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Roadmap: From Clinical Trials to Market

Toronto, ON.

Oct.20, 2025

Biomanufacturing Solutions Inc.

Prerna Mistry, MSc., CQA

Regulatory Compliance Specialist

And Nazish Ahmed, Mbiotech., Ph.D.

CEO

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This document contains confidential information intended solely for the recipient. Unauthorized distribution is prohibited.

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10/20/25

The Biomedical Zone is an incubator supporting medical device startups with clinical testing and early commercialization.

The Innovation Boost Zone supports deep tech startups from early stage ideation and discovery to commercialization.

�

Lab2Market is a national suite of programs that aims to foster innovation and commercial success in Canada by helping you realize and actualize the market potential of your ideas.

Interested in getting involved in our ecosystem?

Please send us an email, or indicate it in our feedback form.

Stephanie Sim biomedicalzone@torontomu.ca	Jane Tsai jane.tsai@torontomu.ca

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Let’s talk about:

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Who we are and how can we help you with;

Clinical Testing in Canada: Biologics vs Medical Devices
Startup Lab to Launch Roadmap
Common Hurdles and challenges
Estimate real world cost

During this webinar you will learn :

Classification of a product under Food and Drugs Act (Health Canada)
The pathway of Clinical Trial to commercial launch
Estimate timeline and cost associated with clinical trials
Common challenges
Available support

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Overview of BMS

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Biomanufacturing Solutions Inc

We empower biotech companies to maximize their impact.

The $60 billion global biomanufacturing market is driven by the demand for biologics, cell therapies and precision medicine.

Canadian biotech ventures raise $1.1 billion VC capital annually.

BMS offers white label GMP compliant biomanufacturing solutions to biotech companies to scale production without the burden of upfront infrastructure and staffing costs or compliance delays.

Biotech

BMS

Design qualification and Quality control

Manufacturing

Regulatory Compliance

License and Distribution

Early development

Raise capital

Market

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Pathway for a startup Biotech – Lab to Launch

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Early Development (Lab Bench / Prototype Stage)

Goal: Proof-of-concept in academic setting,

and models

Preclinical stage

Goal: Transition from “prototype” to regulatory-compliant concept.

Biomanufacturing

Goal: Produce

clinical-grade materials/devices under regulatory standards.

Clinical Trial /Pre-Market Stage

Goal: Conduct Clinical trial / testing

First-in-human material (FHM) or pilot clinical devices.

Commercial Launch

Goal: Demonstrate commercial viability.

Continuous monitoring

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Case Study I – Non-Invasive Device

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A portable, AI-enabled respiratory diagnostic device designed for use in both clinics and at-home patient monitoring. The device combines digital spirometry (measuring lung function through airflow sensors) with acoustic lung sound analysis (capturing and analyzing breath sounds via embedded microphones). By pairing these two measurements, the device aims to provide a more accurate and earlier detection of chronic respiratory conditions such as COPD and asthma, compared to traditional spirometry alone.

The device syncs with a cloud-based software platform that allows healthcare providers to view results remotely, track trends over time, and flag patients showing signs of disease progression or treatment non-compliance. The AI algorithms are trained on large datasets of patient lung function data, enabling the system to distinguish between normal respiratory variations and pathological changes.

Intended use cases include:

Primary care clinics: to support earlier detection of COPD and asthma in at-risk patients (e.g., smokers, elderly populations).
Specialist settings: to provide pulmonologists with a more comprehensive picture of patient respiratory function.
At-home monitoring: for patients already diagnosed with COPD or asthma, to reduce hospital readmissions and provide real-time feedback to providers.

Early Development (Lab Bench / Prototype Stage)

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Case Study II – Biologic Therapy

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A preclinical-stage biotech developing a gene therapy for early-stage Parkinson’s disease. The therapy uses an adeno-associated virus (AAV) vector to deliver a gene that boosts dopamine production in the brain, targeting the underlying cause of motor symptoms rather than just managing them.

