Fierce Clinical Summit 2024: Full Schedule

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9:00am EDT

Chairperson’s Opening Remarks

Friday September 27, 2024 9:00am - 9:15am EDT

9:15am EDT

The Intersection of Digital Transformation and Quality

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

Leverage New Technologies and Methodologies to Close Process Gaps, Assess and Mitigate Risks, and Drive Inspection Readiness

Speakers

Kevin Richards, M.Sc.

Head, Quality Investigations and Analytics, 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 →

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

General Session

9:45am EDT

Keynote Panel: Paving the Way for Innovation

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

How to Integrate People, Processes, and Technology to Effectively Transform Clinical Trials with Next-Generation Innovation

Discuss the importance of critical thinking and novel strategies for assembling high-performing, cross-functional teams
Understand how AI is innovating clinical trials and the potential impact on human resources (both need and make-up)
Examine how innovation continues to impact clinical efficiency and quality, and how to prepare people, processes, and technology for the next generation of innovation

Moderators

Lorena Gomez

Head of Global Business Operations, Clinical Development Operations, AbbVie

-25+ years of experience in varied sponsor and CRO roles with special emphasis in global study start up and business transformation-Servant leader, focused on giving team members growth opportunities and making them feel valued and supported-History of building high-functioning, cohesive... Read More →

Speakers

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 →

David Carruthers

Vice President, Clinical Operations, Clinical Data and Insights, AstraZeneca

Diane Carozza

Head, Vendor Program Strategy, Novartis

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

11:15am EDT

Lilly Case Study: Clinical Study Delivery Engine

Friday September 27, 2024 11:15am - 12:00pm 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

Julie Standley is the Vice President Clinical Laboratory Sciences in the Clinical Design Delivery and Analysis (CDDA) organization at Eli Lilly supporting clinical trial laboratory planning, execution, and data delivery. She has worked in the Pharmaceutical Industry for over 20 years... Read More →

Craig Davenport

VP Investigator Engagement, Eli Lilly

Craig is a graduate of Butler University College of Pharmacy & Health Sciences and has been with Lilly for more than 30 years. His current role leading Investigator Engagement is the highlight of his career. The global, strategic function evaluates, selects and manages investigators... Read More →

Friday September 27, 2024 11:15am - 12:00pm EDT

General Session

12:00pm EDT

Keynote Panel: Patient-Centric Clinical Research

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

Harness Innovative Technologies to Design Trials that Fit the Lives of the Patients

Discuss the meaning of patient-centric clinical trials and how that has evolved
Review the patient and societal benefits of patient-centric trials from increased participation and diversity to advancing safe and effective therapies
Identify the challenges and barriers to advancing patient-centric trials and how to overcome them
Define easy action items to increase the engagement and influence of patients in clinical research

Speakers

Tracy Vanderslice

Vice President & Head, Clinical Operations-Oncology, Gilead Sciences

Tracy Vanderslice currently serves as Vice President and Head of Clinical Operations at Gilead Sciences. In this role, she leads a large global team to support operational delivery across the oncology portfolio. Prior to joining Gilead, she led global teams at GSK in clinical operations... Read More →

Heather Badt, MBA, LSS

Chief Operating Officer, Cancer Support Community

Heather Badt joined Cancer Support Community in 2019. In her role as Chief Operating Officer, Heather oversees the organization’s administration and operations, digital and communications departments, and special projects.Previously, Heather served as Executive Director of CSC’s... Read More →

Eliav Barr

Senior Vice President, Global Clinical Development and Chief Medical Officer, Merck

Eliav Barr, M.D. is Senior Vice President, Global Clinical Development, Chief Medical Officer at Merck Research Laboratories (MRL). Dr. Barr oversees Phase 2 to 5 development programs for pipeline and in-line products in the Cardiovascular, Diabetes/Endocrine/Metabolism, Immunology... Read More →

Janice Chang

CEO, TransCelerate BioPharma, Inc.

Janice Chang is the Chief Executive Officer at TransCelerate BioPharma Inc. Janice has been involved with the organization since its inception. In her current position, Janice works closely with the Board of Directors to shape the long-term strategic vision and priorities for... Read More →

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

General Session

2:30pm EDT

CONCLUDING PANEL - PARTNER FOR SUCCESS

Friday September 27, 2024 2:30pm - 3:15pm EDT

Recognize the Success of the Study Rests in the Successful Collaboration of the Stakeholders and How to Manage Issues when They Arise

Examine strategies for establishing clear communication lines and transparency from the onsite of the partnership
Embrace the “fail forward, fail fast” mentality as learning experiences, and ensure your vendors are aligned
- How do you assess the culture of your partner and know it complements yours?
Discuss courses of action when it becomes clear the partnership is not working – Do you build out-clauses into the contract?
Evaluate the effectiveness of feedback loops and continual improvement strategies and how this strengthens partnerships

Speakers

Grace Crawford

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 →

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, 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 2:30pm - 3:15pm EDT

General Session

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