Tuesday 23rd April 2013

08:00 Registration and refreshments Registration and refreshments

08:40 Chairperson's welcome and opening remarks Ann Merchant, President, Schreiner MediPharm Chairperson's welcome and opening remarks Ann Merchant President, Schreiner MediPharm Ann Merchant is President of Schreiner MediPharm, a business unit of Schreiner Group based in Oberschleissheim near Munich in Germany. Schreiner MediPharm develops and produces innovative, multi-functional specialty labels with value-added benefits for the pharmaceutical industry. Ann is responsible for the sales organization, global strategy and further development of the business unit building o [read more]

08.50 Opening keynote: Drivers for, and industry response to, need for pharmaceutical supply chain security Tim Valko, Executive Director Operations Risk Management, Amgen Criminal threats to the pharmaceutical supply chain are increasing and becoming more sophisticated: counterfeiting, theft, Internet sales, and smuggling/illegal diversion of medicines. Governments are responding to these threats with new requirements around supply chain security including serialization, good distribution practices and incident alerts. Companies are building comprehensive supply chain security programs to support patient safety. Rx-360 is one industry organization that provides a forum for companies to collaborate in sharing and benchmarking different aspects of these programs. This key note talk will summarize these drivers including reviews of recent actual incidents and will introduce attendees the benchmarking whitepapers and networking Rx-360 is producing to assist the supply chain in enhancing security. Increasing criminal threats to the supply chain and growing regulatory attention to controls are driving manufacturers to develop comprehensive Supply Chain Security systems including Recent trends in criminal attacks (counterfeits, thefts, Internet) Analysis of recent actual incidents Key regulatory drivers Company approaches to protecting the supply chain What does a fully integrated, global programme look like and how are companies learning from each other? Introduction to the Rx-360 Supply Chain Security initiative – impacts on both developed and emerging markets Completed benchmarking studies / whitepapers on: Management Systems, Cargo Theft, Market Monitoring, Audit/Assessments of Third Party Providers Current projects: Unlawful Diversion, Management Notification, Serialization Discussion Group Joint and shared supplier audits and other Rx-360 activities Tim Valko Executive Director Operations Risk Management, Amgen Tim Valko has worked in Biopharmaceutical Supply Chain for over 19 years in positions in drug substance and drug product manufacturing, inspection and packaging, planning and inventory management, distribution and logistics, Import/export compliance and project management. Tim joined Amgen in 2007 as supply chain site head, at Amgen’s Fremont California manufacturing facility. C [read more]

09.20 Case study: Combining capacity and global risk management – diversifying centres of supply to manage and mitigate uncertainty worldwide Hillel West, Executive Director, Operations and Supply Chain Strategy, Teva Pharmaceuticals Balancing global supply and demand Geopolitical risk considerations and the shift towards emerging markets as supply centres Increasing scrutiny of API materials by regulators – what this means for network footprints and GMP Supply surprises and realities on the ground Fitting the strategy into an increasingly tender-based world Ensuring preparedness for new markets and technologies Hillel West Executive Director, Operations and Supply Chain Strategy, Teva Pharmaceuticals Hillel West is responsible for development of Operations and Supply Chain Strategy at Teva Pharmaceuticals - the world's largest supplier of generic pharmaceuticals. Teva's strategy includes the balancing of global optimisation with local accountability and a dynamic, entrepreneurial business culture. Hillel has 25 years Supply Chain experience in Pharmaceuticals and CPG, in various Supply Chain M [read more]

09.50 Case study: Securing the Sanofi supply chain Frédéric Bourgeois, AVP, Global Quality Supply Chain, Sanofi Where it all goes wrong – security & integrity done right, and how bad things can be when done wrong Partnerships with regulatory bodies, customs and law enforcement – making the best use of your allies Active surveillance measures to take The utility of dedicated laboratory resources and infrastructure A layered approach towards product protection and security Frédéric Bourgeois AVP, Global Quality Supply Chain, Sanofi Frédéric Bourgeois is head of Global Quality Supply Chain for Sanofi Group. He is pharmacist. He has joined the Industrial Affairs of Sanofi in 1987 as plant manager, then, distribution platform manager in France and in the US, before to become Associate Vice President, in charge of leading and coordinating the Quality, Security and Traceability of Sanofi products [read more]

