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 topics. Fill out the forms below to access the recordings of our webinars.
Available Webinars:
- 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
- PK 101 Part 1: Introducing Pharmacokinetic Concepts & Noncompartmental Analysis
- PK 101 Part 2: Introducing Multiple Dose Pharmacokinetics & Bioavailability
- Timing Considerations for Clinical Pharmacology Studies in Oncology Drug Development
- Designing Smarter Clinical Trials with Modeling & Simulation Approaches
- The Path to IND – Roadblocks, Milestones, and Regulatory Strategy
- Addressing the Challenges of Drug Discovery and Delivery for Combination Peptide Therapeutics
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 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 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.”
