Biotech Entrepreneur Training

The biophyle Biotech Entrepreneur Training Program, supported by funding from the Arkansas Economic Development Commission, is recruiting for a virtual commercialization training program for Arkansas-based life science researchers!

Program Overview

This program is designed to prepare researchers for commercialization through a structured 10-week series of webinars delivered by professional service organizations and subject matter experts, at no cost to participants. The curriculum is detailed below.

Registration Dates: July 29, 2024 – August 30, 2024
Program Dates: September 26, 2024 – November 21, 2024

Click Here to Register

Who should register?

Individual researchers and collaborative research teams within Arkansas who are interested in the commercialization process and/or moving forward their biotherapeutic innovations.

Session 1: Introduction to the Program, Understanding Markets and Commercialization

Presented By: HealthTech Arkansas, Arkansas Small Business and Development Center, and Corval

  • Overview of the program
  • Cohort of researchers introduce themselves, their research, and milestones to date
  • Introduction to commercialization pathways
  • Competitive gap analysis, target product profile, and market size
  • Development of Commercialization Map
  • Case study: an Arkansas researcher with commercialization success
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Session 2: Corporate Legal and IP Portfolio Management

Presented By: UAMS BioVentures and Wright Lindsey & Jennings

  • IP protection and management
  • License terms
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Session 3: Is a Start-up Right for you?

Presented By: SymBiosis, HealthTech Arkansas, Science Venture Studio, and TMC Accelerator for Cancer Therapeutics

  • Identifying a team: management team, board of directors, and scientific advisory board
  • Licensing to industry vs startup
  • Preparing for fundraising
  • Venture capital
  • Grant funding
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Session 4: Regulatory Strategy

Presented By: Proxima CRO

  • Strategies to advance towards regulatory approval
  • Past precedence review
  • FDA interactions planning
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Session 5: Vendor Selection and Management

Presented By: Sequoia

  • Contract development
  • Manufacturing Organizations and Contract Research Organizations
  • Guidelines: Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice
  • Electronic Data Capture, data management, safety, and pharmacovigilance
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Session 6: Planning Pre-Clinical Studies

Presented By: Radyus Research

  • Types of pre-clinical studies:
    • Pharmacokinetics
    • Pharmacodynamics
    • Toxicology
  • When you need these studies and when you don’t
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Session 7: FDA Submissions – Preclinical to Clinical Phase

Presented By: Radyus Research

  • Request for Designation
  • INTERACT
  • Pre-Investigational New Drug
  • Investigational New Drug
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Session 8: FDA Submissions – Clinical Phase

Presented By: Proxima CRO

  • New Drug Application (NDA)
  • Biologics License Application (BLA)
  • Marketing Authorization Application (MAA)
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Session 9: Introduction to Clinical Trials (Phase I – IV)

Presented By: Syneos Health

  • Clinical Studies: Phase I – IV
  • Safety and risk mitigation
  • Protocol development, clinical endpoints, and dose selection
  • Site selection
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Get in touch

Arielle Amrein
SymBiosis
Priya Bargoti
HealthTech Arkansas