1 A Pan-European Conference Effective R&D Controlling in the Pharmaceutical Industry How to avoid waste in R&D, select and prioritize R&D projects, allocate resources and successfully manage R&D risks and collaborations Steigenberger Hotel Berlin 26th & 27th January 2012 For pharma and biotech companies, success in R&D is a crucial factor for sustainable growth and longterm profit. R&D investments are important but an effective R&D controlling is also needed to create transparency, avoid waste and enable managers to take the right portfolio decisions. Plus: Optional Half-Day Interactive Workshop on 25th January 2012 How will R&D deliver valued medicines in a new Pharmaceutical market? The Conference Will Present Case Studies on Cutting Edge Topics such as: R&D controlling as a strategic management tool Valuing R&D projects and pipeline management Cost and resource management of R&D projects Performance measurement in Pharma R&D and KPIs Earned Value Analysis in R&D project controlling Learn to fail fast? Managing risk and uncertainties in R&D Successful outsourcing and collaboration of R&D projects Plus: Panel Discussion on Day One: How much controlling is useful in R&D? Managing the tension between freedom of creativity and controlling of innovations Early Bird Special Offer: Book by and save 10 % Co-operation Partner: In cooperation with Deutsche Bahn, marcus evans provides you the opportunity to travel from just 99, Euro to your conference (round trip). For further details please get on to your contact person at marcus evans. Co-operation Partner: marcus evans Expert Speaker Panel: Pasi Piitulainen Senior Director, Development Finance & Outsourcing, Clinical Development Actelion Pharmaceuticals Ltd. / Switzerland Dr. Christoph Willers Director Research & Development Almirall Hermal GmbH / Germany Dr. Serena Tongiani R&D Director Angelini Pharmaceuticals, Acraf S.p.A. / Italy Hans-Jürgen Federsel, PhD Assoc Professor; Senior Principal Scientist; Pharmaceutical Development AstraZeneca / Sweden Dr. Uwe Schlokat Adjunct Professor Biotechnology University of Applied Sciences Krems, Senior Director & Head of Global Project Management, Hemophilia Franchise Baxter BioScience / Austria Dr. Merike Glass Director Controlling Biotherapeutics / R&D Biotest AG / Germany Riccardo Mariani R&D Business Analysis Manager Chiesi Farmaceutici SpA / Italy Petra Storsberg Pharma Research & Early Development, Global Head of pred Finance F. Hoffmann-La Roche Ltd. / Switzerland Dr. Michael Herschel Director Clinical Research GlaxoSmithKline GmbH & Co. KG, Munich / Germany Dr. Thomas Högberg Director Chemical Research LEO Pharma / Denmark Dr. Jörg Möhrle Director Clinical Development Medicines for Malaria Venture MMV / Switzerland Dr. Markus Rudolph Vice President R&D and Operations Merck Consumer Healthcare Holding GmbH / Germany Riccardo Lampariello Associate Director, Valuation & Analysis, Portfolio Management Merck Serono SA / Switzerland Christoph Schmidt Head of R&D and Central Functions Controlling Nycomed GmbH / Germany Dr. Jörg Rennecke Director of Operations ORION Clinical Services GmbH / Germany Dr. Antti Haapalinna Vice President, Research, R&D ORION PHARMA / Finland conferences
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In addition to the exhibition format the event s educational conference is attended only by delegates who are pre-qualified, in most cases to a minimum spend of US$5 million and many with budgets in excess of $50 million. HOW WILL R&D DELIVER VALUED MEDICINES IN A NEW PHARMACEUTICAL MARKET? What makes a good drug? What are the trends in Pharma R&D? What should be the R&D drivers/ KPIs and critical success factors to deliver valued medicines in a new Pharmaceutical market? Refreshment Break R&D Excellence: leading R&D innovation through Operational Excellence (signature topic and real examples of using Lean and Six Sigma concepts applied in R&D): Process Optimization: Improving and optimising the efficiency and effectiveness of processes across all areas of R&D Project Driven R&D: Enhancing the delivery of drug projects through alignment and collaboration of project and functional teams across R&D Strategy Alliances: Enhancing value by fostering innovative partnerships Seamless R&D: Creating boundaryless, flowing, fast moving and effective R&D organisations Closing Remarks from the Workshop Trainers Chantalle