The current research on cannabis smoking and vaping. How much THC is inhaled, which compounds are formed through heating and combustion, and how is this research done.
DELIC Labs seeks to add scientific insight to cannabis and mushroom production through collaborative research. Their research focuses on process design, optimization, analytics, and formulation. They collaborate with academic and industry partners. Their research topics include process control, kinetics, in-process analytics, computational studies, and process development. CO2 extraction optimization is limited by focusing on single parameters and empirical exploration. DELIC Labs uses over 100,000 data points from multiple instruments and producers to develop machine learning and Bayesian optimization models to identify optimal extraction conditions considering multiple interactive factors.
Don’t hold your breath: Smoke and vaping studies on cannabis products to qua...Markus Roggen
Delic Labs is a research company that collaborates with academic and industry partners to study cannabis and mushroom production through process design, optimization, and analytics research. Their research focuses on understanding thermal degradation of cannabinoids and terpenes during smoking and vaping, as well as quantifying cannabinoid and terpene levels inhaled on a puff-by-puff basis to provide insights into real-world usage. The research aims to add fundamental scientific insights to support the cannabis and mushroom industries.
Cannabis Science Conference 2019: CBDV Fundamental CollaborationMarkus Roggen
CBDV is a research venture that seeks to add fundamental scientific insight to cannabis production through collaboration. It operates a research hub in Vancouver for process design, optimization, analytics, and formulation research. CBDV collaborates with academic and industry partners globally on topics like extraction optimization, analytics for reaction monitoring, and computational studies on decarboxylation rates. The goal is to answer fundamental questions about cannabis cultivation and processing to support a mature cannabis products market.
Dr. Markus Roggen founded Complex Biotech Discovery Ventures (CBDV) to establish a research hub focused on fundamental scientific insights into cannabis production processes like decarboxylation and crystallization through collaborative projects with academic and industry partners utilizing analytical techniques like infrared spectroscopy and computational studies. CBDV seeks to optimize cannabis processing through in-line monitoring, design of experiments, data analytics, and developing a metabolite database to support the industry.
Don't Hold Your Breath! Cannabis Labs Virtual 2021Markus Roggen
CBDV is a research venture seeking to add scientific insights to cannabis and mushroom production through collaborative research on process design, optimization, and analytics. The research focuses on topics like chemometrics, kinetic studies, in-process analytics, and computational studies to understand fundamental cannabis and mushroom chemistry. Studies have found that smoking produces higher levels of toxic thermal degradation products than vaping, and that consumption method, voltage level, and oil weight can impact toxicant levels and THC delivery.
CBDV is a research venture seeking to develop analytical methods like HPLC to quantify psilocybin in psychedelic mushrooms for cultivation sites, as current methods take too long; they developed a 3.5 minute HPLC method using ammonium bicarbonate and acetonitrile to quantify psilocybin without degradation, and will next explore extraction methods from mushrooms.
Artificial Intelligence for Craft Cannabis ProductsMarkus Roggen
Cannabis extraction operations focus on extraction yields. This is an imprecise way to think about production. Defining the yield as yield per pound of biomass is very difference to yield per hour. And yield should not be the only focus for extractors. Quality of extract, cost of extraction, loss in post-processing, all these aspects should be considered too.
Our laboratory undertook extensive experimental studies on the extraction behavior of various solvents. We furthermore analyzed thousands of real-world extractions, from various producers and for different instruments to build a machine learning algorithm that can optimize extraction processes autonomously.
We present our latest results and insights from developing and utilizing our extraction optimization AI, to give the audience most actionable insight on how to make better cannabis extracts.
MJBiz Con: Leading Issues in Hemp ScienceMarkus Roggen
This document summarizes hemp processing techniques including extraction methods using solvents like CO2 and ethanol. It discusses post-processing steps like decarboxylation to convert acids to neutrals, distillation to separate compounds by boiling point, chromatography to separate mixtures, and crystallization to produce pure CBD isolate. The genetic differences between hemp and cannabis are also covered as well as how regulations define hemp based on THC content.
DELIC Labs seeks to add scientific insight to cannabis and mushroom production through collaborative research. Their research focuses on process design, optimization, analytics, and formulation. They collaborate with academic and industry partners. Their research topics include process control, kinetics, in-process analytics, computational studies, and process development. CO2 extraction optimization is limited by focusing on single parameters and empirical exploration. DELIC Labs uses over 100,000 data points from multiple instruments and producers to develop machine learning and Bayesian optimization models to identify optimal extraction conditions considering multiple interactive factors.
Don’t hold your breath: Smoke and vaping studies on cannabis products to qua...Markus Roggen
Delic Labs is a research company that collaborates with academic and industry partners to study cannabis and mushroom production through process design, optimization, and analytics research. Their research focuses on understanding thermal degradation of cannabinoids and terpenes during smoking and vaping, as well as quantifying cannabinoid and terpene levels inhaled on a puff-by-puff basis to provide insights into real-world usage. The research aims to add fundamental scientific insights to support the cannabis and mushroom industries.
Cannabis Science Conference 2019: CBDV Fundamental CollaborationMarkus Roggen
CBDV is a research venture that seeks to add fundamental scientific insight to cannabis production through collaboration. It operates a research hub in Vancouver for process design, optimization, analytics, and formulation research. CBDV collaborates with academic and industry partners globally on topics like extraction optimization, analytics for reaction monitoring, and computational studies on decarboxylation rates. The goal is to answer fundamental questions about cannabis cultivation and processing to support a mature cannabis products market.
Dr. Markus Roggen founded Complex Biotech Discovery Ventures (CBDV) to establish a research hub focused on fundamental scientific insights into cannabis production processes like decarboxylation and crystallization through collaborative projects with academic and industry partners utilizing analytical techniques like infrared spectroscopy and computational studies. CBDV seeks to optimize cannabis processing through in-line monitoring, design of experiments, data analytics, and developing a metabolite database to support the industry.
Don't Hold Your Breath! Cannabis Labs Virtual 2021Markus Roggen
CBDV is a research venture seeking to add scientific insights to cannabis and mushroom production through collaborative research on process design, optimization, and analytics. The research focuses on topics like chemometrics, kinetic studies, in-process analytics, and computational studies to understand fundamental cannabis and mushroom chemistry. Studies have found that smoking produces higher levels of toxic thermal degradation products than vaping, and that consumption method, voltage level, and oil weight can impact toxicant levels and THC delivery.
CBDV is a research venture seeking to develop analytical methods like HPLC to quantify psilocybin in psychedelic mushrooms for cultivation sites, as current methods take too long; they developed a 3.5 minute HPLC method using ammonium bicarbonate and acetonitrile to quantify psilocybin without degradation, and will next explore extraction methods from mushrooms.
Artificial Intelligence for Craft Cannabis ProductsMarkus Roggen
Cannabis extraction operations focus on extraction yields. This is an imprecise way to think about production. Defining the yield as yield per pound of biomass is very difference to yield per hour. And yield should not be the only focus for extractors. Quality of extract, cost of extraction, loss in post-processing, all these aspects should be considered too.
Our laboratory undertook extensive experimental studies on the extraction behavior of various solvents. We furthermore analyzed thousands of real-world extractions, from various producers and for different instruments to build a machine learning algorithm that can optimize extraction processes autonomously.
We present our latest results and insights from developing and utilizing our extraction optimization AI, to give the audience most actionable insight on how to make better cannabis extracts.
