Fierce Clinical Summit 2024: Full Schedule

8:00am EDT

Attendee Registration and Networking Breakfast

Wednesday September 25, 2024 8:00am - 9:00am EDT

Networking

9:00am EDT

Workshop A: Analytical Approaches to Measuring Quality: From Theory to Practical Implementation

Wednesday September 25, 2024 9:00am - 12:00pm EDT

Join us for an interactive workshop designed for clinical operations and clinical quality professionals seeking to enhance their analytical approaches to measuring quality. Structured around three main topics—Understanding the Data & Reporting Landscape, Optimizing Organizational Structure and Governance, and Navigating Change Management—we will embark on a collaborative journey to assess the current state of your organization's quality analytics.

Delve into the core components of quality analytics, moving from theoretical concepts to practical implementation strategies
Engage in group discussions, brainstorming, and actionable planning
Learn from industry experts' real-world implementations
Craft tailored elevator pitches for organizational advancement
Leave with a clear roadmap for impactful quality analytics progression

Speakers

Kevin Richards, M.Sc.

Director, Analytics & Insights, AstraZeneca

Kevin is an analytics leader dedicated to advancing organizations through effective and scalable strategies in data, analytics, and data science. His career is marked by transformative overhauls of analytics frameworks within manufacturing, healthcare, and presently, the pharmaceutical... Read More →

Luke Cash, PhD

Associate Director, Analytics & Insights, AstraZeneca

Luke is an Associate Director of Analytics and Insights at AstraZeneca. He leads technical teams working at the intersection of Clinical Operations and Quality Analytics and is responsible for integrating these data domains into unified analytics infrastructure. Key areas of support... Read More →

Wednesday September 25, 2024 9:00am - 12:00pm EDT

Workshop

9:00am EDT

Workshop B: TBA

Wednesday September 25, 2024 9:00am - 12:00pm EDT

Workshop

12:00pm EDT

Networking Lunch

Wednesday September 25, 2024 12:00pm - 1:30pm EDT

Networking

1:00pm EDT

Workshop D: Innovation Day & Afternoon Reception Presented by IQVIA Technologies

Wednesday September 25, 2024 1:00pm - 5:30pm EDT

Learn more about IQVIA’s Innovation Day through this link and register here.
Agenda:

1-1:15pm - Welcome and Keynote: Cutting through the Noise of Clinical Trial Technology
1:15-2:30pm - Is Technology Delivering on the Promise to Improve Clinical Development Productivity?
2:30-3pm - Refreshments, Demos and Discussions
3-4pm - Panel: Changing How Clinical Trials Work: A Collaborative Approach
4-4:30pm - The Road Ahead: Strategies for the Site, Patient, Sponsor Journeys
4:30-5:30pm - Drinks, Demos, Discussions

Moderators

Melissa Easy

VP Clinical Technologies, IQVIA Technology

Melissa Easy is the vice-president and GM of Clinical Technologies at IQVIA, responsible for the development and delivery of products to streamline processes across the clinical development lifecycle, for sponsors, sites, and patients in the IQVIA Orchestrated Clinical Trials Platform.Melissa... Read More →

Speakers

Nicholas Whitney

Senior Director, Commercial Lead, Site, IQVIA Technologies

Nick Whitney has 17+ years of experience in the life sciences and is currently Director, Trial Management Solutions, which includes technologies helping with Study Planning, Feasibility, Study Start Up and Conduct. Nick has been involved with the delivery of these solutions for 10... Read More →

Anthony Mikulaschek

VP, Commercial Strategy, IQVIA Technologies

As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration... Read More →

Murray Aitken

SVP & Executive Director, IQVIA Institute for Human Data Science, IQVIA

As head of the IQVIA Institute for Human Data Science, Murray Aitken provides policy setters and decision-makers in the global health sector with evidence, analysis, and insights that contribute to the advancement of Human Data Science to improve human health outcomes. Aitken is... Read More →

Jim DiCesare

VP, Financial Management Technology, IQVIA Technology

Jim DiCesare is passionate about delivering innovative Cost Benchmarking, CTA Negotiation and Site Payment services that support clinical research conducted by sponsors and CROs. With over 25 years of industry experience leading clinical operations teams at Merck, DrugDev, and now... Read More →

