Conference Speakers

Sema Z. Ariman

CMC Regulatory Affairs Manager
Abbott Laboratories

Sema Ariman is a Chemistry Manufacturing and Controls (CMC) Regulatory Affairs Manager at Abbott Laboratories. She currently supports a product family that is registered globally. She has expertise in US, EU, Japan, Canadian, Latin America and Asian regulatory CMC submissions. The submissions include support of manufacturing site transfers, original applications, process changes, alternate packaging and alternate analytical methods. She has been involved with several successful site transfers including drug substance intermediates, drug substances and drug products. Before joining Regulatory Affairs, Sema held a variety of positions at Abbott. During her career, she managed a group that supported drug substance clinical manufacturing, held positions in R&D as a Process Engineer and supported commercial drug substance manufacturing.

Sema has received her certification in both US Regulatory Affairs (RAC) and ASQ Manager of Quality/Organizational Excellence. She actively participates in Abbott's recruiting efforts at Northwestern University. In addition, she has presented at several universities over the years. Ms. Ariman earned her BS in Chemical Engineering from Northwestern University and a Regulatory and Quality Compliance Graduate Certification from Purdue University.

Track: Supply Chain
Presentation: Regulatory Strategies and Considerations for Successful Site Transfers

Dilip Ashketar

Sr. Director Quality Control
Gilead Sciences, Inc.

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.

Track: Product Development
Presentation: Bioburden Control for Sterile Filtration for Injectable Biotechnological and Pharmaceutical Drug Product Manufacturing

E. Morrey Atkinson, Ph.D.

Chief Scientific Officer, V.P. of Research and Development, V.P. of Drug Substance Manufacturing
Cook Pharmica, LLC

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.

Track: Product Development
Presentation: Technical Challenges in the Development of Biosimilars

Keith Bader

Sr. Consultant
Hyde Engineering+ Consulting, Inc.

Keith Bader is the Director of Technical and Quality Services at Hyde Engineering + Consulting, Inc. In this role, he is responsible for the implementation of quality and technical standards for Hyde Engineering + Consulting, Inc. on a corporate-wide basis. In addition, Keith serves as project manager for validation and engineering projects, as well as providing high level strategic consultation to Hyde Engineering + Consulting, Inc.'s clients.

Since joining Hyde in 1999, as a Control Systems Engineer, Keith has gained experience on a variety of projects ranging from project engineering and commissioning to process and cleaning validation projects. Keith has experience working with biopharmaceutical process equipment ranging from stand-alone unit operations such as CIP and Ultrafiltration skids, to entire process trains. Prior to joining Hyde, Keith was a Research Engineer at TDA Research in Wheatridge Colorado where he was responsible for the synthesis and testing of novel catalysts, and advanced ceramic composites. All of the work at TDA was funded by various government agencies, including NASA, DOE, and the EPA, through the SBIR program.

Keith earned his bachelors degree in Chemical Engineering from the University of Colorado at Boulder in 1995.

Track: Manufacturing & Process Design
Presentation: Case Study: Translating the New Process Validation Paradigm to Cleaning Processes

Jeffrey C. Baker, Ph.D.

Deputy Director, Office of Biotechnology Products (OBP) Center for Drug Evaluation and Research
U.S. Food & Drug Administration

Dr. Baker received his doctorate in biochemistry from North Texas State University and completed post-doctoral studies at the University of California, Berkeley before joining the biosynthetic process development group at Eli Lilly & Co. While at Lilly, Dr. Baker led the development of several commercial bioproducts from bench top purification to global launch and later became Senior Research Advisor for Manufacturing Sciences and Technology where he formed and led Lilly's Global Validation Practices Team. After completing his certification as a Lean Six Sigma Black Belt, Dr. Baker led several initiatives related to assessment of control and capability and functional governance processes. Dr. Baker left Lilly to form and lead the Manufacturing Science and Technology component at MedImmune, and most recently was appointed Deputy Director of the Office of Biotechnology at the United States Food and Drug Administration.

Track: Keynote
Presentation: Control, Capability, and Capacity: Elements Assuring a Reliable Drug Supply

Johann Bonnet

Strategic Account Manager
Veolia Water Solutions & Technologies

Johann Bonnet joined Veolia Water Solutions & Technologies in 2001 as Sales Engineer. Johann took over, in 2006, the responsibility of the pharmaceutical market of Veolia Water Solutions & Technologies (VWS) as global Market Manager and joined the Corporate Industrial Marketing. In 2011, VWS has appointed Johann as Global Strategic Account Manager (SAM). His main responsibilities include the development of strategic partnerships within large pharmaceutical, biotech & cosmetic companies.

He has 14 years of experience in Sales in Food & Beverage and Pharmaceutical industries. Prior to joining Veolia Water Solutions & Technologies, he held the positions of Sales Engineer with Tetra Pak Hoyer and Product Manager with Tetra Pak Processing in France.

Johann has professional membership with ISPE. Recently, he conducted several presentations about Critical Water Utilities, Outsourcing and Sustainable Development for ISPE, Interphex and Achema conferences.

Track: Facility & Process Design
Presentation: Case Study: Greener Manufacturing with Reduce, Reuse, Recycle & Reclaim of Water

Todd Bucciarelli

Director, Business Development
IIT Research Institute

Todd Bucciarelli is currently the Director of Business Development at IIT Research Institute (Chicago, IL), a non-clinical CRO focusing on drug development toxicology. He co-founded CDI Bioscience, a biologics technology company (Madison, WI) that markets a novel technology for increasing protein yields in mammalian expression systems called RP Shift. Todd lead the development of a high expression CHO K1 cell line currently marketed under the PACE cell name. He is the co-author of 3 patents on protein expression technology and holds a BSCS Degree from the University of Saint Francis and is a Northern Illinois University M.B.A. candidate (May 2012).