The therapy is administered through a one-time, minimally invasive neurosurgical injection into specific brain regions (e.g., the putamen). The goal is to restore dopamine activity, slow disease progression, and improve long-term motor control.

Core components of the program include:

Vector engineering: Optimizing the viral vector to ensure efficient gene delivery and expression without triggering significant immune responses.
GMP manufacturing: Producing the viral vector at clinical grade in a way that can be scaled for human trials and eventual commercialization.
Preclinical validation: Conducting toxicology, biodistribution, and efficacy studies in rodent and non-human primate models before filing regulatory applications.
Regulatory submissions: Preparing an IND (Investigational New Drug) application for the FDA or a CTA (Clinical Trial Application) in Canada to begin first-in-human studies.

Intended use cases include:

Patients with early to mid-stage Parkinson’s disease who are not responding well to existing dopamine replacement therapies (like levodopa).
Clinical trial progression: Initial Phase I/II studies would focus on safety and dosing, followed by larger Phase IIb/III studies measuring improvements in motor symptoms and disease progression.

Early Development (Lab Bench / Prototype Stage)

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Classification of products under Food and Drugs Act

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Early Development (Lab Bench / Prototype Stage)

Reference: Health Canada

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Roadmap: Early development to Commercial launch

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Early Development (Lab Bench / Prototype Stage)

Fundamental Research

In vitro

Preclinical Research

In vivo animal studies

Regulatory approval for protocol

Clinical trial for proof of Safety (Phase I)

Clinical trials for Efficacy (Phase II – III)

Regulatory Approval for Market Access

Post-Market Monitoring (Phase IV)

Discovery and Ideation

Invention and Prototyping

Preclinical

Clinical

Regulatory Decision

Product Launch

Post-Market Monitoring

For Case Study I, a Non-Invasive Device – Clinical testing may or may not be required

For Case Study II, a Biologic Therapy - All stages will apply

Medical Devices

Biologics

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Regulatory requirement in Canada

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Early Development (Lab Bench / Prototype Stage)

Regulatory Feature	Case I: AI-Enabled Diagnostic Device	Case II: Gene Therapy Biologic
Regulatory Directorate	MDD (Medical Devices)	BRDD (Biologics)
Submission Type	ITA or MDL	CTA
Governing Regulation	Medical Device Regulations (SOR/98-282)	Food and Drug Regulations, C.05

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Requirement for Med Devices - Case Study I

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Early Development (Lab Bench / Prtotype Stage)

Determine Device Classification

Device Licensing Pathway

Quality Management System (QMS)

Technical Documentation (Design dossier / device master file)

AI / Machine Learning Specific requirements

Safety and Performance Testing

Clinical Evidence and Labelling and Intended Use

Preclinical stage

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Pre-requisites for Clinical Testing – Medical Device Guidance

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Reference: Health Canada

Preclinical stage

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Regulatory requirement for SaMD - Case Study I

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Select appropriate Health Canada Guidance Document

Review Definition
Review Classification

Software as a Medical Device (SaMD)

Review inclusion criteria
Review exclusion criteria

Classification of SaMD

SaMD Intended use statement: significance of information provided to Healthcare decision, state or condition SaMd is intended for, description of core functionality
Non-IVD SaMD Classification

Reference: Guidance Document SaMD and SaMD Classification Examples

Preclinical stage

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Medical Device Classification Guidance

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Preclinical stage

Reference: Health Canada Device Classification Guidance

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Pre-requisites for Clinical Testing - Case Study I

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Preclinical stage

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Pre-requisites for Clinical Testing - Case Study II

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Product classification and Regulatory Pathway

Pre-clinical (Non-clinical) Data Requirements

Chemistry, Manufacturing and Controls (CMC /Quality)

Regulatory Submission Requirements (CTA Contents)

