STATE OF PHARMA

Ms. Bighash has a Bachelor of Pharmacy, and a Bachelor degree in Pharmacology and Toxicology from University of Toronto, Canada. She also obtained her Masters degree in Business Administration (MBA) from Schulich School of Business. She is a recipient of 2019 UC-University of Toronto alumni of influence award and has been nominated for the Canadian Women Entrepreneur Award. In her current role as the President of AAPS, a post-graduate private college focusing on pharmaceutical and food higher education, she oversees the strategic, educational and training direction of AAPS. She has over 27 years of experience working for a number of multinational pharmaceutical companies such as Genpharm Inc., Bayer Corp. and Eli Lilly & Company. Laleh has also worked with a number of Food and Cannabis organizations in various capacities such as Research and Development, Quality Control, Quality Assurance, Regulatory and Compliance, Strategic Planning, and Business development.

Ms. Bighash has lectured extensively and has been an invited speaker at many global and Canadian academic and industry events focusing on pharma, food and cannabis-related topics such as regulatory, compliance and efficient operations. She has worked closely with the industry players and stakeholders in formulating efficient operating systems, ensuring regulatory compliance and certification.

Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team. She has a B.S. in entomology and an M.S. in mycology, both from the University of Florida. She can be contacted at amcfarland@valsource.com.

Heather Longden is an independent regulatory compliance consultant to the pharmaceutical industry. Heather specialises in data integrity, regulatory compliance, data management, GLP and GMP and computer system validation. She acts as an advisor to various regulatory groups, specifically as a leader at GAMP® Americas steering committee and serves on the the ISPE Boston Area Chapter Board and Education Program Committee (EPC).

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, supplier qualification, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Accomplishments include working on consent decree remediation issues for aseptically produced products, assisting clients in Japan, Dubai, Spain, China, and India by addressing audit observations and corrective actions dealing with sterilization. Performs PAI’s (pre-approval inspections) against current standards as found in the FDA’s ‘Pre-Approval Inspection Compliance Program #7346.832.

Mr. Christie is a speaker and trainer for several professional organizations and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Varun is passionate about Quality Management Maturity and Human Performance in the Lifesciences Manufacturing sector. With over 12 years of experience across Industry and Management Consulting, Varun is a multifaceted professional with commercial (Due Diligence, Strategy and Operational excellence) and technical (Regulatory, Quality and Manufacturing Systems) expertise across the Life Sciences sector.

Varun started out his career in the consulting industry, advising life sciences clients on technology adoption and process improvements. He then moved to Pfizer, working in multiple roles across Operations, Manufacturing and Quality. Subsequently, he took up roles in management and strategic consulting for the Life Sciences sector at PwC and EY. He is currently a Principal consultant for the Pharma & Biotech industry at NSF international, based out of Toronto.

Varun has an undergraduate engineering degree in Biotechnology and a master’s in biotechnology. He is currently pursuing his Global Executive MBA in Healthcare/Life Sciences at the Rotman School of Management, UofT.

Dr. Tim Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.

Dr. Sandle has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing.

In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.

Martti is a pharmacist from Finland and I have graduated from the University of Helsinki. His professional background is in the different areas of the international pharmaceutical industry but has also worked in the largest community pharmacy in Finland and one of the main hospital pharmacies in the country. Currently, Martti act as the chief operating officer at Tepsivo and as a co-founder / operations of RemedyBytes. Tepsivo is a service and product provider for the pharmaceutical industry specialized in the areas of pharmacovigilance, regulatory affairs and clinical data management. RemebyBytes provides services related to healthcare data management and data requests to the registries and databases.

His current role contains a wide range of responsibilities related to process development and management for drug safety and related areas, acting as a product owner for database and automation products, managing teams and a global network of experts, authoring documentation etc. The main driver for Martti is the urge to push things forward in all areas within Tepsivo and RemedyBytes but also in the industry in general.