Tim Riely

VP, Clinical Data Analytics, IQVIA Technology

Tim has 20 years of experience delivering business intelligence, data management and analytical solutions in both leadership and consulting roles.  Tim currently leads the IQIVA Clinical Data Analytics Suite (CDAS), providing both SaaS solutions for the market as well as IQVIA’s... Read More →

Wednesday September 25, 2024 1:00pm - 5:30pm EDT

Workshop

1:30pm EDT

Workshop C: TBA

Wednesday September 25, 2024 1:30pm - 4:30pm EDT

Workshop

4:30pm EDT

Networking Reception

Wednesday September 25, 2024 4:30pm - 5:30pm EDT

Networking

5:30pm EDT

Workshop Day Concludes

Wednesday September 25, 2024 5:30pm - 5:30pm EDT

7:45am EDT

Registration and Networking Breakfast

Thursday September 26, 2024 7:45am - 8:30am EDT

Networking

8:30am EDT

Chairperson’s Opening Remarks

Thursday September 26, 2024 8:30am - 8:45am EDT

General Session

8:45am EDT

Keynote: Modernizing Clinical Trials for the Next Era of Drug Development

Thursday September 26, 2024 8:45am - 9:15am EDT

Examine the impact of adapting and modernizing trial design and protocols to drive efficiencies
Evaluate the utilization of digital health technologies, digital biomarkers, and real-world evidence to enhance clinical data collection
Consider the role of AI in clinical development and how to harness it for optimal results
Discuss the promise of genetic medicines and what it means for the future of clinical trials

Speakers

Bari Kowal

Senior Vice President, Head Development Operations & Portfolio Management, Regeneron

Bari Kowal joined Regeneron in 2015 and became head of global clinical operations in 2017. She currently serves as senior vice president, development operations, portfolio management and biostatistics data management, and is responsible for clinical trial strategy and execution, along... Read More →

Thursday September 26, 2024 8:45am - 9:15am EDT

General Session

Qtag clinicaloperationsfeaturedsession

9:15am EDT

Presentation: TBA

Thursday September 26, 2024 9:15am - 9:45am EDT

General Session

9:45am EDT

Keynote Panel: Strategies to Improve Diversity, Equity and Inclusion in Oncology Clinical Trials

Thursday September 26, 2024 9:45am - 10:30am EDT

Speakers

Jennifer Sheller

Vice President, Head of Clinical Sites, Data Management & Quality, Merck

Jennifer Sheller joined Merck in 2017 as an Associate Vice President, Clinical Operations. She is currently the Global Head of Monitoring Excellence, Site Partnerships / Engagement and Clinical Trial Diversity. Jennifer’s background includes a bachelor’s degree in Molecular Biology... Read More →

Keith Ho

Director of Clinical Innovation and Optimization, Jazz Pharmaceuticals

Keith Ho is the Director of Clinical Innovation and Optimization within the clinical operations organization and the co-lead for the Trial Inclusiveness and Diversity Initiative at Jazz Pharmaceuticals. In his role, his objective is to develop an enterprise-level trial inclusiveness... Read More →

Ariel Katz

CEO and Co-Founder, H1

Ariel Katz, is the CEO and Co-founder of H1 the leading healthcare platform that connects the world to the right doctors. H1 supports the top Pharma and BioTech companies with AI-powered insights that help Medical Affairs and Clinical Operations accelerate drug discovery and commercialization... Read More →

Thursday September 26, 2024 9:45am - 10:30am EDT

General Session

Qtag clinicaloperationsfeaturedsession

10:30am EDT

Networking Break

Thursday September 26, 2024 10:30am - 11:00am EDT

Networking

11:00am EDT

Keynote Panel: Can Patients Derisk Clinical Trial Innovation?