Moerker Partner Bcos Coaching & Consulting Dr. Ludovic Otterbein Consultant R&D Excellence Practise Valeocon During the interactive workshop there will be sufficient time spent on discussions, sharing case studies, and exercises to stimulate ideas from the audience for the participants to take back to their working environment. Workshop Trainers: Chantalle Moerker holds a Masters Degree in Aerospace Engineering from the Technical University of Delft, Netherlands, and a Masters Degree in Organizational Psychology from the Open University Heerlen, Netherlands. She is a certified Lean Six Sigma Master Black Belt and an executive coach. Chantalle has a wide range of experience in supporting leadership teams of multi-national companies in the design and implementation of continuous improvement initiatives, like Six Sigma and Lean Management. She worked in several positions at a multi-national health care company, leading project teams and direct reports of which also six years in the pharmaceutical division of Johnson & Johnson. As of 2010 she started her own business Bcos Coaching & Consulting with the focus to support companies in improving their business processes, optimizing their organization structures and coaching individuals to achieve their goals. Dr. Ludovic Otterbein received a MSC in biochemistry in France and a PhD in biophysics from the Biomedical Research Institute in Boston. He is also a Lean Sigma certified Black Belt and executive coach. Following a productive scientific career working within an American life Science Institute, Ludovic joined AstraZeneca UK as scientist. He became quickly part of the team leading Lean and value chain transformation in R&D. After 8 years at AstraZeneca, Ludovic joined Valeocon Management Consulting, where he leads the R&D pharma service offering. Within Valeocon, Ludovic delivers expert coaching to Life sciences clients.
3 Day One Thursday, 26th January 2011 Booking Line: Tel: +49 (0) Fax: +49 (0) : Registration with Coffee and Tea Opening Address from marcus evans and the Chair Key Note: Methods and measures to increase R&D efficiency Early decision making on candidates Optimization of academic and CRO co-operations Early involvement of market access intelligence into R&D Translational medicine Dr. Christoph Willers Director Research & Development Almirall Hermal GmbH / Germany R&D CONTROLLING AS A STRATEGIC MANAGEMENT TOOL Case Study: Management Innovation to approach some of the fundamental problems in Innovation Merck Consumer Health Care Journey A rare opportunity How to build an Innovations Organisation from scratch and link it with strategy? Lessons learned Solving creative apartheid by building freedom in the front end and discipline in the back end process Accelerating redeployment of resources using a flexible approach on budgeting Giving people a chance to opt in to drive delivery Role of KPIs in getting pull and alignment not just in your kingdom but within the whole company Steering to ensure a consistent flow of new strategic options Structure follows Strategy Strategic pipeline orientation and impact on portfolio value Dr. Markus Rudolph Vice President R&D and Operations Merck Consumer Healthcare Holding GmbH / Germany Refreshment Break Case Study: Valuing R&D projects and pipeline management Project valuation Pipeline value, risk and return on investment Monte Carlo approach to pipeline modelling Riccardo Lampariello Associate Director Portfolio Management Merck Serono International / Switzerland Case Study: Managing the discovery pipeline in mid Pharma Alignment of projects with company objectives Balancing internal and external research Governance structure with separated scientific and strategic assessments Risk mitigation by proper gating criteria Dr. Thomas Högberg Director Chemical Research LEO Pharma / Denmark Luncheon Case Study: Critical R&D milestones to achieve the company s R&D goals Building value through the process of drug development Key documentation readiness Express decision-making with defined milestone achievements Serena Tongiani, Ph.D. Head of Research, R&D Director, Testing Facility Manager Angelini Pharmaceuticals, Acraf S.p.A. / Italy R&D PROJECT CONTROLLING, COST AND RESOURCE MANAGEMENT Case Study: Performance measurement in Pharma R&D A tool for efficiency improvement What are the drivers for measuring performance in R&D? Internal