CannMed 2017 Poster Presenters

Mary Kathryn Dahlgren

Senior Clinical Research Assistant, McLean Hospital

Life is a Highway: Assessing the Residual Impact of Heavy Recreational Marijuana Use Without Acute Intoxication on Driving


This research project used a driving simulator paradigm to assess the impact of heavy, chronic, marijuana use in the absence of acute intoxication.  Preliminary findings indicated that marijuana users performed significantly worse than healthy control participants.  However when the marijuana using group was split by age that regular marijuana use was initiated, the results indicated that driving impairment was localized to early onset marijuana use (regular use before age 16); individuals with late onset marijuana use (regular use at age 16 or older) performed similarly to control participants.  Interestingly, this same type of stratification of impairment has been observed in several other studies of cognitive functioning in heavy marijuana users.  The results from the current study provided evidence that marijuana impairment may persist in the absence of acute intoxication in early onset users, which has significant public health policy implications.  Further, this research highlights the importance of including age of onset of marijuana use in statistical analyses.


Kate is a senior clinical research assistant at McLean Hospital, where she works with the Marijuana Investigations for Neuroscientific Discovery (MIND) program to assess the cognitive and clinical impact of both medical and recreational marijuana use.  Additionally, she is currently enrolled at Tufts University, where she has completed a Master of Science degree en route to pursuing a doctoral degree in experimental clinical psychology.  She is particularly interested in using advanced statistical analyses techniques such as regression modeling to better characterize marijuana use, especially its effect on cognitive function and the efficacy of its medicinal indications.

Penny Daugherty, RN, OCN

Gynecologic Oncology Nurse Navigator, Northside Hospital Cancer Institute

Navigating Patients through the Maze of Information and Mis-Information about Medicinal Cannabis


This presentation was developed in response to the many questions posed by nurse colleagues, patients and physicians about the veracity of medicinal cannabis as an adjuvant to cancer treatment as well as a possible cytotoxic agent. It became obvious to me that there is a crucial need for accurate, evidence-based factual information to empower navigators to disseminate to their patients as well as the patients being empowered with credible data, with which to base their treatment choices upon as well as avoiding poor choices which could be detrimental to both their care and their pocketbook. ALL slide content will be based upon evidence-based, published data.


Penny is currently the Gynecologic Oncology Nurse Navigator at Northside Hospital Cancer Institute in Atlanta, GA. She’s been in this position for 6 years. Prior to that she was the Clinical Research Director of Southeastern Gynecologic Oncology for 10 years where she coordinated, managed and assisted in writing Investigator Initiated trials.


While in the role of research director she participated in the ONS team to create Core Competencies for Clinical Trial Nurses.


Penny’s nursing background was in surgical oncology in her home state of Florida.


She’s  been active in ONS since 1993 serving as Chapter President of Metro Atlanta ONS in 2003. She’s a founding member of Cancer Patient Navigators of Georgia and a member of the ONS Nurse Navigator SIG.


This is a second career for Penny. Her first degree was from the University of Washington in Clinical Psychology working primarily with autistic and Downs Syndrome pediatric patients for 8 years. She returned to school in Miami to pursue a nursing career and finished her degree in 1979.Her final clinical rotation was in an oncology unit and she fell in love with Oncology.


She is currently a co-editor and contributing author of our first comprehensive textbook on Oncology Nurse Navigators which was published by ONS in the summer of 2014. She is co-editing/authoring the companion book, Case Studies in Navigation which will be published in 2016. She is also on the Editorial Board of Oncology Nursing News and contributes a monthly column.

Uma V A Dhanabalan, MD, MPH, FAAFP

Cannabis Therapeutic Specialist, Occupational & Environmental Medicine, Family Medicine

“Cannabis: The EXIT Drug”


Cannabis has been used as a medicine for thousands of years. We have only started to stigmatize this plant over the last century. It is known to help with inflammation, seizures and pain as well as many other ailments. Recent developments have shown that cannabis treatments can be extremely beneficial in treating cancer, epilepsy, autism, chronic diseases, and many other conditions. We all have an Endocannabinoid System in our bodies but sadly most of us do not understand what is does for us. The Endocannabinoid System as a mechanism for drug interaction is widely unexplored and the true potential for positive impact on human health is unknown.


