2020年 團體討論

2月19日 (三)

 

BREAKOUT DISCUSSION GROUPS

4:20 Find Your Table and Meet Your Moderator

4:25 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

5:10 Welcome Reception in the Exhibit Hall

6:45 Close of Day

PATIENT ENGAGEMENT, EXPERIENCE, RECRUITMENT AND PATIENT-CENTRIC TRIAL DESIGN

TABLE 1: How Can We Improve the Patient Experience in Clinical Trials?

Moderators:
Kelly McKee, Head, Patient Recruitment, Vertex Pharmaceuticals Incorporated
Jane Myles, Former Head, Operational Intelligence and Innovation, Roche
Bernadette Tosti, Quest Diagnostics

Judith Reece, PhD, Vice President, Digital Development, GSK

  • How can we learn from other industries?
  • Advocating for both high tech and high touch solutions
  • The role of storytelling and patient communities

TABLE 2: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

Moderators:
Daniela Shikova, General Manager, FindMeCure Foundation
Moderators to be Announced, ERT

Christina Román, Senior Community Engagement Manager, Community Partnerships, Cystic Fibrosis Foundation

John Linnell, Clinical Trial Participant and Member of AZ’s Patient Partnership Program

Valeria Nicoli-Carr, Global Director, Patient Services, Patient Services, mdgroup

Eric Hajjar, Associate Director, Clinical Technology & Innovation, Global Development Operation, Novartis

  • What are current digital patient projects gaining traction, engagement pilots, new technologies, the role of patient communities?
  • What is a complete digital patient experience? What is required to make this a reality for all trials?
  • How do you include patients in clinical trial design?
  • What are we getting right and what are we getting wrong as we re-align our processes and our research organizations around the patient-centric model?

TABLE 3: Building a Personalized Logistics Network with Tech to Enable Patient-Centered Trials

Moderators:
Laura Davis, Business Technology Leader, Biotherapeutic Development, Information Technology, The Janssen Pharmaceutical Companies of Johnson & Johnson

Alan K. Smith, PhD, Executive Vice President, Technical Operations, Bellicum Pharmaceuticals, Inc.

Additional Moderators to be Announced

  • How can we build a personalized logistics network?
  • What technologies will reduce vein-to-vein time?
  • What are the main barriers to new technology adoption in CAR-T trials?

TABLE 4: Shiny New Objects: Can Traditional Recruitment Mediums Merge with Technology-Driven Solutions for Better Engagement?

Moderators:
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
Mary Jo Lamberti, PhD, Associate Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)
Jonas Spott,  Chief Product Officer,  Patiro · Patient RecruitmentTo be Announced, IQVIA
Mike Wenger, Vice President, Engagement, TrialScope

  • What is at the intersection of conversational ai/chatbots and “old school” techniques such as call centers in last mile recruitment strategies?
  • What can traditional media (TV, Print and Radio) teach digital about storytelling?
  • Who is succeeding in marrying technology solutions to identify patients with traditional outreach tactics?
  • Why are more than 80% of patients not aware that clinical trial is a care option? And what do we do?

TABLE 5: eCOa, ePRO, BYOD: Strategies for Improving Study Convenience and Compliance

Moderators:

Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb
Kyle Hogan, Director, Outcome Solutions, Clinical Ink

Matt Noble, Vice President, Product Management, Medidata, a Dassault Systèmes company

Additional Moderators to be Announced

  • Discuss how eCOA supports accurate and timely clinician and patient data collection and improves data quality and accessibility
  • Talk about how ePRO enables patient data to be collected and validated electronically by patients as a part of their daily life — anytime, anywhere
  • Examine how a sound BYOD approach impacts the patient experience and encourages patient engagement and compliance
  • Which strategies shall we use to further proliferate and scale Remote Trials?
  • How to enable culture change in pharma for further innovation in clinical trials?

