513-579-9911 x 12627
Medpace Launches Scientific & Strategic Development Group
Providing science-based, therapeutically focused, and regulatory-driven strategies and solutions to accelerate global therapeutic development
Cincinnati, Ohio, April 9, 2020 – Medpace (MEDP), a scientifically-driven, global full-service clinical research organization (CRO), announced the launch of its in-house Scientific & Strategic Development group. “Our team consists of a team of regulatory strategists with an average of 19+ years of expertise in therapeutic development,” commented Steven B. Johnson, Senior Vice President of Scientific & Strategic Development. “Applying our experience of working with global and local regulatory authorities, competitive intelligence, and in-depth knowledge of the dynamic regulatory landscape for drugs, biologics and devices, we provide strategies to accelerate the global development of medical therapeutics.”
The group aims to support Sponsors with their drug, biologic and device development needs who are under pressure from evolving and increased regulatory requirements. Key offerings include:
- Global, regional, and country-specific strategies at all phases of therapeutic development based on current and anticipated regulatory guidance, practice, and precedence
- Program gap analyses and due diligence for assets based on an understanding of the regulatory and competitive landscape
- Tactical and strategic development considerations, including best approaches to mediate engagement with regulatory bodies
- Unparalleled experience with advanced therapy medicinal products (ATMPs) including gene therapy, somatic-cell therapy, and tissue engineered medicines
“By dedicating resources in this area,” continued Steven B. Johnson, “Medpace can provide end-to-end partnerships with our clients in all stages of their development programs. As a full-service CRO, coordinating all services under one roof provides an accountable, seamless, integrated, and efficient platform – increasing quality and speed while significantly reducing a Sponsor’s need for duplicate management oversight. We believe that this new group within Medpace provides our clients with differentiated services that can augment their organic teams.”
For more information, visit the Scientific & Strategic Development web page.
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,600 people across 37 countries.