The Roundtable: Our Thoughts About Model Based Drug Development

Author: Ellen Leinfuss

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.

Recent Posts

The Ides of March – FDA’s Pharmaceutical and Clinical Pharmacology Advisory Committee Meeting

Ellen Leinfuss

While ominously scheduled for March 15, no such drama (like the assassination of Julius Caesar, the origins of ‘beware the Ides of March’) occurred during the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. It was quite productive, acknowledging the tremendous impact of modeling and simulation in drug development and regulatory review moving the technology further into the mainstream.

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Topics: Model-based Drug Development, PBPK Modeling and Simulation

Annual Report – Simcyp Consortium Meeting

Ellen Leinfuss

It may be 2016, but we just held the 17th annual Simcyp Consortium meeting in Sheffield, UK. This year’s gathering had >120 attendees with representatives from all but one of the 34 consortium member companies joining. The opening session reviewed the progress made by the Simcyp staff toward the field of regulatory science, physiologically-based pharmacokinetic […]

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Topics: Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation

FDA’s PDUFA VI Goals Highlight Model-Informed Drug Development

Ellen Leinfuss

On July 15, the US FDA published its goals and commitment letters for the re-authorization of its Prescription Drug User Fee Act (PDUFA) for fiscal years 2018-2022, known as PDUFA VI.  The document reflects the agency’s performance and procedural goals to expedite bringing safer therapies to patients.  It also reflects and incorporates the advances in […]

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Topics: Model-based Drug Development, PBPK Modeling and Simulation

How Biosimulation Can Provide Insight into Herbal Supplement Safety

Ellen Leinfuss

According to the Council for Responsible Nutrition, a trade group for the $32 billion nutritional supplement industry, 68% of adults take dietary supplements.  Further analysis shows that supplement use is more prevalent among women, the children of women that take supplements, and the elderly.  Like drugs, supplements do not work the same in all patients […]

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Topics: Model-based Drug Development, PBPK Modeling and Simulation

How Biosimulation Technology Impacted the “Class of ’15”

Ellen Leinfuss

It’s been almost 20 years since the FDA approved a group of New Drug Applications (NDA) and Biologic License Applications (BLA) as large as the class of ’15. The 45 approved drugs represent a 10% increase over the prior year and an increase of 114% from the beginning of the decade. What accounts for this increase and how biosimulation has impacted the rise in approvals is the subject of this article.

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Topics: Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation

The Ultimate Guide to the Biosimulation Revolution

Ellen Leinfuss

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.

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Topics: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation

Pediatric Clinical Trials and Tribulations

Ellen Leinfuss

Last month, Certara sponsored the 11th Pediatric Clinical Trials conference in Philadelphia. First, I have to say that the content of this conference was among the best I have ever heard. Each speaker added to the dialogue, and the group was able to share and collaborate on how to make meaningful improvements to the field of pediatric drug approvals.

The subject is complex, often heartbreaking, and in many ways can be defined as a “Catch 22.” It is extremely challenging (both logistically and ethically) to enroll children in clinical trials, yet without a proper and approved clinical process, physicians are left with inaccurate dosing and therapeutic approaches for children. The result is a continuation of the off-label, experiential ‘wild wild west’ of prescribing. Here’s some interesting factoids that were revealed at the conference:

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Topics: Clinical Trial Design, Regulatory Writing

Supporting Pharmacometrics Education at the University of Maryland

Ellen Leinfuss

Nelson Mandela is quoted with saying, “Education is the most powerful weapon which you can use to change the world.” At Certara, we are helping change the world by aiding the development of novel medications through our technology-enabled solutions. Indeed, supporting the education of the next generation of pharmacometricians is essential to our mission. In […]

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Topics: Model-based Drug Development, PK/PD Modeling and Simulation, Training

PBPK modeling and simulation discussed at the AAPS Annual Meeting

Ellen Leinfuss

I recently got the chance to attend the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Diego, California. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. Pediatric drug development, in particular, remains a top challenge for the pharmaceutical industry as […]

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Topics: Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation
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