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Johnson D.E.,Emiliem Inc. | Johnson D.E.,University of California at Berkeley
Expert Review of Clinical Pharmacology | Year: 2010

First-in-human dose-selection criteria for biotherapeutics are changing, primarily based on severe adverse events in a single monoclonal antibody trial in healthy volunteers. Spurred by new EMA guidance, the minimum anticipated biological-effect level (MABEL) for estimating a starting human dose from exposure-response preclinical data have been introduced and should help to create long overdue target mechanism-based models focused on exposure-response relationships. Even though clarity of its application is still developing, this has the potential to become the model for most biotherapeutics in the future. However, maximizing benefit from MABEL will require increased efforts to define and create assays for relevant biomarkers of biological activity and safety as pharmacodynamic end points. Currently, this has not been realized sufficiently to make the model applicable to a majority of biotherapeutics; however, this review suggests how it can be applied universally with monoclonal antibodies. © 2010 Expert Reviews Ltd.

Johnson D.E.,Emiliem Inc. | Johnson D.E.,University of California at Berkeley | Johnson D.E.,University of Michigan
Expert Opinion on Orphan Drugs | Year: 2014

In June 2013, US FDA finalized changes to the Orphan Drug Regulation, clarifying the potential of using a single drug for multiple indications that would cause the total patient population to be > 200,000, but maintaining orphan drug status for a 'subset' of a disease where each patient population is < 200,000. In this editorial, an example is presented where drug candidates targeting biological pathways with the potential for multiple indications could capitalize on orphan indications, while maintaining a broader development strategy. The mammalian target of rapamycin pathway is highlighted with potential orphan indications in ocular diseases, tuberous sclerosis complex-related diseases and rare cancers. © Informa UK, Ltd.

Emiliem Inc. | Entity website

About Management at Emiliem have recognized the fact that there is still no uniform, practical working model to address all needs for dealing with adverse drug reactions from design of molecules to post-marketed medicines. In addition, there is a substantial need for a uniform platform for chemical human health research and regulatory action that would be applicable to allparties ...

Emiliem Inc. | Entity website

Emiliem Inc. | Entity website

Home Emiliem, Inc is a private biotechnology company focused on understanding the molecular determinants of target modulation as it relates to the efficacy of therapeutics and to potential adverse drug reactions. The company is particularly interested in diagnostic markers for rare diseases and the computational aspects of predicting both positive and negative patient outcomes ...

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