Cambridge Healthtech Institute’s 7th Annual

Improving Study Start-Up, Site Activation and Trial Performance  

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

February 20-21, 2020


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

Thursday, February 20

11:30 am Registration Open

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

David 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 Hall

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

Mary-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

 

5:15 Presentation to be Announced

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

Kristi Womack, Director, Clinical Pharmacology Operations, Allergan

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

Carol 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 Reception (Sponsorship Opportunity Available)

7:15 Close of Day

Friday, February 21

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

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

Eric 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

Doug Schantz, Executive Director, Clinical Operations, AstraZeneca

Chrystal 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

Christina 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

Larissa 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

Angelique 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 Talk Title to be Announced

Rick Arlow, Founder & CEO, Complion

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

Megan 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

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

Panelists:

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

Greg Hersch, PhD, Head, Innovation, Global Development Operations, Novartis

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

FDA Panelist to be Announced

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

1:10 SCOPE Send Off Luncheon Presentation (Sponsorship Opportunity Available)

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: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/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: www.scopesummit.com/breakouts

 

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




For more details on the conference, please contact:
Micah Lieberman

Executive Director, Conferences

Cambridge Healthtech Institute (CHI)

Phone: (+1) 541. 482.4709
Email: mlieberman@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457

Email: iquigley@healthtech.com

 

Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349
Email: prose@healthtech.com