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Nuventra’s Webinar Library

Were you unable to attend our live webinars? Watch Nuventra’s past webinars and hear directly from our senior consultants who are experts on these clinical pharmacology and drug development topics. Fill out the forms below to access the recordings of our webinars.

Available Webinars:


Using PBPK Modeling in Pregnancy and Lactation Studies

This webinar covers the use of physiologically-based pharmacokinetic (PBPK) modeling in pregnancy and lactation studies and explains how PBPK can be used to estimate fetal drug exposure during pregnancy and the impact of lactation on drug exposure to neonates in this webinar titled, Using PBPK Modeling in Pregnancy and Lactation Studies.”

PBPK in Pregnancy & Lactation Studies

Regulatory Pathways for Drugs, Devices, & Combination Products

This webinar covers regulatory pathways for drugs, devices, and combination products including the 505(b)(2) pathway for new drugs and the 510(k), Premarket Approval (PMA), and De Novo for devices. Learn more about how these various regulatory pathways intersect for drug-device combination products in this webinar titled, “Regulatory Pathways for Drugs, Devices, & Combination Products.”

Regulatory Pathways for Drugs, Devices, & Combination Products

Practical & Technical Approaches to Determining First-in-Human Dose

This roundtable discussion covers things to consider before starting a First-in-Human (FIH) clinical trial. To kickstart the discussion, a short presentation on some of the different model-independent & model-based approaches to determining FIH dose is presented. Learn more about the different ways to identify the appropriate method as it relates to larger drug development milestones in this roundtable titled, “Practical & Technical Approaches to Determining First-in-Human Doses.”

Roundtable Discussion FIH Doses

Cellular & Gene Therapy 101

This webinar covers an introduction to cellular and gene therapy in drug development. Learn more about cellular and gene therapy fundamentals, issues in integrating and non-integrating vectors, challenges in selecting First-in-Human (FIH) doses for cellular and gene therapies, and more in this webinar titled, “Cellular & Gene Therapy 101.”

Cellular & Gene Therapy 101

Intro to PBPK & QSP: Modeling Approaches for All Stages of Drug Development

This webinar covers an introduction to PBPK and QSP modeling, including a brief explanation of each approach and how they can be applied across all stages of drug development. Learn more about the core principles behind PBPK and QSP modeling, the advantages of integrating these approaches early in your drug development pipeline, and more in this webinar titled, “Intro to PBPK & QSP: Modeling Approaches for All Stages of Drug Development.”

Intro to PBPK & QSP Webinar

Pharmacogenomics & Pediatric Drug Development: When Are Children Not Little Adults & Why?

This webinar covers an introduction of the intersection of ontogeny and pharmacogenomics as it relates to differences in drug biotransformation and pharmacokinetics in pediatrics. Learn more about how ontogeny and pharmacogenomics contribute to variability in pediatric pharmacokinetics and more in this webinar titled, “Pharmacogenomics and Pediatric Drug Development: When Are Children Not Little Adults and Why?”

Pharmacogenomics and Pediatric Webinar

Micro-Dosing: Effects of an Investigational Drug on PK of Concomitant Medication

This webinar covers an introduction to micro-dosing, the advantages and disadvantages of micro-dose probe cocktail studies, information on what substrates have been studied to date, and issues to consider when designing a micro-dose probe cocktail study. Learn more about when a micro-dose probe cocktail study may be appropriate to address drug interaction questions and more in this webinar titled, “Micro-Dosing: Effects of an Investigational Drug on PK of Concomitant Medication.”

Micro-dosing Webinar

Pediatric Drug Development: Allometry and Other Empirical Models

This is the second webinar on allometric scaling presented Dr. Iftekhar Mahmood. The first webinar provides an introduction to allometric scaling and common misconceptions during drug development and can be found below. This webinar provides an introduction to pediatric drug development using allometric scaling and other empirical models in this webinar titled, “Pediatric Drug Development: Allometry and Other Empirical Models.”

Allometric Scaling Webinar Part 2 (Pediatric)

Allometric Scaling: Common Misconceptions During Drug Development

Allometric scaling is one of the tools that drug developers use to predict human PK based upon animal data and to provide a “sneak peek” at how a drug might behave in humans before any clinical studies are conducted. Dr. Iftekhar Mahmood provides an introduction of allometric scaling as well as extrapolation from animals to humans for predicting pharmacokinetic (PK) data and dose selection in this webinar titled, “Allometric Scaling: Common Misconceptions During Drug Development.”

Allometric Scaling Webinar Part 1

Drug Development Considerations for Dermatology: More Than Skin Deep

Topically applied drugs often follow different requirements for pharmacokinetic (PK) assessment than drugs administered orally or intravenously. Dr. Elizabeth Hussey provides an introduction to topical drug development and important considerations for clinical pharmacology aspects for products for dermatological conditions. in this webinar titled, “Drug Development Considerations for Dermatology: More Than Skin Deep.”

