L. Bruce Pearce, PhD joined Biologics Consulting as a Senior Consultant in July 2010. Bruce is a pharmacologist who brings 20-plus years of academic and industry experience encompassing many aspects of biologics development including: design, development, analysis, oversight and regulatory reporting of pharmacology, toxicology, pharmacokinetic, safety pharmacology, physiologic research and Phase I-III clinical trials. He also has expertise in non-clinical and clinical pharmacology/toxicology, program strategic/technical design, quantitative outcomes analysis, and benefit-risk balance assessment. Therapeutic areas include: treatment of anemia due to surgery, trauma, chemotherapy, emergency research under exception to informed consent (21 CFR 50.24) including in/pre-hospital resuscitation from hemorrhagic shock due to trauma. Additionally, Dr. Pearce has experience in the treatment of cardiac, cerebral and peripheral ischemia as well as the therapeutic use of botulinum toxin.
Bruce began his career as a faculty member within the Department of Pharmacology at Boston University School of Medicine with his research interests leading to participation as a principal in founding a biotechnology start-up focusing on the development of therapeutic botulinum toxin. He has directed the non-clinical research and formulation development, participated in the development and design of clinical trials supporting IND, clinical trials, and meetings with FDA. He defined a unit of biologic activity for clinical formulations of botulinum toxin and filed a patent describing the unique efficacy of mixtures of botulinum toxin serotypes. During Dr. Pearce’s tenure at Biopure Corporation, his activities evolved from Manager to Director including responsibility for oversight of nonclinical program development and nonclinical research efforts with CROs, universities, military organizations and foundations, including negotiation of contracts and licensing agreements. He has contributed to design and execution of study protocols, presentation of proposals and study results to regulatory agencies and managed the non-clinical sections of regulatory filings through BLA. Additionally, he has designed, developed and managed pharmacology, pharmacokinetics, teratology, genotox, cardiotox and general toxicology protocols.
Dr. Pearce was the principal investigator directing all studies performed under DoD grants and development of in-hospital Phase II safety protocol to study hemorrhagic shock patients. In this role, he had oversight of nonclinical research in support of the trauma program, including protocol design, data analysis, and authoring reports and publications. He established and chaired an oversight committee of clinical/non-clinical experts in trauma and emergency medicine. Dr. Pearce has designed and authored Phase II protocol with medical scientists and held project management accountability for all functions supporting clinical trials. Dr. Pearce has authored and negotiated cooperative research and development agreement (CRADA) with the US Naval Medical Research Center for new product development and clinical trials in trauma. Co-principal investigator of a Phase II/III protocol for investigating product use in the treatment of hemorrhagic shock proposed under waiver of informed consent for emergency research in the out-of-hospital setting. Led product development as adjunct to radiation therapy in glioblastoma. He is the primary author of the clinical protocol for treatment of life-threatening, severe anemia due to acute myeloid leukemia in Jehovah Witness patients; functioned as project team leader and regulatory affairs representative. In collaboration with internal and external scientists, he led efforts to define and understand safety issues associated with the use of blood substitutes in the treatment of surgical anemia. He has proposed relative efficacy theory identifying issues with the current generation of blood substitutes limiting efficacy compared to standard of care, packed red blood cells. Dr. Pearce has administered and coauthored submissions to FDA, addressing, database, nonclinical and clinical efficacy, safety and risk/benefit profile issues and participated in Advisory Committee meetings.
More recently, Dr. Pearce served as an independent consultant with his research efforts focused on outcomes analysis, the interdependence of safety and efficacy, and risk-benefit balance assessment as it relates to decision making in drug development and regulatory approval. Co-developed methods to provide blinded quantitative assessment of safety and benefit-risk balance at all phases of clinical development in support of regulatory requirements. Established a website (http://www.SIBRA.org) dedicated to promoting the development of quantitative methods for outcome analysis and benefit-risk balance assessment in clinical trials.
Bruce received his undergraduate training in Chemistry and Biology at the University of Massachusetts and graduated magna cum laude and doctoral training in Pharmacology as a graduate fellow at the State University of New York. He completed his postdoctoral training in pharmacology as an NIH postdoctoral fellow within the Departments of Pharmacology at Yale School of Medicine and Harvard Medical School. Dr. Pearce was distinguished as recipient of an Alfred P. Sloan Foundation Fellowship and Glaxo Drug Discovery Grant/Award, has authored more than 70 publications and more than 50 study reports.
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)