ROCKVILLE, Md., April 17, 2019 /PRNewswire/ -- RRD International, a specialized product development company that provides strategic and operational support to biopharmaceutical companies and investors, today announced further expansion of its clinical pharmacology capabilities in support of the Company's unique Product Development Team (PDT) model.
Jennifer DiGiacinto, PharmD, who has played a pivotal role in assessing the clinical pharmacology needs of numerous assets for many RRD partners has been tapped to lead the initiative. Dr. DiGiacinto was promoted to senior vice president, clinical pharmacology late last year and has been focused on building the Company's capabilities through a combination of internal infrastructure and external pharmacometrician strategic advisors. In February, RRD also hired 19-year clinical operations veteran, Anthony Godfrey, PharmD, who has served as principle investigator or sub-investigator on over 2,000 phase 1 trials across multiple therapeutic areas, to further bolster RRD's team of in-house experts.
"The expansion of our clinical pharmacology capabilities aligns strategically with FDA's Model Informed Drug Development (MIDD) initiative and RRD's focus on de-risking development and optimizing asset value for our partners," said Scott Tarrant, president of RRD International. "Leveraging these capabilities will enhance the value of phase-3-ready assets available for acquisition by established biopharma as well as position RRD to accelerate post hPOC development opportunities for new molecular entities (NMEs), repurposed NMEs, 505(b)(2)s and biosimilar products," said Tarrant.
Dr. DiGiacinto joined RRD in 2013 and has over 18 years of experience in biopharmaceutics, clinical pharmacology and regulatory affairs. As senior clinical pharmacology reviewer at the US FDA/CDER for 7 years she provided guidance to sponsors on drug development regulations, policy and procedures. Dr. DiGiacinto earned her Doctor of Pharmacy degree from the University of Nebraska Medical Center, College of Pharmacy and completed her pharmacy residency at University of Nebraska Medical Center Hospital and then completed a two-year clinical pharmacology fellowship funded by FDA at University of Illinois Medical Center.
About RRD International: RRD International is a product development company that provides integrated, expert-level strategic, regulatory and operational support to biopharmaceutical companies and investors. The Company's unique Product Development Team model (PDT) provides an effective, asset-centric alternative to traditional industry practices. While comprehensive in value, structure and function – encompassing all aspects of a development program including strategic planning, management and execution – the PDT model is also highly resource efficient with an intense focus on minimizing cost, time and risk to achieve human proof-of-concept (POC). Since 2002, RRD has worked with more than 100 organizations across all major classes and therapeutic areas. For more information, visit www.rrdintl.com.
SOURCE RRD International