The development of new drugs for rare diseases is a challenging process due to small patient populations and the high cost of clinical trials. One key challenge is identifying optimal dosing regimens. Pharmacokinetics of drugs can vary widely between individuals, and it can be difficult to obtain enough data from clinical trials to make informed decisions about dosing.
This webinar will discuss the challenges and opportunities of developing drugs for rare diseases and how population pharmacokinetic (PPK) modeling can be used to identify optimal dosing regimens for new drug candidates. The webinar will also discuss the advantages of using a medical communications and publications writing team to accelerate the process of publishing drug development research.
Learning Objectives:
- Understand the challenges involved in developing drugs for rare diseases.
- Learn how PPK modeling can be used to identify optimal dosing regimens for new drug candidates.
- Gain insights into the scientific communications process for publishing drug development research.
Contributors
Elliott Offman, MSc, Ph.D.
Elliott Offman is the Vice President of Clinical Pharmacology and Translational Medicine at Certara. Dr. Offman has over 20 years of drug development experience and joined Certara in 2017 where he leads translational pharmacokinetic and pharmacodynamic efforts in Certara’s Clinical Pharmacology & Translational Medicine group. Dr. Offman has supported the development of several oncology products including Asparlas (calaspargase pegol), Oncaspar (pegasparaginase) and brigatinib (Alunbrig), and was instrumental in the approval of RedHill Biopharma’s Talicia for H. pylori infection. Prior to joining Certara, Dr. Offman was responsible for clinical pharmacology and pharmacometrics at Celerion, leading study design, data analysis and interpretation for clinical pharmacology studies including first-in-human, drug-drug interactions, mass balance and special population trials. Prior to joining Certara, Dr. Offman oversaw biopharmaceutics and scientific affairs for Genpharm, a subsidiary of Merck KGaA as well as Mylan. Additionally, as a clinical pharmacologist, Dr. Offman has supported development and approval of Epanova (Omthera), XHANCE (Optinose) and Austedo (Auspex).
Dr. Offman obtained a PhD at the University of Waterloo (Waterloo, Canada) in model-based drug development with a particular focus in physiologically and population based pharmacokinetic modelling of subcutaneously administered large molecules. Dr. Offman is a licensed pharmacist and completed a residency in clinical pharmacy at the London Healthy Sciences Centre (Ontario, Canada) and a MSc in Clinical Pharmacology from Western University in Ontario, Canada. Dr. Offman is a holder of a patent and has co-authored over 50 abstracts and peer-reviewed manuscripts.
Noopur Singh
Noopur’s motivation stems from her desire to help mitigate treatment access challenges seen across indications. She is focused on strategic patient-centered drug development that bridges scientific gaps and cuts through red tape across the drug supply chain. She is determined to increase access to treatments to help fulfill current unmet needs. Her approach stems from the patient journey, ensuring it is integrated throughout the drug development life cycle. In her role as Director of Medical Affairs, Noopur nurtures Xentria’s key relationships with patient experts, key opinion leaders and clinical investigators while leading business development and partnering strategy.
Prior to her role at Xentria, Noopur was the Research Director at the Foundation for Sarcoidosis Research where she played a key role in the development and execution of the organization’s scientific research agenda. Noopur has also worked as Clinical Site Manager for Synexus Clinical Research in Chicago, where she was responsible for operationalizing clinical trials. Noopur held several roles at Lurie’s Children’s Hospital Chicago where she managed over 25 industry-sponsored trials. She has also been an active participant in the Therapeutics Development Network with the Cystic Fibrosis Foundation. Noopur earned a B.S.in Kinesiology from the University of Michigan.
