BIOGRAPHY: Yolande joined Johnson & Johnson about 20 years ago, a year after graduating as master in commercial engineering. She has had several roles within procurement/sourcing and is currently responsible for business excellence within the Global Pharmaceutical Supply Chain organization.

BIOGRAPHY: Gerald Heddell joined the MHRA as Director of the Inspection, Enforcement & Standards Division on 4 January 2005. Gerald is a microbiologist who is a Chartered Biologist and a member of the Institute of Biology and the Royal Society of Chemistry.
Since leaving the UK National Health Service in 1978, he has worked in a succession of progressively senior roles in manufacturing and quality assurance in the pharmaceutical industry. Gerald has experience in most aspects of pharmaceutical manufacture and control.
In his current position with the MHRA, Gerald's responsibilities focus on the quality of medicines in the UK and include a comprehensive surveillance, inspection and enforcement programme, the licensing of pharmaceutical manufacturers and wholesalers, defective medicines reporting, unlicensed imports, borderline products, medicines testing and the British Pharmacopoeia.

BIOGRAPHY: Graham’s current position in Wyeth’s Global Quality & Compliance organization is Senior Director, Process Knowledge/Quality by Design and he is responsible for leading Wyeth’s Quality by Design efforts for all business units (Pharmaceuticals, Biotechnology, Vaccines and Consumer Healthcare) in Europe, Asia-Pacific and Latin America. He holds the Wyeth vote in the ASTM International E55 committee which is developing consensus standards for QbD/PAT in pharmaceutical manufacturing. Graham is involved in several EFPIA QbD/PAT initiatives, and is a member of the control strategy team in the ISPE PQLI initiative. Previous roles in Wyeth included Technology Director for European External Supply and Formulation Director for Wyeth Consumer Healthcare in Richmond, Virginia. Graham has also worked for Reckitt & Colman in formulation development and programme management and for Beecham Pharmaceuticals. He is a registered pharmacist and completed his Ph.D. in pharmaceutics at the School of Pharmacy in London.

ABSTRACT: The new paradigm of Quality by Design, as described in the ICH Q8(R1), Q9 and Q10 guidance documents, presents a tremendous opportunity for the pharmaceutical industry to improve manufacturing efficiencies and enhance the assurance of quality. This presentation will describe Quality by Design, show how PAT is complementary, and why this is a win-win-win for industry, regulators and patients. The application of QbD principles to gain product and process understanding will be described, and examples from Wyeth’s successful QbD/PAT regulatory submissions will be used to discuss how to incorporate this knowledge in a filing. Some of the tools and approaches used to implement QbD within Wyeth will also be described.

BIOGRAPHY: Andrew is a British national and has been Vice President, Global Corporate Security with Novartis Corporation since June 2008. In this capacity Andrew manages Novartis’ global anti-counterfeiting program. Novartis Corporate Security maintains regional offices in Asia, Latin America, US and Europe. Andrew has been with Novartis since August 2002. Andrew worked previously as a Security Adviser for Société Générale de Surveillance (SGS) AG and as an independent security consultant. Prior to moving to the private sector Andrew spent 13 years with the UK Foreign and Commonwealth Office (FCO) and enjoyed postings in the UK, Latin America, and Central and Eastern Europe. Andrew holds an MSc (with distinction) in Security and Crime Risk Management, a BA Hons. in Modern Languages (French and German) and is a qualified linguist in Russian, Czech and Spanish.

ABSTRACT: This presentation covers the Green Chemistry program at Pfizer, information will be given regarding (i) The development of tools to influence greener solvent and reagent selection in medicinal chemistry (ii) The results of the solvent switching program in Pfizer’s Research Division (iii) The environmental benefits of the enzymatic synthesis to manufacture pregabalin.

BIOGRAPHY: Peter Dunn completed his PhD in Organic Synthetic Chemistry at Imperial College, London (1984-1987). He undertook post doctoral research studies at the ETH, Zurich (1987-1988) and at the University of California Berkeley, (1988-1989). From 1989-2000 he worked in Chemical R and D at Pfizer in the UK as a project scientist and during this time was the inventor of the commercial processes to make four drugs including ViagraTM and EmselexTM Between 2000 and 2006 he was Director of Chemical Research and Development in the UK. In 2006 he took up his current role as the Global Green Chemistry Leader for Pfizer. He is also currently co-chair of the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable.

