At $800 Million, Costly New Drug Developments Demand Consistency

NIROSHA REDDY | May 3, 2017

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According to information provided in the Congressional Budget Office’s 2006 study, Research and Development in the Pharmaceutical Industry, it costs pharmaceutical companies an average of 12 years and $800 million dollars to create and bring to market a drug that is based on a new molecular entity (NME). In sharp contrast, drugs that are based on modifications of existing medicines average just 25% of the cost of an NME to develop.

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INC Research/inVentiv Health (Nasdaq:INCR) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to address new market realities where clinical and commercial share expertise, data and insights to accelerate biopharmaceutical performance. With more than 22,000 employees and the ability to support customers in more than 110 countries, our global scale and deep therapeutic alignment enables INC Research/inVentiv Health to help customers successfully navigate an increasingly complex environment. For more information on our Raleigh, N.C.-based company, visit incresearch.com or inventivhealth.com.

OTHER ARTICLES

Comparing HydroxyChloroquine Trials

Article | April 1, 2020

One minor side effect of the pandemic is that perhaps more people will learn about what drug research and clinical trials can really be like. Today’s example: we have a clinical trial of hydroxychloroquine from Wuhan that has just published on a preprint server. What’s good is that this one is blinded, randomized, and controlled (like the earlier hydroxychloroquine which one I blogged about here from Zhejiang University, so we can actually talk about it rather than just spend all our time wondering what the heck is going on.

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Pricing of drugs – at what cost?

Article | February 27, 2020

We go into a doctor’s office and leave with a diagnosis and a prescription. Next we stop by the pharmacy. In Germany, if your insurance is not private, you mostly don’t even know the price of your drug because it’s paid for directly by your insurance. You only notice the 5-10 Euros copay. But how is a drug priced in Germany? And (how) does data play a role in helping pharma secure an attractive price point? Let’s fast forward directly to the launch of a new drug. At the time of launch, the pharmaceutical company has to present patient level evidence of the drug’s added value compared to existing comparative therapies. In the first year, however, the drug’s price can be defined freely by the company.

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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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As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | April 17, 2020

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

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Spotlight

inVentiv Health Commercial

INC Research/inVentiv Health (Nasdaq:INCR) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to address new market realities where clinical and commercial share expertise, data and insights to accelerate biopharmaceutical performance. With more than 22,000 employees and the ability to support customers in more than 110 countries, our global scale and deep therapeutic alignment enables INC Research/inVentiv Health to help customers successfully navigate an increasingly complex environment. For more information on our Raleigh, N.C.-based company, visit incresearch.com or inventivhealth.com.

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