This presentation will provide a physician’s view on the history of cannabis as well as cannabis and its applications as a plant medicine delivered by a  Cannabis Therapeutics Specialist trained in Family Medicine and Occupational & Environmental Medicine. Drawing from over 30+ years experience in both research and patient care, this presentation will highlight the need for better therapies and a new focus on total health care ( . It is time to move beyond the misconceptions and misinformation associated with this healing plant. It is time to increase education, reduce incarceration and learn more about the healing properties of cannabinoids and other medicines in cannabis. We are facing an opioid epidemic. Only about 5% of the world’s population lives in the United States yet they consume about  80% of the world’s pain medication. One American dies from a prescription drug overdose every 19 minutes. Deaths from medication abuse outnumber motor vehicle accident deaths. Dr. Uma states ”Cannabis is not an entrance drug, it is an exit from pharmaceuticals and narcotics.”


Dr. Dhanabalan is a highly respected physician trained in Family Medicine and Occupational & Environmental Medicine. She is a Fellow of the American Academy of Family Physicians and a Diplomate Certified in Cannabis Medicine.


She received her medical degree from the University of Medicine and Dentistry of New Jersey. She did her Family Practice Residency at the Medical University of South Carolina. At the Harvard School of Public Health she earned her Master’s Degree in Public Health and completed her Occupational & Environmental Medicine Residency and Fellowship in heavy metals.


Dr. Dhanabalan is the Founder/CEO of Global Health & Hygiene Solutions., LLC whose mission is to promote wellness and prevent illness. She currently practices at Uplifting Health and Wellness in Natick, MA. She is dedicated to “Educating, Embracing, and Empowering” her patients while promoting cannabis as a treatment option. Dr. Dhanabalan pursues Total Health Care ( and believes that “Cannabis is not an entrance drug, it is an exit drug from pharmaceuticals and narcotics”.

Michael Hufford, Ph.D

VP, Regulatory Affairs, Behavioral Science and Innovation, Pinney Associates

Vaping’s Past as Medicinal Cannabis’ Prologue: How the FDA’s Expectations of Respiratory Drug Delivery Create Parallel Challenges for the Vaping and Medicinal Cannabis Industries


Medicinal cannabis can be delivered in a variety of ways to achieve therapeutic effects. Inhaled medicinal cannabis, with rapid onset and the possibility that clinical benefits can be enhanced by enabling users to titrate to effect, poses challenges for device design and regulatory approval. The vaping industry’s Electronic Nicotine Delivery Systems (ENDS) are working to overcome parallel challenges to address the FDA’s expectations of drug delivery devices. Seen through the lens of pharmaceutical regulations, many existing respiratory delivery systems for medicinal cannabis and ENDS have multiple limitations, including variations in particle size leading to variable deposition and absorption, variable doses of compounds emitted both between devices, as well as within devices over time. Engineering principles drawn from the field of respiratory drug delivery may help to address some of these concerns, including control of particle size and deposition, inhalation rates and resistance, timing of aerosol delivery, and paths to achieving consistency in emitted dose. Medicinal cannabis researchers, entrepreneurs, and the investors that fund them will need to overcome a variety of regulatory challenges moving forward, and the recent experiences of the vaping industry and the FDA’s regulation of ENDS is a potent warning of the challenges that lie ahead.


Dr. Michael Hufford has more than 20 years of experience in clinical research, drug and medical device development, and behavioral science across a wide range of therapeutic areas. He is currently Vice President of Regulatory Affairs, Behavioral Science and Innovation at Pinney Associates, and also an Entrepreneur in Residence at the University of Pittsburgh.