vs. external performance assessment An attempt to define a rationale which to use when Creating transparency in complex organizational matrices by measurement of simple parameters Is it worth the effort? A few case stories to demonstrate added value and avoiding pitfalls Hans-Jürgen Federsel, PhD Assoc Professor; Senior Principal Scientist; Pharmaceutical Development AstraZeneca / Sweden Case Study: R&D cost controlling tools and processes in a matrix organization: Implementation of a new tool of cost variance analysis Cost controlling along different axes: Dealing with the matrix Transparency and different languages of stakeholders Justification for deviation and the need to understand variances Systems supporting the cost variance analysis Riccardo Mariani R&D Business Analysis Manager Chiesi Farmaceutici Spa / Italy Refreshment Break Case Study: Earned Value Analysis in R&D project controlling What is the earned value analysis How earned value can be utilised by the controlling function How to overcome the differences of earned value management and annual budgeting Example of a simple EVM tool Pasi Piitulainen Senior Director, Development Finance & Outsourcing, Clinical Development Actelion Pharmaceuticals Ltd. / Switzerland Case Study: Budgeting and reporting in a project driven organization Budgeting along the project axis Challenges of the matrix Roles and Responsibilities within project teams Monthly follow up and efficient reallocation of resources Optimistic planning vs. realistic budgeting Christoph Schmidt Head of R&D and Central Functions Controlling Nycomed GmbH / Germany Panel Discussion: How much controlling is useful in R&D? Managing the tension between freedom of creativity and controlling of innovations Closing Remarks from the Chair marcus evans Invites: Informal Networking Drinks Reception after Day One. Speakers Will be Available to Answer Your Individual Questions.
4 Day Two Friday, 27th January 2012 Booking Line: Tel: +49 (0) Fax: +49 (0) : Registration with Coffee and Tea Opening Address from the Chair INTEGRATION OF R&D AND FINANCIAL CONTROLLING Case Study: How to marry financial data with a fully integrated project & resource management approach? The role of R&D Finance in a big Pharma company How to fuse portfolio data into financial core information The merits of a global and fully integrated portfolio, project & resource management approach Finance as customer of portfolio data Business partnering in the context of R&D process integration Petra Storsberg Pharma Research & Early Development, Global Head of pred Finance F. Hoffmann-La Roche Ltd. / Switzerland MANAGING RISK AND UNCERTAINTIES IN R&D Case Study: How to deal with technical risk in development project and portfolio management to ensure optimal performance? Capturing project risk for business case & portfolio considerations Calibrating risks across projects for portfolio assessments Handling risk in individual project planning Dr. Uwe Schlokat, PMP Adjunct Professor Biotechnology University of Applied Sciences Krems, Senior Director & Head of Global Project Management, Hemophilia Franchise Baxter BioScience / Austria Refreshment Break Case Study: Learn to fail fast? Risk assessment of current R&D projects according to defined criteria MMV is a not for profit product development partnership financed by public and philanthropic funds MMV has the largest portfolio of antimalarial drugs in development MMV works in collaboration with a large number of partners Decisions to continue or discontinue projects affects external partners and therefore need to be transparent to partners, funders and other stakeholders Dr. Jörg Möhrle Director Clinical Development Medicines for Malaria Venture MMV / Switzerland OUTSOURCING AND COLLABORATION OF R&D PROJECTS Outsourcing of R&D projects: What are the economic advantages and disadvantages? Efficiency and risk as key words for outsourcing Economic model of outsourcing Measuring the cost of outsourcing Tangible and intangible benefits Is there a place for strategic outsourcing? Dr. Michael Herschel Director Clinical Research GlaxoSmithKline GmbH & Co. KG / Germany Luncheon Case Study: Outsourcing and collaboration: What should be outsourced? At what stage and under which conditions is outsourcing useful? Defining the right outsourcing strategy Selection of partners for successful collaboration Core competencies