BIOGRAPHY: Valerio Trifoni is currently Finance and Controlling Director of Technical Operations in Ferring. He completed his Engineering Diploma at the University of Bari in 1990 and his MBA at MIP in Milan in 1993. Valerio started his career in the consumer electronics sector and in 1995 moved to Serono as Site Controller. In Serono he held several positions with increasing responsibilities in the area of Manufacturing Finance & Purchasing. In 2005 he was appointed Corporate Controller for Manufacturing and Process Development for the Serono Group. In June 2008 he moved to Ferring with the responsibility for Finance and Controlling for the Manufacturing Sites of the Ferring Group.

ABSTRACT: Paul currently leads Wyeth's Sourcing & Procurement organisation in EMEA. He created and implemented transformational strategy doubling annualized cost reduction performance over 3 year period whilst increasing productivity through outsourcing & offshoring transactional procurement processes across region.

BIOGRAPHY: Paul has a wide range of Procurement sector experience from engineering to marketing services coupled with considerable experience of strategy definition encompassing organisation, process & technology. His career in Procurement spans 20 years and includes senior management and consulting roles at British Airways, Ernst & Young and KPMG.

BIOGRAPHY: Malcolm obtained a PhD from Imperial college with Professor Donal Craig in 1993. He then joined Medicinal Chemistry at Glaxo at Greenford in 1993. He moved to process research and development in 1994. In 2001, he joined a new department that focused on new technologies and started a programme of work exploring continuous processing for the manufacture of API's.

ABSTRACT: Integration of the process development process into Manufacturing is key if the company intends to reduce Cost of Goods through designing products that will better fit into its industrial network and strategy.
The presentation intends to illustrate through various examples a framework that plans to:
- Analyze the Cost of Good from Development down the Supply Chain
-Understand influential product characteristics on the process to be implemented
-Integration of development input into Manufacturing, and vice versa, in order to fine-tune optimal configuration
-Highlight the benefits of Process Design.

BIOGRAPHY: Marc-Antoine is currently Knowledge & Innovation Manager at Solvay Pharmaceuticals in the Product Development & Support area.
Being a pharmacist and having a PhD in general economics, Marc-Antoine started his industrial career in the production area, where he progressed through line functions and management experience.
After 14 in this area and after significant experience in Technology Transfer, he understood that economics in production could be improved through better management of cost drivers and by embedding quality-in, during product development. He took responsibility in 2006 of a Global Technology Center supporting the Marketed products.
Since June 2009, his current function allows him to both continue working on the Manufacturing interface with plants (where added value is being generated) and giving him opportunity to influence development to make better “Quality by Design”.

ABSTRACT: This presentation will focus on the impact that the EMEA guideline on genotoxic impurities has had on the Pharmaceutical Industry and in particular on process development, and will outline a strategy to allow the risk posed by such impurities to be effectively managed.

BIOGRAPHY: Andrew Teasdale is currently a senior QA executive within AstraZeneca. His primary role is that of chair of the internal genotoxic impurities advisory group. This group is responsible for all matters relating to genotoxic impurities within the business, being responsible for both strategic direction and problem resolution. Andrew has been in QA since 2005 before which he was an analytical chemist in AstraZeneca. As well as his internal responsibilities Andrew leads 2 external groups working in the field of genotoxic impurities. One is an analytical group in the UK; the second, a Product Quality Research Institute (PQRI) working group , focusing on detailed studies of Sulphonate ester formation / decomposition.

ABSTRACT: This presentation will cover an overview of Merck's 'Commercialization Model' which helps accelerate new products through late stage clinical phases onto the market whilst minimizing at risk capital spend, using fungible resources, mitigating technical and scale-up risk and maximizing launch process capability. It will also include examples of how through a combination of organizational alignment, technical capability enhancement and the application of lean six sigma before, during and after launch that we have successfully and rapidly commercialized new products.

BIOGRAPHY: Liam is currently Director of Process Development and Commercialization based at the Merck, Sharp and Dohme, Ballydine, Ireland site. There he is responsible for Development and Commercialization of Drug Substance and Drug Product candidates from Phase IIB through launch and into mature supply. Liam has a BEng in Chemical Engineering from University College Dublin and MSc in Pharmacy, University of Manchester. His career has included roles in Operations, Strategic Planning, Research and Development and Technical Support in both Europe and the US.

ABSTRACT: This session will focus on how to implement a comprehensive and cost effective brand protection strategy to mitigate threats and protect public health. Participants will learn about the multitude of threats that companies face during the manufacture, distribution, marketing and consumption of their products. Threats such as theft, counterfeiting, diversion and product tampering will be discussed, along with how these threats can adversely affect public health. Participants will learn how an industry leader developed this multi-tiered strategy utilizing state of the art technology such as biometrics, RFID and GPS to reduce or mitigate these threats and simultaneously add value to the business.

