The Ultimate Guide to the Biosimulation Revolution

The Ultimate Guide to the Biosimulation Revolution

In my work with biopharmaceutical companies, universities, and regulatory agencies, I fly a lot. Looking out the airplane window, the revolutionary impact of biosimulation on drug development struck me. Unfamiliar with the concept of biosimulation, or modeling and simulation (M&S)? You can think of it as the vast improvements in air travel that have been made in the last half century.

Modeling and simulation gets information about how something behaves without testing it in real life. For instance, say we want to design a plane that has maximum speed. But, we weren’t sure what type of wings would improve non-friction. We would use a computer simulation of the plane to estimate the effect of different wing shapes on the coefficient of friction under different conditions. The simulation would provide insights about decisions we could make for the plane without building one. That’s what modeling and simulation is.

Imagine this applied to the world of drug development. Biosimulation is transforming our approach to precision medicine and supporting critical decision making.

Integrating computer-aided modeling & simulation and pharmaceutical science

Biosimulation is widely used by pharmaceutical companies, academic institutions, and regulatory agencies. The pharmaceutical industry uses this tool throughout the drug development process. During drug discovery, M&S helps identify molecules with the highest efficacy and the least toxicity.

For example, we can explore off-target effects as we design candidate drug molecules. Chemists used to build these models from plastic molecules.  This work is now done in computers. Computer aided drug design technology can probe specific sites of a molecule to test safety and efficacy predictions.

During pre-clinical development, modeling and simulation provides a scientific rather than intuitive approach to dose selection. Again, this method provides the optimal dose so you achieve the best therapeutic window. This is a stark contrast to the historical approach to drug development. In fact, a significant percentage of the doses for approved drugs are actually wrong. These suboptimal dosing regiments create unnecessary toxicity and lower levels of efficacy.

Biosimulation technology is also used in clinical development to reduce toxicity and potential drug-drug interactions (DDIs). To optimize trial outcomes, sponsors leverage biosimulation technology to model different clinical trial designs.

From “one size fits all” to an individualized approach to treating patients

Twenty years ago, we treated all patients the same. Children. Pregnant women. Patients with different comorbidities. Even individuals from different ethnic groups like Chinese, Indian, Hispanic, and African American. They were all treated in the same way— one size fits all.

Several decades ago, we moved to the concept of patient stratification. You looked at patient body size and weight to inform treatment development and delivery.

Over the last five years, we’ve started looking at subgroups of patient populations. These subgroups are based on either genetic mutations or genetic polymorphisms, metabolic profiles, or different aspects of their physiology and physiopathology.

Today, the goal of biosimulation is to treat you as an individual, not as a member of a subpopulation. In the not too distant future, we will be able to build avatars of individuals. Before we test or treat a patient, we will treat his avatar and assess how it responds to the drug. Leveraging M&S approaches will be essential to ensure that treatments become as tailored as possible.

Model-based approaches will help make drug development decisions more predictable and reliable

How can sponsors, regulatory agencies, and healthcare providers maximize their use of biosimulation technology? First, the decision-makers in the industry must adopt M&S as an enabler of drug development. We’re not saying replace human judgment or technical competency with modeling and simulation. That’s not the point. Our mission is to let biosimulation inform drug development and patient care.

Next, we must educate key stakeholders in drug development and patient care on the value of biosimulation. That responsibility falls on the leaders of those organizations and on us. If we don’t educate our peers, we will not be able to influence decision-making.

Last, the entire process from discovery to post-marketing has to be an integrated process. Success adopters of biosimulation technology will embrace a culture of information sharing. They will also adopt the learn/confirm paradigm” as published by Lewis Sheiner in 1997.

Model based drug development technology helps bring safer, new drugs to market

Our CEO, Dr. Edmundo Muniz, was recently recognized by PharmaVoice as one of the 100 most inspiring people in the industry. Read the article to learn about his vision of using modeling and simulation to transform the business of drug development. Have you joined the biosimulation revolution yet? Let me know your thoughts in the comments section below!

Ellen Leinfuss

About the Author

Ellen Leinfuss

Senior Vice President & Chief Commercial Officer, Certara

More Posts by This Author

Ms Leinfuss brings more than 25 years of experience leading marketing, business development and sales management groups for technical and scientific-based organizations. She spent the last nine years at UL EduNeering, a global provider of regulatory compliance educational solutions, delivered via cloud-based technology. At UL, Ms. Leinfuss directed the strategic development of the company’s solutions to the life science market, including pharmaceutical, medical device, biologics, clinical, and managed care health plans. In addition, she managed the Company’s strategic alliances, including the Company’s 15 year Cooperative Research and Development Agreement (CRADA) with the US FDA and its exclusive partnerships with AdvaMed and the Personal Care Products Council, among others. Ms Leinfuss possesses a Master's in Business Administration in marketing from the City University of New York and Bachelor's in Chemistry from the State University of New York.