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:
- Addressing the Challenges of Drug Discovery and Delivery for Combination Peptide Therapeutics
- Allometric Scaling: Common Misconceptions During Drug Development
- Artificial Intelligence and Applications of Deep Learning in Drug Development
- Cellular & Gene Therapy 101
- Clin Pharm 101 Part 1: How to Form a Clinical Pharmacology Strategy for Your NDA/BLA
- Clin Pharm 101 Part 2: The Purpose of Clinical Pharmacology Studies in Drug Development
- Concentration-QT Analysis: Saving Time and Resources with Modeling
- Designing Smarter Clinical Trials with Modeling & Simulation Approaches
- Drug Development Considerations for Dermatology: More Than Skin Deep
- Micro-Dosing: Effects of an Investigational Drug on PK of Concomitant Medications
- Navigating Regulatory Strategies for Cellular & Gene Therapies
- PBPK & QSP: Modeling Approaches for All Stages of Drug Development
- PBPK Modeling in Pregnancy and Lactation Studies
- Pediatric Drug Development: Allometry and Other Empirical Models
- Pharmacogenomics and Pediatric Drug Development: When Are Children Not Little Adults and Why?
- PK 101 Part 1: Introducing Pharmacokinetic Concepts & Noncompartmental Analysis
- PK 101 Part 2: Introducing Multiple Dose Pharmacokinetics & Bioavailability
- Practical & Technical Approaches to Determining First-in-Human Doses: Roundtable Discussion
- Regulatory Pathways for Drugs, Devices, & Combination Products
- The Path to IND – Roadblocks, Milestones, and Regulatory Strategy
- Timing Considerations for Clinical Pharmacology Studies in Oncology Drug Development
Concentration-QT Analysis: Saving Time and Resources with Modeling
This webinar covers concentration-QT (C-QT) analysis, an internationally accepted approach used to establish the risk of prolonging the QT interval. C-QT is a low-cost and efficient option compared to conducting a thorough QT (TQT) study. Learn more in this webinar titled, “Concentration-QT Analysis: Saving Time and Resources with Modeling.”
Navigating Regulatory Strategies for Cellular & Gene Therapies
This webinar covers key regulatory strategies important to first-in-human trials for cellular and gene therapies and how to use the target product profile to guide product development. Understand the unique challenges often presented when developing cellular and gene therapies in this webinar titled, “Navigating Regulatory Strategies for Cellular & Gene Therapies.”
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.”
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.”
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.”
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.”
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.”
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?”
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.”
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: 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.”
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.”
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.”
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.”
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.”
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 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.”
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.”
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.”
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.”
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 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.”