TABLE 6: Diving into TransCelerate’s New and Free Patient Engagement Toolkits

Moderators:
Lani Hashimoto, Clinical Program Benchmark Manager, Patient Engagement & Recruitment, Novartis

Michele Teufel, Patient and Site Engagement Lead, Development Operations, AstraZeneca

Mike Keens, COO, Firma Clinical Research

David Kiger, Chief Commercial Officer, Datacubed Health

Additional Moderators to be Announced

  • How the Patient Protocol Engagement Toolkit (P-PET) toolkit helps prospective advisory board hosts and discussion on implementation considerations
  • Common questions from early users of the Study Participant Feedback Questionnaire (SPFQ) toolkit
  • Access and feedback for the toolkits

TABLE 7: What are the Risks of and Risk Reduction Strategies for Using Social Media in Clinical Trials?

Moderators:
Michael McLaughlin, MS, MSEd, RAC, Associate Director, Clinical Operations, Dermavant Sciences, Inc

Additional Moderators to be Announced

  • What are the potential risks and how to reduce risk when using social media?
  • What can we learn from recent FDA Guidance on Recruiting Study Subjects using Media Advertising and recent FDA Warning Letters from monitoring Social Media?
  • What are some valuable risk reduction strategies?

HEALTH LITERACY, CULTURAL SENSITIVITY, DIVERSITY

TABLE 8: Integrating Health Literacy, Diversity and Cultural Sensitivity into Clinical Trials

Moderators:
Laurie Myers, MBA, Global Health Literacy Director, Global Population Health, Merck & Co., Inc.
Alicia Staley  Senior Director, Patient Engagement  Medidata, a Dassault Systèmes company
Cassandra Smith, MBA, Associate Director, Diversity and Inclusion in Clinical Trials Lead, Janssen R&D

Lauren Gadsby, MBA, Program Manager, Investigator and Patient Engagement, Janssen R&D

Additional Moderators to be Announced

  • Gain sponsorship from senior management and legal
  • Move from concept to action: Identify pilots and coordinate across internal groups
  • Include the perspectives of patients across a range of health literacy levels and from different cultural backgrounds
  • Train investigators in teach back and cultural sensitivity
  • Operationalizing diversity and inclusion into your clinical trials

PROTOCOL OPTIMIZATION, FEASIBILITY AND SITE SELECTION

TABLE 9: Embracing Best Practices in Protocol Design to Reduce Protocol Amendments and Improve Trials

Moderators:
Rob DiCicco, Deputy Chief Health Officer, IBM Watson Health
Sunny Reed, Offering Manager, IBM Watson Health
Moderator to be Announced, Phesi Health

Faye O’Brien, Director, Performance & Metrics, AstraZeneca

Additional Moderators to be Announced

  • What are the updated metrics on the prevalence and causes of protocol amendments and what does this mean for us?
  • How can we as an industry improve our process of protocol development?
  • What are some community initiatives and individual company approaches to finding success?

TABLE 10: Building and Implementing a Data-Driven Site Selection Approach

Moderators:
Sandra Smyth, Global Feasibility & Site Intelligence Director, AstraZeneca
Gabriela Feldberg, Practice Leader, Applied Analytics & Artificial Intelligence, AstraZeneca

Additional Moderators to be Announced

  • Opportunities and challenges of utilizing different types of data sources (internal, external public and commercial, etc.) for site selection
  • Challenges in shifting an organization towards a more data driven culture when the data is imperfect
  • Discussion on how to best leverage internally built tools on outsourced studies

TABLE 11: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

Moderators:
Maya Zlatanova, Co-founder, FindMeCure Foundation
Daljit Cheema, Managing Director, PHARMASEAL

Additional Moderators to be Announced

  • Optimizing the site feasibility process: Improving global site feasibility assessment to identify sites that will recruit on time and within budget
  • Objective country feasibility and selection: Where are the patients?
  • Data-driven site selection: Understand the number of sites, their probability of success, and the impact of site non-performance

TABLE 12: Master Trials – Pragmatic Operations for Complex Oncology Precision Medicine Trials

Moderators:

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

Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

Additional Moderators to be Announced

  • Key considerations in program set-up and execution
  • Benchmarks/Performance – Toss conventional oversight metrics?
  • NextGen clinical trial technology solutions – Do they work?

