Clever Leaves
Clever leaves Logo

Medical cannabis
from Colombia
can change lives.


PROJECT CHANGE LIVES:
CLEVER LEAVES’ $25 MILLION DOLLAR PRODUCT PLEDGE

PROJECT CHANGE LIVES: CLEVER LEAVES’ $25 MILLION DOLLAR PRODUCT PLEDGE

 

Clever Leaves has committed to granting up to USD $25 million retail value in Colombian grown cannabis to help advance research into the potential medical benefits of the cannabis plant.

That’s up to 250,000 bottles of pharmaceutical-grade cannabis oils or approximately 5 tons of medical cannabis flower that will help research institutions in the US develop new therapies.

The benefits of medical cannabis have been well-documented, in epilepsy, multiple-sclerosis, chronic pain, chemotherapy-induced nausea, HIV complications and a variety of other chronic disease states.

However, legal restrictions have delayed millions of patients’ access to the significant symptom improvement in chronic conditions, as well as potentially life-changing therapy options, that cannabis research could unlock.

While there have been some recent policy improvements, there is still an insufficient supply of legal, high-quality, GMP-certified medical cannabis, and researchers cannot always find the standardized cannabis products they need for their scientific studies.

We want to help change that.

 

MEDICAL CANNABIS CAN CHANGE LIVES

 

At Clever Leaves, we know that cannabis can change lives, and it is  our mission to foster a healthier global community by supporting the development of potentially life-changing therapies with pharmaceutical-quality cannabis and cannabis derivatives.

Colombia has one of the friendliest climates for sustainable cannabis cultivation in the world, and we have the capacity and competencies to consistently provide universities, hospitals, and research institutions a variety of formulations for all types of medical research.

JOIN THE CAUSE

Medical cannabis can change lives, and together we can make it happen.

In collaboration with a scientific review panel of clinicians and Biopharmaceutical Research Company (biopharmaresearchco.com), a company which holds federal licenses for importing, analyzing and manufacturing controlled substances in the U.S., we are launching a nationwide call for proposals from researchers seeking medical cannabis to conduct their studies.

With initial investigational studies already underway, we are looking to support additional qualified institutions by supplying up to $25 million dollars’ retail value of our pharmaceutical-grade medical cannabis.

To submit an application and learn more about the RFP process, grant qualifications, and our application review board, please click here.

Not a member of a research institution? Support our mission by signing a Change.Org petition supporting the legalization of medical cannabis in the United States.

WHO WE ARE

Clever Leaves (NASDAQ: CLVR) has worked hard to build one of the largest and most sustainable cultivation and extraction operations in Latin America and the world.

We are a multinational cannabis company with operations and investments in the United States, Canada, Colombia, Germany, and Portugal.

With initial investigational studies already underway, we are looking to support additional qualified institutions by supplying up to $25 million dollars’ retail value of our pharmaceutical-grade medical cannabis.

We are one of the few, fully integrated cannabis companies to be granted the European Union Good Manufacturing Practices (EU GMP) certification for our extraction facilities, and we are already shipping our pharmaceutical-grade products to clients and research facilities in over 15 countries on 5 continents around the world.

Submit an application and learn more about the RFP process

 

PCL Review Panel

Dr. David Casarett

Co-Director of the Change Lives Campaign, Duke

Dr. David Casarett

Co-Director of the Change Lives Project, Duke

Dr. Ryan Vandrey

Johns Hopkins

Dr. Ryan Vandrey

Johns Hopkins

Dr. Ziva Cooper

UCLA

Dr. Ziva Cooper

UCLA

Dr. Donald Abrams

UCSF

Dr. Donald Abrams

UCSF

Dr. Mark Wallace

USD

Dr. Mark Wallace

USD

FAQ

We encourage inquiries early in the process. A brief (1-2 paragraph) summary can help to determine whether this funding mechanism is appropriate for a planned study.  If it appears the project is a good fit for the Change Lives initiative, investigators can use the following steps as a guide:

  1. Obtain a valid Schedule I license.
  2. Submit a Letter of Intent to PCLLOI@cleverleaves.com.  Contents of the LOI are specified in the formal [Request for Proposals LINK will be enabled 6/28/21] and include names and affiliations of investigator(s), project title, brief project description, and a statement of the product requested.
  3. If the LOI is approved, the Change Lives initiative staff will share with the investigator a technical description of the product requested, which will contain sufficient detail for an IRB application and research proposal. 
  4. The investigator submits a formal proposal.
  5. If the proposal is approved, the investigators submit an IND application, using technical data supplied by Clever Leaves.
  6. Once the IND application is approved, the investigator notifies the Change Lives staff and the process for import/export is initiated.