Michael’s drug development experience includes serving as Cypress Bioscience’s Vice President of Corporate and Clinical Development, where he had responsibility for development of the drug and medical device portfolio for multiple CNS assets, including the FDA approval of Savella (milnacipran) for fibromyalgia. Before joining Cypress, he worked at Amylin Pharmaceuticals, leading drug development teams focused on orphan drug development for rare metabolic diseases, and combination peptide and protein therapies for obesity. Michael has also consulted extensively with the pharmaceutical industry, including serving as Vice President of Scientific Affairs at invivodata, where he was responsible for scientific consulting on patient-reported outcome claim construction for more than 50 drug development programs. He also served as Chief Operating Officer for NeuroCog Trials, which specializes in providing clinical and neurocognitive assessment, experimental design and data analysis services for clinical trials.


An entrepreneur, Michael co-founded multiple pharmaceutical, device, and mobile health companies. He is the co-founder of NQ Oncology, a clinical stage oncology drug company. He also co-founded and served as Chief Medical Officer of e-Nicotine Technology, a device company committed to reducing the harms associated with combustible tobacco products. He was also the co-founder and Chief Executive Officer of MindApps, a company that provides mobile electronic Cognitive Behavioral Therapy applications focusing on major depressive disorder, anxiety disorders, and PTSD.


A graduate of Purdue University, Michael earned his master’s and doctoral degrees in clinical psychology from the University of Pittsburgh, where his research focused on smoking and other addictive behaviors.

Ashley Marie Lambros

Clinical Research Assistant II, McLean Hospital

Snap, Crackle, and Pot: Exploring the Use of Marijuana Concentrates and Dabbing


The poster is a compilation of data collected from a national, internet-based survey study that specifically targeted marijuana users and their experiences with marijuana concentrates. The data is currently being analyzed, but preliminary results indicate that more than 4000 participants provided marijuana-use related information. Of those participants, more than 58% reported concentrate use with more than 26% reporting regular concentrate use. Despite a large number of individuals using multiple times per day, most did not know the potency of their products and approximately a third noticed increased tolerance after using dabs. These preliminary data underscore the importance of assessing the use of novel cannabinoid products optimized for increased potency and have implications for public policy in light of recent legalization efforts across the nation.


Ashley joined the Cognitive and Clinical Neuroimaging Core (CCNC) as a Clinical Research Assistant at McLean Hospital after receiving her B.S. in Neuroscience from the University of Vermont in May of 2015. She currently works on several studies designed to assess the impact of recreational and medical marijuana on a range of domains. Her recent interests include characterizing novel modes of marijuana use and their prevalence throughout the United States. She intends to gain more experience in all aspects of clinical research before applying to graduate programs.

Samantha Miller

Biochemist, President and Chief Scientist of Pure Analytics Laboratory, Chief Science Officer, hmbldt

Presenting a data-driven approach to cannabinoid product innovation for specific applications as well as observations and conclusions from 7 years of working with patients to gather data around their novel therapeutic regimens and unique applications.  From specific population responses and correlation of responses to cannabinoids relative to other biochemical indicators and health conditions to observations gained from patient testing around specific cannabinoid-terpene blends administered in dose-controlled delivery devices.


Samantha Miller, is an internationally recognized Biochemist, President and Chief Scientist of Pure Analytics Laboratory a renowned cannabis analysis facility and Chief Science Officer for hmbldt.


As a Beckman and NIH scholar, Samantha discovered and described new reactions allowing the development of potential new cancer and AIDS pharmaceuticals.


Later in her career Samantha was project engineer, product manager and eventually oversaw operational excellence at IDEX Health and Science, supporting the design, development and manufacture of enabling technologies for UPLC/HPLC, mass spectrometry and in vitro diagnostics instrumentation as the key liaison to OEM R&D teams.


