Webinar series: modeling & simulation (M&S) on the critical path

Every few years, a new set of technology buzzwords comes along- and these days, it seems like it's M&S's turn. Everyone seems to be talking about it, but it means different things to different people. At least some of the skepticism is justified- there are applications of M&S out there that are a lot like Chat GPT- capable of providing polished-sounding answers, until you dig a little deeper and realize that it’s all a bunch of hooey. On the other hand, there are many examples where M&S has played an impactful and even pivotal role in drug development. The questions that are asked- and the data that are used to answer them - make the difference between buzzword salad and pivotal analysis.

In this complementary webinar series, we look past the hype and demonstrate how to deploy M&S in a set of real-world scenarios that are all-too-familiar to experienced drug hunters and developers. We will focus on pharmacokinetic/ pharmacodynamic (PK/PD) modeling - a mature and validated approach to data analysis - but will occasionally also discuss techniques derived from other subfields such as Machine Learning. From program inception to clinical proof-of-concept, PK/PD M&S provides a pivotal capability that complements traditional in vitro, in vivo and clinical pharmacology to drive better decisions. M&S techniques can be used to focus preclinical pharmacology and toxicology packages, facilitating better and more reliable study designs. In a very real sense, M&S provides an engineering framework for pharma and biotech R&D, one which Big Pharma companies have successfully leveraged in numerous programs over the past decades.

This webinar series is not an overview of drug discovery and development - it assumes that attendees are familiar with and working in the industry. Instead, the series focuses on the deployment of M&S techniques in the standard drug discovery and development paradigm. Each webinar in the series will showcase the application of M&S to a different facet of drug discovery and development, drawing on our team's decades of combined experience in model-based pharmacology. The emphasis in each talk is on providing an overview of modeling strategy and on explaining how it interlocks with the pharmacology (toxicology) strategy to create impact. In each of the cases presented, impact means better data and decisions- almost always with shorter timelines, lower uncertainty and lower cost. (There is a reason why every major pharma built an internal M&S group over the past decade!)

In a separate webinar series (coming soon) we will focus on how to design and implement PK/PD modeling and simulation analyses. While the two series are intended to be complementary, each webinar in both series will be a stand-alone talk. Feel free to pick and choose!

Individual announcements will be sent a week before each webinar in the series, and the webinar will be repeated at two different times on the listed date (12pm and 4pm Eastern Time), to facilitate access across a wider range of time zones.

Tentative dates and topics:

2/21/23: PK/PD modeling in real-world drug development: beyond the buzzwords

2/28/23: From lab to clinic: model-based approaches in rare disease drug development

3/14/23: The shoestring IND: building a rigorous IND package for a fraction of the cost and time

3/28/23: Staying on track with in vivo pharmacology using model-guided study design

4/11/23: Model-guided toxicology studies- derisking the big gambles

4/25/23: Squeezing more out of your clinical trials: model based clinical development

5/9/23: Model-guided screening and lead optimization: beyond red, yellow and green

5/23/23: Rational development of antibody-drug conjugates using modeling and simulation techniques

6/6/23: Modeling & simulation in business development

6/20/23: Don’t just make it up- using M&S to design a better Target Product Profile

7/4/23: Reformulating drugs for better performance

7/18/23: Is translation even necessary? Dose prediction in the absence of validated preclinical models

8/1/23: Modeling and simulation in the rational design and troubleshooting of gene therapy

8/15/23: Building better biomarkers-a model-guided approach to optimizing biomarker utility

8/29/23: Designing nanoparticle formulations for better performance using modeling

9/12/23: Five common mistakes in preclinical development

(Dates and times subject to change)