Thursday September 26, 2024 11:00am - 11:45am EDT

Moderators

Craig Lipset

Advisor & Founder, Clinical Innovation Partners

Craig Lipset operates at the forefront of innovation in clinical research and medicine development. He brings unique perspective as a pharmaceutical executive and technologist, as well as a patient advocate. For over 20 years Craig has been leading the transformation of clinical trials... Read More →

Thursday September 26, 2024 11:00am - 11:45am EDT

General Session

Qtag clinicaloperationsfeaturedsession

11:45am EDT

Panel Discussion with IQVIA

Thursday September 26, 2024 11:45am - 12:30pm EDT

General Session

12:30pm EDT

Networking Lunch

Thursday September 26, 2024 12:30pm - 1:30pm EDT

Networking

1:30pm EDT

Clinical Operations Track - Chairperson’s Opening Remarks

Thursday September 26, 2024 1:30pm - 1:45pm EDT

Clinical Operations Track

1:30pm EDT

Clinical Quality Track - Chairperson’s Opening Remarks

Thursday September 26, 2024 1:30pm - 1:45pm EDT

Speakers

Grace Crawford, MS MT ASCP

Head, Clinical Operations Quality & Learning, AstraZeneca

Grace is accountable for the development, implementation, maintenance and adoption of business quality management practices and GxP learning services for BioPharma Clinical Operations, and relevant areas within R&D BioPharmaceuticals and R&D Oncology. Grace has extensive experience... Read More →

Justin Ott

Senior Director, Global Development Quality Assurance – GCP, Regeneron Pharmaceuticals

Justin Ott has been working in the Pharmaceutical Industry for nearly twenty years, most of which has been spent auditing in the Clinical Trial space. During that time, he has audited around the world at investigator sites, clinical vendors, and internal process audits. He currently... Read More →

Thursday September 26, 2024 1:30pm - 1:45pm EDT

Clinical Quality Track

1:30pm EDT

DCT & Technology Track - Chairperson’s Opening Remarks

Thursday September 26, 2024 1:30pm - 1:45pm EDT

Speakers

Brandon Maggio

Head of Digital Operations & Process Optimization, GSK

Craig Lipset

Advisor & Founder, Clinical Innovation Partners

Thursday September 26, 2024 1:30pm - 1:45pm EDT

DCT & Technology Track

1:30pm EDT

Medical Writing Track - Chairperson’s Opening Remarks

Thursday September 26, 2024 1:30pm - 1:45pm EDT

Medical Writing Track

1:45pm EDT

Being Comfortable with the Uncomfortable: Integration of a Site Engagement Function

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Delve into the evolution of Site Engagement roles within GSK Clinical Operations, tracing their historical roots from CRAs to the current interdisciplinary approach involving Field Medical, Study Managers, and Study Start-Up.
Highlight the value proposition of investing in a Site Engagement Team, elucidating how they facilitate deep-rooted partnerships with research institutions, streamline processes, advocate for innovative solutions, and expedite the delivery of novel medicines to patients.
Explore real-world examples that showcase the flexibility and adaptability of Site Engagement in navigating organizational red-tape and supporting delivery of priority programs.
Address the question of whether relationship management solely resides with formal Site Engagement Teams, offering insights into broader organizational strategies and collaborative approaches.

Speakers

Gerri Gallagher

Director, US Site Engagement, GSK

Gerri Gallagher is the Director of US Site Engagement at GSK where she is accountable for the strategic oversight and leadership of the country level activities of the Site Engagement Team.Gerri has over 20 years of experience working across Clinical Operations in Research & Development... Read More →

Solomon Yakubov

Associate Director, Site Engagement – Global Clinical Operations, GSK

Results-driven clinical operations leader with a 10+ year career in successfully delivering clinical trials across immuno-oncology, oncology, vaccines, infectious disease, cardiovascular, respiratory, and renal + metabolic therapeutic areas. Currently serving as Associate Director... Read More →

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Clinical Operations Track

Qtag clinicaloperationsfeaturedsession

1:45pm EDT

Building a Framework for Efficient Health Authority Inspections

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Speakers

Priya Chaturvedi, Ph.D.

Vice President, Head of Global Clinical Quality, Eisai

Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai Inc. She has responsibility for Global Clinical Quality Assurance, Clinical Quality Management and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director, CQA at... Read More →

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Clinical Quality Track

1:45pm EDT

Designing Disease Area DCT Approaches

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Speakers

Lauren Bataille

Head, R&D Digital - CVRM , AstraZeneca

Thursday September 26, 2024 1:45pm - 2:15pm EDT

DCT & Technology Track

1:45pm EDT

Navigating a Global Medical Writing Vendor Transition

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Speakers

Lynn Munno

Medical Writing Operations Lead, Takeda

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Medical Writing Track

Qtag medicalwritingfeaturedsession

2:15pm EDT

Financial Empowerment: Fueling Site and Patient Engagement for Successful Clinical Trials

Thursday September 26, 2024 2:15pm - 2:45pm EDT

Effective financial management is the backbone of successful clinical trials. In this discussion, we'll explore how strategic financial management practices by a sponsor can empower trial sites and engage patients, ultimately driving superior trial outcomes. By aligning financial management processes with trial objectives, we can enhance collaboration, transparency, and overall trial efficiency.

