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Daniel Lindwall Vice President
Daniel Lindwall Vice President
Subrata Bose Head Global Feasibility
Operations & Clinical Trial Recruitment Strategy
Pascal Birman VP Clinical Development
Programs Global & Deputy Sr. VP GDD
Jeannett DimsitsDirector
Nancy Meyerson-Hess Former Head Clinical Operations
and Compliance
Isabelle Van der Haegen
Country Head of Country Clinical Operations
What role does clinical research have on patients?
How to make trials more valuable for patients?
New regulations and the impact on clinical trials
Developing a robust clinical trial recruitment and retention strategy
What Makes a Good Feasibility Process?
How to keep the site staff motivated and engaged?
Michelle Crouthamel
Digital Platform Leader
The change in a PATIENT CENTRIC PARADIGM in clinical trials
Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical industry involved in:
EVENTDESIGNED FOR
www.patientrecruitmentsummit.com
10+ One to One Networking Hours
3 Interactive Group Discussions
2,5 Full Day withPresentations
15+ Experience Based Case Studies
Clinical program Management Clinical Operations Clinical Research Recruitment and Retention Clinical Research and Develop-
ment Operations Study Management Clinical Trial Clinical Trial Design Clinical Program Clinical Project Management Clinical Research Clinical Monitoring Clinical Development Patient Affairs Officer Patient Advocates
Gold Sponsor: Bronze Sponsor:
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Chairperson:
Liz MoenchCEO - Managing PartnerPatientDTC
Stephen PartridgeSenior Director Global Clinical Operations
Astellas
Helen Ambrose Associate Director Study Management
AstraZeneca
Carin FelleniusDirector Site Management & Monitoring Western EuropeAstraZeneca
Subrata BoseHead Global Feasibility Operations & Clinical Trial Recruitment StrategyBayer
Isabela NiculaeAssociate Director Global Patient Recruitment and Retention Strategist & Women in Innovation UK Chapter Co-LeadBiogen Idec
Nancy Meyerson-HessFormer Head Clinical Operations and ComplianceGrnenthal Innovation-Development
Jason GubbTA Head, Global Clinical Sciences & OperationsGSK
Michelle CrouthamelDigital Platform LeaderGSK
Pascal BirmanVP Clinical Development Programs Global & Deputy Sr. VP GDD
Ipsen
Bert HartogDirector, R&D Operations InnovationJanssen Pharmaceutical Companies of Johnson & Johnson
Jonathan Crowther Strategic Analyst, OncologyMDCPartners
Cornelis WinnipsGlobal Program Medical Director
Novartis
Jeannett DimsitsDirectorNovo Nordisk A/S
Isabelle Van der HaegenCountry Head of Country Clinical OperationsRoche
Yafit StarkVice President, Chief Clinical Officer, Head of Oncology and Emerging Therapeutics Teva
Lars JoeresClinical Lead CNS EuropeUCB Pharma
Workshop A: Motivation of the patients in clinical trials 21 February 2017, 15:00 - 16:00
Which tools allowed from regulatory are the best to motivate the patients?
How to provide the right information about the clinical trials to the patients?
Site engagement and motivation as a core patient recruit-ment strategy
What are the challenges for the patient recruitment and retention in rare diseases?
What are the common complaints from the patients involved in a trial and how can we learn from this?
New trends and strategies in the electronic recruitment and patient retention
Opportunities and limitations in online patient recruitment for clinical trials
The advances of mHealth and clinical technology Developing apps and novel technology for the clinical
trial industry
Multi-channels and its relevancy
Workshop B: Digitalization and e-recruitment 21 February 2017, 16:00 - 17:00
PRE-CONFERENCE WORKSHOPS
CASE STUDIES PRESENTED BY
BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com
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DAY 1 Wednesday 22 February 2017
BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com
08:00 Registration and Morning Coffee
08:30 Opening Remarks from the Chairperson
08:45 SPEED NETWORKING SESSION
Dont forget your business cards! GREAT 15 MINUTES ICE-BREAKING AND NETWORKING ACTIVITY to meetyour peers before we start.
09:00 CASE STUDY
Patient Centric Approach -New Paradigm and Opportunities in Clinical DevelopmentClinical Development as well as the medicinal drugs and medical devices have become highly innovative, more complex and high costly. Personal Treatment Approach as well as patient Welfare and Health Care is more adopt and implement in clinical trials. From Regulatory point of view Patients Report Outcomes, Quality of life, Patients Satisfaction have become important endpoints to determine the suc-cess of treatment Patients nowadays are more Aware, Technology Driven, exposed to influx of information as well as more active in their roles and agreement to participate in clinical trials. The paradigm must be changed by the Industry: Patients do not only generate clinical data, but also play important and critical role in the Success of clinical development of any given product under development.
