Team

FSD Pharma was founded by Thomas Fairfull (retired), Zeeshan Saeed and Anthony Durkacz. The first initial of the last names of each of the founders represent the letters FSD. Dr. Lakshmi Kotra who is the recipient of the Julia Levy Award joined FSD Pharma with the acquistion of Lucid. Dr. Kotra serves as the CEO of Lucid and is incharge of the Biosciences division and is Head of drug development for FSD Pharma
Our leadership consists of a passionate management team with diverse industry knowledge, committed to science, therapeutic drug discovery and development.
With a highly-accomplished Board of Directors and BioSciences team, we have the adequate depth and breadth required to pursue our strategic vision.

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BOARD OF
DIRECTORS MANAGEMENT
TEAM REGULATORY
ADVISORY BOARD EXPERT RESEARCH AND CLINICAL TEAM

BOARD OF DIRECTORS

Anthony Durkacz

Founder, Interim CEO
Executive Co-Chairman of
the Board

Mr. Durkacz is the “D” in FSD. Mr. Durkacz has served as a director and the Executive Vice-President of First Republic Capital Corporation since 2014. Prior to co-founding the Company, Mr. Durkacz was President of Capital Ideas Investor Relations.

He previously served as the Chief Financial Officer and a director of Snipp Interactive Inc., a global marketing solutions company that provides a modular software-as-a-service technology suite. Mr. Durkacz was instrumental in the financing and public listing of Snipp Interactive Inc. with operations in Canada, the United States of America, Mexico and India. From 2006 to 2009, he served as Chief Operating Officer and Chief Financial Officer of MKU Canada Inc. and engaged in mergers and acquisitions of companies around the world. Mr. Durkacz also served as the Chief Financial Officer and a director of Astris Energi Inc., a dual-listed public company in the United States and Canada which was acquired by an international conglomerate. Mr. Durkacz began his career at TD Securities on the capital markets trading floor. He holds an Honours Bachelor of Business Administration from Brock University with a major in both Accounting and Finance.

Zeeshan Saeed

Founder, President &
Executive Co-Chairman of
the Board

Mr. Saeed is the “S” in FSD. Mr. Saeed started as a partner in FSD when it was just a business plan on paper. He was instrumental in raising the initial seed capital and assisted FSD’s transition into a public company. He played a key role in bringing together a team of professionals to facilitate crucial relationships and develop the Company’s business plan.

Prior to founding the Company, Mr. Saeed served as President of ZZ Telecommunications Inc., a long-distance telecommunications common carrier. He has experience in international capital markets and has helped various start-ups with raising initial funding and obtaining listings on various stock exchanges. Before entering capital markets, Mr. Saeed was the founder and Chief Executive Officer of Platinum Telecommunications Inc. He has a Bachelor of Science in Mechanical Engineering.

Dr. Lakshmi P. Kotra, B.Pharm.(Hons), PhD

Director
CEO Lucid Psycheceuticals, President FSD Biosciences, CEO FSD Pharma Australia Pty Ltd (subs of FSD Pharma)

Dr. Lakshmi Kotra received his Ph.D. in Pharmacy (Medicinal Chemistry) from the University of Georgia under Prof. David Chu’s supervision, and completed postdoctoral training at Wayne State University under Prof. Shahriar Mobashery’s supervision. He joined the Faculty of Pharmacy, University of Toronto in 2000, and University Health Network in 2006, where he led a very active research group and drug discovery program with multiple portfolios.

An academic entrepreneur, Dr. Kotra has contributed to a number of important drug discovery and development projects, including metabolic disorders, neurodegenerative and immunological disorders, anti-HIV drugs, antibacterials, and antimalarials. He has authored/co-authored over 130 publications and delivered over 140 scientific talks internationally. Dr. Kotra is the recipient of several awards for his accomplishments, including the Julia Levy Award in 2021 from the Society of Chemical Industry (SCI) Canada in recognition of his substantial contribution to the successful commercialization of innovation in Canada in the field of biomedical science and engineering. In addition to Lucid Psycheceuticals, he co-founded WinSanTor Biosciences, a San Diego, CA-based company developing treatments for peripheral neuropathies, and CannScience Innovations (Scientus Pharma), a Toronto, ON-based company focused on medical cannabis and cannabinoids. Dr. Kotra served as the CEO of Lucid Psycheceuticals since 2020, which was acquired by FSD Pharma in 2021. Dr. Kotra transcends early and clinical development incorporating commercial and regulatory vision for efficient drug development and commercialization with solid leadership.

