Dr. Cynthia Kirk has joined PRA International as Vice President, Global Regulatory Affairs.
RESTON, Va., February 14, 2006 – PRA International (Nasdaq: PRAI), one of the world's leading global clinical research organizations (CROs), today announced Dr. Cynthia Kirk has joined the company as Vice President, Global Regulatory Affairs.
Most recently, Dr. Kirk was Vice President of Regulatory Affairs at Sepracor Inc., a research-based pharmaceutical company with a focus on respiratory and central nervous system disorders. Dr. Kirk is currently President-Elect of the Drug Information Association (DIA). She is a graduate of the University of Missouri-Kansas City, qualifying as a Ph.D. in Pharmaceutical Sciences with a concentration in Pharmacology/Toxicology.
"Our clients are increasingly looking to us to help them navigate complex regulatory structures on a global basis," said Dr. Monika Pietrek, Executive Vice President, Global Scientific and Medical Affairs. "Dr. Kirk's pharmacology experience, industry knowledge and regulatory acumen further our ability to support their drug development efforts."
Prior to joining Sepracor, Dr. Kirk held several senior level positions in regulatory affairs at pharmaceutical companies and in the CRO industry, where she represented numerous companies before the U.S. Food and Drug Administration as a strategic liaison for products reviewed and approved across various FDA divisions.
"PRA International presents me with an exceptional opportunity to work with leading pharmaceutical and biotech companies that are defining the future of medicine," said Dr. Kirk. "I look forward to helping our clients formulate their regulatory and safety strategies."
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.