3rd  Annual  

Data & Tech Driven Clinical Trials

Advancing Clinical Trials with New Tools and Analytics  

April 25-26, 2017

Technology and data are at the forefront in driving clinical trial decision making. With further advancements in new technologies (such as mobile devices and wearables) and the rise of online communities, the pharma and biotech industry are poised to capitalize on these advancements to innovate existing clinical trial processes and systems. Cambridge Healthtech Institute’s Data & Tech Driven Clinical Trials gathers leaders across pharma, biotech and academia for discussions and case studies on leveraging new technologies and clinical trial data to advance clinical research.

Tuesday, April 25

10:00 am Conference Registration

TECH TOOLS AND THE FUTURE OF CLINICAL TRIALS

1:45 Chairperson’s Remarks

Karim Damji, Senior Vice President, Products, Solutions & Marketing, Saama Technologies

1:50 Intelligent Automation & Robotics in Clinical Development: An AbbVie Case Study

Aman Thukral, Assistant Director, Strategy & Innovation, Clinical Data Sciences, AbbVie

Pharmaceutical companies across the globe are leaving no stone unturned to make clinical trials more efficient and productive. Embarking on the same theme, AbbVie piloted robotics in one of the clinical development function. Currently, the data sciences group creates accounts for investigators and site staff in the Interactive Response Technology (IRT) system by entering information manually using the admin module. Before the creation of the account in the IRT system, additional due diligence is performed if site staff has completed the required GxP training for access. The process is labor-intensive, time-consuming, and error-prone. To mitigate these challenges, a robotics software was deployed that used human credentials and worked on the front end admin module to create accounts. The robot also ensured the training and other requirements before access was provided. This yielded several benefits: 1. Significant productivity improvement; 2. Improvement in accuracy due to reduction in human errors; 3. Faster overall turnaround time enabling quicker site setup.

2:20 Remote Trials: Moving beyond the Concept

Hassan Kadhim, Business Consultant, IS BP R&DM, Boehringer Ingelheim

Remote Trials have been gaining more traction over the past few years as a new and innovative way to run clinical trials. The concept is certainly very interesting, but operationally very challenging to coalesce. In this talk, we will address some of these challenges, review the stakeholders’ perceptions around the implementation of Remote Trials, and propose the steps forward to be able to run Remote Trials in the near future.

2:50 pm RBM And The Role Of New Age Analytics In Clinical Trial Quality

Rajneesh Patil, Senior Director, Risk-Based Monitoring & Analytics, QuintilesIMS

RBM models rely significantly on data and analytics to assess risks to site performance, subject safety and data quality. However, the early generations of these models focus on single parameters to identify issues, which, out of context, can often lead to false positives/white noise. The new age analytics models can differentiate the relative risk between sites and indicate which sites or subjects are at higher risk. In this session we will explore of few of our implementations as case studies.

3:20 Refreshment Break in the Exhibit Hall

4:05 PANEL DISCUSSION: What Do Clinical Trials Look Like in 2020?

John Reites, Chief Product Officer & Partner, THREAD

Hassan Kadhim, Business Consultant, IS BP R&DM, Boehringer Ingelheim

Karim Damji, Senior Vice President, Products, Solutions & Marketing, Saama Technologies

The panel will discuss existing technologies (apps, data viz tools, wearables, sensors, etc.) and analytics and where they may take us for clinical trials in the future. These technologies will help address the challenge of patient recruitment, clinical trial onboarding, remote clinical trial visits and more.

5:05 Close of Day

5:05 Dinner Short Course Registration

Wednesday, April 26

8:30 am Interactive Breakout Discussion Groups with Continental Breakfast

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. 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.

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9:25 Session Break

WEARABLES, SENSORS, DIGITAL BIOMARKERS, AND
MHEALTH FOR CLINICAL TRIALS

9:40 Chairperson’s Remarks

Manoj Vig, Enterprise Architect Big Data, Information Technology, Shire Pharmaceuticals

9:45 Validating Digital Tech for Clinical Trials

Georgia Mitsi, Senior Director, Search Evaluation, Digital Healthcare, Sunovion

10:15 Are We Ready to Use Wearable Sensors in Clinical Studies?

