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19: InnovationTheaters [clear filter]
Monday, June 20
 

11:50am CDT

#101 IT: Advanced Clinical Innovation Theater: Implementing Innovative Patient and Site Engagement Strategies for More Predictable Outcomes
Component Type: Session

Innovative patient and site engagement strategies have provided significant value for pharma and biotech companies through the design, predictability and success of their clinical programs. You will learn about real cases that have positively impacted site-sponsor relationships and successfully incorporated the patient voice, including:

  • Study-specific strategies
  • Novel patient and site engagement methods
  • Decentralized clinical trial (DCT) components


Chair

Advanced Clinical

Speaker

Speaker
Donna Hanson

Speaker
Caroline Redeker

Speaker
Stacey Arrambide, MS

Speaker
Cheryle S. Evans, RN



Speakers
avatar for Advanced Clinical

Advanced Clinical

United States
avatar for Stacey Arrambide

Stacey Arrambide

Senior Vice President, Functional Service Solutions, Advanced Clinical, United States
Stacey Arrambide, M.S., has over 21 years of global statistical and data management experience across a broad range of therapeutic areas. Stacey oversees strategic growth and operational delivery of biometrics services for Advanced Clinical. He has held numerous leadership positions... Read More →
avatar for Donna Hanson

Donna Hanson

Senior Director, Strategy and Optimization, Advanced Clinical , United States
Donna Hanson has been in the clinical trial industry for nearly 20 years. Donna has a comprehensive background, including leading teams in patient recruitment and engagement, feasibility and site engagement, bids and proposals and vendor management/outsourcing. Her passion is to enhance... Read More →
avatar for Caroline Redeker

Caroline Redeker

Senior Vice President, Corporate Development, Advanced Clinical, United States
Caroline Redeker is a results-oriented professional with 30 years of experience in planning and managing pharmaceutical, biotech and medical device clinical research, creating successful partnerships with sponsor companies to add value to their programs. Areas of specialty include... Read More →
avatar for Cheryle Evans

Cheryle Evans

SVP, Global Clinical Bio Ops, Advanced Clinical, United States
Cheryle is a senior-level executive with extensive, progressive clinical research experience and is responsible for the strategic planning and tactile operations in project management, clinical monitoring, site activation, safety and document management. She has led global teams across... Read More →


Monday June 20, 2022 11:50am - 12:20pm CDT
Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

11:50am CDT

#102 IT: Syneos Health Innovation Theater: Leveraging the Power of Medical Affairs - Overcoming Obstacles to Optimize Product Development
Component Type: Session

Medical Affairs (MA) has become one of the most critical success factors for realizing the full promise of biopharma innovation – but there are hurdles yet to cross. To get a clear snapshot of the landscape, Syneos Health surveyed MA executives on key challenges, opportunities for growth and how the function is positioning itself for the future. This session will discuss the results of this survey to understand the pain points MA faces and potential solutions to optimize product development.

Chair

Syneos Health

Speaker

Speaker
Suma Ramadas, PhD

Speaker
Colin Oliver, PhD, MBA



Speakers
avatar for Syneos Health

Syneos Health

United States
avatar for Colin Oliver

Colin Oliver

Managing Director, Medical Affairs Consulting, Syneos Health, United States
Colin Oliver is a managing director in the medical affairs consulting practice at Syneos Health with over 10 years of pharmaceutical/biotechnology experience at small, medium and large companies. Colin has broad Medical Affairs experience, from working in the field as a Medical Science... Read More →
avatar for Suma Ramadas

Suma Ramadas

Executive Vice President, Head of Global Medical Affairs, Syneos Health, United States
Suma Ramadas, Ph.D. has over 17 years of experience as a thought leader in industry, consulting and integrated commercialization solutions specializing in the Medical Affairs space. She leads the Medical Affairs and Value, Access, and HEOR Advisory at Syneos Health, where she has... Read More →


Monday June 20, 2022 11:50am - 12:20pm CDT
Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

11:50am CDT

#103 IT: Microsoft Innovation Theater: Accelerating Clinical Research - How a New Collaboration is Driving Digital Data Flow Solutions from Protocol Design to Electronic Data Capture
Component Type: Session

TransCelerate, in collaboration with Accenture, CDISC and Microsoft, have developed and released a vendor agnostic, open-source approach Study Definitions Repository that utilizes technology and data standards to manage the information flow across systems. A new protocol study definition standard developed by CDISC compliments these efforts. Join this session to discover how these efforts are paving the way for new innovations in the R&D landscape and more seamless, open collaboration.

Chair

Microsoft Corporation

Speaker

Speaker
David Meyers

Speaker
Robert DiCicco, PharmD

Speaker
William Illis, MPH



Speakers
avatar for Microsoft Corporation

Microsoft Corporation

Microsoft Corporation, United States
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also... Read More →
avatar for William Illis

William Illis

Global Head, Collaboration/Technology Strategy, Clinical Development & Analytics, Novartis , United States
Bill is Global Head of Technology Strategy and Collaboration in Clinical Development and Analytics responsible for developing and implementing the analytics technology strategy and managing collaborations with internal and external partners. He has been responsible for leading large-scale... Read More →
avatar for David Meyers

David Meyers

National Director Life Sciences, US Health and Life Sciences, Microsoft, United States
Dave Meyers is the National Director for the Life Sciences Industry in the U.S. Health and Life Sciences group at Microsoft. He is focused on strategy, business development, and managing the portfolio of solutions in pharmaceuticals, genomics and precision medicine – collaborating... Read More →


Monday June 20, 2022 11:50am - 12:20pm CDT
Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:35pm CDT

#105 IT: CRIO Innovation Theater: Creating an EMR to EDC Pipeline Through eSource
Component Type: Session

EMR-to-EDC integration is challenging to scale due to the fragmentation of health care providers. With EMR interoperability, patients have the power to collect their own medical records and direct them into e-clinical platforms. CRIO and Pluto Health will demonstrate a groundbreaking innovation whereby Pluto Health aggregates medical records on behalf of patients and sends them to CRIO’s integrated eSource-to-EDC platform, thus creating the industry’s first truly scaleable EMR-to-EDC pipeline.

Chair

Clinical Research IO

Speaker

Speaker
Raymond Nomizu, JD

Speaker
Seung Park

Speaker
Elena Christofides



Speakers
avatar for Clinical Research IO
avatar for Elena Christofides

Elena Christofides

Chief Executive Officer, Endocrinology Associates Inc., United States
Elena Christofides, MD, FACE, is a physician and CEO at Endocrinology Associates, Inc, an adult-only specialty practice in Columbus, Ohio. She is also the founder and director of Endocrinology Research Associates, Inc, an independent research facility. Dr. Christofides earned her... Read More →
avatar for Raymond Nomizu

Raymond Nomizu

CEO, CRIO, United States
Raymond Nomizu is the co-founder and CEO of CRIO, an e-clinical provider for sponsors, CROs and sites. CRIO's system allows research sites to collect data accurately and contemporaneously, and sponsors to view the data in real-time, without costly source data verification. Prior to... Read More →
avatar for Seung Park

Seung Park

Chief of Informatics, Pluto Health, United States
Seung Park MD is the Head of Medical Informatics at Pluto Health. He was the first 2-year trained subspecialty Medical Informaticist in the country, a board-certified Clinical Pathologist, a formally-trained computer scientist, and has been CIO, CHIO, and CMIO at some of the largest... Read More →
avatar for Seung Park

Seung Park

Head of Medical Informatics, Pluto Health, United States
Seung Park MD is the Head of Medical Informatics at Pluto Health. He was the first 2-year trained subspecialty Medical Informaticist in the country, a board-certified Clinical Pathologist, a formally-trained computer scientist, and has been CIO, CHIO, and CMIO at some of the largest... Read More →


Monday June 20, 2022 12:35pm - 1:05pm CDT
Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:35pm CDT

#106 IT: IQVIA Innovation Theater: Redefining Patient Centricity in a Post-Pandemic Era
Component Type: Session

The pandemic forced our industry to challenge the status quo. We found innovative ways to reach patients, accelerate processes and leverage technology. These advances have one commonality: each puts the patient at the center of the clinical trial. How do we take the best of those innovations, turn them into best practices and not fall back into the way “we have always done it?” This session explores the next best for the future of patient-centric drug development.