Track: Manufacturing & Packaging
Presentation: Single Use Technology Enabling Biosimilar Manufacturing

J. Richard Creekmore, Ph.D., R. Ph.

US Technology Manager
AstraZeneca Pharmaceuticals LP

Richard Creekmore is currently the US Technology Manager at AstraZeneca Pharmaceuticals in Wilmington, DE. He has over 25 years of experience in pharmaceutical industry working in the area of formulation and technology transfer. Dr. Creekmore has worked at AstraZeneca for 23 years and was employed by the A.H. Robins Co. of Richmond, VA before moving to AstraZeneca. At AstraZeneca, Dr. Creekmore led a formulation team that developed products from early development which culminated in technology transfers to Operations including two high revenue products. He is a member of AAPS and ISPE and has served on the USP Excipient Monograph 2 Committee, PQRI Technical Group for Risk Management, and is currently serving as a member of the IQ Consortium Drug Product Leadership Group.

Dr. Creekmore received his Ph.D. in Pharmacy from the University of Iowa. He received his B.S. in Pharmacy and M.S. in Pharmacy (specializing in Nuclear Pharmacy) from The University of North Carolina at Chapel Hill.

Track: Product Development
Presentation: Making Risk Assessment Part of Technology Transfer

Listen to Richard's special audio recording to learn more about his session:

Thomas Dale

Director of Supply Chain Marketing and Vertical Market Development
FedEx

Thomas A. Dale is the Director of Supply Chain Marketing and Vertical Market Development at FedEx. His career spans more than 20 years in the third-party logistics/supply chain space. Mr. Dale joined FedEx in 1995 and has held a variety of positions in business development, operations, and marketing. He is currently responsible for leading a team that drives the global ideation, development, launch and promotion of outsourced supply chain (fulfillment, transportation management, service parts logistics and fleet) and vertical market (healthcare, sensor, postal) service offerings.

Track: Supply Chain
Presentation: Supply Chain Security

Kevin Lear

Principal Engineer, Regional Director, Massachusetts
Hyde Engineering + Consulting, Inc.

Kevin Lear joined Hyde Engineering + Consulting, Inc. in 2011, and is responsible for the management of the Massachusetts region. Kevin has over 30 years of extensive experience in the pharmaceutical and medical device industry. He is recognized as an experienced Project Manager who has delivered several projects involving building systems, installations, and clinical trials. Kevin's expertise includes commissioning and qualification of quality processes for medical device assembly and manufacturing improvement. Kevin was previously at Xcellerex Corporation where he served as Director of Project Management for Flex factory builds. In this role he was responsible for resource allocation and budgeting for Disposable Bioreactors, Mixers and Downstream processing equipment. Kevin used a methodical approach to identify, source, deliver and manage the product integration and in house testing for timely release of products to customers. He was also responsible for the management and coaching of Field Service and Engineering teams to build modular Disposable Bioreactors, Mixers and Modular DSP (Down Stream Process) equipment.

Prior to joining Xcellerex, Kevin has held various senior roles in Engineering, Design and Project management at organizations that include Integrated Process Technologies, Process Facilities Inc (PFI), Ciba Corning Diagnostics, BioKinetics, ACT Medical and Kimberly Clark.

Kevin is originally from London, UK, and graduated with a BS in Chemical Engineering from the North East London Polytechnic.

Track: Manufacturing & Packaging
Presentation: Case Study: Implementing Single-Use Technologies in a GMP Facility

Angie Drakulich

Editorial
Pharmaceutical Technology

Check back soon...

Ed Dubeau

Director and Team Leader of Manufacturing for Consumer Healthcare Operations
Pfizer, Inc.

Ed DuBeau is Director and Team Leader of Manufacturing for Consumer Healthcare Operations for Pfizer in Pearl River, N.Y., a facility that employs roughly 2,500 colleagues on a 550-acre campus approximately 20 miles north of Manhattan. The site is one of Pfizer''s five primary research sites and a central hub for Vaccine and BioTherapeutics research. It is the Pfizer global network''s largest-volume producer of the Prevnar® vaccine, and the largest-volume producer of the Centrum® family of dietary supplements for the domestic U.S. market. In his role as Director and Team Leader, Ed is responsible for the site's Supply Chain Management functions and overall Consumer Healthcare Operations, including manufacture of the Centrum family of multivitamins for the U.S. market: Centrum; Centrum® Silver®; Centrum Performance®; Centrum Cardio®, Centrum® Chewables, Centrum Kids®, and Centrum Ultra Women's®. Ed has over 20 years of manufacturing experience in the pharmaceutical and cosmetics industries, most notably at Sandoz Pharmaceuticals and The Estee Lauder Companies. He first came to Pearl River in 2004 as Director, Operations Resource Management, Vaccines, and later moved into his role as head of the site's Supply Chain Management organization with responsibility for Biotech and Consumer Healthcare planning, warehousing and logistics. Ed's business acumen and strong leadership skills earned him his current dual leadership role in Pearl River in April 2010 when he was appointed Director and Team Leader of Consumer Healthcare Operations in addition to his Supply Chain Management responsibilities.

Track: Regulatory QA/QC
Presentation: Proven Processes and Metrics to Optimize Operational Excellence

Abe Germansderfer

Associate Director
Gilead Sciences, Inc.

Abe Germansderfer is a Quality professional with over ten years of experience providing guidance on multiple aspects of Manufacturing Controls, Quality and Product Development. He has successfully led development and implementation of appropriate statistical methods for analytical method development and validation, process and product characterization and commercialization. Prior to joining Gilead Sciences' Quality organization, Abe Germansderfer worked as a statistician and quality engineer at Amgen and Genzyme, and as a molecular biologist at Therion Biologics. Abe holds BS and MS in biotechnology from Worcester Polytechnic Institute.

Ajit Ghorpade, Ph.D.

Technical Director for Biological Processes
Veolia Water Solutions & Technologies

Dr. Ajit Ghorpade is Technical Director for Biological Processes with Veolia Water's technological solutions subsidiary , Veolia Water Solutions & Technologies in the US. During his career, Dr. Ghorpade has consulted with multinationals, supported global manufacturing Pharmaceutical companies and marketed optimal environmental solutions to clients. He has worked in the industrial wastewater treatment field for over 20 years, devising novel treatment technologies for global clients. His work started in this field with the late Dr. Wes Eckenfelder and continued with Merck, GSK and Veolia (formerly Vivendi). His areas of expertise are pollution prevention, waste minimization and optimized industrial wastewater treatment.

