The Certara Blog

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

Modeling & Simulation Take a Prominent Role in FDA’s Newly Published DDI Guidances

On October 25, 2017, the FDA published two new guidance documents on drug-drug interactions (DDI). These guidance documents replace the February 2012 guidance, “Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.” According to the FDA, these new guidances reflect the agency’s current thinking and greater learnings on DDI and provides a […]

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FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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

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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A report on the Simcyp consortium

Annual Report—Simcyp Consortium Meeting

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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picture of pills

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

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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herbal supplements

How Modeling and Simulation Can Provide Insight into Herbal Supplement Safety

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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How Modeling and Simulation Technology Impacted the “Class of ’15”

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 […]

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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 […]

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Pediatric Clinical Trials and Tribulations

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 […]

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Supporting Pharmacometrics Education at the University of Maryland

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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PBPK Modeling and Simulation Discussed at the AAPS Annual Meeting

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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