Expanding Access to Our Medicines

| November 21, 2018

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Every day, 1,000 young women and girls get HIV, 4,000 lives are lost to TB and millions who could be helped suffer from serious mental illnesses. Johnson & Johnson's efforts in tackling these health threats, alongside many others, is why the company has continued to rank among the top three working to expand global access to medicines in low- and middle-income countries according to the Access to Medicine Index (ATMI).

Spotlight

Drug Discovery and Development Centre (H3D), University of Cape Town

H3D is Africa’s first integrated drug discovery and development centre. The Centre is an accredited University of Cape Town research centre within the Faculty of Science but with strong affiliations with the Faculty of Health Sciences and specifically the Division of Pharmacology and the Institute for Infectious Diseases and Molecular Medicine (IDM). H3D operates within UCT’s world-class translational medicine research environment.

OTHER ARTICLES

5 Pharma Trends and Their Impact on Packaging

Article | February 27, 2020

The pharmaceutical industry is changing at an unprecedented pace. New biological treatments for cancer, and a dramatic rise of widespread diseases such as diabetes, call for new processing and packaging solutions to fulfill the different needs all over the world. Keep your eye on these five main packaging trends for 2020 for the global pharmaceutical market.

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Clinical Supply Availability & Speed to Study Start-Up

Article | March 26, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | February 17, 2020

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Spotlight

Drug Discovery and Development Centre (H3D), University of Cape Town

H3D is Africa’s first integrated drug discovery and development centre. The Centre is an accredited University of Cape Town research centre within the Faculty of Science but with strong affiliations with the Faculty of Health Sciences and specifically the Division of Pharmacology and the Institute for Infectious Diseases and Molecular Medicine (IDM). H3D operates within UCT’s world-class translational medicine research environment.

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