Beyond Model-Informed Drug Development: How Model-Integrated Evidence is helping to eliminate White Space in Pharmaceutical R&D

  • Thursday, November 20, 2025 | 10am EST (NA) / 3pm GMT (UK) / 4pm CET (EU-Central) | 60 mins
  • Free
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Why attend?

Model-informed drug development (MIDD) is an approach whereby mathematical and statistical models are applied to better inform drug development decision-making and accelerate pharmaceutical R&D. Since MIDD’s emergence in the early 2000s, the expansion of its regulatory acceptance and value proposition have continued to accelerate. The authors of two recent publications independently estimated that utilization of MIDD approaches save an average of 10-14 months of R&D cycle time per development program1,2, equating to an estimated $140 – $196 million in recouped sales revenue per asset3. Similarly, the increasing regulatory acceptance of MIDD is described in the 2019 publication by Zhu et al4. In this paper, the authors reported that during a three year period in 2015-2018, the FDA released 13 guidances for industry advocating for the use of MIDD approaches, more than the combined total released in the preceding 15 years.

In this webinar, we will discuss a history of MIDD and examine its current state-of-the-art application. But beyond this, we will also mark the next stage in the MIDD revolution: the emergence of model-integrated evidence (MIE). With MIE, validated modeling approaches are being used to generate decision-grade evidence for regulatory approvals, as a supplement to, or in some cases, a substitute for clinical data. As such, MIE has the potential to address many of the challenges currently facing the pharmaceutical industry: dependence on large, inefficient clinical study designs, inclusion of under-served populations, and rare disease drug development, to name a few.

Join us as we envision a future in which model-integrated evidence is treated as primary evidence, further accelerating the biopharmaceutical R&D process and ultimately improving treatment options for patients.

References

  1. Galluppi GR, Brar S, Caro L, et al. Industrial Perspective on the Benefits Realized From the FDA’s Model-Informed Drug Development Paired Meeting Pilot Program. Clin Pharmacol Ther. 2021;110(5):1172-1175. doi:10.1002/cpt.2265.
  1. Sahasrabudhe V, Nicholas T, Nucci G, Musante CJ, Corrigan B. Impact of Model-Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost. Clin Pharmacol Ther. 2025 Aug;118(2):378-385. doi: 10.1002/cpt.3636. Epub 2025 Mar 26. PMID: 40135941; PMCID: PMC12272314.
  1. Smith ZP, DiMasi JA, Getz KA. New Estimates on the Cost of a Delay Day in Drug Development. Ther Innov Regul Sci. 2024 Sep;58(5):855-862. doi: 10.1007/s43441-024-00667-w. Epub 2024 May 21. PMID: 38773058.

Zhu H, Huang SM, Madabushi R, Strauss DG, Wang Y, Zineh I. Model-Informed Drug Development: A Regulatory Perspective on Progress. Clin Pharmacol Ther. 2019;106(1):91-93. doi:10.1002/cpt.1475

Who is Fortrea?

Fortrea is a leading global clinical research organization (CRO) with over 30 years of clinical research experience, providing comprehensive Phase I-IV trial management, clinical pharmacology, and consulting services across 20+ therapeutic areas. Evolved from Covance and Labcorp, Fortrea is built for biotech and biopharma, medical device and diagnostic innovators, delivering agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions in about 100 countries. We combine scientific rigor and operational excellence with innovation to help bring therapies from pipeline to patient. Together, exceptional is possible. Learn more about us at www.fortrea.com and follow us on LinkedIn and X (formerly Twitter).

Speakers

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Dr. Liang Zhao
Professor, School of Pharmacy, University of California San Francisco (UCSF)

Dr. Liang Zhao is currently a professor and establishing the Center for Global Regulatory Science and Innovation at the School of Pharmacy, University of California San Francisco (UCSF). Prior to joining UCSF, he had served as the Director of Division of Quantitative Methods and Modeling (DQMM), ORS/OGD/CDER/FDA between 2015 and 2024. Dr. Zhao and his team have introduced a broad array of innovative tools in the realm of drug deliveries, bioequivalence assessment, and big data tools including machine learning to pharmacometrics. During his tenure in FDA, he had worked as a clin pharm reviewer and pharmacometrics team leader covering oncology, rheumatology, pulmonary, and inflammation. His team had also implemented the Model Integrated Evidence (MIE) Industry Meeting Pilot to support regulatory communications between generic applicants and the FDA and proposed a regulatory mechanism of using Model Master File to support regulatory submissions. Liang had served as the Chair of the FDA ModSim WG for the Modeling & Simulation community. He has published over 130 peer reviewed publications, 2 books, and 8 book chapters. His current research focuses on model/AI guided drug discovery, delivery, and development. He received the 2023 Gary Neil Prize for Innovation in Drug Development from ASCPT in recognition to his contribution to clinical pharmacology and pharmacometrics.

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Jill Fiedler-Kelly
President of Strategic Consulting Services, Simulations Plus

Jill Fiedler-Kelly is President of Strategic Consulting Services at Simulations Plus. Jill co-founded Cognigen Corporation in 1992 along with two other partners, growing the company over 20+ years until acquisition by Simulations Plus. The Services team she now leads supports pharmaceutical and biotechnology companies around the globe with strategic design and implementation of model-informed drug development approaches, including physiologically based pharmacokinetics, quantitative systems pharmacology, clinical pharmacology, pharmacometrics, and regulatory strategies solutions. Jill is also an Adjunct Professor of Pharmaceutical Sciences at SUNY Buffalo and co-authored an introductory pharmacometrics textbook entitled Introduction to Population PK/PD Analysis with Nonlinear Mixed Effects Models in conjunction with Dr. Joel Owen. She has published numerous scientific papers in peer-reviewed journals, presented at national and international symposia, and held leadership positions in organizations such as the East Coast Population Analysis Group, AAPS, ISoP and ASCPT. In 2016, she was named

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Mark Lovern
Executive Director, Medical Scientist, Fortrea

Dr Mark Lovern is Executive Director of Medical Science Services at Fortrea, and has 25+ years of experience in the application of model-informed drug development (MIDD).  Throughout his career, Mark has led and contributed to numerous projects involving quantitative pharmacology. Prior to his present position, Mark spent over 10 years at Certara in a variety of capacities. His work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Certara.)  In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught over 50 technical training workshops on modeling tools and methodology.  His most recent therapeutic area experience has been with therapies for infectious disease, metabolic, and autoimmune disorders.

Mark was awarded a Ph. D. in Biomathematics from North Carolina State University in 1997.  His favorite leisure activities include hosting dinner parties, traveling, reading, and enjoying films.

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