Patients Role in Clinical Trials must be changed to be more active. Design of any clinical trial must be shared with group of patients
and or patients support group. Clinical Trials are to be Tailored to Patients Needs. Informed Consent Forms which are scientific by nature to written
in a Laymen Language are better Reviewed and receive input from Patients suffering the investigated disease.
Study endpoints which are to meet regulatory requirement need to also incorporate Endpoints Related to patients benefit ad welfare.
The change in patients Centric Paradigm in Clinical trials will be further presented and discussed
Yafit Stark Vice President, Chief Clinical Officer, Head of Oncology and Emerging Therapeutics Teva
09:45 CASE STUDY
Enhanced clinical trial requirement: finding and insights from patients and physicians interviewsPatients recruitment in clinical trials is a major challenge. Understanding key issues faced by patients and physicians to be aware of and participate to trials will help Pharma Companies to propose adequate tools and solutions to optimize clinical trial recruitment. For this purpose, patients with neuro-endocrine tumours (NET) and physi-cians involved in NET management have been interviewed.
Telephone interviews with 10 patients from a US patient associ-ation
Telephone interview with 10 US physicians involved in NET man-agement
Patient and physician maps have been constructed and some interdependencies observed
Areas for interventions are proposed
Pascal Birman VP Clinical Development Programs Global & Deputy Sr. VP GDD Ipsen
10:30 NETWORKING COFFEE BREAK
11:00 CASE STUDY
The patients perspective in clinical trials: experi-ence from preference study in epilepsyUCB is putting the patients at the centre of medical research. Therefore to identify the patient needs and expectations on drug research UCB is involving patients as consultants in the design of clin-ical research projects. Here we present jointly an example of a recent project design from the patient and the researcher perspective.
Patient centered research Patient involvement in study design Patient perspective and value
Lars Joeres Jasmine Smith Clinical Lead CNS Europe Patient and consultant for UCBUCB Pharma
11:45 PRESENTATION
Utilising big data to enhance patient recruitment: Analysing public information for feasibility and site selectionThe path to clinical trial success is burdened with underperforming site selection, poor patient recruitment and frequent delays. Such barriers result in failures to meet targets and dwindling statistical sig-nificance. Comprehensive planning via a feasibility survey can alleviate these issues however, it has been suggested that the accuracy of a survey may be below 10%. As big data becomes more applicable in the clinical trial setting, capitalizing on the wealth of publicly available clinical data is essential. The clinical business intelligence platform, ta-Scan, semantically links trial, investigator and site information to provide a robust feasibility analysis to help address the following questions:
Estimation of appropriate patient cohorts Key Opinion Leaders in the field Competing and historic trials across the therapeutic area Suitable geographic setting for a trial IRB and timing issues that may affect trial start-up
Jonathan Crowther Strategic Analyst, OncologyMDCPartners
12:30 LUNCH
13:30 CASE STUDY
Trends in Oncology Patient Recruitment ServicesDelays to oncology clinical studies are often a direct result of patient recruitment challenges. Prospective selection of patients whose tumours harbour specific molecular alterations provides patients with the opportunity to be enrolled in studies of investigational agents where there is theoretically the greatest likelihood of clinical benefit. Whilst targeted treatments for cancer may be an incentive to patient participation, these tailored studies require innovative solutions to enable recruitment of eligible patients within planned time frames. Potential solutions will be exemplified based on experience in an ongoing early clinical study.
Utility of patient matching services in oncology clinical studies Implementation and adoption of molecular profiling approaches
for patient selection Site activation strategies for prospective recruitment of patients
with uncommon markers
Helen Ambrose Associate Director Study ManagementAstraZeneca
Michelle CrouthamelDigital Platform LeaderGSK
Pascal BirmanVP Clinical Development Programs Global & Deputy Sr. VP GDD
Ipsen
Bert HartogDirector, R&D Operations InnovationJanssen Pharmaceutical Companies of Johnson & Johnson
Jonathan Crowther Strategic Analyst, OncologyMDCPartners
Cornelis WinnipsGlobal Program Medical Director
Novartis
Jeannett DimsitsDirectorNovo Nordisk A/S
Isabelle Van der HaegenCountry Head of Country Clinical OperationsRoche
Yafit StarkVice President, Chief Clinical Officer, Head of Oncology and Emerging Therapeutics Teva
Lars JoeresClinical Lead CNS EuropeUCB Pharma
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DAY 1 Wednesday 22 February 2017
BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com
14:15 CASE STUDY
Using mHealth platform to enable patient-centric clinical trials
The challenges of Patient Recruitment and Retention Considerations of patient-centric clinical trials Case study of GSK PARADE study
Michelle Crouthamel Digital Platform LeaderGSK
15:00 INTERACTIVE PANEL DISCUSSION
In this session, the audience has an opportunity to ask questions and have an open interactive discussion with the discussion panelists.
