Agnes Shanley is currently an industry editor and journalist. Agnes was previously a senior editor and project manager for Chemical Week Associates and for McGraw-Hill, where her work won awards for editorial excellence. While at McGraw-Hill, she ran a continuing education program for scientists and engineers, and subsequently launched a magazine focused on Web-based technologies for the process industries. With a B.A. in liberal arts from Barnard College, Columbia University, and a B.S. in chemistry and life sciences from the City University of New York, she has covered the pharmaceutical, biotech, and chemical industries extensively for publications that include Chemical Engineering, Chemical Processing, Chemical Business, Chemical Marketing Reporter, and the Homeland Defense Journal. She has also worked as a research analyst, focusing on industrial applications of IT, for FIND/SVP.

Dr Beatrice was elected Vice President, Corporate Regulatory and Quality Science by Abbott's board of directors, effective November 1, 1999. Prior to joining Abbott in this position, Dr Beatrice was a Vice President at Quintiles, in Rockville, Maryland. Before joining Quintiles in 1996, Dr Beatrice, a retired Admiral and Assistant Surgeon General in the United States Public Health Service held various executive management positions at the U.S. Food and Drug Administration. He serves on the Executive Advisory Council of The College of Integrated Science and Technology at James Madison University, and is a Principal Visiting Staff Member at University College, London. In addition, he is a charter member of the Food and Drug Administration Alumni Association and a member of the Association of Food and Drug Officials.

With the current challenges facing the pharmaceutical industry, an integrated and holistic approach to quality systems based on scientific principles can help transform pharmaceutical manufacturing. Dr. Frank Deane, the President of Manufacturing for Eli Lilly and Company, who is the member of Lilly’s senior management council and operations committee, speaks on how this is possible by creating a sustainable quality culture, meeting regulatory and patient expectations, and by increasing efficiency and effectiveness of manufacturing operations.

Lean manufacturing is associated with being effective and productive. This can involve better ways of performing work, using technology or having less people doing the work. It is the latter aspect that is often the focus of adverse comments about Lean. It is sometimes said that going Lean may lead to issues such as regulatory compliance. Nigel Holcombe with over 25 years experience in the Pharmaceutical industry, who has held a number senior level positions in both research and commercial operations examines the principles of Lean and shows how they can actually help to improve regulatory compliance and also lead to productivity gains. He will also discuss reduction in variability and errors, as well as the use of technology, visual performance indicators and other principles.

An important FDA initiative that has gained a lot of attention and momentum in the past couple of years is the application of process analytical technology (PAT). This initiative encourages the use of modern analytical technology in pharmaceutical production of clinical supplies and commercial manufacturing operations. It supports building in quality and monitoring the quality as the product is being manufactured rather than testing the product to quality. Dr. Richard Winokur, the Associate Vice President, Clinical Investigational Products for Sanofi-Aventis, with over 30 years of experience in all aspects of manufacturing and packaging of pharmaceutical products, addresses the use of Near-IR (NIR) spectroscopy for on-line monitoring of packaging and release of clinical supplies. Learn how a proven and reliable technology like NIR, which is likely to be far better than that of a traditional sampling and testing scheme, can provide tighter process control and improve documentation for process validation.

ICH Q9 risk based approach has initiated a new wave of thinking in the pharmaceutical companies. Traditionally the Commissioning and Qualification has been driven by bottom up approach focused on equipment and systems. The new paradigm is focused on “Risk to Patients” initiating a much needed migration to focus commissioning and qualification to critical aspects of the design intent. However, this new approach is still in it’s infancy with the pharmaceutical companies struggling to operationalize this concept. There is skepticism about the value and uncertainty around the logistics. Dr. Mohan, the recipient of the top leadership award within Lilly and the author of “Pharmaceutical Operations Management” with over 18 years of Bio/Pharmaceutical experience presents an overall strategy of integrating the risk based approach in the commissioning and qualification plan. He also presents a logical approach for implementing this strategy.

