The GBLX Drug Discovery Program has 5 Strategic Advantages that allow us to Patent Protect the GBLX Accelerated Drug Development Program to finish in 3-5 years instead of the 15-20 years required in the Traditional Pharmaceutical Development Program.
Certified Cannabis-based Extracts
GB Sciences promotes the use of certified plant extracts as the basis for novel drug development. While the pharmaceutical industry has exploited this rich source of chemical compounds by identifying single active ingredients in plants and making synthetic copies, GB Sciences utilizes combinations of active ingredients including cannabinoids and terpenoids found in plants, such as Cannabis, to achieve higher therapeutic effectiveness. Through the GrowBLOX Technology Suite, GBLX produces, certifies, and performs clinical trials to validate its safe and consistent GBLX formulations.
Traditional Drug Development Program
The Traditional Drug Development Program requires 15-20 years and over $1 Billion. This Traditional model is not producing new drugs at a rate that is consistent with patients needs, especially as the population is aging. Accelerated Models are required to reinvigorate the bio-pharmaceutical Industry.
Time – 23.5 years
Cost / Trial > $ billion
Revenue Time
GBLX Accelerated Drug Development Program
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion? Start with phase IV. Under state-regulated medical marijuana programs, GB Sciences can validate the effectiveness of its cannabis-based therapies in human phase IV clinical trials (1) that are coordinated through the GBLX-PRO smartphone app (2). The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses (3). GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process (4).
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion?
Step #1: Conducting human phase IV trials through state-regulated medical marijuana establishments. 
Step #2: Coordinated of human phase IV clinical trials through the GBLX-PRO smartphone app.
Step #3: The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses.
Step #4: GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process.
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion?
Step #1: Conducting human phase IV trials through state-regulated medical marijuana establishments. 
Step #2: Coordinated of human phase IV clinical trials through the GBLX-PRO smartphone app.
Step #3: The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses.
Step #4: GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process.
Time – < 15 years
Cost / Trial > $ 1 billion
Revenue Time
Drug Discovery Engine
The GBLX-PRO (GrowBLOX™-Patient Reported Outcomes) smartphone application is our novel drug discovery engine. GBLX-PRO allows for phase IV human clinical research by combining patient history data with real-time data collection and analysis of symptom surveys, cognitive tests, and biometric data. In real time, the GBLX-PRO creates a personalized medical cannabis treatment program for each individual patient. The long-term aggregated patient data sets will also strengthen our predictive treatment algorithms to improve future patient care. When the analytical correlations between Cannabis strains (ratios of active ingredients) and symptom relief have reached statistical significance, additional patents will be filed to capture those novel combinations of active ingredients.
Partnering Strategy
In the GBLX Drug Development Ecosystem, GB Sciences holds the patents and coordinates the research data from all of its research partners. All partner data is aggregated and partners are incentivized with equity in proportion to the value of the data they contribute. Bonus equity can be rewarded retroactively when data previously contributed becomes a part of a patent, IND filing, or NDA filing. This equity incentive system should increase efficiency and productivity in drug discovery; as well as encouraging both real and virtual collaboration among the researchers in the ecosystem. (Put following in a separate text box below the figure as a legend.) GB Sciences fills the DISCOVERY role in the ecosystem. The other members of the GBLX Drug Development Ecosystem include universities, small and medium biotechnology companies and clinical research organizations (CRO). PRECLINICAL research is run by our University partners. CLINICAL Trials are run by our Clinical Research Organization (CRO) partners, or may be licensed to Pharmaceutical Licensees prior to the Human Phase III trials. DISTRIBUTION is through specialty pharmaceutical channels, including hospitals and research centers.
GB Sciences fills the DISCOVERY role in the ecosystem. The other members of the GBLX Drug Development Ecosystem include universities, small and medium biotechnology companies and clinical research organizations (CRO). PRECLINICAL research is run by our University partners. CLINICAL Trials are run by our Clinical Research Organization (CRO) partners, or may be licensed to Pharmaceutical Licensees prior to the Human Phase III trials. DISTRIBUTION is through specialty pharmaceutical channels, including hospitals and research centers.
Is Cannabis Research Possible?
Human trials to determine the effects of Cannabis are possible. Three different Federal Agencies are involved. The US FDA has published guidance on "Marijuana Research with Human Subjects" at: click me
Typical Process for Conducting Research with Marijuana
Step 1: Sponsor obtains pre-IND number from FDA.
