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Unlocking patient access: Modernizing clinical trial regulatory frameworks and trial delivery

The rules that govern our clinical trial infrastructure were written decades ago and did not anticipate the advances we made to increase clinical trials access for patients, efficiency in delivery and lower burden for both investigators and patients.

Although the FDA’s recent Final Guidance on decentralized clinical trials was a significant step forward, the regulatory framework still prioritizes traditional study designs, tools, and infrastructure over more modern and accessible approaches such as community-based research. The result: many people are still hindered from participating in clinical trials.

In this discussion, you’ll learn:
  • The remaining barriers that prevent community-based research and other clinical trial innovations from becoming standard practice.
  • What can be done to remove those barriers to broaden patient access to clinical research.
Who should attend:
  • Clinical trial regulators
  • Study investigators & site staff
  • Community-based physicians, providers
  • Policymakers
  • Biopharmaceutical industry
  • Patient advocacy organizations
  • Media

Join Eli Lilly and Company to examine the current barriers limiting access to clinical trial participation and how Eli Lilly and Company is working to modernize the trial landscape to increase patient participation and deliver innovative treatments to patients.

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Janelle A. Sabo

Janelle A. Sabo

Senior Vice President of Clinical Capabilities, Eli Lilly and Company

Dr. Janelle A. Sabo is a recognized leader in drug development, clinical research, and product delivery. Her unique background has driven a strong patient focus and desire to find innovative ways to deliver new therapies faster to patients and the global medical community.

Janelle is currently Senior Vice President of Clinical Capabilities at Eli Lilly and Company. Her organization encompasses over 1500 employees across the globe delivering over 500 clinical trials. Clinical Capabilities is responsible for the delivery of clinical studies, including investigator engagement, trial capabilities, clinical labs and systems, clinical trial material, ancillaries and related supply planning/delivery, clinical development systems, clinical research services, clinical innovation and digital health.

Janelle started her career in clinical development and has held key leadership roles across clinical development, chemistry manufacturing and controls, portfolio management and led drug development and brand teams from early discovery to launch. In each role, Dr. Sabo has driven innovative designs, delivery and transformation, leading to accelerated drug development and savings of over $1B. As an example, she transformed the clinical supply chain to be end to end, resulting in 15-20% faster cycle times and savings of over $200M. During the COVID-19 pandemic, Janelle led the COVID-19 Therapeutics Platform, which delivered multiple neutralizing antibodies in under 12 months from discovery to market and utilized novel approaches for clinical and commercial delivery.

Dr. Sabo is the recipient of multiple awards at Eli Lilly and in the industry. She has been named to the Global Product Development President’s Council, twice honored with the Lilly Research Laboratories President’s award, selected as the University of Missouri Pharmaceutical Industry Alumni of the Year and the Pharma We Work for Health award. She has served on dean’s advisory boards, including Butler University and UMKC Dean’s Advisory Board. Janelle holds a Doctorate of Pharmacy from the University of Missouri, Global Executive MBA from Georgetown University, and a Global Executive MBA from ESADE- Barcelona, Spain.

Dr. Sabo is a guest lecturer at several universities and colleges of pharmacy on drug development and has spoken at conferences within the pharmaceutical industry and was the keynote graduation speaker for the UMKC School of Pharmacy. To connect with her, visit @ https://www.linkedin.com/in/janelle-sabo-16248114.

Arsalan Arif
Moderator

Arsalan Arif

Founder & publisher, endpoints news

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.