Ethics and Institutional requirements

Post-CTA Requirements

Preclinical stage

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Preclinical Testing – Case Study I

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Preclinical stage

Bench performance and verification

Hardware Safety and Electromagnetic compatibility

Biocompatibility (if patient contact parts present)

Sensor Validation

Software Verification and Validation

AI Algorithm Development and Preclinical Validation

Usability / human Factors Engineering

Preclinical Clinical Simulations / Pilot

Security and Privacy Assessment

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Preclinical Testing – Case Study II

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Preclinical stage

Proof of Concept / Pharmacology

Biodistribution and Persistence

Toxicology (GLP)

Shedding and Germline Transmission Risk

Immunogenicity and Immune Toxicology

Safety Pharmacology

Integration / Genotoxicity Assessment

Biodistribution and Environmental Risk

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Preclinical Testing – Common to Case Study I and II

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Preclinical stage

Operational and Quality Considerations

Protocols and final reports must follow regulatory expectations.

Standard Operating Procedures and data integrity should be followed and maintained

Ethics Oversight – REB approval

CDMO Selection – use experienced GLP and device testing CDMO with prior regulatory experience

Regulatory interactions on every stage to prevent surprises

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Regulatory requirement

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Regulatory Feature	Case I: AI-Enabled Diagnostic Device	Case II: Gene Therapy Biologic
Regulatory Directorate	MDD (Medical Devices)	BRDD (Biologics)
Submission Type	ITA or MDL	CTA
Governing Regulation	Medical Device Regulations (SOR/98-282)	Food and Drug Regulations, C.05
Preclinical Work	Bench + software + AI validation	GLP tox + biodistribution + NHP
Clinical Phase	Performance & usability validation	I–III (multi-phase)
Lab / Maufacturing Site	BSL Level II + ISO 9001 Certified	BSL Level II + GMP Certified
Study Sites	Clinics / home environment	Hospitals (neurosurgical)
Ethics Oversight	REB	REB + Biosafety
Key Focus	Accuracy, reproducibility, human factors	Safety, dose, long-term follow-up
Post-Market	PMS, AI drift monitoring	10-year safety follow-up

Clinical Trial/ Pre-Market

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Clinical Testing Protocol – Case Study I

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Pre-Clinical

In vitro Testing / validate sensors, accuracy of microphone, device safety
Software verification and validation
AI Performance validation

Determine Clinical Testing Study Objective

Demonstrate equivalence to standard spirometry
Demonstrate clinical performance and safety in detecting disease
Identify Testing / Manufacturing site
Identify study sponsor / investigator

Investigational Testing Authorization (ITA), if required

Submit to Health Canada:

Protocol, informed consent forms, risk analysis, investigator CVs.

Device description, safety evidence, REB approval.

REB + ITA approval required before starting.

Clinical Trial/ Pre-Market

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Clinical Testing Protocol – Case Study I

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Clinical Study Design

Performance Validation Study to verify accuracy with gold standard spirometry
Usability Study to confirm safety and ease of home use
AI validation study to validate algorithms predictive accuracy in real world use

Ethics and Oversight

Clinical Sites participation - REB approval required for each site
Data handled as per GCP and privacy laws, PIPEDA (CAN) or HIPAA (US)

Data Management

Audit Trail and data integrity controls
Data captured electronically from device and cloud platform
Use centralized clinical data management system (CDMS) for metrics

Clinical Trial/ Pre-Market

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Biomanufacturing – Case Study I

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Biomanufacturing

Manufacturing must conform to ISO 13485 and related standards

Hardware Manufacturing - as per ISO 13485, IEC 62304 (software) and IEC 60601 (electrical safety)

Software Manufacturing - develop and release as per IEC 62304 and ISO 82304

Cloud / Data Pipeline

Testing and release

QMS

Regulatory Manufacturing submissions

Scalability and Tech Transfer

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Clinical Testing Protocol – Case Study II

