Cambridge Healthtech Institute’s 7th Annual

Improving Study Start-Up, Site Activation and Trial Performance
( 臨床研究啟動、臨床試驗設施建立、改善實績 )

Strategically Implementing Process, Tech and Systems for Rapid Study Start-Up and Improved Site-CRO-Sponsor Interactions

2020年2月20日~21日


Clinical trial site activation and efficient study start-up for both site-based and remote/de-centralized trials are critical to drug development programs, in terms of time, cost and quality of data. To improve start-up times and outcomes, one needs an experienced clinical research investigator, motivated and capable team members and efficient communication by all. Everyone (Sponsor, CRO, Site) must communicate and execute effectively to improve: the study feasibility process, site investigator’s experience, consent process, rollout and implementation of technologies across a study, contract and budget negotiations, payments, and development of patient recruitment and retention programs. Understanding and planning for the challenges faced by your study participants, investigators, sites and industry partners is the key to improving trial efficiencies and outcomes. Knowing when and where to use and to effectively scale technology is now a must in the age of digital trials. CHI’s 7th Annual “Improving Study Start-Up, Site Activation and Trial Performance” will cover the topics one should consider when strategically implementing a process for rapid study start-up, whether with sites or for de-centralized trials.

Arrive early and attend Part 1 (Wed - Thurs): Protocol Development, Global Site Selection, Feasibility and Site Management

Final Agenda

2月20日(四)

11:30 am Registration Open

12:30 BRIDGING LUNCHEON PRESENTATION: Humanizing Patient Engagement through Behavioral Sciences

Kiger_DavidDavid Kiger, Chief Commercial Officer, Datacubed Health

During this presentation, we will describe the advantages of modern design and UX (user experience) concepts, like those used in consumer apps. We will show how these standard modern approaches yield a more rewarding patient-centric experience. We will describe several innovative concepts used to nudge and track patients, to create a 360-degree experience for participants, clinical sites, and primary care physicians.

1:00 Coffee and Dessert Break in the Exhibit HallBioTelResearch

 

2:00 Afternoon Plenary Keynotes

3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing

SITE ENGAGEMENT DURING FEASIBILITY PROCESS & IMPROVING START-UP TIMELINES WITH ADVANCED PLANNING FOR EARLY AND LATE-STAGE TRIALS

4:10 Chairperson’s Remarks

4:15 Site Engagement During the Site Feasibility Process and Impact on Study Start-Up Timelines

Tomas_MaryAnneMary-Anne Tomas, Director, Site Intelligence & Selection, Study Optimization, Global Product Development, Pfizer

This presentation will look into the impact of insourcing site intelligence and site engagement for site feasibility from a sponsor point of view. It will examine the impacts of site relationships on study start-up timelines and success. It will also highlight approaches with respect to site architecture, therapeutic alignment, and methods of approach.

4:45 Presentation to be Announced

 

Oracle-Health-Sciences5:15 Avoid Rescue Studies, Reduce Costs and Timelines, and Accelerate Clinical Operations with Metrics

Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences, Oracle, Inc

You can’t manage what you don’t measure. Granular real-time metrics provide operational insights allowing you to take control of your studies by being proactive instead of reactive. Drive competitive performance and operational excellence by focusing your resources on bottlenecks and processes ripe for optimization. Introduce efficient resource allocation and parallelization of operational activities that can significantly compress operational timelines, improve downstream quality and regulatory compliance, while speeding entry to market.

5:45 INTERACTIVE PANEL: Sponsor and Site Interactions in Phase 1 Site Selection, Recruitment and Contract Negotiations

Womack_KristiKristi Womack, Director, Clinical Pharmacology Operations, Allergan


Scheetz_MarkMark Scheetz, Associate Director, Program Lead for Phase I Studies, Allergan


Miller_CarolCarol Miller, Senior Director, Business Development, Spaulding Clinical Research

Phase 1 doesn’t fit into the late Phase mold. Start-up is much quicker and procedures differ for these studies. Study enrollment goals and duration are much shorter than most late phase studies. Discussions pertaining specifically to Phase 1 are lacking and there is a need for discussion on these topics within the clinical operations community. This panel is an open dialogue between Sponsor representatives and site representatives sharing “what works” and the lessons are relevant to those working in both early and late phases:

  • Site selection process from the sponsor point of view
  • Meeting recruitment and retention goals: How Phase 1 centers distinguish themselves to retain a healthy volunteer database, and how do we find the special patient populations?
  • Maintaining strong sponsor and site relations: How does contracting play a role?

6:15 Networking ReceptionIBM-Watson-Health

7:15 Close of Day

2月21日(五)

7:15 am Registration Open

7:45 Breakfast Presentation to be Announced

8:15 Session Break

IMPROVING SITE SELECTION, ENGAGEMENT AND PROCESS: CONSENT, EHR PLATFORMS, CONTRACTING & DATA-DRIVEN COURSE CORRECTION

8:20 Chairperson’s Remarks

8:25 CASE STUDY CO-PRESENTATION: Create and Control: BI’s Move to a DIY Consent Process

Signs_KristenKristen Signs, Senior Associate Director, Clinical Operations, Boehringer Ingelheim


Delente_EricEric Delente Head, Patient Consent, IQVIA Technologies

Boehringer Ingelheim took a major step and insourced their consent process with a SaaS technology so they could create, manage, distribute, control and report on consent documents all in-house. BI will discuss their journey, including why they decided to go this direction, managing change within their organization, reactions from sites and ethics committees, the successes and struggles of their implementation and pilot trials, and the importance of early adopters in driving transformational change.

