Cambridge Healthtech Institute's

Feasibility & Site Selection

April 7-8, 2020


The ability to identify and select high-performing sites is critical to clinical trial success. New technology and analytics create opportunity to predict site performance and make informed decisions on site success. Coupled with innovative, patient centered protocol design and stakeholder collaboration in the feasibility process, pharma has the opportunity to measurably impact outcomes. Learn more at this lively conference program at CHI's 9th Annual Clinical Trial Innovation Summit.

Final Agenda

MONDAY, APRIL 6

2:30-5:30 pm Pre-Conference Workshops

Workshop 2: Data-Driven Clinical Development: Tutorial and Case Studies

Workshop 3: Inspection Readiness in Changing Global Regulatory Environment

*Workshops are included in your registration. However, please RSVP to reserve your seat.

TUESDAY, APRIL 7

8:15 am Registration and Morning Coffee

Real World Data, Artificial Intelligence and Analytics to Reshape Clinical Development

9:00 Organizer’s Opening Remarks

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

9:05 Chairperson’s Remarks (Sponsorship Opportunity Available)

9:10 Digitalization of Clinical Trials: Breakthroughs in Technologies and Data

Peter BergethonPeter Bergethon, MD, Vice President, Head of Digital and Quantitative Medicine, Biogen

Medicine as systems science characterizes the health state by measurable properties. Changes in state over time (dynamics) define trajectories through growth, health and disease. Dynamic transitions define trajectories between health, illness and therapeutic interventions. Capturing time dependence is the power of digital technology. Herein lies the power of digital medicine. We will review specific cases showing how this paradigm is transforming our clinical trial landscape.

9:30 CO-PRESENTATION: The Role of Real-World Data in Creating New Pathways to Biopharma Industry Transformation

Alan LouieAlan Louie, PhD, Research Director, Life Sciences, IDC Health Insights


Alan LouieCharles Makin, Global Head, Real World Evidence Strategy, Biogen


In parallel to other industry best practices, the biopharmaceutical industry is embracing digital transformation as it seeks to better leverage data across the life science ecosystem. In conjunction with these efforts, increasingly available real-world data (RWD) promises to bring new patient-specific data and insights to the industry, data which bring researchers closer to understanding patient-level treatment responses while also opening new channels to engagement. With strong support from regulators, real-world evidence offers significant potential to accelerate new drug discovery and development, improve process efficiencies, and improve patient outcomes over the near term.

9:50 AI in Human Health – Connecting Data Modules from Discovery Biology to Clinical Development

Rangaprasad SarangarajanRangaprasad Sarangarajan, PhD, CSO & Senior Vice President, Clinical and Translational Sciences, Research & Development, BERG

Drug development programs in companies are predicated on biological insights supporting a hypothesis of target and its role in disease etiology. This presentation will focus on the data modules essential for linking discovery biology to early/late stage clinical development and the leveraging of AI in the integration of the various dataflow to make data-driven informed decisions and ensure success. It will outline how to utilize data, AI analytics with RWD-based support for planning drug development to propel products all the way through the clinic.

10:10 Grand Opening Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)

PROTOCOL OPTIMIZATION & FEASIBILITY ASSESSMENT

11:10 Chairperson’s Remarks (Sponsorship Opportunity Available)

11:20 Data Science in Protocol Optimization

Beth MahonBeth Mahon, Global Feasibility Therapeutic Area (TA) Head, Feasibility Center of Excellence (FCoE), Clinical Insights and Experience, Oncology, Janssen

Potential to merge, overlay, and analyze data is proving to increase the ability to be predictive in achieving earlier and better outcomes in the area of protocol optimization. Janssen is using natural language processing in the development of benchmarks for computing patient burden and site burden and the correlation of trial burden, trial costs, and actual enrollment with design parameters and amendments. Ultimately, this allows for protocol design with better consideration of patient and site voice and fewer protocol amendments.