MJBiz Con: Leading Issues in Hemp ScienceMarkus Roggen
This document summarizes hemp processing techniques including extraction methods using solvents like CO2 and ethanol. It discusses post-processing steps like decarboxylation to convert acids to neutrals, distillation to separate compounds by boiling point, chromatography to separate mixtures, and crystallization to produce pure CBD isolate. The genetic differences between hemp and cannabis are also covered as well as how regulations define hemp based on THC content.
Cannabis Chemistry Industrial Applications of Chemistry & Innovation and Entr...Markus Roggen
Lecture at the chemistry department of Imperial College, London. A brought overview and specific deep dive into the chemical aspects of cannabis production.
CannMed 2018: Controlling Terpenes and Cannabinoids in Flower and ExtractMarkus Roggen
This document summarizes a presentation about controlling terpenes and cannabinoids in cannabis flowers and extracts. It discusses how cultivation conditions, drying/curing methods, extraction techniques, and post-processing can influence terpene and cannabinoid levels and ratios. It provides an example of how using THC from different cultivars in a CBD/THC oil caused a patient's seizures to resume, demonstrating the importance of chemovars for medical effects. The presenter advocates for research collaborations to better understand these complex relationships.
1) CBDV is a research venture that seeks to add scientific insight to cannabis and mushroom production through process design, optimization, analytics, and formulation research conducted in collaboration with academic and industry partners.
2) CBDV's research topics include chemometrics, kinetics, in-process analytics, computational studies, and process development for fundamental cannabis and mushroom chemistry.
3) CBDV has expertise in analytical chemistry, process chemistry, engineering, physics, data science, and statistics and is led by Dr. Markus Roggen and Prof. Glenn Sammis to provide scientific insights and solutions for the cannabis and mushroom industries.
Out of the Shadows: Identifying Impurities in Cannabis ProductsMarkus Roggen
Highly concentrated cannabis products have seen rapid growth, as customers become more accustomed to cannabis consumption and actively seek out high-potency products. Cannabis concentrates come in various forms and product names, from Badder, Budder and Crumble to Distillate, Oil and Shatter. Those products can have THC concentrations are high as 95%, compared with less than 25% common in cannabis flower.
While the actual THC concentration can vary between 70 and 95%, what is common for all cannabis concentrates is that the total of identified compounds seldomly goes above 95% of product weight.
Delic Labs is a research venture that seeks to add fundamental scientific insight to the field of cannabis and mushroom production. In this regard, we set out to identify those compounds in the missing mass balance for cannabis concentrates. This presentation will show our latest advances in characterizing and quantifying impurities in cannabis concentrates. For example, we found reduced cannabinoid species in CBN products, THC isomers in distillates and oxidation products in CBD formulations.
Lecture given by Ed Griffen UKQSAR meeting Sept 2017. Covers material from work in our paper http://pubs.acs.org/doi/10.1021/acs.jmedchem.7b00935 background discussed in https://www.linkedin.com/pulse/first-draft-medicinal-chemistry-admet-encyclopedia-ed-griffen/
SCI What can Big Data do for Chemistry 2017 MedChemicaEd Griffen
This document discusses how advanced analytics and big data techniques can be applied in the chemistry industry. It provides examples of how matched molecular pair analysis has been used to extract statistically valid structure-activity relationships from large datasets and summarize them in the form of transformation rules. These rules have helped suggest new molecules, explore structure-activity relationships, identify exceptional structure-property relationships, and enable the rapid optimization of drug candidates. The document argues that combining data from multiple sources yields more comprehensive rules and that interfaces must be designed with the intended users in mind.
The relative risk of cancer from smoking and vaping nicotine yfzsc5g7nm
- Vaping exposes users to lower levels of carcinogens compared to smoking, as key carcinogens in tobacco smoke are present at far lower doses in e-cigarette vapor.
- Modelling studies predict the lifetime risk of cancer from vaping will be substantially less than from smoking, ranging from 0.4-1.4% of the risk from smoking.
- Based on the dose and cancer potency of carcinogens present, experts assess that switching from smoking to vaping nicotine substantially reduces lifetime cancer risk, though long-term risks are not fully known.
From Leaf to Lab: Uncovering the Molecular Mysteries of CannabisMarkus Roggen
This lecture presents our cannabis research, conducted in collaboration with the University of British Columbia (UBC) Chemistry Department.
Bridging the gap between analytical chemistry, machine learning, and synthetic chemistry, this compilation of studies explores the multifaceted nature of cannabis compounds. We begin with advancements in extraction techniques, utilizing machine learning to optimize yield predictions in large-scale botanical recovery, specifically focusing on cannabis. This approach significantly enhances the efficiency and precision of extraction processes. We then transitions to molecular analysis, examining the stability and transformation of CBD derivatives, highlighting the need for robust quality control in product development. Additionally, the lecture addresses the critical aspect of safety in cannabis use by exploring innovative strategies for heavy metal testing, demonstrating how pooling methods can reduce testing resources while maintaining safety standards. The lecture will answer the question of how to build the best joint, the implications of joint architecture on cannabis consumption, offering insights into optimizing product efficacy and consumer experience.
Overall, this lecture encapsulates the collaborative efforts between academia and innovative research, providing a comprehensive understanding of the complexities and potential of cannabis chemistry.
How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Re...MMS Holdings
What You Will Learn
The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.
In this webinar, a cross-functional team of statistical programmers and regulatory experts will share actionable insights to help study teams prepare for the new requirements.
Attendees will learn how to:
Understand nonclinical study data submissions to CDER and CBER
Differentiate biologics from drug submission in non-clinical studies
Prepare for this change to ensure a successful submission.
Solve the challenges of a SEND package
Ensure compliance with both SEND 3.1 and 3.1.1 for submission of nonclinical data to CDER and CBERHo
Separate SEND IG DART 1.1 from SEND IG
Manage legacy studies and studies that already meet requirements
Differentiate between submission packages
Use the FDA’s data standard catalog, technical conformance guide and controlled terminology
Who Will Benefit from Attending?
Regulatory Affairs and Submissions Professionals
Pharmaceutical Data and Programming Professionals
Nonclinical/Preclinical Development Professionals
The document discusses Good Laboratory Practice (GLP) standards which are regulations for conducting non-clinical safety studies to support research and product approvals. It provides an overview of the history and development of GLP, describing how poor laboratory practices in the 1970s led the FDA to create formal GLP regulations in 1978. It also discusses the key principles of GLP for ensuring quality, integrity and traceability of non-clinical study data.
InSyBio is developing an integrated cloud platform for biomarker discovery to improve precision medicine and clinical trials. Their platform performs end-to-end biomarker analysis from raw biological data through extraction, interpretation and applications. This is more efficient than existing fragmented methods. InSyBio's biomarkers are highly accurate with small sample sizes and can reduce clinical trial costs and times. Their platform has applications in nutrition, pharma and diagnostics.
Presentation: Medicinal Cannabis Evidence for Efficacy Clinical Guidance Deve...TGA Australia
The document summarizes reviews of evidence for the efficacy of medicinal cannabis. Regarding epilepsy, randomized controlled trials and observational studies indicate CBD may provide therapeutic benefits for reducing seizure frequency and improving quality of life. CBD was generally well tolerated, with some reports of sleepiness and elevated liver enzymes. For palliative care, a review of 9 studies found cannabinoids may provide a trend toward reducing cancer pain and significantly improved pain in HIV/AIDS, but did not significantly impact appetite or pain reduction compared to placebo.
