Fierce Clinical Summit 2024: Full Schedule

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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