Step 2: Sponsor contacts NIDA to obtain information on the specific strains of marijuana available, so that information can be included in the IND application.
Step 3: Sponsor contacts DEA for registration application and Schedule 1 license.
Step 4: Sponsor receives Letter of Authorization (LOA) from NIDA.
Step 5: Sponsor sends copy of IND/protocol and LOA to FDA and DEA.
Step 6: FDA reviews the IND.
Step 7: Sponsor contacts NIDA to obtain the marijuana after the FDA completes its review of the IND, and the DEA registration is received.
188 US FDA Registered Clinical Trials
Searching the NIH database of human clinical trials at www.clinicaltrials.gov, indicated 188 human Cannabis trials that were registered, as well as their corresponding phase of development and the sponsors. The search was performed by: 1) using marijuana or cannabis as keywords (yielded 519), 2) removed device or behavioral intervention studies; and 3) removed rimonabant or other CB1 antagonist trials(yielded 188).
Who Sponsors Clinical Trials?
In the 188 Cannabis trials from our NIH database search, sponsorship was split almost equally between biopharmaceutical companies and universities. In addition, 21% were sponsored by collaborations between biopharmaceutical companies and universities.
The GBLX Drug Discovery Program has 5 Strategic Advantages that allow us to Patent Protect the GBLX Accelerated Drug Development Program to finish in 3-5 years instead of the 15-20 years required in the Traditional Pharmaceutical Development Program.
Certified Cannabis-based Extracts
GB Sciences promotes the use of certified plant extracts as the basis for novel drug development. While the pharmaceutical industry has exploited this rich source of chemical compounds by identifying single active ingredients in plants and making synthetic copies, GB Sciences utilizes combinations of active ingredients including cannabinoids and terpenoids found in plants, such as Cannabis, to achieve higher therapeutic effectiveness. Through the GrowBLOX Technology Suite, GBLX produces, certifies, and performs clinical trials to validate its safe and consistent GBLX formulations.
Traditional Drug Development Program
The Traditional Drug Development Program requires 15-20 years and over $1 Billion. This Traditional model is not producing new drugs at a rate that is consistent with patients needs, especially as the population is aging. Accelerated Models are required to reinvigorate the bio-pharmaceutical Industry.
Time:  ~ 23.5 years
Cost/Trial:  > $ 1 billion
Revenue Time:
GBLX Accelerated Drug Development Program
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion? Start with phase IV. Under state-regulated medical marijuana programs, GB Sciences can validate the effectiveness of its cannabis-based therapies in human phase IV clinical trials (1) that are coordinated through the GBLX-PRO smartphone app (2). The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses (3). GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process (4).
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion?
Step #1: Conducting human phase IV trials through state-regulated medical marijuana establishments. 
Step #2: Coordinated of human phase IV clinical trials through the GBLX-PRO smartphone app.
Step #3: The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses.
Step #4: GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process.
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion?
Step #1: Conducting human phase IV trials through state-regulated medical marijuana establishments. 
Step #2: Coordinated of human phase IV clinical trials through the GBLX-PRO smartphone app.
Step #3: The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses.
Step #4: GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process.
Time:  < 7 years
Cost/Trial:  < $ 10 million
Revenue Time:
Drug Discovery Engine
The GBLX-PRO (GrowBLOX™-Patient Reported Outcomes) smartphone application is our novel drug discovery engine. GBLX-PRO allows for phase IV human clinical research by combining patient history data with real-time data collection and analysis of symptom surveys, cognitive tests, and biometric data. In real time, the GBLX-PRO creates a personalized medical cannabis treatment program for each individual patient. The long-term aggregated patient data sets will also strengthen our predictive treatment algorithms to improve future patient care. When the analytical correlations between Cannabis strains (ratios of active ingredients) and symptom relief have reached statistical significance, additional patents will be filed to capture those novel combinations of active ingredients.