Chair

IQVIA

Speaker

Speaker
Cynthia L. Verst, PharmD, MS



Speakers
avatar for IQVIA

IQVIA

United States
avatar for Cynthia Verst

Cynthia Verst

President, R&D Solutions D&DI; 2023 President, IQVIA, United States
Dr. Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. She is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late... Read More →


Monday June 20, 2022 12:35pm - 1:05pm CDT
Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:35pm CDT

#107 IT: SAS Innovation Theater: Level Up! Advancing Clinical Trial Operations with Novel Methods and Richer Data
Component Type: Session

Join SAS for a lightning-round presentation on next-generation approaches for driving excellence in clinical trial operations including:
  • Integrating multiomics data to identify druggable targets and the best patients for trials
  • Leveraging observational data to generate synthetic control arms
  • Rescuing trial enrollment with simulation


  • These methods can help you design and execute better clinical trials, improve diversity and more. Don’t miss this chance to level up!

    Chair

    SAS Institute Inc.

    Speaker

    Speaker
    Matt Becker

    Speaker
    Jim Box, MBA, MS

    Speaker
    Sherrine Eid, MPH

    Speaker
    Scott McClain



    Speakers
    avatar for SAS

    SAS

    SAS Institute Inc, United States
    avatar for Matt Becker

    Matt Becker

    Life Science Strategic Advisor, SAS Institute Inc., United States
    Matt Becker is an Advisory Industry Consultant with the SAS Global Hosting and U.S. Professional Services division. Matt’s more than 30 years of life science experience includes over 9 years with SAS concentrating on next generation clinical trials, data management, analysis, advanced... Read More →
    avatar for Jim Box

    Jim Box

    Principal Data Scientist, SAS Institute Inc., United States
    Box provides strategic insights across the life sciences industry, with a focus on optimizing the execution of clinical trials. He spent 18 years in the CRO industry, holding leadership roles in statistics, statistical programming, data management and information technology. Throughout... Read More →
    avatar for Scott McClain

    Scott McClain

    Principal Consultant, SAS Health Care and Life Sciences, SAS, United States
    Dr. McClain brings 30 years of experience in toxicology, biotechnology, and product safety risk assessment. His academic background is environmental and molecular toxicology with a focus in quantitative risk assessment. He received his advanced degrees from Miami University in Oxford... Read More →


    Monday June 20, 2022 12:35pm - 1:05pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:40pm CDT

    #125 IT: PPD, part of Thermo Fisher Scientific Innovation Theater: Patients as Influencers - How Today’s Patients are Shaping Tomorrow’s Clinical Trial Designs
    Component Type: Session

    Today’s data increasingly supports the notion that patients prefer to engage in clinical research when and where more digitally flexible options are made available to them and their loved ones. Study participants are actively shaping the design and functionality of clinical research – sharing their outcomes and data through multiple modern channels and platforms. As life science leaders, we must help drive momentum for these changes and enhance access for underrepresented patient groups.

    Chair

    PPD, Inc.

    Speaker

    Speaker
    Rose Blackburne, MD, MBA



    Speakers
    avatar for Rose Blackburne

    Rose Blackburne

    Vice President, Clinical Research, PPD, part of Thermo Fisher Scientific, United States
    Rose Blackburne, MD, MBA is Vice President and Global Head of Women’s Health/General Medicine. Dr. Blackburne is board certified in Obstetrics/Gynecology with over 25 years of experience in Health Care, including 17 years in clinical research. Dr. Blackburne is a globally recognized... Read More →


    Monday June 20, 2022 2:40pm - 3:10pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:40pm CDT

    #126 IT: Medable Innovation Theater: The Real R&D Accelerator
    Component Type: Session

    Innovation in medicine no longer resides in research labs.Indeed the key to solving R&D stagnation is deploying technology that can slash clinical trial timelines & accelerate needed therapies to market.Recent evidence shows that DCT solutions save 1-3 mths for a typical phase 2/3 trial generating a net benefit of up to 14x the initial investment.These savings could cover substantial portions of top pharma companies’ total yearly R&D spend & open possibilities of bringing more drugs to patients.

    Chair

    Medable

    Speaker

    Speaker
    Pamela Tenaerts, MD, MBA

    Speaker
    Kenneth Getz, MBA



    Speakers
    avatar for Medable

    Medable

    United States


    Monday June 20, 2022 2:40pm - 3:10pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:40pm CDT

    #127 IT: RWS Innovation Theater: Advancement Through Adversity - How COVID-Driven Innovations are Becoming Best Practices for Pharmacovigilance
    Component Type: Session

    The global Covid-19 vaccine rollout created an explosion in pharmacovigilance (PV) and related multilingual data requirements. This created an opportunity for language providers to adapt processes and technologies. In this session, we’ll discuss how:

  • Human and machine translation can help address 24x7 requests and unpredictable volumes
  • Hybrid AI/human options provide scale and flexibility to transform PV
  • Investment in PV-specific innovations can be transferred across the ecosystem


  • Chair

    RWS

    Speaker

    Speaker
    David Paré

    Speaker
    Silvio Scozzari



    Speakers
    avatar for RWS

    RWS

    United States
    DP

    David Paré

    RWS, United States
    Dave Paré, Executive Director RI/CRO at RWS, is a specialized translation solutions expert who has been helping life science companies unlock global understanding for over 20 years. Driven and passionate about language he said - “I believe that language is a bridge between people... Read More →
    avatar for Silvio Scozzari

    Silvio Scozzari

    Senior Account Director, RWS, United States
    Silvio Scozzari, Senior Account Director RI/CRO at RWS, is a localization expert with over 20 years’ experience in the practice, process and complexity of localization and internationalization. Silvio has held roles in Project, Program and Operations Management as well as having... Read More →
    avatar for Silvio Scozzari

    Silvio Scozzari

    RWS, United States
    Silvio Scozzari, Senior Account Director RI/CRO at RWS, is a localization expert with over 20 years’ experience in the practice, process and complexity of localization and internationalization. Silvio has held roles in Project, Program and Operations Management as well as having... Read More →


    Monday June 20, 2022 2:40pm - 3:10pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:20pm CDT

    #128 IT: Castor Innovation Theater: A New Paradigm in CDMS
    Component Type: Session

    The key to revolutionizing antiquated clinical trial models into more patient-centric, decentralized trials is leveraging the power of simplicity. Simple, reusable, and self-service tools within a single platform allow researchers the flexibility to create trials that focus on serving patients and their communities.

    In this session, CEO Derk Arts and Solutions Consultant Kristen Harnack showcase how to apply flexible, digital tools to support the stages of transformation for trials shifting from traditional clinical trials models to the next generation of CDMS.