to be kept in house Effect on internal and external resources Dr. Jörg Rennecke Director of Operations ORION Clinical Services GmbH / Germany Case Study: Challenges in improving early phase R&D productivity Balanced discovery project portfolio Metrics in discovery projects Increase in productivity with partnering Management and comparison of internal and collaboration projects Antti Haapalinna, PhD Vice President, Research, R&D ORION PHARMA / Finland Case Study: Collaboration deals between Pharma giants and biotech companies: Always a success story for the smaller partner? Partnering strategies for small pharmaceutical companies Financial KPIs depending on deal structures Press release and stock market reaction vs. making the partnership work Success criteria from partnering for long time growth Dr. Merike Glass Director Controlling Biotherapeutics / R&D Biotest AG / Germany Closing Remarks from the Chair End of Conference We would like to thank everyone who has helped with the research and realisation of this marcus evans conference, in particular the speakers for their continued support and commitment. Linda Kretschmer Conference Producer marcus evans (Germany) Ltd Who Should Attend: Directors, Heads of Department, Vice Presidents, Managers and Executives responsible for: R&D-Controlling Research and Development Project Controlling Portfolio Management R&D Cooperation Product Development Pre / Clinical research Business Planning Business Development Accounting Investment and financial planning Partner Management from the Pharmaceutical and Biotech Industries
5 Speaker Profiles Dr. Hans-Jürgen Federsel is a renowned specialist in the field of process R&D where he has spent his entire professional career spanning a period of over 30 years. Starting off as bench chemist in former Astra at the major Swedish site in Södertälje he has climbed the ranks occupying positions both as line and project manager. After the merger that formed AstraZeneca he has been the Head of Projects Management and was appointed Director of Science in Global Process R&D in In connection with this he was also given the prestigious title Senior Principal Scientist. The strong academic links have been further developed throughout the years after obtaining the PhD in organic chemistry at the Royal Institute of Technology (KTH) in Stockholm, which was recognized by awarding him the Associate Professorship title. He also holds a seat on the Board of the School of Chemical Science and Engineering since Dr. Hans-Jürgen Federsel has published in peer reviewed journals and books and is lecturing frequently. In 2009 he was elected to the Royal Swedish Academy of Engineering Sciences (IVA). As part of a major company restructuring, he was confirmed in the role of Senior Principal Scientist in Chemical Science in the newly created Pharmaceutical Development Department from August Dr. Merike Glass studied economics and japanology at the University of Heidelberg, Germany and Keio University, Japan. After receiving her PhD in Finance in 2004, she started to work for Boehringer Ingelheim. During that time she was responsible for the economic evaluation of Boehringer Ingelheims new oncology pipeline. She was also part of negotiation teams for the in-licensing of new compounds, for example the collaboration of Boehringer Ingelheim and Ablynx. In 2009 she joined Biotest to rebuild the company s strategic R&D controlling. Dr. Antti Haapalinna has received his MSc in Pharmaceutical Sciences and Doctor of Pharmacy in Neuropharmacology and Pharmacology from the University of Kuopio, Finland. He has over 60 peer reviewed scientific papers and is co-inventor in 13 patents & applications. He is also adjunct professor (Nonclinical R&D) in the University of East Finland. Dr. Haapalinna received his emba from the Turku School Economics in University of Turku. Dr. Haapalinna has over 20 years of experience in Drug Discovery and Development at his previous and current position at Orion Corporation, Orion Pharma. Previously he was heading the nonclinical R&D organisation for five years which was responsible for nonclinical documentation from discovery to marketing authorisation. Activities included molecular biology (incl. genomics), biochemistry, pharmacology, medicinal chemistry, bioanalytics, pharmacokinetics and toxicology. Since 2009 he has been responsible for the Research