The International Conference on Harmonisation (ICH) aims to harmonize technical requirements for pharmaceutical registration across regions to ensure safe, effective, and high-quality medicines are developed efficiently. It was established in 1990 by representatives from the European Union, Japan, and the United States. ICH has guidelines covering areas like safety, quality, and efficacy testing which are intended to streamline drug development and registration processes while reducing unnecessary animal and human testing.
Safety is the prime attention of regulatory bodies as it is the critical factor which can destroy even the humankind. Quality system like GLP has a lot tom play in the field of safety
assessments to reach its goal. There are various toxicity studies for assessing the degree of its toxicity. Academic research and peer reviewed journals has their own pitfalls as they could not
monitor or inspect the studies which has been conducted. This presentation speak about the Importance of safety assessment, various studies to evaluate the safety and Importance of GLP in safety assessment.
Cochrane reviews: Summarising the best evidence to inform healthcare decisionsCochraneTAG
Talk given at the UKCTAS early career researcher conference Sept 2015 by Jamie Hartmann-Boyce & Nicola Lindson-Hawley of Cochrane Tobacco Addiciton Group
Consensus Models to Predict Endocrine Disruption for All Human-Exposure Chemi...Kamel Mansouri
AAAS annual meeting (Boston, Feb 2017)
Humans are potentially exposed to tens of thousands of man-made chemicals in the environment. It is well known that some environmental chemicals mimic natural hormones and thus have the potential to be endocrine disruptors. Most of these environmental chemicals have never been tested for their ability to disrupt the endocrine system, in particular, their ability to interact with the estrogen receptor. EPA needs tools to prioritize thousands of chemicals, for instance in the Endocrine Disruptor Screening Program (EDSP). Collaborative Estrogen Receptor Activity Prediction Project (CERAPP) was intended to be a demonstration of the use of predictive computational models on HTS data including ToxCast and Tox21 assays to prioritize a large chemical universe of 32464 unique structures for one specific molecular target – the estrogen receptor. CERAPP combined multiple computational models for prediction of estrogen receptor activity, and used the predicted results to build a unique consensus model. Models were developed in collaboration between 17 groups in the U.S. and Europe and applied to predict the common set of chemicals. Structure-based techniques such as docking and several QSAR modeling approaches were employed, mostly using a common training set of 1677 compounds provided by U.S. EPA, to build a total of 42 classification models and 8 regression models for binding, agonist and antagonist activity. All predictions were evaluated on ToxCast data and on an external validation set collected from the literature. In order to overcome the limitations of single models, a consensus was built weighting models based on their prediction accuracy scores (including sensitivity and specificity against training and external sets). Individual model scores ranged from 0.69 to 0.85, showing high prediction reliabilities. The final consensus predicted 4001 chemicals as actives to be considered as high priority for further testing and 6742 as suspicious chemicals. The same approach is now being applied on a larger scale project to predict the potential androgen receptor (AR) activity of chemicals. This project called CoMPARA (Collaborative Modeling Project for Androgen Receptor Activity) is a collaboration between 35 international groups working on a common set of ~55k chemicals.
This abstract does not necessarily reflect U.S. EPA policy
CRISPR Gene Editing Congress, 25-27 February 2015 in Boston, MADiane McKenna
Key industry leaders will gather at the inaugural CRISPR Precision Gene Editing Congress with an ultimate purpose of addressing the importance of overcoming specificity, efficiency and delivery challenges associated with the CRISPR/Cas9 system. Pioneers will showcase the expanding biomedical and therapeutic potential of gene editing tools for drug discovery and development.
Electronic cigarettes for smoking cessation: What's the evidence?Health Evidence™
Health Evidence hosted a 90 minute webinar examining the effectiveness of electronic cigarettes for smoking cessation.
Muhannad Malas and Robert Schwartz led the session and presented findings from their recent review:
Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, et al. (2016). Electronic cigarettes for smoking cessation: A systematic review. Nicotine & Tobacco Research, 18(10), 1926-1936.
http://healthevidence.org/view-article.aspx?a=electronic-cigarettes-smoking-cessation-systematic-review-29830
Cigarette smoking is among the top causes of preventable death and disease. Electronic cigarettes have been increasing in popularity among smokers who report using them for quitting or reducing smoking. This review examines the effectiveness of electronic cigarettes as cessation aids. Sixty two articles, including RCTs, experimental, longitudinal and cross sectional studies are included in this review. Findings suggest there is inconclusive evidence due to low quality of research. This webinar provides a comprehensive overview of current literature examining the effectiveness of electronic cigarettes for smoking cessation.
Published Research, Flawed, Misleading, Nefarious - Use of Reporting Guidelin...John Hoey
Much published health sciences literature is misleading and biased
Efforts to correct this include use of reporting guidelines- criteria for doing science and reporting the results properly
Also discussion of conflicts of interest - how to report them.
12 weeks Switch to Vaping: Science of Vaping Fontem Ventures
A randomised, parallel group clinical study was performed to evaluate the safety profile of an e-vapour
product (EVP; 2.0% nicotine) in smokers of conventional cigarettes (CCs) switching to use the EVP for 12
weeks.
Cannabis Chemistry Industrial Applications of Chemistry & Innovation and Entr...Markus Roggen
Lecture at the chemistry department of Imperial College, London. A brought overview and specific deep dive into the chemical aspects of cannabis production.
CannMed 2018: Controlling Terpenes and Cannabinoids in Flower and ExtractMarkus Roggen
This document summarizes a presentation about controlling terpenes and cannabinoids in cannabis flowers and extracts. It discusses how cultivation conditions, drying/curing methods, extraction techniques, and post-processing can influence terpene and cannabinoid levels and ratios. It provides an example of how using THC from different cultivars in a CBD/THC oil caused a patient's seizures to resume, demonstrating the importance of chemovars for medical effects. The presenter advocates for research collaborations to better understand these complex relationships.
1) CBDV is a research venture that seeks to add scientific insight to cannabis and mushroom production through process design, optimization, analytics, and formulation research conducted in collaboration with academic and industry partners.
2) CBDV's research topics include chemometrics, kinetics, in-process analytics, computational studies, and process development for fundamental cannabis and mushroom chemistry.
3) CBDV has expertise in analytical chemistry, process chemistry, engineering, physics, data science, and statistics and is led by Dr. Markus Roggen and Prof. Glenn Sammis to provide scientific insights and solutions for the cannabis and mushroom industries.
Out of the Shadows: Identifying Impurities in Cannabis ProductsMarkus Roggen
Highly concentrated cannabis products have seen rapid growth, as customers become more accustomed to cannabis consumption and actively seek out high-potency products. Cannabis concentrates come in various forms and product names, from Badder, Budder and Crumble to Distillate, Oil and Shatter. Those products can have THC concentrations are high as 95%, compared with less than 25% common in cannabis flower.
While the actual THC concentration can vary between 70 and 95%, what is common for all cannabis concentrates is that the total of identified compounds seldomly goes above 95% of product weight.
Delic Labs is a research venture that seeks to add fundamental scientific insight to the field of cannabis and mushroom production. In this regard, we set out to identify those compounds in the missing mass balance for cannabis concentrates. This presentation will show our latest advances in characterizing and quantifying impurities in cannabis concentrates. For example, we found reduced cannabinoid species in CBN products, THC isomers in distillates and oxidation products in CBD formulations.
