Fast-track Route for first-in-patient Studies

Early phase Trials

What is it?

Early Phase Trials Platform

Developed to get to patients sooner, without an IND

Small 1-2 site trials in patients with safety and efficacy endpoints (sometimes with a dose-escalation arm)

10-30 patient studies with some safety and efficacy endpoints

What is it?

What are the guidelines?

Safety and Regulatory Requirements

Goes through 3 regulatory bodies for approval (IRB, UHAP, COFEPRIS)

Designed with multiple stops for safety, DSMB heavy

Conducted under GCP regulations and ICH guidelines

What are the guidelines?

For who is it?

Platform Objectives

Tailored for small/mid size startup biotech/pharma/device companies

Designed for riskier areas and exploratory ideas (neurosciences, implantable devices, etc.)

Fast fail/Success idea developed with venture capital input

For who is it?

What are the benefits?

Main Advantages

Skip 1 Year / $2M – $4M USD Investing Just To Get To Patients

De-Risk Earlier / Fast Fail

IND Not Required With Valid Data for FDA Submission

What are the benefits?

Where are the trials conducted?

Location: Monterrey & Mexico City (MX)

Convenient Location – 200 Miles South of Houston

Large, Willing Patient Population due to strong patient-doctor relationship

US and local KOLs and regulatory experts to guide trial design

Where are the trials conducted?

First-in-human data Faster

Early Phase
Platform

Platform developed to provide insight into safety and efficacy early, without consuming all small company’s resources.

It informs later trial for Phase II (endpoints, outcome selection). The studies are conducted with GCP, FDA compliant CRO oversight, so data can be used in the United States for filing purposes later.

Early phase Trials