Canna-Pharma EastCanna-Pharma East chemical or other phenotypic data where available. The combined process contributes to a database that, using the correct methodology, provides a

PharmaEd Resources, Inc. • 2810 Robeson Park Drive • Champaign, IL 61822tel. 217.721.5774 • web. www.pharmaedresources.com

Canna-Pharma EastAdvancing the Science of Medicinal Cannabis Through GMP,

Regulatory Compliance, and Emerging Therapeutic ApplicationsMarch 18–19, 2020, Sheraton Silver Spring, MD

Featuring Lessons Learned and Case Studies from Industry Experts:

With Comprehensive Coverage On:

With Representation From:

• Challenges in Creating Standards for Quality Control of Cannabis Derived Products

• Updates from Industry Working Groups: ASTM D37, AHPA, USP, & AOAC International

• Analytical Testing Strategies for Pesticides, Trace Metals & Other Contaminants

• Regulatory Panel Discussion—Hear from the Experts

• Cannabis Genetics: The Path to Better Medicinal Cannabis

• Hot Topics in Therapeutic Cannabis Research• Key Formulation Considerations for

Improved Bioavailability of Cannabinoids• Cleaning Validation and GMPs for Medicinal

Cannabis Products• Cannabis-Based Drug Delivery--From Lab

Bench to Clinical Trials

• Cannabis Product Ingredients: What Interlocking Regulatory Boundaries Make Sense?

• Cannabis Fungal Endophytes & Their Interplay with the Cannabis Genome

• BenefitsofFDAGMPPracticesfortheCannabis Industry

• And Much More!

Anthony Macherone

Agilent Technologies

Jasmine Musakhanian

Gattefossè

Charlotte Peyton

EAS Consulting Group

Andrea Small-Howard

GBS Global Biopharma

Beth Kroeger

Steris

Michael Moussourakis

Alconox

Tomas Skrinskas

Ascension Sciences

Wayne Nasby (Event Chair)Ocean Grown

Ventures

Ralph ParoliNational

Research Council of Canada

Susan Audino

AOAC International

Reggie GaudinoFront Range Biosciences

Jeffrey Raber

The Werc Shop

Andrew KlineNat’l Cannabis Industry Assoc.

David Mangone

The Liaison Group

Kevin McKernan

Medicinal Genomics

Jennifer Raeder-Devens

Project Yosemite

Andrew Samann

Orion GMP Solutions

Audra Stinchcomb

University of Maryland

Michelle Bailey Vertex

Pharmaceuticals

Lori DodsonMD Medical

Cannabis Comm.

Hope JonesAdivina

Biosciences

Robert Morgan

ASTM

Len MayEndoCanna Health

Register Now to Guarantee Your Space! Online: www.pharmaedresources.com • Phone: 217.721.5774

Canna-Pharma 2019

Canna-Pharma East Sponsored By


Canna-Pharma East

competence to build methods that are well characterized to a number of parameters as well as forming a determi-nation of measurement uncertainties.

This session will discuss progress chemists have made to the development of standard test methods with the as-sistance of international scientific organizations. Specif-ically, participants will leave with a list of test methods established by cannabis working groups in AOAC Inter-national and ASTM International, in particular.

9:50 Quality Control & Analytical Testing: Achieving Standardization

Moderator: Chair Wayne Nasby

Panelists: Ralph Paroli, Susan Audino

Participants: The Audience

10:30 Morning Coffee & Networking Break

11:00 Practical Implementation of Cannabis Regulations Through FDA Good Manufacturing Practices (GMPs)

Charlotte Peyton, EAS Consulting Group

While FDA regulations for Good Manufacturing Practic-esarefairlycertaininHempasspecifiedbyCongressinThe Farm Bill of 2018, the FDA’s role in Marijuana seems less certain. This presentation will focus on the ways

that both types of cannabis business owners can benefitfrom the development and implementation of an FDA Good Manufacturing Practices (GMPs) quality system including the consistent manufacture of a higher quality cannabis product; more efficiency in overall operations with lesswaste; trained employees that follow procedures; prepara-tion in the event of a product recall; and most importantly ensuring the safety of products for your customers. Cus-tomers and investors alike, will be more attracted to your company because of your GMPs and the fact that you will be ready when the FDA assumes regulatory authority of the industry. All of this AND compliance with your state regula-tions. Be ahead of the curve, begin the practical implemen-tation of GMPs at your facility now.

