Curran M. Simpson joined HGS in March 2003 as Vice President, Manufacturing Operations. He was promoted to Senior Vice President, Operations, in December 2005. Prior to joining HGS, Mr. Simpson was Director of Manufacturing Sciences at Biogen's North Carolina facility. In this role, he led the technology transfer, start-up and validation activities for Biogen's large-scale manufacturing facility, and completed a successful pre-approval inspection (PAI) resulting in commercialization of Amevive. Previous to his position with Biogen, Mr. Simpson held process development and manufacturing positions with several biotechnology companies, including Genencor, Genentech, Novo-Nordisk (U.S. and Europe) and Covance. Mr. Simpson has been involved in the scale-up and manufacturing operations for a number of commercial products, including Pulmozyme, TNKase, Herceptin and Retavase. Mr. Simpson earned his M.S. degree in Surface and Colloid Science (Physical Chemistry) from Clarkson University, and his B.S. degree in Chemical Engineering/Chemistry from the Clarkson College of Technology.

Jim leads the Corporate Environment, Health and Safety group responsible for the full range of EHS programmes, including setting the direction for EHS at GSK and the provision of environment, health and safety governance and support to all operations. Prior to joining GSK in 1983, Jim has worked in the chemical industry and the US Environmental Protection Agency on environmental issues in the areas of research, design, construction, permitting, and enforcement. Jim has an undergraduate degree in chemical engineering, a Masters degree in Environment Health Engineering and another in Management Sciences, and a PhD in Environmental Engineering. He is a registered Professional Engineer in Pennsylvania and Maryland, and is a Certified Quality Manager.

Novo Nordisk has set ambitious business targets to be achieved through implementation of a Lean Six Sigma program. A major focus of this initiative has been on the importance of change management and communication to ensure the workforce is fully involved. The workforce has been engaged from top to bottom and across multiple sites and has been encouraged to identify best practices to leverage this across the organization. Tangible results, effectively communicated have reduced skepticism and ensured that the workforce remains engaged and supportive of the process.

Olivia Darmuzey has been leading the QbD team at Novartis' Stein (Switzerland) drug product manufacturing facility for almost 2 years. Prior to this position at Novartis, Olivia had been working on the development of novel pharmaceutical technologies at FMC, Brussels. Her experience in development of these innovative technologies has given her the opportunity to gain expertise in QbD, continuous manufacturing and quality risk management. Her current role includes the approval of a QbD submission and the successful first QbD pre-approval inspection within Novartis.

Dr. Robert Miller is the Executive Director at the Shingo Prize for Operational Excellence, based in the USA. Widely acknowledged as the pinnacle in lean recognition, the Shingo Prize for Operational Excellence operates on the philosophy that world class business performance is achieved through the application of lean tools and techniques to create a sustainable culture of continuous improvement.

Dr. Martens is a leader in the biotechnology industry with over 20 years life science experience in manufacturing operations and advanced product development technologies. He joined MannKind Corporation (Nasdaq: MNKD) in 2005 as Corporate Vice President of Operations and Chief Technology Officer. MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. As a member of the executive team, he is responsible for all technology development activities, technology transfer and the implementation of commercial manufacturing infrastructure. Dr. Martens previously served as Vice President of Pharmaceutical Technology Development for Nektar Therapeutics (Nasdaq: NKTR), a leading pioneer in advanced drug delivery technologies. In this role, he increased development capabilities by 100% by implementing process improvements which impacted the entire product life cycle. In his earlier career, he held technical management positions at Aerojet Fine Chemicals and FMC Corporation. Before that, he held a variety of management positions with progressive roles and responsibilities in R&D and plant management at Lonza AG, in both Switzerland and the United States.

Abigail E. Smith joined MannKind Corporation (Nasdaq: MNKD) in 2006 as the Vice President of Corporate Engineering. Her responsibilities included construction and renovation of a 250,000 square foot facility to commercially manufacture MannKind's lead product Afrezza(r). In January of 2009, she assumed the role of Vice President of Manufacturing Operations, responsible for Technology Transfer, Clinical and Commercial Manufacturing. MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. Abigail Smith was formerly employed by Nektar Therapeutic as Sr. Director of Facilities and as a Process/Project Engineer at Alcon Laboratories, ALZA Corporation and Merck. Previous to employment at MannKind Corporation she established a Project Management Company in Jackson, WY.