Utilizing a Right First Time approach, Pfizer reengineered the artwork release and vendor proof approval process across its Packaging Services Organization. By streamlining and eliminating low value-added activities while maintaining the highest quality service to their customers, Pfizer was able to identify significant cost savings of over $1 million, 2 headcount, in addition to time-to-market savings. Judy Bickart, the Director of Package Design and Development, in Pfizer’s Global Manufacturing organization, who is also the Vice-Chair of the Pharmaceutical Packaging and Labeling Committee (of the IOPP) speaks on how to transform your process from the “conventional” methods of managing artwork for packaging (which have long been the standard of the U.S. pharmaceutical industry) to a leaner and more cost and time effective process. This change in process benefits both the customer and supplier, in a true win-win situation.

Randy Maddux, the Vice President of Manufacturing Operations for Human Genome Sciences, who is responsible for three manufacturing facilities and supporting functions, and Supply Chain activities, examines the state of the industry in 1997 versus 2007, providing a valuable insight into the direction where the industry is heading. This presentation also explores listens from other industries, and how they can be important to the future of Pharmaceutical industry.

“Your organization’s right to exist depends on your ability to adapt”. In this increasingly difficult marketplace, the current business models for Supply chain organization will no longer be effective. Supply Chains must reinvent themselves and LEAN Sigma tactics enable that transformation regardless of size, product mix and customer orientation. LEAN Sigma enables an organization to work smarter in a resource constrained environment. Bruce Sawyer, the Senior Director Operations Excellence Global Pharmaceutical Sourcing Group at Johnson & Johnson, a certified Six Sigma Black Belt, addresses issues associated with inventory management, cost, quality, customer focus and people which are all critical issues for the Pharma industry over the next 60 month.

Ralph Napolitano is currently the Director of Quality Management Assurance for Hoffmann-LaRoche, Nutley NJ. His degree is in Chemistry/Forensic Science. He began his career in the pharmaceutical field as an FDA Investigator in the NJ office in 1977 where he rose to the position of Supervisory Investigator. He left FDA for Hoffmann-LaRoche in 1989 and since 1993 as been the Director of Quality Management Assurance. In this position his responsibilities include disposition of all marketed and clinical drug products for the USA market

At present the pharmaceutical industry is looking into improving efficiency of manufacturing to reduce cost by improving cycle time, minimizing in-process inventory and reducing the number of deviations and loss of batches. Process benchmarking should be conducted on regular basis to identify process gaps, build and maintain “fingerprint” of the input and in-process materials, monitor trajectories of unit operations, observe practices of operators, ensure clarity of batch records and note precision and accuracy of unit operation equipment. This will enrich the understanding of the science behind manufacturing to make the processes more robust and reliable. Dr. Prakash Parab, the Director of Manufacturing Technology in Bristol-Myers Squibb, Technical Operations, with twenty one years of experience in pharmaceutical product development and manufacturing presents case studies of benchmarking, instrumentation to characterize in process materials, PAT applications and quality by design in sale up and site transfer.

To balance the high cost associated with R&D under today’s difficult economic pressure, one of the strategies for the Biopharmaceutical industry is outsourcing and off-shoring. Manufacturing has been an area where many industries have realized great cost-savings by moving abroad. For the Biopharmaceutical companies there is an added incentive to manufacture abroad, so that they can access the growing markets for healthcare products in developing economies. As offshore locations for manufacturing establish better intellectual property protection and the operating environment in these countries improve over the next five to ten years, more companies are expected to follow this strategy. Victor Batista, the Technology Director at Wyeth, who has extensive experience in the pharmaceutical industry, primarily in the International Standards and requirements for Validation, Manufacturing and Quality Assurance, provides a comparative overview of different offshore alternatives, from the tax havens such as Puerto Rico, Ireland and Singapore, to the affordable manufacturing countries such as China and India. This presentation explores the advantages and disadvantages of the different offshore manufacturing operating models; foreign direct investment, join venture/partnership, and international outsourcing. Additionally, how to maximize the experience and understand the risks associated with this strategy, as the industry faces new global quality and regulatory requirements.

