June 12-14 2017
The Westin Boston Waterfront, Boston, US
Register before Friday, May 12 to save up to $500!

Morning Workshops
June 12, 2017

09.00 - 12.00
Workshop A: Collecting Clinical Outcome Data Remotely: Advanced Analytics for mHealth Collected Data
Workshop Leader: Elena Izmailova, Senior Director, Capabilities and Devices, R&D Informatics , Takeda Pharmaceuticals Inc

Big data analytics and new clinical mHealth technology promise to significantly change how trials are conducted and increase the value of the data and insights that come out of these trials.

Advancements in computing power and predictive analytics tools enable us to process vast amounts of information and develop insights in mere seconds. But what methods are available to collate disparate data sources so that we can share data and use advanced analytics to make better decisions — all with the goal of getting effective drugs to market faster ?

In this workshop we will address:

  • Challenges and potential solutions of deploying wearable devices in the clinic, in forging a path to novel outcome measures
  • Consumer and medical grade devices – fit-for-purpose principle
  • Areas of opportunity and successes in utilizing big data for wearable and sensor enabled trials
  • The major challenges around ensuring data integrity, intellectual property, sharing and data standards
  • Current methodologies and food for thought in overcoming the variability of the collected data and how to deal with the different sources of data
  • Diving into the detail of defining novel digital disease biomarkers, phenotypes and end types

Elena Izmailova, Senior Director, Capabilities and Devices, R&D Informatics , Takeda Pharmaceuticals Inc

Elena Izmailova

Elena has a unique background of technology innovation, scientific strategy and business management. She is a Senior Director of Devices and Novel Data Streams at Takeda Pharmaceuticals Inc., working on implementation of innovative technologies in drug development.  Elena demonstrated a consistent record of achievement in pharmaceutical industry and academic research. She successfully lead teams, improved business processes, and delivered timely, impactful results. Elena has proven herself as an agent of change adept to driving teams to high performance in the complex, cross-functional, rapidly evolving environments.

 

Elena joined Millennium Pharmaceuticals, Inc. in 2003 where she has led scientific teams in Inflammation and Oncology therapeutic areas, representing Translational Medicine business in late preclinical and early clinical development.  The main focus of her work was on biomarker strategies, bioanalytics and clinical implementation. Elena continued expanding Translational Medicine business after Takeda’s acquisition of Millennium, adjusting to the global operating model and late stage programs. She developed scientific and business strategies that resulted in pharmacology and biomarker data included in several INDs, biomarker studies executed in more than 50 clinical trials. Elena implemented a new, cost and resource efficient, business model for clinical biomarker development, validation and global implementation.  Later, Elena transitioned into the R&D Informatics and Data Science group where she pioneered implementation of biosensors in clinical trials, evaluation of digital technologies and establishing partnerships.

 

Elena holds PhD in Biology.  She completed postdoctoral trainings at Massey Cancer Center/MCV and Children’s Hospital/Harvard Medical School; she also held a visiting scientist position at Whitehead Institute, MIT.

09.00 - 12.00
Workshop B: Combining Crowdsourced Protocol Design & Digital Study Execution – Putting Patients & Clinicians at the Center of the Clinical Development Process
Workshop Leader: Marc Foster, COO , Transparency Life Sciences, LLC

Recent applications of open innovation and mobile health in biopharma R&D create an opportunity for an all-digital approach to clinical trial design and execution that promises to put key stakeholders at the center of the design process, lower costs and increase convenience of data collection, and pave the way for novel endpoints.

This workshop will focus on the intersection of protocol design and digital study execution, presenting case studies in diverse therapeutic areas from the perspectives of end-users, sponsors, and technology suppliers. The goal is for workshop participants to leave with an enhanced toolkit for exploiting the potential for all-digital clinical development.