As founder of Pure Analytics Samantha merged her over 20 years of cannabis cultivation experience with her extensive scientific, product development and business background and has been responsible for the development of unique techniques in cannabis analytics, research and strain isolation. Samantha also pioneered an educational program, teaching thousands of patients and the general public about cannabis, cannabinoid therapeutics, cannabis physiology and dosage development.


Samantha applies the breadth of her experience with patients and knowledge of cannabis therapeutics to the development of innovative and consumer-tested products for hmbldt, a cannabis innovations company selected by TIME magazine as designing one of the top inventions of 2016.

Ilya Reznik, MD

MaReNa Diagnostic and Consulting Center, Bat-Yam/Tel-Aviv, Israel

Cannabinoids-based Medicine as a Pivotal Model for Personalized Integrative Care


I will describe a proposed model of interdisciplinary Clinic (PICaC), utilizing the best methods of contemporary traditional (mainstream) medicine altogether with various cannabinoids-based and other complementary treatment modalities, including Personalized Integrative Rehabilitation Plan (PITP) and Harm Avoidance/Reduction Program (HARP).


Dr. Ilya Reznik is a Board-certified specialist in Adult Forensic & Clinical NeuroPsychiatry at MaReNa Diagnostic and Consulting Center, Israel.


Dr. Ilya Reznik has superior educational and professional record and documented contributions to the field of neuropsychiatric research, such as publications and other innovative activities.


Dr. Reznik has published many original papers (including controlled trials), reviews and case reports in leading peer-reviewed journals in field of clinical psychiatry and neuropsychopharmacology.

His current main interest is in the field of the medical use of cannabis and cannabinoids, especially for various neuropsychiatric illnesses, such as Chronic Pain Syndrome, Fibromyalgia, Post-Traumatic Stress Disorder (PTSD), OCD, Gilles de la Tourette syndrome, Parkinson’s and Alzheimer diseases etc.


During last 8 years he coordinates the activity of Israel National Forum/Association for Medical Cannabis Research & Treatment. He is Associate Member of The Canadian Consortium for the Investigation of Cannabinoids (CCIC), Member of International Cannabinoid Research Society (ICRS). In 2013 he was elected to the Board of Directors, International Association for Cannabinoid Medicines (IACM) and promotes educational and international activity within IACM

Markus Roggen, Ph.D

Vice President, Extraction, OutCo

A whole-plant extract poses a far more complex problem when studying its medical effects, positive or negative, than a single molecule pharmaceutical. In particular cannabis, with its multitude cannabinoids, terpenes, flavonoids, and other compounds, is especially difficult to control.
Potency of the main cannabinoids and composition of minor cannabinoids and terpenes often varies between cannabis strains, harvested crops, and extraction batches. OutCo will report on our efforts to control extraction parameters to target consistent potency and composition for every run.


Markus brings an outside perspective, founded on a solid scientific base, to the cannabis field. An organic chemist by training, Markus took the plunge into the cannabis world by establishing a testing laboratory. He also built an extraction facility for large volume supercritical CO2 extraction. Markus is deeply interested in the molecular properties of the plant, including testing, extracting, and the transformation of active ingredients. As a strong proponent of basic research, Markus constantly tests the limits of current cannabis science and is always willing to help others with their research.
Born in Germany, Markus took a very international route in the pursuit of his chemistry doctorate. His various stops around the globe include undergraduate studies at Imperial College, London, research stays in Germany and Singapore, a Ph.D. at ETHZ in Switzerland, and, finally, postdoctoral studies at The Scripps Research Institute in San Diego.

Savino Sguera

Bioanalytical Researcher

Understanding Cannabis Data: Analysis to Analytics


As the Cannabis plant and its extracts come into more frequent use, it is crucial to begin viewing it not as a single-ingredient pharmaceutical but as an entourage of possibly many active ingredients. An overview of different data from typical chemical analyses is given, ranging from potency assessment to chemical and microbial contamination testing. The amount of chemical profile data can seem overwhelming, with potentially dozens of chemical concentrations associated with one sample. Methods based in machine learning are here presented for data compression and visualization with a focus on simplicity for patients and doctors. With the inclusion of biochemical and other clinical data, these simple tools have the potential to accelerate the understanding not only of cannabis but as well the underlying pharmacodynamics of its medical properties, helping to quantify what has until recently been largely qualitative.