10.20 Innovation spotlight: Strengthening the supply chain by thinking out of the box Markus Bauss, Senior Project Manager, Schreiner MediPharm Combating the counterfeiters with smart and efficient security solutions Multi-level security systems for tamper-evidence, authentication and track & trace Innovative and unconventional approaches to adapt proven security technologies to your specific application Case studies and practical examples to meet your anti-counterfeiting challenges Markus Bauss Senior Project Manager, Schreiner MediPharm Markus Bauss is Senior Sales & Project Manager of Schreiner MediPharm, a business unit of Schreiner Group based in Oberschleissheim near Munich in Germany. Schreiner MediPharm develops and produces innovative, multi-functional specialty labels with value-added benefits for the pharmaceutical industry. Markus is in charge of global key account management and responsible for the mark [read more]

Morning refreshments and networkingSpeaker’s corner 10.30 Morning refreshments and networking Morning refreshments and networking Morning refreshments and networking 10.30 Speaker’s corner Speaker’s corner An area dedicated to interaction with the previous session’s speakers and panellists. This is your opportunity to network and speak openly and candidly about any questions not covered during their session.

11.00 Tackling security and traceability from both a strategic and tactical level – Engaging with stakeholders and learnings from on-the-ground pilots Jyrki Syvari, Corporate Director Supply Chain Integrity, Boehringer Ingelheim Global serialisation updates and pilots underway Aggregation – the hidden challenge Manufacturing process challenges Downstream distributor setbacks 1D vs. 2D barcode implementations The role of worldwide harmonisation and patient safety Jyrki Syvari Corporate Director Supply Chain Integrity, Boehringer Ingelheim Jyrki Syväri, Pharmacist and Chemist, made his PhD Theses in Pharmaceutical Chemistry and his Diploma in Chemistry in Analytical Chemistry. He joined Schering AG in Berlin and headed there a R&D Laboratory for the development of parenteral drugs. He left Schering AG to join Boehringer Ingelheim (corporate headquarters), where he became a Project Manager in Operatio [read more]

11.45 Empowering an end-to-end serialization solution Torben Vogt, Life Science Industry Expert, NNIT Think beyond compliance – understand the full scope, direct and indirect of Pharmaceutical Serialisation and reap significant benefits for your company Identifying the weakest link in your serialisation efforts, by thorough end-to-end planning of your initiative Choose an existing experienced full service provider with deep pharma and serialization insight Torben Vogt Life Science Industry Expert, NNIT Torben Vogt is a Life Science Industry Expert at NNIT, responsible for Business Development of Serialisation and Track & Trace. He has 25 years of experience from the industry and has been working at management level in number of functions, spanning from Finance, Planning, Logistics, Supply Chain, Sales & Marketing to IT. Prior to NNIT, he worked for 7 years at gene [read more]

Networking lunchSpeaker’s corner 12.15 Networking lunch Networking lunch Networking lunch 12.15 Speaker’s corner Speaker’s corner An area dedicated to interaction with the previous session’s speakers and panellists. This is your opportunity to network and speak openly and candidly about any questions not covered during their session.

13.15 Security and serialisation think-tank: Driving the benefits throughout the supply chain David DeJean, Vice President, Systech International Quantifying the benefits beyond regulatory compliance and counterfeiting – valuable applications in manufacturing, end to end visibility and optimisation and elsewhere With European traceability regulations still in the distant future, and with supply chain benefits readily evident, is now the right time to implement your own solution? Putting systems in place now to enable serialization data to be used for a competitive advantage How do we overcome the implementation hurdles? Structure: 5 minute presentation + 35 minute audience think tank and Q&A + 5 minute wrap-up David DeJean Vice President, Systech International Mr. DeJean, Vice President and veteran of Systech International for more than 25 years, is responsible for Systech’s Subject Matter Expertise Center, driven to support and educate customers and stakeholders on best practices for implementing a serialization program. As a member of the Executive Leadership Team, David brings a wealth of market knowledge, hands-on experience in se [read more]

14.00 Case study: Global product traceability in pharmaceutical production with SAP Track & Trace solutions Stefan Hockenberger, Sales & Marketing Manager, Movilitas Consulting Peer Laslo, Principal Consultant, SAP Deutschland Case study: Global product traceability in pharmaceutical production with SAP Track & Trace solutions Stefan Hockenberger Sales & Marketing Manager, Movilitas Consulting Stefan Hockenberger studied business administration in the “Berufsakademie Mannheim”, University of Cooperative Education. From 2002 to 2009 Stefan worked as Solution Sales Executive at SAP Germany AG & Co. KG and had the overall Pre-Sales responsibility for the “SAP Solutions for item Serialization (SAP AII/OER)& [read more] Peer Laslo Principal Consultant, SAP Deutschland Peer Laslo studied Business Administration at “Hochschule Pforzheim” University for Business Administration, Technology and Arts,. Peer worked from 1997 to 2001 for KPMG as Consultant focusing on ERP implementation projects. For the next three years, Peer worked as freelancer for various ERP and Business Development Projects. In February 2005 Peer joined SAP B [read more]