11:40 Keynote Address: Cannabis Product Ingredients: What Interlocking Regulatory Boundaries Make Sense?

Dr. Jeffrey C. Raber, CEO, The Werc Shop

There is an old FDA axiom that summarizes when a sub-stance is a drug and/or a food, if it can potentially be both: “First a food, always a food. First a drug, never a food.” Suchgatingdetailsandthecompositionaldefinitionsof

food, dietary supplements, and drugs are instructive to those interested in any cannabis-derived or -inspired products. The reasons are manifold including likely draft U.S. hemp regulations and, perhaps in the foreseeable future, U.S. fed-eral adult-use marijuana product regulation. We will syn-thesize the relevant regulatory doctrine before providing a potential road-map for incorporating all cannabis products

Wednesday, March 18

7:30 Complimentary Breakfast

8:05 Opening Remarks from Chairperson

Wayne Nasby, COO, Ocean Grown Ventures

Critical Issues—Spotlight on Quality Control and Analytical Testing Standards for the Medicinal Cannabis Industry

8:30 Developing Normative Standards at ASTM International

Dr. Ralph M. Paroli, Director, R&D, National Research Council of Canada and Robert J. Morgan, Director, ASTM International

Standard developing organizations (SDOs) such as ASTM International develop product safety standards using the consensus process. This, of course, gives everyone an equal voice in the process. The purpose of these voluntary standards is to help enhance safety and performance. The standards help enhance safety because it provides regulators with tools to develop

laws and regulations to ensure that the products we are consumingaretestedoranalyzedwithconfidenceusingmethodswhichhaveappropriatecertification,calibration,etc. For example, pesticide presence needs to be mea-sured accurately so that the levels allowed by regulators are within the appropriate tolerances. This presentation will provide an update on what has been accomplished at ASTM International Committee D37 in the areas of: Indoor and Outdoor Horticulture and Agriculture; Quality Man-agement Systems; Laboratory; Processing and Handling; Security and Transportation; Personnel Training, Assess-ment, Credentialing; and Industrial Hemp.

9:10 Cannabis Testing in a Rapidly Changing IndustryDr. Susan Audino, Chair, Cannabis Advisory Panel and Chair, Cannabis Working Group, AOAC International

In a rapidly changing industry, regulatory bodies, product manufactures, and scientists strive to provide

cannabis consumers with safe products with known con-centrations of constituents of interest. Although canna-bis cultivators and product manufacturers may conduct in-house testing to ascertain the status of product devel-opment, all parties look to the external third-party testing labs to provide empirical data that attests to the veracity of the statements made about the final product.

These third-party analytical testing laboratories must rely on solid scientific processes and technologies to yield sound results accurately and precisely. Relying on laboratory accreditation to the pinnacle international standard of laboratory quality that is ISO/IEC 17025, lab-oratories are compelled to develop analytical test meth-ods that are based using appropriate technology and

KEY NOTE


Canna-Pharma East

ionizationliquid chromatography-tandem mass spec-trometry (Ni-APCI LC-MS/MS) for PCNB with a precursor ion of 275.5 m/z. However, a laboratorian must consider selectivity as much as sensitivity in the application of a certain analytical methodology and in this case, the ion-ization mechanism is reported as the loss of HCl followed by formation of an ammonium ion adduct. There are two intrinsic problems with this description 1) the empirical formula for PCNB is C6Cl5NO2thus there is no hydrogen atom to lose as H-Cl, and 2) the formation of a positive-ly charged ammonium ion in negative ionization mode is improbable. In this presentation we prove the correct ionization mechanism for PCNB using Ni-APCI LC-time-of-flight mass spectrometry (Ni-APCI LC-QTOF) and eval-uate the appropriateness of this analytical technique for PCNB in terms of selectivity, sensitivity, and the fit of the coefficient of determination compared to GC-MS/MS methodologies.

Critical Issues—Best Practices in Cleaning Validation for Cannabis GMP

4:45 Cannabis, Keeping it CleanBeth Kroeger, Technical Services Manager, STERIS

As cannabis use becomes more mainstream, there is a growing demand for testing to ensure the safety of not only medical marijuana, but recreational cannabis as well. Both in Canada and the US, strict guidelines have been

imposedontheindustrytoensurethefinalproductdoesnotcontainsignificantlevelsofharmfulsubstances.Thispresen-tation will provide an overview of the industry from cultiva-tion, harvesting, and extraction along with the industry issues for meeting these requirements at each of these stages.