Savino Sguera is the founder and CSO of Digamma Consulting, a firm specializing in cannabis research and development. He has been a chemist in the cannabis industry since 2010, directing analytical laboratories in California and Nevada and working with legislators from multiple states to write regulations.  He has developed methods for analysis of products for chemical constituency and contamination by means such as gas and liquid chromatography, mass spectrometry, and light spectroscopy. He also serves as Vice Chair of the Nevada DPBH Independent Laboratory Advisory Committee, providing scientific and empirical insight to state legislators that are drafting and implementing cannabis regulations. Savino holds a B.Sc. in Biomedical Engineering from Columbia University and has worked previously in pharmaceutical formulation and biomedical device development.

D. Robert Sievers, Ph.D

Chief Scientist, Sievers Biotech Professor & Director Environmental Program, University of Colorado, Boulder


Post Doctoral Researcher, Department of Chemistry and Biochemistry, University of Colorado, Boulder



Alternative methods of delivering cannabinoids to the bloodstream that are rapid, consistent, and efficient are greatly needed. The majority of extracted cannabis products available today are oil-based, and vary considerably in potency, purity, stability and bioavailability. By coprocessing cannabinoids with selected ingredients (United States Patent Application #20160228385) through our patented Carbon Dioxide-Assisted Nebulization with a Bubble Dryer (CAN-BD) process (United States Patent #6,630,121), we were able to successfully manufacture a fine, dry powder with the correct properties for inhalation into the respiratory system. The powder is also compressible into wafers that rapidly dissolve under the tongue (United States Patent Application #20130202655). Our dry, stable, oil-free powders allow for the dose and specific ratios of different cannabinoids to be precisely controlled and efficiently delivered to the bloodstream, bringing cannabis-based therapies into the realm of pharmaceutical science to an unprecedented extent.


D. Robert Sievers, Ph.D


Dr. Robert Sievers is an analytical chemist and public health scientist, and has mentored the research studies of graduate and undergraduate students at the University of Colorado, Boulder and elsewhere. Forty grad students in analytical chemistry have earned their PhD degrees under his mentorship. He and his students have co-authored more than 200 journal publications and book chapters, which have been cited by more than 6000 other research groups. They have also been awarded more than 26 US and foreign patents. (See website at for the issued patents.) Others are still pending. He has served widely as a consultant, and was a recipient of the Twsett Chromatography Award in Barcelona. He has served as an advisor to NIST on analytical standards and trace analysis of biological fluids.


Lia Rebits, Ph.D. 


Dr. Rebits has a history of translational education and research that encompasses such topics as molecular biology, biochemistry, organic chemistry, and analytical chemistry, and applies to the currently proposed project. As an undergraduate, she completed the requirements for three majors: Molecular, Cellular and Developmental Biology; Biochemistry; and Chemistry. Because of this, her understanding of chemistry and biology is very translational and she is able to comprehend literature on a wide range of subjects, including genetics and microbiology. After graduating with her Bachelor’s degree, she worked as a research scientist for Aktiv-Dry, LLC for four years, during which she served as a quality control manager overseeing the analysis of inhalable dry powder vaccines. This position required her to work with active ingredient stabilization with excipients, optimize dry powder formulations, develop analytical methods, write standard operating procedures, and analyze and report data. One of the methods was published in the Journal of Aerosol Science: “Method for Quantifying the Sample Collected by an Anderson Cascade Impactor Using Total Carbon Analysis.”