Aligning Financial Stakeholders: We’ll explore how sponsors, sites, and patients can work together seamlessly.
Understanding Financial Impact: Let’s discuss the tangible effects of financial management decisions for each stakeholder group.
Integration with Trial Objectives: We’ll understand how financial management strategies be harmonized with trial goals and outcomes.

Speakers

Jim DiCesare

VP, Financial Management Technology, IQVIA Technology

Thursday September 26, 2024 2:15pm - 2:45pm EDT

Clinical Operations Track

Qtag clinicaloperationsfeaturedsession

2:15pm EDT

Optimizing Sponsor-provided Technology to Become Inspection Ready

Thursday September 26, 2024 2:15pm - 2:45pm EDT

Presented by Advarra

Gain valuable insights for integrating sponsor-provided technology to become inspection ready
Learn successful site-specific strategies for a proactive approach to FDA inspections
Gain an in-depth understanding of an FDA inspection and post-inspection activities for sites and sponsors
Understand best practices to assure study integrity and GCP compliance

Thursday September 26, 2024 2:15pm - 2:45pm EDT

Clinical Quality Track

2:15pm EDT

Presentation: TBA

Thursday September 26, 2024 2:15pm - 2:45pm EDT

DCT & Technology Track

2:15pm EDT

Presentation: TBA

Thursday September 26, 2024 2:15pm - 2:45pm EDT

Medical Writing Track

2:45pm EDT

Panel: Explore the Potential of AI in Clinical Trial Operations

Thursday September 26, 2024 2:45pm - 3:30pm EDT

Clinical Operations Track

2:45pm EDT

Panel: Unlocking Value: Integrating RBQM End-to-End

Thursday September 26, 2024 2:45pm - 3:30pm EDT

Moderators

Paul Houri

Vice President, Head of R&D Quality Assurance, Bristol Myers Squibb

Speakers

Grace Crawford, MS MT ASCP

Head, Clinical Operations Quality & Learning, AstraZeneca

Thursday September 26, 2024 2:45pm - 3:30pm EDT

Clinical Quality Track

2:45pm EDT

Panel Discussion: TBA

Thursday September 26, 2024 2:45pm - 3:30pm EDT

DCT & Technology Track

2:45pm EDT

Panel : Health Literacy in Clinical Research to Drive Patient Engagement

Thursday September 26, 2024 2:45pm - 3:30pm EDT

Medical Writing Track

Qtag medicalwritingfeaturedsession

3:30pm EDT

Networking Break

Thursday September 26, 2024 3:30pm - 4:00pm EDT

Networking

4:00pm EDT

From Partnership to Performance: Using a Sponsor-CRO Partnership to Overcome Resource Restraints in Building Site Engagement

Thursday September 26, 2024 4:00pm - 4:30pm EDT

Learn how CinRx leverages its resources across subsidiaries and therapeutic areas through a shared services model for staff enabling cost-efficient drug development
Discover how this cross-functional model lends itself to partnering with companies who can provide a broader reach and enhanced site engagement during the study lifecycle
Understand how building relationships with investigators and site teams leads to scientific and operational optimization of clinical trials

Speakers

Brendan Doran, PharmD

Executive Director, Clinical Operations, CinRx Pharma

Brendan Doran, PharmD serves as the Executive Director of Clinical Operations for CinRx Pharma and brings more than 15 years of experience in the pharmaceutical industry and clinical pharmacy practice. Dr. Doran oversees clinical operations for CinRx’s 6 therapeutically focused... Read More →