STUDY START UP AND OPERATIONS, SITE-SPONSOR-CRO PERSPECTIVES

TABLE 13: Ask a Site – Tips, Tricks and Trends in Site Operations, Compliance and Site-Sponsor Relationships

Moderators:
Tamara O’Black, JD, Senior Director, Compliance, Quality & Regulatory, Minneapolis Heart Institute Foundation (MHIF)
Lisa Tindell, RN, Senior Director, Clinical Research Operations, Minneapolis Heart Institute Foundation (MHIF)

Additional Moderators to be Announced

  • Study feasibility and start-up – getting to a 90-day launch
  • Working with IRBs – myths of central IRB review
  • Site-Sponsor relationships – the good, the bad & the ugly: how sites and sponsors can work more effectively together
  • Auditing & monitoring – whether it’s sponsor monitors or the FDA, how sites and sponsors can partner for quality

TABLE 14: Transforming Clinical Operations with a Data-Driven Approach

Moderators:

Tom Doyle, Vice President, Data Science, Acorn AI by Medidata, a Dassault Systèmes company

Marie Eckerd, Feasibility and Recruitment Partner, Director, AstraZeneca

Additional Moderators to be Announced

  • Using analytics from a unified platform to inform better decision making
  • Using data to Identify potential problems before they become bigger issues ensuring better outcomes
  • Data that drives effectiveness in clinical trial operations, not just efficiencies

TABLE 15: Improving Both Time and Quality in Site Activation and Study Start-Up (Sponsor, CRO and Site Perspectives)

Moderators:
Linda Glaser, MD, PhD, Medical Director, Coastal Biomedical Research

Raj Pallapothu, mHealth Global Business Lead, Bayer Pharmaceuticals; mHealth Global Advocate

Lindsey Riley, MPH, Senior Associate Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson’s Research

Additional Moderators to be Announced

  • Identifying and consolidating site start up activities that are redundant, inefficient and needlessly complex
  • What are key learnings and opportunities for different approaches, including a centralized approach of study activation and site performance?
  • How can sponsors, CROs and site streamline site activation and study startup?
  • Barriers and opportunities in site adoption of clinical trial technology

EARLY PHASE TRIAL PLANNING AND OPS, A FOCUS ON PHASE 1

TABLE 16: Sponsor and Site Interactions in Phase 1 Site Selection, Recruitment and Contract Negotiations

Moderators:
Kristi Womack, Director, Clinical Pharmacology Operations, Allergan
Mark Scheetz, Associate Director, Program Lead for Phase I Studies, Allergan
Carol Miller, Senior Director, Business Development, Spaulding Clinical Research

Additional Moderators to be Announced

  • Sponsor representatives and site representatives sharing “what works” in Phase 1 trials
  • Early phase Site Selection process from the Sponsor point of view
  • Meeting recruitment and retention goals: How Phase 1 centers distinguish themselves to retain a healthy volunteer database and how do we find the special patient populations?
  • Maintaining strong Sponsor and site relations: How does contracting play a role?

