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Why do I need to consider botanical drug IND?

Dietary supplements:

  • Can not make medical claims

  • Have low market barrier and high market competition

  • High product development cost results in low-profit margin

What a botanical drug IND provides:

  • Ability to make unique medical claims and use that as a market barrier to reduce competition

  • No need to identify active ingredients

  • Can be a single plant or a mixture of multiple plants

  • No need to describe the mechanism of action

  • If an already known effective botanical product, the success rate is much higher than synthesizing a new chemical molecule or purifying a chemical molecule.

  • Spend initial investment to obtain IND# from FDA or complete phase 1, then to out-license to big pharma. The fee received from out-licensing could be US$5~12M depending on indications and terms

 
 

​What is the difference between isolating active ingredients vs botanical drug approach?

​​Isolating active ingredients approach:

  • Identifying active ingredients responsible for medical benefits is time consuming

  • After isolating one active ingredient from a botanical product, whether that active ingredient is still producing the same medical benefits is uncertain

  • Isolated active ingredient is the traditional small molecule drug development approach in which sponsors need to describe mechanism of action

  • Studying mechanism of action takes time and resources

 

Botanical drug approach:

  • Under FDA botanical drug development category, no purification or isolation of active ingredients is required

  • A botanical drug product can be a single plant, a portion of a single plant, or mixture of multiple plants

  • No mechanism of action is required

  • As long as a final drug product shows safety and efficacy through FDA IND phase 1,2,3 trials, the product is approved as a prescription drug on the US market. FDA is looking for safety and efficacy for the totality of the drug product, not for ingredients inside.

 

Conclusion: The botanical drug IND development pathway is an efficient drug development pathway.

Botanical IND
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What data is required to open an IND with the FDA?

  • Product name, description of plant products, a short description of the manufacturing process, and the final product formulation

  • Historical background information on the product development

  • in vitro pharmacology, in vivo pharmacology, in vivo toxicology, pharmacokinetics 

  • HPLC full spectrum fingerprints of the final drug product

  • Product scale-up and final formulation

  • Animal and clinical studies plans

  • Proposed indication or context of product development

  • Summary of studies completed

  • Prior human experience, if any

  • Proposed clinical study plan, whether the animal efficacy rule is being considered

pre-IND
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Preclinical Studies

​Different from a single molecule IND process, the preclinical development of drug products of mixed plants is much more complex. Although ingredients and indications differ among IND applications, all botanical drug preclinical studies share the same success formula. ABDA R&D Center offers high quality study design suitable for the FDA IND process.

  • Qualification and quantification of ingredients in a botanical drug product

  • Establishment of quality control mechanism for a botanical drug product

  • Identification of unknown ingredients in a botanical drug product

  • Quantification of known ingredients in a botanical drug product

  • In-vitro study for a botanical drug product with many ingredients

  • In-vivo study for a botanical drug product with many ingredients

  • Pre-clinical pharmacokinetics study for a botanical drug product with many ingredients

  • Dose-response study for a botanical drug product with many ingredients

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FDA Botanical Drug pre-IND Briefing Package Development

ABDA experts explain the FDA Botanical Drug Development Guidance and provide actionable direction and guidance on content development.

ABDA expert team review raw materials, collect contents, and develop the pre-IND packlet. We submit the packet to FDA, meet with FDA for discussion, and interpret FDA decision letter.

 

Certificate of Analysis

ABDA affiliated labs are FDA and DEA certified with schedule I to V permits. ABDA provides Certificate of Analysis (CoA) for cannabis and herbal products, after the following procedures:

  • Identification and quantification of THC according to FDA guidance

  • Full-spectrum cannabis testing and fingerprint

  • Full-spectrum herbal product testing and fingerprint

  • Identification of unknown ingredients

  • Quantification of known ingredients

  • Product stability test

  • Bioavailability test

  • Bioequivalence test

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Botanical Lab

ABDA has a botanical product specialized research laboratory and a GMP manufacture facility:

  • guarantee that all our laboratory experiment methods and GMP botanical production meet regulatory requirement. We repeat for free if necessary.

  • specialized in botanical product analytics and production:

    • qualitative analytics of botanical 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 products

    • develop drug product quality control methods and standards

    • animal safety test

    • pharmacokinetics study for botanical product

    • pharmacodynamics study for botanical product

    • drug stability test

    • extensive medical and toxicological literature review