11:50 PANEL DISCUSSION: Incorporating Site Input into the Protocol Development Process

Moderator:

Christina BrennanChristina Brennan, MD, MBA, Vice President, Clinical Research, Northwell Healthcare


Panelists:

MarieElena Cordisco, MA, APRN, NP-C, Nuvance Health; Director Clinical Trials, Western Connecticut Health Network; Interim Director, Division of Research, Health Quest


Jane HartJane Hart, Vice President, Global Clinical Affairs, 3M Health Care


Beth MahonBeth Mahon, Global Feasibility Therapeutic Area (TA) Head, Feasibility Center of Excellence (FCoE), Clinical Insights and Experience, Oncology, Janssen


We’ve all experienced the frustration of an “ideal” sponsor protocol that is challenging for sites to execute or for patients to participate in. This panel discussion will provide interactive insights into how sites and industry can partner together more effectively to design relevant clinical trial protocols and optimize study execution for all stakeholders.

12:35 pm Transition to Luncheon Presentation

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:25 Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunity Available)

INNOVATIONS TO IMPROVE STUDY SUCCESS

2:00 Chairperson’s Remarks (Sponsorship Opportunity Available)

2:10 PANEL DISCUSSION: Building and Implementing an IT Ecosystem for Master Trials

Moderator:

Len RosenbergLen Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS


Panelists:

Hugh LevauxHugh Levaux, Founder and CEO, Protocol First


Rick ArlowRick Arlow, CEO, Complion, Inc.


We are in the age of information, but we don’t necessarily use, analyze, or share data in the most effective way. What would happen if pharma routinely participated in Master Trials managed by non-profits as an alternative to traditional clinical trials? Should it be a core element of their pipeline strategies? A centralized resource to quickly and efficiently examine drug candidates. What if our collaborative efforts would streamline decision-making so that the most effective drugs could be fast-tracked into clinical trials? Could we save time, money, and other resources if our go/no-go decisions were made in months instead of years? This panel will describe a novel approach to genomic-based decision-making to optimize breakthrough therapeutics. This drug development model combines scientific innovation and next-gen e-clinical technologies to radically change the drug development landscape.

Teckro2:40 Simplifying and Modernizing Clinical Trials at Cancer Research Site Networks

Drobek_CayceCayce Drobek, Director, Clinical Operations, Teckro

Teckro is currently collaborating with large oncology research institutions to help to modernize and simplify cancer research. Join this session to learn more about how Teckro is working with site networks to simplify the conduct of trials and make them more transparent and inclusive for investigators, site staff, and patients.

 

2:55 PANEL DISCUSSION: The Tried and True Traditional vs. the AI Enabled Promise: Compare and Contrast

Moderator:

Jane MylesJane Myles, Founder and Director, JemTech; Former Head, Operational Intelligence and Innovation, Roche


Panelists:

Brandon Maggio, Associate Director, Global Clinical Operations, Boehringer Ingelheim Pharmaceuticals


Ronald DorenbosRonald Dorenbos, PhD, Head, Innovation Management & Scouting, Innovation & Technology Science, Takeda


Gabriela FeldbergGabriela Feldberg, Practice Leader, Applied Analytics & Artificial Intelligence, AstraZeneca


In this session our panel will offer real life examples of using our tried and true approaches to solving problems for clinical trials and compare them to AI-enabled solutions for similar problems. The intent is to help the audience understand what might be an appropriate problem for AI support and what the challenges are in implementing that. If possible we’ll compare outcomes for the problems that were tackled.


3:25 Transition to Keynote

Why Do Trials Succeed and Why do they Fail? Insights from Industry and Academia

3:35 Organizer’s Opening Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech

Institute

3:40 Chairperson’s Remarks (Sponsorship Opportunity Available)

3:45 BEST CLI Trial: Lessons Learned From Execution Of A Complex Multicenter RCT

Alik FarberAlik Farber, MD, Chief, Division of Vascular and Endovascular Surgery, Associate Chair for Clinical Operations, Department of Surgery, Boston Medical Center; Professor of Surgery and Radiology, Boston University School of Medicine

The BEST-CLI trial is the largest RCT ever undertaken to evaluate strategies for treatment of critical limb ischemia (CLI). This study is an international, multispecialty, prospective, multicenter, randomized comparative effectiveness trial of endovascular versus open surgical revascularization in patients with CLI who are candidates for both procedures. The study has been performed at 134 sites and has enrolled 1843 patients. Its execution had had multiple obstacles and challenges that the trial leadership team has successfully navigated.

