Our Team

Bruce Pearce, PhD, is a classically trained pharmacologist and toxicologist with broad expertise in early and late-stage development of small molecules and biologics. Prior to Dr. Pearce’s decade plus tenure at Biologics Consulting, he held a number of positions in both the biotech industry and academia including as an independent consultant and within biotech as Director of Clinical Research and Pharmacology and Manager of Trauma Program Manager for a Hemoglobin-based Blood Substitute and a principle in the development of a Botulinum Toxin based therapeutic. The scope and depth of Dr. Pearce’s research and drug development interests is reflected, in part, in his more than 85 publications including peer-reviewed journals.

Dr. Pearce’s expertise comprises design, oversight, reporting of in vitro and in vivo pharmacology studies, safety pharmacology, mode of action, receptor interaction studies, pharmacokinetics tissue distribution, and translational pharmacology supporting clinical testing. Toxicological testing of small molecules, biologics and combination products, including juvenile and adult animal acute and chronic toxicology, genotoxicity, drug metabolism and transporter studies supporting drug-drug interaction. Developmental and reproductive toxicology (DART) testing. Toxicological risk assessments of drug candidates and excipients genotoxicity, carcinogenicity testing and submissions to the Executive Carcinogenicity Assessment Committee (Exec CAC). Biocompatibility and toxicology (ISO 10993) testing for medical devices.

Dr. Pearce routinely provides gap analyses, program development plans, study monitoring and complete program oversight including acting as a virtual head of nonclinical development.  Due diligence review at all stages of development, program analysis for pitfall avoidance, troubleshooting and strategy development for problem resolution. Authoring regulatory submissions and participation in 505(b)(1) and 505(b)(2) INTERACT, preIND, IND, End of Phase 2, preBLA, preNDA, Advisory Committee Meetings and preparation of BLAs and NDAs.  Biowaivers under 21 CFR 320.22(b)(3) and 510(k) submissions for medical devices.

Consultation for drugs and biologics including small molecules, peptides and proteins, particularly engineered recombinant proteins. The latter including monoclonal antibody (mAb) receptor and signaling pathway agonists and antagonists including engineered cytokine super agonists and antagonists, bispecific antibody (BsAbs) conjugates, bispecific fusion proteins, including BsAb coupled to T cell receptor (TCR) ligands, albumin (HSA), toxins, and BsAb fragments such as single-chain variable fragments (scFv), FcRN ligands and immunomodulators. Recombinant Toxins, and Enzymes. Therapeutic blood products including Human IgGs and Hemoglobin-based oxygen Carriers (HBOCs). Bacteriophages, and Botulinum toxin-based therapeutics, small inhibitory RNAs, siRNAs, nanoparticle-based therapeutics including nanoparticle encapsulated signaling and immune modulators, exosomes/extracellular vesicle (EV)-based therapeutics both tissue-derived and engineered.  Therapeutic enzyme inhibitors including Monoamine Oxidase Inhibitors (MAOIs).

Received his BA in both Chemistry & Biology at the University of Massachusetts at Boston and his Ph.D. in Pharmacology and Experimental Therapeutics at SUNY at Buffalo and was an NIH postdoctoral fellow at Yale University School of Medicine and Harvard Medical School and recipient of a Glaxo Cardiovascular Discovery Award and Alfred P Sloan Foundation Fellowship. Dr. Pearce joined Biologics Consulting as a Senior Consultant in April of 2010. He currently resides with his family in Hudson, New Hampshire.

Education
Postdoctoral Pharmacology, Harvard University, Cambridge, MA (1985-1987)

Postdoctoral Pharmacology, Yale University, New Haven, CT (1983-1985)

PhD, Pharmacology, State University of New York, NY (1984)

BA, Chemistry/Biology, University of Massachusetts, MA (1978)