Cambridge Healthtech Institute's

Analytics-Driven Feasibility, Site Selection and Study Activation
( 强调分析的实现可能性评价、临床试验实施设施之选定、开始临床研究 )

Improving Protocol Development, Global Site Selection, Feasibility and Site Management

2019年9月17日~18日



We are pleased to announce production of Cambridge Healthtech Institute’s Analytics-Driven Feasibility, Site Selection and Study Activation conference being held 17-18 September 2019 at the Crowne Plaza Barcelona-Fira Center in Barcelona, Spain. Analytics and data-driven global site selection, an optimized protocol development and feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. Too often companies fail to learn from past mistakes and take the same approach to trial planning and execution. In order to overcome challenges in clinical trial planning, operations and site management leaders should learn from the best practices of their peers, utilize multiple data sources and technology to support decision making, and improve communication and relationships between sites, CROs, and sponsors.

The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, five conference tracks focused on specific issues and functions within the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please see the overall program map below for 2019.

Final Agenda

9月17日(二)

7:30- 17:00 Registration Open

7:30 Morning Coffee


8:35 Opening Plenary Keynotes

10:00 Grand Opening Coffee Break in the Exhibit Hall

PATIENT-CENTRIC FEASIBILITY AND EVIDENCE-DRIVEN SITE SELECTION: REAL-WORLD EXAMPLES FOR IMPROVING PROTOCOLS AND DEVELOPMENT PLANS

10:50 Chairperson’s Opening Remarks

Marcy Kravet, Head, Operational Design Center (ODC), Global Clinical Operations, Merck KGaA

10:55 OPENING CO-PRESENTATION: Shifting the Paradigm in Building Evidence-Driven Site Profiles for Clinical Trial Participation

Serra-Ortiz_OriolOriol Serra, MBA, Head, Site Intelligence & Site Selection, Study Optimization, Pfizer

Jonathan Crowther, Associate Director, Site Intelligence & Feasibility Lead, Study Optimization, Pfizer

Can we challenge the status quo to effectively develop predictive algorithms to build an ideal site profile based on key indicators on performance, start up, quality and competitive intelligence? This presentation will provide a real-world demonstration on how a new methodology can improve transparency and collaborative efforts to optimize study execution. We have developed an innovative approach that aims to change the paradigm in site selection.

Hu_DaoyingDaoying Hu, PhD, MBA, Associate Director, Strategic Feasibility, Global Clinical Sciences and Operations, UCB BioSciences, Inc.


Ramdeen_CamillaCamilla Ramdeen, PhD, Director, Strategic Feasibility, PAREXEL

Data-driven feasibility is a vital component of implementing a successful clinical trial. Whilst much attention is given to big data and the role of RWD in trial planning, we believe strongly that evaluating from a patient perspective is crucial in understanding trial challenges and building a deliverable operational plan. We worked to integrate patient insights upfront and will present a case study to discuss multi-faceted feasibility including a patient-centric approach deployed to support study design, operational risk assessment and influence regulatory decision.

11:45 Forces of Evolution: Can the Industry Change its Approach to Protocol Development?

Brindle_BobBob Brindle, Venture Lead, Life Sciences, Cognizant

We have seen few meaningful changes in approaches to protocol development in the last 20-30 years, despite huge advances in science and technology. Research demonstrates almost no impact on measurable outcomes, including protocol complexity and avoidable amendments. Join this session for an analysis of current protocol development practices across the industry and a discussion on protocol evolution: Are there constraints that will always hold us back or is there a path to a better future?

12:10 The #1 Way to Make Clinical Trials Patient-Centric: Ask Patients What They Want

Elmer_MaryMary Elmer, MSN, Director, Patient, Caregiver and Consumer Experience, Merck

While the clinical trials industry talks more about being patient-centric, the number one way to be truly patient-focused is to listen to what patients want. At TransCelerate we are providing sponsors with free tools to understand the patient experience during a clinical trial. The Patient Protocol Engagement Toolkit (P-PET) provides a framework for how sponsors can work with patients to design protocols centered around the patient. The Study Participant Feedback Questionnaire (SPFQ) asks participants about their experience at the start, middle, and end of their participation in the trial. The questionnaire was created following the FDA’s Clinical Outcomes Assessment development methodology and allows sponsors to take immediate action to update their clinical trial based on participant feedback.