Yes. Proof of a Schedule I license must be included in the grant application.

Clever Leaves does not currently expect to offer financial or administrative assistance to Schedule I license applicants but we will provide any required information that investigators need to help support their own license applications.

Yes. Applications will be considered on a rolling basis, on the first day of every month.  Proposals submitted in the middle of the month will be reviewed the following month.
If a proposal is sent for external review, investigators will receive reviewers’ comments.  Proposals that are not selected for external review will receive a summary statement.

Yes. Up to two resubmissions are permitted.  A cover letter should include a point-by-point summary of how reviewers’ comments were addressed.  All changes should be tracked.

The Change Lives Initiative has assembled a panel of reviewers who are recognized experts in clinical cannabis use, cannabis researchers, and research methods.  Reviewers will score applications using standard National Institutes of Health (NIH) categories (e.g. significance, impact, approach, etc.).

Yes. IRB approval is required before product can be shipped.  Although IRB approval is not required before proposal review, investigators are encouraged to submit an IRB proposal as early as possible in order to expedite product availability once a proposal is funded.

Usually—most academic institutions will require one. 

Products meet GACP and EUGMP standards for the cultivation process.

Product development is conducted to EUGMP standards and follows German Pharmacopeia standards for testing requirements.

Shipping can be initiated once an investigator has received funding approval, IRB approval, and IND approval.  Once these steps are achieved, the typical time to receipt of product is approximately 30 days.

The following products are available now

  • CBD isolates.
  • Full spectrum high CBD bulk extracts with up to 4% THC.
  • Full spectrum high THC bulk extracts with up to 6% CBD.
  • Standard CBD bulk extracts with <1% THC.
  • Oral CBD solutions with <1% THC.

The following products will be available by Q3-Q4 2021

  • Broad spectrum high CBD bulk extracts with less than 0.2% THC.
  • Distillate high THC bulk extracts.
  • Oral balanced CBD and THC solutions.
  • Oral solutions with high THC.
  • Oral solutions with high CBD and non-detectable levels of THC.

OTHER FAQ

Clever Leaves is committed to study of medical cannabis and the development of the scientific knowledge of the plant, including through clinical studies that will allow medical cannabis to be of greater help and benefit to patients worldwide. We have decided to begin our initiative in the United States, but we anticipate that over the next 5 years we will be able to expand our efforts into new countries as global laws and regulations develop.

The program has initially been proposed for a period of 5 years in the United States. We hope that the results of our US campaign will be promising and that in the future we will be able to explore the possibility of extending Project Change Lives to other countries. 

Our goal is to provide up to $25 million in cannabis products for federally-legal research purposes in the United States over the next 5 years with the following specific Key Goals:

 

  • Promote high-quality interventional cannabis research
  • Encourage innovation in data collection methods that facilitate the efficient creation of generalizable knowledge through non-traditional research designs (e.g. adaptive and pragmatic trials)
  • Encourage the use of innovative and efficient strategies for collecting patient-reported outcomes
  • Guide the cannabis research field toward standardizing data elements and move the field toward more consistency in instruments, variables, and methods of data collection
  • Support and encourage women and underrepresented minority scientists and researchers working in the cannabis space and in academia.

We believe that supporting scientific research into medical cannabis will bring significant benefits to patients around the world who suffer from different pathologies and who will have access to more and better medical cannabis products.

Studies have suggested that the use of medical cannabis has shown signs of effectiveness for a range of pathologies including, chronic pain, multiple sclerosis spasticity, chemotherapy nausea and vomiting, and refractory epilepsy; and the plant’s potential for human benefit is known to be immense.

 

We hope that the possibility of having the pharmaceutical-grade product to develop research protocols aimed at finding quality solutions to treat other sensitive pathologies will be of interest to different scientific and research organizations.

 

At Clever Leaves we believe that medical cannabis should receive the same scientific rigor as any other medicine and science should focus its efforts on rigorous research into its therapeutic potential.

 

CULTIVATE MOJO, CREATE VALUE, CHANGE LIVES