Dr. Ghorpade was awarded his Bachelor's degree in Chemical Engineering from the Karnataka Institute of Technology, Surathkal (formerly KREC). He completed his Master's in Chemical Engineering at UDCT under Prof. Sharma's guidance. After a brief position with Hindustan Lever, he came to the US for further studies as a Rotary International scholar. He completed his MS and PhD degrees at the University of Louisville. He evaluated the use of pure oxygen for increasing the capacity of wastewater treatment plants and the use of genetically altered bacteria for degrading textile dye wastewater.

He has published and presented many technical works at various conferences. He served on the Editorial Board of Environmental Progress. He has been a keynote speaker, conference chair and member of various professional technical committees of American Institute of Chemical Engineers (AIChE) and Water Environment Federation (WEF). He currently serves on WEF's Program and Industrial committees. He was also a Past President of the Rotary Club in King of Prussia, Pennsylvania.

Track: Facility & Process Design
Presentation: Case Study: Meeting Sustainability Challenges with the Revamping of Your Wastewater Plant

John Gilroy, P.E.

Sr. Vice President and Principal
IPS - Integrated Project Services

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.

Track: Facility & Process Design
Presentation: Case Study: Optimizing Execution with Modular Construction

Igor Gorsky

Associate Director, Validation, Global Pharmaceutical Technology
Shire Pharmaceuticals, Inc.

Igor Gorsky has been a pharmaceutical industry professional for over 26 years. He held multiple positions with increasing responsibility at Alpharma and Wyeth Pharmaceuticals. He worked in Production, Quality Assurance, Technical Services and Validation. He is currently holds a position of an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. His over the years accomplishments include validation of all of the aspects of pharmaceutical production and quality management, technical support of muti-billion dollar drug product lines and introduction of new products onto the market. He had published articles and white papers in pharmaceutical technology magazines and textbooks. In addition he had been a presenter at Interphex. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.

Track: Manufacturing & Packaging
Presentation: Case Study: Aspects of a Sustainable Maintenance for a Lifecycle Cleaning Validation Program

Listen to Igor's special audio recordings to learn more about his session:

Juergen Klemmer

Head of Wastewater Department
Roche Diagnostics GmbH Penzberg

Juergen Klemmer started his career as a laboratory assistant at Boehringer Mannheim / Germany, predecessor of his current employer Roche Diagnostics. After further education in biotechnology, he was appointed Head of the Waste Water Laboratory at the Boehringer Penzberg site. Since 1999, he is the head of the Wastewater department at the Roche Penzberg site.

His project responsibilities included the extension of the wastewater treatment plant. As a first step, a membrane bioreactor was installed; a pure oxygen high performance step was added at the next stage. The most recent extension included an anaerobic pre-treatment stage (BIOBED® Technology) – the Roche Wastewater Treatment plant is an example of state-of-the-art technology and one of the most advanced industrial wastewater treatment plants in Europe.

Track: Facility & Process Design
Presentation: Meeting Sustainability Challenges with the Revamping of Your Wastewater Plant

KR Karu

Pharmaceutical Industry Principal
Sparta Systems

KR Karu is the pharmaceutical industry principal for Sparta Systems' product management group. In this role, Karu manages the relationships with some of the company's largest pharmaceutical customers, helping them track and better understand ongoing regulatory changes and trends in the industry. Karu has worked to provide technology solutions to the global life sciences industry for 25 years, and is a member of the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE) and an active participant in the GAMP Forum.

Track: Regulatory QA/QC
Presentation: Case Study: An Enterprise-Wide Approach to Global Change Management

Niranjan Kulkarni, Ph.D.

Operation Specialist
CRB Consulting Engineers, Inc.

Niranjan Kulkarni, PhD, is a Industrial and Systems Engineering graduate from Binghamton University, NY. He is a certified Lean Six Sigma Black Belt and works as Operations Specialist at CRB Consulting Engineers. His job responsibilities include helping clients operate their facilities smarter with lower costs, greater throughputs, higher quality, greener facility and other innovative engineering solutions. Niranjan has worked with pharmaceutical, chemical, semiconductor / electronics assembly and packaging, manufacturing and financial industries. He has numerous publications and has also co-authored a book chapter.

Track: Manufacturing & Packaging
Presentation: Case Study: Path to Reduce Operational Expenses and Improve Operational Efficiency

Track: Facility & Process Design
Presentation: Case Study: Why Logistics Modeling and Architectural Layouts is Important

Listen to Niranjan's special audio recording to learn more about his session:

Robert Lechich

Director, Operational Excellence
Pfizer, Inc.

Robert Lechich is currently the Director of Operational Excellence in the External Supply Biotech organization at Pfizer Pharmaceuticals. His work is focused on improving contract manufacturing and business processes with the supply chain. Robert has a diverse background in the pharmaceutical and biotechnology industries and has worked in many areas including manufacturing, quality assurance, process engineering, facilities management, automation and information systems and supply chain management. He holds a bachelor's degree in Chemical Engineering, master's degree in Technology Management from Stevens Institute of Technology and a certificate in Supply Chain and Logistics from Georgia Institute of Technology. In addition to being a Certified Six Sigma Master Black Belt from North Carolina State University, he holds other certifications including Certified Pharmaceutical Industry Professional (CPIP) from ISPE , Project Management Professional (PMP), Certified in Production and Inventory Management (CPIM) and Supply Chain Management Professional (CSCP).

Track: Supply Chain
Presentation: Deploying Lean Six Sigma in Global Manufacturing Networks

Marco Lederle

Director Consulting / Partner
i+o Consulting

Mr. Lederle has managed large scale IT Automation, Manufacturing Execution Systems (MES) and PCS (Process Control Systems and SCADA) projects within the biopharm industry. He has extensive international experience from assignments in Europe, USA and Asia that involve managing geographically distributed project teams working in in a multi-cultural environment.

Areas of specialization include Strategic Planning, Project Roadmaps, EBR design and Project Management that supports URS development, functional specifications, and project implementation from vendor selection/proposal/bid review through final project implementation.

