Alain Guimond Email & Phone Number

Montreal, Canada Area

Montreal, Canada Area

Montreal, Canada Area

InSymbiosis 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.

• Responsibilities: 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.
• 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.

• Responsibilities: 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).

• Responsibilities: 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.