Gilles Dubé
LA JOLLA,CA
Summary
Senior professional with over 25 years of expertise in drug discovery, development, and operations within large pharmaceutical and small biotech sectors in the USA and Canada. Proven track record in directing programs, research teams, and external collaborations that accelerate the identification and characterization of novel drug candidates, advancing them through non-clinical, IND, and early clinical development phases. Strong understanding of pharmacology, ADME/PK, non-clinical safety and toxicology, CMC, and early clinical development for both small and large molecule therapeutics, including engineered live biotherapeutic products (LBPs). Skilled in developing and adjusting project plans, budgets, and timelines to respond swiftly to evolving corporate priorities while maintaining a comprehensive understanding of business processes related to new technologies, competitive intelligence, and regulatory documentation.
Overview
29
29
years of professional experience
Work History
Sr. Director of PCLN Development - IND Operation
Neurocrine Biosciences
San Diego, CA
11.2020 - Current
- Reporting to the VP Preclinical, track and manage preclinical timelines and activities for all late-stage research and early development assets at Neurocrine. Liaise with research, CMC and PCLN team members to ensure that all functional lines are aligned and able to support lead characterization and IND-enabling activities. Provides regular updates to senior management. Manage authoring, reviewing and QC of research and preclinical sections of regulatory documents (e.g., IND, CTAs) to support new regulatory submissions. Liaise with all relevant functional lines, e.g., regulatory affairs, medical writing, program management, regulatory operation to ensure smooth execution of regulatory submissions. Track, gather, organize all relevant documentation to support regulatory submissions (e.g., internal and CRO-generated technical reports, literature) Core team preclinical representative for selected programs. Preclinical point person for several external collaborations – working closely with alliance management and business development.
Head of Product Development
Azitra Inc.
Branford, CT
11.2017 - 11.2020
- Dermatology-focused biotech company developing engineered skin commensal bacteria- (live biotherapeutic products – LBP) based therapeutics for the treatment of skin diseases and cosmetic applications. Reporting to the CSO and COO. Leading all the non-clinical development strategies activities, in vitro and in vivo safety and toxicology studies, target engagement demonstration (and all other IND-enabling activities) and compiling all relevant preclinical technical data. Leading regulatory affairs activities (including orphan and rare pediatric strategies) and documentations (e.g. information packages for INTERACT, PIND, IND applications). Coordinating with preclinical, CMC, bioanalytical and clinical teams to ensure that company milestones and objectives are met (budgets and timelines).
- Biotech company focused on microbiome and skin disease
Research consultant
Mitobridge Inc.
Cambridge, MA
11.2016 - 01.2018
- Mitochondria dysfunction-focused biotech company developing small molecules aimed at improving mitochondrial function. Reporting to the VP research I provided consulting support to complete and finalize all of the research and nonGLP reports to support IND filing for small molecules targeting PPARγ for the treatment of acute kidney injury (AKI) and wrote a first draft of a manuscript for a journal for PPARγ molecule for AKI. Mitobridge was acquired by Astellas in Jan 2018.
- Biotech company focused on mitochondrial associated diseases
Senior Director of Pharmacology / Non-Clinical Development & General Manager of the Montreal site
Thrasos Therapeutics Inc.
Boston and Montreal
01.2010 - 01.2016
- Nephrology-focused company developing new treatments for acute kidney injury, and chronic kidney diseases (CKD) renal fibrosis and rare diseases. Reported to the CSO/CMO. Headed all the discovery, pharmacology, and nonclinical development (ADME-PK, safety pharmacology and toxicology activities; planned and managed budgets and project plans; oversaw operations of the Montreal site. Part of the team that brought a compound from discovery lead to end of Phase 2 clinical trial for AKI and other contributor to regulatory filings.
- Biotech company focused on renal diseases and disorders
Consultant, Drug Discovery and Non-Clinical Development
01.2009 - 01.2016
- Provide knowledge and technical support for drug discovery and non-clinical development to biotechnology companies in various therapeutic areas. Services include: Critical review of data, gap analysis, preparation of non-clinical development plans, compilation of data and reports for regulatory submissions, corporate documents and presentations, management of research activities in-house or through CRO/academics
- Co-Founder - WrX Medical Writing and Consulting
Director of Pharmacology
PainCeptor Pharma Corp.
Ville St-Laurent, QC, Canada
01.2006 - 01.2009
- CNS-Pain focused company. Reported to the Senior VP Research. Provided leadership and direction to a research team of up to 14 scientists in three separate locations and managed all discovery activities (in vitro and in vivo) for novel CNS/pain/inflammation drug discovery programs. Identified and managed opportunities for external collaborations (CROs and academic). Part of PainCeptor’s Management Team that completed a novel first-in-human (Phase 0) study in Europe.
