InSymbiosis - Preclinical and Clinical Drug Development CRO

InSymbiosis, a Canadian company based in Montréal, is a leading contract research organization (CRO) providing customized preclinical and clinical drug discovery and development services. InSymbiosis offers a broad range of innovative services spanning from early target and drug discovery, efficacy models, chemistry, manufacturing and control (CMC), regulatory toxicology and safety pharmacology through to IND and phase I for both small molecule and biological drugs.

Semi-virtual drug development services

InSymbiosis has created a new paradigm in the provision of drug development services by way of combining our unique ‘semi-virtual’ drug development services model with a strong project management emphasis. This model allows InSymbiosis to create a "one-stop-shop" of services and offer our clients the assurance that their projects and programs are well planned and executed by our strong internal project management team. Further, the InSymbiosis model generates unparalleled cost-effectiveness that results from our mode of operations and our Canadian location.

Drug development programs performed by InSymbiosis are customized to the exact scientific, budgetary and temporal needs of our client. Cutting-edge facilities, innovative study design and access to proprietary technology and GLP / GMP compliant laboratories ensure that our programs are innovative, compliant and meet the demands of our diverse and international client base.

Drug development services from discovery through to IND and phase I

InSymbiosis have the ability to create a customized package of studies to meet the needs of our clients. By utilization of internal expert drug developers and our external network of laboratories and CROs, InSymbiosis provide the following range of services:

Drug discovery

• Target validation and transgenesis
• Discovery biology (assay development and HTS)
• Medicinal chemistry
• In vitro ADME, bioanalytical chemistry
• Early toxicology studies including cardiac toxicity (hERG and other assays)

Pharmacokinetic studies and bioanalysis

• Pharmacokinetic studies for early drug development and optimization
• All species including NHP
• Non-GLP and GLP studies
• Bioanalytical method development and bioanalysis (HPLC, LC-MS, GC-MS, ELISA)
• Strong expertise in peptides and small molecule drugs
• Pharmacokinetic data analysis and modeling

Specialized efficacy models

• In vivo models in multiple therapeutic areas including oncology, inflammatory and immune disease, CV disease, metabolic disease, infectious disease
• Ability to develop new models and enter new therapeutic areas

Pharmaceutical development, biologics development and formulation

• Chemical development and manufacturing (GMP compliant chemistry, manufacturing and control (CMC))
• Biologics development
• Formulation
• Analytical services
• Stability programs
• Regulatory affairs and auditing

Regulatory toxicology and safety pharmacology

• GLP and Non-GLP
• All species including NHP
• Acute, chronic and carcinogenicity programs
• Infusion, inhalation, dermal and general toxicology
• Immunotoxicology and genetic toxicity
• Specialized cardiac, CNS and respiratory safety studies
• Provide analytical and bioanalytical services including method development, method transfer and validation
• Specialization in IND/IMPD enabling packages

Phase I and Bioequivalence studies

• Multiple Phase I units in Canada
• Identify optimal Phase I unit for Client
• Provide program management and protocol design services

Toxicology and regulatory consulting

• Interaction with regulatory authorities on behalf of clients
• Product development and registration strategies
• Data reviews and gap analyses
• Toxicology consulting (providing expert opinions and strategic advice on preclinical and regulatory issues)
• GLP support (inspections, study monitoring, and SOP review and preparation)
• Developing and reviewing toxicology protocols, study designs, and draft reports
• Impurity assessment and qualification
• Interact with regulatory authority for study approval

What makes InSymbiosis unique?

InSymbiosis has created a ‘semi-virtual’ model of drug development, allowing InSymbiosis to select the best resources and skills for the project and to command competitive pricing by negotiation.

At the heart of InSymbiosis is a multidisciplinary team of drug developers who are all expert project managers. All projects are thus well planned and professionally executed, where scientific, regulatory, budgetary and scheduling parameters are the core drivers. The InSymbiosis project management process is thorough but practical, fostering project progression without unnecessary bureaucracy.

The InSymbiosis business model provides unparalleled cost effectiveness based on three key factors:

• A ‘semi-virtual’ operational model (with minimal overhead costs and ‘incremental’ project investment when needed)
• Privileged partnerships with partner CROs and laboratories providing competitive pricing
• Generous Canadian government financial incentives leveraged to further reduce the costs to our clients