    Chair

    Castor

    Speaker

    Speaker
    Kristen Harnack

    Speaker
    Derk Arts, MD, PhD



    Speakers
    avatar for Castor

    Castor

    Netherlands
    avatar for Derk Arts

    Derk Arts

    Founder & CEO, Castor, Netherlands
    Derk Arts MD, PhD has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials... Read More →
    avatar for Kristen Harnack

    Kristen Harnack

    Castor, United States


    Monday June 20, 2022 3:20pm - 3:50pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:20pm CDT

    #129 IT: Precision for Medicine Innovation Theater: Solving the Unique Central Lab Services Challenges of Precision, Biomarker-Driven Trials
    Component Type: Session

    In today's drug development landscape, the collection, management, and reporting on patient samples has never been more relevant; being able to physically and virtually follow a sample over its lifecycle is a key component of most clinical trials. Join us as we discuss how a precision approach to central lab services leveraging smart, integrated technologies can generate impactful operational insights and help ensure clinical trial success.

    Chair

    Precision for Medicine

    Speaker

    Speaker
    Joseph Neal



    Speakers
    avatar for Joseph Neal

    Joseph Neal

    Vice President, Central Lab Services, Precision for Medicine , United States
    Mr. Neal is the Vice President of Central Lab Services at Precision for Medicine. He serves as the Global Head for the Global Shipping & Logistics, Biorepository, Clinical Trial Kitting, and sample processing within Precision’s labs. He is responsible for all aspects of the design... Read More →


    Monday June 20, 2022 3:20pm - 3:50pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:20pm CDT

    #130 IT: Deloitte Innovation Theater: Sanofi’s Approach to Automating Adverse Event Case Processing Through Machine Learning and Innovation
    Component Type: Session

    With the mission of protecting and improving human health and safety of medicines, life sciences organizations primarily drive to three objectives: Scientific innovation to discover & develop medicinal therapies; Deliver and sell therapies to healthcare professionals and patients; Continuously monitor safety and efficacy of therapies to protect patients. To ensure patient safety, life science organizations conduct continuous monitoring of the safety of their products by collecting, assessing and reporting Adverse Events (AE) from various sources a time-sensitive manner. Pharmacovigilance Organizations considers this a core/foundational activity to protect patients safety with over hundreds of thousands of AE cases annually. Processing of AE cases is an intensive, manual, expensive, and time-consuming activity and the entire process is highly regulated by global health authorities. In this presentation, learn how PV Organizations have demonstrated success and realized significant operational and scientific benefits through combining business and technology transformation leveraging natural language processing, machine learning and artificial intelligence with Deloitte’s ConvergeHEALTH Safety Cognitive Case Processing Platform.

    In this presentation you will hear:
  • Strategies for bringing AI to reality in a highly regulated environment
  • Actual benefits and improvements in quality and efficiency that were achieved by real clients
  • Methodologies for measuring benefits and costs in the automation journey
  • Mitigation strategies for potential roadblocks, such as GxP validation expectations, quality management system adjustments, and vendor/outsourcing cooperation
  • Lessons learned from our clients’ journey from proof-of-concept to production roll out
  • Change management, communication and negotiation strategies required to achieve benefits both with internal and external stakeholders


  • Chair

    Deloitte

    Speaker

    Speaker
    Sapna Elzer

    Speaker
    Amanda Bowles, MS

    Speaker
    Glenn Carroll, MBA



    Speakers
    avatar for Amanda Kirby Bowles

    Amanda Kirby Bowles

    Managing Director- Life Sciences Strategy & Analytics, Deloitte, United States
    Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global... Read More →
    avatar for Glenn Carroll

    Glenn Carroll

    Principal, Deloitte, United States
    Glenn Carroll is a principal in our life science strategy practice with over 15 years pharmaceutical and biotech experience. Glenn leads Deloitte's US Safety and Medical practices. He has a strong track record in delivering strategic and operational excellence, specifically in the... Read More →
    avatar for Deloitte

    Deloitte

    United States
    SE

    Sapna Elzer

    PV Data Strategy Lead, Sanofi, United States


    Monday June 20, 2022 3:20pm - 3:50pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    5:15pm CDT

    #146 IT: Labcorp Innovation Theater: How AI Modeling of Diagnostic Data is Providing Actionable Insights for Difficult to Diagnose Conditions
    Component Type: Session

    NASH and CKD affect different organs but suffer from the same fundamental problems in clinical care and research: under-diagnosis and low awareness. We will discuss how world class diagnostic capabilities, medical expertise, and artificial intelligence combine to develop new ways of identifying individuals at risk of these diseases. Outcomes include development of registries, supporting diversity, research ready patient communities and accelerating trial enrollment.

    Chair

    Labcorp Drug Development

    Speaker

    Speaker
    Earl Seltzer, MBA



    Speakers
    avatar for Fortrea

    Fortrea

    United States
    avatar for Earl Seltzer

    Earl Seltzer

    Senior Director, Global Feasibility, Labcorp Drug Development, United States
    Earl Seltzer has over 17 years of industry experience shared across clinical investigator sites in the United States and working at CROs in the strategic planning and feasibility space. At Labcorp, Mr Seltzer leads the global feasibility team as part of the larger, feasibility recruitment... Read More →


    Monday June 20, 2022 5:15pm - 5:45pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    5:15pm CDT

    #147 IT: Care Access Innovation Theater: The DRO Model for Global Clinical Trials: A Demonstrated Transformation that Delivers Game-Changing Speed, Quality, and Access
    Component Type: Session

    Innovations that include transformation at both the sponsor- and site-side of clinical research hold much potential for impact. The Decentralized Research Organization (DRO) model breaks down the activities and responsibilities of sites and sponsors into their atomic units, re-thinks and re-organizes those units, and then reassembles them in new ways that unlock untapped potential. Through this approach, 18 months of enrollment can be shortened to 3-6 months; diverse and underserved populations can participate in previously inaccessible study opportunities; and higher-quality data can be produced to assess the efficacy and safety of new medication.

    Chair

    Care Access

    Speaker

    Speaker
    Ahmad Namvargolian, MPA



    Speakers
    avatar for Care Access

    Care Access

    United States
    avatar for Ahmad Namvargolian

    Ahmad Namvargolian

    Chief Executive Officer & Co-founder, Care Access, United States
    Ahmad Namvargolian co-founded Care Access in 2015 which quickly grew into one of the most trusted clinical research companies in the US. His one core mission for Care Access is to remove barriers in clinical research for sponsors, physicians, and patients; making clinical research... Read More →


    Monday June 20, 2022 5:15pm - 5:45pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    5:15pm CDT

    #148 IT: Parexel Innovation Theater: An Ethical Framework to Guide the Development of AI in Clinical Research
    Component Type: Session

    Scores of ethical concerns are rising with the increasing scale of AI applications, from the impact of unintended consequences to wealth inequality created by machines. In clinical research, how do we ensure trust and confidence when relying on AI-powered solutions to boost speed, accuracy and deeper insights across clinical trial design, planning, and execution? This session focuses on an ethical framework based on the philosophy of technology and science for the intended use of AI tools in research.

    Chair

    Parexel

    Speaker

    Speaker
    Mark Graves



    Speakers
    avatar for Parexel

    Parexel

    United States
    avatar for Mark Graves

    Mark Graves

    NLP Data Scientist, Director, Parexel, United States
    Mark Graves is NLP Data Scientist, Director, at Parexel AI Labs where he leads natural language processing (NLP) data science projects to extract information from electronic medical records for clinical trials and from scientific literature and regulatory documents for pharmacovigilance... Read More →


    Monday June 20, 2022 5:15pm - 5:45pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
     
    Tuesday, June 21
     

    10:20am CDT

    #216 IT: Clario Innovation Theater: Decentralized Clinical Trials - Real Solutions in Real-Time
    Component Type: Session

    During this Innovation Theater, we'll poll the audience and explore how you feel about pressing issues and timely DCT topics. Our expert panel includes Jen Horonjeff, Craig Lipset, Bryan McDowell, and moderator, Matt McCarty will provide technology, science, and patient perspectives throughout the discussion and offer you real DCT solutions in real-time.