4:15 CO-PRESENTATION: What Causes Studies to Fail? Understanding Causal Drivers of Operational Success Using Machine Learning

Marcy KravetMarcy Kravet, BS, MBA, Head, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany


Sylvia MareckiSylvia Marecki, PhD, Design Analyst, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany


It is currently unknown what drives successful study enrollment despite extensive analysis conducted across the industry, which largely has focused on correlations. The Operational Design Center at EMD Serono has leveraged causal machine learning to analyze hundreds of variables across thousands of clinical trials with the objective of identifying causal drivers of enrollment success, which can be optimized to conduct faster, less expensive trials. Early insights will be shared.

4:45 Welcome Reception in the Exhibit Hall (Sponsorship Opportunity Available)

5:45 End of Day

WEDNESDAY, APRIL 8

7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

NEW TRENDS AND INNOVATIONS IN SITE SELECTION 

8:25 Chairperson’s Remarks

Chairperson to be Announced, Teckro Ltd.

 

8:35 Improving Clinical Trial Site Selection Using Advanced Analytics

Kaitlin FolweilerKaitlin Folweiler, PhD, Data Scientist, R&D Data Science, Analytics and Insights, Janssen

Determining which sites will achieve on-time and on-target patient enrollment is one of the most difficult aspects of clinical trial site selection. Relying solely on historical performance has been shown to be a weak predictor of future site performance and of overall trial timelines. To deliver robust predictions of site enrollment, we developed an advanced analytics pipeline using big data analytics and machine learning to assist with site selection internal trials. We will explore approaches to scaling our pipeline to the entire portfolio of clinical trials and will highlight recent successes and the challenges that lie ahead.

9:00 Shifting the Paradigm in Building Evidence-Driven Site Profiles for Clinical Trial Participation

Justin HenspergerJustin Hensperger, MS: Clinical Trial Science, Site Intelligence Lead – Associate Director, Internal Medicine, 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.

9:25 CO-PRESENTATION: Challenges and Successes in Building and Implementing a Data-Driven Site Selection Approach

Sandra SmythSandra Smyth, Head, Global Feasibility & Site Intelligence, AstraZeneca


Gabriela FeldbergGabriela Feldberg, Practice Leader, Applied Analytics & Artificial Intelligence, AstraZeneca


In an environment of growing complexity, the need to utilize advanced analytical techniques is more pressing now than ever to ensure selection of the optimal investigators for a study. This presentation will be a lively discussion sharing the challenges and successes in building and implementing data-driven site selection to ensure that teams have meaningful information needed, at the time needed, to make the best decisions for their studies.

9:50 Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)

TOOLS AND STRATEGIES TO IMPROVE SITE ACTIVATION & STUDY START-UP

10:40 Chairperson’s Remarks (Sponsorship Opportunity Available)

10:50 Expediting Study Start-Up in Global Clinical Trials

Amanda HaydenAmanda Hayden, Senior Director, Global Clinical Services, Clinical Operations, Alkermes

When planning for study start-up in Ex-US countries, sponsors focus on regulatory approvals, site level clinical trial agreements, study drug shipment availability and study equipment readiness to allow for timely site activations. Sometimes there are hurdles in regulatory pathways that delay start-up whereas other times there could be issues with shipping equipment or drug supply. As a sponsor company, one needs to stay on top of the changing regulatory and compliance landscape and clinical site level complications for study conduct. CROs play a vital role in overseeing local activities supporting start-up and partnering with them effectively is key to ensure sponsor companies meet start-up objectives and goals. This presentation will share obstacles in planning Ex-US clinical studies and how to plan efficiently to meet your site activation goals.

