INTERPHEX would like to thank the 2012 Advisory Board Members; a volunteer panel of industry experts whose combined experience represents the spectrum of pharmaceutical and biopharmaceutical manufacturing. Their valuable insights have played a strong role in determining the event's conference program and direction.
Dilip Ashtekar, Ph.D.
Sr. Director Quality Control, Gilead Sciences, Inc.
Track Advisor: Product Development
Dr. Ashtekar is currently responsible for Quality Control, Microbiology and Quality Control Chemistry at Gilead Sciences, Inc. at San Dimas, CA. He also currently serves on the USP Committee of Experts in Microbiology.
He 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 several positions with increasing responsibilities at Amgen Inc., Medimmune, Watson-Schein Pharmaceutical, Jensia-Sicor Inc, Advance Tissue Science and Ciba-Geigy. In addition, he has over 20 years of experience in microbial, mycoplasma and viral contamination control. Dr. Ashtekar has a strong background in regulatory compliance and extensive experience in remediation of regulatory compliance actions, such as Consent Decree and Warning Letters.
Dr. Ashtekar has also authored several patents; book chapters on microbiology related topics and is a key member of several PDA Task Forces (TR13 - Environmental Monitoring, Chairman of Mycoplasma Filtration Committee and Rapid Microbiological Methods TR33). He has published in excess of dozen publications in anti-infective area in top national and international journals.
Richard Poska, R.Ph.D.
Director, Regulatory Affairs, Abbott Laboratories
Track Advisor: Regulatory QA/QC
As a Regulatory Affairs Director in Abbott's Pharmaceutical Products Group, Rich focuses on strategic CMC initiatives. He earned his B.S. degree in Pharmacy from the University of Illinois College of Pharmacy and has worked with solid dosage forms at both Searle Laboratories and The Upjohn Company before joining Abbott. His 20 years of technical experience includes solid dosage form research, production troubleshooting, process improvement and support, harmonization of excipients and processing, application of statistics for manufacturing controls, Puerto Rico liaison and FDA inspection administrator. He is internationally known for his presentations and publications on the application of microwave drying to pharmaceutical processing. He chaired the SUPAC Equipment Equivalents Steering Committee for the International Society of Pharmaceutical Engineers (ISPE) which won the Vice-President's National Performance Review "Hammer Award" for building a government that works better and costs less. Rich has also chaired PhRMA's Technical Leadership Committee and Drug Product Technical Committee and has represented ISPE and PhRMA on the Drug Product Technical Committee of the Product Quality Research Institute. He is a member of the ISPE Community of Practice CMC Steering Committee and is currently a member of the editorial board for the Journal of GXP and the Journal of Validation Technology.
Morrey Atkinson Ph.D.
Chief Scientific Officer, Vice President of Research and Development, Vice President of Drug Substance Manufacturing, Cook Pharmica LLC
Track Advisor: Supply Chain
Dr. Atkinson holds a B.S. in Biology from Indiana University, and a PhD in Biological Sciences from Stanford University.
Upon completion of his PhD, Morrey joined Geron Corporation, where he studied the biochemistry of human telomerase. In 1995, Morrey joined Targeted Genetics Corporation, where he served in various roles, including Vice President of Development, focusing on the development and production of vaccines and gene therapies.
In 2002, Morrey joined Eli Lilly and Company, where he held a variety of management positions in Bioproduct Development and Manufacturing, and gained extensive experience working with antibodies, peptides, enzymes, and other recombinant proteins.
Prior to joining Cook Pharmica, he was Head of Biotechnology Manufacturing Sciences at Eli Lilly's commercial site in Kinsale, Ireland.
Morrey has numerous publications and patents on Process Development of Biologics, focusing on upstream, downstream, viral safety, analytical, and Quality by Design. Morrey joined Cook Pharmica, LLC in 2011.
Scott Rudge, Ph.D.
Chief Operating Officer, RMC Pharmaceutical Solutions, Inc.
