This webinar will dive into the journey of Rimegepant, Biohaven Pharmaceutical’s innovative CGRP antagonist, designed for the treatment of migraines. This session will explore how clinical pharmacology, model-informed drug development (MIDD), and medical affairs were integrated across various phases of drug development, driving the success of Rimegepant.
Key topics include:
- Understanding the CGRP antagonist mechanism and its role in migraine therapy.
- A detailed look at Rimegepant’s early development, including the clinical pharmacology study with acid-reducing agents (ARA) and the development of a new salt formulation.
- How Physiologically Based Pharmacokinetic (PBPK) modeling was utilized to address the effects of ARAs on the new salt formulation.
- The impact of population PK modeling on Rimegepant’s development trajectory.
- The importance of medical writing and cross-functional collaboration to demonstrate thought leadership
Joining us in this discussion is Dr. Rick Bertz from BioHaven Pharmaceuticals, a seasoned expert in drug development, who will share his insights on establishing a framework for successful partnerships and strategies for optimizing drug development.
The webinar will conclude with an engaging Q&A session, offering attendees the opportunity to dive deeper into these topics. Don’t miss this opportunity to learn about the science and strategy behind the development of Rimegepant and how innovative drug development practices can optimize therapeutic success.
Speakers:
Raj Bhardwaj, PhD, Senior Director, Certara
Raj Bhardwaj, PhD is a senior director, integrated drug development at Certara. He has been a consultant in clinical pharmacology for pharma and biotech companies working on drug development in neuroscience, inflammation, oncology, and rare diseases.
His expertise includes clinical pharmacology strategy, designing and analyzing clinical trials, evaluating drug metabolism and pharmacokinetics, PK/PD, and assessing potential drug interactions. During his career, he has played an important role in optimizing drug therapy to ensure the best possible outcomes for patients while minimizing risks.
He has more than 15 years’ experience in drug discovery and development and supporting projects at different levels. He has published more than 30 manuscripts, book chapters, and abstracts on pharmacokinetics and clinical pharmacology.
Craig Comisar, PhD, Senior Director Certara
Craig has 16 years of Phramacometrics experience including 2 years at Children’s Hospital of Philadelphia, 4 years at Johnson and Johnson, and 10 years at Quantitative Solutions/Certara. He is active in the modeling community with 5 years of service for the American Conference of Pharmacometrics Science Committee ending with a year as the Scientific Chair for the conference. Additionally, he currently organizes the soccer social event at the Population Approach Group of Europe since 2017.
Amy Porter, Principal Writer, Certara
Dr. Porter is a Certified Medical Publication Professional (CMPPTM) with over 10 years of demonstrated expertise as a scientific and medical publication writer. She also has over 10 years of experience in the pharmaceutical industry in neuroscience drug development leading cross-functional drug discovery teams. She has demonstrated expertise in publication planning and tactical execution for pharmaceutical industry clients. She has prepared and edited peer-reviewed publications, abstracts, posters, and review articles in oncology, neuroscience, infectious disease, immunology, gastrointestinal disease, dermatology, diabetes, and transplantation. She has experience in nonclinical and clinical manuscripts with a focus on pharmacology, biomarkers, modeling and simulation, and ADME across all stages of the drug development process. She has worked as a primary author, editor, and subject matter expert.
Rick Bertz, PhD, Senior Vice President, Biohaven
Dr. Richard (Rick) Bertz is currently Senior Vice President, Clinical Pharmacology and Pharmacometrics at Biohaven Pharmaceuticals. Dr. Bertz has worked in the pharmaceutical industry for over 25 years, previously with Bristol-Myers Squibb, where he led the Clinical Pharmacology and Pharmacometrics Group and prior to that with Abbott Labs.
Dr. Bertz has been involved in all phases of clinical drug development, with a focus on the analysis and interpretation of clinical pharmacology and pharmacometric data. He has mentored, coached, managed, and developed numerous clinical pharmacologists and drug development scientists. Dr. Bertz has been integrally involved in the completion of components of NDA submissions that have led to worldwide regulatory approval for several antiviral drugs for treatment of HIV and HCV and a neuroscience drug for the treatment of migraines.
Dr. Bertz has coauthored over 80 peer-reviewed publications and given numerous invited presentations at national and international scientific meetings. He previously held a faculty appointment as Professor and Associate Dean at the University of Pittsburgh, School of Pharmacy, where he is currently an Adjunct Professor. Dr. Bertz received a BS in Pharmacy from the University of Wisconsin and earned his PhD from the University of Pittsburgh Clinical Pharmaceutical Scientist Graduate Program.