Get a Demo
LIVE DISCUSSION

Scaling Regulatory Operations: How to best leverage partners & technology for growth

 

Date: July 16th, 2024

Time: 10 am PT  | 1 pm ET

 

Building and managing a regulatory function as a small-to-medium sized sponsor presents unique opportunities…and unique challenges. The processes, tools and workflows that the big guys use aren’t accessible to those of us that are single-person regulatory teams, or have only a few teammates to lean on. So how do you build a lean regulatory function that will not only support your first IND, but will scale sustainably alongside your pipeline?

Choosing the right partners - both services and software - can accelerate or hinder your ability to get the job done with less manual work and a lot less stress

What you'll learn:

  • How to balance speed and cost as you scale
  • Choosing the right partners for your needs
  • Streamlining collaboration with content & regulatory partners
  • Maximizing consistency & efficiency as your submissions grow
  • Project management tips & tricks 

Hope to see you there!



 

Register Today

circle--blur
SPEAKERS

Toban Zolman

Toban serves as CEO of Kivo, a software provider focused on streamlining the drug development process for emerging life science companies. Toban has over 20 years of experience in the development and deployment of computerized systems for clinical trials. He has consulted at 47 of the top 50 pharma companies and worked directly with over 200 companies to align to electronic submissions standards. As CEO of Kivo, Toban leverages his many years of experience working with regulators combined with best practices in engineering and process management to bring life science software into the 21st century.

 

Lisa Jenkins VanLuvanee, PhD 

Lisa leverages over 20 years of strategic regulatory experience in her current role as COO of Facet Life Sciences. Facet provides regulatory science and development solutions to help small biopharmaceutical and device companies progress their products through FDA, including overarching regulatory strategy; orphan drug and breakthrough therapy designation requests; submission leadership; nonclinical and CMC consulting; small business waiver and grant assistance; contract CMC and clinical vendor selection/management; and due diligence. 

 

Kevin Tate

Chief Revenue Officer of Kivo and moderator of this session, Kevin Tate is a Go-to-Market executive with 25 years of Marketing and Sales leadership experience. He has led revenue growth as CRO or CMO at Series A & B companies across a range of industries, from eCommerce to Enterprise SaaS.