3rd Annual Patient Recruitment & Retention in Pharma

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1 Amsterdam, 23rd - 24th February rd Annual Patient Recruitment & Retention in Pharma Who will I meet there? Chairperson Liz Moench President and CEO MediciGlobal Wolfgang Eglmeier Head Clinical Operations Germany Grunenthal Dr E. David G. McIntosh Global Scientific Affairs Senior Expert Novartis Members of Board, Vice President, Directors, Head and Senior Managers involved in: Clinical Research Clinical Operations Clinical Monitoring Clinical Trials Clinical site Management Patient Recruitment Medical Director Petra Schloesser Head Clinical Research Consulting Bayer HealthCare Bonnie Brescia Founding Principal BBK Worldwide Diana Anderson President & CEO D. Anderson & Company Trond Tennoe Regional Head, Clinical Operations Victoria DiBiaso Head of Protocol Feasibility & Patient Enrollment Genzyme USA Joseph Kim, MBA Clinical Operations Director Michael Herschel Director of Clinical Research Carol Parish Director, Clinical Development. Head of EU and Emerging Markets Annelies Legters MSc, Head of Section, Stroke, Clinical Operations Lundbeck Ridwaan Jhetam MD MBA Clinical Operations Head: Oncology. Senior Director Stroke, Clinical Operations J&J Global Clinical Operations Kathrin Schoenborn- Sobolewski Vice President, Clinical Trial Management Full Development Merck Serono Carlos Camozzi Medical Director, Director of Medical Affairs Department, Orphan-Europe Cristina Ghezzi Corporate Medical Director Recordati Terttu Haring, MD Regional Head Clinical Study Units Network, Northern Europe Sanofi Aventis Netherlands BV Linda Pavis CEO SMO Clinica Dake Chu M.D. Principle Investigator State Key Laboratory of Cancer Biology, China Stuart Redding Director The Medical Research Network Ltd Silver Sponsors Co Sponsor

2 Amsterdam, 23rd -24th February rd Annual Patient Recruitment Retention in Pharma Day Registration and Morning Coffee Opening Remarks from the Chairman 09:10 Site activation a key driver to successful patient recruitment Selection of appropriate sites Site activation metrics Challenges with site activation Opportunities for improving site activation timelines Relationship between site activation and patient enrolment Ridwaan Jhetam MD MBA Clinical Operations Head: Oncology Senior Director: J&J Global Clinical Operations 09:50 Recruitment and Retention in Paediatrics Implications of paediatric legislation and regulations Different approaches neonates, infants, children, adolescents What about trials with long-term follow-up? Role of technology and incentives Vaccine trials and other trials in healthy subjects Ethical issues related to paediatrics Dr E. David G. McIntosh Global Scientific Affairs Senior Expert Novartis 10:30 Networking Coffee Break 11:00 Current patient recruitment and retention practices Gaining internal endorsement before the RFP process Understanding local adoption of recruitment tactics: Legal vs. Illegal vs. Non-Customary vs. Inappropriate Creating a Country-by-Country Tactical Adoption Guide Joseph Kim, MBA Clinical Operations Director 11:40 Ethics and Risk Management in Social Media Ethical obligations to protect study participants: Challenges for ethics committees Changing definitions of privacy, autonomy and transparency Does controlling information conflict with the underlying concept of informed consent Protecting data quality, intellectual property and confidentiality in an open environment. The risk of avoiding this movement 12:25 Lunch Bonnie Brescia Founding Principal BBK Worldwide 13:25 Enrollment Feasibility: How to ensure your protocol can recruit the intended patient populations and feasibility methodologies used to identify high performing sites Identify protocol design strategies and practices that impact execution and operational performance Review methodologies which allow for the identification of high performing sites to reduce enrollment cycle times Define Patient Recruitment strategies that will enable successful enrollment into your trial what are the key drivers to successful patient recruitment Explain the importance of having well defined responsibilities and accountabilities for enrollment performance Victoria DiBiaso Head of Protocol Feasibility & Patient Enrolment Genzyme USA 14:05 Presentation by: Liz Moench President and CEO MediciGlobal 14:50 Benefits of using SMOs in emerging countries for Pharmas, Biotechs and CROs What is the definition of a SMO? are there different models co-existing? how does a SMO enable to secure recruitment getting high recruitment and high retention rates? Strategies to ensure Quality across different sites and countries Case studies: India & Russia Linda Pavis CEO SMO Clinica Networking Coffee Break Best practices to speed up patient recruitment and increase retention rates Consumer attitudes towards clinical trials planning your enrolment and retention well The future of clinical portals in patient recruitment Trends and innovations in technology (datadriven recruitment) for faster and successful patient recruitment and enrollment process Achieving enrolment and retention goals and overcoming problems Discover strategies to build better relationships with patients to retain their loyalty Wolfgang Eglmeier Head Clinical Operations Germany Grunenthal 16:40 Why do patients buy a clinical trial? Patient recruitment from a Marketing Sciences perspective. In this presentation we will discuss: the clinical trial as an unsought good for patients; what drives patients to consent to participation in a clinical trial how can we use this knowledge to improve recruitment and retention in our clinical trials. how to address recruitment in different therapeutic areas Terttu Haring, MD Regional Head Clinical Study Units Network, Northern Europe Sanofi - Aventis Netherlands BV Interactive discussion panel Techniques to ensure adequate resource allocation within trial sites Expediting early patient identification & enrollment Retaining patients... What works? Moderator: Stuart Redding, Director, The Medical Research Network Ltd Victoria DiBiaso, Head of Protocol Feasibility & Patient Enrolment, Genzyme USA Michael Herschel, Director of Clinical Research, Terttu Haring, MD, Regional Head Clinical Study Units Network, Northern Europe, Sanofi - Aventis Joseph Kim, MBA,Clinical Operations Director, Cocktail Reception

