Alain Guimond Email and Phone Number
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Summary: - Prepare and attend preIND and preCTA meetings. - Writing and reviewing of regulatory submissions. - Management of IND enabling toxicology studies. - Management of API and drug products manufacturing campaigns with associated CMC regulatory responsibilities. - Stability programs design/supervision API and Drug pruducts. - Analytical and bioanalytical methods development. - Inhalation device selection and optimization - Inhaler formulation development (DPI and MDI) - Contract negotiation with CROs CMOs. - Oligonucleotides therapeutics.Specialties: Manufacturing/Stability testing/CMC, Toxicology, Project/budget planning and management, Analytical/bioanalytical development, DPI and MDI formulation development , Regulatory Affairs, Contract negotiation with CROs CMOs. Oligonucleotides therapeutics..
Insynchrony Ventures
View- Website:
- insynchronyventures.com
- Employees:
- 3
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Managing PartnerInsynchrony Ventures Mar 2016 - PresentMontreal, Canada Area
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Vice-President, R&D OperationsInsynchrony Ventures Mar 2016 - PresentMontreal, Canada Area
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Chargé De CourUniversité De Sherbrooke Jan 2010 - Present -
Senior Project DirectorInsymbiosis Sep 2010 - Mar 2011Montreal, Canada AreaInSymbiosis is a contract research organization (CRO) providing customized drug development services to the global biopharmaceutical and biotechnology industries. At InSymbiosis, we utilize our expertise to plan, design, execute and deliver preclinical and Phase I clinical research and development projects on behalf of our clients. Our combination of a CRO and a consulting model provides clients the option to engage InSymbiosis as a CRO, as a consulting and project management group or a combination of the two. Our lean “virtual” company structure and our Canadian location enables us to deliver extremely productive and cost effective solutions for our clients outsourcing needs.
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Director, Preclinical DevelopmentTopigen Pharmaceutique Jan 2007 - May 2009Responsibilities: Reporting directly to the CEO, or the V-P Development. I was responsible for managing the interactions with CROs and CMOs in relation to CMC, toxicology and regulatory activities including contract/budget negotiation, internal and external project management. Achievements: • Successfully managed the GMP manufacturing of one batch of API and four batches of drug products and managed the stability programs of these batches. • Managed several GLP tox studies (3 genotox, 1 cardiotox and 2 inhalation tox studies. • Supervised the development of pMDI and DPI formulations and the testing of several nebuliser devices.• Coordinated the preparations of a pre-IND meeting at FDA and a Pre-CTA meeting in Canada and was directly involved in four successful CTA applications in Canada and Europe with three products.
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Project ManagerTopigen Pharmaceutique Sep 2005 - Dec 2006Responsibilities: Under the supervision of the Vice-President Product Development, I was responsible for the management and coordination of toxicology studies and clinical projects. Achievements: • Prepared the phase I and II clinical study performed by Topigen; actively involved in the first study that demonstrated activity of an oligonucleotide drug administered in the lungs. • Transferred methodology to central labs and coordinated the implementation of clinical procedures at the clinical sites (sputum induction and study medication preparation).
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Project Leader (Scientist)Topigen Pharmaceutique Jun 2003 - Aug 2005Responsibilities: As project leader of the ASM8 group, I was supervising up to 3 technicians that developed essential methods to support pharmacology, toxicology and clinical studies.Achievements: • Under tight timelines, my group developed, improved and validated a published bioassay that was successfully transferred to a CRO for the PK measurement of clinical samples. • Implemented real time PCR methodology to measure gene knock down in different biological matrices.
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RaNational Research Concil 1995 - 2000
Alain Guimond Skills
Alain Guimond Education Details
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Biologie Moléculaire
Frequently Asked Questions about Alain Guimond
What company does Alain Guimond work for?
Alain Guimond works for Insynchrony Ventures
What is Alain Guimond's role at the current company?
Alain Guimond's current role is Vice-President R&D Operations.
What is Alain Guimond's email address?
Alain Guimond's email address is alainguim@aei.ca
What schools did Alain Guimond attend?
Alain Guimond attended Université Laval.
What skills is Alain Guimond known for?
Alain Guimond has skills like R&d, Drug Discovery, Formulation, Molecular Biology, Toxicology, Formulation Development, Strategic Planning, Program Management, Product Development, Manufacturing, Drug Delivery.
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Alain Guimond
Directeur Des Opérations / Director Of Operations, Bombardier Customer TrainingMontreal, Qc -
2nutreco.ca, nutreco.com -
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