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Preclinical foundation

Before first in-human testing the following must be completed:

GLP Toxicology, biodistribution and efficacy studies in rodent + non-human primate (NHP) models
Establish no observed adverse effect level and dose for humans
These results are a part of the non-clinical module of CTA

CTA Submission and Approval

Identify Sponsor, PI & Site.
Prepare CTA Modules:

Quality (CMC) - Manufacturing, stability, vector characterization
Nonclinical - Pharmacology, toxicology, biodistribution
Clinical – protocol, investigations brochure (IB), informed consent and REB Approval

Obtain CTA approval (if received) - proceed

Perform Clinical Testing Phases

Phase I / IIa - evaluate safety, tolerability and dose
Phase IIb - assess biological activity
Phase III - Confirm efficacy and long-term safety
Phase IV - post market surveillance
Data captured electronically from device and cloud platform
Use centralized clinical data management system (CDMS) for metrics

Clinical Trial/ Pre-Market

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Clinical Testing Protocol – Case Study II

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Clinical site and oversight requirements

Conduct in licensed hospitals or research centers
Principal investigators must have gene therapy experience
REB Approvals required
Long term patient monitoring for delayed adverse events

Patient enrollment and Ethics

Eligible patients (with early or mid Parkinson's)
Informed Consent to address

Irreversibility of gene therapy
Unknown long-term risks
Data storage and privacy

Data Collection and Reporting

Data captured in GCP compliant systems
Safety reporting to HC
Annual updates through Clinical Trial Annual Reports

Clinical Trial/ Pre-Market

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Biomanufacturing – Case Study II

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Biomanufacturing

Strategic framework as per required regulatory bodies

Upstream (Vector production)

Downstream (Purification)

Formulation and Fill

Develop analytical and potency assays

QMS and GMP Infrastructure

Scalability and Tech Transfer

Regulatory Manufacturing submissions

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Commercial Launch – Biggest Hurdles (Case Study I)

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Biomanufacturing

Design for Manufacturability (DFM)

A prototype made in a lab (3D printed, hand-assembled) may not be suitable for repeatable large-scale production.

Transitioning to ISO 13485-compliant manufacturing requires redesign for injection molding, CNC machining, or automated assembly.

Supplier Qualification & Materials

Medical-grade biocompatible materials (ISO 10993 tested) must replace lab-grade plastics/metals.

Early stage often uses research grade components that aren’t traceable or certifiable.

Pilot Manufacturing Facility

Startups often lack pilot manufacturing workshops with validated equipment.

Startups must partner with device incubators, design houses, or CMOs to scale.

Quality System Implementation

Devices must be developed under ISO 13485 QMS (design controls, traceability, risk management).

Academic teams rarely have experience with formal documentation and regulatory QA practices

Commercial Launch

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Commercial Launch – Biggest Hurdles (Case Study II)

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GMP Manufacturing Infrastructure

Academic labs lack GMP-compliant cleanrooms, validated equipment, and QA/QC systems required for clinical-grade production.

Moving from research-grade to clinical-grade material is a massive step.

Process Transfer & Scale-Up

Lab methods (small bioreactors) don’t directly scale to 50L–200L bioreactors.

Requires process engineering, optimization, and tech transfer to a CDMO (Contract Development & Manufacturing Organization).

CMC (Chemistry, Manufacturing, Controls) Documentation

Health Canada (and FDA/EMA) require full control of raw materials, stability, sterility, viral clearance, etc..

Academia rarely have QA/QC groups trained in regulatory CMC documentation.

Cost

GMP laboratory setup may cost 250k- multi million depending on complexities of production

GMP batch production may also run over $1M+ for biologics.

Commercial Launch

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Pathway to Commercial Launch – Biggest Hurdles

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Common across both Case Studies

Regulatory Alignment: Scaling up without understanding Health Canada requirements (CTA for biologics, ITA/device license for devices) leads to wasted work.