5:20 Happy Hour Mingle

Thursday, March 19 7:30 Complimentary breakfast

8:15 Critical Cleaning—The Key to Quality & Safety Michael Moussourakis, Senior Director, Strategic Affairs, Alconox Inc.

Critically clean processing equipment, whether it be labware, glassware, instrumentation, or processing and extraction equipment, is vital. The potency, purity

and quality, essential characteristics of any drug, rely on critically clean surfaces. Cannabis is no different, and in fact, likely more difficult than traditional drug manu-facturing. Waxy, resin, oily and sticky residues abound which can be highly adherent, difficult to emulsify, and just a plain challenge to remove. Strong solvents and harsh chemicals might be a quick answer, for sure. But the wise answer, the innovative answer, are detergents that are not only effective, but end-user safe, aqueous, free-rinsing, interfering residue-free, biodegradable, and without any added dyes, fragrances, brighteners or soft-eners. In other words, maintaining the whole reason why cannabis, and its “natural” state is sought after.

into the existing landscape while highlighting the role an-alytical chemistry has to play. Importantly, we will describe why this issue must be collaboratively addressed by all stakeholders—including hemp, marijuana, and pharma—if we hope to succeed any time soon.

12:20 Lunch Break

Q & A—Ask the Experts

1:30 Regulatory Panel: The Present & Future of Medicinal Cannabis Regulation

Moderator: Chair Wayne Nasby

Presenters/Panelists:

Lori Dodson, Deputy Director, Maryland Medical Can-nabis Commission

Andrew Kline, Director of Policy, National Cannabis Industry Association

David Mangone, Director of Policy, The Liaison Group

Participants: The Audience

2:10 Best Practices for Cannabis Processing & Extraction

Andrew Samann, CEO, Orion GMP Solutions

Abstract Coming Soon.

2:55 GMP and Validation for Continuous Manufacturing of Cannabis Products

Michelle Bailey, Assoc. Director for Validation, Vertex Pharmaceuticals


3:35 Afternoon Networking Break

4:05 Tackling Pesticide Analysis in Cannabis: The Analytical Suitability of a Multi-Platform Approach

Dr. Anthony Macherone, Senior Scientist & Strategic Program Manager, Agilent & The Johns Hopkins University School of Medicine

Residual pesticide analyses in cannabis matrices iscomplicated because of matrix effects and target

analytes like pentachloronitrobenzene (PCNB) that are not amenable to common techniques using electrospray ionization (ESI). To overcome this issue, it has been sug-gested to use negative atmospheric pressure chemical


Canna-Pharma East

chemical or other phenotypic data where available. The combined process contributes to a database that, using the correct methodology, provides a proxy for sequence infor-mation, and where applicable, functional outcome. This in-formation can be used to screen for new cultivars, or breed forspecificcultivarsofmedicalimportance.

11:20 Sequence and Annotation of 42 Cannabis Genomes Reveals Extensive Copy Number Variation in Cannabinoid Synthesis and Pathogen Resistance Genes

Kevin McKernan, CSO, Medicinal Genomics

Cannabis is a diverse and polymorphic species. To better understand cannabinoid synthesis inheritance and its impact on pathogen resistance, we shotgun sequenced and assembled a Cannabis trio (sibling

pairandtheiroffspring)utilizinglongreadsinglemol-ecule sequencing. This resulted in the most contiguous Cannabis sativa assemblies to date. These reference assemblies were further annotated with full-length male and female mRNA sequencing (Iso-Seq) to help inform isoform complexity, gene model predictions and iden-tificationoftheYchromosome.Tofurtherannotatethegenetic diversity in the species, 40 male, female, and monoecious cannabis and hemp varietals were evaluat-ed for copy number variation (CNV) and RNA expression. ThisidentifiedmultipleCNVsgoverningcannabinoidexpression and 82 genes associated with resistance to Golovinomyces chicoracearum, the causal agent of pow-dery mildew in cannabis. Results indicated that breeding for plants with low tetrahydrocannabinolic acid (THCA) concentrations may result in deletion of pathogen resis-tance genes. Low THCA cultivars also have a polymor-phism every 51bases while dispensary grade high THCA cannabisexhibitedavariantevery73bases.Arefinedgenetic map of the variation in cannabis can guide more stableanddirectedbreedingeffortsfordesiredchemo-types and pathogen-resistant cultivars.