Topical Drug Development Webinar

Artificial Intelligence and Applications of Deep Learning in Drug Development

Applications of deep learning could transform drug development. Recent progress indicates that deep learning methods will help speed up and aid human investigations. Dr. Jason Pirone covers the rise of deep learning in drug development, the relationships among artificial intelligence, machine learning, and deep learning, challenges and opportunities, select applications of deep learning in drug development, and more in this webinar titled, “Artificial Intelligence and Applications of Deep Learning in Drug Development.”

AI & Deep Learning Webinar

Clinical Pharmacology 101 Part 1:
How to Form a Clinical Pharmacology Strategy for Your NDA/BLA

All drug programs must address clinical pharmacology to enable an approvable NDA or BLA. Understanding basic clinical pharmacology strategies is important for your program’s overall strategy. Learn more about clinical pharmacology strategy for your NDA or BLA from Nuventra’s CEO, Geoffrey Banks in part one of our clinical pharmacology 101 series: “How to Form a Clinical Pharmacology Strategy for Your NDA/BLA.”

Clin Pharm 101 Part 1 Webinar

Clinical Pharmacology 101 Part 2:
The Purpose of Clinical Pharmacology Studies in Drug Development

Clinical pharmacology studies are designed to gain understanding regarding the safety, pharmacokinetics (PK), pharmacodynamics (PD), drug interactions, and PK/PD in special populations of new chemical entities (NCEs) or biologics. Learn more about why we need to perform clinical pharmacology studies from Nuventra’s CSO, David Mitchell, in part two of our clinical pharmacology 101 series: “The Purpose of Clinical Pharmacology Studies in Drug Development.”

Clin Pharm 101 Part 2 Webinar

PK 101 Part 1:
Introducing Pharmacokinetic Concepts & Noncompartmental Analysis

PK data contributes to much of what is on a drug package label. NCA analysis provides the most elementary information for a drug (i.e., the rate and extent of absorption and elimination). Hear Mark Bush, PhD present part one of this PK 101 series covering  PK and NCA fundamentals in the webinar titled, “PK 101 Part 1: Introducing Pharmacokinetic Concepts & Noncompartmental Analysis.

PK 101 Part 1 Webinar

PK 101 Part 2:
Introducing Multiple Dose Pharmacokinetics & Bioavailability

Multiple dose studies are one of the earliest studies performed in clinical drug development and are intended to fully characterize the PK of a drug and its metabolites at steady state. Bioavailability studies should also be conducted early in the process to help guide and select formulations. Hear Scott Brantley present on these topics in the webinar titled, “PK 101 Part 2: Introducing Multiple Dose Pharmacokinetics & Bioavailability.

PK 101 Part 2 Webinar

Timing Considerations for Clinical Pharmacology Studies in Oncology Drug Development

Clinical pharmacology plans are not “one size fits all.” This is especially true for oncology, as the time from the first-in-human (FIH) dose to approval is shorter for oncology relative to other indications and the medical need is substantial. Hear from Nuventra’s consultants, Gene Williams and Brian Furmanski as they present this webinar titled, “Timing Considerations for Clinical Pharmacology Studies in Oncology Drug Development.

Oncology Webinar

Designing Smarter Clinical Trials with Modeling & Simulation Approaches

With modeling and simulation, your existing data can be leveraged to provide important insights, design more efficient trials, and used to potentially avoid certain clinical studies, saving money and time. This webinar will cover modeling and simulation fundamentals, real-world examples, and best practices to implement in your development program. Hear from Mark Sale, M.D., and Lauren Lohmer, Ph.D. as they present the webinar titled, “Designing Smarter Clinical Trials with Modeling & Simulation Approaches.”

Modeling & Simulation Webinar

The Path to IND – Roadblocks, Milestones, and Regulatory Strategy

The Investigational New Drug (IND) application is the primary pathway through which new drugs and biologics are approved to be tested in humans. But, what exactly is an IND and does your program really need one? What are the requirements for a successful IND and what paths can you take to get there? Hear from Todd Shearer, Ph.D. and Brian Furmanski, Ph.D., as they present this webinar titled, “The Path to IND – Roadblocks, Milestones, and Regulatory Strategy.

The Path to IND Webinar

Addressing the Challenges of Drug Discovery and Delivery for Combination Peptide Therapeutics

There has been growing interest and activity in the use of peptide therapeutics to treat a variety of human diseases. This webinar will present approaches to discover, optimize, assess, and deliver combination peptide therapeutics for treatment of metabolic diseases. Hear from Nuventra’s Mark Bush PhD, and Intarcia Therapeutics’ Paul L. Feldman PhD, as they present this webinar titled, “Addressing the Challenges of Drug Discovery and Delivery for Combination Peptide Therapeutics.

Peptide Webinar

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