Thursday September 26, 2024 4:00pm - 4:30pm EDT

Clinical Operations Track

Qtag clinicaloperationsfeaturedsession

4:00pm EDT

The Astellas-CSU PharmD Industry Rotation Partnership

Thursday September 26, 2024 4:00pm - 4:30pm EDT

Learn about Astellas’ recent experience welcoming Chicago State University PharmD candidates for rotations in Quality Assurance
Understand the benefits for both students and Astellas of this collaboration, and what other biopharma companies can take away from these learnings to initiate their own partnerships

Speakers

John Bolling

Director, Clinical Quality Assurance, Astellas Pharma US

John leads a team of global Asset Quality Leads in GCP with Astellas. He started his career 'on the bench', then managed laboratories before shifting to Quality Assurance for the lab/preclinical space (GLP). He has 20 years of QA experience and has been with Astellas for 11 years... Read More →

Thursday September 26, 2024 4:00pm - 4:30pm EDT

Clinical Quality Track

4:00pm EDT

Toward Excellence: Technology Standards Redefining Modern Trials

Thursday September 26, 2024 4:00pm - 4:30pm EDT

Establishing Robust Technical Standards: Delve into critical areas of technical standards and regulatory work in clinical research.
Exploring Key Topics: Cover risk-based assessments, AI/ML applications, telehealth approaches, and cybersecurity in clinical research.
Staying Informed: Learn about the latest regulations, guidelines, and FDA guidance shaping the field.
IEEE-SA CTTMN Insights: Gain knowledge from ongoing efforts in developing technical standards across crucial domains.

Speakers

Isaac Rodriguez-Chavez, PhD, MHS, MS

Co-Chair, IEEE-SA-DCT/DHT Program & CEO/Principal Consultant, 4Biosolutions Consulting, IEEE

Dr. Isaac R Rodriguez-Chavez is a scientific and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, Vaccinology and rare diseases. His experience covers the entire life cycle of medical products from basic, preclinical, interventional... Read More →

Mathew E. Rose, MD MS

Co-Chair, IEEE

Dr. Mathew Rose is an Investor, Physician, Entrepreneur, and Blockchain Specialist focused on innovations that improve health and quality of life. He founded SAAVHA, a social impact startup that personalizes patient experiences to reduce inequity and administrative friction around... Read More →

Thursday September 26, 2024 4:00pm - 4:30pm EDT

DCT & Technology Track

4:00pm EDT

Evolution of Clinical Medical Writing and Publications: A Small Biotech Perspective

Thursday September 26, 2024 4:00pm - 4:30pm EDT

Speakers

Mary Hanson, PhD

Senior Director, Clinical Medical Writing, Vaxcyte

Mary Hanson, PhD, is the Head of Clinical Medical Writing at Vaxcyte, Inc. In her role, she is responsible for driving and shaping the medical writing processes, procedures, and strategies; generation and maintenance of essential clinical trial documents, and developing and driving... Read More →

Thursday September 26, 2024 4:00pm - 4:30pm EDT

Medical Writing Track

Qtag medicalwritingfeaturedsession

4:30pm EDT

Presentation: TBA

Thursday September 26, 2024 4:30pm - 5:00pm EDT

Clinical Operations Track

4:30pm EDT

Presentation: TBA

Thursday September 26, 2024 4:30pm - 5:00pm EDT

Clinical Quality Track

4:30pm EDT

Presentation: TBA

Thursday September 26, 2024 4:30pm - 5:00pm EDT

DCT & Technology Track

4:30pm EDT

Presentation: TBA

Thursday September 26, 2024 4:30pm - 5:00pm EDT

Medical Writing Track

5:00pm EDT

Panel: Optimizing Clinical Trials Post-Pandemic Through Efficient Trial Design

Thursday September 26, 2024 5:00pm - 5:45pm EDT

Explore the evolving dynamics between clinical trial sponsors and research sites, focusing on remote operations and site access challenges post-COVID-19
Quantify the impact of protocol complexity on patient burden and site operations
Leverage data-driven approaches to streamline start-up activities, lower costs, and enhance enrollment efficiencies.
Discuss strategies for effective collaboration and relationship building, with an emphasis on integrating site and patient perspectives in protocol design

Speakers

Victor Lucariello

Associate Director, Study Optimization, Bristol Myers Squibb

Suzanne Parker

Vice President, Clinical Operations and Study Management, TuHURA Biosciences

Suzanne Parker is a pharmaceutical industry professional with over 25 years of experience leading teams through the various stages of the clinical development process from study concept, enrollment, reporting and health authority submissions in major global and emerging markets. Suzanne... Read More →