Donal Carroll

Director

Donal Carroll joined FSD Pharma as interim Chief Financial Officer in 2018 and was appointed to the position on a permanent basis in December 2019. An experienced business executive, Mr. Carroll has 20 years of corporate finance leadership and public company experience, as well as deep expertise in syndicate investing both in equity and debt securities.

With a balance of prudent financing practices and business insights, Mr. Carroll has successfully guided companies through expansion and growth. Mr. Carroll was previously with Danaher, Alberto Culver (now Unilever (NYSE:UL) and Cardinal Meats, where he was instrumental in major restructuring activities, mergers and acquisitions and the implementations of new internal controls and ERP systems resulting in significant efficiencies through periods of substantial change and strong company growth. Mr. Carroll has been a Director of Bird River Resources Inc., since September 15, 2017.

He holds a CPA-CMA designation as well as a Bachelor of Commerce degree from University College Dublin.

Lawrence (Larry) Latowsky

Director

Mr. Latowsky is currently Chief Executive Officer of Canntab Therapeutics Ltd., an innovator in cannabinoid and terpene blends in hard pill form for therapeutic application. Mr. Latowsky has held a number of leadership positions throughout his career, including Chairman and Chief Executive Officer of Top Drug Corp.

From 2014 to 2020 and previously President and CEO of Katz Group Canada, overseeing the largest network of pharmacy retailers in Canada operating as Rexall, Pharmaplus, IDA and Guardian Drugstores. Mr. Latowsky also led Propharm Technology and DC Labs, a vertical manufacturing and packaging division of pharmaceuticals and over-the-counter drug store product. Mr. Latowsky is a graduate of the University of Toronto Rotman Business School and Institute of Corporate Directors of Canada program and has served on many profit and non-profit boards, including as Chairman of the board for Well.ca, one of Canada’s leading E-commerce companies. Mr. Latowsky’s experience is a unique blend of traditional retail bricks and mortar, distribution, manufacturing and e-commerce/internet-based marketing and sales.

Adnan Bashir

Director

Mr. Bashir is one of the first investors of FSD Pharma. He brings a wealth of over 14 years of experience in strategic management and operations. In the last decade, Mr. Bashir was General Manager for Al Batha group, a diversified business conglomerate based in Dubai, UAE. Mr. Bashir was responsible for overseeing the management and operations of 4 companies within the group and was instrumental in acquiring and developing new businesses and partners from Europe, the US and China

Mr. Bashir also has extensive experience in executing turnaround strategies, transforming weak businesses into sustainable and profitable ones, and implementing new technologies. Mr. Bashir holds a Bachelor of Science Degree in Mechanical Engineering from University of Engineering and Technology Lahore and has completed extensive executive education, including in strategic management, audit, sales management and technical management.

Fernando Cugliari

Director

Mr. Cugliari has over 20 years of experience in finance and law, and is an attorney qualified to practice in Ontario and the Cayman Islands. Mr. Cugliari is currently an International Investment Advisor at CIBC FirstCaribbean International Bank, where he provides comprehensive investment advisory services to high and ultra-high-net-worth individuals and their families, as well as insurance, corporate, institutional and pension fund clients.

From November 2017 to April 2018, Mr. Cugliari worked as the Head of the Private Client and Private Equity Group at Etienne Blake Attorneys at Law, a law firm in the Cayman Islands, and from September 2016 to September 2017 he worked as General Counsel and Chief Operating Officer for FasPay Global, an international financial and payments technology company. He previously held senior positions in law firms in Ontario.

Nitin Kaushal

Director

Since March 2020, Nitin Kaushal has served as President of Anik Capital Corp., his family’s holding company. In February 2020, he retired from PricewaterhouseCoopers Canada (“PwC”) where he was a Managing Director in the corporate finance practice, which focused on the pharmaceutical and healthcare spaces.