RISK-BASED MONITORING AND QUALITY MANAGEMENT

TABLE 17: Using eSource, eConsent, Etc and Building a Clinical Quality Management System (CQMS) from the Ground Up

Moderators:
Laura Whitmore, Head, Clinical Operations, Oversight, Cerevel Therapeutics
Hilde Vanaken, Senior Industry Advisor, TCS Life Sciences and Healthcare, Tata Consultancy

Services 

Jonathan Rowe, PhD, Executive Director, Head of Clinical Development, Quality Performance and Risk Management, Pfizer

Additional Moderators to be Announced

Gayle Hamilton, Associate Director, Risk Based Monitoring, Project Operations and Business Performance, IQVIA

  • Barriers to eTrials and Best Practices
  • Future of eTrials
  • What are the minimum requirements for a CQMS?
  • How to build a CQMS with limited resources and budget
  • Learn from each other’s current experiences with building a CQMS

TABLE 18: Quality Monitoring, Quality Tolerance Limits

Moderators:
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Ruma Bhagat, MPH, MBBS, Senior GCP Strategy Lead, Site Innovation Group Lead, Genentech, Inc.
Janis LIttle, Vice President, Global R&D Quality, Allergan

Erin Reynolds, Manager, Clinical Analytics, Data and Statistical Science, Research & Development, Abbvie

Rachel Lewis, Director, Project Management, Project Management Office, Global Clinical Trial Operations, Merck & Co., Inc.

Additional Moderators to be Announced

  • How many QTLs do we need?
  • What areas should we apply QTLs for?
  • Should the QTLs be set at failure points or reasonable expectations of the quality?
  • What other benefits could QTLs give us?
  • Are your QTLs linked to your QbD initiative?

BUDGETING, CONTRACTING, AND RESOURCE MANAGEMENT

TABLE 19: Coordinating Contracting and Payments to Enhance Efficiencies

Moderators:
Debora Araujo, Founder & CEO, ClinBiz
Chris Chan, Executive Director, R&D Finance, Fibrogen
Kelly Willenberg, President, Kelly Willenberg, LLC

Additional Moderators to be Announced

  • Understand how contracting and Investigator payments are connected
  • Review standard terms to use on both ends of the contracting process
  • Discuss how to improve and implement a plan to streamline operations

TABLE 20: Navigating New Laws, Regulations, and Strategies for Clinical Trial Contracts and Speedy Study Start-Up

Moderators:

John Conley, JD, PhD, Professor, Law, University of North Carolina School of Law

Christina Greene, Esq., Associate Director, Global Site Agreements, Merck Sharp & Dohme Corp.

Ly Kawaguchi, Senior Director, Head, Outsourcing and Procurement, MyoKardia

Additional Moderators to be Announced

  • Barriers to speedy study start-up and efficient contracting
  • Review contracting strategies: standard templates, language, culture
  • Strategies for navigating the revised Common Rule, the US-EU Privacy Shield, and California privacy laws, as well as EU-based regulations, including GDPR
  • How these laws and regulations affect clinical trial design, operations, and execution

TABLE 21: Developing Resource Management Tools for Complex Trials and Diverse Portfolios

Moderators:
Piet Theisohn, Director, Head, Resource Management in Clinical Operations, R&D-ClinOps - Business Excellence & Innovation, Bayer AG Pharma Division
Laila Mork, Senior Manager, Systems, Analytics & Reporting, Business Operations, Allergan
Anca Copaescu, CEO and Founder, Clinical Maestro by Strategikon Pharma

Additional Moderators to be Announced

  • Understand the important factors that need to be tracked to successfully capacity plan and how to integrate them into a tool
  • Discuss how to get buy-in from key stakeholders by demonstrating value, cost savings, and efficiency
  • Discuss change management and how to roll out a new tool or process

OUTSOURCING, STRATEGIC PARTNERSHIPS, AND KPIS

TABLE 22: Vendor Performance Metrics and KPIs

Moderators:
Keith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI Ltd.

Caro Unger, Senior Clinical Operations Standards and Innovation Manager, Clovis Oncology

Additional Moderators to be Announced

  • How effective are your KPIs for measuring vendor performance and quality?
  • What is your strategy for establishing KPIs and metrics?
  • What are the key areas that should be evaluated for vendor performance and quality?