Mr. Lederle holds a Master of Science in Business Information Systems and currently serves as Operations Manager for the US office of i+o Industry Planning + Organization located in Bethlehem, PA. i+o is an international consulting firm that provides services that are independent from software, hardware and solution providers.

Track: Regulatory QA/QV
Presentation: Manufacturing Execution Systems (MES) for BioPharm Manufacturers

Listen to Niranjan's special audio recording to learn more about his session:

Betty Lee, Ph.D.

Microbiologist
U.S. Department of Commerce

Dr. Betty Lee is a Microbiologist/Licensing Officer in the Department of Commerce, Bureau of Industry and Security, Office of Nonproliferation Controls & Treaty Compliance, Chemical and Biological Controls Division. The Division is responsible for reviewing license applications of chemical and biological exports for dual-use purposes. She educates chemical and biological industries about the Export Administration Regulations (EAR) and participates as an instructor in the Exporter Services seminar programs given by the Bureau of Industry and Security nationwide. She has represented Commerce in interagency meetings of the Executive branch on biosecurity and biosafety.

In addition, she participated in the interagency discussions hosted by the National Security Council and the Office of Science and Technology Policy that culminated in the Executive Order titled "Optimizing the Security of Biological Select Agents and Toxins in the United States" signed by the President Obama on July 2, 2010.

Before joining the U.S. government, Dr. Lee worked in the biotechnology industry as a scientist and a technology transfer specialist. She is an Assistant Editor for the Association of Women in Science (AWIS) magazine. She completed her postdoctoral training at the National Cancer Institute and the University of Colorado Health Science Center. Dr. Lee received her Ph.D. in Pharmacology from Dartmouth Medical School, M.S. in Biochemistry from LSU Medical Center, M.S. in Clinical Chemistry from the University of Windsor and B.S. in Pharmacy from the University of Santo Tomas.

Track: Regulatory QA/QC
Presentation: Export Control on Processing Equipment

Listen to Betty's special audio recording to learn more about her session:

Paul Lopolito

Technical Services Manager
STERIS Corporation

Paul Lopolito is a technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to critical environment and process research cleaners, which includes field support, site audits, training presentations and educational seminars. Paul has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events including the PDA, ISPE, INTERPHEX, AALAS, and IVT. Paul has published several articles and book-chapters related to cleaning and cleaning validation. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.

Track: Product Development
Presentation: Case Study: Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multiproduct Facilities

Listen to Paul's special audio recording to learn more about his session:

Sandra Lueken

Director of Quality
Baxter Pharmaceutical Solutions

With more than 20 years of industry experience, she is responsible for developing, deploying and maintaining the overall quality system within the manufacturing facility. Her role includes managing a diverse group of 200+ individuals responsible for all aspects of Quality Control and Quality Assurance operations supporting the manufacture of liquid and lyophilized vials, syringes, and cartridges for more than 40 clients.

As a Quality/Regulatory professional with expertise in contract manufacturing production, Sandra's experience includes process/product/assay transfer and validation activities, aseptic drug product manufacturing, project management, CAPA, laboratory operations, and leading/managing FDA and international regulatory inspections resulting in numerous PAI approvals and several successful clinical to commercial product launches.

Educated in Biochemistry with a Masters Degree in Business Administration from the Eller School of Business, University of Arizona, Sandra's career path includes positions with HollisterStier Laboratories, Ventana Medical Systems, Inc., Systems Integration Drug Discovery Company, and the Jerry L. Pettis Memorial VAMC.

Sandra is a member of Parenteral Drug Association, Regulatory Affairs Professionals Society, National Association of Professional Women, and is co-Chair of the GMP Leadership Group in the International Consortium for Innovation and Quality in Pharmaceutical Development.

Track: Supply Chain
Presentation: Guidance for Industry Process Validation: General Principles and Practices - A CMO's Approach

Philip R. Lyman, Ph.D.

Director, Process Simulation
CRB Consulting Engineers, Inc.

Philip R. Lyman, PhD is Director of Simulation at CRB Consulting Engineers and has 19 years of experience in process modeling. Dr. Lyman uses computer modeling technologies to improve plant designs, de-bottleneck existing facilities, and optimize operations for pharmaceutical and biotech companies.

Before joining CRB, Dr. Lyman started a specialized engineering firm focusing on process simulation for the pharmaceutical and biotech industries. Prior to that, he held positions with Dow Corning Corp. and Air Products and Chemicals. He is an active member of ISPE and AICHE and has earned several degrees in Chemical Engineering: a BS from University of Wisconsin-Madison, and a MS and PhD from Lehigh University in Bethlehem, PA.

Track: Manufacturing
Presentation: Case Study: Path to Reduce Operational Expenses and Improve Operational Efficiency

Listen to Philip's special audio recording to learn more about his session:

Track: Facility & Process Design
Presentation: Case Study: Why Logistics Modeling and Architectural Layouts is Important

Listen to Philip's special audio recording to learn more about his session:

Jim Miller

President
PharmSource Information Services, Inc.

Track: Keynote
Presentation: What the New Bio/Pharma Business Model Means for CMOs and CROs

Arminda O. Montero

Global Distribution QA Program Manager
Global Pharmaceutical Operations
Abbott Laboratories

Arminda Montero has worked in the pharmaceutical industry for over 15 years. She is the global distribution quality assurance program manager for the pharmaceutical products group of Abbott Laboratories. In her current role, she has led the development and implementation of quality systems and strategies for global distribution, with specialized focus on temperature control management for both cold chain and controlled room temperature products. Prior to this role, she had positions in engineering, manufacturing operations management and operational excellence. Arminda holds a Bachelor of Science degree in Chemical Engineering from the University of Illinois at Urbana-Champaign.

Track: Supply Chain
Presentation: A Knowledge-Based Approach to Supply Chain Pharmaceutical Temperature Control Management

Elaine Morefield, Ph.D.

Deputy Director, Office of New Drug Quality Assessment
CDER
U.S. Food & Drug Administration

Track: Product Development
Presentation: Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing

Susan Morrison

Principal Construction Engineer
Parsons Engineers @ Goddard Spaceflight Center, NASA

Susan Morrison is a construction lead engineer helping to design and build laboratories at NASA Goddard. One of her principal accomplishments was in the Robotics Servicing Clean Room. She gave direction to an outside Engineering firm to value engineer this project, removing $5 million (out of a $9.9 million project) from the overall design budget while still providing a clean room that met all the class and metrology needs. This project came in on-time and on-budget, meeting all the required performance criteria.