He had worked at PwC since 2012. Mr. Kaushal has over 30 years of experience in the healthcare and financial services industries, focusing on the biotechnology, medical devices and healthcare services markets. He was a Managing Director of leading healthcare investment banking teams at a number of Canadian investment banks including Desjardins Securities Inc., Orion Securities Inc., Vengate Capital, HSBC Securities Inc. and Gordon Capital. He has been involved in over 50 mergers and acquisitions, strategic advisory roles and licensing assignments for a range of companies from early-stage biotechnology companies to large pharmaceutical companies. He has participated in capital market transactions ranging from private placements to initial public offerings to bought deal underwritings in excess of $2B and has been a speaker at leading biotech conferences, including BIO and BioFinance. His entry into the biotech/healthcare space was in 1991 with MDS Capital Corp., a leading healthcare venture capital firm. Mr. Kaushal sits on a number of public and private company boards in the biotech and healthcare space, including Delta 9 Cannabis Inc., The Valens Company Inc., High Tide Inc. VieMed Healthcare Inc., Starton Therapeutics Inc., Flower One Holdings Inc., PsyBio Therapeutics Corp. and 3 Sixty Risk Solutions Ltd. Mr. Kaushal has a Bachelor of Science in Chemistry from the University of Toronto and is a Chartered Professional Accountant.

ADVISORS TO THE BOARD

Kevin Harrington

As an original “shark” on the hit TV show Shark Tank, the creator of the infomercial, pioneer of the As Seen on TV brand, and co-founding board member of the Entrepreneur’s Organization, Kevin Harrington has pushed past all the questions and excuses to repeatedly enjoy 100X success.

His legendary work behind the scenes of business ventures has produced more than $5 billion in global sales, the launch of more than 500 products, and the making of dozens of millionaires. He’s launched massively successful products like The Food Saver, Ginsu Knives, The Great Wok of China, The Flying Lure, and many more. He has worked with amazing celebrities turned entrepreneurs including, like Billie Mays, Tony Little, Jack LaLanne, and George Foreman to name a few. Kevin’s been called the Entrepreneur’s Entrepreneur and the Entrepreneur Answer Man, because he knows the challenges unique to start-ups and has a special passion for helping entrepreneurs succeed.

David Allan

Recipient Julia Levy Award (2017)

Recipient Life Sciences Ontario Award (2016)
Recipient Biotech Canada Gold leaf Award (2012)

David Allan, has been a member of the Awards Selection Committee of Canada’s Network of Centers of Excellence; the Multidisciplinary Assessment Committees of the Canada Foundation for Innovation, the Ontario Biotechnology Advisory Board and was, formerly, a Governor of the Toronto Stock Exchange. He is the Principal at Cresswell Advisors Inc; was the Founding and Sunset Chairman, and CEO from 1998 to 2011, of YM BioSciences Inc. until its acquisition by Gilead Sciences (Nasdaq: GILD) in 2013; Founding Chairman of Formation Biologics, acquired by Bristol Myers Squibb (NYSE: BMY) in 2020, and Executive Chairman of Stem Cell Therapeutics Inc., acquiring Trillium Therapeutics in 2013, and itself acquired by Pfizer Inc. (NYSE: PFE) in 2021.

Currently, Managing Director and Board member of eQcell Inc, a One Health company, the first to be cleared by Health Canada for clinical trials in equine osteoarthritis with mesenchymal stromal cells; an Advisory Board member at Inteligex Inc., a company developing novel stem cell therapies for the treatment of traumatic spinal cord injuries and other diseases of the Central Nervous System, and Haygain Ltd, the UK-based international equine health company.
He is the recipient of the 2017 Society of Chemical Industry’s Julia Levy Award for commercialization of bio-medical innovation; the 2016 Life Sciences Ontario Leadership Award; and the 2012 BIOTEC Canada Gold Leaf Award for Industry Leadership.

Dr. Ravinder Kumar, PhD

Dr. Ravinder Kumar, PhD is an award-winning pharmaceutical industry leader, with over 30 years of global experience developing and commercializing novel drug solutions. Through his advisory role, Dr. Kumar will contribute his expertise in clinical discovery, regulatory and compliance, preclinical R&D, manufacturing, drug development and commercialization.

Dr. Kumar is currently the Special Advisor to the President of the Centre for Medicinal Chemistry at the University of Toronto, and Chief Strategy Officer of Dalriada Drug Discovery. Prior to his current roles, Dr. Kumar was the Chief Science Officer and Advisor to The Green Organic Dutchman, Managing Director of Apotex India, and Vice President of R&D, Business Development & Classic Brands at GSK Canada.

Jason Sawyer

Jason Sawyer brings 29 years of alternative investment and business experience to FSD’s drug development efforts. He currently serves as the General Manager of Access Alternative Group S.A. (“AAG”), a Bahamas-based boutique venture investment and advisory firm.