As an analytical chemistry graduate student working in a biochemistry lab, Dr. Rebits became familiar with many analytical biochemistry techniques, such as infrared spectroscopy, nuclear magnetic resonance, high performance liquid chromatography, and mass spectrometry of biomolecules. She routinely developed methods for the HPLC purification of modified DNA strands, utilized various size exclusion methods, and has analyzed DNA strands using electrospray ionization mass spectrometry. Another part of her project required her to synthesize a modified deoxynucleotide, the analysis of which included IR spectroscopy and NMR.

Rosemary T. Smith

Research Project Manager, McLean Hospital

At CannMed 2017, Rosemary will present preliminary results from the MIND program investigating the impact of three months of medical marijuana treatment on symptoms of pain, quality of life, and cognition in patients with chronic pain. Thus far, patients report reduced pain ratings and improved quality of life following three months of treatment compared to baseline. Further, patients tend to perform better on measures of executive function, including tasks of working memory, cognitive flexibility, and inhibitory function after three months of treatment. Preliminary data suggest that medical marijuana treatment may be a viable option for chronic pain, and that some improvement in executive function may also be demonstrated as symptoms are alleviated. This research highlights the importance of investigating the impact of medical marijuana treatment on clinical symptomatology as well as cognitive function, as few studies thus far have examined these endpoints despite the growing number of states that have enacted full medical marijuana laws.


Rosemary (Rosie) is a Research Project Manager at McLean Hospital, where she works with Dr. Staci Gruber and the Marijuana Investigations for Neuroscientific Discovery (MIND) program, designed to assess the impact of medical marijuana on clinical state, quality of life, cognition, and brain structure and function. Rosie also works on projects related to recreational marijuana use in adolescents and young adults. Rosie’s background in both clinical and pre-clinical neuroscience research has led to a particular interest in determining the impact of medical marijuana use on specific clinical symptoms, such as anxiety and pain, and concurrent alterations in cognitive function.

Marco Troiani

Chemical Researcher

Terpenes and Terpenoids of Cannabis: A Medical Review


The class of organic compounds referred to as terpenoids can be found extensively throughout the biochemical world, produced naturally in plants and insects. Chemical properties make them candidates in treating a wide array of medical conditions. In addition to creating the characteristic smell and taste of cannabis, many terpenoids enhance or attenuate the effects of cannabinoids or possess independent medicinal properties altogether. Potential treatment targets range from psychological conditions such as anxiety and depression to inflammatory disorders, cancer, and antibiotic-resistant infections. A review of published literature is presented regarding clinical effects of terpenoids found in Cannabis and laboratory data for terpenes in Cannabis is presented for hundreds of samples.


Marco Troiani is the founder and CEO of Digamma Consulting, a firm specializing in cannabis research and development. He has been a chemist in the cannabis industry since 2013, managing analytical laboratories in California and Nevada. He has developed methods for analysis of cannabis for chemical constituency and contamination by means such as gas chromatography, mass spectrometry, and light spectroscopy. Marco holds a B.Sc. In Molecular, Cellular, and Developmental Biology from the University of California at Santa Cruz and previously worked in research on toxic peptides by synthesizing peptide analogues for use in permeability and other chemical property assays.

Denise A. Valenti, OD

CEO/President, Impairment Measurement Marijuana and Driving (IMMAD)

Acute Marijuana Use: Functional Findings of Retinal Ganglion Cell Impairment


This project identified significant functional impairment to visual perception and processing within the central twenty degrees of vision with acute marijuana use.  There are cannabinoid receptors throughout the retina with substantial density within the retinal ganglion cell layers.  Marijuana use has been demonstrated to cause dysfunction in the retinal ganglion cells with chronic use and photoreceptor and retinal ganglion cell dysfunction with acute use.  Other research has shown decreased recovery of central field glare function and reduced central visual perceptions with acute use of marijuana.  One of the more common diseases that causes retinal ganglion cell dysfunction is glaucoma.  Neurologic disease that impacts retinal ganglion cells also include Alzheimer’s disease and Parkinson’s disease.  Tests of retinal ganglion cell function include visual field tests.  This study identified functional impairment of the retina with acute marijuana use, utilizing a specialized visual field test that has identified retinal ganglion cell impairment in glaucoma, Alzheimer’s disease, and Parkinson’s disease.  The dysfunction identified was significant with marijuana use when compared to a large normative database.