Track Advisor: Product Development
Dr. Rudge is a founder, COO, Chairman of the Board and Principal Consultant with RMC Pharmaceutical Solutions Inc. RMC Pharmaceutical Solutions is a privately held, internationally recognized expert services consultancy focusing on manufacturing and quality issues in the pharmaceutical, biotechnology, medical device and nutraceutical industries. He also serves as Sr. Vice President of Product Development for Bradmer Pharmaceuticals, a start up biotechnology company developing targeted radiolabeled antibodies for the treatment of glioblastoma multiforme. Prior to forming his expert services business, Dr. Rudge was Vice President of Operations with FeRx Inc., a magnetic drug delivery research and development company. Prior to his seven years with FeRx, Dr. Rudge held positions in Process Development and Process Engineering with Amylin and Synergen, and as a Staff Scientist with the National Institute of Standards and Technology. Dr. Rudge serves as an Adjunct Professor of Chemical Engineering at the University of Colorado, where he teaches courses in bioprocessing and bioseparations, and supervises graduate students. Dr. Rudge received his undergraduate degree at Worcester Polytechnic Institute and his Masters and Doctorate degrees in Chemical Engineering at Purdue University. He is the co-author of a best selling text book on bioseparations and engineering entitled Bioseparation Science and Engineering (Oxford Press), and has sixteen other scholarly publications. Dr. Rudge serves on the editorial advisory board to Contamination Containment and Control magazine.
EJ Brandreth
Vice President, Quality & Regulatory Affairs, Althea Technologies, Inc.
Track Advisor: Regulatory QA/QC
Mr. Brandreth brings over twenty-five years experience in the biotechnology and pharmaceutical industries, and is currently the Vice President, Quality and Regulatory Affairs at Althea Technologies. Prior to Althea he was VP of Quality at Favrille, Inc., a personalized medicine start-up. He led the Process Validation Programs for five CBER/EMEA product launches, including Aldurazyme®, Naglazyme®, Zevalin® and Rituxan®. Previous to Favrille, Mr. Brandreth was Senior Director of Quality at BioMarin Pharmaceuticals for five years, and held management positions at IDEC Pharmaceuticals for over eight years. He is an author of PDA Technical Reports, and is currently Chairman of the PDA Biotech Advisory Board. He was a Director for 10 years and President of ISPE, San Diego Chapter. He is a frequent conference speaker, and is a current member of the Interphex Advisory Board. He holds a BS in Biology, UCSD, and a Masters in Business Administration.
Jaspreet Singh , PhD
Vice President, Business Development & Pharmaceutical Microbiology, Molecular Epidemiology
Track Advisor: Manufacturing & Packaging
Vice President, Business Development & Pharmaceutical Microbiology, Molecular Epidemiology, Dec 2004 - present
Principal Scientist/Laboratory Research Director, University of Washington, Seattle, WA, Aug 2001-Dec 2004
Senior Research Scientist, University of Washington, Seattle, WA, 1996-2001
Visiting Scientist, University of Washington, Seattle, WA, 1993-1996
Post-Doctoral Fellow, University of Washington, Seattle WA, 1990-1993
Education, Certifications and Interests
PhD, Biochemistry, 1989, Brunel University and Max-Planck Institute for Biophysical Chemistry, Goettingen, Germany
BS (Honors), Applied Biochemistry, 1985, Brunel, University of West London, UK
Professional Memberships
• PDA
Past Memberships
• ISPE
• RAPS
John Gilroy P.E.
Sr. Vice President and Principal, IPS - Integrated Project Services
Track Advisor: Facility & Process Design
Mr. Gilroy brings more than 25 years of diverse EPCM experience providing project management and mechanical services to the petrochemical, semi-conductor, pharmaceutical industries and commercial sector. His experience includes design engineering from concept through implementation, system evaluation/analysis and troubleshooting, cost estimating, budget generation, scheduling and overall project execution.
Leading the Design and Project Delivery group at IPS, Mr. Gilroy and his team have completed more than $1B of in-place, technically-based construction in the United States. He has taken the lead in developing and implementing a "Lean" Project Delivery Process, resulting in reduced waste and real value for clients. He established execution methodologies which offer ways to do things better and more efficiently, ultimately delivering higher quality while controlling costs and maintaining long-term operational dependability.
Russ F. Somma Ph.D.
President, SommaTech, LLC
Track Advisor: Product Development
Dr. Somma has more than 30 years of experience working in the pharmaceutical industry, specifically in the areas of production troubleshooting, dosage form development, manufacturing scale up, technology transfer and project management. He has a particular technical interest in the area of solid dosage forms and the physical pharmacy associated with them. Dr. Somma has utilized his technical and managerial talents within cross- and multi-functional teams, mentoring colleagues and direct reports alike. He has had direct responsibility for senior staff, both domestically and internationally, as well as technical development and life cycle management support for a variety of oral solid dosage, novel formulations and therapeutic groups. Additionally, he has served as an invited investigator trainer and liaison for the FDA on various projects and initiatives, affording a unique perspective within Pharmaceutical Regulatory Affairs.