    Chair

    Clario

    Speaker

    Speaker
    Jen Horonjeff, PhD

    Speaker
    Craig H Lipset, MPH

    Speaker
    Bryan McDowell, MBA, MSc

    Speaker
    Matthew McCarty



    Speakers
    avatar for Clario

    Clario

    United States
    avatar for Jen Horonjeff

    Jen Horonjeff

    Founder and CEO, Savvy Cooperative, United States
    Jen Horonjeff, PhD, is a patient advocate and the founder & CEO of Savvy Cooperative, the first and only patient-owned co-op that helps innovators connect directly with diverse patients to get the insights they need to build better and more inclusive healthcare solutions. Jen was... Read More →
    avatar for Matthew McCarty

    Matthew McCarty

    Chief Strategy & Marketing Officer, Clario, United Kingdom
    As Chief Strategy and Marketing Officer at Clario, Matt leads the enterprise’s strategic direction and marketing capabilities. Matt has 15 years’ experience in executive leadership roles leading clinical research and commercial healthcare organizations. Most recently, Matt spearheaded... Read More →
    avatar for Bryan McDowell

    Bryan McDowell

    Vice President, eCOA Clinical Science & Consulting, Clario, Switzerland
    In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide... Read More →


    Tuesday June 21, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    10:20am CDT

    #217 IT: Flatiron Health Innovation Theater: Leveraging Access at the Point of Care and Next-Generation Electronic Source (eSource) Technology to Accelerate Clinical Research
    Component Type: Session

    Recent regulatory guidance and increased use of EHR in interventional clinical research and RWE have clarified the role that EHRs and eSource technologies may play in bridging the divide between clinical care and clinical research. In this session we will show how Flatiron Health is leveraging its unique access at the point of care and suite of e-source technologies (including the industry's first system-agnostic EHR-to-EDC connector application) to meaningfully accelerate clinical research.

    Chair

    Flatiron Health

    Speaker

    Speaker
    Hugh Levaux, PhD

    Speaker
    Lauren Sutton



    Speakers
    avatar for Flatiron Health

    Flatiron Health

    United States
    avatar for Hugh Levaux

    Hugh Levaux

    Vice President, Growth Strategy for Clinical Research, Flatiron Health, United States
    Dr. Hugh Levaux is VP of Growth Strategy at Flatiron, where he drives product and overall strategy, and supports commercial activities. Before Flatiron, Dr. Levaux was Founder and CEO at Protocol First, bringing 20+ years of experience in trial design and operations—notably, SVP... Read More →
    avatar for Lauren Sutton

    Lauren Sutton

    Senior Director, Product Management, Flatiron Health , United States
    Lauren Sutton is a Senior Director of Product Management at Flatiron Health where she leads the clinical research product team. Prior to Flatiron, Lauren worked as an oncology clinical research associate with Quintiles. Lauren graduated from the University of North Carolina at Chapel... Read More →


    Tuesday June 21, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    10:20am CDT

    #218 IT: Twilio for Life Sciences Innovation Theater: Delivering Personalized Experiences through Omnichannel Engagement
    Component Type: Session

    Today’s rapid acceleration of virtual channels requires an omnichannel engagement strategy that meets customer demands and helps health organizations move towards a digital-first vision. Organizations investing in building unified solutions are making it possible to deliver frictionless experiences for patients that enable better health outcomes. Learn key considerations on how to infuse omnichannel engagement across your operations to make health more connected, simpler, and more affordable.

    Chair

    Twilio

    Speaker

    Speaker
    Susan Collins

    Speaker
    Kimberly Howland, PhD



    Speakers
    avatar for Susan Collins

    Susan Collins

    Global Head of Healthcare, Twilio Inc., United States
    Susan Collins is a globally recognized expert on healthcare technology and go to market strategy, speaking regularly at conferences and contributing thought leadership to a variety of professional journals and media outlets. Currently Global Head of Healthcare for Twilio, Collins... Read More →
    avatar for Kimberly Howland

    Kimberly Howland

    Vice President, Product Management, EnlivenHealth (an Omnicell company), United States
    Kim leads the product management organization for EnlivenHealth®. She works closely with customers and partners to develop the roadmap for current and future products, and then collaborates closely with EnlivenHealth’s engineering teams to deliver the innovative new digital solutions... Read More →
    avatar for Twilio

    Twilio

    United States


    Tuesday June 21, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #233 IT: JMP Statistical Discovery Innovation Theater: Interactive Safety Assessment Reports to Aggregate, Filter, and Subgroup Clinical Trial Data
    Component Type: Session

    When conducting safety assessments, medical doctors and reviewers of clinical trials data have high expectations for the level of sophistication with which clinically relevant safety data is presented. Both tabulations and graphical visualizations should be interactive and customizable, bending to the will of the reviewer. Whether users are grouping, filtering, or performing subgroup analysis, clinical trials software should be intuitive and flexible.

    Chair

    JMP Statistical Discovery

    Speaker

    Speaker
    Rebecca Lyzinski, MS

    Speaker
    Geoff Mann, PhD



    Speakers
    avatar for JMP Statistical Discovery

    JMP Statistical Discovery

    JMP, A Business Unit of SAS, United States
    avatar for Rebecca Lyzinski

    Rebecca Lyzinski

    Senior Software Developer, JMP Statistical Discovery, United States
    Rebecca Lyzinski is a Clinical Research Developer in the JMP Life Sciences group where she develops new reports and analyses for JMP Clinical software. Before joining JMP, Rebecca worked in statistical programming for the pharmaceutical industry. She was a Manager of statistical programming... Read More →
    avatar for Geoff Mann

    Geoff Mann

    Advanced Analytics Manager, JMP Statistical Discovery, United States
    Geoffrey Mann is Advanced Analytics Manager for the health and life sciences industry at JMP. In this role, he explores needs for visual and statistical discovery software in the clinical segment of the pharmaceutical and healthcare industries. After joining SAS in 2000, he helped... Read More →


    Tuesday June 21, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #234 IT: Labcorp Innovation Theater: The Labcorp Patient Recruitment Ecosystem - Designing a Better Clinical Trial Experience
    Component Type: Session

    What does “a better clinical trial experience” mean to patients, sites, clinicians and sponsors? And how can the industry deliver on this promise to drive participation that benefits all? We discuss (with examples) approaches that integrate diagnostic data, artificial intelligence and analytic techniques, patient and site informed design, site enablement techniques, direct-to-patient recruitment, and diversity & inclusion initiatives to bring “a better clinical trial experience” to benefit all.

    Chair

    Labcorp Drug Development

    Speaker

    Speaker
    Ben Quartley, PhD



    Speakers
    avatar for Fortrea

    Fortrea

    United States
    avatar for Ben Quartley

    Ben Quartley

    Labcorp Drug Development, United States
    Ben has spent 25 years in the Pharmaceutical Industry and has a broad range of experience, having worked in Pharma, CROs and at a Site Management Organization. During his time in Pharma he recognized the opportunities and challenges of clinical trial delivery from the site perspective... Read More →


    Tuesday June 21, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #235 IT: Veeva Innovation Theater: Clinical Trials Prepare for a Digital, Connected Future
    Component Type: Session

    COVID-19 accelerated decentralized trial adoption, however, a decentralized model is only the beginning. We must continue the momentum toward patient- and site-centric trials with a digital trial model that is paperless and connected. Join Veeva as we explore the industrywide move toward end-to-end digital trials for seamless process execution and data flow across patients, sites, and sponsors to create a connected trial ecosystem.

