Profile

Najib Babul

Cinergen, LLC

Contact Details

Cinergen, LLC

Bio

I am an drug development consultant with extensive experience in bringing new [505(b)(1)] and repurposed [5050(b)(2)] drugs to market. I have an undergraduate degree in pharmaceutical sciences from the University of British Columbia, a doctor of pharmacy degree from the SUNY, Buffalo and  an MBA from the California Institute of Advanced Management.

Presently I am a drug development consultant to investment banks, law firms and pharmaceutical companies. My prior experience, in chronologic order includes: (i) V.P., Clinical Development at Cadence Pharmaceuticals; (ii) CSO of TheraQuest Biosciences; (iii) V.P., Global Clinical Drug Development and Therapeutic Leader, Analgesia & Rheumatology at Scirex Corporation (now Premier Research), a boutique CRO; and (iv) Director, Clinical Research at Purdue Pharma.

I have been an invited speaker at FDA, FDA Advisory Committees, NIH, and national scientific meetings. I have designed drug development programs and clinical trials on several dozen new [505(b)(1)] and repurposed [5050(b)(2)] compounds. I am on the editorial board of the Journal of Opioid Management. I have published ≥ 170 abstracts and manuscripts in leading medical journals, including the Lancet, JAMA, Journal of Clinical Oncology, Cancer, Journal of Clinical Pharmacology, Pain and Clinical Pharmacology & Therapeutics. My publications have focused on acute, cancer, chronic and neuropathic pain, cancer supportive care and clinical trials methodology.

My Contributions

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Posted By Najib Babul Oct 19, 2017 11:58 PM
Found In Community: LSN CENTRAL COMMUNITY Blogs
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 of the role of human microbiota in human health and disease. Although this NIH initiative is over, it has   spurred continued ...
Posted By Najib Babul Mar 15, 2017 8:04 PM
Found In Community: LSN CENTRAL COMMUNITY Blogs
Some Alzheimers Disease (AD) stakeholders may look back at the past year with a sense of dismay, given the failure of several important clinical trials aimed at translating putative mechanisms into FDA approved drugs. Others may be encouraged by the wholesome year of scientific achievements and strides ...
Posted By Najib Babul Jan 27, 2017 2:54 AM
Found In Community: LSN CENTRAL COMMUNITY Blogs
Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug using the 505(b)(2) regulatory pathway. What are 505(b)(2) new drug applications (NDAs) and do they really provide a meaningful advantage to pharmaceutical companies? The term 5
Posted By Najib Babul Jan 23, 2017 3:22 PM
Found In Community: LSN CENTRAL COMMUNITY Blogs
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 ...