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| Navita Mallalieu, Roche Pharmaceuticals |
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Navita Mallalieu obtained her Ph.D. from Rutgers University in field of pharmacokinetics in 1994. She is currently employed at Roche Pharmaceuticals in Nutley, NJ where she joined the Discovery Pharmacology Department in 1999 to provide expertise for the conduct of preclinical PK studies. After five years of service, she was appointed discovery coordinator to serve as a liaison between the discovery and non-clinical organizations. She has recently transferred to the clinical pharmacology department within Roche, which is responsible for the conduct of pharmacology studies in Phase I to Phase III of drug development. Prior to her employment at Roche, she worked as a pharmacokineticist in Procter and Gamble Pharmaceuticals in Cincinnati, Ohio in the Anti-Infective division. Dr. Mallalieu has gained several years of experience in drug discovery and development and is considered an expert by internal and external colleagues in area of pharmacokinetic support for compounds from discovery to lead optimization. She has participated and chaired numerous Roche global workshops to shape how preclinical PK studies should be conducted and to develop ways to transform the information from the individual studies into long-term knowledge sharing.
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A Roadmap for Integrating Modelling & Simulation in Pre-Clinical DMPK Research
Navita Mallalieu, Roche Pharmaceuticals
Integration of modeling and simulation in preclinical research is still a dream for some organizations and in its in infancy for others. Bringing a new twist to existing pathways is both a challenge and an exciting opportunity. But most importantly, bringing in new blood into an entrenched system must deliver on its promise of a better outcome than the current paradigm. I’d like to share with you my experience with incorporation of modeling and simulation into the world of preclinical DMPK at Roche. The emphasis of this presentation is on development and utilization of a PBPK based PK model approach. We have tapped into the vast amount of preclinical data that is generated as part of routine drug development at Roche and tied it together using the PBPK model to show management an alternative approach for decision-making in discovery. The presentation will cover the following topics:
* Results of validation of the rat PK model using 45 compounds and a retrospective prediction of human pharmacokinetics using 10 compounds.
* Contrast of the PBPK approach with currently utilized approaches like allometric scaling and the FDA recommended Maximum Recommended Starting Dose (MRSD) for the first dose in humans.
* A proposal for incorporating M&S into the discovery screening strategy. I will share a road-map of how best to utilize the latest tools and expertise in M&S to complement the existing information and generate knowledge.
Our emphasis was to improve decision-making by showing an integrated view of the preclinical data. This approach also offers the potential to reduce experimentation by replacing it with simulations, where appropriate, thereby decreasing cycle-times.
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