12:00 Lunch Break

1:10 Cannabis Is Personal: The Intersection Between Human Genetics and Cannabis

Len May, CEO & Co-Founder, EndoCanna Health

With increased access to legal cannabis, more and more consumers have a growing interest in incor-porating cannabis into their lifestyles. Len May, the founder of Endocanna Health, a research and develop-

ment bio-technology company specializing in direct-to- consumer genetic testing, will discuss how human DNA and the endocannabinoid system interact with cannabis. Until now, there was no comprehensive way to test one’s unique DNA and align it with the latest research to pre-dict how humans may respond to cannabis use. Since some people are more sensitive to cannabis than others, this presentation will look at how human genetics can be helpful for consumers in determining their compatibility in varying strengths and strains of cannabis plants.

Critical cleaning is defined as when the level of cleaning directly impacts the value of the final product. The can-nabis and related industries certainly apply, and mastery of both the right detergents, for the right applications, right procedures, and right guidance documentation, en-sures the end product is at its highest efficacy possible.

Research Spotlight—Unlocking the Therapeutic Potential of Cannabis Derived Compounds

8:50 Adivina Presentation on MicropropagationDr. Hope Jones, CEO, Adivina Biosciences


9:30 Cannabis-Based Drug Delivery: University Lab to Clinical Trials

Dr. Audra Stinchcomb, Professor, University of Maryland & Founder, F6 Pharma, Inc.

Topical, transdermal, and oromucosal dosage form development will be discussed. Primary research fo-cus areas will include microneedle-enhanced deliv-

ery and translational research models for public-private partnerships. Currently Dr. Stinchcomb is focusing sig-nificant effort in concert with the FDA on the evaluation of multiple dermal dosage forms in human subjects, with the end goal of creating validated in vitro-in vivo cor-relation studies that may help to improve the efficiency and cost of the drug development process. The research group is also developing the best way to formulate and evaluate drug delivery from oromucosal systems in vitro.

10:10 Morning Coffee & Networking Break

10:40 Keynote: Cannabis Genetics: The Path to Better Medicinal Cannabis

Reggie Gaudino, Ph.D., VP of Research & Development, Front Range Biosciences

As interest in Cannabis grows, identifying genes and gene networks involved in production of the desired metabolites (cannabinoids and terpenes) as well as

networks necessary to optimize cultivation potential, will becomeincreasinglyimportantasdemandforspecificme-tabolites or cultivars grows. In addition to the work Steep Hill has done identifying and analyzing cannabinoid and terpene genes, we have also started a systematic analysis of upstream genes in the cannabinoid and terpene metabol-ic networks, and genes related to growth, development and oil production. Recent advances in reference to genome availability have allowed us to identify and map novel genes and begin the process of metabolic network annota-tionandSNPidentification.SNPsidentifiedinthegenesofinterest are screened using a panel of known cultivars to identify any potential informative regions associated with one or more SNPs. Informative regions are then further as-sessed for their level of informativeness by comparison to

KEY NOTE


Canna-Pharma East

2:50 Enhancing the Bioavailability of Cannabinoids in Pharmaceutical Dosage Forms

Jasmine Musakhanian, Scientific & Marketing Director, Gattefossé USA

With the looming ease of regulations around the globe, there is an expressed need for adequately dosed, age appropriate cannabinoid medicines. The window of

opportunities for new cannabinoid drugs currently in-cludes the treatment of multiple sclerosis, seizures, neu-ropathic/intractable pain in cancer patients, and nausea. There are also indications for anti-inflammatory effect, psychotherapy, and rehabilitation from opioid addiction.

Meanwhile, studies show that only 3 – 8% of orally ad-ministered cannabinoids reach the systemic circula-tion. This poor bioavailability is in part attributed to the poor gastrointestinal (GI) solubility of these compounds resulting in erratic and variable absorption from the GI tract. Additionally, cannabinoids undergo a significant first pass metabolism in the liver following GI absorp-tion. These properties render cannabinoids as excellent candidates for Lipid-Based Drug Delivery (LBDD). This presentation discusses the key considerations for en-hancing the delivery of cannabinoids, focusing on LBDD for immediate or sustained action.

