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Botanical Lab

  • specialized in botanical product analytics and production

  • qualitative analytics of botanical drug products with complex ingredient profiles

  • quantitative analytics of drug substances: mass balance test, test for residual pesticides, elemental impurities, residual solvents, ...

  • HPLC or GC profiling of botanical drug products

  • develop drug product quality control methods and standards

  • animal safety test

  • stability test

  • extensive medical and toxicological literature review

  • blood levels of active constituents

Mission

     The global market for botanical or plant-derived drugs is expected to grow to $39.6B by 2022 with a compound annual growth rate (CAGR) of 6.1%. The FDA Botanical Drug Development Guidance for Industry defines a pathway for herbal medicines and cannabis-derived products to become prescription drugs in the US.

     The American Botanical Drug Association, ABDA, is an industry organization with missions to:

  • Increase public awareness of botanical drugs

  • Increase options in the healthcare system

  • Facilitate the formation of healthcare policies 

  • Serve as a platform for dialogue and collaboration between government agencies, private entities, and academics, by means of conferences and meetings

  • Promote collaboration between the pharmaceutical and botanical industries

  • Establish international standards for botanical drugs and their medical usage​

 

ABDA collaborates with research institutes and companies to evolve safe and effective botanical products into prescription botanical drugs using the FDA's botanical drug development pathway.

 

Background
     The pharmaceutical industry has been thriving for many decades but experienced slowdown in recent years. New drug development methods are needed. The FDA ”Botanical Drug Development Guidance for Industry" opens doors for botanical products like herbal medicines and cannabis-derived products to develop into prescription drugs; if a drug product is a single plant or from a mix of plants, the Guidance waives the requirement of

1) identifying active ingredients,

2) describing the mechanism of action.

 

As long as botanical products demonstrate safety and efficacy in phases 1, 2, and 3 of clinical trials, they are approved as a prescription medication in the US market. Between 2016 and 2019, 195 botanical drug clinical trials were registered, of which 81 are phase 2. By the end of 2018, over 600 IND applications were in clinical development under the botanical drug category. Two botanical products have been approved as prescription drugs:

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

  • Mytesi® (crofelemer, old name Fulyzaq), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.

The ABDA's mission is to facilitate this evolution of botanical drugs into prescription level drugs.​

 
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Botanceutical

     Modern herbal medicines come in formats of pills or capsules. Their safety and efficacy have been demonstrated by daily use on a large population. Identifying already known effective herbal medicines with promising efficacy and developing them to the US prescription botanical drugs is an efficient drug development pathway. ABDA promotes FDA botanical drug guidance and collaborates with entities around the globe to develop research and development of herbal medicines.

 

     Because herbal medicine companies are often small and lack sufficient funding to take a product through the entire FDA IND process, ABDA advocates a collaborative approach. In the collaborative approach, herbal medicine companies conduct preclinical studies and file for FDA botanical drug pre-IND and phase 1 IND. Then, herbal medicine manufactures outlicense the products for late stage development. Herbal medicine manufactures can repeat the process for several products till they have the financial strength to advance the drug product clinical development themselves.

 
 
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Industry Survey: if you are a botanical manufacture (herb or hemp), what is your view on developing your products to botanical drugs?

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