SPEAKERS
6 Annual Patient Recruitment and Retention Summit 2014 th Free Adobe InDesign Template 18 - 20 February 2014 I Berlin Kempinski Hotel Bristol Berlin ***** SPEAKERS INCLUDE: TEVA - Yafit Stark SANOFI - Terttu Haring SANOFI - Julia Yang JANSSEN - Suzann Johnson BRISTOL MYERS SQUIBB - Susanne Busta GET INSPIRATION ON HOW TO RECRUIT AND RETAIN PATIENTS MORE EFFECTIVELY PATIENT RECRUITMENT & How to bridge global protocols with local LEGISLATIONS RETENTION In 2013 we had participants from over 30 countries 13 How can pharmaceutical companies work together to make it easier for patients to enroll? How to go from competition to collaboration? Gold sponsor: Silver sponsors: Bronze sponsor: CASE STUDIES FROM COMPANIES: • Ipsen • Janssen • Sanofi • Bristol Myers Squibb SPEAKERS Chairperson Liz Moench President and CEO MediciGlobal Peter Myrenfors Medical Director Ipsen Steffan Ekman Senior Clinical Scientist Roche Suzann Johnson Director, Global Clinical Operations Janssen Terttu Haring Regional Head Clinical Study Unit, Northern Europe Sanofi Cellia K. Habita President and CEO ARIANNE Holger Maria Rohde Director, Strategy Implementation Lead Merck Serono Julia Yang Senior Medical Director, North America Clinical Study Unit, Sanofi Emre Basar Medical Science Liaison Rigosertib Baxter Deutschland GmbH Leo Ballering Global Clinical Trial Manager MSD Yafit Stark Vice President, Global Clinical Advisor Teva Ines Koch Head of Clinical Research A. Menarini Research & Business Service GmbH Michael-Friedrich Boettcher Senior Expert Clinical Pharmacodynamics Bayer Dietrich Bosse Head, Region Central and Northern Europe, Global Clinical Research and Development Novartis Vaccines Bonnie Brescia Founding Principal BBK Worldwide Darren Cowann Bittner Head, USA Study Start Up Unit Pfizer Susanne Busta Associate Director Site & Data Mngt. BMS Gretchen Goller Sr. Director – Patient Access and Retention Services (PARS) PRA Stuart Redding Vice President - Global Business Development, Marketing & PR The Medical Research Network Joel Roberts Global Project Manager UBC Who should attend The 6th Annual Patient Recruitment and Retention Summit has been designed for Members of Board, Vice Presidents, Directors, Head and Senior Managers from pharmaceutical industry involved in: Clinical Operations Monitoring Operations Clinical Development Clinical Research Study Management Medical Clinical Research & Development Clinical Trial Operations Patient Recruitment and Retention 6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT The pharmaceutical industry is highly competitive nowadays and ‘time is money’ is a more then accurate phrase to be used, especially when it comes to clinical trials. For a new drug to be released, the trial needs to be finished successfully. But what happens when the patient enrollment takes too long? Or what if there are not enough patients in a study? Or even after a successful recruitment, the patients start to drop-out? The answer is simple: the release of the new drug becomes more and more expensive. Patient recruitment and patient retention represent a challenge itself and pharmaceutical companies are trying to find their ways to overcome these challenges. KEY TOPICS • • • • • Recruitment challenges Patient retention Site selection and its impact on patient recruitment Online technologies for successful patient recruitment The effect of legislation and regulatory environment on clinical trials EVENT PROMISE By attending this event you will : • Gain the new ideas on identification and targeting of the quality patients • Discover the influences of study procedures on clinical laboratory parameters • Improve your ability to recognize the ‘right’ trial sites • Get new ideas on how to ensure successful and on time recruitment • Learn how to support patient satisfaction & retention by using mobile health applications • Explore new approaches how to motivate your patients to be engaged in a study and avoid drop-outs Benefits of attending • Learn how the BIG pharmaceutical players deal with challenges related to patient recruitment • Discover how some of the pharma companies approach patient retention • Hear about how novel online technologies can be used for successful patient recruitment • Learn about best practices when it comes to picking the right trial site and how Back-to-Back interviews can support the search • Find out more about Variability of clinical laboratory parameters and new exploratory biomarkers under typical Phase I Study