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Monday, June 20
 

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
  19: InnovationTheaters, Session

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
  19: InnovationTheaters, Session

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 PPD, part of Thermo Fisher Scientific
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
  19: InnovationTheaters, Session

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 Precision for Medicine
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
  19: InnovationTheaters, Session

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
  19: InnovationTheaters, Session
 
Tuesday, June 21
 

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
  19: InnovationTheaters, Session

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
  19: InnovationTheaters, Session

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 Precision for Medicine
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
  19: InnovationTheaters, Session

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
  19: InnovationTheaters, Session

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
  19: InnovationTheaters, Session
 
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
  19: InnovationTheaters, Session

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
  19: InnovationTheaters, Session

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
  19: InnovationTheaters, Session

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 Axiom Real-Time Metrics
    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
      19: InnovationTheaters, Session

    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 PointClickCare
    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
      19: InnovationTheaters, Session
     
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  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
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  • Featured Topics
  • AI and Machine Learning
  • COVID-19
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  • Digital
  • Diversity Equity and Inclusion
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