Lecture given by Ed Griffen UKQSAR meeting Sept 2017. Covers material from work in our paper http://pubs.acs.org/doi/10.1021/acs.jmedchem.7b00935 background discussed in https://www.linkedin.com/pulse/first-draft-medicinal-chemistry-admet-encyclopedia-ed-griffen/
SCI What can Big Data do for Chemistry 2017 MedChemicaEd Griffen
This document discusses how advanced analytics and big data techniques can be applied in the chemistry industry. It provides examples of how matched molecular pair analysis has been used to extract statistically valid structure-activity relationships from large datasets and summarize them in the form of transformation rules. These rules have helped suggest new molecules, explore structure-activity relationships, identify exceptional structure-property relationships, and enable the rapid optimization of drug candidates. The document argues that combining data from multiple sources yields more comprehensive rules and that interfaces must be designed with the intended users in mind.
The relative risk of cancer from smoking and vaping nicotine yfzsc5g7nm
- Vaping exposes users to lower levels of carcinogens compared to smoking, as key carcinogens in tobacco smoke are present at far lower doses in e-cigarette vapor.
- Modelling studies predict the lifetime risk of cancer from vaping will be substantially less than from smoking, ranging from 0.4-1.4% of the risk from smoking.
- Based on the dose and cancer potency of carcinogens present, experts assess that switching from smoking to vaping nicotine substantially reduces lifetime cancer risk, though long-term risks are not fully known.
From Leaf to Lab: Uncovering the Molecular Mysteries of CannabisMarkus Roggen
This lecture presents our cannabis research, conducted in collaboration with the University of British Columbia (UBC) Chemistry Department.
Bridging the gap between analytical chemistry, machine learning, and synthetic chemistry, this compilation of studies explores the multifaceted nature of cannabis compounds. We begin with advancements in extraction techniques, utilizing machine learning to optimize yield predictions in large-scale botanical recovery, specifically focusing on cannabis. This approach significantly enhances the efficiency and precision of extraction processes. We then transitions to molecular analysis, examining the stability and transformation of CBD derivatives, highlighting the need for robust quality control in product development. Additionally, the lecture addresses the critical aspect of safety in cannabis use by exploring innovative strategies for heavy metal testing, demonstrating how pooling methods can reduce testing resources while maintaining safety standards. The lecture will answer the question of how to build the best joint, the implications of joint architecture on cannabis consumption, offering insights into optimizing product efficacy and consumer experience.
Overall, this lecture encapsulates the collaborative efforts between academia and innovative research, providing a comprehensive understanding of the complexities and potential of cannabis chemistry.
How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Re...MMS Holdings
What You Will Learn
The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.
In this webinar, a cross-functional team of statistical programmers and regulatory experts will share actionable insights to help study teams prepare for the new requirements.
Attendees will learn how to:
Understand nonclinical study data submissions to CDER and CBER
Differentiate biologics from drug submission in non-clinical studies
Prepare for this change to ensure a successful submission.
Solve the challenges of a SEND package
Ensure compliance with both SEND 3.1 and 3.1.1 for submission of nonclinical data to CDER and CBERHo
Separate SEND IG DART 1.1 from SEND IG
Manage legacy studies and studies that already meet requirements
Differentiate between submission packages
Use the FDA’s data standard catalog, technical conformance guide and controlled terminology
Who Will Benefit from Attending?
Regulatory Affairs and Submissions Professionals
Pharmaceutical Data and Programming Professionals
Nonclinical/Preclinical Development Professionals
The document discusses Good Laboratory Practice (GLP) standards which are regulations for conducting non-clinical safety studies to support research and product approvals. It provides an overview of the history and development of GLP, describing how poor laboratory practices in the 1970s led the FDA to create formal GLP regulations in 1978. It also discusses the key principles of GLP for ensuring quality, integrity and traceability of non-clinical study data.
InSyBio is developing an integrated cloud platform for biomarker discovery to improve precision medicine and clinical trials. Their platform performs end-to-end biomarker analysis from raw biological data through extraction, interpretation and applications. This is more efficient than existing fragmented methods. InSyBio's biomarkers are highly accurate with small sample sizes and can reduce clinical trial costs and times. Their platform has applications in nutrition, pharma and diagnostics.
Presentation: Medicinal Cannabis Evidence for Efficacy Clinical Guidance Deve...TGA Australia
The document summarizes reviews of evidence for the efficacy of medicinal cannabis. Regarding epilepsy, randomized controlled trials and observational studies indicate CBD may provide therapeutic benefits for reducing seizure frequency and improving quality of life. CBD was generally well tolerated, with some reports of sleepiness and elevated liver enzymes. For palliative care, a review of 9 studies found cannabinoids may provide a trend toward reducing cancer pain and significantly improved pain in HIV/AIDS, but did not significantly impact appetite or pain reduction compared to placebo.
The International Conference on Harmonisation (ICH) aims to harmonize technical requirements for pharmaceutical registration across regions to ensure safe, effective, and high-quality medicines are developed efficiently. It was established in 1990 by representatives from the European Union, Japan, and the United States. ICH has guidelines covering areas like safety, quality, and efficacy testing which are intended to streamline drug development and registration processes while reducing unnecessary animal and human testing.
Safety is the prime attention of regulatory bodies as it is the critical factor which can destroy even the humankind. Quality system like GLP has a lot tom play in the field of safety
assessments to reach its goal. There are various toxicity studies for assessing the degree of its toxicity. Academic research and peer reviewed journals has their own pitfalls as they could not
monitor or inspect the studies which has been conducted. This presentation speak about the Importance of safety assessment, various studies to evaluate the safety and Importance of GLP in safety assessment.
Cochrane reviews: Summarising the best evidence to inform healthcare decisionsCochraneTAG
Talk given at the UKCTAS early career researcher conference Sept 2015 by Jamie Hartmann-Boyce & Nicola Lindson-Hawley of Cochrane Tobacco Addiciton Group
Consensus Models to Predict Endocrine Disruption for All Human-Exposure Chemi...Kamel Mansouri
AAAS annual meeting (Boston, Feb 2017)
Humans are potentially exposed to tens of thousands of man-made chemicals in the environment. It is well known that some environmental chemicals mimic natural hormones and thus have the potential to be endocrine disruptors. Most of these environmental chemicals have never been tested for their ability to disrupt the endocrine system, in particular, their ability to interact with the estrogen receptor. EPA needs tools to prioritize thousands of chemicals, for instance in the Endocrine Disruptor Screening Program (EDSP). Collaborative Estrogen Receptor Activity Prediction Project (CERAPP) was intended to be a demonstration of the use of predictive computational models on HTS data including ToxCast and Tox21 assays to prioritize a large chemical universe of 32464 unique structures for one specific molecular target – the estrogen receptor. CERAPP combined multiple computational models for prediction of estrogen receptor activity, and used the predicted results to build a unique consensus model. Models were developed in collaboration between 17 groups in the U.S. and Europe and applied to predict the common set of chemicals. Structure-based techniques such as docking and several QSAR modeling approaches were employed, mostly using a common training set of 1677 compounds provided by U.S. EPA, to build a total of 42 classification models and 8 regression models for binding, agonist and antagonist activity. All predictions were evaluated on ToxCast data and on an external validation set collected from the literature. In order to overcome the limitations of single models, a consensus was built weighting models based on their prediction accuracy scores (including sensitivity and specificity against training and external sets). Individual model scores ranged from 0.69 to 0.85, showing high prediction reliabilities. The final consensus predicted 4001 chemicals as actives to be considered as high priority for further testing and 6742 as suspicious chemicals. The same approach is now being applied on a larger scale project to predict the potential androgen receptor (AR) activity of chemicals. This project called CoMPARA (Collaborative Modeling Project for Androgen Receptor Activity) is a collaboration between 35 international groups working on a common set of ~55k chemicals.