BIOGRAPHY: Richard Widup is the Senior Director, Brand Protection within the Corporate Security team at Purdue Pharma L.P. Before joining Purdue, Richard was the Director, Americas Region for Pfizer Global Security. At Pfizer he had responsibility for all security related matters in the Western Hemisphere, including oversight of product integrity investigations involving counterfeiting, tampering and diversion of Pfizer products. At Purdue he is responsible for product integrity related issues. Richard previously served as a federal agent with the United States Army Criminal Investigation Command (CID) and with the United States FDA Office of Criminal Investigations. At FDA, Richard managed various programs involving counterfeiting, product diversion and product tampering. Richard also served as the FDA-OCI representative on the Permanent Forum on International Pharmaceutical Crime; an international law enforcement group developed to exchange and develop information regarding the global pharmaceutical counterfeiting problem.

ABSTRACT: EBR is a favourite theme for the Pharmaceutical industry for years. More and more companies evaluating and implementing EBR systems. What is really under the hood of EBR? How to balance investment versus benefits? Beside the obvious, where are the hidden benefits and the hidden pit falls? The talk shares experience of deploying an EBR and looks holistically on all aspects of challenges and results. Themes like deployment of EBR systems, process design, recipe authoring, recipe validation, recipe approval, execution and eBatch records review strategies are covered.

ABSTRACT: Pharmaceutical manufacturing is a highly complex process and requires robust and scaleable automation solutions to ensure consistent and compliant product output. Scaleable technology solutions enable easier technical transfer of pharmaceutical products as they move through their lifecycle by allowing the same technology, S88 model and recipe structure to be used at all stages of manufacture. PlantPAx from Rockwell Automation is just such a solution and this case study will describe how Rockwell Automation enabled a large Pharma customer to develop systems at both development & clinical scale.

ABSTRACT: EBR is a favourite theme for the Pharmaceutical industry for years. More and more companies evaluating and implementing EBR systems. What is really under the hood of EBR? How to balance investment versus benefits? Beside the obvious, where are the hidden benefits and the hidden pit falls? The talk shares experience of deploying an EBR and looks holistically on all aspects of challenges and results. Themes like deployment of EBR systems, process design, recipe authoring, recipe validation, recipe approval, execution and eBatch records review strategies are covered.

Brandenburg Economic Development Board (ZAB) and Berlin Partner are the regional development agencies for investors. Germany’s capital region offers outstanding potential for companies active in pharmaceutical production. Berlin Brandenburg boasts a large pool of educated professionals, unique and investor-friendly cooperation with public authorities, and the best subsidy opportunities available in Europe. Global players such as Nycomed, BASF, Bayer Schering Pharma and Menarini produce pharmaceutical products at state-of-the-art facilities. Regional pharmaceutical industry with further global players such as Pfizer and sanofi-aventis profits from the region’s outstanding scientific landscape, its renowned clinical research environment and its close proximity to the federal government.

During this session, we will introduce existing customer cases that exhibit how pharmaceutical companies spend significant time in expense planning, designing, customizing, and validating (IQ/OQ/PQ) their LIMS project.
Reduce your total cost of ownership - up to 85% versus traditional systems.
Speed of deployment - up to 75% time reduction
Reduce validation costs - up to 92% reduction by deploying industry best practice workflows.
~90% reduction in project personnel.
Very detailed documentation - CAPA and deviation cases such as Stability, OOT/OOS, and other laboratory anomalies such as calibration failures, SST failures and other exceptions that need a documentation history.

ABSTRACT: Quality by Design (QbD) starts in process development. This is where the best opportunity exists to design improved processes based on new process measurements and by taking advantage of previous experiences with similar processes. With the introduction of Process Analytical Technology (PAT) as a tool for achieving QbD in pharmaceutical and biotechnology processes, the volume of electronic and paper-based data collected during process development and manufacturing has increased dramatically. A critical success factor for achieving the goals of QbD is thus to provide on-demand access all of this data for end users in a collaborative analytics, trending and reporting environment in which the multidisciplinary team can collaborate productively. The most important requirements for this system are: a simple user-centric interface for direct, on-demand access to all the data from disparate sources; a practical way to capture paper-based data and make it easily available in electronic form; the ability to work with continuous (on-line) and discrete data together; sharing data, analysis results and reports across disciplines, scales of operation, and geographically dispersed sites; simplifying the preparation and distribution of analysis results; and automating the generation of periodic reviews and reports of batches and campaigns. This presentation will illustrate how these requirements can be satisfied with technologies readily available today.