality assurance and validation.
Michael A. Zupon, Ph.D., Vice President, Pharmaceutical and Manufacturing Technology, MannKind Corporation. Dr. Zupon's pharmaceutical development experience encompasses both organic small molecule and biotechnology products, and a diverse array of pharmaceutical dosage forms, such as semi-solids, liquids, parenterals, controlled release products, aerosols and dry powder inhalers.About INTERPHEX
INTERPHEX is produced by Reed Exhibitions, which manages more than 460 trade events annually worldwide and is a member of the Reed Elsevier Group plc, a world-leading provider of information-driven services and solutions. For more information, visit www.INTERPHEX.com