14.30 Proactive risk management to prevent drug shortages: Strengthening a fragile supply chain Thomas Zimmer, Corporate SVP, Environmental, Health, Safety and Sustainability, Boehringer Ingelheim Conducting a root cause analysis: discovering where risks originate and the impacts on product supply globally What regulatory bodies are doing in response – dealing with closer supply chain scrutiny FDA and EU updates and expected regulation Practical tools that can be immediately implemented to systematically assess and mitigate quality risk The ethical dilemma: cost of goods vs. margin vs. standards Working together: proactive collaboration to solve drug shortages Thomas Zimmer Corporate SVP, Environmental, Health, Safety and Sustainability, Boehringer Ingelheim SVP of the Corporate Division Quality & Environm. Health and SafetyHe studied pharmacy at the Johann Wolfgang Goethe University in Frankfurt/Main and made his PhD in Pharmaceutical Technology.Since 1981 Thomas Zimmer is with Boehringer Ingelheim where he had several positions in the Pharmaceutical Development and Pharmaceutical Manufacture and in the Area Management Operations (Ame [read more]

Afternoon coffee & networkingSpeaker’s corner 15.00 Afternoon coffee & networking Afternoon coffee & networking Afternoon coffee & networking 15.00 Speaker’s corner Speaker’s corner An area dedicated to interaction with the previous session’s speakers and panellists. This is your opportunity to network and speak openly and candidly about any questions not covered during their session.

Afternoon Focus Workshops

Product data change management, busine...Item serialization, compliance reporti...Recruiting, motivating & retaining... 15.30 Product data change management, business intelligence & master data done right: And how bad it can be when done wrong… Egbert Huensche, Head Global Supply Chain Development, Bayer Consumer Care AG Adrian Barrass, Strategic Information Director, AstraZeneca The key to end-to-end visibility: communicating between supply and demand across multiple locations globally Master Data The more we automate, the more important master data settings become It’s all about quality – how do you measure this? Setting targets and KPIs Exchanging master data with upstream suppliers to optimise the supply chain Navigating the complex regulatory issues Transferring from launch site to manufacturing site Picture of master data gone wrong Selling the need for consolidation and investment internally – overcoming the unsexy factor Egbert Huensche Head Global Supply Chain Development, Bayer Consumer Care AG Egbert has joined Bayer in 2001 when he took over responsibility for production planning and logistics at a fully automated production site. Beginning 2005 within the Acquisition of Roche Consumer Health he moved to Basel and held several positions. During the last Years he was responsible for Global Supply Chain development of Consumer Care which includes global master data strategy and operation [read more] Adrian Barrass Strategic Information Director, AstraZeneca A technology leader with extensive project management, general management and IT project leadership expertise. 20+ years experience delivering technology projects within pharmaceutical, chemical, oil and gas and FMCG across large and multinational organisations. Investigated, developed and deployed operations data strategy to create a step change in business performance a [read more] 15.30 Item serialization, compliance reporting and product traceability with SAP Track & Trace solutions Stefan Hockenberger, Sales & Marketing Manager, Movilitas Consulting Peer Laslo, Principal Consultant, SAP Deutschland Comply with country-specific legal regulations on serialization with one global solution Handle the creation, transfer and acknowledgement of notifications to authorities to achieve regulatory compliance Track business processes, assets, and goods in transit in real time Gain a corporate-level view on a cross-system product genealogy Execute precision product withdrawals and recalls Stefan Hockenberger Sales & Marketing Manager, Movilitas Consulting Stefan Hockenberger studied business administration in the “Berufsakademie Mannheim”, University of Cooperative Education. From 2002 to 2009 Stefan worked as Solution Sales Executive at SAP Germany AG & Co. KG and had the overall Pre-Sales responsibility for the “SAP Solutions for item Serialization (SAP AII/OER)& [read more] Peer Laslo Principal Consultant, SAP Deutschland Peer Laslo studied Business Administration at “Hochschule Pforzheim” University for Business Administration, Technology and Arts,. Peer worked from 1997 to 2001 for KPMG as Consultant focusing on ERP implementation projects. For the next three years, Peer worked as freelancer for various ERP and Business Development Projects. In February 2005 Peer joined SAP B [read more] 15.30 Recruiting, motivating & retaining talent Julian Amey, Principal Fellow, Warwick University Helena Buckley, Director, Talent Management, Supply Chain, Johnson & Johnson Developing a talent pipeline to meet the pharma’s current and future needs is one of the most pressing challenges facing SC management. This workshop addresses several high level perspectives on how SC leaders are pushing human capital efforts internally within the SC, rather than leaving this key function to the traditional HR route. Crucial requirements to develop human capital Building flexibility and redundancy into organisational structure by training people to be multi-skilled Practical skills and SC expertise Special SC needs Cultural and language needs SC management leader development – key capabilities Global perspective of regional and corporate culture Technical capabilities Cross-functional, relational leadership and communication Developing the right solution for talent-resilient supply chain organisation Combating the high competition for talented professionals in these regions Overcoming the profession’s low profile Professional accreditation Exploiting web-based training On-going education, retention strategies and incentives Exporting talent to emerging regions without leaving a gap in established region capability Julian Amey Principal Fellow, Warwick University Julian Amey joined ICI in 1978 as a control engineer. He had roles in engineering, production management, and production planning (on secondment in the US). From 1991 he had responsibilities for aseptic manufacture and new product introduction. In 1994 Julian coordinated supply chain re-engineering in Zeneca Pharmaceuticals until in 1998 he headed up Zeneca’s Supply Chain Group. [read more] Helena Buckley Director, Talent Management, Supply Chain, Johnson & Johnson Helena Buckley is the Global Talent Director for Johnson & Johnson Supply Chain supporting the Janssen Supply Chain and Customer Logistics Services Organisations. Helena has over twenty years experience in Human Resources across a range of industries in Medical Devices, Pharmaceuticals, Commercial and the service Industry. Helena’s experience to date has focused [read more]

