Thank you This live web event has ended. Thank you for attending. Contributors Joyce Macwan, Ph.D. Joyce Macwan is a Senior Scientist in Simulations Studies group at Simulations Plus, Inc., where she performs primarily PBPK/PD modeling and simulation consulting services for the pharmaceutical industry. She has an extensive experience in mechanistic absorption and PBPK modeling to support model-based drug development. She earned Ph.D. in Clinical Pharmacokinetics from the University of Rhode Island, RI, USA and B.S. and M.S. degrees in Pharmaceutical Sciences from Sardar Patel University, India. Her expertise in PBPK modeling and simulations facilitates the decision-making process during drug discovery and through various stages of the drug development by integrating the knowledge of drug metabolism, pharmacokinetics, pharmacodynamics, formulation and pathophysiological factors. She has worked on numerous studies including formulation optimization, bioequivalence studies, first-in-human dose predictions, drug-drug interactions, disease states modeling, and pediatric drug development across different therapeutics areas and routes of administrations. She has been involved in many studies that informed regulatory decisions. She continues to contribute in scientific community by her peer reviewed publications and presentations at the various conferences. Stephanie Dodd, Ph.D. Stephanie Dodd is a Senior Fellow and Biopharmaceutics Modeling Expert for the Chemical & Pharmaceutical Profiling Group at Novartis Institutes for Biomedical Research (NIBR). She has worked in the group since its inception in 2004 in various roles involving stability & analytics, formulation, and solid form selection. Stephanie is currently responsible for consistent application of PBPK modeling to synthetic drug candidates across the breadth of therapeutic areas at NIBR. Her primary focus is to guide formulation development for pharmacology, pharmacokinetic, toxicology and clinical service formulation. She achieves this by understanding key risks affecting absorption based on the route of administration, and guiding compound and ultimately formulation selection accordingly to mitigate or manage risks for poor performance as appropriate. Stephanie’s focus of research continues to be influencing early stage drug discovery teams in improving solubility of new molecular entities, new techniques for building successful IVIVC, and prediction of clinical outcomes of PPI/ARA drug-drug interactions and food effects in human dosage formulations. Aktham Aburub, Ph.D. Aktham is a Senior Research Advisor at Eli Lilly & Company. He is the leader of product design and the CMC leader of the oral peptide delivery program. He has more than 15 years of industry experience spanning interface with discovery through late stage commercial development. He is experienced in regulatory submissions utilizing Quality by Design (QbD) with numerous successful interactions with regulatory agencies. Aktham has been invited to provide training to regulatory agency reviewers on various aspects of product development including QbD, Risk Management, Clinically Relevant Specifications and In Vivo Bridging. Aktham is an adjunct professor at the University of Minnesota, School of Pharmacy. He received a PhD in pharmaceutical sciences from the University of Iowa and a BSc in Pharmacy from Jordan University of Science and Technology. Amjad Alhalaweh, Ph.D. Amjad Alhalaweh is a Senior formulation scientist at Recipharm’s development facility in Uppsala, Sweden. He is responsible for developing solutions for complex formulation challenges for both newly discovered compounds and existing drugs, along with finding new, cost-effective approaches for formulation design including computational predictions. Dr. Alhalaweh has specific expertise in the development of liquid formulations through an understanding of the solubilization mechanism of different excipients, crystallization of a compound, solid-state characterization, and solid form selection. He represents Recipharm in the Swedish Drug Delivery Forum in collaboration with Uppsala University and supervises master and Ph.D. students. He published 30+ scientific paper in international journals.