Gregory P. Dubé, Ph.D. Email & Phone Number

Greater Boston Area

Responsible for preclinical validation of hemoglobin-based oxygen therapeutics in new clinical indications and all phases of clinical development. Widely networked with academic, industry and U.S. military collaborators.

Souderton, Pa

• Provided input on study design and data interpretation in the evaluation of HBOC-201 as a therapy for cardiac ischemia/reperfusion injury, assessed via cardiac function and magnetic resonance imaging (MRI).• Provided guidance on strategy and data interpretation for various studies designed to develop hemoglobin-based oxygen therapeutics for the perfusion and preservation of donor organs for transplantation.• Co-developed for FDA review, a briefing document and clinical trial protocol for a phase III clinical trial, convincing FDA to remove clinical hold.

Cleveland, Oh

Responsible for preclinical new molecular entity (NME) proof-of-concept and characterization studies, IND-enabling study implementation and management, IND application submission and early-stage clinical development.

• Developed strategy for hemoglobin-based oxygen carrier (HBOC) product development (new indications, new markets). • Drafted various components of regulatory submissions to the Scientific Center for Expert Assessment of Medical Products in the Russian Ministry of Health.• Trained and educated preclinical collaborators and clinical end users in the use of HBOC-201.• Solicited, compiled and analyzed study data from preclinical and clinical studies.• Authored or co-authored study reports.• Drafted and updated Clinical Investigator’s Brochures.• Authored scientific papers for publication.

• Advised company regarding indications likely to benefit from the therapeutic properties of the Clarimedix LED illumination technology.• Supported the development of preclinical study protocols designed to evaluate the Clarimedix technology in vivo.

Designed, implemented and managed preclinical studies at CROs to explore the therapeutic potential of s-nitrosoglutathione reductase (GSNOR) inhibitors in cardiovascular disease models.Developed intermediate and long-term drug discovery strategy for cardiovascular and inflammation disease indications.

Developed intracoronary administration of hemoglobin-based oxygen carrier in preclinical animal models and validated efficacy in man in collaboration with a clinical trial site in Europe.Networked with thought leaders in the US and Europe to develop clinical research and regulatory strategies for advancing development of Biopure products for use in conjunction with new medical devices.Co-developed IND applications for FDA review. Played key role in developing phase II clinical trial protocols to evaluate Hemopure and oxygenated HBOC-201 in cardiovascular disease indications including cardiogenic shock, percutaneous coronary interventions, peripheral limb ischemia and anemia.Co-authored clinical study reports and Investigator Brochure supporting development of Hemopure in cardiovascular diseases. Represented Biopure interests at the FDA, European Medicines Agency (EMEA) and the Medicines Control Council (MCC) of South Africa.Collaborated with CROs and clinical trial sites to develop clinical trial protocols and statistical analysis plans.Developed and managed portfolios of preclinical research collaborations and clinical trials in the U.S. and Europe supporting the development of Hemopure for anemia and cardiovascular disease indications.Facilitated clinical trial operations in Europe.

Supervised research teams in the selection, development, validation and implementation of multiple, cost-effective pharmacokinetic and pharmacodynamic animal models that became standard assays for the efficient evaluation of cardiovascular and renal pharmacotherapies.Implemented and directed high-priority R&D projects.Led Biomarker Project Team in development of clinically-relevant assays of bioavailable nitric oxide (NO).Trained diverse NitroMed sales force of 220 on the role of nitric oxide in heart failure and the mechanisms of recently launched heart failure drug, BiDil.

Indianapolis, Indiana Area

Championed projects to identify novel, selective new chemical entities to treat unmet medical needs in atherosclerosis, inflammation, diabetes and heart failure.Supervised cross-functional collaborations to develop models of accelerated atherosclerosis, vascular inflammation and arteriogenesis to generate PK, PD and biomarker data critical to strategic decisions affecting compound prioritization.Established the Vancouver Vascular Biology Research Centre (VVBRC) in Vancouver, B.C. Managed on site the Lilly-VVBRC collaboration involving five concurrent preclinical and clinical research projects spanning diverse technical disciplines and areas of expertise.Led the Vascular Therapeutics In Vivo Team in project prioritization, PD and PK assay coordination and ex vivo biomarker assay development.Networked with clinicians in Biomarker Strategy Group to align In Vivo Team with need for clinically-relevant biomarker assays.

Vancouver, British Columbia

Established and managed drug discovery programs uniquely designed to link basic, drug development and clinical research expertise focused on cardiovascular and metabolic diseases

Ph.D., Pharmacology & Cell Biophysics

Activities and Societies: Ryan Fellowship Recipient, Albert J. Ryan Foundation. Liaison Committee for Medical Education.

B.S., Biology

Activities and Societies: Phi Kappa Phi Honors Society, Northeastern University. Academy Honors Society of College of Liberal Arts.

Postdoctoral Fellowship, Cardiology