TABLE 23: Strategies for Becoming a Partner of Choice

Moderators:
Rosalie Filling, Vice President, Clinical Operations, Research and Development, Endo Pharmaceuticals
Wes Bonner, Vice President, Strategic Development, Meridian Clinical Research
Justin Bandura, JD, Contract Manager, Clinical Operations, Boehringer Ingelheim

Additional Moderators to be Announced

    • What initiatives can different departments take on to enhance the experience of working with partners?
    • How do small vs. large sponsors, CROs, and sites compete?
    • What strategies exist to stand out in a dense market?

    TABLE 24: FSP vs. Hybrid vs. Strategic Partnership Outsourcing – Choosing an Appropriate Model

    Moderators:
    Todd Reul, Associate Director, Global Strategic Sourcing, BioMarin Pharmaceutical Inc
    Erin O’Boyle, Senior Director, Clinical Operations, Rezolute, Inc.
    Minji Bae, Associate Director, Vendor Management, AbbVie
    Rick O’Hara, Director, Clinical Business Operations, Clinical Operations, Endo Pharmaceuticals, Inc.

    • Strategies for choosing an appropriate outsourcing model for individual trials vs. the entire portfolio
    • Determining pros and cons of each model – cost, resources, performance, study start-up
    • Determining sourcing needs vs. budget vs. relationships with previous and new partners

    DIGITAL TECH, WEARABLES, AND DIGITAL BIOMARKERS

    TABLE 25: Digital Biomarkers and Endpoints

    Moderators:
    Michael Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office, GlaxoSmithKline
    Michelle Crouthamel, Digital Platform Leader, Abbvie
    Matt Pipke,Chief Technology, Officer physIQ

    Vanja Vlajnic Statistician, Clinical Statistics, Bayer 

    Christina Silcox, PhD, Managing Associate, Duke-Margolis Center for Health Policy, Duke University

    Additional Moderators to be Announced

    • Appropriate application of wearables
    • Identifying criteria to use digital biomarkers
    • Challenges presented in digital biomarker exploration. What is the value, beyond scientific interest?
    • Where do we want to be in 5 years (and why we are not there already!)? Key challenges for industry uptake?

    TABLE 26: Digital Technologies in Clinical Trials: How to Choose, Implement and Work with Vendors

    Moderators:
    Jaquie Finn, Global Head, Digital Health, Cambridge Consultants
    Krista Emmons, Associate Director, Portfolio Relationship Management, Portfolio Relationship & Sourcing Management
    Narayanan R., Chief Architect (Life Sciences and Healthcare) and Head of TCS Connect Clinical Trial platform, TCS Life Sciences and Healthcare, Tata Consultancy Services Ltd.
    Robert G. Wilson III, Consultant, Wilson Digital Health Consulting

    • Scaling technology partners for digital clinical trials
    • Coming up with strategy and developing common language
    • Medical vs. commercial grade devices
    • Dos and don’ts of technology partnerships

    CLINICAL DATA MANAGEMENT, ANALYTICS, AND AI/ML

    TABLE 27: Advances in Clinical Data Management and Analytics

    Moderators:
    Dermot Kenny, Global Head, Data Operations, Novartis
    Nareen Katta, Head, Clinical Analytics, AbbVie
    Ozgur Ozkan, IT Director, Clinical Decision Support, The Janssen Pharmaceutical Companies of Johnson & Johnson
    Charles Romano, Vice President, Global Clinical Research, Peachtree Bioresearch Solutions

    Moderator to be Announced, Integron

    • Data Operations
    • Process Automation
    • Innovation in Clinical Trials
    • Machine Learning/Artificial Intelligence

    TABLE 28: Artificial Intelligence and Machine Learning: Reporting Progress

    Moderators:
    Balazs Flink, MD, Head, Clinical Trial Analytics, Bristol-Myers Squibb
    Francis Kendall, Director, Biostatistics & Programming, Cytel, Inc.