Timothy P. Howard, CPIP, P.E.
Vice President and Company Officer, Commissioning Agents, Inc.
Track Advisor: Facility & Process Design
Mr. Howard is a Vice President and Company Officer at Commissioning Agents, Inc., responsible for the Commissioning and Validation services business unit. His responsibilities include maintenance and implementation of the internal quality system, hiring, training, and professional development of resources, and oversight of all major projects.
Mr. Howard serves as a Director on the ISPE international board of directors. He was a member of the Task Team that developed the ASTM standard E2500 on science and risk base qualification and a contributing author to ISPE Guidance Documents on ASTM E2500 Implementation.
He is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Mr. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional (CPIP), and a registered professional engineer.
Robert Timko
Director CMC Group, Global Regulatory Affairs, AstraZeneca Pharmaceuticals LP
Track Advisor: Product Development
Robert J. Timko RPH, PhD has over 30 years of pharmaceutical industry experience in product development and manufacturing and regulatory affairs. He is presently a Director in the Chemistry, Manufacturing and Controls (CMC) Group of the Global Drug Regulatory Affairs Department, AstraZeneca LP. Dr. Timko has also served as the Team Director, Oncology Therapeutic Area, in the Global Regulatory Affairs Chemistry, Manufacturing and Controls Group.
Prior, Dr. Timko was a Section Manager in the Product and Analytical Development Department where he was responsible for various phases of the drug development process including drug discovery support, physical pharmacy, formulation and process development and scale-up, clinical supply manufacture, and facilities support. Dr. Timko joined ZENECA in 1984 as a Group Leader of Solids Development in the Product Development Section. In 1987, he was promoted to Manager of Solid Dosage Form Development. He became a Section Manager in the Pharmaceutical Development Department of Pharmaceutical Research and Development in 1990. He joined the Marketed Products Group of the Drug Regulatory Affairs Department in 1997.
Dr. Timko earned his Bachelor of Science in Pharmacy in 1974 from Rutgers University where he also earned Master of Science and Doctor of Philosophy Degrees in Pharmaceutical Science in 1977 and 1979, respectively. After graduation, he joined Ortho Pharmaceutical Corporation as a Research Scientist in their Pharmaceutical Process Development Group of Pharmaceutical Development where he was responsible for in-line product support, process development and scale-up, and process validation for a variety of dosage forms. In 1981, Dr. Timko was promoted to Senior Research Scientist, and in 1984, he transferred to the Technical Operations Group of the Advanced Care Products Division where he provided technical support to Product Development and Quality Assurance for consumer pharmaceutical and diagnostic products.
Dr. Timko is an active member of a number of professional organizations including AAPS and ISPE. He is a Registered Pharmacist in New Jersey and Pennsylvania. He holds several formulation patents, and has written journal articles and made presentations in the in the areas of formulation and process development and optimization, and equipment instrumentation.
M.J. Kimmel
Principal, MJK Solutions
Track Advisor: Facility & Process Design
Over 30 years experience in the Pharmaceutical Engineering and Facility Operation and Maintenance. Currently Principal with MJK Solutions, an engineering consulting firm to the Pharmaceutical Industry. Prior to this, Jim was Senior Director of Engineering and Maintenance for Cephalon, Inc. in Malvern, PA with global responsibility for the Cephalon's Research Facilities worldwide, and the Corporate Headquarters. Prior to Cephalon, held long term positions with Wyeth Pharmaceuticals and ICI Americas (now Astra Zeneca).
Has served the Delaware Valley Chapter of ISPE as President of the Chapter in 2004 -2005, as Membership Committee Chair, and as a general member of the Board of Directors for several years. Currently serves at the International level as member of the Body of Knowledge Task Team, and Chairman of the Facility of the Year Committee.
Married with three grown children, resides in West Chester, PA with wife Pat.