3 Amsterdam, 23rd -24th February rd Annual Patient Recruitment Retention in Pharma Day Registration and Morning Coffee Opening Remarks from the Chairman Operational metrics as a clinical trials performance enhancer Using key metrics to ensure delivery Goal-setting: Study teams and Investigators A Metrics focus case study Metrics user support Interpretation techniques Metrics and it s pitfalls Trond Tennoe Regional Head, Clinical Operations Patient Recruitment Strategies for Conducting Global Oncology Clinical Research Advantages and challenges of global Oncology studies, patient recruitment challenges Patient recruitment initiatives: How to start via implementation to did it work? Examples, Lessons Learned and key take-home points Kathrin Schoenborn-Sobolewski Vice President, Clinical Trial Management Full Development Merck Serono 10:30 Networking Coffee Break 11:00 Clinical Trials for Rare Diseases The scope of the problem Ethical mandates Scientific dilemmas Sample size and study designs Cooperation with patient organizations Michael Herschel Director of Clinical Research 11:40 Patient recruitment issues in Acute setting trials Why are acute setting trials different? What role does the sponsor have if the trial is outsourced How to identify the right site and key sitestaff How to keep sites motivate in low recruiting trials 12:20 Lunch Annelies Legters Patient recruitment and retention specialist Lundbeck 13:20 Case study: How to ensure a satisfactory enrolment? What can be done before study start? Protocol design and informed consent Selection of the investigators (Sponsor/CRO) Back-up sites Advertisements Newsletters Cristina Ghezzi Corporate Medical Director Recordati 14:00 Interactive Discussion Panel Discover evaluation of Prognostic Predictor for Patients with Colorectal Cancer How to make tailored treatment for each individual patient Methods of raising awareness about the study Contribution of clinical trial combined with molecular investigation How to prevent patients from receiving excessive or insufficient adjuvant treatment Moderator: Diana Anderson President & CEO D. Anderson & Company Annelies Legters, Patient recruitment and retention specialist, Lundbeck Trond Tennoe, Regional Head, Clinical Operations Kathrin Schoenborn-Sobolewski, Vice President, Clinical Trial Management,Merck Serono Dake Chu M.D., Principle Investigator, State Key Laboratory of Cancer Biology, China Patient recruitment issues in emerging countries Migration of Clinical research from the U.S. and Western Europe to cheaper offshore locations What are the reasons why a growing number of clinical trials are performed in emerging countries, including cost benefits, large populations, pharmacogenetic profiling...? Market challenges, regulatory environment and changing healthcare Carol Parish Director, Clinical Development. Head of EU and Emerging Markets Networking Coffee Break Current patient recruitment and retention practices Trends and innovations in technology for faster andsuccessful patient recruitment and enrollment process Discover strategies to build better relationships with patients to retain their loyalty Carlos Camozzi Medical Director, Director of Medical Affairs Department, Orphan-Europe Selecting the best investigator sites Discover the optimal geographic areas where the patient population meets the study inclusion/exclusion criteria How to ensure the Site Compliance Challenges of a cross national investigation Petra Schlosser Head Clinical Research Consulting Bayer Healthcare Closing Remarks from the Chairman

4 Floorplan Conference 3rd Annual Patient Recruitment Retention in Pharma 23rd -24th March

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