Thursday September 26, 2024 5:00pm - 5:45pm EDT

Clinical Operations Track

Qtag clinicaloperationsfeaturedsession

5:00pm EDT

Panel: Navigating the New Normal of Inspection Readiness

Thursday September 26, 2024 5:00pm - 5:45pm EDT

Review what has changed in how inspections are managed post-COVID including remote/hybrid models and changes within inspectorates
Share vendor partner best practices and how they can best support sponsor organizations during an inspection
Understand the practical insights and tools to conduct thorough clinical quality due diligence and enhancing preparedness for regulatory inspections during and after mergers and acquisitions
Discuss the challenges with validating electronic health records based on EMA’s increased focus on electronic systems during inspections and the implications of this for the industry

Moderators

Priya Annamalai

Director, Inspection Program – Quality Operations, Quality Assurance, Astellas

My professional career spans across various QA and compliance roles within the pharmaceutical industry with responsibilities in the areas of Quality Systems/CAPA management, regulatory intelligence, product complaints, pharmacovigilance and most recently, leading global regulatory... Read More →

Speakers

Mary MacDonald, MS, RQAP-GCP

Head of Clinical Quality Assurance, Neuroscience, Takeda

Mary MacDonald is the Head of Clinical Quality Assurance, Neuroscience. In this role she partners with the Neuroscience Therapeutic Area Unit and additional quality and research and development business partners to ensure compliance and inspection readiness for all Takeda clinical... Read More →

Thursday September 26, 2024 5:00pm - 5:45pm EDT

Clinical Quality Track

5:00pm EDT

Panel Discussion: TBA

Thursday September 26, 2024 5:00pm - 5:45pm EDT

DCT & Technology Track

5:00pm EDT

Panel: Innovative Ideas to Sustain and Grow Cross-Functional Relationships Between Sponsor and Medical Writing Service Providers

Thursday September 26, 2024 5:00pm - 5:45pm EDT

Medical Writing Track

Qtag medicalwritingfeaturedsession

5:45pm EDT

Networking Reception

Thursday September 26, 2024 5:45pm - 6:45pm EDT

Networking

6:45pm EDT

Day 1 of Summit Concludes

Thursday September 26, 2024 6:45pm - 6:45pm EDT

7:45am EDT

Registration and Networking Breakfast

Friday September 27, 2024 7:45am - 8:30am EDT

Networking

8:30am EDT

Chairperson’s Opening Remarks

Friday September 27, 2024 8:30am - 8:45am EDT

General Session

8:45am EDT

Keynote: TBA

Friday September 27, 2024 8:45am - 9:15am EDT

General Session

9:15am EDT

Presentation: TBA

Friday September 27, 2024 9:15am - 9:45am EDT

General Session

9:45am EDT

Keynote Panel: Transforming Clinical Trials: Integrating People, Processes, and Technology for Next-Generation Biopharma Innovation

Friday September 27, 2024 9:45am - 10:30am EDT

Discover novel strategies for assembling high-performing, cross-functional teams
Learn how artificial intelligence is innovating trial design, patient recruitment, and data anaylsis
Uncover best practices for streamlining processes to enhance trial efficiency and quality

Moderators

Lorena Gomez

Head of Global Business Operations Clinical Development Operations, AbbVie

Speakers

Charlie Semenchuk

Senior Director, Head of Global Clinical Development Operations Business & Technology Capabilities, Jazz Pharmaceuticals

David Carruthers

Vice President Clinical Operations, Clinical Data and Insights, AstraZeneca

Diane Carozza

Novartis, Head, Vendor Program Leadership

Diane Carozza has over 30 years of diverse experience in the pharmaceutical, technology andclinical services industries where she held various roles across Clinical Operations, R&D, R&DIS, Professional Services and Product Development. She joined Novartis in Aug 2023 as theHead of... Read More →