Funding: Pilot-scale facilities and GMP/ISO certification are very expensive (millions). Students usually need government grants, VC, or incubator partnerships.

Talent Gap: Startups focus on science/engineering, QA, regulatory, and manufacturing engineering expertise are the gaps

Quality System: relevant document Management system not available, data integrity and audit trails not maintained.

Commercial Launch

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Cost Estimate (Case Study I)

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Biomanufacturing

Product Type: AI enabled respiratory diagnostic device (Hardware + SaMD)

Assumptions: Early development stage is complete, classified at Class II device, Clinical trial is not required

Collaborate with Small Canadian Medtech company / CMO, look for:

low volume production and pilot run of 100 - 1000 units
Includes hardware tooling, software (SaMD) validation and clinical performance study
QMS Setup (as per ISO 9001 and ISO 13485)
Regulatory validation

Summary Ranges:

Prototype → clinically validated device (pilot production + clinical validation): $0.6M – $2.5M
Initial small commercial launch (first ~1k units and support): $1.0M – $4.0M
Total to scale (commercial readiness + ISO 13485 + cloud scale): $1.5M – $5M+

Practical tips to reduce cost

Start with a Minimum Viable Medical Device (MVMD) that meets intended use with minimal hardware complexity
Use off-the-shelf sensors where possible
Use retrospective datasets to reduce prospective study size/cost

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Cost Estimate (Case Study I)

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Biomanufacturing

Activity	Description	Estimated Cost Range (CAD)
Hardware development & prototyping	PCB design, sensor integration, enclosure design, engineering iterations, and parts sourcing	$50,000 – $300,000
NRE / Tooling for pilot production	Tooling, moulds, and jigs for limited-run manufacturing	$20,000 – $150,000
Pilot production run (100–1,000 units)	Manufacturing setup, material, assembly, and test fixtures	$30,000 – $300,000
Per-unit manufacturing cost (low volume)	Unit cost for early production, dependent on sensor quality and BOM	$150 – $800 per unit
Software & AI development, validation, and locking (SaMD)	AI model development, dataset curation, clinical validation, backend/API setup	$150,000 – $1,200,000
Clinical validation study	Performance testing vs spirometry or gold-standard devices; data management and site costs	$100,000 – $1,000,000
Regulatory testing & certification	EMC, IEC 60601 electrical safety, and biocompatibility testing	$30,000 – $200,000
QMS & ISO 13485 certification, documentation, and consulting	Quality system setup, internal/external audits, documentation, and registrar fees	$30,000 – $250,000
Regulatory submission preparation (MDL)	Consulting support, dossier preparation, Health Canada MDL filing fees	$10,000 – $150,000

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Estimate Costs (Case Study II)

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Biomanufacturing

Product Type: AAV Gene Therapy (Biologic)

Assumptions: Early development complete, HC approval required for validation protocol, GMP lab for phase I safety clinical trial, scale up GMP lab for phase II trial

Collaborate with Small Canadian CMO: look for,

AAV capability, early clinical scale (single GMP batch sizes typical for Phase I/II).
Estimates include CMC development + GLP bridging + clinical GMP lots,
QMS Setup (as per Health Canada GMP Requirements), ISO 9001 compliance

Summary Ranges:

Preclinical → IND/CTA ready (CMC + GLP nonclinical supply): $250k – $1.2M
Phase I clinical GMP (1–3 GMP batches + QC testing): $250k – $2.5M /batch (total for trial $0.5M–$5M)
Scale-up / commercial process validation (3 commercial lots, full validation, stability): $2M – $15M+
Total to commercial manufacture readiness (end-to-end CMC + scale-up): ~$3M (very lean) → $20M+

Practical tips to reduce cost

Optimize yield early – reduce per batch/ dose cost
Negotiate bundled packages with CMOs
Consider small CMOs like BMS for lower cost

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Cost Estimate (Case Study II)