Process in R&D. The Research process is responsible for initiating and carrying out new proprietary product development projects from the origination of an idea to the stage when the test product is ready to enter clinical studies. Dr. Michael Herschel graduated with a medical degree from the Ruprecht-Karls-Universität Heidelberg, where he also wrote his dissertation in Dr. Michael Herschel also holds a Diploma in Pharmaceutical Medicine from the Royal College of Physicians in London (1988) as well as an MBA from Brunel University / Henley Management College in London (1998). After work stations as Research Fellow at the Harvard Medical School / McLean Hospital and medical officer at the German Federal Armed Forces Dr. Michael Herschel joined Boehringer Mannheim as medical project leader. Between 1985 and 1999 he occupied different positions at Boehringer Ingelheim such as Head of Clinical Studies and Department Director. In 1999, he joined Glaxo Wellcome (Germany) as Director Clinical Research and in 2001 became Director Clinical Research at Glaxo SmithKline. Dr. Thomas Högberg has spent 40 years in the pharmaceutical industry, i.e. in big pharma (Astra and AstraZeneca), mid pharma (ALK-Abello and presently LEO Pharma) and biotech industry (7TM Pharma). He has had leading managerial and project roles from early drug discovery up to marketed products with experience from several therapeutic areas including dermatology, metabolic diseases, inflammatory diseases, respiratory diseases, CNS diseases, pain, and infection. Dr. Thomas Högberg is a Fellow of the Royal Society of Chemistry since 1991 and he has published over 100 scientific papers and 50 patent applications Riccardo Lampariello holds an MSc in Statistics and an MBA. He started his career in the pharmaceutical industry in 1999 as a Biostatistician. He then worked as a Clinical Operational Manager, and finally in the last four years as an associate director in the Group Portfolio Management. He is responsible for the valuation and analysis of the company pipeline. Riccardo Lampariello also has working experience in Genetics and Public Health and he is a guest speaker at University graduate courses throughout Europe. Riccardo Mariani Is holding a degree in Organic Chemistry at Universita degli Studi di Milano and an MBA at SDA Bocconi Milano. He started his career as medicinal chemist at Vicuron Pharmaceutical Spa working on the development of new antibacterials. In 2004 he joined Gentium Spa, a biotech company focused on products for the treatment of cancer, inflammation and thrombotic disorders, where he led Project Management Office s activities. Since 2009 he is Corporate R&D Business Analysis Manager at Chiesi Farmaceutici Spa, where he acts as Corporate R&D Financial Controller as well as R&D Planning Systems business administrator and R&D Key Performance Indicators and Benchmarking System owner. Dr. Jörg Möhrle obtained his M. Phil in Biochemistry from the University of Cambridge, UK in 1989, and his PhD from the University of Basel, Switzerland in In 2006, he received his Master of Business Administration from GSBA Zürich and the State University of New York, Albany, New York. From 1996 to 1999 he was Clinical Research Scientist at Glaxo Wellcome as a Clinical Research Scientist in the areas of urology, respiratory diseases, oncology, pain therapy, and antimalarials. From 1999 to 2005 he joined Serono International SA, Geneva, Switzerland, as Senior Clinical Research Project Manager and Clinical Trial Leader, responsible for phase II and III clinical trials in inflammatory bowel disease, neurology, rheumatoid arthritis, reperfusion injury / cardiology, and oncology. In 2005, he was appointed Associate Director Clinical Development, and has been Director Clinical Development since 2007 at Medicines for Malaria Venture. He is the Head of MMV's Translational Medicine Group overseeing projects from candidate selection to end of phase managing MMV s portfolio of translational projects and guiding the collaboration with MMV s academic and pharmaceutical partners in developed and developing countries. Dr. Möhrle is a Chartered Scientist of the Science Council (CSci), Fellow of Institute of Clinical Research (FICR), Member Board of Directors Malaria Clinical Trials Alliance, and Visiting Lecturer at the University of Applied Sciences Nordwestschweiz (Switzerland).