Partnering Strategy
In the GBLX Drug Development Ecosystem, GB Sciences holds the patents and coordinates the research data from all of its research partners. All partner data is aggregated and partners are incentivized with equity in proportion to the value of the data they contribute. Bonus equity can be rewarded retroactively when data previously contributed becomes a part of a patent, IND filing, or NDA filing. This equity incentive system should increase efficiency and productivity in drug discovery; as well as encouraging both real and virtual collaboration among the researchers in the ecosystem. (Put following in a separate text box below the figure as a legend.) GB Sciences fills the DISCOVERY role in the ecosystem. The other members of the GBLX Drug Development Ecosystem include universities, small and medium biotechnology companies and clinical research organizations (CRO). PRECLINICAL research is run by our University partners. CLINICAL Trials are run by our Clinical Research Organization (CRO) partners, or may be licensed to Pharmaceutical Licensees prior to the Human Phase III trials. DISTRIBUTION is through specialty pharmaceutical channels, including hospitals and research centers.
GB Sciences fills the DISCOVERY role in the ecosystem. The other members of the GBLX Drug Development Ecosystem include universities, small and medium biotechnology companies and clinical research organizations (CRO). PRECLINICAL research is run by our University partners. CLINICAL Trials are run by our Clinical Research Organization (CRO) partners, or may be licensed to Pharmaceutical Licensees prior to the Human Phase III trials. DISTRIBUTION is through specialty pharmaceutical channels, including hospitals and research centers.
Is Cannabis Research Possible?
Human trials to determine the effects of Cannabis are possible. Three different Federal Agencies are involved. The US FDA has published guidance on "Marijuana Research with Human Subjects" at: click me
Typical Process for Conducting Research with Marijuana
Step 1: Sponsor obtains pre-IND number from FDA.
Step 2: Sponsor contacts NIDA to obtain information on the specific strains of marijuana available, so that information can be included in the IND application.
Step 3: Sponsor contacts DEA for registration application and Schedule 1 license.
Step 4: Sponsor receives Letter of Authorization (LOA) from NIDA.
Step 5: Sponsor sends copy of IND/protocol and LOA to FDA and DEA.
Step 6: FDA reviews the IND.
Step 7: Sponsor contacts NIDA to obtain the marijuana after the FDA completes its review of the IND, and the DEA registration is received.
188 US FDA Registered Clinical Trials
Searching the NIH database of human clinical trials at www.clinicaltrials.gov, indicated 188 human Cannabis trials that were registered, as well as their corresponding phase of development and the sponsors. The search was performed by: 1) using marijuana or cannabis as keywords (yielded 519), 2) removed device or behavioral intervention studies; and 3) removed rimonabant or other CB1 antagonist trials(yielded 188).
The GBLX Drug Discovery Program has 5 Strategic Advantages that allow us to Patent Protect the GBLX Accelerated Drug Development Program to finish in 3-5 years instead of the 15-20 years required in the Traditional Pharmaceutical Development Program.
Certified Cannabis-based Extracts
GB Sciences promotes the use of certified plant extracts as the basis for novel drug development. While the pharmaceutical industry has exploited this rich source of chemical compounds by identifying single active ingredients in plants and making synthetic copies, GB Sciences utilizes combinations of active ingredients including cannabinoids and terpenoids found in plants, such as Cannabis, to achieve higher therapeutic effectiveness. Through the GrowBLOX Technology Suite, GBLX produces, certifies, and performs clinical trials to validate its safe and consistent GBLX formulations.
Traditional Drug Development Program
The Traditional Drug Development Program requires 15-20 years and over $1 Billion. This Traditional model is not producing new drugs at a rate that is consistent with patients needs, especially as the population is aging. Accelerated Models are required to reinvigorate the bio-pharmaceutical Industry.
Time – 23.5 years
Cost / Trial > $ billion
Revenue Time
GBLX Accelerated Drug Development Program
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion? Start with phase IV. Under state-regulated medical marijuana programs, GB Sciences can validate the effectiveness of its cannabis-based therapies in human phase IV clinical trials (1) that are coordinated through the GBLX-PRO smartphone app (2). The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses (3). GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process (4).
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion?
Step #1: Conducting human phase IV trials through state-regulated medical marijuana establishments. 
Step #2: Coordinated of human phase IV clinical trials through the GBLX-PRO smartphone app.
Step #3: The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses.
Step #4: GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process.
How do you get from phase I to phase IV human trials in less than 15 years and for less than $1 Billion?
Step #1: Conducting human phase IV trials through state-regulated medical marijuana establishments. 
Step #2: Coordinated of human phase IV clinical trials through the GBLX-PRO smartphone app.
