I am an accomplished biotech entrepreneur, drug development scientist and inventor with almost 20 years of experience in bringing new drugs to market. My drug development experience spans from opening pre-IND to NDA. I have an undergraduate degree in pharmaceutical sciences from the University of British Columbia and a doctor of pharmacy degree from the SUNY, Buffalo.

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) Founder, CEO and CSO at Relmada Therapeutics, Inc (pka, TheraQuest Biosciences), a clinical stage company focusing on chronic pain and addiction; (iii) consultant to pharmaceutical companies and investment banks through Cinergen, LLC; (iv) V.P., Global Clinical Drug Development and Therapeutic Leader, Analgesia & Rheumatology at Scirex Corporation (now Premier Research), a boutique CRO; and (v) Director, Clinical Research at Purdue Pharma.

I am the founder of Relmada Therapeutics and served as its CEO and CSO until my departure in 2012. At Relmada, my achievements included: (i) raising significant capital in the USA and South Korea; (ii) out-licensing product rights for Asia; (iii) securing seven FDA orphan drug designations; (iv) inventing products including abuse deterrent opioid analgesics; (v) Drafting and filing more than 32 provisional patent applications which form the basis of 8 US patents or applications, each supporting one or more of four dosage forms in development. Relmada has since gone public.

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. 

Najib Babul 116sc

Najib Babul

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