In the last couple of years there has been a breakthrough in Modeling and Simulation called PBPK (Physiological-Based Pharmacokinetics or SIMCYP) that regulators have used and encouraged sponsors to use for providing information on a drug label. In fact it has become expected that PBPK be included in submission materials.
The approach that Certara uses, and that the FDA is using/encouraging, could result in avoiding a clinical trial, and certainly can impact your label claims. In the very least it well help companies inform dosing, look at special populations, help design more precise clinical trials and of course save time and money. This technology is not extremely well known, so we are trying to publicize it’s use as well.
On Wednesday, 9/16/15 from 8-10 AM, at the Hyatt Regency La Jolla at Aventine, we are holding a breakfast seminar with the following content:
Dr.s Karen Rowland Yeo and Nathan Teuscher will be leading these breakfast seminars by providing guidance, case studies and scientific evidence that supports how to use biosimulation to:
- Improve precision of your drug label either through expansion or de-risking
- Impact the reliability and predictability of label claims
- Interact with regulators to increase probability of approval
- Reduce development time and cost by recommending smaller targeted studies or via complete study avoidance
You will hardly be late for work, have a nice breakfast, and you will learn something extremely valuable for your drug development program.
Please call with any questions.
Please sign up here
, or send the appropriate person from your organization.