    Chair

    Veeva Systems, Inc.

    Speaker

    Speaker
    Jim Reilly



    Speakers
    avatar for Veeva Systems, Inc.

    Veeva Systems, Inc.

    United States
    Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →
    avatar for Jim Reilly

    Jim Reilly

    VP, Vault R&D and Quality, Veeva Systems, United States
    As Vice President of R&D and Quality Strategy at Veeva, Jim is responsible for customer engagement, market adoption, and strategic alliances. For the last 20 years, Jim has held various senior positions in life sciences technology, where he has led software delivery and sales efforts... Read More →


    Tuesday June 21, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #238 IT: Precision for Medicine Innovation Theater: Bridging Clinical Operations and Translational Science to Meet Critical Endpoints in Precision Medicine Trials
    Component Type: Session

    Precision, biomarker-driven clinical trials are becoming the norm yet carry complex challenges in clinical sample logistics and specialty lab assays. Join Precision as we discuss how primary, secondary, and exploratory objectives, and technologies like flow cytometry, IHC, and PBMC processing impact trial logistics. We’ll also share solutions to ensure a seamless handshake between sample logistics, specialty lab assays, and data analysis to help meet critical clinical milestones.

    Chair

    Precision for Medicine

    Speaker

    Speaker
    Deborah Phippard, PhD



    Speakers
    avatar for Deborah Phippard

    Deborah Phippard

    Chief Scientific Officer, Precision for Medicine , United States
    Dr. Deborah Phippard is a pharma industry veteran and expert at biomarker-driven clinical trial design and execution with more than 25 years of biotechnology and clinical translational research experience. She is a leader of biomarker and drug development programs for pharmaceutical... Read More →


    Tuesday June 21, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #239 IT: IQVIA Innovation Theater: Delivering Better Outcomes with Connected Intelligence
    Component Type: Session

    Join Nagaraja (Sri) Srivatsan, SVP and Chief Digital Officer, Technology Solutions, IQVIA and Murray Aitken, SVP and Executive Director of The IQVIA Institute for Human Data Science and learn from recent research how the COVID pandemic is impacting clinical development, what it is doing to the adoption and use of technologies in clinical development, and how it is creating opportunities for faster development. This is a DIA discussion you don’t want to miss!

    Chair

    IQVIA

    Speaker

    Speaker
    Murray Aitken, MBA

    Speaker
    Wendy Morahan



    Speakers
    avatar for Murray Aitken

    Murray Aitken

    Executive Director, IQVIA Institute for Human Data Science, United States
    Murray Aitken is a senior vice president of IQVIA and Executive Director of the IQVIA Institute for Human Data Science. The Institute undertakes independent research for publication, drawing upon the resources of IQVIA, and focuses on improving understanding of critical healthcare... Read More →
    avatar for IQVIA

    IQVIA

    United States
    avatar for Wendy Morahan

    Wendy Morahan

    Senior Director, Clinical Data Analytics Suite, IQVIA, United States
    Wendy has 25+ years’ experience in the life sciences industry with a career spanning academic research, preclinical drug discovery, and clinical trials, culminating in a focus and passion for delivering technology solutions that help bring treatments to patients faster. Wendy is... Read More →


    Tuesday June 21, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #240 IT: Microsoft Innovation Theater: The New Reality of Work in Pharma - How Mixed Reality is Modernizing Operations, Accelerating Research and Improving Patient Engagement
    Component Type: Session

    Mixed reality has become a key driver of digital transformation in Pharma. Discover how Microsoft and Altoura are helping organizations use mixed reality to train frontline workers, visualize operations data, and optimize manufacturing processes. Hear how companies like Thermo Fisher Scientific and Ecolab are using mixed reality to accelerate time to productivity, reduce errors, and improve customer engagement. Following, a HoloLens 2 demo will be available in Microsoft booth 2006.

    Chair

    Microsoft Corporation

    Speaker

    Speaker
    Daniel Carchedi

    Speaker
    Jamie Fleming

    Speaker
    Mark Reagan



    Speakers
    avatar for Microsoft Corporation

    Microsoft Corporation

    Microsoft Corporation, United States
    avatar for Daniel Carchedi

    Daniel Carchedi

    Director of Business Development and Strategy, US Health & Life Sciences, Microsoft, United States
    Daniel leads the development and implementation of strategic plans/partnerships associated with new product/partner offerings in Life Sciences (Pharma/Biotech/MD&D) at Microsoft. Previously, he was a founding member and the Director of Business Development and Strategy for Microsoft... Read More →
    avatar for Jamie Fleming

    Jamie Fleming

    CEO, Altoura, United States
    Jamie is the founder and CEO of Altoura. He is a recognized industry leader with a deep understanding of spatial computing and enterprise customers’ digital transformation priorities. Following his vision and leadership, Altoura has grown to a multinational corporation with over... Read More →
    avatar for Mark Reagan

    Mark Reagan

    Plant Manager, Ecolab, United States
    Mark is a plant manager at Ecolab and has a background working in manufacturing, both in operations and quality. He is passionate about creating simplified processes that are easy for users—and he’s excited about using mixed reality to help improve manufacturing processes. Mark... Read More →
    avatar for Jamie Fleming

    Jamie Fleming

    CEO, Altoura, United States
    Jamie is the founder and CEO of Altoura. He is a recognized industry leader with a deep understanding of spatial computing and enterprise customers’ digital transformation priorities. Following his vision and leadership, Altoura has grown to a multinational corporation with over... Read More →


    Tuesday June 21, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #258 IT: IBM Watson Health Innovation Theater: User Centricity in Clinical Data Management - The Next Revolution for eClinical Solutions
    Component Type: Session

    While speed, cost, and efficiency are common industry metrics to grade effectiveness of EDC and CDMS solutions, user experience are often overlooked by many technology vendors. Join IBM Watson Health to learn how user-centric design is at the core of their solution development, and why this obsession over ease-of-use has revolutionized clinical data management for many of their clients.

    Chair

    IBM Watson Health

    Speaker

    Speaker
    Walker Bradham

    Speaker
    Sofia Puerto



    Speakers
    avatar for Merative

    Merative

    United States
    avatar for Walker Bradham

    Walker Bradham

    Lead Product Manager, IBM Watson Health, United States
    Walker Bradham is the Product Leader for IBM Clinical Development, IBM Watson Health's flagship CDMS solution. He brings 20 years of experience defining, designing and deploying web applications to the marketplace, and leads the product roadmap for all EDC/CDMS and eCOA offerings... Read More →
    avatar for Sofia Puerto

    Sofia Puerto

    Senior Client Program Specialist, Biorasi, United States
    As a Senior Client Program Specialist, Sofia Puerto is responsible for building relationships with our partners, understanding their development goals, and developing the budget and overall strategy to successfully execute their clinical studies. Sofia has been working in this role... Read More →


    Tuesday June 21, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #259 IT: UBC Innovation Theater: Modernizing Observational Research and Decentralized Studies with Patient Mediated Electronic Medical Record Release
    Component Type: Session

    Data acquisition in observational studies has traditionally relied on health care providers performing a review of the patient chart & manually entering data into a bespoke Electronic Data Capture system (EDC). This paradigm has been disrupted with the proliferation of interoperability solutions that enable the acquisition of secondary data for research purposes. One such solution that is fundamentally changing observational research is called Patient Mediated Electronic Medical Record Release.

