Alexandria, Virginia - May 11, 2022 - Biologics Consulting is pleased to welcome a new member to its Nonclinical Team, Dr. Emily Noonan-Place, Ph.D., MPH. Emily joins Biologics Consulting after 9 years at FDA (CDER), Office of Oncologic Diseases and has extensive experience with small molecules, biologics (mAbs, ADCs, bi-specifics), oligonucleotide therapeutics and an emphasis in oncology. Dr. Noonan-Place holds a Ph.D. in […]
Alexandria, Virginia - January 7, 2020 - Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today that Kenneth P. Guito, MBA was hired as its Chief Operating Officer (COO) following a 35-year career in the Biotech/Biopharmaceutical Industry. Mr. Guito’s broad career experience spans Operations, Corporate and Business Development, and Research and Development (R&D). […]
Alexandria, Virginia - September 12, 2018 - Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today its acquisition of new talent to bolster its Medical Device Specialty Group and support the growing demand for medical device regulatory and product development support. Christy Foreman, MBE, Lisa Graney, RAC and Sam Mostafavi, MS, MBA join […]
Seattle - January 5, 2017 - IDRI is expanding its Board of Directors, comprised of international leaders in industry and academia, with the recent addition of Norman Baylor, Ph.D., who has extensive experience in the field of vaccines and vaccine-related products, including 20 years with the Food and Drug Administration (FDA).
Alexandria, Virginia - April 24, 2017 - Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today that its Chemistry, Manufacturing, and Controls (CMC) Specialty Group advised BriaCell Therapeutics Corp. (TSXV: BCT) (OCTCQB: BCTXF), a clinical-stage company dedicated to the development of immuno-oncology treatments, in the preparation and filing of a CMC amendment detailing the extensive testing performed on BriaVax™, the company’s proprietary vaccine for advanced breast cancer. Following its review of the amendment, the FDA granted BriaCell authorization to initiate its Phase I/IIa clinical trial.
Alexandria, Virginia - July 7, 2017 - Biologics Consulting announced today the expansion of its Pharmacology-Toxicology team with the addition of two new senior consultants with more than two decades of combined experience in research, discovery, preclinical development, nonclinical development, and regulatory affairs.
Alexandria, Virginia - January 4, 2017 - Biologics Consulting announced today that it is opening a new office in the center of Maryland's Technology Corridor and Life Sciences Hub.
Alexandria, Virginia - August 16, 2016 - Biologics Consulting announced today the addition of three new consultants, further increasing the company's capacity to deliver comprehensive scientific, technical and strategic guidance to clients in any stage of the regulatory approval and product development processes.
Alexandria, VA - April 19, 2016 - Biologics Consulting announces the launch of its Clinical Trials Planning and Oversight Group.
Alexandria, VA - January 19, 2016 - Biologics Consulting has launched a rebranding effort that includes the introduction of new brand positioning, as well as a new logo and interactive website.