6 Speaker Profiles Pasi Piitulainen is Senior Director of Business and Science Affairs at Actelion Pharmaceuticals, He is CFA Charter holder and member of the Swiss CFA Society. Prior to his current position Pasi Piitulainen held several management positions within Actelion. Before joining Actelion, he worked in the telecom and software industry in Switzerland and Finland. Pasi Piitulainen is responsible for ensuring value across the product development process at Actelion. In his role, he is responsible of the Clinical Development Finance, Global Clinical Outsourcing and Portfolio Management at Actelion. Dr. Jörg Rennecke graduated in technological Biology from the University of Stuttgart, Germany and obtained his Ph.D. based on work at the German Cancer Research Center in Heidelberg. His 14 years career in clinical research started as project and logistic manager in a central laboratory. From 1999 to 2005 he had various roles in clinical development and outsourcing and was appointed Head of Project Management at Sankyo Pharma GmbH. Insight into the Biotech sector was gained from as Director Clinical Operations with Fresenius Biotech GmbH. The main task was here to conduct the European clinical trial program and to establish CRO management and outsourcing. Since 2006 he has been Director of Operations in charge of the German affiliate for ORION Clinical Services GmbH, an international, privately owned, medium size, full service CRO. Dr. Markus Rudolph studied Pharmaceutical Sciences and received a PhD in Pharmaceutical Technology from Frankfurt University, Germany. After several years as a research associate at the Goethe-University in Frankfurt where he taught courses in Biopharmaceutics and Pharmacokinetics he started his industrial career. He held several R&D positions with increasing responsibility in the OTC environment. In his current position at Merck Consumer Health Care, Darmstadt, Germany he is responsible for Research & Development and Operations for the OTC and Food Supplement Business Prof. Dr. Uwe Schlokat received his academic education in Germany (Marburg & Heidelberg) and the USA (Muncie, IN), ultimately gaining a PhD in Biology from Heidelberg University. Thereafter, he worked and held positions of increasing responsibility in Research and Development at Genentech (South San Francisco / USA) and Immuno AG (Orth / Austria), before he joined Baxter Healthcare. Currently, he heads the team of Project / Program Leaders located in Chicago, Los Angeles, and Vienna, who are in charge of new Biologics and Device product developments as well as life cycle programs at Baxter BioScience. Prof. Dr. Uwe Schlokat is a member of the senior management team of the Hemophilia Business Unit. He has been certified by Project Management Institute as a Project Management Professional, is a member of DIA and PMI, holds an Adjunct Professorship for Medical and Pharmaceutical Biotechnology at the University of Applied Sciences in Krems / Austria, and has issued approximately 50 Scientific Articles and Patents. He has organized Scientific Congresses and functions as a reviewer to scientific journals and the European Community. Christoph Schmidt graduated in 2003 with a degree in economics and worked as an internal auditor for the largest private health insurance company in Germany. In 2006 he started working as Project Controller for Schwarz Pharma / UCB. In 2008, he became Head of Project Controlling at Nycomed and was appointed Head of R&D and Central Functions Controlling in Petra Storsberg builds on 20 years of business finance experience with Roche and Boehringer Mannheim. A graduate in economics her career expanded from Corporate Finance functions to business controlling responsibilities encompassing, Sales & Marketing in Scandinavia, Discovery in Switzerland, Biotech Manufacturing in Germany and since 2006 Research & Early Development on a global level at the headquarters in Basel / Switzerland. Dr. Serena Tongiani graduated from University Perugia, Italy, with a diploma in Pharmaceutical Science and received a PhD in Chemistry and Pharmaceutical Science from the University of Urbino, Italy. From 2002 to 2005 she worked at the University of Kansas as research associate conducting research on new drug delivery technologies. During this time she synthesized and structurally characterized a new family of cyclodextrin derivatives possessing superior binding capacity, known as sulfoalkyl-alkyl ether cyclodextrins. In 2005 Dr. Serena Tongiani joint Schering Plough Corporation, and started to work in the oral and solid formulation product development group. There she followed the development of new drugs from bench to commercialization scale up. In 2010 she took over the position of Head of Preclinical Development departments in ACRAF, Angelini in Rome. In this responsibility she has led the non clinical research group to develop drug products for various therapeutic areas supporting the company portfolio across multiple disease areas. In May 2011 Serena Tongiani became R&D Director of ACRAF, Angelini. Dr. Christoph Willers is a board certified dermatologist and venerologist. He wrote his doctoral thesis on the subject of molecular changes in primary cutaneous lymphomas, his master thesis was about finance controlling in cross-sectoral health care of patients in Germany. Dr. Christoph Willers has seven years of experience in clinical medicine, 13 years in the pharmaceuticals industry, and two and a half years as Medical Director of a CRO.
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