12:35 Lunch in the Exhibit Hall (Community Networking)

EFFICIENT SITE SELECTION & START-UP PROCESS: NEW EU CLINICAL TRIALS DIRECTIVE (EU-CTR), OPERATIONAL DESIGN CENTER (ODC), & EARLY PATIENT INSIGHTS

13:55 Chairperson’s Remarks

Mary Elmer, MSN, Director, Patient, Caregiver and Consumer Experience, Merck

14:00 New EU-Clinical Trials Regulation: Industry Preparation via Pilot Procedures

Ruppert_ThorstenThorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

The presentation will provide an overview to the topic and problems with the actual EU Clinical Trials Directive (EU-CTR). The pilots in different European member states enable sponsors of clinical trials to test the status of their preparation for the new authorization system in Europe. The presentation will also show details from the experience of the pharmaceutical industry, share insight into the status of the pilot project in Germany, and will address the status of industry preparation for the new European authorization system for clinical trials. This will enable an in-depth discussion on the overall status in Europe.

14:25 CO-PRESENTATION: Strengthening Control over Clinical and Financial Outcomes through an Operational Design Center (ODC)

Kravet_MarcyMarcy Kravet, Head, Operational Design Center (ODC), Global Clinical Operations, Merck KGaA


Phillipp_MarcMarc Philipp, MBA, Partner, Managing Director, Pharma & Life Sciences, Accenture GmbH

With its new Operational Design Center (ODC), Merck KGaA found a formula for success in building and embedding new, data-driven capabilities into established ways of working – in a bootstrapped approach enabled by smart external partnerships. The ODC provides clin ops insights to enrich Merck’s study designs. In the fully outsourced model, the ODC improves transparency on protocol designs' decisions impacting financial and performance metrics, enabled by application of advanced analytics. The ODC provides data and insights to teams and development leaders, strengthening decision-making on the trade-offs between time, cost and quality of clinical research.

14:50 Starting Off Right: Driving an Efficient Site Selection & Start-Up Process

Ebhogiaye_ChibbyChibby Ebhogiaye, Head, Feasibility Services, Solution Adoption Center, IQVIA

This session will explore how standardized profiles and enrollment forecasts, based on performance metrics, are driving the start-up process from feasibility through to site enrollment, by increasing the accuracy of study planning and drastically reducing start up timelines. This session demonstrates how analytics derived from feasibility assessments and enrollment benchmarks can be used throughout the site start-up process. The unique selling proposition and differentiator is the emphasis (and reliance) on feasibility, enrollment metrics and active site engagement. A comprehensive overview and understanding of the pitfalls and misconceptions that should be avoided in order to enable and implement an efficient site selection and start-up process.

15:15 Who’s Listening to the Patient? Building Insights into Clinical Development Plans and Protocols

Allin_SharonSharon Allin, Sr Manager, Feasibility, Enrollment & Retention Optimisation, Global Clinical Operations, Biogen

Over the years clinical development programs have been developed with great input and insights from pharma companies, expert medical advisory boards and regulators. However, a key stakeholder is missing from this list: the patient. Over the last few years the tide has changed somewhat and patients are now being asked what is important to them, and the industry is listening. In this session Narinder will review opportunities to gain insights from patients (and their families/caregivers) and share how these have been built into clinical development plans or protocols.

15:30 Refreshment Break in the Exhibit Hall

BREAKOUT DISCUSSION GROUPS

16:10 Find Your Table and Meet Your Moderator

16:15 Interactive Breakout Discussion Groups (Session #1)

17:00 Networking Reception in the Exhibit Hall

18:00 End of Day

9月18日(三)

8:00 Morning Coffee

UTILIZING EHR/RWD TO ENHANCE PROTOCOL FEASIBILITY, SITE SELECTION AND PATIENT RECRUITMENT: HOSPITAL-SPONSOR COLLABORATIONS

8:30 Chairperson’s Remarks

Marc Philipp, MBA, Partner, Managing Director, Pharma & Life Sciences, Accenture GmbH

8:35 Federated EHR Platform Technology: Evidence of Enhancing Site Selection and Patient Recruitment

Sundgren_MatsMats Sundgren, PhD, Director, Health Informatics, Advanced Analytic Center - Global Medicine Development, AstraZeneca

Capabilities of new health data-collection/re-use technologies including EHRs will have a huge impact to support clinical research and trial execution over the next years. The foundation of federated EHR platform technology is here, processes are in place and regulators are supportive. The technology is disruptive to the current Business Models by collaborating directly with HCOs. Results from two service providers and hospital networks will be presented in various impact areas ranging from EHR-enabled study design, site selection and recruitment.

9:00 CO-PRESENTATION: EHR/RWD Platforms Lead to Strategic Data-Driven Partnerships between Hospitals and Sponsors

Hasselbaink_DannyDanny Hasselbaink, PhD, Associate Director, Global Feasibility Lead, Feasibility Center of Excellence, Janssen Biologics B.V.

