Fierce Clinical Summit 2024: Full Schedule

8:30am EDT

Conference Welcome

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

General Session

8:45am EDT

Opening Keynote: Modernize Clinical Trials

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

Celebrate Recent Advancements and Recognize the Importance of Embracing Change to Optimize Clinical Research

Examine the impact of adapting and modernizing trial design and protocols to drive efficiencies
- Evaluate the utilization of technology and AI to enhance clinical trials
- Highlight how the needs of patients have evolved clinical trials
- Discuss the promise of genetic medicines and what it means for the future of clinical trials
Outline strategies for combatting the industry's reluctance to change and need for transparency with regulators

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

Risk-Based Clinical Development

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

Understand and Address the Barriers Preventing the Industry from Realizing the Promises of Risk-Based Approaches

Understand the evolution of the regulators' expectations when it comes to risk-based approaches
Examine why the industry has struggled to benefit from the promises of risk-based approaches
Discuss industry data detailing what is holding trial sponsors back
Outline ideal approaches for realizing the efficiency and resource benefits

Speakers

Jonathan Rowe

Principal, Head of R&D Quality, Operations, and Risk Management, ZS

Jonathan Rowe has more than 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Principal, Head of R&D Quality, Operations and Risk Management... Read More →

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

General Session

9:45am EDT

Keynote Panel: DEI In Clinical Research

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

Optimize Patient Outcomes and Promote Health Equity by Ensuring Clinical Data Accurately Reflects the Patient Population

Why are we still talking about this? Have we made progress as an industry?
Examine the power and importance of defining a DEI goal and align partners behind it
Identify actions the industry can take to make studies more approachable to ALL communities

Speakers

Tyrone Quarterman, MPH

Senior Manager, Health Equity, Diversity, Equity, and Inclusion, and University Programs, Myriad Genetics

I am a dedicated Diversity, Equity, Inclusion, and Belonging (DEIB) professional with nearly a decade of experience navigating the intersections of for-profit, non-profit, and government healthcare settings. My career has been marked by a commitment to driving systematic change and... Read More →

Jatin Shah, M.D.

Chief Medical Officer, Sumitomo Pharma America

Dr. Jatin Shah has served as Chief Medical Officer – Oncology of Sumitomo Pharma America since April 1, 2024. Prior to this role, he served as the Chief Oncology Development Officer since the Company’s formation in 2023, and as Executive Vice President, Chief Medical Officer and... Read More →

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 →

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

General Session

Qtag clinicaloperationsfeaturedsession

11:00am EDT

Charting the Future: Technology's Impact on Productivity

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

Evaluating Present Realities and Future Possibilities in Clinical Development

Discuss the current state of industry-level productivity based on IQVIA Institute’s Global Trends in R&D 2024 report

Explore how shifts in the funding, emerging biopharma, product portfolio, regulatory, and policy environments are changing the clinical development landscape
Understand where productivity enablers appear to be having an impact and where there is additional opportunity
Assess the potential implications of upcoming elections on innovation in life sciences

Speakers

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 →

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

General Session

11:45am EDT

Keynote Panel: A Future Without Pharma

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

Can Non-Profit and Patient Organizations Own the Future of Next Generation Clinical Trial Innovation?

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 →

Speakers

Len Rosenberg, PhD, RPh

Head, Clinical Operations, Beat AML, a division of The Leukemia & Lymphoma Society

Executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and new product/licensing... Read More →

Craig Martin

Founder & CEO, Orphan Therapeutics Accelerator

My experience includes more than two decades in biotech, health tech, digital health and healthcare markets -- providing executive leadership, business strategy, business development, corporate, product and pipeline communications, stakeholder engagement, policy and advocacy, as a... Read More →

Tracey Sikora

Co-Founder, Every Cure

Tracey Sikora is the Co-Founder of Every Cure, a nonprofit organization dedicated to finding additional uses for existing drugs. She has a 15 year career conducting pre-clinical and clinical research in multiple rare diseases, including MPS I, Niemann-Pick Type C, Familial Hypercholesterolemia... Read More →

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

General Session

Qtag clinicaloperationsfeaturedsession

9:00am EDT

Chairperson’s Opening Remarks

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

General Session

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

Qtag dct&techfeaturedsessions