a CRO specialized in developing plant products, such as herbal medicine and cannabis-related products (hemp or controlled products), to prescription botanical drugs through US FDA botanical drug regulatory filing and clinical development
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developing cannabis hemp products (HTC below the regulated threshold) for US FDA botanical drug regulatory filing and clinical development
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developing herbal medicines for US FDA botanical drug regulatory filing and clinical development
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pre-clinical analytic testing of plant products with complex and unknown ingredients
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quantitative description of plant product substances using chemistry and biological techniques
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expertise in identifying safe and efficacious plant products for FDA botanical drug development
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know-how in shortening plant product drug development process from pre-clinical to proof-of-concept (Phase-IIa)
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High success rate from pre-clinical to proof-of-concept study (phase-II) due to safety nature of herbal medicine
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already-known safe and efficacious herbal medicines have significantly higher success rates for Phase-II and -III clinical trials than that of new synthetic chemical drugs.
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out-license after Phase-I or after Phase-IIa, IIb to large pharmas
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marketing exclusivity for up to 5 years even in the absence of patent protection
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not-required to identify active ingredients is better than IP rights and patterns
[FDA Botanical Drug Guidance]
In 2004, the FDA issued Botanical Drug Development Guidance for Industry; in 2016, 2nd edition. If a drug product is derived from single plant or from mix of plants, the Guidance waivers the requirement of:
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identifying active ingredients
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description of mechanism of action
As long as a botanical product demonstrates safety and efficacy during Phase I, Phase II, and Phase III clinical trials, they are approved as prescription drugs on the US market. Two botanical drugs have been approved so far as prescription drugs on the US market:
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Veregen (sinecatechins), a topical drug for the treatment of genital and anal warts
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Fulyzaq (crofelemer), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy
By the end of 2018, over 600 botanical drugs are in FDA IND drug development stages.
[Botanical Drug Development Pathway]
For cannabis-related products, FDA encourage to stay away from diary supplement or functional food and to file for botanical drugs. FDA outlines botanical drug development pathway for cannabis hemp drugs and cannabis controlled drugs.
Modern herbal medicines in the forms of pills or capsules with demonstrated safety and efficacy on large scale population are perfect candidates to develop into US prescription botanical drugs:
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choosing known safe adm effective herbal medicines reduces time and cost of drug discovery
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demonstated safety significantly increases success rates from pre-clinical tests up to phase-IIa
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demonstrated efficacy significantly improves success rates of Phase-IIb and Phase-III trials
The technical challenge of developing CMC contents is tedious but doable.