Biopharmaceutical manufacturing operations continuously generate a large and rich set of process data. The potential for leveraging these data for process improvement and other purposes has grown exponentially over the past 10 years with increased availability of enterprise systems and computing power. Effectively gathering and utilizing the right data requires an approach that addresses a number of technical and organizational barriers. Jack Prior, the Director of Process Analysis and Engineering at Genzyme Corporation, who is involved in developing and leveraging process data systems for monitoring and improving biologics manufacturing operations in Massachusetts and Europe, and providing expertise in process modeling, scheduling, economic, and capacity analysis across Genzyme maps out the diverse business processes supported by manufacturing process data systems and summarizes lessons learned in the area over time.

Peptides have long been used for therapeutic purposes. In the past, these were relatively simple peptides meaning a few amino acids. These molecules were relatively easy to synthesize in the small quantities that were required. A significant effort currently is focused on development of new peptides that are longer in chain length and required in higher volumes. Control of the manufacturing processes that this scale presents unique challenges to maintain consistent quality required to ensure safety and efficacy to the patient. Steven R. Beck, Ph.D., the Director of Engineering and Facilities for Roche Colorado Corporation, who is responsible for the planning and executing all capital investment projects as well as maintenance of all facilities, and has authored over 20 publications and presentations, addresses how the use of new control technologies allow for the economical manufacture of these compounds which offer therapies to treat increasingly difficult diseases.

With the worldwide increase in pharmaceutical product counterfeiting, many approaches are being tried. One of the most promising to-date has been RFID tags on the packing containers or individual bottles. However, one problem is that individual doses are not covered by this program. Emil Ciurczak, with more than 35 years of experience in the pharmaceutical industry, who has published over three dozen articles, over 150 magazine columns, and nearly two hundred technical papers, and is currently a consultant in the field of Pharma NIR for various pharmaceutical companies, instrument manufacturers, and the FDA, who also holds patents for NIR-based devices and software, discusses how technologies, such as Near Infrared or Raman, in Conjunction with RFID, can assist in verification of the actual product at any spot. This combination, utilizing the “process signature” (determined from a robust PAT program) of a product, which in fact, are simple and inexpensive, should enable enforcement agents, hospitals, and pharmacies to determine whether a product is real or counterfeit.

The Quality by Design paradigm drives better definition of the design space for processes to manufacture active pharmaceutical ingredients and drug products. This current trend increases the importance of the more quantitatively defined processes designed to match the existing or planned capabilities of the manufacturing platform. Jeff Martin, the Director of API Engineering Center in Global Process and Maintenance Engineering at Eli Lilly and Co. discusses a current approach being implemented to better assure that measurement and control capabilities of unit operations match the needs of the processes to manufacture new products

Statistical Process Control (SPC) is an analytical data-driven methodology using data collection, analysis and interpretation to measure and control quality, primarily, but not exclusively, in manufacturing processes. Dr. Nick Dayton, the Director of Business Process Improvement for Hospira, Inc., Global Operations, who has been responsible for Six Sigma/Lean program development and deployment for manufacturing and related business processes speaks on how SPC can be used as one of the most powerful tools in a process improvement professional’s arsenal for fighting and reducing process variance and how this can result in reducing costs, improving customer satisfaction and providing meaningful continuous process improvement activities.

Richard Fecteau is Chairman of SOLABS’ board since 2002. In February 2005, he joined the management team of SOLABS as CEO. Richard has 20 years of experience, including over 15 directly in the pharmaceutical industry. Prior to joining SOLABS on a full time basis, he was Senior Vice-President of Confab Laboratories, a cGMP contract manufacturing organization (CMO). Prior to Confab, he was Vice-President and general manager of Invensys Pharmaceutical Solutions, a company of Invensys plc. Under his leadership, the company saw its operation quadruple in size in less than 5 years. Richard earned his Bachelor of Science degree in Industrial Engineering from l’École Polytechnique de Montréal in Canada. He is a member of Quebec’s OIQ engineering Association, and a certified Project Management Professional (PMP), and graduate from executive business school at McGill (Management) and Queen’s University (Finance). Richard speaks on new paradigm in business process management (document / workflow optimization / cost reduction / compliance risk mitigation). This is the opportunity for you to learn how the burden of regulatory compliance can be transformed into a strategic advantage using available technology and regulations.