Hospital Presenter to be Announced

Secure, GDPR compliant and innovative EHR/RWD platforms, leveraging federated data management, enable the re-use of EHR data for clinical research. During this presentation, a case study will be presented illustrating these new data-driven partnerships for protocol feasibility and recruitment. Benefits for both the sponsor and the hospital partners will be presented. For example: for sponsor companies, these platforms can be complementary to traditional feasibility approaches. At the hospitals, clinicians can use RWD/EHR platforms to support research studies and re-use the care data for insights into treatments and outcomes for their patient populations.

9:25 Reducing the Administrative Burden on Sites

Comis_LarissaLarissa Comis, Product Lead, Shared Investigator Platform, Life Sciences Products & Platforms, Cognizant

Every sponsor wants to make life easier for investigators, but what are the initiatives that are delivering measurable benefits today? This session will share the practices that are truly making a difference. Use cases of solutions that have proven to reduce investigator frustration, burnout, and drop-out will be explored.

9:50 Coffee Break in the Exhibit Hall

DATA MONITORING COMMITTEES, ACCURATE COUNTRY/SITE SELECTION, RELIABLE FEASIBILITY & BIOMARKER-DRIVEN TRIALS

10:35 Keeping Pace: How Data Monitoring Committee Identification Can Evolve to Support Current Clinical Trial Demands

Herradon_AnaAna Herradon, Associate Director, Site Monitoring Manager and Regional Clinical Operations, Iberia, Bristol-Myers Squibb

The increasing number and complexity of clinical trials has resulted in an increasing need for independent Data Monitoring Committees (DMC). However, the number and availability of qualified candidates, coupled with a lack of cultivation of new generation DMC candidates has resulted in few available DMC candidates. This presentation will share the results of a TransCelerate initiative which collaborated with and built on existing CTTI DMC assets and expert network recommendations. Specifically discussed will be a future concept for a DMC Registry as well as a proposed DMC apprenticeship model.

11:00 How to Assess: Is Your Clinical Trial Attractive for Patients in this Country

Zlatanova_MayaMaya Zlatanova, Co-Founder, FindMeCure Foundation; Partner, International Alliance of Patients' Organizations & ACRES

We often speak about the country as site selection and focus so much on identifying the best set of sites that have both historical data on performing clinical trials and access to patients. Reality shows that where clinical research experience makes the sponsor and CROs work easier with the site, this does not ensure patients are on board in time. Why? Because at the end of the day, it's the patient's decision to participate or not. So how can we leverage data to understand what patients want and need, and improve our decision-making process on-the-go? Tricks and hacks how you can predict whether you might face difficulties with patient recruitment while selecting countries and sites and how to see further opportunities to improve patient engagement and plan better budget allocation (more sites or patient recruitment activities or both?).

11:25 CO-PRESENTATION: It Shouldn't Be This Hard: Overcoming Barriers of Delivering Reliable Feasibility and Commercial Research

Turgoose_TanyaTanya Turgoose, Industry Operations Manager, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre


Cooper_MattMatt Cooper, PhD, Director, Business Operations, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre

Efficient and effective delivery of research is imperative for all stakeholders, especially patients. During setup and delivery, issues are often encountered; we discuss how we overcame these using existing resources and infrastructure, to deliver the trial successfully.

11:50 SOPHiA Trial Match: Leverage SOPHiA’s Clinical Research Community to Improve Trial Performance

Czwan_EstebanEsteban Czwan, Senior Vice President, Clinical Trials Business Area, SOPHiA GENETICS

Of the challenges faced in trial planning and execution, accurate sites selection and enrollment are still major bottlenecks for the industry. SOPHiA, the AI empowering Data-Driven Medicine, has analyzed over 330,000 genomic profiles to date ... one every four minutes! SOPHiA's Clinical Research Community includes institutions that analyze a patient’s genomic profiles and can now match them to ongoing biomarker-driven clinical trials.

12:15 Lunch in the Exhibit Hall (Community Networking)

13:25 Transition to Breakouts & Keynotes

BREAKOUT DISCUSSION GROUPS

13:35 Find Your Table and Meet Your Moderator

13:40 Interactive Breakout Discussion Groups (Session #2)


14:10 Clinical Research News’ European Innovations Awards & Closing Plenary Keynotes

15:25 Close of Conference


PLENARY KEYNOTE PRESENTATIONS ON TUESDAY AND WEDNESDAY
& CLINICAL RESEARCH NEWS EUROPEAN INNOVATIONS AWARDS

Clinical Research News European Innovations Awards

Clinical Research News' European Innovation Awards recognizes outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations—that manifestly improve the clinical trial process.

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

This year due to positive feedback we will be running two breakout discussion sessions, one on Tuesday afternoon and a second on Wednesday afternoon. Attendees will thus have a chance to join two topic discussions.

Please see details at: breakout-discussions


* 活动内容有可能不事先告知作更动及调整。

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