Can America Be First if We Put Science Last? Impacts of the New Administration’s Budget Blueprint

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By: Jennifer L.S. Knaack

It has been just over a month since the new administration released its 2018 fiscal year budgetary plan  for the United States, “America First: A Budget Blueprint to Make America Great Again.” It outlines planned cuts to the National Institutes of Health (NIH) amounting to just over 18% of the 2017 annualized continuing resolution level, a proposed 31% funding cut to the Environmental Protection Agency, and potential cuts to the Department of Energy totaling 5.6%, including a 20% cut to the Office of Science. Ultimately, these reductions are still just a “plan” until the budget is passed by Congress. Continue reading

Points to Ponder When Defining a Non-clinical Pharmacology Strategy for Topical Drug Product Development

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By Kevin Warner

Your project team is tasked with developing a topical semisolid product for a dermatological disease. The site of action for this dermal disease is thought to be at the epidermal/dermal junction. You develop a panel of prototype formulations for an in vitro skin penetration study. The study results show measurable amounts of API in the skin tissues (epidermis and dermis) and steady-state skin flux that is maintained for several hours. However, these results don’t address the key question: “Will the formulation provide adequate exposure at the site of action to elicit the desired pharmacodynamics outcome?” Developing a strategy to address this question will help de-risk clinical trials. Continue reading

Orphan Drug Transporters: Therapeutic Targets Identified with New Technology

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By Robert S. Jones

A brighter future in the field of pharmaceutical sciences depends, in part, on the consistent discovery of novel targets and delivery modalities. Dr. Marilyn E. Morris’ lab contributes to this paradigm by characterizing novel drug transporters in order to better understand their role in human physiology and disease. Through the utilization of high-throughput bioanalytical approaches and the development of genetically-engineered preclinical mouse models, we aim to shed light on transporter proteins that have no defined functional role or endogenous substrates—termed “orphan” transporters. Continue reading

A New Strategy for Overcoming Immunogenicity

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By Fiona Yau

Unwanted immune response towards a therapeutic protein is a clinical complication that could compromise the safety and efficacy of the therapy. Patients born with Hemophilia A (HA) have the deficiency or dysfunction of the essential blood clotting protein, Factor VIII (FVIII), and recombinant FVIII is the first line of therapy for these patients. However, about 30% of severe HA patients develop neutralizing antibodies (Nabs) against FVIII, which abrogate the activity of the protein, rendering the therapy less efficacious and increasing the risk of bleeding tendencies. Continue reading

Clinical Pharmacology Studies to Support a Demonstration of Biosimilarity and Interchangeability

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By Peijuan (Penny) Zhu, Shrinivas Savale, and Gillian Woollett

Clinical pharmacology studies are critical in demonstrating biosimilarity because they provide clinical pharmacokinetic/pharmacodynamic (PK/PD) similarity data to confirm biosimilarity. These studies address residual uncertainties after the analytical evaluation, add to the totality of evidence supporting biosimilarity, and guide the need for any subsequent clinical testing. In some cases, clinical pharmacology studies alone can be sufficient to address whether there are clinically meaningful differences between products. Continue reading