This abstract does not necessarily reflect U.S. EPA policy
CRISPR Gene Editing Congress, 25-27 February 2015 in Boston, MADiane McKenna
Key industry leaders will gather at the inaugural CRISPR Precision Gene Editing Congress with an ultimate purpose of addressing the importance of overcoming specificity, efficiency and delivery challenges associated with the CRISPR/Cas9 system. Pioneers will showcase the expanding biomedical and therapeutic potential of gene editing tools for drug discovery and development.
Electronic cigarettes for smoking cessation: What's the evidence?Health Evidence™
Health Evidence hosted a 90 minute webinar examining the effectiveness of electronic cigarettes for smoking cessation.
Muhannad Malas and Robert Schwartz led the session and presented findings from their recent review:
Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, et al. (2016). Electronic cigarettes for smoking cessation: A systematic review. Nicotine & Tobacco Research, 18(10), 1926-1936.
http://healthevidence.org/view-article.aspx?a=electronic-cigarettes-smoking-cessation-systematic-review-29830
Cigarette smoking is among the top causes of preventable death and disease. Electronic cigarettes have been increasing in popularity among smokers who report using them for quitting or reducing smoking. This review examines the effectiveness of electronic cigarettes as cessation aids. Sixty two articles, including RCTs, experimental, longitudinal and cross sectional studies are included in this review. Findings suggest there is inconclusive evidence due to low quality of research. This webinar provides a comprehensive overview of current literature examining the effectiveness of electronic cigarettes for smoking cessation.
Published Research, Flawed, Misleading, Nefarious - Use of Reporting Guidelin...John Hoey
Much published health sciences literature is misleading and biased
Efforts to correct this include use of reporting guidelines- criteria for doing science and reporting the results properly
Also discussion of conflicts of interest - how to report them.
12 weeks Switch to Vaping: Science of Vaping Fontem Ventures
A randomised, parallel group clinical study was performed to evaluate the safety profile of an e-vapour
product (EVP; 2.0% nicotine) in smokers of conventional cigarettes (CCs) switching to use the EVP for 12
weeks.
This document summarizes a workshop on mapping the UK diagnostics landscape. The workshop included sessions on industry views, clinicians' views, the current diagnostics system, how diagnostic pathways can be achieved, and the role of health technology assessment in diagnostics. Speakers discussed topics like the potential for rapid diagnostics in community healthcare, barriers to diagnostic usage, tackling antimicrobial resistance, and how industry is driving greater diagnostic uptake. The goal of the workshop was to evaluate how fit the current diagnostics system is for purpose and identify ways to improve it.
The document discusses the drug development process from pre-clinical research through Investigational New Drug (IND) application. It outlines the typical studies required to evaluate safety and toxicity, identify target organs of toxicity, determine appropriate dosing for clinical trials, and communicate risks. These include pharmacology, pharmacokinetics, safety pharmacology, acute and repeat-dose toxicology studies in two animal species along with genetic toxicology assays. The goals are to estimate initial safe doses for clinical trials and identify parameters that can monitor toxicity. The process seeks to identify potentially safe compounds for human testing while eliminating those that may be unsafe.
Christopher Layfield has over 15 years of experience in quality assurance and auditing in fields related to public health, biological research, and toxicology. He has a Master's in Public Health Epidemiology and is a Certified Quality Auditor. As a Senior Quality Systems Specialist at Battelle, he provides quality assurance oversight and management for several contracts, including studies evaluating the behavioral and pharmacological effects of tobacco products being conducted for the FDA.
Similar to What is in your vape?! CannMed 2019 Presentation (20)
Total Legal: A “Joint” Journey into the Chemistry of CannabinoidsMarkus Roggen
This lecture gives an overview of the state of the cannabis science, the North American markets and our cannabis research.
Bridging the gap between analytical chemistry, machine learning, and synthetic chemistry, this compilation of studies explores the multifaceted nature of cannabis compounds. We begin with advancements in extraction techniques, utilizing machine learning to optimize yield predictions in large-scale botanical recovery, specifically focusing on cannabis. This approach significantly enhances the efficiency and precision of extraction processes. We then transitions to molecular analysis, examining the stability and transformation of CBD derivatives, highlighting the need for robust quality control in product development. Additionally, the lecture addresses the critical aspect of safety in cannabis use by exploring innovative strategies for heavy metal testing, demonstrating how pooling methods can reduce testing resources while maintaining safety standards. The lecture will answer the question of how to build the best joint, the implications of joint architecture on cannabis consumption, offering insights into optimizing product efficacy and consumer experience.
Overall, this lecture encapsulates the collaborative efforts between academia and innovative research, providing a comprehensive understanding of the complexities and potential of cannabis chemistry.
Unveiling the Cannabis Plant’s PotentialMarkus Roggen
Cannabinoid research is one of the most exciting areas of the cannabis science field, with new information being discovered about the potential therapeutic benefits of cannabinoids on a seemingly frequent basis. As we learn more about the cannabinoids that make up the cannabis plant and their unique qualities, research must be conducted with a focus on applying knowledge toward developing wellness products and cannabis therapies for patients. This panel will discuss the unique challenges facing the cannabinoid research field, results from recent research efforts, and what the future may hold for therapeutic applications of cannabinoids.
Have a Good Trip? How to Analyze PsychedelicsMarkus Roggen
Entheogens, frequently used interchangeably with hallucinogens and psychedelics, are naturally occurring psychoactive substances. Historically, these substances have been used to induce a change of perception, mood, consciousness, or behavior for the purposes of spiritual development or social enrichment. In addition to these uses, these substances have become strong candidates for alternative medicines for the treatment of psychological disorders. Cannabis, a more common entheogen, has paved the way for decriminalization and legalization of other substances, such as psilocin, psilocybin, MDMA, and LSD to be used for clinical treatments. While these compounds in many places are still classified as Schedule I substances under the Controlled Substances Act, other entheogenic plants with different psychoactive compounds are not, such as Mitragyna speciosa and Amanita muscaria, which already appear on the market in the form of edibles, extracts, or powders. With the lack of standardized methods for these psychoactive targets, and with the rise of legalization and clinical treatment centers, it is important to understand this emerging market from a safety and quality perspective. This session will focus on emerging products, testing targets, sample preparation, method development, and analytical challenges. Attendees of this session will learn technical steps that need to be considered to develop robust, reproducible analytical methods, and a quality assurance program to expand into this new and evolving area of testing.
Your Secret Sauce to Succeeding as a Cannabis Business: A Data-Driven ApproachMarkus Roggen
The cannabis industry is going through boom-bust cycles, many businesses are losing money or barely scrape by. All that is set against an ever-growing market with sales growing 20-30% year over year.