8:55 CO-PRESENTATION: Lessons Learned in Site Selection and Site Engagement Using EHR Platforms

Schantz_DougDoug Schantz, Executive Director, Clinical Operations, AstraZeneca


Oley_ChrystalChrystal Oley, Associate Director, Site Partnerships, AstraZeneca

In 2019 AstraZeneca began to explore how to make smarter site selection decisions by leveraging electronic health record systems capability to pre-identify potential participant clusters. We discovered that the success of this strategy is rooted in three primary drivers: technology platform capabilities, data access across multiple institutional platforms and institutional line-of site across the patient care delivery system. Our findings suggest that although the technology capabilities are important the drivers are the human factors: leadership support of cross institutional database access and institutional line of site into patient care access points. Successful implementation of an EMR strategy is achievable but awareness of an individual site’s commitment to this process is essential to converting the numeral data to patient lives impacted by clinical research.

9:25 Navigating the Study Start-Up Labyrinth: The Importance of Upfront Planning and Cross-Functional Alignment to Efficient Site Contracting

Greene_ChristyChristina Greene, Esq., Associate Director, Global Site Agreements, Merck Sharp & Dohme Corp.

CTA execution is an essential element to activating an industry-sponsored clinical trial at a clinical site, yet site contracting and budgeting remain one of the top reasons for delayed site activation. What are the root causes and how can it be avoided? Which techniques and approaches should we apply to avoid excessive delays in study start-up? What are we (sponsors, CROs, sites) doing together to avoid unnecessary delays and what are we missing? Learn about efficiency improvement opportunities in contracting aspects of study start-up.

9:55 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.  

10:25 Networking Coffee Break

SITE-LEVEL TRIAL ACCELERATION AND DATA-DRIVEN COURSE CORRECTION

10:55 Chairperson’s Remarks

Linda Glaser, MD, PhD, Medical Director, Coastal Biomedical Research

11:00 When Data Drives Intervention: An Analytics Approach to Site Level Acceleration and Trial Course-Correction

Hopkins_AngeliqueAngelique Hopkins, Director, Clinical Trial Analytics, Business Insights and Analytics, Bristol-Myers Squibb Company

There are weak link sports (soccer) and strong link sports (basketball), the best method for improving performance in each situation depending on whether investing in the worst component of a team or the greatest strength on a team makes the biggest difference. For years the preferred method for accelerating clinical trials and improving site performance has been to focus on the highest performing sites. Using trial simulation and modeling techniques, we can see how a “weak link” approach to site performance (focusing middle and lower tier sites) may be a better although less intuitive method for increasing performance and accelerating timelines.

11:30 Why Effective Site Regulatory Doc Oversight is the Key to Stress-Free Inspection Readiness

JT Tan, Pharma/CRO Innovation Lead, Complion

At its core, Inspection Readiness is straightforward: everyone's been doing what they should be doing, so there's nothing wrong with taking a look, right?  Yet that pit in your stomach tells a different story - why?  In this talk, we will unpack the challenges behind effective regulatory document oversight and introduce a new, pro-active approach to TMF quality through automation.

12:00 pm Transition to Shared Sessions

FACILITATING THE TRIALS OF THE FUTURE NOW VIA THE CONNECTED PATIENT & DECENTRALIZED TRIALS (SPECIAL SHARED SESSION)

Chairperson’s Remarks

Neil Weisman, President, Continuum Clinical

12:05 The Connected Patient: A “One Stop Shop” for Trial Information and Data

McBride_MeganMegan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Learn how we are creating a connected experience for trial participants before, during and after the trial where patients can access meaningful information, their individual data to share with their EHR, aggregate study results and provide ongoing feedback and insights to ensure a better experience for patients, caregivers and the site teams. Explore the possibilities to remain connected via communities to raise awareness around trials. The audience can gain insights as to the ins and outs of how we managed to create a platform to share data directly with patients–from legal, privacy, regulatory and other key stakeholder hurdles to our vision for broadening the scope of data sharing across industry.

12:35 INTERACTIVE PANEL: Translating Virtual to Reality: Decentralized Trial Transformation

Myles_JaneModerator: Jane Myles, Head, Operational Intelligence and Innovation, Roche


Panelists:

Akbari_BardiaBardia Akbari, PharmD, Senior Vice President, Clinical Operations, Science37


Kadhim_HassanHassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb


Melvin_CarrieCarrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO


McBride_MeganMegan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Our expert panel will include a variety of perspectives and the aim is to provide pragmatic solutions and actionable advice to make virtual trials a realistic option for your study needs. We’ll discuss strategic and tactical needs to help you determine how to navigate and implement virtual and decentralized options to drive your pipeline goals. Topics to be discussed include:

  • Discuss the settings for virtual trials and help define best fit options for study needs.
  • How and when does the regulatory strategy get set to enable a successful filing?
  • What are the challenges to drive both site and patient participation in virtual trials?
  • What are the timeline and cost differences in planning for and executing virtual trial components?
  • What are the key lessons learned from those who have been early adopters and champions?

1:05 Transition to Lunch

Teckro 1:10 SCOPE Send Off Luncheon Presentation to be Announced

1:40 Closing Remarks

1:45 SCOPE Summit 2020 Adjourns

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes
For more details on the Participant Engagement Award

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: breakouts

 

Arrive early and attend Part 1 (Wed - Thurs): Protocol Development, Global Site Selection, Feasibility and Site Management


* 活動內容有可能不事先告知作更動及調整。

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