Data-driven approach to establish a design space for raw materials properties and manufacturing conditions for pharmaceutical drug stability assurance

Pharmaceutical companies are required to perform stability testing of their drug products by regulation. A drug product that succeeds on stability testing means that its identity, potency, and purity remain within pre-established limits over its shelf life. Nowadays, drug products are more frequently reformulated in response to a highly competitive market, new research discoveries and the availability of new suppliers of raw materials.

Prevention of hepatitis C virus (HCV) re-infection after liver transplantation

Over 170 million persons worldwide are chronically infected by hepatitis C virus (HCV), leading to endstage liver disease and cancer. HCV is the single most common indication for liver transplantation in Canada and the rest of the Western world. After transplant, HCV re-infection is universal and is the chief cause of graft loss. Treatment of post-transplant recurrent HCV is more difficult than pretransplant, with lower response rates that partly reflect the effects of immunosuppression.We propose that the ideal management of post-transplant HCV is its prevention.

An Adaptive Phase I Intra-Patient Dose Escalation Study Of Fenretinide In Adult Cystic Fibrosis Patients

The proposed research project is a Phase 1 clinical trial looking at the safety of fenretinide, a molecule based on the structure of vitamin A, on patients with a disease called cystic fibrosis. Fenretinide has been shown in our laboratory to help cystic fibrosis mice by lowering molecules involved in inflammation and increasing the levels of docosahexaenoic acid (DHA), which is a fatty acid known to decrease inflammation. The intern will be involved in patient sample processing, analyzing and logging.

Sensors Western Operational Research and Development (SWORD)

Accurate monitoring of a patient’s vital signs – including body temperature, blood pressure, and pulse oxygenation – is central to the ability of clinicians to provide appropriate medical care. In spite of this, the standard equipment used to take these measurements is inefficient, inconvenient, and expensive. Adept Diagnostics will break into the medical device market with the development of novel wireless sensor systems to track these physiological variables continuously and inobtrusively.

Evaluation of viral sensitizer technology for improving influenza vaccine in an egg-basedmanufacturing process

Vaccination remains the most effective preventative measure for influenza infection. Seasonal influenza epidemics and the emergence of pandemic strains have increased the global demand for influenza vaccines, putting significant pressure on vaccine manufacturers. However, current vaccine manufacturing strategies rely primarily upon production in eggs, an age-old method that needs to be significantly improved. Recently, research from our lab identified a panel of novel compounds termed viral sensitizers (VSes) that increased virus production up to 1000 fold in cultured cells.

Design and synthesis of novel influenza M2 proton channel inhibitors with drug resistant antiviral activity

Seasonal influenza causes significant mortality and morbidity worldwide, and we are currently unprepared to mitigate a fatal pandemic outbreak like the 1918 Spanish Flu. A proven influenza antiviral target is the M2 viroporin, or viral ion channel. Amantadine, an M2 inhibitor was an effective antiviral for 20 years. However, current influenza antivirals are increasingly ineffective as viruses develop resistance. For example, the M2 mutation S31N is now present in >90% of influenza strains and confers resistance to adamantanes.

Radiochemistry for the Pharmacokinetic Evaluation of Novel Bone-Targeting Peptide Hormone Derivatives Year Two

This proposed research project is about development of new bone-targeting drug called PTHPEG- BP, this new compound will overcome shortages of current clinical peptide hormone PTH, and show better treatment efficacy and lower price then the latter; several new technologies will be used on research of this PTH, such as micro Positron Emission Tomography (PET/CT), and several of its characteristics will be identified such as structure, bioactivity, and metabolism inside body.

Investigating the biophysics and structural basis for state dependent drug blockade of persistent/late sodium current (INa(P)) in the heart using photoactivatable crosslinking unnatural amino acidsYR2

Electrical activity in the heart is controlled by the concerted activity of many proteins called ion-channels that regulate the transfer of different ions across cell membranes. Recently, researchers in biomedical science have identified that a particular component of sodium carrying ion-channel activity (called the persistent or late sodium current also known as INa(P)) played a major role in controlling the electrical activity of the heart. More recent research suggests that this late sodium current may be involved in various cardiac diseases.

The evaluation of pain management strategies for either caustic paste or cautery disbudding in dairy calves Year Two

Destruction of the horn bud in 4-6 wk old calves using either hot-iron or chemical disbudding is a common practice in the dairy industry. There is a limited body of research on the effects of chemical disbudding and the pain it causes to the animal as well as research on appropriate methods to mitigate the pain following this procedure, and research to identify appropriate pain managements is needed.

An omics study of plant responses to non-oncogenic Agrobacterium infection

ime-course biochemical and transcriptomic (gene expression) analysis of Nicotiana benthamiana in response to Agrobacterium infection and monoclonal antibody (mAB) expression. Host response to Agrobacterium infection may provide insight into novel approaches to increase recombinant protein production. Understanding changes in host gene expression may help identify targets for future engineering to limit negative impacts on the host due to infection and recombinant gene expression. Differential gene expression analysis may also reveal specific up-regulated host defenses (e.g.