Skip to main content

Read-Across as an Alternative Approach for Assuring the Safety of Excipients

Description

Read-across is the only accepted alternative to animal testing at present. Cheminformatic approaches to choose and assess the suitability of analogs for read-across have been developed, and high-content biotechnology methods such as global gene expression analysis have been used to prove biological similarity of analogs.

Contributors

  • George Daston

    Procter & Gamble

    George Daston is a toxicologist with Procter & Gamble and holds adjunct professorships at University of Cincinnati and Texas A&M University. His research is in mechanistic and predictive toxicology. He has published more than 150 peer-reviewed papers and edited several books in the fields of teratology and toxicology. He has served on advisory boards for the National Academy of Sciences, USEPA, NTP, and CalEPA, among others. He is a past-president of the Society of Toxicology and the Teratology Society (now the Society for Birth Defects Research and Prevention).

  • Ron Filler

    President & CEO, Drug Development Consultants, LLC. (DDC)

    Ron is a broadly trained Toxicologist who blends basic scientific research with regulatory experience to his current role as a Consultant to the pharmaceutical industry.

    Prior to becoming a Consultant in 1999, Ron held senior managerial positions as a Reproductive and Developmental Toxicologist with a specialty in male fertility assessment at FDA’s National Center for Toxicological Research and as Director of Nonclinical Toxicology and Pharmacology at Forest Laboratories.

    DDC is a consulting company specializing in developing regulatory and toxicological strategies for new molecular entities, 505(b)(2) applications and the justification for safety of impurities present in drug products. To accomplish these goals, DDCI employes scientific approaches that involve the transition from predominantly traditional animal testing by applying New Approach Methods that include various computational platforms interacting with Big Data Bases along with selective in vitro approaches as part of the 21st Century’s development of predictive toxicology.

  • Jeffrey Pitt

    Lead Toxicologist, IFF

    Jeffrey Pitt is a lead toxicologist for IFF. He graduated with a Ph.D. in toxicology from the University of Michigan in 1997 and completed a Post-Doc at US EPA in RTP North Carolina followed by a few years at Contract Research Labs before joining Sanofi. For the last few years, Jeff worked for Dow, DowDuPont and now IFF in their Pharma Divisions. Jeff has been an active member of IPEC-Americas for many years and has represented IPEC-Americas at several IID and novel excipient meetings with the FDA.

  • Teresa Wegesser

    Scientific Associate Director, Amgen

    Teresa Wegesser, a board-certified Toxicologist with over 10 years of industry experience, serves as a nonclinical safety Project Team Representative (PTR) and impurities subject matter expert (SME) at Amgen Inc. She represents nonclinical safety on broader drug development teams for both small and large molecule projects. Teresa is actively engaged in US and European working groups, including the IQ DruSafe impurities working groups, PhRMA nitrosamines taskforce, IPEC Americas, ICH Q3E, and EFPIA impurities working group. She has published on impurities and excipient safety. Previously, Teresa worked as a Lead Toxicologist at Chevron, focusing on identifying and assessing human health and environmental risks associated with chemical additives and complex mixtures in petroleum products. She holds a PhD in Pharmacology and Toxicology from the University of California, Davis, where her research focused on characterizing the pro-inflammatory and toxic potential of specific constituents of coarse particulate matter using in-vivo animal models.

October 30, 2024
Wed 9:00 AM EDT

Duration 2H 0M

You can access this item by buying entire course

Buy entire course:

Already Registered?