Dr. Shah has over 21 years of varied experience in process R&D, bulk manufacture, outsourcing and regulatory filings at Pfizer Global R&D. During his tenure at Pfizer, Dr. Shah was responsible for developing cost effective outsourcing strategies and implementing the best business practices for which he is well regarded and recognized within Pfizer and CRO’s across the globe.

Counterfeit drug distribution is a growing problem worldwide. Pharmaceutical manufacturers, wholesalers, and government regulatory organizations have taken notice and have begun to take action to combat this serious threat. Many companies have begun to upgrade the anti-counterfeiting measures they use for their drug packaging and some have even tried pedigree tracking methods based on proposed government regulations. However, packaging protection alone does not solve the problem. Jim Whittle, the Vice President of Business Development, who is leading NanoInk’s worldwide business development activities, discusses how unit dosage protection measures created by NanoInk’s Nanoencryption™ technology are also required to more fully ensure that patients are receiving the right medication by enabling authentication of each individual dosage at any point in the supply chain. Gain insights on how unit dosage protection can be vital to providing the highest level of patient safety and why it should be utilized as part of a multilayered approach to fighting anti-counterfeiting and illegal diversion.

Package inserts and outserts have undergone their most significant changes in the past 25 years with the 2006 FDA regulations. These regulations now dictate new formats for providing information. As a leader in package insert and outsert markets within the healthcare industries, pharmagraphics has faced multiple opportunities to address and solve the packaging concerns which all drug companies are facing. The awareness of technologies to assist in the printing, folding and general converting of product that function and provide value to the end user will be addressed by Ernest Chaplin, the Vice President of Marketing and Sales for Pharmagraphics. Ernest also highlights their work in 2006 to successfully launch Exubera, the first inhaled insulin on the market with Pfizer Pharmaceutical. He also shows how their expertise can be of benefit in many applications calling for compliance to the new regulations.

Dr. Vijay Tammara is currently Director, Global Regulatory Affairs at Merck& Co., Inc. Dr. Tammara received his Ph.D. in Pharmaceutics from University of Louisiana, Monroe, LA. He is an Editor for the Journal, “Clinical Research and Regulatory Affairs” and an Adjunct Associate Professor of Pharmaceutics at the University of Louisiana, Monroe, LA as well as the University of Pacific, Stockton, CA.. He previously served as a Senior Associate Director at Wyeth Pharmaceutuicals, Inc. and as an Assistant Director at Sanofi-Synthelabo, for Strategic Planning and Clinical Drug Development in the Division of World Regulatory Affairs. His independent career started at the FDA, where he held Reviewer, Senior Reviewer, and Team Leader positions in the Office of Clinical Pharmacology and Biopharmaceutics. He was elected as AAPS Fellow in 2006. He received several awards at the FDA including the CDER Outstanding Reviewer Award, FDA Outstanding Achievement Award.

Today, more than ever, pharmaceutical manufacturers are challenged to “do more with less”. They must comply with stricter FDA regulations, improve product quality, and enhance data security, all while reducing costs to remain competitive and profitable. Pharmaceutical companies face a number of challenges when it comes to reporting, data security, supplier quality, and cost. The inability to systematize and consolidate quality data coming from multiple facilities (including external suppliers) into a single system for analysis makes it difficult to streamline operations and quality initiatives. Without an effective real-time quality system, companies have to wait until after products are produced to measure quality, which could result in a great deal of waste, or even warranty claims and recalls. Doug Fair, the Vice President of Statistical Applications at InfinityQS, the author of two books on Statistical Process Control (SPC) and a columnist for Quality Digest, addresses managing quality across your enterprise and solutions on how your company can effectively collaborate with suppliers to implement a real-time supply chain quality management system to prevent quality issues from occurring.

