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.

Spotlight

Bellicum Pharmaceuticals, Inc.

Bellicum Pharmaceuticals, located near the Houston Medical Center, is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT) and CAR T cell therapy.

OTHER ARTICLES

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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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | April 17, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

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Comparing HydroxyChloroquine Trials

Article | April 17, 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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WANT LESS “LIABILITY” AND MORE “RELIABILITY” FROM YOUR CLINICAL MOBILITY SOLUTION?

Article | April 17, 2020

I recently discussed the different ways that consumer-grade smartphones can compromise patients’ health, safety and overall care. However, some clinicians and healthcare administrators have indicated in recent months that they need help selecting the right enterprise-grade mobility solutions for their unique operating models and workflows. There are many different hardware and software options, and a single rugged device can come in multiple configurations. So, how do you know if you’re picking the right communication tools for your clinicians? The key is to first set performance expectations for the total mobility solution rather than the device alone.

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Spotlight

Bellicum Pharmaceuticals, Inc.

Bellicum Pharmaceuticals, located near the Houston Medical Center, is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT) and CAR T cell therapy.

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