Marc Foster, COO , Transparency Life Sciences, LLC

Marc Foster

Marc brings 16 years of biotech and 15 years of high-tech experience to TLS. Prior to Transparency, he worked in business development for FoldRx Pharmaceuticals, where he helped craft and implement the business development strategy of the company’s protein misfolding pipeline and discovery platform, leading to an acquisition by Pfizer in 2010. Marc began his biotech career working on behalf of Schrodinger in product development. Subsequently he co-founded and built Reify Corporation, developer of high-content assay systems for pre-clinical discovery and toxicology. During his high-tech career Mr. Foster held operating, co-founding, and advisory roles with numerous firms that created substantial shareholder value through acquisition or public offering, including NETBot, Apropos, and InTouch Systems. Mr. Foster holds a BS in Electrical Engineering and a BA in English from Brown University, and a MBA in Finance from The University of Chicago Booth School of Business. He served as a Research Fellow at BIDMC/Harvard Medical School in Endocrinology.

Afternoon Workshops
June 12, 2017

13.00 - 16.00
Workshop C: The Role of Games and Gamification in the Future of Clinical Trials
Workshop Leader: Faith Gunning, Associate Professor of Psychology in Psychiatry, Weill Cornell Medical College Workshop Leader: Jyoti Mishra, Assistant Professor , University of California San Francisco

Games provide a fun and engaging approach to learning and equally provide a compelling environment to measure aspects of cognition and movement, when integrating real-time biosensing, neurostimulation, or motion-based approaches. Gamified trials measuring health outcomes offer particular value in niche indications, but whilst still their infancy of use, a number questions remain as to their universal applicability and validity.

This workshop will explore:

  • The use of neuroscience- inspired videogames to improve mood and cognitive control through:
    – Reviewing role of poor cognitive control across a number of cognitive and psychiatric conditions
    – Presenting rationale for the use of videogames to enhance functioning of cognitive control systems
    – Reviewing preliminary data demonstrating the change in neural circuitry pre and post a videogame intervention
  • Interactive game-based technologies that are providing:
    – Better informed trial participants with associated reduced
    dropouts, and increased participation in clinical trials.
    – Engaging approaches to drive behavior and act as assessment tools in disease areas with a lack of end points.
  • Learnings from training the brain from Silicon Valley to the streets of Delhi
    – The evolving state of clinical mental health research games
    – examples, goals, budgets.
    – Interfacing multiple intervention methods and technologies within a user-focused package.
    – Scale-up across diverse cultural settings.

Faith Gunning, Associate Professor of Psychology in Psychiatry, Weill Cornell Medical College

Faith Gunning

Dr. Gunning is the Vice Chair of Psychology and Director of Neuropsychology. In addition she is a co-PI on an NIMH funded study focused on using therapeutic video games to treat cognitive and mood symptoms.

Jyoti Mishra, Assistant Professor , University of California San Francisco

Jyoti Mishra

Dr. Mishra is a translational neuroscientist with expertise in attention, learning and brain plasticity. In her research, she has developed and implemented digital mental health technologies in both local and global community settings. Her interests lie in optimizing neurotechnologies for brain health, which target brain plasticity mechanisms and are also feasible to deploy at large scale. She has conducted clinical studies in healthy aging, children with attention deficit disorder and children with adverse early childhood experiences. Dr. Mishra’s research has been recognized by the Hellman award, Klingenstein foundation, NIH Fogarty institute, National Academies Keck Futures Initiative, amongst others.

13.00 - 16.00
Workshop D: Best Practices in Assessing Clinical Trial Quality to Drive Clinical Trial Performance
Workshop Leader: Stella Stergiopoulos, Research Fellow, Tufts Center for the Study of Drug Development

Recently, clinical trial performance data has demonstrated how expensive and disruptive poor protocol design can be on clinical development performance and cost, ultimately delaying medicines to patients. This workshop will focus on best practices in assessing clinical trial performance to design higher quality clinical trials.

The goal is for workshop participants to leave with a robust toolkit measuring clinical trial performance.

  • Review current trends in protocol design; e.g. protocol complexity; protocol amendment prevalence; adaptive trial design; and management practices to enhance protocol design
  • Utilize patient and investigator feedback to drive clinical trial protocol optimization
  • Conduct root cause analyses by capturing meaningful impact measures on clinical trial performance

Stella Stergiopoulos, Research Fellow, Tufts Center for the Study of Drug Development

Stella Stergiopoulos

Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a BA from Brandeis University, and an MS and MPH from Tufts University.