3:30 ExploitingtheEntourageEffectforTerpenesinCannabis Drug Delivery

Jennifer Raeder-Devens, CSO, Project Yosemite


4:10 An Overview of the Nanoparticle Discovery and Development Process foer Cannabis Drug Delivery

Tomas Skrinskas, Ph.D., CEO & Founder, Ascension Sciences

Nanoparticles are emerging as an important tool for cannabis drug delivery due to their ability to be tuned for specific indications, administrative routes, tissues

and therapeutic effects. Furthermore, with careful formu-lation, the pharmacokinetics of the drug-excipient com-bination can be rationally adjusted.

Inherent in the nanoparticle development process is choosing the appropriate method to formulate the par-ticles. The top-down approach calls for a process that mixes the components into large particles which are then broken apart with an input of energy (e.g., high-shear mixing, sonication, homogenization). Bottom-up assembly of the nanoparticles is often termed a low-en-ergy method that involves spontaneously forming the particles by taking advantage of the constituents’ hydro-phobic and hydrophilic, or charge, interactions.

Specifically, the presenter will:

• Explain how cannabis commodity developers can cre-ate and market products based on human genetics

• Discuss the latest breakthroughs in cannabis-connected genetics research or pharmacogenetics

• Revisitthescienceofhowgeneticsinfluencecannabiseffectiveness

• Demonstrate how to best educate the cannabis consumer about cannabis and the Endocannabinoid system

• Review research that concludes why consumers need both CBD and THC, which in tandem work together as a neuro-protectant.

1:50 CCCM™: A Natural Product Approach to Cannabis-based Therapies

Andrea L. Small-Howard, Ph.D., Chief Science Officer and Director, GBS Global Biopharma, Inc. (Ottawa, Canada) and Chief Science Officer and Director, GB Sciences, Inc., (Las Vegas, Nevada)

GBS uses a novel, whole plant approach to discovering proprietary formulations of cannabis-derived compounds thatshowpromiseforthetreatmentofspecificdiseases.GBShasfocuseditseffortsonfindingtherapiesforpatientgroups that are largely underserved, and they are using novel delivery methods to ensure bioavailability and to provide time-released versions of their patent-pending, cannabinoid-containing complex mixtures (CCCM™).

Although many cannabis researchers and biophar-ma companies have focused on the activities of single cannabinoids, GBS leverages powerful molecular syn-ergies derived from whole plant extracts that are then further-refined and standardized. Most other canna-bis-based biopharmaceutical companies are studying one of the two most abundant cannabinoids in the plant, either tetrahydrocannabinol (THC) or cannabidiol (CBD); whereas, GBS embraces naturally occurring mixtures of approximately 480 bioactive compounds in the cannabis plant. GBS has demonstrated correlations between ex-tracts from different “chemovars”, chemical variations of the cannabis plant, and potential therapeutic efficacy for different specific human diseases.

Our drug discovery process combines: 1) high throughput screening of tens of thousands of combinations of com-pounds derived from specific chemovars of the cannabis plant in well-established cellular models of diseases and 2) a proprietary network pharmacology algorithm for the prediction of complex therapeutic mixtures. By carefully screening the contributions of the individual compounds within our disease-specific chemovars, we discovered our patent-pending CCCM™ for the treatment of neurodegenerative disorders, inflammatory disorders, cardiovascular disorders, and chronic/neuropathic pain.

2:30 Afternoon Networking Break


Canna-Pharma East

In reviewing the methods and tools for nanoparticle development, researchers can better determine which approach is most suitable for their particle develop-ment needs, shorten development cycles and ensure scalability.

4:50 End of Program

Within these two categories, various instrumentation ex-ists, each with pros and cons that further relate to the type of particle to be designed—nanoemulsions vs. li-posomes vs. polymeric nanoparticles and combinations thereof. Choosing the right instrument must be purpose-ful; while considering scaling, manufacturing and an un-derstanding of how to get from bench to bedside.

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Documents

Canna-Pharma EastCanna-Pharma East chemical or other phenotypic data where available. The combined process contributes to a database that, using the correct methodology, provides a