9th Annual Patient Recruitment and Retention Summit - Brochure

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:

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

DAY 1 Wednesday 22 February 2017


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


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


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

DAY 1 Wednesday 22 February 2017


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

DAY 1 Wednesday 22 February 2017 DAY 2 Thursday 23 February 2017


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

DAY 2 Thursday 23 February 2017


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


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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