Optimizing Clinical Trial Protocols: How Digitized Protocols are Accelerating Clinical Research

In this webinar, the expert speakers will explore how digitized protocols are accelerating clinical research processes.

This session aims to illustrate how protocol digitization can significantly enhance efficiency and reveal valuable new insights. It has been designed to equip participants with the knowledge needed to formulate a strategic perspective on protocol digitization and identify key areas of opportunity. The speakers will discuss the value of protocol digitization and provide a structured framework for understanding and prioritizing its numerous use cases.

A compelling case study will be presented, demonstrating the positive impact of integrating digitized protocols into an internal large language model (LLM) for document generation purposes. Additionally, speakers will offer a forward-looking analysis of the new insights and trial optimization opportunities that digitized protocols can unlock, with a focus on the next two to five years.

This is a unique opportunity to learn from industry experts at the forefront of clinical research innovation. Join this webinar to gain insights into protocol digitization, understand how it can drive efficiencies and discover how it can elevate clinical trials.

Speakers

Matthew Herod, MS, Director, Enterprise Data Strategy, PPD Clinical Research Business of Thermo Fisher Scientific

Mr. Herod serves as a Data Strategy Director for PPD, the clinical research business of Thermo Fisher Scientific. In this role, he champions the drive for rapid adoption of AI in clinical research and provides project expertise and consulting broadly to apply technology innovations into the clinical product development lifecycle.

Matthew joined PPD in 2022 and has a prior background in healthcare data and informatics, data governance and supporting development of analytical and AI tools for use in hospital operations and management. Matthew holds an MS in Computer Information Systems from Middle Tennessee State University.

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Dayle Cohen, PhD, Executive Director, Head of People Management, Hematology/Oncology Therapeutic Unit, PPD Clinical Research Business of Thermo Fisher Scientific

Dr. Cohen currently serves as Head of People Management for CRG’s Hematology/Oncology Therapeutic Unit, overseeing talent management, operations and resourcing for Project Managers and Clinical and Startup Managers.

She previously served as Head of Global Medical Writing, leading the global team of writers, editors and managerial staff who were focused on the preparation of regulatory, clinical and patient-facing materials. She also supported strategy and implementation of digital and artificial intelligence tools for medical writing.

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Dr. Cohen joined PPD in 2007 as a Medical Writer and began her people management career in 2011, followed by roles of increasing responsibility for functional operations, employee training and development, client management and process development. Prior to joining PPD, Dr. Cohen completed a PhD and brief postdoc in Pharmacology at the University of North Carolina at Chapel Hill. She maintains a Regulatory Affairs Certification and is a Lean Six Sigma Yellow Belt.

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Maria Hopfgarten, Head of Global Medical Writing, PPD Clinical Research Business of Thermo Fisher Scientific

Ms. Hopfgarten brings more than 20 years of experience leading global, high-performing teams and implementing technology improvements and increasing revenue and profitability via expanded business services. Maria currently serves as the Head of Global Medical Writing team at PPD, leading a global team focusing on regulatory, clinical and patient-facing materials.

Previously, Maria established PPD’s language services department for the Clinical Development Services Division. Throughout Maria’s career, she has implemented AI for language efficiencies and overall process improvements and helping reduce timelines and cost.

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Dr. Debra Schaumberg, ScD, OD, MPH, Vice President & Global Head, Strategic Development Consulting; Chair, Research Leadership Council, PPD Clinical Research Business of Thermo Fisher Scientific

An internationally recognized expert in ophthalmology clinical research, Dr. Schaumberg brings to the life sciences community more than 25 years of expertise and experience leading clinical development and medical affairs strategy.

She has developed and led numerous research and development programs spanning the spectrum of early to late clinical development through medical affairs, including all aspects of evidence generation and integration for drugs, biologics, devices and diagnostics.

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Dr. Schaumberg leads medical science and strategy for ophthalmology within the PPD clinical research business of Thermo Fisher Scientific. She heads a team of Senior Scientific Strategists and Scientists who work collaboratively with biotech and biopharma clients to facilitate the acceleration of access to medical products through strategic input into preclinical, clinical and regulatory strategy, driving program optimization, innovating evidence generation and creating value through the advancement of scientific knowledge and insights to meet the needs of the client’s internal and external stakeholders.

Previously, Dr. Schaumberg served on the faculties of Harvard Medical School and the Harvard TH Chan School of Public Health, as well as the University of Utah School of Medicine. She formerly served as the Global Medical Director for Ophthalmics and as the Head of Medical Evidence at Shire. She has authored hundreds of scientific publications, lectures and scientific presentations.

Dr. Schaumberg received her ScD from the Harvard TH Chan School of Public Health, an MPH from the Johns Hopkins Bloomberg School of Hygiene and Public Health, a research fellowship at the Johns Hopkins School of Medicine and OD summa cum laude from the Illinois College of Optometry.

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