    Chair

    UBC

    Speaker

    Speaker
    Aaron Berger, PMP

    Speaker
    Dana Hosseini



    Speakers
    avatar for Aaron Berger

    Aaron Berger

    Head of Evidence Development Solutions, UBC, United States
    Mr. Berger joined the UBC team in 2003 and has served in a range of diverse roles leveraging global capabilities in the execution of peri- and post-marketing product development programs and real-world evidence generation. He currently leads the Evidence Development Solutions team... Read More →
    DH

    Dana Hosseini

    CBO & Co-Founder, Seqster, United States
    Dana Hosseini is the Chief Business Officer and Co-Founder of Seqster. Dana is a seasoned executive with decades of experience in the life sciences and CRO space and also as a serial entrepreneur having managed and co-founded a number of genomics-based companies including ProdermIQ... Read More →
    avatar for UBC

    UBC

    United BioSource Corporation, United States


    Tuesday June 21, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #260 IT : Appian Innovation Theater: Shape the clinical trials journey by bringing people, process and data together on a unified platform
    Component Type: Session

    Learn how Appian partners with customers to streamline and reduce cycle time of the startup phase of clinical trials. Various factors are responsible for the delay of the startup phase of clinical trials, and understanding the impact of each element allows for optimization and faster execution.

    Join Appian to learn how users have leveraged new technologies and proven cloud-based solutions to manage successful trials with record-breaking cycle time.

    Chair

    Appian

    Speaker

    Speaker
    Paul Bidez



    Speakers
    avatar for Appian

    Appian

    United States
    PB

    Paul Bidez

    Industry Vice President, Life Sciences, Manufacturing & Automotive, Appian, United States


    Tuesday June 21, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #263 IT: Certara Innovation Theater: Optimizing Patient Narrative Technology - Automating the Complicated and Creating Efficiency
    Component Type: Session

    Narratives are a key component of clinical study reporting. To present a concise & medically relevant patient story, writers must analyze large volumes of data for patients. Implementing technology will ensure quality, consistency, and decreased turn-around times. We will discuss the automated approach to work through complex sources to produce streamlined narratives for submission. Greater efficiencies will empower writers to focus on critical thinking, a quality which remains unique to humans.

    Chair

    Certara

    Speaker

    Speaker
    Reema Selva Raju



    Speakers
    avatar for Certara

    Certara

    United States
    avatar for Reema Selva Raju

    Reema Selva Raju

    Safety Project Manager, Certara Synchrogenix, United States
    Reema SelvaRaju has more than 12 years of regulatory writing and project management experience in the pharmaceutical industry. Specialties include writing, auditing & project management. As the Safety Project Manager, Reema works closely with Sponsors to identify project requirements... Read More →


    Tuesday June 21, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #264 IT: Veeva Innovation Theater: Defining Digital Trials to Operationalize Decentralized Trials
    Component Type: Session

    Defining a clear strategy for digital trials requires clear and precise definitions, covering what, where, and how for digital trials. In this interactive “DTRA Clubhouse Live” session, our presenters will debate with each other and the audience three key questions:

  • What does DCT mean?
  • What does the implementation of DCT entail?
  • What are the expected outcomes of DCT?
  • The discussion includes what it means to “go digital” when managing clinical data in a decentralized trial.

    Chair

    Veeva Systems, Inc.

    Speaker

    Speaker
    Richard Young

    Speaker
    Craig H Lipset, MPH

    Speaker
    Saran Kukreja



    Speakers
    avatar for Veeva Systems, Inc.

    Veeva Systems, Inc.

    United States
    Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →
    avatar for Richard Young

    Richard Young

    Vice President, Vault CDMS Strategy, Veeva Systems, United Kingdom
    As a veteran of almost 25-years in life sciences, Richard has held multiple operational roles in Pharma and CRO organisations, such as GlaxoWellcome, Novo Nordisk, Chiltern and Parexel, before moving into eClinical Solutions, with Cmed and Medidata. Today, Richard brings Veeva customers... Read More →
    avatar for Saran Kukreja

    Saran Kukreja

    Senior Director, Business Engagement & Technology, Vertex Pharmaceuticals, United States
    Saran Kukreja has over 25 years of leadership and business strategy experience and has built a strong portfolio of success in strategic information management, data analytics, white-space management, smart sourcing, new product development, project management, and total quality management... Read More →


    Tuesday June 21, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #265 IT: M-Files Innovation Theater: Does your Document Management System Support your Growth Trajectory? A Charles River Labs Story
    Component Type: Session

    Charles River was at a technology crossroads and needed an upgraded document management solution to support their growth trajectory. They were seeking a solution that would drive consistency and efficiency organization-wide and integrate seamlessly with current systems. Most importantly, it had to support faster delivery of client reports with minimal operational impact. M-Files outperformed the competition in CRL's calculations on time savings for priority tasks and overall cost savings.

    Chair

    M-Files

    Speaker

    Speaker
    Dennis Street

    Speaker
    Jenith Charpentier



    Speakers
    avatar for M-Files

    M-Files

    United States
    avatar for Dennis Street

    Dennis Street

    Principal Customer Success Manager, M-Files, United States
    Dennis Street has been working with M-Files for almost 8 years, always focused on growing relationships with clients to determine how they can get the most from their M-Files solution. Working with Charles River, Dennis has a solid understanding of the unique objectives and challenges... Read More →
    avatar for Jenith Charpentier

    Jenith Charpentier

    Senior Director of Data Enablement and Report Delivery Services, Charles River Laboratories, United States
    Jenith Charpentier, Senior Director of Data Enablement and Report Delivery Services at Charles River Laboratories, has made vast contributions to the success of the Report Services group. Her ability to take poorly organized and diverse documents and re-present them as clearly written... Read More →


    Tuesday June 21, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
     
    Wednesday, June 22
     

    10:20am CDT

    #314 IT: Datacubed Health Innovation Theater: How Innovations in ePRO Are Powering Better Patient Engagement
    Component Type: Session

    Most studies fail to reach their recruitment targets. And those that do face high dropout rates. As such, many organizations preach better patient engagement, but few discuss the “why." This session will discuss how your organization can adopt a more meaningful patient engagement approach as part of an eCOA strategy that is long term, drives transferability between teams and sites, and provides a sustainable approach beyond a few trials.

    Chair

    Datacubed Health

    Speaker

    Speaker
    Kyle Hogan



    Speakers
    avatar for Datacubed Health

    Datacubed Health

    United States
    avatar for Kyle Hogan

    Kyle Hogan

    President, Datacubed Health, United States
    Kyle has been dedicated to advancing the voice of the patient through the promise of ePRO/eCOA since 2007, in that time helping deliver over 500 successful trials for CROs and Pharmaceutical companies globally. He is a recognized expert for implementing innovative and patient centric... Read More →


    Wednesday June 22, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    10:20am CDT

    #315 IT: RxTROSPECT Innovation Theater: Oncology - Expediting Strategy
    Component Type: Session

    Learn how to expedite regulatory strategy with the rapid identification of regulatory precedent. Join us at the innovation theatre to learn how a tremendous range of companies, from pre-revenue to the very largest, have adopted RxTROSPECT to rapidly identify precedent in oncology and de-risk strategy.