Robert Lippe is the Director of Manufacturing at Genentech’s Vacaville bulk bio-pharmaceutical manufacturing facility. For 25 years, Robert has held positions of operational leadership in manufacturing, research and military environments. Prior to joining Genentech, Robert worked at Lawrence Livermore National Laboratory and the U.S. Coast Guard

Ms. Murray is a Senior Manager in the GCMC Regulatory Affairs department and oversees global regulatory submissions for both investigational and commercial products within Pfizer Biotech. Ms. Murray has provided the regulatory leadership for the execution of Quality Risk Management across Pfizer’s Biotech sites. Her risk management experience includes efforts in the areas of facility design, operations and controls, process containment, cross-contamination prevention and control, as well as multi-product/multi-host considerations. Ms. Murray frequently represents Pfizer at conferences, community symposia, and within industry working groups.

In his role as Risk Management Principal, Mr. Reich leads Pfizer’s Quality Risk Management community of practice, and facilitates development and harmonization of Quality Risk Management best practices across a global network of locations. He routinely provides organizational leadership, project management, training, and facilitation for risk management programs and initiatives. Mr. Reich’s leadership of pharmaceutical risk-based initiatives has included diverse topic areas such as quality systems, multiproduct facilities, manufacturing operations, engineering & maintenance, finished product AQLs and packaging, and the integration of QRM with Lean Six Sigma operational excellence (OE) initiatives.

After finishing PhD in organic chemistry at UEA in England, (supervisor Sandy McKillop) Peter worked for the next ten years for Parke-Davis/Warner Lambert in drug discovery and chemical development. He moved to Genzyme in 1994 and assumed leadership of chemical development in 1997. The development group now focuses on chemical and analytical development, PAT, statistical process control and process modelling, clinical trial supply and regulatory filings.

Mitch is the Director for Global Engineering at Biogen Idec. In this position he is currently focused on providing scenario evaluations and front end planning for global footprint strategies including office, lab and internal manufacturing facilities.

Sue Fleet is CEO of Britest, a not-for-profit company focused on delivering innovations in process design via unique partnerships between industry and academia. Sue’s career spans key roles with the UK Police’s Forensic Science Unit and various Government Departments, including the Chemicals Unit of the now Business Innovation & Skills Department where she was responsible for managing innovation and skills activities and promoting collaboration between industry, academia and government. 1n 1999, Sue became an independent consultant to the UK Chemical Industry before being appointed CEO of Britest in 2004. She has a degree in Chemistry and Earth Sciences, is a member of the General Assembly of the F3 Factory; a European Union Framework VII Project, and Chair of the UK Chemistry Innovation Academic Stakeholder Forum.

Since 2000 Professor Dr. Thomas Friedli is a member of the Faculty of the Institute of Technology Management at the University of St. Gallen (HSG). After graduating in Business Administration he wrote his PhD thesis about management of co-operations at the University of St. Gallen. In 2004 Thomas Friedli became Privatdozent and Assistant Professor at the Institute of Technology Management. He is also Managing Director of the Transfer Center for Technology Management (TECTEM) since 2004. Thomas Friedli’s main focus is the management of industrial enterprises. His area of expertise is in strategic operations management and management of industrial services. He leads a group of postgraduate students who develop new management solutions for European manufacturing companies in today’s business landscape. He is an expert for the EU in the 6th framework programme and a consultant to several major European manufacturing companies. Amongst others, he was responsible for the recent survey of operational excellence in the pharmaceutical industry together with APV (Germany). He is teaching in several executive programmes in St.Gallen, Fribourg and Aachen.

Todd joined Oracle through the acquisition of Agile (08/2007). As Sr. Director of Life Sciences at Oracle he is responsible for aligning industry requirments with Oracle applications and drive future product development in the industry. As Sr. Director at Agile Software he was responsible for managing the Agile PLM life science practice (since 2002). Todd Hein has more than 25 years of experience in the life science industry. Prior to working in the software industry, Hein held executive positions in medical device companies responsible for developing, FDA registrations, manufacturing, and marketing of class II and III medical devices.

Ellen Reilly is a Managing Director with PricewaterhouseCooper’s Life Sciences practice. She leads our US Life Sciences Supply Chain operations. Ms. Reilly’s experience includes: Supply Chain, Manufacturing, Logistics, Order to Cash, IT enablement and Regulatory Compliance business functions and processes. Prior to joining PwC, Ms. Reilly was employed at BearingPoint. Prior to consulting, she was employed by Roche Pharmaceuticals, Centocor, and Rorer Pharmaceuticals in a variety of roles. She holds a Bachelors degree from LaSalle University, and an MBA in the International Management program at Drexel University . She is a member of BIO, Healthcare Women's Business Association, Institute of Business Forecasting, and HDMA.

RJ is the Pharmaceutical Market Manager at Donaldson Torit. For 15 years, RJ has held positions as a sales engineer and market manager in the Pharmaceutical industry as well as the Sanitary Food and Dairy markets, covering North and South America, Europe and the Middle East. Prior to joining Donaldson Torit, RJ worked for GEA NIRO Filtration Process Engineering.