In this session we are analysing various factors exerting pressure on the industry, from taxes to testing costs, but also business strategies and operational decisions. This is all funded on extensive analysis of dataset from sales, business performance, production processes and public sources.
The work from an interdisciplinary team of economists, data scientists and chemists cumulated in an in-depth analysis of the cannabis economy and guiding principles for industry-wide success.
Hot Topics and Hotboxing: Latest research on cannabis aerosolsMarkus Roggen
Cannabis testing focuses on harm reduction, by testing for unwanted pesticides, heavy metals and biological contamination. On one side, cannabinoid levels are precisely measured in the product.
Although these final product tests miss one important aspect of cannabis consumption. The actual process of consumption. For inhalable products, like joints and vape cartridges, the dosing of cannabinoids and chemical changes during burning/vaporization are mostly unknow.
We have developed a testing platform to quantify cannabinoid and terpene levels on a puff per puff basis. This setup also allows us to screen the aerosol and gas phase for potential toxicants present. We also looked at cannabinoid concentrations puff by puff, how those compare between joints and vapes, and how those levels change over the lifecycle of a product.
In this talk we will present our findings from our latest vape and joint experiment and answer the longstanding question: Which part of a joint is the best to smoke? And, will cannabis kill you?
How Long Is Your Trip? Analysing the Micros and Heroics of PsychedelicsMarkus Roggen
Psychedelics are a diverse group of drugs that are known for their ability to alter consciousness, perception, mood, and thought. Detecting the presence, quantity and quality of these compounds is crucial to research development and involves various analytical tools such as High Performance Liquid Chromatography (HPLC) with optical or mass detectors, and other instruments types. These analytical tests are performed for a variety of reasons, including product, drug, or safety testing, all of which are subject to regulations and guidelines set by the licensing authorities. Besides the regulations, we face several other challenges with psychedelic analysis, such as the lack of standardized testing methods, difficulties in sample preparation, and analyte stability.
Birds, Bees and Buds: How to Talk About Cannabis and How to Label it CorrectlyMarkus Roggen
The current labeling of cannabis products is complicated, useless, and even gives the wrong incentive to the customer. The current market is tilted towards buying the highest total THC percentage, because it is a number that everyone believes they understand. There is a lot wrong with this. Starting from the problem that total THC is miscalculated. Adding the fact that “potency” and intoxication are not directly linked. Cannabis offers more bioactive compounds then just THC and CBD, but current labeling doesn’t show it. How can we present a cannabis product in a new way to guide the customer/patent to the right product. This presentation will build on my publications in the area of total THC labeling and chemovar research.
Crystallizing the science of CBD purificationMarkus Roggen
Cannabidiol, or CBD, is the new star of functional ingredients. It is a food, medicine, saviour of the farmers, even a health elixir.
The cannabis and hemp industries have recently experienced extreme growth and progress in all fields. Countries, states and countries are legalizing hemp and/or cannabis, cannabinoid producers see unpreceded business growth, new treatment option for various conditions are researched and approved. But while the markets are growing, hemp and cannabis producers are suffering. An overproduction depresses commodity prices, and inefficient processes squeeze the profit margins. Additionally, hemp and cannabis products require high purity of cannabinoid ingredients, both from a regulatory level and for patient care.
This presentation will cover the latest research on CBD isolation, from its solubility behaviour in common extraction solvents to purification via crystallization. Our latest findings in understanding, controlling, and optimizing cannabis production in analytics, processing, extraction and formulation are presented. The collaborative effort of the multidisciplinary research team at Delic Labs led to a diverse set of insight in every stage of production.
Simulations of Test Reduction Using Pooled Heavy Metals Analysis in CannabisMarkus Roggen
Background: Cannabis species have a propensity to bioaccumulate toxic heavy metals from their growth media. Increased testing for these metals is required to improve the safety of the legal medical and recreational cannabis industries. However, the current methods used for mandated heavy metals tests are not efficient for a large framework. As a result, there is limited testing capacity, high testing costs, and long wait times for results across North America.
Objective: This study aimed to demonstrate that pooling strategies can be used to increase the throughput in cannabis testing labs and reduce some of the strain on the industry.
Methods: This paper presents an algorithm to simulate different pooling strategies. The algorithm was applied to real world data sets collected from Washington and California state testing labs.
Results: Using a single pooling method, for the California lab, pooling four samples on average resulted in a 54.1% reduction in tests required for 100 samples. Conclusion: The algorithms generated from lab data demonstrated that pooled testing strategies can be developed on a case- by-case method to reduce the time, effort, and costs associated with heavy metals tests.
Highlights: The benefits of pooled testing will vary depending on the region and rate of contamination seen in each testing lab. Overall, our results demonstrate pooled testing has the potential to reduce the fiscal costs of testing through increased efficiency, allowing increased testing, leading to greater safety.
Structure Activity Relationship between the Emerging Psychedelic Industry and...Markus Roggen
DELIC Labs seeks to establish a research hub in Vancouver to study cannabis and mushrooms through process design, optimization, analytics, and formulation research. It collaborates with academic and industry partners globally. The document discusses psychedelic compounds and their medical potential but also highlights flaws in current clinical trials, a lack of knowledge about psilocybin mushroom composition, and Delic Labs' work using metabolomics to address this. It also covers the patenting of psilocybin crystal structures and questions whether this is appropriate given the medical applications of these compounds.
- DELIC Labs conducts research on cannabis and mushroom production, collaborating with academic and industry partners. Research topics include process optimization, analytics, and formulation studies.
- CBD usage is increasing globally but users face confusion over legality, regulation, and determining proper dosages. CBD concentrations in e-liquids were found to deviate significantly from labeled amounts in some cases.
- CBD is subject to degradation over time from factors like heat, light, pH levels, and metal leaching. On average, 20% degradation was observed after 30 days at 37°C.
Deep Purple: Discolouration in CBD productsMarkus Roggen
Presentation at ACS Spring 2022 conference.
Recently, there has been a flood of cannabidiol (CBD)-containing products, with divers marketing claims for a plethora of use cases. With this new market segment, regulatory oversight is still developing, and label claims of CBD concentration is often verifiable. CBD is unstable in solution and some CBD products are anecdotally reported to turn purple on storage; however, the decomposition products of CBD are mostly unknown.
Delic Lab embarked on a long and painstaking hunt for those decomposition products, established their identity through complementary chemical methods and established reaction pathways between them.
We will present our findings about common CBD oxidation products, who those are highly photochemically unstable and decomposes rapidly. Decomposition leads to a multitude of new cannabinoid derivatives.
Cannabis/Hemp Decarboxylation Monitoring by IRMarkus Roggen
CBDV is a research venture focused on supporting the cannabis and mushroom industries through collaborative research. Some areas of research include process design, optimization, and analytics. CBDV utilizes various analytical techniques like infrared spectroscopy to monitor decarboxylation reactions for cannabis extracts. IR spectroscopy allows for fast, easy, and economical in-process monitoring of decarboxylation without sample preparation. CBDV has developed IR monitoring methods for crude oil and flower and shown IR can predict cannabinoid concentrations during decarboxylation. Computational studies explored rate differences in THCA and CBDA decarboxylation. In summary, CBDV utilizes IR spectroscopy to monitor and control decarboxylation, a key processing step.
Data Analytics for Process OptimizationMarkus Roggen
Understanding the cannabis production processes is key to improve them. We present our data analytics and optimization principles for cannabis extraction and processing.
