Art Gertel established an independent consultancy in 2012, MedSciCom, LLC, after 35 years serving in Senior Management positions in the pharmaceutical and related industries. He provides independent and collaborative strategic regulatory consulting – applying drug/device development, medical writing, bioethics, and DSMB expertise.
With a strong interest in Biomedical Ethics in the context of clinical trials, he has developed seminars on the topic and leads workshops, worldwide. Recently, Art co-chaired the development of CORE Reference, a medical writer’s guide to compliance with ICH E3. He has been involved in the development of clinical study protocol standards under the auspices of CDISC (Clinical Data Interchange Standards Consortium) and TransCelerate Biopharma, and is a Charter Member of the CDISC Glossary Group. He serves on the Advisory Board of an IRB, and chairs the Alliance for Clinical Research Excellence and Safety (ACRES) Global Ethical and Regulatory Innovation (GERI) Steering Committee. He has published on pre-approval access issues, and has served on ethics panels addressing issues of patient protections and integration of clinical practice into the new drug research and development process.
He has been active in the establishment of standards of authorship for AMWA, EMWA, and ISMPP, as well as CDISC data transformation standards for protocols, registries, and health records. Art is a founding member of GAPP (Global Alliance of Publication Professionals) – a rapid-response task force with a remit to address misconceptions about authorship. As a Registered Agent with FDA, Art represents ex-US biopharmaceutical companies in FDA interactions.
Art is Past President of the American Medical Writers Association (AMWA) and a Fellow of both AMWA and the European Medical Writers Association (EMWA), continuing to serve on committees and lead workshops and plenary sessions. He received AMWA’s Swanberg and Eric Martin Awards.