11:15 Accelerating Study Start-Up – A Site Perspective

Lale Akca, MBA, CCRA, Executive Director, Clinical Trials Unit, University of Louisville

Both sponsors and sites have a common goal: a successful trial. Success can only be achieved if multiple perspectives are considered. A collaborative approach in site selection leads to increased success in study enrollment. After being selected as a site by the sponsor, UofL Clinical Trials Unit uses its own sponsor questionnaire to evaluate the project from the site perspective. The goal is to make sure that the study is the right one both for the sponsor and the site.

11:40 Transition to Breakout Discussions

INTERACTIVE ROUNDTABLE BREAKOUT DISCUSSIONS

11:45 Find Your Table and Meet Your Moderator

11:50 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.

12:30 pm Community Networking Lunch in the Exhibit Hall (Sponsorship Opportunity Available)

1:40 Transition to Plenary Keynote

Understanding the Patient Journey to Improve Trials

1:45 Organizer’s Opening Remarks

Kaitlin Searfoss Kelleher, Senior Conference Director, Cambridge Healthtech Institute

1:50 Chairperson’s Remarks (Sponsorship Opportunity Available)

1:55 The Journey from Patient to Advocate to Leader: Changing the Clinical Research Game

Rob LongRob Long, Executive Director, Uplifting Athletes

I will talk about my journey from Division I football and top NFL prospect to cancer patient. My experience of undergoing chemo and radiation and fighting through a battle with brain cancer has enabled me to leverage my story to make a difference in the lives of those affected by rare diseases. The attendees will gain insights into what it means to be a volunteer at the front lines of oncology research and clinical trials. New approaches to partnering with advocates, disease communities and young researchers will be shared. In addition, we will discuss the future of rare disease research and outreach and illustrate where industry and the patient community can go together in collaboration.  Read an article published about Rob Long's journey,  Ex-Syracuse punter Rob Long takes on cancer, survival and what comes next

NOTE: Uplifting Athletes and Cambridge Healthtech Institute are proud to include some new young researchers in rare disease at this conference. They are our future partners. Advocacy groups interested in nominating young researchers for the Uplifting Athletes Young Investigator Draft can submit to: https://www.upliftingathletes.org/rare-disease-research; Nominations open on November 21, 2020. Click here for additional information on applying for a guest pass directly.

2:10 PATIENT CO-PRESENTATION: The Patient’s Point of View: Clinical Trial Perceptions and Experiences

Annick de BruinAnnick de Bruin, MBA, Director, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP)


Phyllis KaplanPhyllis Kaplan, Trial Volunteer and Patient with T1D


Results from a large-scale global study conducted in 2019 among patients and the public offer robust insights into the latest perceptions of clinical research and enrollment barriers, as well as patient engagement preferences (exploring patient receptivity to virtual trial models and the latest technologies). The 2019 CISCRP Perceptions & Insights study is the largest global study of its kind (over 12,400 responses from around the world, including experiences of 3,600+ prior study participants), offering robust global insights that audience members can directly apply within their own organizations. Learn what information is critical to support the participation decision-making process from the patient’s point of view. Identify key participation elements which matter most to patients and their support network. Determine which convenience-enhancing solutions create the biggest impact on overall experiences.

2:30 CASE STUDY CO-PRESENTATION: Co-Creating with Patients to Create a Better Clinical Trial Experience

Jackie ZimmermanJackie Zimmerman, Patient Advocate


Maura SnyderMaura Snyder, MBA, Global Head, Clinical Trial Engagement, Clinical Insights and Experience, Janssen Pharmaceuticals


Janssen, in partnership with one of our patient advocates, will co-present on an initiative established in 2019 to bring the global patient perspective and input into the Janssen patient engagement plans in immunology. While it’s important to hear about the strides that the industry is making in the areas of patient engagement – it’s more important to hear directly from the patients about their perspective on this. This discussion will provide the audience practical, tangible ways to approach patient engagement. There are a variety of methodologies to approach this patient voice work and we will share one way that we have found to be very beneficial and successful.

2:55 Closing Remarks

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

3:00 Close of Conference


Japan-Flag Korea-Flag China-Simplified-Flag China-Traditional-Flag

 

From the Producers of:

From the Producers of SCOPE