Adam Brown is a researcher and community advocate. He attended Wittenberg University in Springfield, Ohio, with a bachelor’s degree in biology. Throughout Adam’s professional career, he has been a senior research associate, global analyst, executive, and board member. Adam was listed on Venue Magazine’s 40 under 40 lists in 2021 and featured on the Cincinnati Business Journal cover for his work. As an executive, he founded ClinArk to help small and large life science companies with community engagement by implementing community-based participatory research approaches to build awareness around community health. In addition to this experience, Adam previously served as a board member at The Conscious Connect Community Development Corporation (CDC), where he helped develop strategies to help advanced equitable access to the park and green spaces for residents in southwest Ohio. Adam is passionate about helping improve research and communities in ways that will enhance and address the quality of life and health outcomes for communities

Kay Gaynor is a technical specialist with over 30 years of experience in the pharmaceutical, consumer health and chemical industry with in-depth experience in regulatory affairs and new product development, including assignments in early drug discovery and material science research, product development & scale-up/validation, competitive product characterization, analytical development & validation, clinical supply manufacturing, technology transfer to internal/external partners, quality compliance & audits, project management and regulatory products filing. She is currently an independent Regulatory Affairs Consultant in the biologics and vaccine industry specializing in CMC and Quality & Risk Management. She previously was director in the Regulatory Affairs, Quality and Compliance department at ACIC, where her group was responsible for guiding offshore global CDMOs/CMOs on end-to-end product development, filing new dosage forms, and hosting PAI audits by authorities. Prior to ACIC, she has held various technical positions in GlaxoSmithKline, Colgate-Palmolive, Xerox Research and Mount Sinai Cancer Research. She has also co-authored 3 material science patents. She has a Master of Business Administration degree (information and Technology Strategy) from Athabasca University and a Bachelor of Science degree in Biochemistry from University of Waterloo.

Kim McDonald-Taylor, MSc, CRPC operates a clinical consultancy, McDonald-Taylor Consulting, where her passion for her clients’ projects results in exceeded expectations for her training, project management, SOP creation/review, medical writing, teaching, meeting facilitation and strategic planning. Kim has worked in the clinical trials area for 35 years, including her 12-year tenure with Endpoint Research holding positions such as VP Operations and Managing Director of Canada. She has worked in virtually every therapeutic area. Kim received the Excellence in Clinical Research award in 2018 at the Canada Talks Pharma conference. Kim has volunteered with the Clinical Research Association of Canada (CRAC) ™ for the past 22 years. In her various roles, including President, Kim has provided leadership as CRAC went online, helped develop a certification program (CRPC) and continues to recommend quality speakers for the membership on topics of importance in Canadian clinical research. She volunteered on the Board of Directors for Brain Injury Canada as secretary from 2013-2019 and was named Volunteer of the Year for 2016. Kim earned her MSc in toxicology from the Ontario Veterinary College at the University of Guelph. She has presented and co-chaired sessions at DIA, DIA Canada, ACRP and other meetings over the past 25 years. In her spare time, Kim enjoys photography, birding, genealogy, music and downhill skiing. You can follow her on Twitter @kimmcdt.

Manar Hammood is the Founder & Director of PV Operations at Zenith PV Solutions Inc. Zenith specializes in providing the pharmaceutical industry, guidance and support in ensuring that all medications used in Canada meet strict drug safety reporting standards established by Health Canada. Zenith is a fast-growing company with a talented team, supporting large and midsized pharmaceutical companies and hospitals across Canada. After spending some time in Senior Medical and Operations roles in the pharmaceutical industry, now as a spirited and enterprising entrepreneur, Manar has helped several firms meet Health Canada and other global regulatory compliance standards.

Coming Soon

Nicholas Nedin is currently the Product Development and Quality Assurance Manager at Greenway Greenhouse Cannabis Crop. Nicholas has been working in the Canadian Cannabis Industry since 2016, starting as a Research and Development consultant, he leveraged years in an array of positions in hospitality, manufacturing and beverage alcohol to provide insights for cannabis companies on how to bring unique cannabis products and brands to market, while fitting their operations into government based grant structures and tax incentive programs. In his free time, Nicholas produced more than 150 podcast episodes for The Cannabis Act Podcast, The Flower Hour Podcast, and The Cannalysts. He is also a regular contributor to Inside The Jar, writing about Cannabis, food and popular culture. He was also an executive member of The Podcast Mashup along with The Cannalysts, CFAMM, Lift & Co, and Ernst & Young, helping raise over $30,000 for Cannabis related charities in 2019.