- Pain Therapeutics
Associate Research Investigator (2005-2006) Senior Research Pharmacologist (2002-2005) Research Pharmacologist (2001-2002)
Abbott Laboratories - Pain and Neuroscience Division
Abbott Park, IL, USA
01.2001 - 01.2006
- Provided electrophysiology expertise within the Hit-To-Lead/Exploratory CNS-Pain and Cholinergic Channels groups. Work focused on the characterization of a broad panel of analgesic, inflammatory, and cognitive targets (ion channels, GPCRs, enzymes). Developed and applied new skills (e.g., HTS, molecular modeling and data mining) that led to the more rapid identification of potential active drug-like compounds. Supervision of 3 Scientists.
RIKEN-MIT Postdoctoral Associate
Center for Learning and Memory, Massachusetts Institute of Technology (M.I.T.)
01.1997 - 01.2001
- Subject: Investigation pre- and post-synaptic function of single glutamatergic mammalian central synapses using a unique multi-electrode electrophysiological approach. Investigated synapse maturation and receptor clustering and its relationship to presynaptic activity and calcium fluxes. The research focused on understanding mechanisms of synaptic plasticity that underlies learning & cognition processes and synaptic dysregulation.
Education
Ph.D. - Physiology
University of Ottawa
CanadaM.Sc. - Physiology
University of Ottawa Heart Institute
CanadaB.Sc. - Biochemistry and Microbiology
Laval University
CanadaSkills
- Oversight of multidisciplinary R&D teams
- Innovative problem-solving
- Effective internal and external communication
- Regulatory document preparation
- Effective communication and mentorship facilitation
- Cross-functional project coordination
- Extensive professional network
Selected Publications
- Dodds, D., Bose, J. L., Deng, M. D., Dubé, G. R., Grossman, T. H., Kaiser, A., Kulkarni, K., Leger, R., Mootien-Boyd, S., Munivar, A., Oh, J., Pestrak, M., Rajpura, K., Tikhonov, A. P., Tuccreek, T., & Whitfill, T. (2020). Controlling the Growth of the Skin Commensal Staphylococcus epidermidis Using d-Alanine Auxotrophy. mSphere, 5(3), e00360-20.
- Whitfill, T., Dubé, G.R., Oh, J. (2020) Skin microbiome alterations in skin diseases (Book Chapter) published in Skin Microbiome Handbook: From Basic Research to Product Development.
- Dubé, G. R., Elagoz, A. and H. Mangat (2009) Acid Sensing Ion Channels and Acid Nociception, Current Pharmaceutical Design, 15: 1750-1766
- Dubé, G. R., S.G. Lehto, N.M. Breese, S.J. Baker, X. Wang, M.A. Matulenko, P. Honore, A.O. Stewart, R. B. Moreland and J. D. Brioni (2005) Electrophysiological and in vivo characterization of A-317567, a novel blocker of acid sensing ion channels, Pain 117: 88-96.
- Tang, Y.P., Shimizu, E., Dubé, G.R., Rampon, C., Kerchner, G.A., Zhuo, M., Liu, G., Tsien, J.Z. (1999) Genetic enhancement of learning and memory in mice. Nature 401:63-69.
- Dubé, G. R., Marshall, K.C. (1997) Modulation of Excitatory Synaptic Transmission In Locus Coeruleus By Multiple Presynaptic Metabotropic Glutamate Receptors. Neuroscience 80: 511-521.
Timeline
Sr. Director of PCLN Development - IND Operation
Neurocrine Biosciences
11.2020 - Current
Head of Product Development
Azitra Inc.
11.2017 - 11.2020
Research consultant
Mitobridge Inc.
11.2016 - 01.2018
Senior Director of Pharmacology / Non-Clinical Development & General Manager of the Montreal site
Thrasos Therapeutics Inc.
01.2010 - 01.2016
Consultant, Drug Discovery and Non-Clinical Development
01.2009 - 01.2016
Director of Pharmacology
PainCeptor Pharma Corp.
01.2006 - 01.2009
Associate Research Investigator (2005-2006) Senior Research Pharmacologist (2002-2005) Research Pharmacologist (2001-2002)
Abbott Laboratories - Pain and Neuroscience Division
01.2001 - 01.2006
RIKEN-MIT Postdoctoral Associate
Center for Learning and Memory, Massachusetts Institute of Technology (M.I.T.)
01.1997 - 01.2001
M.Sc. - Physiology
University of Ottawa Heart Institute
B.Sc. - Biochemistry and Microbiology
Laval University
Ph.D. - Physiology
University of Ottawa