Clinical Operations
Strategy Meeting East Coast USA 2023

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
Enhancing Trial Knowledge And Driving Better Outcomes By Using RBQM And Deep Learning (Topic TBC)
-Prajna Kumar
Vice President, Head of Clinical and Pharmacovigilance Quality
Blueprint Medicine

DECENTRALIZED/HYBRID TRIALS
Improving Digital Patient Recruitment For DCT’s To Enhance Diversity And Representation In Clinical Trials By Utilizing Digital Recruitment Techniques To Target Qualified Participants, While Also Taking Into Account Patient Population Demographics

EMERGING BIOPHARMA / OUTSOURCING
What future developments and commercial realities businesses with concentrated pipelines or single assets are facing?
-Elina Lavit
Vice President of Business Development
OncoNano Medicine

DIGITAL MEASUREMENTS/ CLINICAL DATA
Utilize And Support A More Digital Environment To Stay Relevant As The Industry Changes

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
Building connections that ease site and sponsor load and enhance the patient experience

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
Describing the tactics for promoting more community participation and enhancing clinical trial diversity
-Siew Tin Gan
Head Of Clinical Operations
Acumen Pharmaceuticals

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
Making the Most of Your RBQM Solution Through the Establishment of Key Risk Indicators And Setting The Appropriate Thresholds (Topic TBC)

DECENTRALIZED/HYBRID TRIALS
Leveraging Site Selection for Clinical Trial Decentralization

EMERGING BIOPHARMA / OUTSOURCING
Building a foundation for future development and success by fostering a culture of innovation and compliance for an evolving organization (Topic TBC)

DIGITAL MEASUREMENTS/ CLINICAL DATA
Smart Signals/Devices To Capture Real-World Behavior, Gather Data More Often, And Run A Simulated Research While Remotely Monitoring Patient Safety (Topic TBC)

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
Discover how a single sponsor/vendor partnership uses solution integration to address issues with technology platforms, burden for sites, invaluable applications of data, and inefficient change management procedures (Topic TBC)

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
How Can We Recognize And Eliminate Obstacles That Prevent Minority Involvement, Such As Historical Distrust, Accessibility Issues, And A Lack of Awareness

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
A Developed Risk-Based Quality Management Approach To Mitigate Potential Risks and Liabilities
-Penny Carlson
Vice President, Head of Innovation & Data
Takeda Pharmaceuticals

DECENTRALIZED/HYBRID TRIALS
Practical factors to take into account while switching to hybrid or decentralised clinical trials

EMERGING BIOPHARMA / OUTSOURCING
Building connections that ease site and sponsor load and enhance the patient experience
-George Naumov
COO & CBO
RS Oncology

DIGITAL MEASUREMENTS/ CLINICAL DATA
Discussing The Quality of Additional Data Resulting From New Approaches Used In Clinical Trials

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
What are the biggest feasibility errors that even the most experienced sponsors occasionally make and how can we have a hands-on approach to avoid these mistakes?
-Emilio Neto
Head of US Clinical Country & Site Management, Senior Director
Biogen

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
What obstacles do pharmaceutical and biotech businesses have to overcome in order to adequately represent various populations in clinical trials?

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
A Developed Risk-Based Quality Management Approach To Mitigate Potential Risks and Liabilities

DECENTRALIZED/HYBRID TRIALS
How can we guarantee that the DCT’s many components use patient data in an effective and secure manner?

EMERGING BIOPHARMA / OUTSOURCING
What techniques can we employ to create a scalable culture in emerging biopharmaceutical companies?

DIGITAL MEASUREMENTS/ CLINICAL DATA
What strategies can we use to align digital transformation, and leverage data analytics in order to improve clinical trials and encourage growth?

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
What tactics can we employ to successfully choose a site and do precise feasibility assessments?

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
Tactics to promote change and inclusion in clinical research by using strategies that foster diversity in all elements and phases of clinical research

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
Choosing The Best Monitoring Method To Improve Patient Compliance And Data Consistency – Centralized Monitoring vs Remote Monitoring

DECENTRALIZED/HYBRID TRIALS
Improving Retention: Supporting decentralized techniques that lessen patient burden and maintain patient engagement

EMERGING BIOPHARMA / OUTSOURCING
Discussing the challenges in limited resources, inadequate infrastructure, delays in manufacturing and clinical supply, and funding concerns emerging biopharma and biotechs face
-Eyal Ron
Executive Board Member and Co-Founder
Keyron

DIGITAL MEASUREMENTS/ CLINICAL DATA
How Can We Use Algorithms And Other Modern Methods To Clean And Interpret Data?

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
Identifying Your Sites by Examining Selection Criteria and Site Performance: What Selection Criteria May Inhibit Your Clinical Trial’s Success?

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
Eliminating Health Inequities: How can we improve the diverse representation of clinical trial programs to drive health equity?