Tabitha Fritz is the co-founder and CEO of Fritz’s Cannabis Company, an edibles company that was established in 2016, and successfully transitioned from the legacy market to the regulated Canadian space in 2021. Fritz’s products are currently listed throughout Canada, and the company recently launched the first solvent-free edible in the regulated Canadian market. At the same time she was co-founding Fritz’s, Tabitha was co-founding Bast, a cannabis brand that formulates cannabis products for women, including a condom-compatible personal lubricant, suppositories, and infused topicals.

Prior to working in the cannabis industry, Tabitha was a teacher, curriculum developer, and educational administrator, roles that helped her develop her skills as a cannabis educator and create comprehensive budtender training curriculums, including the Level UP Budtender Education Program, the first online and in-person training program made specifically for Canadian budtenders. Through her varied experiences in connecting face-to-face with consumers during Fritz’s legacy market days and her work with budtenders and retailers, Tabitha has developed a deep understanding of cannabis products, the Canadian consumer, and the spaces where they intersect. This understanding informs her work creating and presenting workshops on a variety of cannabis education topics, including her most recent online course “The 5 Dimensions of a Cannabis Experience”.

Tabitha is a board member of The Hash Corporation, a publicly traded company that produces traditional cannabis hashish, as well as the Canadian Business History Association, an organization dedicated to the preservation and presentation of Canadian Business History. She holds an MBA from the University of Toronto, where she studied behavioural economics and entrepreneurship.

Dr. Brian Pilecki is a clinical psychologist at Portland Psychotherapy that specializes in the treatment of anxiety disorders, trauma and PTSD, and psychedelic-assisted therapy. Brian practices from an orientation based in Acceptance and Commitment Therapy (ACT) and has extensive experience in the areas of mindfulness and meditation that he incorporates into therapy with clients. At Portland Psychotherapy, Brian is an active researcher and a study therapist on a clinical trial investigating the use of MDMA-assisted therapy for the treatment of social anxiety disorder and understanding processes of change in psychedelic therapy. He is a consultant and instructor for Fluence Training and co-chairperson for the Psychedelic Special Interest Group of the Association for Contextual Behavioral Science. He also co-hosts a podcast called Altered States of Context about the intersection of psychedelics and psychotherapy and is affiliate faculty at the Oregon Health and Science University.

Jeff Goldenberg is the Co-Founder of Ministry of Sativa. He also co-founded Dodi Blunts, along with NFL Superstar Marshawn Lynch, a brand of diamond infused blunts sold in California. He is also the Co-Founder and Chief Strategy Officer of Abacus Growth Agency, voted the best cannabis advertising agency. He was formerly a co-founder of High 12 Brands (now Materia Ventures), a cannabis CPG brand factory.

Hardeep is Chief Product Officer and one of the co-founders of Elevated Signals, an organization that develops GMP-validated manufacturing software for the cannabis industry. With a strong focus on quality, the company manages 8+ million sq ft of production area represented by craft producers right through to enterprise level operators.

Day-to-day Hardeep helps Licensed Producers get the most out of their teams by leveraging technology to streamline operations, and compliance. Having a technical and management background, he helps his peers navigate tough choices around change management and make data-led decisions. With over 14 years of experience in software development, he is passionate about bringing technical best practices from other industries and applying them to the cannabis space, in order to help the market become sustainable from both an operating and business perspective.

Prior to co-founding Elevated Signals, Hardeep was a Lead Software Developer at Adobe. He studied Computing Science at Simon Fraser University in British Columbia.

Dr. Cogan received his Ph.D. in Pharmaceutical Sciences from the University of Colorado School of Pharmacy, where his training under professor Tad Koch was focused in the field of bioorganic and medicinal chemistry. His postdoctoral studies in phosphoramidite and oligonucleotide chemistry were continued at the University of Colorado under Professor Marvin Caruthers. His past research interests have included the design and synthesis of superpotent anthracycline prodrugs, orthogonal nucleotide protecting groups, and novel ionic liquid solvent systems amenable to phosphoramidite coupling.