Susan's other duties include providing the government with exposure on new technologies, providing technical expertise to other construction engineers on the design and building of clean rooms and laboratories, and providing technical information to Parsons' internal design engineers. Among the other activities in her 30+ years of clean room engineering experience, Susan also designed and consulted on a clean room for the Japanese Atomic Energy Research Institute (JAERI), was the chair of the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Handbook Committee for the Technical Committee 9.11 (TC911), developed and restored a severely damaged facility after the Serra Grande Fire at Los Alamos, and constructed a facility for the International Atomic Energy Agency (IAEA) in Vienna, Austria.

Track: Facility & Process Design
Presentation: Case Study: You Need a Small Clean Room For….. So Where Do I Start?

Listen to Susan's special audio recording to learn more about her session:

Fernando J. Muzzio, Ph.D.

Director, NSF ERC on Structured Organic Particulate Systems, Professor II, Department of Chemical and Biochemical Engineering
Rutgers University

Track: Product Development
Presentation: Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing

Moheb Nasr, Ph.D.

Vice President, CMC Regulatory Strategy, Global Regulatory Affairs, GlaxoSmithKline Former Director of the FDA Office of New Drug Quality Assessment
CDER

Track: Product Development
Presentation: Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing

Wenzel Novak, Ph.D.

Director Pharmaceutical Research and Development
Groninger

After study of biology he started his PhD in physics at the Max-Planck-Institute for Neurochemistry in Munich. The main aspect of the thesis was the activity correlated signal distribution on linear grown brain cells measured by potential-sensitive fluorescent dyes.

In the next position he was head of laboratory in a biotech-company based in Germany and Switzerland. The main interest of this company was differentiation and cultivation of skin-sheets, created out of hair roots (Keratinocytes) used for wound healing.

As head of production for presterilzed syringes, in a company manufacturing plastic and glass primary packaging components, he designed and built the manufacturing area, installed the QA-system and operated the start-up phase of production.

Next he took over responsibility for the project management 'presterilized syringes', focusing on new customer requests in syringe functionality.

Since January 2006 he became director pharmaceutical research and development at a supplier of pharmaceutical equipment, primarily focusing on liquid filling. Center of his business is to improve the knowledge base of standard processes and looking into new attempts to be used in filling and attendant pharmaceutical processes.

Track: Manufacturing & Process Design
Presentation: Case Study: Use of Pre-Sterilized Single Use Disposable Fluid Paths in Sterile Manufacturing

Robert K. Orgera, AIA, LEED, AP

Sr. Architect, CRB Architects & Engineers
CRB Architects & Engineers, Inc.

Robert K. Orgera, AIA, LEED AP is a Senior Architect at CRB Architects & Engineers. Rob has over 20 years of architectural design experience focused on the programming, master planning, and design of "technically driven" biopharmaceutical manufacturing and research facilities.

Mr. Orgera's experience encompasses the full spectrum of Life Science facilities - from discovery and development labs to large scale manufacturing facilities with specialized design expertise in the master planning of complex and multi-product GMP-compliant manufacturing operations, including both mid-range and large scale bulk biologics and pharmaceutical production, as well as aseptic fill/finish facilities.

Before joining CRB, Mr. Orgera was a Principal Architect in the Life Science division of CH2M HILL and prior to that, he was Director of Architecture for the Biopharmaceutical division of Lockwood Greene. He is an active member of ISPE the AIA, as well as the US Green Building Council. Mr. Orgera holds a Bachelor of Architecture degree from the Pennsylvania State University.

Track: Facility & Process Design
Presentation: Case Study: Why Logistics Modeling and Architectural Layouts is Important

Listen to Robert's special audio recording to learn more about his session:

Mike Porter

Consultant
Commissioning Agents, Inc.

Mike Porter has 23 years of diverse experience across product development and manufacturing operations in pharmaceutical, medical device, laboratory and medical diagnostic businesses, providing leadership in quality, operations, process engineering and project management. He is a proven manager of large and small groups with demonstrated abilities to coach and develop technical staff and managers, identify root cause and quickly resolve issues, and successfully implement business processes. Mike held various positions of responsibility for 19 years with Eli Lilly and Company, for 4 years with Myriad Genetic Laboratories, Inc. and joined CAI in June of 2011.

Track: Regulatory QA/QC
Presentation: Streamlining Risk Management Evaluations for New Manufacturing Processes

Yihong Qiu, Ph.D.

Research Fellow, Oral Drug Products, Manufacturing Science and Technology, Global Pharmaceutical Operations
Abbott Laboratories

Dr. Yihong Qiu is a research fellow of the Volwiler Society at Abbott Laboratories. His in-depth knowledge, broad expertise and extensive experience encompass various phases of product development, including preformulation, drug delivery, product/process design, biopharmaceutics/pharmacokinetics, formulation/process development, scale-up and optimization, technical trouble-shooting, intellectual property and regulatory registration for NCE's, line-extension and marketed products. He also plays a key role in the product life cycle management, IP strategy, scientific and regulatory assessment of business opportunities. His work has resulted in successful commercial IR and MR products, patented drug delivery technologies, IVIVC's and biowaivers.

Dr. Qiu is a fellow of the American Association of Pharmaceutical Scientists (AAPS). His research interests include modified-release delivery systems, dissolution, bioavailability, IVIVC, drug delivery technology and science-based regulation. He has more than 50 publications in journals and books, 30 patents granted or pending, and numerous conference presentations. He contributes regularly to professional organizations and institutions, such as AAPS, CPA, FDA, and universities by presenting, lecturing, editing/refereeing publications, and organizing meetings. Dr. Qiu received a BS in Pharmacy, a MS. in Pharmaceutics from China Pharmaceutical University, and Ph.D. in Pharmaceutics from The University of Iowa.