David M. Powell is a Vice President and Partner of A.T. Kearney, Inc. He has 17+ years of industry and consulting experience primarily in the Consumer Goods, Pharmaceutical and Medical Device industries. Mr. Powell’s expertise includes such areas as Supply Chain network strategy, External manufacturing, Strategic Sourcing, Product portfolio/complexity management, Market entry and Organization restructuring. Prior to joining A.T. Kearney in 1996, Mr. Powell held positions as a Product Development Engineer and in Engineering Project Management. Mr. Powell earned his MBA degree in Strategy and Finance from Case Western Reserve University, and his M.Sc. B. Sc. in Engineering from The Ohio State University.

David Hanfland is a senior partner in A.T. Kearney’s Healthcare and Operations practices. He has been advising clients on topics including supply chain management, manufacturing strategy, merger integration, SG&A cost reduction, and strategic sourcing for over 20 years. David primarily serves multi-national clients in the pharmaceutical and medical device manufacturers and pharmacies in North America. In addition for being with A.T. Kearney for over 12 years, David also led an operational consulting practice for Huron Consulting Group for five years. David has an MBA from The University of Chicago Booth School of Business and a BS in Business from The Indiana University Kelley School of Business. He is a Certified Public Accountant and is on the Dean’s Advisory Council for the Kelley School of Business and is a member of the advisory board for Clarke Environmental.

Holly Gamage is the Vice President of Strategic Initiatives for Heritage Environmental Services, a nationwide environmental services company focused on providing innovative value-driven solutions to manufacturers largest environmental problems. Ms. Gamage’s career with Heritage has included key roles such as VP of Business Growth and Development, Account Development Manager and Senior Operations Manager. In these roles Ms. Gamage has provided organizational leadership, strategic planning, new business development, implementation and program management. Holly leads the Heritage National Program Management group responsible for a full range of solutions for Heritage’s nationwide customer base. She is responsible for managing innovation and promoting collaborative programs between Heritage and customers to achieve optimum value for every one. Holly has dedicated her career to a cleaner environment making her a vital asset to the Heritage family and its customers.

Sean is the Global Director of Cleanroom and Bio-Pharma Segment for Camfil Farr. In 1983, Sean started his career with Ireland-based Allied Filters and Pumps in the manufacturing area. Allied Filters and Pumps was Camfil Farr’s first acquisition in 1985. Sean’s talent and expertise has paralleled Camfil Farr’s substantial growth holding multiple leadership positions across the organization. He advanced into a sales management role for the Ireland operations early in his career and shortly thereafter expanded his sales management responsibilities to the UK market. In the mid-1990’s, Sean was appointed as the first cleanroom segment manager for Camfil Farr with focus in the semiconductor industry. From there, he assumed the sales and marketing manager position for the Asia-Pacific region while still holding the role as group cleanroom segment manager. Sean relocated to the U.S. as regional sales manager and bio-pharma segment manager for North America in 2002. Capitalizing on his wealth of experience for this key market segment, Camfil Farr promoted Sean in 2009 to his current position where he is globally responsible for cultivating, managing, and supporting Camfil Farr’s cleanroom/bio-pharma clients. Sean has been an active member in ISPE since 1995. He is recognized as an industry expert on air filtration applications and solutions presenting regularly to industry associations.

Randy Tatlock is currently a Sr. Applications Specialist at Aegis Analytical Corporation. He has more than 25 years of experience in manufacturing, process control, manufacturing informatics and process intelligence in E.I. DuPont, Westinghouse SRC, G.E. Plastics and Eli Lilly and Company. Just prior to joining Aegis, Randy worked as an Information Consultant in global manufacturing operations for Eli Lilly and Company. During his 18+ year tenure at Eli Lilly he had many varying responsibilities with the most recent focused on providing integrated manufacturing data along with reporting and analysis tools to the business to facilitate and enhance their operational effectiveness. This resulted in a global program to implement the Aegis Discoverant environment throughout Eli Lilly’s manufacturing operations.

Actually Sales Director in the Industrial and Tertiary Markets Department of Veolia Environnement Group, Jean-Jacques DELOBELLE has an experience of more than 20 years within the group. He handled in particular the management of the waste recycling subsidiaries, before turning to the industrial sector and the demand of global waste management. Then he completed this experience by integrating the energy and water services supplied to the industrial customers. Today, he’s more specifically in charge of sales management for the pharmaceutical sector, to answer the quality requirements of the industrial customers as well as the new challenges which the sector has to face both at the level of economical and environmental performances. Veolia Environnement has an unparalleled experience with leaders of pharmaceutical sector as Wyeth, Pfizer, BMS particularly in Europe and worldwide.