Dr. Stephan P. B. Taylor is Director of Project & Process Optimization Systems in Process R&D, at the Bristol-Myers Squibb Company. Steve obtained his Ph.D. in Organic Chemistry in 1974 from the University of Vermont and then spent a year postdoc with Prof. Emil White at Johns Hopkins University, before joining the Process Development department at E. R. Squibb and Sons, later to become Bristol-Myers Squibb. His responsibilities have included process development, optimization and pilot plant scale-up, as well as, process transfer to manufacturing facilities. Steve supervised process development groups for 20 years, leading the Biorecovery Group, supporting the synthesis and isolation of natural products. Steve has been actively involved in Training, IT, Information Management, GMP, EHS, and green chemistry and engineering initiatives for many years. Steve was a BMS member of the IntelliChem consortium for “Synthesis” software. Steve was a member of Collaborative Electronic Notebook Systems Association (CENSA) and has served on its Steering Committee 2001-2003, and is a member of the AspenTech BatchPlus User Group.

Vivek Wadhwa is an Executive in Residence/Adjunct Professor for the Pratt School of Engineering at Duke University and a Wertheim Fellow at the Labor and Worklife Program at the Harvard Law School. He is a also a technology entrepreneur and a columnist for BusinessWeek.com. Wadhwa was named a "Leader of Tomorrow" by Forbes.com, and his company Relativity Technologies was named as one of the 25 "coolest" companies in the world by Fortune Magazine. Mr. Wadhwa holds a B.A. in Computing Studies from the Canberra University in Australia and an MBA from New York University.

Ms. Boire brings over 10 years of experience in Pharmaceutical manufacturing and regulatory compliance. She joined SOLABS in 2007 From ABBOTT where she was Quality Assurance Auditor. She previously had responsibilities in Documentation control and Quality Control. She holds a B.Sc. from Montreal University and is a certified 6-Sigma Green Belt.

Asish Adhikari currently heads the MES business in TCS and has 11 years of industry experience specializing in Manufacturing IT Systems. Asish is an expert in functional and architectural consultancy for MES systems and has extensive experience across Pharmaceuticals, Petrochemicals, Chemicals, Automotive, and Metal industry. He has varied experience in consulting global companies to help decide on their Manufacturing IT investments. He has advised Life Sciences companies in defining manufacturing IT framework that aims to dovetail all the industry challenges and drive operational excellence. The four pillars on which this IT strategy is based are: providing information and analyses to multiple layers of management, correlating & managing information from multiple sources, contextualizing information and redefining processes to support continuously shortening business cycles, and sharing information and actively collaborating across business units and enterprises

Mike is a Business Consultant in Business Systems Solutions providing leadership in consulting and business development for Invensys Validation Technologies (IVT) to their pharmaceutical and biotechnology industry clients. With 17 years of industry experience in quality and validation business processes, Mike has spent the last 7 years providing business system compliance/validation consulting to Invensys’ global life science clients. His current position with Invensys involves business development, solution development and project delivery support for client business systems (Performance Management Dashboards, ERP, MES, LMS, DMS, LIMs, Quality Systems, CRM and IS/IT Infrastructures). He holds a B.Sc. in Chemistry from the University of Toronto.

Tracy is the Subject Matter Expert in Plant Compliance providing leadership in consulting and business development for Invensys Validation Technologies (IVT) to their pharmaceutical and biotechnology industry clients. His 20 years in the industry have been spent managing process development, regulatory compliance and validation initiatives in established and expanding organizations. In addition, he provides strategic consulting in subject areas such as CGMP compliance, process/cleaning development/validation and utilities/equipment validation and cold chain assurance utilizing industry leading risk-based methods for clients in North America, Europe and Asia Pacific. Tracy is IVT’s voting member of ASTM for the E55 working standards on Process Analytical Technology (PAT) and is an active member of ISPE and PDA. He holds a B.Sc. in Chemistry from of York University.