Dr. Cogan’s current research interest lies in the realm of medical marijuana and is focused on investigating the evidence for popular therapeutic claims made of cannabidiol and other cannabinoids.

Carl is a cannabis policy analyst and advocate from Washington DC currently living in Phuket Thailand where he writes the Substack newsletter, Cannabis in Thailand. His company Thai Hub of Cannabis distributes cannabis grown in Thailand’s Northeast region to dispensaries and cafes on the island of Phuket. He reports on cannabis legal reform in Thailand as well as import & export policy in ongoing efforts to assess what makes growth happen in the new Thai cannabis sector.

Jenna Perry is a seasoned customer success expert focusing on driving engagement and education within the cannabis industry. The Cannabis Industry provides a unique challenge to cultivate a great customer experience for all patrons, from newcomers to experienced users. Jenna connects with Cannabis Producers and Storefronts daily to ensure that all retail team members are equipped with the knowledge to create a remarkable in-house experience while maintaining brand standards.

Colin Bambury is a creative marketer and entrepreneur focused on the cannabis industry. Colin got his start in the early legacy market and has worked in legal cannabis since 2016. Bambury founded ADCANN, the number one educational resource for industry marketers in 2018 and grnhouse, an agency that represents a variety of cannabis-related clients in 2021. Having worked with top companies in the space including Weedmaps, 7ACRES, Khalifa Kush, THC Canada and more - Colin is currently the Marketing Manager at leading premium Canadian cannabis brand, Ghost Drops.

Amplifying impact as a dynamic and socially-conscious entrepreneur, Patrick uses his creativity and passion for human connectivity/happiness to unite individuals across social and corporate spectrums.

Evolving from a successful career in photography, and co-founding a number of cannabis companies, Patrick's focus is helping businesses achieve financial success while supporting nonprofits & charities in emerging industries.

Currently President at Microdose Psychedelic Insights, he's developing the organization into the industry's premier events and media platform alongside a highly motivated and engaged startup team.

Trained as a chemist and pharmaceutical scientist, Samantha has eight years of experience working with early stage therapeutics development and biotechnology companies entering growth stages and clinical development life cycles. Her areas of expertise are central nervous system disorders, neuroscience biotechnology, and psychoactive therapeutics. Samantha’s skillset is strong on both the operational side with a demonstrated history of assisting startups with the maturation of their corporate development and enterprise portfolio management strategies in addition to the investor side, performing due diligence activities for both venture capital firms and investment banks with active holdings in the life sciences. Samantha has had a large client base seeking to develop research and development initiatives in both the cannabis and psychedelics arenas and is in tune with the psychedelics movement from both an industrial and academic perspective.

Dr. Mark Johnston has been practicing psychiatry for over 15 years. His focus has always been on our aging community and what can be done to improve quality of life. He is dedicated to contributing to the effort to find a cure for Alzheimer’s disease through conducting numerous clinical trials at his research clinics in Kentville and Halifax.

Shahbaaz has spent the last 5 years dedicating his life and career to improving cannabis accessibility globally. He spent 18 months as the head of sales at Lift&Co, helping launch Cannsell and the Lift Expos as well as 2 years at Dutchie as the director of the Canadian team, helping bring e commerce and POS to retailers in Canada. Currently he is the Managing Director of KIND and helped drive the first and largest legal budtender sampling event. He is passionate about cannabis and sports and hopes to one day help the Canadian Beach Soccer team leverage cannabis to win a global championship.

Paola is a Colombian-Canadian physician, specialist in integrative medicine, a recognized international speaker on topics related to the evidence-based use of medical cannabis and the ethics of medical cannabis research. She is currently the medical and scientific advisor for the Canadian cannabinoid and psychedelic contract research organization Knowde Group Inc., she is vice president of the Interdisciplinary Latin American Society of Cannabinology, the coordinator of the diploma course in therapeutic applications of cannabinoids at the Universidad del Rosario de Bogotá, Colombia, and is part of the teaching staff and the academic coordination of the International Diploma in Endocannabinology of the PUIS of the UNAM. Paola has directed the Oncology Research board of the Princess Margaret Hospital in Toronto, and has chaired research ethics committees in her home country, Colombia.