Track: Product Development
Presentation: Case Study: Product and Process Understanding in Supporting Post-approval Change

Rosario Quintero-Vives

Sr. Regulatory & Compliance Specialist
RQV Consulting

Validations Specialist with 6 years of experience in the Pharmaceutical and Biopharmaceutical industries. Including expertise in compliance, commissioning, remediation and CAPA projects in Puerto Rico and the Continental US. With experience in diverse environments like the Academia, design and Project management. Worked on laboratory for final and intermediate products. Experience in environments such as Consent Decree and warning letters. Constructions for regulated environments and commercialization of new drugs.

Track: Regulatory QA/QC
Presentation: Seven Things You Should Do Before Facing an Inspection

Jim Robertson

Sr. Technical Director of Facilities Integration
Fluor Enterprises, Inc.

Jim is a technical specialist who integrates the architectural, process, building systems and equipment features necessary to ensure a regulatory compliant facility design within the parameters of clients' cost and schedule objectives. Jim has more than 29 years of experience in planning and executing projects from initial feasibility through construction administration. He has been dedicated to the definition and integration of Pharmaceutical and Biotech facilities at Fluor Enterprises for over 24 years. During this period his practice has been focused on the development of industry specific tools for scope definition, total facility master planning and the conception of solutions for technology-driven architectural designs.

Jim has recent, relevant, experience in both the optimization analysis of existing facilities and the application of new technology innovations, such as, SUT (single use technology) systems. SUT design integration ranges from selective application of specific systems to the development of comprehensive manufacturing prototypes.

Track: Facility & Process Design
Presentation: Case Study: Asset Optimization & Flexible Multi-Product Facility Concepts

Craig Sandstrom, Ph.D.

Director of Process Engineering
Fluor Enterprise Inc.

Craig is a Fluor Technical Fellow specializing in biopharmaceutical process development and facility design. He has a PhD in chemical engineering and has more than 20 years of biotech manufacturing experience. Craig has industry-leading cell culture expertise, including bioreactor and purification system design and optimization, as well as familiarity with formulation and fill & finish technologies. He has closely followed the industry development of single use/ disposable systems and has been widely published on the subject.

Track: Facility & Process Design
Presentation: Case Study: Asset Optimization & Flexible Multi-Product Facility Concepts

Jeff Slutsky

Director of Design for Six Sigma
Bausch and Lomb

Jeff Slutsky is Bausch & Lomb's World Wide Director of Design for Six Sigma. His is responsible for successful worldwide deployment of Design Excellence (DEX) on all appropriate B&L product development efforts.

Mr. Slutsky has worked in Korea, Germany, France, England, The US, and Malaysia with dozens of companies including 3M, Samsung, Maytag, Hoover, Westinghouse Air Brake, Trane Air Conditioning, Becton-Dickinson, Cummins Engine and StorageTek where he has trained and certified over 1,000 DFSS Green, Black and Master Black Belts.

His expertise includes corporate deployment of DEX, new product development process re-engineering, integration of DEX with product development processes, systems engineering and FDA/ISO design control, gate keeping and the DFSS tools including stakeholder analysis, quality function deployment, measurement system analysis, design of experiments and robust design.

He gained this expertise as former CEO of Product Development Systems and Solutions (PDSS), Inc., worldwide DFSS/product development consultant for Sigma Breakthrough Technologies (SBTI), Inc., a control systems designer, a current product/manufacturing engineer, and senior systems development engineer for Eastman Kodak and Johnson&Johnson Health Care. Mr. Slutsky has spent twenty-five years in medical products development.

Mr. Slutsky is an adjunct professor at the Rochester Institute of Technology where he teaches graduate and undergraduate courses in Control Systems, Robust Design and Product and Production Systems Development. He is co-author of the Prentice Hall text, "Design for Six Sigma in Technology and Product Development" and the CRC Press text "Corporate Sigma".

Track: Manufacturing & Process Design
Presentation: Case Study: Translating the New Process Validation Paradigm to Cleaning Processes

Richard Smith

Director, Life Sciences & Specialty Services
FedEx

Richard Smith has a deep understanding of the valuable role logistics serve in connecting people and goods and creating economic growth. As the son of FedEx founder Frederick W. Smith, he literally grew up with the business watching FedEx evolve from an express shipping company to a worldwide portfolio of services. In his role as Managing Director of Life Sciences & Specialty Services, Smith provides strategic direction for developing customized logistics and supporting specialized services.

Smith joined FedEx Services in 2005 as a Senior Solutions Analyst. In 2007 he was promoted to Manager of Supply Chain Solutions, responsible for FedEx SupplyChain. In 2009 he was promoted to Managing Director of Life Science and Specialty Services.

Smith earned his undergraduate degree from George Washington University and his Juris Doctor from the University of Mississippi School of Law. He serves on the following Boards: Greater Memphis Chamber, LeBonheur Children's Hospital Foundation, and Blue Streak Scholarship Fund.

Track: Keynote
Presentation: Creating Innovative Cold Chain Solutions for your Pharmaceutical and Biopharmaceutical Products

Raul Soikes

Sr. Director, Program Management R&D
Baxter Healthcare Corporation

Responsible for global contract manufacturing project management of small volume parenteral products (liquid and lyophilized vials, syringes, and cartridges). Manage an interdisciplinary group of 30 individuals responsible for clinical and commercial products from 40+ pharmaceutical and biotech companies, translating into 60+ projects, providing revenue of more than US $300M.

A hands-on pharmaceutical and diagnostics professional with expertise in process/product development, validation, in-house/contract drug substance, drug product and immuno-diagnostics manufacturing, project management, risk management, in/out-licensing, operations, facility design/start-up, and leading global interdisciplinary drug development teams.

Educated in Microbiology with post-graduate degree in Immunology & Toxicology at San Jose State University, Soikes' career path includes positions with Bristol-Myers Squibb, Vion Pharmaceuticals, Inc., Genelabs Diagnostics Pte. Ltd, Singapore, and Genelabs Technologies, Inc.,

Soikes has proven success in national and international matrix organizations developing manufacturing processes, transferring technology, creating procedures and documentation, establishing regulatory compliance, preclinical and clinical development of chemicals, biological and vaccines, and new chemical entity global regulatory submissions, approvals and launch.

Track: Supply Chain
Presentation: Is Your CMO Committed to Your Success?

