Presented by:

 
 
 

Commercialization Training 101 for Arkansas-based Life Science Researchers

HealthTech Arkansas and SymBiosis – supported by funding from the Arkansas Economic Development Commission – are recruiting for a virtual Commercialization Training Program for Arkansas-based life science researchers!

This 10-week program – at no cost to participants – is designed to empower and educate researchers by administering a structured commercialization webinar series to impart essential education, mentoring, and grant access to an extensive network of professional service organizations and subject matter experts.

Registration for this program is open July 8 – August 16, 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. 

ABOUT THE PROGRAM

The Commercialization Training Program is a multi-topic, 10-week program offering a structured platform to impart essential education and mentoring from professional service organizations and subject matter experts. This program will have weekly webinars from September 9, 2024 – November 15, 2024. The curriculum is detailed below.

Session 1: Introduction to the Program

Presented By: HealthTech Arkansas and SymBiosis

  • Overview of the program

  • Cohort researchers introduce themselves, their research, and milestones to date

  • Introduction to commercialization pathways

  • Case study: an Arkansas researcher with commercialization success

  • Introduction to lean startup with assigned homework: initial lean canvas draft

 
 

Session 2: Understanding Markets and Commercialization

Presented By: Arkansas Small Business and Technology Development Center and Corval

  • Competitive gap analysis, target product profile, and market size

  • Development of Commercialization Map  

 
 
 
 

Session 3: Corporate Legal and IP Portfolio Management

Presented By: UAMS BioVentures and Wright Lindsey & Jennings

  • IP protection and management

  • License terms

 
 

Session 4: Is a Startup Company Right for You?

Presented By: HealthTech Arkansas, Science Venture Studio, SymBiosis, 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 

 
 
 
 

Session 5: Regulatory Strategy

Presented By: Proxima CRO

  • Strategies to advance towards regulatory approval

  • Past precedence review

  • FDA interactions planning

 
 

Session 6: 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 

Session 7: Planning Pre-Clinical Studies

Presented By: Radyus Research

  • Types of non-clinical studies:

    • Pharmacodynamics

    • Pharmacokinetics

    • Toxicology

  • When you need these studies and when you don’t

 
 

Session 8: FDA Submissions – Pre-Clinical to Clinical Phase

Presented By: Radyus Research

  • Request for Designation

  • INTERACT

  • Pre-Investigational New Drug

  • Investigational New Drug

 
 

Session 9: FDA Submissions – Clinical Phase

Presented By: Proxima CRO

  • New Drug Application (NDA)

  • Biologics License Application (BLA)

  • Marketing Authorization Application (MAA)

 
 

Session 10: Introduction to Clinical Trials

Presented By: Syneos Health

  • Clinical Studies: Phase I - IV

  • Safety and risk mitigation

  • Protocol development, clinical endpoints, and dose selection

  • Site selection

 
 

REGISTER HERE

Register for the 2024 cohort!