Chad Wachter
Sr. CMC Manager, BTG International
Track Advisor: Supply Chain
Chad Wachter is the Senior CMC Manager for BTG International, located in West Conshohocken, PA, working on the development and US commercialization of a treatment for varicose veins. Prior to joining BTG, Chad was the Business Ops Manager for GlaxoSmithKline responsible for the Biopharmaceutical R&D Unit GMP OPs facility located at Upper Merion, Pennsylvania. Chad has over 20 years experience in nearly all dosage forms; with intensive engineering, construction, commissioning and qualification biopharm experience during the last 6 years. He has worked in research and development, industrial operations (commercialization), design, GMP, quality assurance and validation areas. Chad has held positions of increasing responsibility throughout his career with many presentations on the aforementioned topics in trade forums. Chad has a BS and MS in Chemical Engineering with a published thesis on red blood cell deformability in patients with artificial hearts from the University of Pittsburgh, a MBA from Drexel University, and he is a registered Professional Engineer in the State of Pennsylvania.
Albert Manigo-Bey Jr.
Manager, Procurement, Watson Pharmaceuticals
Track Advisor: Manufacturing & Packaging
Albert Manigo-Bey is a Senior Strategic Sourcing manager at Watson Pharmaceutical, Inc.
He has worked within Procurement for more than 13 years, procuring process manufacturing and facility equipment, sourcing both engineering and construction services. Also, consistently delivering projects on time and under budget while exceeding his clients' expectations.
Mr. Manigo-Bey is people-oriented influence, balanced arbitration, and excellent negotiation skills has helped him to successfully work with mid to large sized companies in building facilities and equipment procurement.
Michael A. Zupon, Ph.D.
Vice President, Pharmaceutical and Manufacturing Technology, MannKind Corporation
Track Advisor: Manufacturing & Packaging
Michael Zupon obtained his PhD in biopharmaceutics and also has a BS in pharmacy and an MBA. He spent 13 years at Schering-Plough Corporation and many additional years working in start-up companies. He joined MannKind Corporation in 2007. He has led research/development teams from discovery through regulatory approval in both the US and Europe. His pharmaceutical development experience encompasses both organic small molecule and biotechnology products, and a diverse array of pharmaceutical dosage forms, e.g., semi-solids, liquids, parenterals, controlled release products, aerosols and dry powder inhalers.
Sanjay Patel
Sr. Director, Global Materials Management, Shire Pharmaceuticals, Inc.
Track Advisor: Supply Chain
Sanjay Patel is currently the head of Global Materials Management at Shire Pharmaceuticals. In his role, he leads the planning, external manufacturing, and distribution teams of virtual supply in fast growing Specialty Pharmaceuticals. He has twenty years experience in various roles including facilities, manufacturing support, procurement and planning.
Sanjay began his career as an engineer, after gaining a B.S. in Electrical Engineering from the New Jersey Institute of Technology.
Michelle M. Gonzalez, P.E.
BioPharm Engineering Consultant
Track Advisor: Supply Chain
Ms. Michelle M. González – Engineering Director (Retired), with Amgen Inc. in Thousand Oaks, California, has had extensive experience in industry leadership activities dealing with facilities engineering and process systems design, and management of construction projects. Since relocating to the United States in 1965, she has held technical positions of increasing responsibility in mechanical and process engineering with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, and Amgen.
Ms. Gonzalez holds an MS in Architecture from the Pontificia Universidad Javeriana in Bogotá, Colombia. She has been a regular lecturer at the Stanford School of Engineering, and holds professional memberships in the American Institute of Chemical Engineers (AIChE), and the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) Standard, where she has served as Chair of the BPE's Subcommittee on Surface Finishes, voting member of the Executive and Main Committees, as well as the Certification, and Dimensions & Tolerances Subcommittees. For the past four years she has also been a member of INTERPHEX's Advisory Board.
Additionally, Ms. González has for 21 years been an active member of the International Society for Pharmaceutical Engineering (ISPE), where she has served as a regular technical speaker, a member of the Membership Development Committee, the Program Committee, and the Body of Knowledge Committee; President of the Greater Los Angeles Chapter (2007-2008), and a participating member on the preparation of the ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water and Steam Systems, the Biopharmaceutical Manufacturing and Process Development Baseline® Guide, the Good Practice Guide for Process Gases, and the soon to be published revision of the Water & Steam Baseline® Guide. Also, she is the author and editor of ISPE's Glossary of Applied Terminology for the Pharmaceutical Industry.
Ms. González has authored various published technical papers dealing with materials of construction for the biopharmaceutical industry including "single use" products technology; facilities programming, pilot plants, and biotechnology process systems.