17:00 Building a secure, global track and trace platform to protect patients and ensure compliance in today’s diverse regulatory and supply network environment Shabbir Dahod, President and CEO, TraceLink The patient safety, track and trace compliance and market access challenges confronting Life Sciences Why big data, massive global networks, diverse track and trace regulations and changing technology standards are driving a Life Sciences transformation The global cloud-based network information architecture required to meet this transformation How leading companies are using cloud-based networks to protect product integrity and ensure compliance from ingredient to patient The global track and trace environment and its business, operational and IT implications for Life Science companies The hidden product, serialization and supply chain transaction data management challenges that put your company at risk  The network information architecture required to meet emerging global compliance deadlines Case study of how one Top-10 pharmaceutical company designed their core serialization and track and trace strategy to meet the global challenge and their learnings throughout deployment Shabbir Dahod President and CEO, TraceLink Shabbir Dahod, President and CEO of TraceLink, has been a cutting-edge innovator focused on the intersection of technology, business and management to improve corporate performance for over 29 years. He led new collaboration and knowledge management initiatives at Microsoft before launching numerous startup companies including SupplyScape Corporation, the de-facto leader in software solutions to s [read more]

17.30 Californian E-Pedigree requirements: Taking a leadership role to drive national standards with international impacts Virginia Herold, Executive Officer, California State Board of Pharmacy History of the e-Pedigree movement Determining the stakes at risk by delaying Which technology solutions will maintain compliance – message/cloud/etc Rule exemptions Timelines: What must be done and by when? Benefits to the recall process, patient health and manufacturer costs Potential pre-emption by federal legislation / FDA action – what you need to know about the introduction of a national drug supply chain security bill into Congress Virginia Herold Executive Officer, California State Board of Pharmacy Virginia Herold is the executive officer of the California State Board of Pharmacy, a position she has held since July 2006. Prior to this appointment, Ms. Herold served as assistant executive officer of the Board for 16 years.A graduate of the University of California, Ms. Herold holds Bachelor of Science and Master of Science degrees. Her education involved a blend of consumer protection, econom [read more]

18.00 Chairperson's summary & end of summit Chairperson's summary & end of summit

18.15 LogiPharma networking drinks reception LogiPharma networking drinks reception

19.30 LogiPharma Pre-Conference Networking Dinner To be hosted by Camelot Management Consultants This invitation-only dinner is solely for manufacturers attending Logipharma to network before the main conference begins. If you are interested in attending, please contact logipharma@wbr.co.uk Otherwise, you will receive a personal invitation from Camelot Management Consultants.