MATTER Workshop: Building a Robust Investigational New Drug (IND) Package

MATTER members and partners: use your discount code for 100% off the registration price. If you don't know your code, please email info@matter.health for assistance. 

ABOUT THIS WORKSHOP

Companies developing drugs that have not been previously approved for the proposed clinical indication, dosing regimen or patient population must submit an Investigational New Drug (IND) application to the FDA prior to initiating research on human subjects. In recent years, the FDA has developed fast-track programs to help accelerate this process for drugs addressing serious or life-threatening conditions and/or unmet clinical needs. Navigating the options for innovative ideas and cost-effective clinical strategies requires scientific and regulatory expertise, as well as input from the FDA itself.

Join this workshop to learn how to:

• Develop a strategy for acquiring information required for submission including pre-clinical safety for testing in human subjects, quality information, clinical information, CMC data, general investigative plan for clinical studies over the upcoming year, the Investigator’s Brochure and other information

• Create flexible submission materials to meet regional requirements

• Determine if your product qualifies for Fast Track or other special designations for the IND submission process

Can't attend in person? Join us in our virtual classroom. To join this workshop virtually via Webex, select the "Virtual classroom" ticket type at checkout - access instructions will be included in your email receipt.

ABOUT THE INSTRUCTOR

Richard Johnson, Ph.D., of BioPhia Consulting, is a protein biochemist with extensive experience in biologics and medical device development. He has lead teams in the development of anti-inflammatory biologics (both protein and nucleic acid based) and is a complement biochemistry expert with extensive experience in hemocompatibility applications (from novel coating technologies to regulatory testing requirements (ISO10993 Part 4)). He is proficient in protein isolation, characterization, modification, and structure-function analysis, including ligand-receptor interactions, forced degradation studies and immunogenicitym as well as cell isolation, cell culture and analysis, including flow cytometry, working with WBC subsets and CD34+ human stem cells. Prior to BioPhia, Richard headed research/development departments at Baxter and started a biotech company based on complement-inhibiting peptides. He is currently and Adjunct Professor at Rosalind Franklin University.