This document discusses using data analytics to optimize cannabis extraction and production processes. It describes how tracking additional metrics like net weight collected, run time, and flow rate can help producers increase yields and profit margins. Specifically, a predictive algorithm could help fill data gaps. The document also discusses cannabis extraction variables that impact yields, such as temperature, pressure and run time. It suggests extraction runs have an initial mass transfer mode where longer times yield more, but eventually reach a diffusion mode with diminishing returns. Overall, the document advocates for data-driven approaches to optimize cannabis extraction and production efficiency.
Optimization of the Decarboxylation Reaction in Cannabis ExtractMarkus Roggen
Presentation at Emerald Scientific Conference 2019. We present our work on building an in-process analytical method for cannabinoid quantification by IR for cannabis extract to track decarboxylation. Finding the endpoint is important for process efficiency, but surprisingly difficult. Therefore having a reliable quick and cheap tool to do so is of high value.
Presenting our research on molecular changes in flower and extract. A visual guide through the production pipeline. With added data sets for better insight.
Microbial interaction
Microorganisms interacts with each other and can be physically associated with another organisms in a variety of ways.
One organism can be located on the surface of another organism as an ectobiont or located within another organism as endobiont.
Microbial interaction may be positive such as mutualism, proto-cooperation, commensalism or may be negative such as parasitism, predation or competition
Types of microbial interaction
Positive interaction: mutualism, proto-cooperation, commensalism
Negative interaction: Ammensalism (antagonism), parasitism, predation, competition
I. Mutualism:
It is defined as the relationship in which each organism in interaction gets benefits from association. It is an obligatory relationship in which mutualist and host are metabolically dependent on each other.
Mutualistic relationship is very specific where one member of association cannot be replaced by another species.
Mutualism require close physical contact between interacting organisms.
Relationship of mutualism allows organisms to exist in habitat that could not occupied by either species alone.
Mutualistic relationship between organisms allows them to act as a single organism.
Examples of mutualism:
i. Lichens:
Lichens are excellent example of mutualism.
They are the association of specific fungi and certain genus of algae. In lichen, fungal partner is called mycobiont and algal partner is called
II. Syntrophism:
It is an association in which the growth of one organism either depends on or improved by the substrate provided by another organism.
In syntrophism both organism in association gets benefits.
Compound A
Utilized by population 1
Compound B
Utilized by population 2
Compound C
utilized by both Population 1+2
Products
In this theoretical example of syntrophism, population 1 is able to utilize and metabolize compound A, forming compound B but cannot metabolize beyond compound B without co-operation of population 2. Population 2is unable to utilize compound A but it can metabolize compound B forming compound C. Then both population 1 and 2 are able to carry out metabolic reaction which leads to formation of end product that neither population could produce alone.
Examples of syntrophism:
i. Methanogenic ecosystem in sludge digester
Methane produced by methanogenic bacteria depends upon interspecies hydrogen transfer by other fermentative bacteria.
Anaerobic fermentative bacteria generate CO2 and H2 utilizing carbohydrates which is then utilized by methanogenic bacteria (Methanobacter) to produce methane.
ii. Lactobacillus arobinosus and Enterococcus faecalis:
In the minimal media, Lactobacillus arobinosus and Enterococcus faecalis are able to grow together but not alone.
The synergistic relationship between E. faecalis and L. arobinosus occurs in which E. faecalis require folic acid
Mechanisms and Applications of Antiviral Neutralizing Antibodies - Creative B...Creative-Biolabs
Neutralizing antibodies, pivotal in immune defense, specifically bind and inhibit viral pathogens, thereby playing a crucial role in protecting against and mitigating infectious diseases. In this slide, we will introduce what antibodies and neutralizing antibodies are, the production and regulation of neutralizing antibodies, their mechanisms of action, classification and applications, as well as the challenges they face.
BIRDS DIVERSITY OF SOOTEA BISWANATH ASSAM.ppt.pptxgoluk9330
Ahota Beel, nestled in Sootea Biswanath Assam , is celebrated for its extraordinary diversity of bird species. This wetland sanctuary supports a myriad of avian residents and migrants alike. Visitors can admire the elegant flights of migratory species such as the Northern Pintail and Eurasian Wigeon, alongside resident birds including the Asian Openbill and Pheasant-tailed Jacana. With its tranquil scenery and varied habitats, Ahota Beel offers a perfect haven for birdwatchers to appreciate and study the vibrant birdlife that thrives in this natural refuge.
Signatures of wave erosion in Titan’s coastsSérgio Sacani
The shorelines of Titan’s hydrocarbon seas trace flooded erosional landforms such as river valleys; however, it isunclear whether coastal erosion has subsequently altered these shorelines. Spacecraft observations and theo-retical models suggest that wind may cause waves to form on Titan’s seas, potentially driving coastal erosion,but the observational evidence of waves is indirect, and the processes affecting shoreline evolution on Titanremain unknown. No widely accepted framework exists for using shoreline morphology to quantitatively dis-cern coastal erosion mechanisms, even on Earth, where the dominant mechanisms are known. We combinelandscape evolution models with measurements of shoreline shape on Earth to characterize how differentcoastal erosion mechanisms affect shoreline morphology. Applying this framework to Titan, we find that theshorelines of Titan’s seas are most consistent with flooded landscapes that subsequently have been eroded bywaves, rather than a uniform erosional process or no coastal erosion, particularly if wave growth saturates atfetch lengths of tens of kilometers.
The cost of acquiring information by natural selectionCarl Bergstrom
This is a short talk that I gave at the Banff International Research Station workshop on Modeling and Theory in Population Biology. The idea is to try to understand how the burden of natural selection relates to the amount of information that selection puts into the genome.
It's based on the first part of this research paper:
The cost of information acquisition by natural selection
Ryan Seamus McGee, Olivia Kosterlitz, Artem Kaznatcheev, Benjamin Kerr, Carl T. Bergstrom
bioRxiv 2022.07.02.498577; doi: https://doi.org/10.1101/2022.07.02.498577
3. Current Vaping
• 380 confirmed and probable cases
• 36 US states, one territory effected
• 6 deaths
• Symptoms: cough, chest pain, shortness of breath, fatigue and vomiting
• This is a new indication, not a previously misdiagnosed one
4. Current Vaping
• 380 confirmed and probable cases
• 36 US states, one territory effected
• 6 deaths
• Symptoms: cough, chest pain, shortness of breath, fatigue and vomiting
• This is a new indication, not a previously misdiagnosed one
Pulmonary Illness Related to E-Cigarette Use in Illinois and Wisconsin
— Preliminary Report; DOI: 10.1056/NEJMoa1911614
5. Current Vaping
• No single cause identified yet
• Mostly from the illicit market, one death from Oregon dispensary
• Some reoccurring compounds: Vitamin E acetate, MCT oil, propylene
glycol and vegetable glycerin (all GRAS)
Vit. E Acetate
PGVGDiacetyl
MCT
6. GRAS
GRAS: Generally Recognized As Safe
FDA: “the use of a food substance may be GRAS either through scientific
procedures or, for a substance used in food before 1958, through
experience based on common use in food Under 21 CFR 170.30(b), general
recognition of safety through scientific procedures requires the same
quantity and quality of scientific evidence as is required to obtain
approval of the substance as a food additive.”