conditions • Learn how to enhance patient enrolment into clinical trials SCHEDULE TUESDAY I 18 February 2014 CASE STUDY Tracking subject recruitment and real time statistical power analysis enable dynamic decision making in a Phase 2 clinical trial Leo Ballering I MSD Networking Coffee Break 11:15 Optimizing the feasibility process to optimize patient recruitment Terttu Haring I Sanofi 12:00 SPECIAL FEATURE: Round table discussion Open discussion time Lunch Berlin City Tour (Complimentary) THURSDAY I 20 February 2014 WEDNESDAY I 19 February 2014 Registration and Morning Coffee Registration and Morning Coffee 09:00 Opening Remarks from the Chairperson 09:00 Opening Remarks from the Chairperson 09:15 Challenges in Patient Enrollment into Very Complex Indications, such as Early Disease Stage Yafit Stark I Teva CASE STUDY 08:20 09:15 Efficient strategies for patient retention Suzann Johnson I Janssen 10:00 Variability of clinical laboratory parameters and new exploratory biomarkers under typical phase I Study conditions Michael-Friedrich Boettcher I Bayer CASE STUDY 08:20 10:00 Augmenting Patient Recruitment: Having Feet on the Street 12:00 12:45 14:00 Seven new-school solutions to old-school challenges Bonnie Bresca I BBK Worldwide Lunch Recruit to retain, quality vs quantity Steffan Ekman I Roche 14:45 15:30 16:00 17:30 Interactive panel discussion Moderator: Stuart Redding I The Medical Research Network Group of speakers Cocktail reception 10:45 Networking Coffee Break 11:15 Clinical Trial Data Transparency and Patient Communication Holger Maria Rohde I Merck Serono 12:00 MENA role in Clinical Research vs more established NEEs Cellia K. Habita I ARIANNE Lunch 14:00 Novel Online Technologies for Successful Patient Recruitment Emre Basar I Baxter Deutschland GmbH 14:45 Innovative Approaches to Patient Retention in Long-Term Studies and Registries Joel Roberts I UBC 15:30 Networking Coffee Break How to pick the right trial sites? Can Back-to-back Interviews support the Search? Gretchen Goller I PRA 12:45 Reducing Clinical Trial Costs with New Strategies for Patient Recruitment Liz Moench I MediciGlobal Susanne Busta I Bristol-Myers Squibb Gmbh 16:45 CASE STUDY Medical Operation Strategy and Success in Patient Recruitment Julia Yang I Sanofi CASE STUDY 11:15 Networking Coffee Break CASE STUDY 10:45 CASE STUDY 14:00 CASE STUDY CASE STUDY 12:45 CASE STUDY CASE STUDY 10:45 Opening Remarks from the Chairperson Accelerating Study Start Up Darren Cowan Bittner I Pfizer CASE STUDY 10:00 Registration and Morning Coffee Networking Coffee Break 16:00 Recruitment challenges Peter Myrenfors I Ipsen 16:45 SPECIAL FEATURE: Round table discussion Open discussion time 17:30 Closing Remarks from the Chairperson CASE STUDY 08:20 09:00 09:15 CASE STUDY CASE STUDY CASE STUDY DAY 1 18 FEBRUARY 2014 6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014 08 : 20 Registration and Morning Coffee 09 : 00 Opening Remarks from the Chairperson 09 : 15 Darren Cowan-Bittner Head, USA Study Start Up Unit Pfizer Accelerating Study Start Up The presentation will address key acceleration topics: • Are we asking the right site selection questions? • What is the industry standard timelines to start a site • What strategies do those in the top tier percentile apply to accelerate? Tracking subject recruitment and real time statistical power analysis enable dynamic decision making in a Phase 2 clinical trial 10 : 00 Leo Ballering Global Clinical Trial Manager MSD • Monitorin-g Subject Recruitment • Prediction of total enrollment • Statistical Power Analysis 10 : 45 Networking Coffee Break 11 : 15 Terttu Haring Optimizing the feasibility process to optimize patient recruitment Northern Europe Regional Head Clinical Studies Sanofi 12 : 00 Round table discussion • Real-time identification, approach and recruitment of eligible patients for clinical trials • The Whole Recruitment Population: Tips and Tricks to Reach Out to All • How to measure the feasibility of a protocol accurately? SPECIAL FEATURE: Round table discussion Suggested topics: • How can pharmaceutical companies work together to make it easier for patients to enroll? How to go from competition to collaboration? • Patient Recruitment in Emerging Markets • Development in vaccines and and differences to regular drug development • Electronic informed consent form – do you utilize the opportunity offered by the evolution in technology 12 : 45 14:00 Lunch Complimentary Berlin City Bus Tour CASE STUDY BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com