Microbiome Modulation: The Next Frontier in Clinical Therapeutics

In August 2017, the NIH hosted a workshop to mark the 10th and final year of the Human Microbiome Project (HMP), a two-phase program that greatly increased our understanding the role of human microbiota in human health and disease. Although this NIH initiative is over, it has spurred continued funding for human microbiome research from the NIH, other government…

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Why Treatment Advances in Fibromyalgia Have Been Slow

Fibromyalgia is a common medical condition characterized by chronic widespread muscle pain, fatigue, and sleep disturbance affecting two to three percent of the total population. It is five to ten times more common in women than men, increases with age and can also be worsened by many factors, including physical trauma and emotional stress. In…

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505(b)(2) New Drug Applications: Is there an adequate ROI?

Najib Babul, PharmD, MBA Experienced Senior Drug Development Consultant In this post, intended for a general audience, I share a few thoughts about the benefits and limitations of developing drugs using the 505(b)(2) regulatory pathway. Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug…

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Najib Babul Discusses the Pharmaceutical Industry’s Role in Transforming Global Health

Each year, 1.7 billion citizens of developing countries need treatment for neglected diseases, according to the World Health Organization’s (WHO) 2016 World Health Statistics. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing…

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Najib Babul Discusses the Benefits and Limitations of Opioids for Neuropathic Pain

Neuropathic pain is pain arising as a direct consequence of a lesion or disease affecting the somatosensory system, or put more simply, pain due to injury to sensory nerves. Neuropathic pain can be broadly divided into peripheral neuropathic pain and central neuropathic pain. Until relatively recently, a limited number of older tricyclic antidepressants and anti-epileptics…

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Najib Babul Offers Insight into How Baseball Might Speed Up Drug Development

The pharmaceutical R&D environment has become increasingly challenging due to rising costs, inefficient and complex drug development, high attrition and long regulatory review cycles. The success rate in bringing new drugs to market is rather low, with only about 11.3% of drugs that enter human trials receiving marketing approval, according to the Center for the…

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Najib Babul Discusses Current Challenges with Chronic Pain Management

Chronic pain is a major public health problem that afflicts a significant number of patients, resulting in personal suffering, reduced productivity, and increased health care costs. A report from the National Academy of Medicine states that chronic pain affects approximately 100 million adults in the U.S. and costs the economy over $600 billion annually, a…

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