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Biomanufacturing

Activity	Description	Estimated Cost Range (CAD)
CMC process development (upstream + downstream optimization)	Process mapping, optimization, scale-down models, and comparability studies	$75,000 – $750,000
Analytical method development & validation	Development and validation of potency, qPCR, NAb, and host residual assays	$50,000 – $500,000
GLP toxicology study vectors / nonclinical GMP lots	Small GLP vector lots for toxicology or biodistribution studies	$50,000 – $400,000
Clinical-grade GMP AAV batch (per batch)	Manufacturing of GMP vector material, with full release testing and fill-finish if included	Low: $150,000–$350,000 Mid:$350,000–$1,200,000 High: $1,000,000–$3,000,000+
Stability studies (real-time + accelerated)	Shelf-life data generation supporting CTA and long-term NDS submissions	$20,000 – $200,000
GMP QA/QC release testing & batch documentation	Sterility, endotoxin, identity, and potency testing per batch	$25,000 – $250,000 per batch
Facility access / campaign booking & project management fees	CDMO overhead and project management charges per campaign	$25,000 – $250,000 per campaign
Regulatory / CMC consulting and filings	Pre-CTA consultation, CMC dossier preparation, and response handling	$30,000 – $300,000
Stability studies (real-time + accelerated)	Shelf-life data generation supporting CTA and long-term NDS submissions	$20,000 – $200,000

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Estimate Timelines (Case Study I and II)

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Category	Case Study I	Case Study II
Preclinical Duration	6–9 months (bench + dataset prep)	18–30 months
Clinical Duration, if needed	6–9 months (performance validation)	1–5 years (Phases I–III)
Biomanufacturing Setup	6–12 months (pilot to scale)	18–24 months to reach GMP readiness
Regulatory Review	3–6 months (MDL)	12–18 months
Total Time to Market	12–24 Months	2–4 years
Key Bottlenecks	Clinical data diversity, ISO 13485 readiness	GMP process validation, clinical durability data
Parallel Workstreams	Hardware ↔ AI model ↔ Regulatory dossier	Preclinical ↔ CMC ↔ IND-enabling

Biomanufacturing

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Available Support

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Biomanufacturing

Funding:

Mitacs Accelerate Entrepreneur (salary support)
NSERC, discovery or youth grant or Idea to Innovation (I2I) grants
MaRs
OCE, Ontario Centres of Excellence
University internal funding

Incubators:

MaRS, OBIO, Creative Destruction Lab, UHN’s GMP lab, NRC facilities.

CDMO

Therapure Biopharma, CCRM Toronto, OmniaBio, Lonza (global), Charles River and BMS.

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Conclusion

Road to commercial launch is lonely and confusing,

Consider regulatory requirements as early in the journey as possible,

Be aware of the regulatory classification for your product,

Plan, Prepare, Pivot.

Finding the right partner is the single most important decision you will make.

With BMS as your partner, success is within your reach.

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This document contains confidential information intended solely for the recipient. Unauthorized distribution is prohibited.

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The Biomedical Zone is an incubator supporting medical device startups with clinical testing and early commercialization.

The Innovation Boost Zone supports deep tech startups from early stage ideation and discovery to commercialization.

�

Lab2Market is a national suite of programs that aims to foster innovation and commercial success in Canada by helping you realize and actualize the market potential of your ideas.

Interested in getting involved in our ecosystem?

Please send us an email, or indicate it in our feedback form.

Stephanie Sim biomedicalzone@torontomu.ca	Jane Tsai jane.tsai@torontomu.ca

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This document contains confidential information intended solely for the recipient. Unauthorized distribution is prohibited.

Thank you for your time!

Questions?

Prerna Mistry and Nazish Ahmed

prernam@biomanufacturingsolutions.com

nazishahmed@biomanufacturingsolutions.com

+1 647 854 4873

Biomanufacturing Solutions Inc.