SAN DIEGO -- (BUSINESS WIRE) -- SynteractHCR, a full-service, global contract research organization (CRO), is pleased to announce that Martine Dehlinger-Kremer, Ph.D., has been appointed as global vice president of medical and regulatory affairs. An expert in working with global regulatory organizations, Dehlinger-Kremer has more than 28 years of experience in the clinical research industry. She will be based in Germany.
Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars, from early development stages through clinical studies and final registration. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) in local and common technical document format, electronic common technical document (eCTD) and NeeS format; in the maintenance of products on the market and in numerous clinical studies across all phases. In addition, she has an impressive background in multiple levels of pediatric drug development and has worked closely with various stakeholders and authorities to help improve clinical research in children. Her experience in this area includes serving as the chair of the Pediatric Working Group of the European CRO Federation (EUCROF) and as the lead member of the Pediatric Franchise at Research Pharmaceutical Services Inc.
Dehlinger-Kremer has co-authored numerous papers for industry and scientific publications and has chaired and participated in regulatory sessions at the European Medicines Agency (EMA), Drug Information Association (DIA), New Paradigms, Bio2Device Group, International Quality & Productivity Center (IQPC) and more.
“With her extensive global industry and regulatory experience, Martine’s knowledge and expertise will further augment the consultative capabilities we can offer clients globally, to support them through all stages of their drug development needs,” said CEO Wendel Barr. “We are pleased to have Martine join the global leadership team here at SynteractHCR.”
For 19 years, Dehlinger-Kremer served as a vice president of international and global regulatory affairs and global medical affairs at various CROs with headquarters in the US. She also worked in fundamental research at the CNRS Institute of Physiology in Strasbourg, France and the Max-Planck Institute for BioPhysics in Frankfurt, Germany. Dehlinger-Kremer holds a doctorate in sciences from the University of J.W. Goethe in Frankfurt, a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France and a Master of Science from the University Moulin de la House in Reims, France.
“SynteractHCR has a strong senior leadership team that I am very honored to join,” said Dehlinger-Kremer. “I have been impressed by the organization’s reputation of clinical development excellence across therapeutic areas and the spectrum of clinical trials, and am extremely pleased to be a part of this knowledgeable team.”
About SynteractHCR (www.synteracthcr.com)
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. SynteractHCR has conducted Phase I-IV studies on six continents and in more than 50 countries, offering expertise across multiple therapeutic areas and with notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. With its “Shared Work – Shared Vision” philosophy and ICD+ approach, SynteractHCR provides customized services collaboratively and cost effectively, ensuring on-time delivery of quality data so clients get to decision points faster.