    Demetris Zambas, Vice President and Global Head, Data Monitoring and Management, Pfizer Inc

    Nechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

    Additional Moderators to be Announced

    • Will data science and machine learning disrupt the provision of clinical evidence or compliment it?
    • With Machine Learning becoming needing Big data sets, how could the industry share more data in a precompetitive framework?
    • As more Deep learning techniques are deployed - how can we gain confidence in “Black Box” approaches?
    • In what ways, if any, will we have to change how we work with regulators?

    TABLE 29: Virtual Trials: The New Ecosystem

    Moderators:
    Pam Duffy, Senior Director & Digital Strategic Planning and Demand Lead, Pfizer
    Kevin Bateman, Distinguished Scientist & Scientific Associate Vice President, Merck & Co., Inc.

    Julia Andrews, Strategic Feasibility Manager, Program Delivery, UC
    Katherine Vandebelt, Global Head, Clinical Innovation, Oracle Health Sciences, Global Business Unit, Oracle, Inc. 

    Jennifer Tontini, Vice President, Global Business Development, Educational Measures

    Moderators to be Announced, Deloitte Consulting

    • Let’s discuss terminology: Site-less, de-centralized, virtual? Does it have to be one model, or can we mix (e.g. central and remote)?
    • Where do retrospective/eTrials fit in? virtual control arms? Does digital technology inevitably lead to virtual trials?
    • What are some specific challenges in retaining patients and investigators? What are the data science considerations in de-centralized/virtual trial?

    CLINICAL SUPPLY AND LOGISTICS

    TABLE 30: Clinical Supply in Hybrid Virtual Trials

    Moderators:
    Adama Ibrahim, EMBA, Associate Director, Global Clinical Operations, Biogen
    Abby Stephens, Project Manager II, Group Lead Services, Suvoda

    Additional Moderators to be Announced

    • What is the value to stakeholders?
    • What are the main barriers to adoption? How can they be addressed?
    • Defining success metrics and sharing case studies

    OPS AND DATA OWNERSHIP IN SAMPLE, BIOMARKER, BIOSPECIMEN MANAGEMENT

    TABLE 31: Data Ownership and Returning Results to Patients

    Moderators:
    Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck
    David Leventhal, Senior Director, Clinical Innovation, Global Product Development, Pfizer Inc.

    Emily Castellanos, MD, Associate Medical Director, Research Oncology, Flatiron Health

    Additional Moderators to be Announced

    • Who owns the patient data in clinical research?
    • Do the patients get longitudinal choice and control of ongoing use of their data?
    • Returning biomarker data to patients

    TABLE 32: Technologies and Partnerships to Streamline Sample/Biomarker Management in Clinical Trials

    Moderators:
    Brenda Yanak, Principal, Clinical Transformation Partners
    Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

    Deborah Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Global Product Development, Oncology, Pfizer Inc.

    Mary Zuniga, Consultant, Translational Science, Immunology, Eli Lilly and Co.

    Additional Moderators to be Announced

    • Biorepositories: in house vs. outsourcing
    • Advanced informatics for biospecimen management
    • Central and reference labs: building the relationship
    • Informed consent and data sharing

    MEDICAL DEVICE CLINICAL TRIAL OPERATIONS AND REGULATIONS

    TABLE 33: Pre- Vs. Post-Market Medical Device Studies: Different Challenges and Strategies

    Moderators:
    Jane Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc
    Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation

    Additional Moderators to be Announced

    • Strategies for pre- vs. post-market studies: site identification, study start-up, etc.
    • Comparing study types and their unique requirements
    • Using national registries for post-market studies

    TABLE 34: Obstacles to Implementing RBM on Medical Device Studies & How to Overcome Them

    Moderators:
    Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)
    Erin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)

    Additional Moderators to be Announced

    • Leadership and regulatory support
    • Change Management concerns
    • The impact of the lack of technology and resources

    REAL-WORLD DATA (RWD/RWE)

    TABLE 35: Global Regulatory Atmosphere Surrounding Real World Data and Innovative RWD-Based Studies 

    Moderators:
    Steven Draikiwicz, MD, Global Medical Bioinformatics Lead, Sanofi
    Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen
    Gracie Lieberman, Senior Director, Regulatory Policy, Genentech

    Charles Makin, Global Head, Real World Evidence Strategy, Biogen
    David Van Brunt, PhD, Senior Research Fellow and Head, HEOR Division of Evidence and Analytics AbbVie, Inc.