Bhaskar Dutta, Principal Biomedical Informatics Scientist, AstraZeneca

Remarkable progress in wearable sensor technologies over last few years has enabled us to passively collect high-resolution dynamic data in clinical studies, which were not feasible before. Wearable sensor technology, often coupled with cell-phone applications, brings the promise of improving management of chronic diseases, identification of adverse effects in clinical trials, use of new efficacy endpoints, gaining understandings of diseases and patient behaviors. Fulfillment of these promises and future adoption of wearable sensors in clinical studies will depend on several factors, such as quality of the sensor data, patient engagement, cost, and regulatory requirements. Currently, several wearable sensors are commercially available, hence, requiring a comprehensive review of the sensors based on the above-mentioned parameters. We carried out a study to compare wearable sensors in healthy volunteers and implemented a comprehensive data analysis strategy. Findings of this study have paved the way for improved design of future studies involving wearable sensors.

10:45 Refocusing on Risk Mitigation in Starting Clinical Trials

Robert Wynden, Ph.D., Vice President, Technology & Engineering, Product Development, goBalto

Risk-based challenges are escalating as clinical trials become more global and complex. A focus on study startup, including best practices for the identification and mitigation of potential risks before they occur is essential to stem the tide of study delays and cost overruns, often leading to rescue studies.

11:00 Coffee Break

11:30 PANEL DISCUSSION: Considerations for Using Wearables/mHealth to Accelerate Clinical Trials

Georgia Mitsi, Senior Director, Search Evaluation, Digital Healthcare, Sunovion

Bhaskar Dutta, Principal Biomedical Informatics Scientist, AstraZeneca

Joe Dustin,Director, Mobile Health, Medidata

As pharma and biotech companies increasingly look towards new digital tools to help monitor patients during clinical trials, there are many considerations that need to be taken into account before their selection and use. The panel will cover such topics as commercial vs. medical grade wearables and sensors, regulatory concerns and data quality.

12:30 pm Luncheon Presentation (Sponsored Opportunity Available)

1:15 Session Break

DIGITAL TECHNOLOGY AND DATA MOVING CLINICAL TRIALS
TO A PATIENT-CENTERED MODEL

2:00 Chairperson’s Remarks

Manoj Vig, Enterprise Architect Big Data, Information Technology, Shire Pharmaceuticals

2:05 Co-Presentation: Connecting Clinical Trials, Patients and Physicians with the Help of Digital Technologies and Big Data

Manoj Vig, Enterprise Architect Big Data, Information Technology, Shire Pharmaceuticals

Venki Balakrishnan, Analytics Solution Architect, Shire Pharmaceuticals

This talk will focus on emerging trends in Mobility, Big Data, distributed search, connected devices and machine learning that can be applied to take relevant trials to patients and their physicians instead of continuing with the traditional model that is focused on finding patients based on historical metrics. We will discuss how mobile health applications are not only improving the patient-physician relationship and overall outcome of a treatment but how they are also shifting the entire health eco-system from a “research focused” model to a “patient focused” model. Mobile apps of various nature will be playing an enormous role in taking healthcare models to the next level in years to come.

3:05 Complexity in Clinical Trial Design and Conversion to Commercial Success

Michael Liebman, Ph.D., Managing Director, IPQ Analytics, LLC

Clinical trials focus on the need to achieve clinical success and FDA approval, but this is not a guarantee of commercial success, only the first step. While real world clinical practice and real world patients may not be included in trial design, a lack of understanding the complexities that they present can lead to success at the trial level but failure of the product. Our modeling enables better decision making as to what to include and exclude in trial design and patient recruitment.

3:35 Close of Conference. Arrive early to attend Big Data for Clinical Trials.