7. GRAS
Current number of GRAS compounds: 859
Used to be GRAS: trans fat
GRAS but not good to inhale: sea water
Not GRAS: butane
https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory
8. THC Inhalation Methods
• Maximum available THC/CBD tested
• Cannabis Joints and Dabs studied
M. Hädener et. al., Forensic Science International 295 (2019) 207–212
9. THC Inhalation Methods
• THCA/CBDA are fully decarboxylated
• Smoke temperature: 44˚C (111˚F)
M. Hädener et. al., Forensic Science International 295 (2019) 207–212
11. Puff by Puff Inhalation
R. Zimmermann, S. Ehlert, J. Heide, A. Walte; Universität Rostock, photonion
• Puff by puff concentrations are dependent on consumption method
12. Puff by Puff Inhalation
R. Zimmermann, S. Ehlert, J. Heide, A. Walte; Universität Rostock, photonion
• Puff by puff concentrations are dependent on consumption method
• Puff by puff analysis of spliffs shows THC, CBN and nicotine in smoke
14. Thermal Degradation
• ATD-GCMS
• identified and quantified gaseous
degradants
• target analytes and a non-target analysis
J. Meehan-Atrash et. al., ACS Omega in press
15. Thermal Degradation
C4 – C5 C6 – C7 C8 – C10
O
O
O
O
+
J. Meehan-Atrash et. al., ACS Omega in press
16. Puff by Puff Inhalation
R. Zimmermann, S. Ehlert, J. Heide, A. Walte; Universität Rostock, photonion
17. Thermal Degradation
• Cannabinoids and terpenes have
similar degradation mechanisms
• More terpenes = more VOCs
J. Meehan-Atrash et. al., ACS Omega in press
Group 1 Carcinogen Group 3 Carcinogen
Group 2B Carcinogen
Group 2A Carcinogen
Group 2B Carcinogen
18. Thermal Degradation
• Dabbing produces higher levels of degradants
• Increased voltage on vape cartridges = more degradants
Component THC dab SND dab Vape 3.2 V Vape 4.0 V Vape 4.8 V
Methacrolein, g 2.7 0.8 12 0.82 5.6 E-3 3.2 E-2 1.9 E-1
Benzene, ng 33 14 360 120 9.9 E-1 2.7 E+0 3.6 E+1
Isoprene, g 9.6 1.7 44 3.5 3.0 E-2 8.3 E-1 6.0 E+0
Other Alkenes, g 5.3 0.7 21 11 4.2 E-2 7.2 E-1 7.9 E+0
Total VOCs, g 2.0 E+01 7.7 E+01 9.4 E-2 1.5 E+0 1.2 E+1
J. Meehan-Atrash et. al., ACS Omega in press
19. Risk Factors
Quantitative risk assessment to interpret data
• QRA treatment may be applied to literature values for smoking
• Caution when interpreting data:
1) Machine smoking does not represent realistic use
2) Despite the presence of carcinogens in cannabis
smoke, long-term data does not support carcinogenicity
J. Meehan-Atrash et. al., ACS Omega in press
20. Risk Factors
• HI: Quantitative risk assessment for non-cancer effects
• ELCR: Quantitative risk assessment for cancer effects
J. Meehan-Atrash et. al., ACS Omega in press
Consumption type HI ELCR
Smoking flower 2 E+2 4 E-4
Dabbing distillate 2 E-1 2 E-7
Vaping distillate @ 4.8 V 4 E-2 2 E-7
Vaping distillate @ 4.0 V 6 E-3 2 E-8
Vaping distillate @ 3.2 V 8 E-4 2 E-9
22. Limitation
• Most research done on reference standards
• Limited access to real-world products
• Little understanding of real-life usage
• No collaboration between actors
23. Fundamental Collaboration
CBDV collaborates with academic, industry and private groups around the
globe. Some highlights of those collaborations are:
• University of British Columbia, Vancouver
• Loyalist College, Belleville
• Vialpando, LLC by Dr. Monica Vialpando
• Veridient Science by Dr. Linda Klumpers
• Fritsch Milling
• PerkinElmer
24. Complex Biotech Discovery Ventures
CBDV is a young research venture that seeks to add fundamental scientific
insight to the field of cannabis production.
We seek to support the cannabis industry by establishing a centralized
hub in Vancouver, BC for collaborative research focused on:
• Process Design
• Process Optimization
• Process Analytics
• Formulation Research
28. Thank You
Thanks go to our collaborators:
• Prof. Dr. Robert M. Strongin, Portland State University
• Jiries Meehan-Atrash, Portland State University (jiries2@pdx.edu)
• Prof. Dr. Ralf Zimmerman, Universität Rostock
• Dr. Monica Vialpando, Vialpando LLC
• Dr. Linda Klumpers, Veridient Science
29. FOUNDERS
Dr. Markus Roggen
Dr. Roggen received his Masters in Science degree from Imperial College, London, UK in 2008, and
his PhD in Organic Chemistry at the Federal Institute of Technology in Zürich (ETHZ), which he
received in 2012. He was awarded a DAAD postdoctoral fellowship to pursue further training in
physical organic chemistry at The Scripps Research Institute in La Jolla from 2013-2014. He then
entered the cannabis industry, at first as laboratory director for Davinci Laboratories of California, an
analytical laboratory from 2014 to 2016. In 2016 he moved into an executive position overseeing
production, R&D and process optimization for OutCo, a cannabis manufacturer. Dr. Markus Roggen
is also a trusted advisor and mentor for multiple startups, startup accelerators and organizations.
Positions include advisory positions at Bloom Automation, a cannabis robotics company, Redfield
Proctor, a waste management company, and former co-chair of the NCIA Scientific Advisory
Committee.
Prof Dr. Glenn Sammis
Prof Sammis is an Associate Professor in the Chemistry Department at the University of British
Columbia. He has built an internationally recognized research group working on the development of
novel synthetic methods for the preparation of natural products and pharmaceuticals. Prof. Sammis
received a B.Sc. in Chemistry with Honors and Distinction from Stanford University in 1999. He then
went to work with Prof. Eric Jacobsen at Harvard University as an NSF Predoctoral fellow, obtaining a
PhD in Chemistry in 2004, followed by a two-year NIH postdoctoral fellowship with Prof. Erik Sorensen at
Princeton University.
30. CBDV TEAM
Luiz Geraldo – VP Finance
Currently pursuing his MBA, Luiz is an Industrial
Engineer and has 5 years of experience in strategy
and operations consulting and strategic planning.
Gursaanj Singh Bajaj – Data Science Associate
Gursaanj is an Astrophysics major in the
department of Physics and Astronomy at UBC, with
a background in data analysis. He will be going into
his 4th year of his undergraduate degree.
Kendra Payne – VP Business Operations
Experienced Program Manager/Coordinator and
Senior Administrator with a demonstrated history of
working in the education management and
biotechnology industries. Skilled in Biotechnology,
Project Coordination and Life Sciences.
Callum MacPhee – Business Associate
Callum is a going into his fourth year at the
University of British Columbia and is pursuing
a Bachelor of Commerce.
Sajni Shah – Research Associate
Currently studying Chemical Biology in the
Department of Chemistry at UBC. She is
going into her final year of her undergraduate
studies.
Klara Wyse – Marketing Associate
Klara is a Media Studies and Urban Studies
student at UBC, going into their fourth year.