    • Regulatory standards for use of real-world data (R+D and Medical Affairs)
    • Challenges of international data application
    • High level review and commentary of latest FDA guidelines – commentary on expanding international real-world data usage
    • Types of studies (pragmatic, hybrid, learning healthcare, etc.); How to integrate novel studies into existing programs

    TABLE 36: RWD To Accelerate Design and Execution of Clinical Trials

    Moderators:
    Xia Wang, PhD, Director, Health Informatics & Global Medicines Development, AstraZeneca
    Michael Kelsh, PhD, Director, Center for Observational Research, Amgen
    Jyotsna Mehta, Senior Director & Head, HEOR, Karyopharm Therapeutics

    David Tabano, PhD, MA, Associate Director, Center for Observational Research & Data Sciences (CORDS), Business Insights & Analytics, BristolMyers Squibb

    Yue Yang, PhD, Director, International Center for Food and Drug Policy and Legal Research, Shenyang Pharmaceutical University

    Additional Moderators to be Announced

    • Leverage the power of RWD to enable evidence-based trial feasibility assessment and patient recruitment
    • How can RWD support Clinical Operations and the Medical organization overall?
    • What opportunities exist to collaborate between Medical and Commercial on RWD assets and insights?
    • Which functions can help bridge and facilitate the ingestion of RWD for actionable insights?
    • RWE needs to go beyond analysis and clinical trial is calling new clinical-health service to link healthcare and clinical trial research

    CLINICAL RESEARCH AS A CARE OPTION (CRAACO)

    TABLE 37: Clinical Research as a Care Option (CRAACO): Changing Large Health Organizations from Bureaucratic Behemoths to Operationally Efficient Research Centers

    Moderators:
    Jim Kremidas, Executive Director, ACRP

    Additional Moderators to be Announced

    • Defining roles and responsibilities of academic and health system-based site staff
    • Driving change to ensure operational efficiency and quality via standardized performance metrics and processes
    • Ensuring career paths for site staff to drive employee engagement

    PHARMACOVIGILANCE

    TABLE 38: Consistency in SAE Data Collection Fields

    Moderators:

    Karen Outten, Executive Director, Clinical Trial Safety Reporting within Global Clinical Safety and Pharmacovigilance (GCS&PV). Merck Research Laboratories (MRL)

    Robert Taylor, Director, Safety Management, Global Regulatory Affairs and Clinical Safety, Merck

    Additional Moderators to be Announced

    • Optimization of SAE data collection and reporting results in increased efficiency for both investigator and Sponsor
    • High quality SAE case data leads enhance safety signal detection
    • Simplification of SAE data collection and reporting in joint venture and business partner collaborations
    • New CDISC standard

    CLINICAL DEVELOPMENT PARTNERING IN CHINA

    TABLE 39: Bringing New Therapies to Market in the West and in China: Clinical Development Partnering

    Moderators:
    Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
    Jane Fang, MD, MS, Director, Leader of Digital Clinical Innovations, RWD/RWE for Clinical Trials, AstraZeneca
    Sean Zhao, PhD, Head, US Patient Safety, AstraZeneca
    Wendy Wang, PhD, MD, Managing Director, Linical Accelovance China

    Additional Moderators to be Announced

    • Best practices for developing and bringing new therapies to market here in the West and in China
    • Conducting clinical development programs in China and partnering with up-and-coming Chinese biotech companies and CROs
    • Chinese innovators and CROs working with US-based CROs or licensing partners to expand their market and reach to collaborate

    * 活動內容有可能不事先告知作更動及調整。

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