Protecting Public Health & Advancing Medical Progress: The Role of Clinical Research & Actionable Opportunities for Improvement

Protecting Public Health & Advancing Medical Progress:
The Role of Clinical Research & Actionable Opportunities for
Improvement

Thursday, March 12, 2020
12:00-1:00 pm
2325 Rayburn House Office Building

***Lunch is Provided***

RSVP – Please email Patrick Cooney (patrick@federalgrp.com)

Program Overview

The ongoing global spread of coronavirus highlights the critical importance of rapid medical
discovery to public health. Clinical research, an essential step in the drug development and
approval process, needs federal attention guided by a modern view of issues impacting the
speed and efficiency of medical discovery. As one of the world’s largest organizations
representing the professionals who work in clinical research, the Association of Clinical
Research Professionals invites congressional stakeholders to this briefing that will provide
valuable information and forward-thinking solutions for delivering new treatments to the
benefit of consumers and public health.

Scheduled Speakers

Jennifer Byrne
CEO and Board Chair of Javara Inc., an Integrated Research
Organization

Javara Inc. is an Integrated Research Organization (IRO) that offers
comprehensive clinical research site services, as an integrated offering,
within leading healthcare organizations. Ms. Byrne’s involvement in the
clinical research enterprise has been vast including collaborations with
hundreds of pharma, device, Contract Research Organizations (CROs),
technology, site organizations, and other research service providers while
working alongside hundreds of investigators and over 115,000 trial
participants. Prior to co-founding Javara Inc, Jennifer was formerly the
CEO of PMG Research, a pre-eminent Site Management Organization, for
which nearly 8,000 Phase I-IV clinical trials were conducted during her
tenure. In addition to her Board of Trustees role with ACRP, she also serves
as Board Chair for Greater Gift, is the Advisory Board Chair for the Wake
Forest University Master’s in Clinical Research degree, is the Board Chair
for Summit School, and serves in an advisory capacity for CISCRP, The
Wake Forest Institute of Regenerative Medicine, The Dioko Fund, and The
North Carolina Biotech of the Piedmont Triad. Jennifer is a graduate of
Texas A&M University.

Kenneth A. Getz, MBA
Deputy Director & Research Professor, Tufts Center for the
Study of Drug Development (CSDD)

Mr. Getz is an internationally recognized expert on R&D and clinical trial
management practices and trends, the global investigative site landscape,
site management and patient recruitment and retention practices, and the
worldwide market for outsourcing clinical research functions. Mr. Getz’s
research studies on protocol design complexity and clinical research
efficiency and effectiveness, conducted over the past two decades, are
considered by many in the research-based life sciences industry to be
pioneering work. His 20+ years of original research benchmarking R&D
management practices, global outsourcing and the investigative site
landscape have contributed to industry-wide understanding of these
critical markets and to improvements in management strategy and
execution.

Jim Kremidas
Executive Director, Association of Clinical Research
Professionals

Mr. Kremidas joined ACRP as Executive Director in October 2015. Mr.
Kremidas has over 30 years of experience in the health care industry,
including positions in the lab, sales, marketing, strategic sourcing, and
clinical operations at Eli Lilly and Company, Quintiles, inVentiv Health, and
CenterWatch. While at Lilly, he led the development of the first functional
area to focus on global enrollment optimization. Kremidas is a founding
advisory board member at the Center for Information & Study on Clinical
Research Participation and a volunteer for the Clinical Trials
Transformation Initiative.