What Makes a Good Feasibility Process? Achieving the appropriate level of oversight for sponsors working
with CRO partners Meeting Regulatory expectations and building trust Engendering pro-activity empowerment,
the One team concept Optimizing contracts fixed price vs. service driver Incentives and penalties striking the right balance
15:30 NETWORKING COFFE BREAK
16:00 CASE STUDY
Patients know best how to improve clinical trial design: methods to generate insights in multiple disease areas and countries Every year, thousands of clinical trials commence, many of which will not meet original study milestones. The reasons for such delays are multi-fold, but one characteristic that many of these trials share is the lack of patient engagement in design and implementation.This presen-tation will demonstrate how different market research methods have been applied to clinical trials, to obtain direct input from on design and implementation. Traditional methods such as interviews and (online) surveys, as well as novel methods such as clinical trial simula-tion workshops.
The majority of clinical trials still struggle meeting recruitment and retention targets, patients hold the key.
Learn how insightful information can be obtained from patients in a compliant and secure manner
See how patients can become part of design and implementation of your trials
Transform your portfolio to become truly patient and site-centric
Bert HartogDirector, R&D Operations InnovationJanssen Pharmaceutica NV
16:45 CASE STUDY
Patients and Clinical Trials in Low Income CountriesThis presentation gives an overview of patient-specific aspects of clinical trials in low income countries. Discussed are informed consent procedures, patient rights and protection, use of information tech-nology in areas with lack of infrastructure. Some specific of studies in typical third-world diseases such as HIV, malaria and tuberculosis will be presented.
Introduction Global distribution of patients by income segments Typical diseases in low-income countries and evolution Patient-related aspects of clinical trials in this environment
Cornelis WinnipsGlobal Program Medical DirectorNovartis
17:30 PRESENTATION
Presentation by PatientDTC LLC
Liz MoenchCEO - Managing Partner
PatientDTC LLC
18:15 DISCUSSION
Roundtable Discussion - Digitalization and E-RecruitmentAll attendees will have a great opportunity to discuss a selection of the most interesting topics addressed during the conference in small groups with their peers. Every table will nominate a head of table, which will summarize the topic discussed, present the main puzzles, and questions posed.
Digital platforms in clinical trials and patient recruitment Opportunities and limitations in online patient recruitment for
clinical trials Developing apps and novel technology for the clinical trial indus-
try how will this change the way CROs and Pharma companies interact with the patients and each other?
How to make digital platforms accessible, compelling and with attractive and responsive design for the patients?
18:45 Coctail Reception
Jason Gubb GSK
Stephen Partridge Astellas
Yafit Stark Teva
Pascal BirmanIpsen
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DAY 1 Wednesday 22 February 2017 DAY 2 Thursday 23 February 2017
BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com
08:00 Registration and Morning Coffee
08:30 Opening Remarks from the Chairperson
08:45 SPEED NETWORKING SESSION
Dont forget your business cards! GREAT 15 MINUTES ICE-BREAKING AND NETWORKING ACTIVITY to meetyour peers before we start.
09:00 CASE STUDY
How to ensure your study site staff are kept engaged in your study?A story about how Novo Nordisk developed a set of study supporting activities that kept the site staff engaged. The activities were focused on study activities and requirements as well as scientific updates rele-vant to the studies.
A description of the number of value adding activities whereby sites are being continuously kept engaged in the trials as well as in the collaboration with sponsor.
This both involves activities for the study nurses as well as for the investigators
Jeannett Dimsits Director Novo Nordisk A/S
09:45 CASE STUDY
Engaging Patients Clinical research is talking about engaging patients early on in research. What outcome can be expected from these initiatives? Is this really new and innovative? Discussion on the various approaches, including patient working groups, patient spokespersons. What are the expectations from both the industry and the patient view?
Looking to the role of patient advocacy groups. How does industry interact with patient groups? What role does clinical research have on patients?