    Chair

    RxTROSPECT

    Speaker

    Speaker
    Mark Rutter



    Speakers
    avatar for RxTROSPECT

    RxTROSPECT

    United States
    avatar for Mark Rutter

    Mark Rutter

    Co-Founder, Head of Product Development & Strategy, RxTROSPECT, United States
    Mark spearheaded the design and development of the RxTROSPECT Oncology US and EU modules, Co-founding RxTROSPECT and building a team of US-based clinical and regulatory experts to deliver an innovative, cloud-based technology for oncology strategy professionals. RxTROSPECT was guided... Read More →


    Wednesday June 22, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    10:20am CDT

    #316 IT: ATCOR Medical Innovation Theater: Non-Invasive Central BP Monitoring - Improving Efficiency and Success of Drug Development
    Component Type: Session

    For products targeting cardiovascular disease, incorporation of central aortic blood pressure (BP) measurement and monitoring into clinical trials can improve key decisions during development (go/no go, endpoints, population characteristics, benefit-risk profile, dosing, etc.) and enhance the likelihood of both regulatory and commercial success. The presentation will review non-invasive arterial blood pressure measurement and the rationale for use in drug and medical device development programs

    Chair

    ATCOR Medical

    Speaker

    Speaker
    Steven Kesten, MD



    Speakers
    avatar for Steven Kesten

    Steven Kesten

    Chief Medical Officer, ATCOR Medical, United States
    Steven Kesten, MD, FCCP, has held roles including Chief Medical Officer and Executive Vice President at Cytori Therapeutics, Chief Medical Officer at Uptake Medical, and a Vice President at Boehringer Ingelheim Pharmaceuticals. He also served as the Medical Director at The Toronto... Read More →
    avatar for ATCOR Medical

    ATCOR Medical

    United States


    Wednesday June 22, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #331 IT: IQVIA Innovation Theater: Real World Evidence (RWE) to Enhance Clinical Development
    Component Type: Session

    The growing acceptance of RWE in product development has changed when and where RWE can lend rigor to the process. We see new uses of RWE to support trial design, provide context for interventional studies, and create pragmatic approaches to long term monitoring of cell and gene therapies—but this trend is quickly moving from fringe to mainstream. In this presentation we will discuss these changes and demonstrate how and when to consider RWE for maximum impact to your development process.

    Chair

    IQVIA

    Speaker

    Speaker
    Paul Petraro, DrSc, MPH

    Speaker
    Barbara Isquith Arone, MS



    Speakers
    avatar for IQVIA

    IQVIA

    United States
    avatar for Paul Petraro

    Paul Petraro

    Global Head Real World Evidence, Boehringer Ingelheim Pharmaceuticals, Inc., United States
    Paul is an executive director and the Global head of the Real World Evidence Analytic Center of Excellence at Boehringer Ingelheim. Paul works to ensure the management and oversight of high-quality real world studies along with developing and implementing the real world evidence (RWE... Read More →
    avatar for Barbara Isquith Arone

    Barbara Isquith Arone

    Vice President, Evidence Generation for Medical Affairs, IQVIA, United States
    Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →


    Wednesday June 22, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #332 IT: Deloitte Innovation Theater: Ushering in Next-Gen Regulatory Intelligence
    Component Type: Session

    Advances in regulatory intelligence (RI) are reshaping the ability for regulatory to accelerate global product approvals. Deploying cognitive computing, advanced analytics and AI within RI can unlock novel and timely insights that transform the development of regulatory strategies, submission planning, and requirements management. RI can drive increased efficiency and improved compliance. Deloitte will share details around its industry-leading next-gen RI solutions.

    Chair

    Deloitte

    Speaker

    Speaker
    Norman Elliott

    Speaker
    Mukesh Singhal, MBA



    Speakers
    avatar for Deloitte

    Deloitte

    United States
    avatar for Norman Elliott

    Norman Elliott

    Senior IT Business Relationship Manager - Regulatory Affairs & Quality Assurance, AstraZeneca, United States
    A visionary IT leader, Norm Elliott drives complex business strategy to deliver technical solutions. He has a tech background, supply chain expertise, and broad exposure to a range of business processes. Because he's engaged in multiple business areas, he can help eliminate barriers... Read More →
    avatar for Mukesh Singhal

    Mukesh Singhal

    Principal-Life Sciences Strategy & Analytics, Deloitte, United States
    Mukesh Singhal is a leader in Deloitte’s R&D and Regulatory practices, with over 15 years of industry experience shaping and leading digital transformations across the industry. Mukesh has led a cross-industry Regulatory Intelligence forum since 2018, helping to shape an industry... Read More →


    Wednesday June 22, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #333 IT: Curebase Innovation Theater: Learning by Doing - An Analysis of a Curebase DCT Patient Experience
    Component Type: Session

    There is no better way to comprehend the DCT participant journey than through experience. Join VP of Clinical Trial Innovation, Jane Myles as she breaks down key results from a timely, hands-on Curebase study. Walk away with full knowledge of the participant experience, as well as a firsthand experience of Curebase DCT capabilities.

    Chair

    Curebase, Inc.

    Speaker

    Speaker
    Jane Myles, MS



    Speakers
    avatar for Curebase, Inc.

    Curebase, Inc.

    United States
    avatar for Jane Myles

    Jane Myles

    Program Director, Decentralized Trials and Research Alliance (DTRA), United States
    Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first... Read More →


    Wednesday June 22, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #337 IT: Yseop Innovation Theater: Automate Medical Writing with Artificial Intelligence (AI)
    Component Type: Session

    With recent global events serving as a catalyst for change, the life sciences industry has re-evaluated their drug approval and reporting processes. Firms are looking at how they can move with greater speed and agility, while still maintaining the highest safety standards. In this session, panelists will discuss how pharmaceutical companies are accelerating their regulatory report submissions and writing processes through artificial intelligence (AI).

    Chair

    Yseop

    Speaker

    Speaker
    Emmanuel Walckenaer



    Speakers
    avatar for Yseop

    Yseop

    United States
    avatar for Emmanuel Walckenaer

    Emmanuel Walckenaer

    CEO, Yseop, United States
    Emmanuel joined Yseop as CEO in 2017, leading the company’s growth and vision to bring the benefits of automation and NLG to enterprise companies globally. He brings over 25 years of international experience in high-tech service and business development.


    Wednesday June 22, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #338 IT: Evernorth Innovation Theater: Trends in Behavioral Health - Effects of Telehealth, Medications, and Outpatient Treatment on Total Cost of Care
    Component Type: Session

    Increased attention on mental health conditions throughout the pandemic have placed emphasis on ensuring people receive the help and treatment they need. Attend this session to learn results of real-world evidence analyzing important trends on behavioral treatment patterns, telehealth usage, and improvement in individual health.

    Chair

    Evernorth

    Speaker

    Speaker
    Ria Westergaard, PharmD



    Speakers
    avatar for Evernorth

    Evernorth

    United States
    avatar for Ria Westergaard

    Ria Westergaard

    Director of Product Strategy for Clinical Trial Solutions, Evernorth, United States
    Dr. Westergaard’s role at Evernorth focuses on designing solutions that use integrated health data to meet market needs, such as clinical trial patient recruitment, real-world evidence generation, provider profiling for commercialization and more. Her 20+ years of pharmacy experience... Read More →


    Wednesday June 22, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #339 IT: Parexel Innovation Theater: FSP Futureview - Building Infrastructure and Talent for a Flexible Future
    Component Type: Session

    The roles and demands on research professionals are evolving rapidly with the rising tide of new digital technologies and development approaches. Clinical trials of the future require flexible research infrastructures & workforces to better manage escalating time, cost & complexity. This session will feature recent research findings & discuss best FSP practices for talent development, operating models and geographical strategies that reduce cost and timelines while driving additional benefits over time.