Friday September 27, 2024 9:45am - 10:30am EDT

General Session

10:30am EDT

Networking Break

Friday September 27, 2024 10:30am - 11:00am EDT

Networking

11:00am EDT

Building an Optimized Clinical Study Delivery Engine

Friday September 27, 2024 11:00am - 11:30am EDT

Follow Lilly’s journey to optimize clinical trial delivery and reach more patients over the past three years through continuous process improvement reducing burden and friction for clinical sites and patients
Demonstrate how standardizing systems and streamlining communications both cross functionally and with investigators has doubled their portfolio volume and sped up the overall clinical trial process to intake more and diverse patients
Examine the impact of more accessible and better understood clinical trials by patients and investigators to help shift the view on clinical research to a clinical healthcare delivery option

Speakers

Julie Standley

VP, Clinical Laboratory Sciences, Eli Lilly

Craig Davenport

VP Investigator Engagement, Eli Lilly

Friday September 27, 2024 11:00am - 11:30am EDT

General Session

11:30am EDT

Presentation: TBA

Friday September 27, 2024 11:30am - 12:00pm EDT

General Session

12:00pm EDT

Panel Discussion: TBA

Friday September 27, 2024 12:00pm - 12:45pm EDT

General Session

12:45pm EDT

Networking Lunch

Friday September 27, 2024 12:45pm - 1:45pm EDT

Networking

1:45pm EDT

Clinical Operations Track - Chairperson’s Opening Remarks

Friday September 27, 2024 1:45pm - 2:00pm EDT

Clinical Operations Track

1:45pm EDT

Clinical Quality Track - Chairperson’s Opening Remarks

Friday September 27, 2024 1:45pm - 2:00pm EDT

Speakers

Justin Ott

Senior Director, Global Development Quality Assurance – GCP, Regeneron Pharmaceuticals

Grace Crawford, MS MT ASCP

Head, Clinical Operations Quality & Learning, AstraZeneca

Friday September 27, 2024 1:45pm - 2:00pm EDT

Clinical Quality Track

1:45pm EDT

DCT & Technology Track - Chairperson’s Opening Remarks

Friday September 27, 2024 1:45pm - 2:00pm EDT

DCT & Technology Track

1:45pm EDT

Medical Writing Track - Chairperson’s Opening Remarks

Friday September 27, 2024 1:45pm - 2:00pm EDT

Medical Writing Track

2:00pm EDT

Practical Applications of Analytical Technology for Regulatory Submissions

Friday September 27, 2024 2:00pm - 2:30pm EDT

Speakers

Radhesh Nair

Director, Data Science & Analytics, AbbVie

Beata Nowak, MBA

Director, Digital and Data Strategy, AbbVie

Friday September 27, 2024 2:00pm - 2:30pm EDT

Clinical Operations Track

Qtag clinicaloperationsfeaturedsession

2:00pm EDT

Risky Business – Like the 80s Film But Different

Friday September 27, 2024 2:00pm - 2:30pm EDT

Evaluate GCP risk proportionality and risk-based quality management.
Explore innovation and the new technology frontier.
Evolve with clinical trial design.
Ensure ICH GCP renovation at your firm

Speakers

Sheryl Crean

Senior Director Quality Assurance Strategic Advice, AstraZeneca

As the Senior Director, Research & Development Quality Assurance, Strategic Advice at AstraZeneca, Sheryl is responsible for providing strategic advisory guidance to clinical development and operational teams including study compliance and issue management, inspection readiness and... Read More →

Friday September 27, 2024 2:00pm - 2:30pm EDT

Clinical Quality Track

2:00pm EDT

From Theory to Action in Decentralized Trials: Reshaping Assumptions for Long-Term Adoption

Friday September 27, 2024 2:00pm - 2:30pm EDT

Speakers

Dr. Arturo Loaiza-Bonilla, MD, MSEd

Medical Director of Oncology Research, Capital Health

Dr. Arturo Loaiza-Bonilla, MD, MSEd, is board certified in both medical oncology and hematology and has extensive experience in the diagnosis and treatment of genomic biomarker-driven cancers and serves as enterprise Medical Director of Oncology Research at Capital Health. Dr. Loaiza-Bonilla... Read More →

Anna Yang, PharmD

Principal Clinical Innovation and Technology Leader, Genentech

Anna Yang, PharmD, is a Principal Clinical Innovation and Technology Leader in the US Medical Affairs Evidence Generation Team at Genentech. Anna leads discussions related to DCT strategy and implementation with study teams across the portfolio, infusing insights and best practices... Read More →