Dr.-Ing. Karl F. Rix

Chief Executive Officer
DASGIP BioTools, LLC

Dr. Karl F. Rix is the Executive Director of North American Operations at DASGIP AG in Germany as well as the CEO at DASGIP BioTools, LLC in the US. DASGIP is an industry-leading supplier of benchtop bioprocessing hard- and software solutions for the biotech, pharmaceutical and chemical industries as well as academia and research institutions.

Karl is responsible for the North American ventures of DASGIP focusing on sales, service and support excellence of DASGIP's operations. As an experienced international professional in biotechnology holding a doctoral degree in mechanical engineering, Karl has more than 15 years of knowledge and experience in the application of advanced process technology. Karl received a Master of Sciences and later a PhD in Mechanical Engineering from the RWTH Aachen University. Karl started at DASGIP as the Director of Marketing and Sales in 1997 and became Director of North American Operations in 2003.

Track: Product Development
Presentation: Integrated Design of Experiment (DoE) for Benchtop Bioreactors

Ivan Toponarski

Project Engineer
Allergan Medical

Ivan Toponarski is a Project Engineer at Allergan, Inc. in Boston, MA. Prior to this role, Ivan joined a start-up medical device company, Serica Technologies, Inc. (formerly Tissue Regeneration, Inc.) in 2005. Serica Technologies developed silk-based biomaterial platforms used for soft tissue repair of weaknesses caused by disease, trauma or aging. During the start-up phase, Ivan supported the company's growth in almost all areas including research and development, quality control, pre-clinical and clinical studies.

During this fast paced and volatile time, Ivan learned how to diligently and effectively work on multiple projects while maintaining focus to perform well on each. Ivan continued to grow with the company as it was acquired by Allergan, Inc. in 2010. Today, as a Project Engineer supporting GMP and new process development activities, he brings his passion, commitment, and problem solving attitude to his everyday work at Allergan.

Ivan was born and raised in Croatia. In 2002, he earned his Bachelor's degree in Mechanical Engineering from University of Rijeka, Croatia. Following his graduation, Ivan moved to the United States to continue his education and received his Masters of Science in Mechanical Engineering from Tufts University.

Track: Regulatory QA/QC
Presentation: Streamlining Risk Management Evaluations for New Manufacturing Processes

Michael Trocchia, P.E. CPIM

Director Project Management, Supply Chain Management
Novartis Pharmaceuticals Corporation

Mike started his career with Novartis in 1984 as a process engineer at the then Ciba-Geigy facility in Summit NJ. Mike steadily progressed to senior Process engineer in the Chemical Development group, overseeing the manufacture of Drug Substance used in clinical testing. Mike then went on to manage the Commercial Drug Substance operations at the Summit site. His next assignment was to direct all Commercial Manufacturing operations at the Summit site before the site was closed and operations moved to alternate Novartis facilities. Mike then moved to the Suffern, NY site as head of Quality Management and Training where he laid the groundwork for the very successful LEAN manufacturing implementation at the plant.

In 2001, Mike moved to the Supply Chain Management organization at the East Hanover, NJ site. Mike's current role at Novartis involves Project management for the Supply Chain area for all new Product launches, Production transfers, and Life cycle management changes for the Novartis US pharmaceutical business.

Mike has a BE degree in Chemical Engineering from Stevens Institute of Technology, a Master's certificate in Project Management from The George Washington University, holds the APIC's CPIM certification and is a licensed professional engineer in the state of NJ. He lives locally in the East Hanover Area with his wife and son, and is very active in the local community volunteering his time for several charitable organizations.

Track: Supply Chain
Presentation: Case Study: Pharmaceutical Distribution Outsourcing

NAME

title
company

Bio

Track: track name
Presentation: presentation name

Listen to Peter's special audio recording to learn more about his session:

Aaron Weinstein

Northeast Regional Director - Commissioning & Qualification
IPS - Integrated Project Services

Aaron Weinstein has over twelve years experience in validation. His broad range of practice includes: Validation and Commissioning Master Plan development, project compliance consulting, validation project management, validation training, quality review, development of commissioning documents and IQ/OQ and PQ protocols. He has audited validation programs for compliance with FDA and corporate requirements. Aaron is assisting with implementation of the ASTM Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment for a number of clients. His experience includes validation and commissioning of facilities, warehouses, utilities, critical utilities and bioprocess, API and OSD process equipment.

Track: Facility & Process Design
Presentation: Implementing Commissioning and Qualification In Line with the FDA's Recent Process Validation Guidance

Listen to Aaron's special audio recording to learn more about his session:

Bill Whitford

Sr. Market Manager, Cell Culture
Thermo Fisher Scientific

Bill Whitford is Sr. Market Manager, Cell Culture for Thermo Scientific Cell Culture and Bioprocessing in Logan, UT with over 20 years experience in biotechnology product and process development. He joined the company nine years ago as a team leader in R&D developing products supporting biomass expansion, protein expression, and virus secretion in mammalian and invertebrate cell lines. Products he has commercialized include defined and animal product-free hybridoma media, fed-batch supplements, and aqueous lipid dispersions. He had previously served as Manufacturing Manager for PHASE-1 Molecular Toxicology in Santa Fe, New Mexico producing custom and standard DNA microarrays. An invited lecturer at international conferences, Bill has published over 150 articles, book chapters and patents in a number of fields in the bioproduction arena. He now enjoys serving on the Editorial Advisory Board for BioProcess International.

Track: Manufacturing & Packaging
Presentation: Single Use Technology Enabling Biosimilar Manufacturing

Steven Wisniewski

Principal Compliance Consultant
Commissioning Agents, Inc.

