a CRO specialized in developing botanical products (herbal and hemp) to prescription botanical drugs through US FDA botanical drug IND regulatory filing and clinical development, and CMO for GMP clinical supply manufacturing

  • developing hemp products (HTC below the regulated threshold) for US FDA botanical drug regulatory filing and clinical development​

  • developing herbal medicines for US FDA botanical drug regulatory filing and clinical development​

  • pre-clinical analytic testing of botanical products with complex and unknown ingredients

  • quantitative description of botanical product substances using chemistry and biological techniques

  • know-how in shortening plant product drug development process from pre-clinical to proof-of-concept (phase-IIa)

  • high success rate from pre-clinical to proof-of-concept study (phase-II) due to safety nature of botanical products

  • marketing exclusivity for up to 5 years even in the absence of patent protection

  • expertise and capability with Good Manufacturing Practices (GMP) regulations for the clinical manufacturing of pharmaceutical formulations for clinical studies and specialty pharmaceutical products

[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 waives the requirement of:

  • identifying active ingredients

  • 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:

  • Veregen (sinecatechins), a topical drug for the treatment of genital and anal warts

  • 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, sponsors often conduct "clinical trials" to show medical benefits, but their classification as dietary supplement prohibits sponsors from labelling medical claims. FDA encourages sponsors to develop cannabis products through the botanical drug development pathway for hemp products and for controlled products.

     Modern herbal medicines in forms of pills or capsules with demonstrated safety and efficacy on large scale population are good candidates to develop into US prescription botanical drugs:

  • choosing known safe and effective herbal medicines reduces time and cost of drug discovery

  • demonstrated safety significantly increases success rates from pre-clinical tests up to phase-IIa

  • demonstrated efficacy significantly improves success rates of Phase-IIb and Phase-III trials

The technical challenge of developing CMC contents is tedious but doable.

developing safe and efficacious plant products to botanical drugs is an efficient drug development pathway

Philadelphia, USA