The impairment of visual perception/visual cognitive function identified has serious implications for quality of life and safety with acute marijuana use.  The dysfunctions identified would be considered a significant impairment to drive a motor vehicle or operate heavy machinery.  Further research is warranted to determine if the results identified in this preliminary study can be generalized to larger populations and to determine the correlations to biologics such as blood, saliva or breath, as well as correlations to motor performance during a driving task. 


Dr. Denise A. Valenti received her undergraduate degree and gerontology training from Oregon State University. Her optometry education is from Southern California College of Optometry where she did internships with the Santa Monica Center for Partially Sighted and the New York Lighthouse for the Blind.  This education was followed by a low vision residency at the University of Houston which emphasized rehabilitation aspects of driving.  Dr. Valenti’s current research work is in the visual system, neurodegenerative diseases and cannabis.  Dr. Valenti has participated in a variety of research activities including sitting on the National Institutes of Health Study Sections including; Bioengineering of Neuroscience and Vision and Low Vision Technologies.  She has undertaken pharmaceutical funded research related to Alzheimer’s disease and Namenda efficacy and NIH funded research regarding Optical Coherence Tomography imaging and Alzheimer’s disease. Dr. Valenti has had additional training as an MGH/MIT/HMS Functional MRI Fellow at the Martinos Center for Biomedical Imaging in Boston, Massachusetts and participated in the yearlong seminar series in the Boston University Sleep Disorders Center Fellowship program.   Dr. Valenti reviews for a variety of journals related to vision and neurosciences.  Dr. Valenti currently works with a technology to determine fitness to drive after cannabis consumption; IMMAD-Impairment Measurement Marijuana and Driving.  Dr. Valenti has presented scientific abstracts and lectures nationally and internationally on the visual system, Alzheimer’s disease, Parkinson’s disease, cannabis and cannabinoids.

Daniel Wang

Pharmaceutical Public Health Policy Consultant, Pinney Associates

Beyond Schedule I or II: On the Development of Cannabinoid-Based Drugs Appropriate for Less Restrictive Scheduling under the Controlled Substance Act


As medicines derived from cannabis move from clinical development and towards regulatory review, the influence of the Controlled Substance Act (CSA) on ultimate scheduling decisions for these drugs will have a profound impact on patients’ access to these therapies, as well as their commercial viability. In developing CSA scheduling recommendations, the Drug Enforcement Administration, Food and Drug Administration, and National Institute on Drug Abuse, must consider 8 factors listed in the CSA to develop their recommendations for new medicinal products. Although unusual, that can lead to products with the same active ingredient being scheduled differently.


Lessons learned in the development and regulation of cannabinoids and more recently opioid medications have important implications for the development of cannabis-based pharmaceuticals. These lessons can not only increase their chances of approval for therapeutic use, but also to support recommendations for placement in schedules that are less restrictive than II. This poster will summarize the types of testing and outcomes that would likely be required to support placement in schedules less restrictive than II.


Daniel Wang joined Pinney Associates in 2010 as a Junior Associate after coordinating early phase preclinical drug development at the Hospital of the University of Pennsylvania.  


As an Associate, Daniel supports Pinney Associates’ clients with research and analysis for a variety of projects throughout the drug development cycle, including clinical study reports, literature reviews, and postmarketing risk management. He also supports the development and coordination of postmarketing and risk management surveillance programs, including contributing to reports based on surveillance from Internet and media monitoring, public use datasets, and proprietary datasets. Additionally, Dan contributes to Pinney Associates’ science, policy, and marketing intelligence efforts.


Daniel graduated from the University of Pennsylvania in 2008 with a degree in the Biological Basis of Behavior.