CASE STUDY CASE STUDY CASE STUDY DAY 2 19 FEBRUARY 2014 08 : 20 Registration and Morning Coffee 09 : 00 Opening Remarks from the Chairperson 09 : 15 Yafit Stark Challenges in Patient Enrollment into Very Complex Indications, such as Early Disease Stage • The Challenges in Diagnosis of Early Disease before Switching into Definite Disease • The Involvement of Imaging Technology in Diagnosis • Recruitment of Qualified Centers with Capabilities of Enrollment of Early Disease Patients 10 : 00 Michael-Friedrich Boettcher Variability of clinical laboratory parameters and new exploratory biomarkers under typical phase I Study conditions Clinical Pharmacodynamics Bayer Pharma AG • Intra- and inter-day-to-day variability • Influences of study procedures on clinical laboratory parameters • The role of new exploratory liver, kidney and vascular biomarkers 10 : 45 Networking Coffee Break 11 : 15 Julia Yang Medical Operation Strategy and Success in Patient Recruitment Vice President, Global Clinical Advisor Teva CASE STUDY Senior Medical Director, North America Clinical Study Unit Sanofi • Development and implementation of global recruitment strategy and patient identification pathway • Effective site recruitment model and success experiences • Above and beyond the medical/clinical operation strategy and excellence 12 : 00 Bonnie Brescia Seven new-school solutions to old-school challenges 12 : 45 Lunch Founding Principal BBK Worldwide CASE STUDY 6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014 14 : 00 Steffan Ekman Senior Clinical Scientist Roche CASE STUDY 14 : 45 Liz Moench President and CEO MediciGlobal No matter how much the pharmaceutical R&D industry and patient recruitment sub-specialty evolve, some challenges remain the same. What’s exciting is that now we have new innovations with which to take on these challenges. This presentation will review the top “new-school” solutions, including mobile apps as a recruitment and retention tactic, new technologies for site selection and engagement, mobile website optimization to increase your referrals, and more. Attend this session to learn about what you need to implement in order to more effectively tackle “old-school” challenges, and graduate to a higher level of understanding about new technologies and solutions for enrollment success. Recruit to retain, quality vs quantity • Understand the importance to recruit the right patients • Plan upfront, prevent later challenges • Being flexible to maximize information Reducing Clinical Trial Costs with New Strategies for Patient Recruitment • • • • Using digital strategies to set up recruitment for rapid enrollment How to avoid costly delays and keep trials on track Using metrics for cost and time management The role of patient-centric approaches to optimize success BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com DAY 2 19 FEBRUARY 2014 CASE STUDY 15 : 30 16 : 00 Susanne Busta Associate Director Site & Data Mngt. Regional Clinical Operations DACH Bristol-Myers Squibb Gmbh 6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014 Networking Coffee Break How to pick the right trial sites? Can Back-to-back Interviews support the Search? • In order to ensure successful & on time recruitment, identification of the ‘right’ trial sites is of utmost importance • Since patient potential is easily over-estimated, this poses a challenge for both parties, sponsor as well as site • In order to guide this process a wide range of feasibilities tools is already utilized • The Back-to-Back interview can be a valuable addition to this toolbox 16 : 45 SPECIAL FEATURE: Interactive Panel Discussion Moderator: Stuart Redding In this session, the audience has an opportunity to ask questions and have an open interactive discussion with the discussion panelists Vice President - Global Business Development, Marketing & PR The Medical Research Network Yafit Stark Michael-Friedrich Boettcher Dietrich Bosse Ines Koch 17 : 30 Suggested topics: • Tools for successful patient recruitment (classic/on-line) • Local regulations and their impact on patient recruitment/retention • Retention of patients in long term, patient outcome studies • Recruitment obstacles - excl/incl criteria, study design, ICF • How can you use virtual environment technologies to fuel your own organizations’ clinical trial processes? Cocktail Reception BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com CASE STUDY DAY 3 20 FEBRUARY 2014 08 : 20 Registration and Morning