On Demand Webinar:

Optimizing Your Endpoint Adjudication Process Today and Beyond – 3rd Annual Industry Event

Listen to this replay and gain practical insights to manage the complex adjudication process for Clinical Endpoint Committee management, along with where the industry is heading. With innovation and technology in clinical trials advancing faster than ever – connecting to the latest news, thought leaders and innovations for managing endpoint adjudication in clinical development is vital for optimizing resources, meeting regulatory requirements and keeping one step ahead.

  • The Future State of Endpoint Adjudication: Where is it going in the next 3-5 years?
  • Lessons Learned from Challenging Adjudication Trials: Diving deep into the challenges and overcoming roadblocks.

Speakers:

Andrea Falkoff, Vice President, Product Management, Medidata Adjudicate & Imaging

Andrea Falkoff works directly with customers and internal cross-functional teams to ensure the development of imaging and adjudication aligns with industry practices and customer needs. She has over 18 years of experience working in the clinical trial space with a proven track record for customer satisfaction and quality delivery. She has a true passion for her work and being part of creating technology that will transform clinical trials in the future.

Jillian Wnukowski, Solution Product Specialist, Adjudication, Medidata

Jillian Wnukowski is primarily focused in Endpoint Adjudication and prior to Medidata, she spent 11 years in the Contract Research Organization (CRO) space, providing clinical operational oversight in areas including endpoint adjudication, data monitoring committees, steering committees, and medical imaging. She holds a Bachelor’s Degree in Project Management from Southern New Hampshire University.

Diego Bartolome, Head of Research, ai.now, TransPerfect

Diego Bartolome is an expert in Machine Translation (MT), Natural Language Processing (NLP), and Generative AI for Life Sciences. He oversees the Generative AI business unit at TransPerfect, which helps companies to achieve more with Generative AI.

Shea Hogan, Clinician-Scientist, CPC Clinical Research

Dr. Shea Hogan is an interventional cardiologist and vascular medicine specialist at Denver Health and Hospital Authority, an Associate Professor of Clinical Medicine in the University of Colorado School of Medicine, and Clinician-Scientist at CPC Clinical Research (an Academic Resource Organization affiliated with the University of Colorado). She started adjudication for the VOYAGER PAD trial in 2019 and has helped lead CPC’s Clinical Endpoint Committee since 2021. Since then, she has led endpoint adjudication for cardiovascular trials, including OPTIMIZE, EVOLVE, PRECISE, and V1P.

Sadaf Sharfaei, MD, Medical Director at Baim Institute

Sadaf Sharfaei, MD, is the Medical Director at Baim Institute for Clinical Research, she oversees and leads multiple clinical research projects across various therapeutic areas and phases, ensuring quality, compliance, and timeliness. Sadaf has over five years of experience in the contract research organization (CRO) industry, where she has developed strong expertise in clinical trial design and development, execution, and monitoring, as well as medical writing, data analysis, and regulatory affairs.

Ben Shim, Data Strategist in Excellence and Quality, Eli Lilly

Ben Shim partners with the data science and quality groups to define/update procedures per ICH/FDA/EMA guidelines.  Ben creates new business tools and systems that affect new business processes for both quality and timeline improvements.  He was responsible for defining the process of adjudication from data entry in the electronic data capture (EDC) to the submission of the adjudication package to the clinical endpoint committee (CEC).

David Saunders, Senior Director, Integrated Evidence, Medidata AI

David is a Senior Director of Integrated Evidence, Medidata AI. He serves clients and builds solutions to generate insights using clinical trial patient level clinical data via AI, machine learning and statistical approaches. These insights help pharmaceutical companies make informed decisions across the life cycle of their assets, generate material for publications to further areas of research and support trial design and operations. Previously he was a management consultant and MD.