Steven J. Wisniewski is Principal Compliance Consultant for Commissioning Agents, Inc. a highly respected provider of technical services for biotech and pharmaceutical manufacturers world-wide. Commissioning Agents focuses on the manufacturing process, with services including commissioning, validation, technology transfer, PAT, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining CAI he was Senior Associate and Director of Compliance for IPS. Steve was senior consultant for Drug and Device Associates and has served in senior management roles at Sterling Winthrop and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities and upgrades. He holds a BSME from Rensselaer Polytechnic Institute, is a Member of PDA, and an active Member of ISPE. He served on the ISPE board of directors beginning in 1982, and was chairman of the board in 1991. Currently, Wisniewski was chairman of the ISPE Community of Practice for Commissioning and Qualification from 2008/2010, and was on the ISPE task team that developed the ASTM E2500 Verification Standard. He also was a leader on the Task Teams that developed the ISPE Guide' for Verification (C&Q), and on the Task Team developing the new ISPE QRM C&Q Good Practice Guide .

Track: Manufacturing & Packaging
Presentation: Case Study: Introduction to the New ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

Matthew P. VonEsch

Manager Manufacturing Fill/Finish
United Therapeutics

Matthew P. VonEsch holds the position of Manager, Manufacturing Fill/Finish with United Therapeutics, a rapidly growing pharmaceutical company based in Silver Spring, MD, where he is responsible for managing the company's sterile manufacturing operation. Prior to joining United Therapeutics Mr. VonEsch was employed by Wyeth, Human Genome Sciences and MedImmune where he held various positions of escalating responsibility in manufacturing and product development. With over 10 years of professional experience, Mr. VonEsch has been directly involved in several facility design and startup projects including successful PAI inspections. Mr. VonEsch holds a B.S. in Biochemistry from Merrimack College.

Track: Manufacturing & Process Design
Presentation: Case Study: Use of Pre-Sterilized Single Use Disposable Fluid Paths in Sterile Manufacturing

Shane Yount

Principal / Author
Competitive Solution, Inc.

Shane Yount is a Principal/Author with Competitive Solutions, Inc. Shane is a highly respected performance improvement consultant in the areas of strategic business solutions, work team implementation, and employee and leadership development. He brings extensive experience in the food processing industry, having joined Perdue Farms, Inc. the nation's third largest poultry grower, and processor. Shane blends both a comical and a no-nonsense approach to his presentation style. Popular on the lecture and leadership development circuit, Shane energizes his audience through the power of real life situations and innovative business solutions that all leaders and employees can immediately implement. Shane is the author of numerous training programs and implementation modules currently being taught in corporations throughout the country.

Track: Regulatory QA/QC
Presentation: Proven Processes and Metrics to Optimize Operational Excellence

Glenn Alto

President and CEO
Pharmalucence, Inc.

Glenn Alto is the President and Chief Executive Officer of Pharmalucence, Inc. Pharmalucence specializes in contract manufacturing services and the manufacturing and marketing of radiopharmaceuticals. Glenn holds responsibility for developing the company's strategic plan and assuring its implementation via investment in physical infrastructure, human resources and quality systems. His current focus is on the construction of a new corporate headquarters including 50,000 square feet of technical space featuring barrier isolation enabled aseptic drug manufacturing, formulation, development, QC and microbiology laboratories, cGMP warehousing, labeling, inspection and packaging facilities. Prior to his twenty years with Pharmalucence and its predecessor organization, Glenn held marketing and sales roles at several early-stage biotech companies specializing in large-scale recombinant protein and antibody manufacture. Glenn holds a B.S. Biochemistry from the University of New Hampshire and an M.B.A. from Bentley University.

Track: Thursday Special Presentation
Presentation: Making It in Massachusetts: A Small Company's Road to the CMO Market

Listen to Glenn's special audio recording to learn more about his session:

Edward Connolly

Chief Operating Operator
Pharmalucence, Inc.

Ed Connolly is the Chief Operating Officer at Pharmalucence, Inc. located in Bedford MA. He has been at Pharmalucence since December 1997. Ed's responsibilities include General Operations, Plant Engineering/Validation, Pharmaceutical Development and Contract Services Management. He has over 25 years experience in small volume parenteral product development/ technology transfer and manufacturing. Prior to joining Pharmalucence, he spent 18 years at the DuPont Merck Pharmaceutical Company in Billerica, MA where he held various positions within the Research and Development Group. Ed received his BS in Biology (1979) from Westfield Sate College and a Certificate of Special Studies in Business Management and Administration (1985) from Harvard University. Ed is a long time member of both the PDA and ISPE and serves on the ISPE Sterile Products Processing COP Steering Committee.

Track: Thursday Special Presentation
Presentation: Making It in Massachusetts: A Small Company's Road to the CMO Market

Listen to Edward's special audio recording to learn more about his session:

Suneela Prodduturi, Ph.D.

Director
STEER Engineering

Track: Product Development
Presentation: Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing

Shams Rustom, M.Pharm, RPh.

Senior Director, Product Development & Manufacturing
Labopharm

Track: Thursday Special Presentation
Presentation: Development of Novel CR Formulation Mitigating Dose Dumping & Misuse

Listen to Sham's special audio recording to learn more about his session:

Amit Srivastava

Project Manager
Labopharm

Amit Srivastava works as the Project Manager at Novartis Institute of Biomedical Research in Cambridge MA. He is currently leading their Operational Excellence program. Prior to this, Amit has held position with key responsibility in life science/ technology domain. He received his MS degree in Electrical & Computer Engineering from the Mississippi State University and an MBA from the Babson College.

Track: Manufacturing & Packaging
Presentation: Case Study: Path to Reduce Operational Expenses and Improve Operational Efficiency

Leonard W. Mestrandrea, PhD., RM (NRM)

Principal Consultant
Mestrandrea Consulting LLC

Len has more than thirty five years of QA/QC experience in the Pharmaceutical Industry. He was the Senior Science Advisor for Pfizer's Global Quality Technical Services Group; the Director Worldwide Microbiology Support at Schering-Plough; Associate Director of QA at Sandoz and the Chief Microbiologist at the Brooklyn District Office of the FDA. He also has more than 25 years experience as an Adjunct Professor teaching at a number of universities and colleges in the New York and New Jersey areas and is a member of the USP Microbiology and Sterility Assurance Expert Committee. He holds a Doctorate in Microbiology from St. John's University/Pacific Western University, a Master of Science degree in Clinical Microbiology from Wagner College and a Bachelor of Science degree from St. John's University.

Track: Regulatory QA/QC
Presentation: Microbiological Considerations for Non-Sterile Pharmaceutical Products