Coffee 09 : 00 Opening Remarks from the Chairperson 09 : 15 Suzann Johnson Patient retention 10 : 00 Gretchen Goller Augmenting Patient Recruitment: Having Feet on the Street Director, Global Clinical Operations Janssen CASE STUDY • Retaining enrolled patients with effective ‘customer service’ • What is truly essential in retention of qualified subjects in clinical trials? • High retention rates are crucial. How to achieve them? Sr. Director – Patient Access and Retention Services (PARS)/ PRA • Discuss the strategy of having enrollment specialists/ managers work with clinical sites at their site to devise recruitment plans, build referral networks, and utilize local resources • Present case studies and results of using this strategy 10 : 45 Networking Coffee Break 11 : 15 Holger Maria Rohde Clinical Trial Data Transparency and Patient Communication 12 : 00 Cellia K. Habita MENA role in Clinical Research vs more established NEEs President and CEO ARRIANE • Region • Regulations • Issues to consider 12 : 45 Lunch CASE STUDY CASE STUDY 6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014 Director, Strategy Implementation Lead Merck Serono 14 : 00 Emre Basar Medical Science Liaison Rigosertib Baxter Deutschland GmbH CASE STUDY • Data Transparency from Clinical Trials - History and Landscape • The empowered patient as relevant stakeholder and data requestor • Industry commitments and other obligations to communicate clinical trial results to the patient • Communication of Clinical Trial Results to the Patients - preparing grounds for the next clinical trial recruitment • Increase the “share of voice” from your developmental program by proactively communicating clinical trial results • Clinical Trial Registries and patient advocacy groups - Information broker and interpreter for the patient as well as for the industry Novel Online Technologies for Successful Patient Recruitment • Digital Pharma Solutions to Promote Disease Awareness & Patient Communication • Social Media Strategies to Enhance Patient Enrollment into Clinical Trials • Mobile Health Applications to Support Patient Satisfaction & Retention BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com CASE STUDY CASE STUDY DAY 3 20 FEBRUARY 2014 6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014 14 : 45 Joel Roberts Innovative Approaches to Patient Retention in Long-Term Studies and Registries 15 : 30 Networking Coffee Break 16 : 00 Peter Myrenfors Recruitment challenges 16 : 45 Round table discussion SPECIAL FEATURE: Round table discussion Global Project Manager UBC Medical Director Ipsen • Understand the unique challenges for patient retention in long-term studies and registries and those factors that most impact patient adherence and compliance. • Provide innovative, effective tools to enhance retention while observing the regulatory, ethical, cultural and budgetary considerations impacting patient retention. • • • • Patient populations Study endpoints Treatment rational vs clinical practice Recruitment time and falling inclusion rates Open round table discussion for the attendees to summarize the information learned throughout the 2 days, opportunity to raise the final questions and comments. Open discussion time. Suggested topics: 17 : 30 • How to increase number of patients in small disease studies? • What are the best methods to integrate your global protocols to local legislations? • What are the other tools outside the regular ways to recruit patients? • How to increase patient recruitment and retention in rare diseases? Closing Remarks from the Chairperson BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com 6th Annual Patient Recruitment and Retention Summit 2014 Sales Contract Conference Code AL-P-16 18 - 20 February 2014 I Berlin PLEASE FILL IN REQUIRED DETAILS IN BLOCK AND FAX or E-MAIL TO: Fax: +421 252 444 225 / e-mail: [email protected] DELEGATE DETAILS Kempinski Hotel Bristol Berlin ***** PAYMENT METHOD Mr./Ms. Name of Card Holder Name Card Billing Address Job Position (Street, City, Post Code) e-mail Mr./Ms. VISA Master Card Euro Card AMEX Diner Club Name Last 3 (three) digits on the back of the card: Job Position Card Security Code (AMEX) : e-mail Card Number: Mr./Ms. Valid From: (mm / yy) Name / Expiry Date: / I confirm that I have read and agree to the terms and conditions of booking and Allan Lloyds debiting my credit card, I the signatory is authorised to sign or behalf of contracting organisations. 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