Marque Todd

Background

About Marque Todd

Independent consultant specializing in early and late stage nonclinical regulatory toxicology strategy and program execution with extensive experience in biotherapeutics drug development for oncology, immunology and inflammation, metabolic, and cardiovascular diseases, and for small molecule programs in oncology. Maintains oversight of nonclinical toxicology program strategy/execution and dossier preparation to meet key milestones including IND filings, FDA and global health authority meetings, and product registration. • Board certified regulatory toxicologist with over 20 years experience in industry • Extensive experience with a variety of biologic modalities including monoclonal antibodies, immunomodulators, bi-specifics, Fc and other fusion proteins, antibody-drug conjugates, cytokines/interleukins, protein replacement therapies, nanoparticles, cell therapies, and therapeutic vaccines • Ability to design and execute strategic, integrated toxicology programs (from exploratory phase to IND and through to product registration) to fulfill FDA and global regulatory requirements, including non-human primate only programs and programs requiring the use of homologous /surrogate molecules • Independent external expert to conduct toxicology program and/or dossier reviews and gap analyses of existing programs with respect to stage of development, type of modality, and therapeutic area in preparations for IND submissions, global health authority meetings, and/or global registration • Extensive, well-established personal connections to nonclinical biotherapeutic experts in major pharma/biopharma companies as well as with pharm/tox reviewers at FDA CDER and CBER