Nancy Meyerson-Hess Former Head Clinical Operations and Compliance Grnenthal Innovation-Development
10:30 NETWORKING COFFEE BREAK
11:00 CASE STUDY
Working with flexible staff sourcing solution in Clinical Operations Working with insourced staff via CRO vendors in Clinical Operations is an attractive flexible solution for clinical study execution in many countries. However to get the best outcome for both parties the agreement, process and responsibilities must be clearly defined.
Setting Master Service Agreements with vendors for flexible staff solution- hints and tips
Process for staff request Introduction of insourced staff Responsibilities of line managers by sponsor vs CRO vendor Follow-up with vendor and reporting
Carin Fellenius Director Site Management & Monitoring Western EuropeAstraZeneca
11:45 DISCUSSION
Interactive Roundtable Discussion - Collaboration with CROs and site staffAll attendees will have a great opportunity to discuss a selection of the most interestingtopics addressed during the conference in small groups with their peers.Every table will nominate a head of table, which will summarize the topic discussed,present the main puzzles, and questions posed.
How to implement novel ways of effective collaboration to the sponsor - CRO partnership?
What is a typical partnership now and how can it be upgraded and innovative?
How to improve transparency between CRO and sponsors: how to align systems, avoid duplicating work and manage mergers & acquisitions?
Why partnerships dont always work: Why do they fail and what could be done to avoid this?
12:15 LUNCH
13:30 CASE STUDY
Developing a robust clinical trial recruitment and retention strategy Anticipating recruitment and retention issues earlier Defining triggers and escalation strategy Planning outreach upfront
Subrata Bose Head Global Feasibility Operations & Clinical Trial Recruitment StrategyBayer
14:15 CASE STUDY
What is the impact of the new Clinical Trial Regulation?
Impact on the preparation, submission and life cycle management of a Clinical Trial Application
Advantages to the patient Advantages and challenges to the Research Industry as a sponsor
and to the Regulators What will be the drivers for change, the drivers for success?
Isabelle Van der Haegen Country Head of Country Clinical Operations Roche
CLICK ON IMAGE FOR PLAY
VIDEO TESTIMONIALS
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DAY 2 Thursday 23 February 2017
BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com
15:00 NETWORKING COFFE BREAK
15:30 CASE STUDY
Patient Focus Groups: Incorporating the Patient Voice into Clinical ResearchA case study exploring Patient Focus Groups and Incorporating the Patient Voice into Clinical Research
Why is the patient voice needed in clinical development Current clinical research landscape Opportunities Experiences/Case Study Conclusion
Isabela NiculaeAssociate Director Global Patient Recruitment and Retention Strategist & Women in Innovation UK Chapter Co-LeadBiogen Idec
16:10 DISCUSSION
Interactive Roundtable Discussion - Site selection and feasibilityAll attendees will have a great opportunity to discuss a selection of the most interesting topics addressed during the conference in small groups with their peers. Every table will nominate a head of table, which will summarize the topic discussed, present the main puzzles, and questions posed.
How to engage and motivate clinical trial sites the best to maxi-mize enrolment potential?
How to evaluate the site and what has to be considered when selecting it?
How does the site selection affect the clinical trial? How to optimize the sites for further trials? Exploring new ways to work with the sites: examining better
opportunities to improve the site selection process Engaging patients in site activation process
16:50 CLOSING REMARKS FROM CHAIRPERSON
LONDON MARRIOTT HOTEL KENSINGTONThe 9th Annual Patient Recruitment and Retention Summitwill be placed in the London Marriott Hotel Kensington,147c Cromwell Road, Kensington, London SW5 0TH,United Kingdom.
Things to do in London:
London Eye Ride on one of the worlds tallest observation wheels
Experience the London you have read about in the Harry Potter books and seen in the movies
Take a fascinating guided tour of Shakespeares Globe The-atre
Cruise along the Thames River and see the city from the water
I am looking forward to welcoming you personally at the 9th Annual Patient Recruitment and Retention Summit in February!
Vladimira Krasinska Production Manager
BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com
VENUE LONDON
Allan Lloyds is the leading provider of the most di-versified business intelligence events. Quality has always been our priority and we understand every industry is unique with different needs and chal-lenges. We turn events into a unique experience based on interaction, discussions and networking. Today, we are trusted by senior experts within For-tune 500 companies as a top business enriching interaction event provider. Our summits bring in a diverse group of speakers and initiate sessions on topics going beyond any usual case studies.
These summits can change the course of your business and lead to a sustainable relation between your company and customers.
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BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.patientrecruitmentsummit.com
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