Step #3: The GBLX-PRO app coordinates strain profile information with symptom relief as a part of the GBLX Drug Discovery Program. Our GBLX Accelerated Regulatory Strategy leverages established Cannabis safety profiles as well as FastTrack Approvals or Orphan Drug designations to reduce clinical trial times and expenses.
Step #4: GBLX is also able to earn revenue from sales of the certified raw materials through dispensaries sales during the drug discovery process.
Time – < 15 years
Cost / Trial > $ 1 billion
Revenue Time
Drug Discovery Engine
The GBLX-PRO (GrowBLOX™-Patient Reported Outcomes) smartphone application is our novel drug discovery engine. GBLX-PRO allows for phase IV human clinical research by combining patient history data with real-time data collection and analysis of symptom surveys, cognitive tests, and biometric data. In real time, the GBLX-PRO creates a personalized medical cannabis treatment program for each individual patient. The long-term aggregated patient data sets will also strengthen our predictive treatment algorithms to improve future patient care. When the analytical correlations between Cannabis strains (ratios of active ingredients) and symptom relief have reached statistical significance, additional patents will be filed to capture those novel combinations of active ingredients.
Partnering Strategy
In the GBLX Drug Development Ecosystem, GB Sciences holds the patents and coordinates the research data from all of its research partners. All partner data is aggregated and partners are incentivized with equity in proportion to the value of the data they contribute. Bonus equity can be rewarded retroactively when data previously contributed becomes a part of a patent, IND filing, or NDA filing. This equity incentive system should increase efficiency and productivity in drug discovery; as well as encouraging both real and virtual collaboration among the researchers in the ecosystem. (Put following in a separate text box below the figure as a legend.) GB Sciences fills the DISCOVERY role in the ecosystem. The other members of the GBLX Drug Development Ecosystem include universities, small and medium biotechnology companies and clinical research organizations (CRO). PRECLINICAL research is run by our University partners. CLINICAL Trials are run by our Clinical Research Organization (CRO) partners, or may be licensed to Pharmaceutical Licensees prior to the Human Phase III trials. DISTRIBUTION is through specialty pharmaceutical channels, including hospitals and research centers.
GB Sciences fills the DISCOVERY role in the ecosystem. The other members of the GBLX Drug Development Ecosystem include universities, small and medium biotechnology companies and clinical research organizations (CRO). PRECLINICAL research is run by our University partners. CLINICAL Trials are run by our Clinical Research Organization (CRO) partners, or may be licensed to Pharmaceutical Licensees prior to the Human Phase III trials. DISTRIBUTION is through specialty pharmaceutical channels, including hospitals and research centers.
Is Cannabis Research Possible?
Human trials to determine the effects of Cannabis are possible. Three different Federal Agencies are involved. The US FDA has published guidance on "Marijuana Research with Human Subjects" at: click me
Typical Process for Conducting Research with Marijuana
Step 1: Sponsor obtains pre-IND number from FDA.
Step 2: Sponsor contacts NIDA to obtain information on the specific strains of marijuana available, so that information can be included in the IND application.
Step 3: Sponsor contacts DEA for registration application and Schedule 1 license.
Step 4: Sponsor receives Letter of Authorization (LOA) from NIDA.
Step 5: Sponsor sends copy of IND/protocol and LOA to FDA and DEA.
Step 6: FDA reviews the IND.
Step 7: Sponsor contacts NIDA to obtain the marijuana after the FDA completes its review of the IND, and the DEA registration is received.
188 US FDA Registered Clinical Trials
Searching the NIH database of human clinical trials at www.clinicaltrials.gov, indicated 188 human Cannabis trials that were registered, as well as their corresponding phase of development and the sponsors. The search was performed by: 1) using marijuana or cannabis as keywords (yielded 519), 2) removed device or behavioral intervention studies; and 3) removed rimonabant or other CB1 antagonist trials(yielded 188).
Who Sponsors Clinical Trials?
In the 188 Cannabis trials from our NIH database search, sponsorship was split almost equally between biopharmaceutical companies and universities. In addition, 21% were sponsored by collaborations between biopharmaceutical companies and universities.
Who Sponsors Clinical Trials?
In the 188 Cannabis trials from our NIH database search, sponsorship was split almost equally between biopharmaceutical companies and universities. In addition, 21% were sponsored by collaborations between biopharmaceutical companies and universities.
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