Friday September 27, 2024 2:00pm - 2:30pm EDT

DCT & Technology Track

2:00pm EDT

Exploring Emerging Regulatory Guidance on Technology Innovations in Clinical Research

Friday September 27, 2024 2:00pm - 2:30pm EDT

Medical Writing Track

Qtag medicalwritingfeaturedsession

2:30pm EDT

Presentation: TBA

Friday September 27, 2024 2:30pm - 3:00pm EDT

Clinical Operations Track

2:30pm EDT

Presentation: TBA

Friday September 27, 2024 2:30pm - 3:00pm EDT

Clinical Quality Track

2:30pm EDT

Presentation: TBA

Friday September 27, 2024 2:30pm - 3:00pm EDT

DCT & Technology Track

2:30pm EDT

Presentation: TBA

Friday September 27, 2024 2:30pm - 3:00pm EDT

Medical Writing Track

3:00pm EDT

Panel: Ensuring Data Reliability Under the New ICH E6(R3) Guidelines

Friday September 27, 2024 3:00pm - 3:45pm EDT

Explore key aspects of the new E6(R3) language around risk-based proportionate approaches to data reliability, including requirements for computerized systems validation, data handling procedures, and monitoring practices
Discuss strategies and best practices for ensuing compliance with the updated reliability requirements, and practical implications for quality systems, data management processes, and vendor oversight
Gain insight on how sponsor organizations and CROs can prepare for these changes to ensure reliable data under the new guidelines

Speakers

Michael Walega

Head of Centralized Monitoring, Bristol Myers Squibb

Michael Walega is the Head of Centralized Monitoring at BMS. In this capacity, he is responsible for providing protocol teams with actionable insights to achieve higher quality, ensure that centralized monitoring processes are aligned to relevant regulatory requirements, and championing... Read More →

Friday September 27, 2024 3:00pm - 3:45pm EDT

Clinical Operations Track

Qtag clinicaloperationsfeaturedsession

3:00pm EDT

Panel: A Risk-Based Approach to Vendor Management in an Evolving Regulatory Landscape

Friday September 27, 2024 3:00pm - 3:45pm EDT

Speakers

Nicole Victoria, Ph.D.

Associate Director, Quality Compliance, Head of Vendor Management, Sage Therapeutics

Nicole Victoria, Ph.D. is a neuroscientist with over 15 years of experience in scientific investigations and over 13 years of experience in regulatory, ethical, and safety compliance. In 2022, Nicole transitioned to Sage Therapeutics as an Associate Director of Research Quality, where... Read More →

Kelly Simpliciano

Director Audit Management, BioNTech

Kelly Simpliciano is a Director at BioNTech where she leads the Audit Management and Vendor Compliance departments within Global Development Quality Assurance. Kelly’s experience spans all of the GxPs but the majority of her experience and passion is clinical. Prior to joining BioNTech... Read More →

Friday September 27, 2024 3:00pm - 3:45pm EDT

Clinical Quality Track

3:00pm EDT

Panel: Leveraging Investigator and Site Engagement to Drive Patient Recruitment and Decentralized Clinical Trial Success

Friday September 27, 2024 3:00pm - 3:45pm EDT

Speakers

Shafaat Ali Khan, M.B., B.S.

Associate Director – Investigator Engagement Clinical Research Lead (CRL), Eli Lilly

Ali is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As the leader of Lilly's Site and Investigator Engagement organization, Ali spearheads efforts to operationalize and execute highly decentralized clinical trials... Read More →

Jared Callen

Associate Director in Clinical Outsourcing and Innovation, Jazz Pharmaceuticals

Jared is an Associate Director in Clinical Outsourcing and Innovation at Jazz Pharmaceuticals. In this role he is tasked with enabling Jazz’s global clinical development organization to capitalize on novel and innovative solutions with new partners and build successful ways-of-working... Read More →

Friday September 27, 2024 3:00pm - 3:45pm EDT

DCT & Technology Track

3:00pm EDT

Panel Discussion: TBA

Friday September 27, 2024 3:00pm - 3:45pm EDT

Medical Writing Track

3:45pm EDT

Summit Concludes

Friday September 27, 2024 3:45pm - 3:45pm EDT