Service

 
partnering with ABDC (www.BotanicalDrug.com) to serve the cannabis and herbal industry for prescription botanical drug IND development
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Why do I need to consider botanical drug IND?

Dietary supplement:

  • can not make medical claims

  • low market barrier and high market competition

  • high product development cost results in low profit margin

Botanical Drug IND:

  • 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 mixture of multiple plants

  • no need to describe mechanism of action

  • if choose already known efficacious botanical products, success rate is much higher than to synthesize a new chemical molecule or to purify 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

Why Botanical Drug?
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​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: botanical drug IND development is an efficient drug development pathway.

Botanical Drug IND
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Botanical Drug Product Initial Assessment (Paid Service)

"Is my botanical product good for botanical drug IND?"

 

Drug Product Initial Assessment: a fee-based service to evaluate data/material already collected, and to identify data gap and measures to close the gap

  • review data/materials provided by sponsors

  • assess data validity and usability for FDA botanical drug IND

  • identify data gap

  • identify measures to close a gap

  • identify timelines and costs associated with closing a gap for the purpose of obtaining a FDA IND#

  • advise on selection of medical indication

  • estimate the success rate of gaining a FDA IND#

  • estimate the likelihood to outlicense a drug product after phase-1 to big pharma

Initial Assessment
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What data are required to open an IND with FDA?

  • product name, description of plant products, short description of the manufacture process, and the final product formulation

  • historical background information on the product development concept

  • HPLC full spectrum fingerprints of the final drug product

  • product scale-up and final formulation, and 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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Hemp and Herbal Product Preclinical Study Design and Execution (Paid Service)

Different from small single molecule study design and execution, drug product of mixed plants is much more complex and requires different study design and execution:

  • qualification and quantification of ingredients in a botanical drug product

  • establish quality control mechanism for a botanical drug product

  • identify unknown ingredients in a botanical drug product

  • quantify 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

 

FDA Botanical Drug pre-IND Briefing Package Development (Paid Service)

  • guide on material gathering

  • review, organize, and analyze data

  • use best data to develop sections in the pre-IND package

  • submit pre-IND package to FDA

  • meet with FDA for Q&A

  • revise pre-IND package if needed

  • Goal: receive an IND# from US FDA for botanical drug clinical development

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Certificate of Analysis (Paid Service)

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

  • 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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