    Chair

    Parexel

    Speaker

    Speaker
    Chris Baker, MBA



    Speakers
    avatar for Parexel

    Parexel

    United States
    avatar for Chris Baker

    Chris Baker

    EVP, Global Head Parexel FSP, Parexel, United States
    Chris Baker is the Executive Vice President and Global Head of Parexel’s FSP business. In this role, Chris provides leadership and strategic direction for the Parexel FSP business. With more than 25 years of biopharmaceutical experience, Chris’ expertise spans clinical research... Read More →


    Wednesday June 22, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #357 IT: Labcorp Innovation Theater: Transforming the Patient Experience in Decentralized Clinical Trials
    Component Type: Session

    Studies must become more patient-centric to expand patient diversity. Effectively supporting decentralized clinical trials requires the application of flexible and scalable technologies and solutions that empower participants with remote study visits and allow electronic data collection from patients and mobile clinicians. These solutions may include: eConsent, telemedicine; eCOA/ePRO; device integrations for digital biomarkers, and eSource solutions that allow remote visit data collection.

    Chair

    Labcorp Drug Development

    Speaker

    Speaker
    Kurt Lumsden, MBA



    Speakers
    avatar for Fortrea

    Fortrea

    United States
    avatar for Kurt Lumsden

    Kurt Lumsden

    Head, Global Operations, Fortrea, United States
    Kurt Lumsden, is a proven leader and clinician with extensive experience in the healthcare and clinical research sectors gained over 35 years in the US and UK, including operational and client account management with pharmaceutical, CRO, hospital, home care, eClinical technology and... Read More →


    Wednesday June 22, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #358 IT: Axiom Innovation Theater: Saving Patient Lives – The Value of Time
    Component Type: Session

    The world of clinical research depends on the planning, quality and speed by which clinical trials are conducted. Too much time is lost in processes that take away from the goals of delivering life saving products to patients.

    More energy, commitment and leadership is needed in the conduct of trials and its foundation of operations, and determination of where we can save time in the many processes to deliver studies.

    There is a direct correlation to saving patient lives
  • Get smarter results faster to manage outcomes
  • Eliminate humans doing manual tasks
  • Improve oversight of compliance via technology


  • Chair

    Axiom Real-Time Metrics

    Speaker

    Speaker
    Andrew Schacter



    Speakers
    avatar for Andrew Schacter

    Andrew Schacter

    Chief Executive Officer and Founder, Axiom Real-Time Metrics, Canada
    As Founder and Chief Executive Officer of Axiom Real-Time Metrics, Andrew Schachter delivers the visionary leadership integral to the company's 20 years of eClinical technology and Managed services success. Under his leadership, Axiom has grown into a well-established and recognized... Read More →


    Wednesday June 22, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #359 IT: Calyx Innovation Theater: Meeting Regulatory Expectations on IRT Data Ownership
    Component Type: Session

    Discuss how they impact sponsors, sites and vendors and understanding the emerging expectations on what IRT data ownership really means.

    Chair

    Calyx

    Speaker

    Speaker
    Sylvain Berthelot, MSc



    Speakers
    avatar for Sylvain Berthelot

    Sylvain Berthelot

    Director, Solution Consultant, Calyx, United Kingdom
    Sylvain has been in the clinical trials industry for over 12 years. He has been involved in strategic developments and decisions for multiple eClinical products, including eCOA, Patient Sensors, EDC and IRT. Through the various roles Sylvain has had over his 12+ years at Calyx, he... Read More →
    C

    Calyx

    United States


    Wednesday June 22, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #362 IT: PointClickCare Innovation Theater: LTPAC EHR Data - Patients Included!
    Component Type: Session

    Describing ways to include and understand patient populations, needs, and outcomes in interventions, trials, and research, mitigating unnecessary risk to patients via modeling and simulation. Prepare for trials right with dynamic PICOTSS visualizations to find the data you (actually) need.

    Chair

    PointClickCare

    Speaker

    Speaker
    Brittin Wagner, PhD



    Speakers
    avatar for Brittin Wagner

    Brittin Wagner

    Senior Research Scientist, PointClickCare, Canada
    Brittin Wagner is Senior Research Scientist at PointClickCare. She holds a PhD is in Sociology, PhD Minor in Social Statistics from the University of Washington, with postdoctoral training in health services research & development. She has a longstanding commitment to measurement... Read More →


    Wednesday June 22, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #363 IT: ZS Innovation Theater: Shaping the Future of Clinical Development - A Novel Approach for Today’s Siloed Model
    Component Type: Session

    What if we could break the chain of linear clinical trial design and planning and create an environment that’s fluid, agile and friction-free? The new paradigm is closer than you may think. To accelerate trial timelines—which increased by 20% over the last decade despite investment and innovation—we need a new approach. In this session, ZS and industry leaders will share our vision for a new clinical development model and unveil how platforms fuel interoperable data across the trial life cycle.

    Chair

    ZS

    Speaker

    Speaker
    Mike Martin

    Speaker
    Lauren Wall, MS

    Speaker
    Rob Scott, MD

    Speaker
    April Lewis



    Speakers
    avatar for ZS

    ZS

    United States
    ZS is the world’s largest firm focused exclusively on helping companies improve overall performance and grow revenue and market share through end-to-end solutions—from customer insights and strategy, to analytics, to operations and technology. More than 5,000 ZS professionals... Read More →
    avatar for April Lewis

    April Lewis

    Head of Patient Centered Innovation, ZS Associates, United States
    April serves as the head of patient centered innovation in ZS’s clinical development excellence practice. With 25 years of success in leading global teams focused on innovating and disrupting clinical operations, April is a change agent who has worked directly within Sponsors... Read More →
    avatar for Mike Martin

    Mike Martin

    Clinical Development Practice Area Lead, ZS, United States
    Mike is a partner at ZS leading ZS’s clinical development service line with a unique combination of consulting expertise and deep knowledge of healthcare organization strategy. Mike’s insight, guidance and support enable his clients to consistently reach new levels of results... Read More →
    avatar for Rob Scott

    Rob Scott

    Former Chief Medical Officer, AbbVie, Independent Consultant, United States
    Dr Rob Scott is a Zimbabwean born physician and a graduate of University of Cape Town. Rob has held leadership positions in global Pharma for over thirty years. At Pfizer he developed Lipitor and Norvasc. He invented and developed the first commercially available Polypill - Caduet... Read More →
    avatar for Lauren Wall

    Lauren Wall

    Senior Director, Cancer Clinical Research, University of Chicago Comprehensive Cancer Center, United States
    Lauren has over 15 years of experience in Hematology/Oncology clinical research operations spanning industry and academic healthcare. As Sr. Director of Cancer Clinical Research, her primary responsibilities include planning, organizing, directing, and overseeing daily operations... Read More →


    Wednesday June 22, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #364 IT: Florence Healthcare Innovation Theater: Design Better Trials with Always-On Connectivity to Sites - A Case Study
    Component Type: Session

    Sponsors and CROs are rethinking how to design studies with remote, always-on connectivity to study sites.

    This session will demonstrate how several sponsors are using a digital research infrastructure to establish a hybrid network of study sites that mixes traditional research sites with new patient access points, such as pharmacies and primary care providers.

    Find out how they are using these remote links to study sites to speed up timelines by embedding directly into site workflows.

    Chair

    Florence Healthcare

    Speaker

    Speaker
    Ryan Jones, MBA



    Speakers
    FH

    Florence Healthcare

    United States
    avatar for Ryan Jones

    Ryan Jones

    Cofounder and Chief Executive Officer, Florence Healthcare, United States
    Ryan is CEO of Florence Healthcare. Florence advances cures for disease by enabling clinical trial sites to do their best work. Before joining Florence, Ryan was president of Pubget (acquired by the Copyright Clearance Center), a research platform serving clinicians at over 600 hospitals... Read More →


    Wednesday June 22, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
     

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