Prior to his role at AAG, Sawyer was a Principal at Crane Capital Associates and Head of its Absolute Return Strategies Group where he successfully raised more than $3.5 billion for some of the world’s leading private equity and hedge funds. In 2016, he founded Pacific West Stone and led the capital formation, investing $4.5MM in its first-year start-up phase and securing private equity financing backed by one of Canada’s largest pension funds.

Dr. John McGraw

Dr. McGraw has more than 20 years of executive experience commercializing health technologies including medical devices, therapeutics and health services. He is currently serving as President and Director, at Izotropic, a company developing a dedicated breast computed tomography (CT) imaging platform, and President of Spratley Advisors Inc., an advisory company with drug development experience across many therapeutic areas.

Previously, Dr. McGraw served as VP of Operations for Novadaq Technologies Inc., a medical device imaging company acquired by Stryker Corporation in 2017 for approximately CDN$900 million, and SVP Business Development & Strategy for CML HealthCare Inc., a medical imaging service and laboratory medicine provider acquired by OMERS and merged with LifeLabs Medical Laboratory Services in 2013 for approximately CDN$1.2 billion. Prior to those positions, Dr. McGraw was a Co-Founder of medical device development company Trimanus Medical. Dr. McGraw earned his MSc and PhD from the University of British Columbia focusing on brain injury and repair.

Dr. Navdeep Jaikaria

Dr. Navdeep Jaikaria is trained as a medical scientist and brings over twenty years of Financial Markets, business leadership & deep scientific experience to FSD.

Dr. Jaikaria founded SGN Nanopharma and its Indian subsidiary, New India Biopharma Pvt. Ltd., in 2010 and has successfully guided SGN into a cutting edge, commercial stage, nanotherapeutics company.
Before founding SGN, Dr. Jaikaria was a consistently top ranked Biotechnology Equity Research Analyst on Wall Street and won several distinctions including one of the five best stock-pickers in Biotechnology in the Wall Street Journal’s annual “Best on the Street” Analysts survey in 2007.
During his tenure on Wall Street, he held several positions. He served as Managing Director & Head of Equity Research at Rodman and Renshaw, New York; Senior Vice President & Senior Biotechnology Equity Research Analyst at Leerink Swann & Co. (now SVB Securities); Senior Equity Research Analyst covering large and mid-cap biotechnology companies at Mehta Partners – a global health care hedge fund with over $100MM under management.
He covered over 50 Biotechnology and Biopharmaceutical companies and his coverage universe spanned several therapeutic class areas including Multiple Sclerosis, HIV & Infectious Diseases, Pulmonary Arterial Hypertension.
Dr. Jaikaria served on several industry-focused and investor panels and his opinions were widely cited in print and broadcast media including The Wall Street Journal, Financial times, Businessweek, Forbes, CNNfn, CNBC and CNN.
Dr. Jaikaria obtained his B.Sc. from All India Institute for Medical Sciences, New Delhi in Human Biology (Rank II), Ph.D. at the New York Medical College in Cell Biology & Anatomy and post-doctoral fellowship at The Rockefeller University, New York.

Joseph Romano

Joseph has been a consultant for FSD since 2019 and has made valuable contributions to the organization.

After Graduating from Osgoode Hall Law School, Joseph L. Romano was called to the Ontario Bar and works as a litigator. He founded and managed a successful litigation practice before transitioning into multiple successful business ventures. Joseph is a distinguished litigator with court decisions that made new case law in Ontario on three separate occasions. Joseph has consulted for multiple foreign Governments, and has assisted in the drafting and formation of new legislation that was enacted into law. Joseph has appeared at every level of court in Ontario with success.

MANAGEMENT TEAM

Dr. Lakshmi P. Kotra, PhD

CEO of Lucid

Recipient of Julia Levy Award (2021)

Recipient of the Julia Levy Award (2021) Dr. Lakshmi Kotra, Senior Scientist at Krembil Brain Institute, University Health Network (UHN), and Professor of Medicinal Chemistry at the University of Toronto, joined FSD Pharma as CEO of its wholly-owned subsidiary, Lucid, upon completion of its acquisition of Lucid Psycheceuticals in September 2021.

Dr. Kotra received his Ph.D. in Pharmacy/Medicinal Chemistry from the University of Georgia and completed postdoctoral training at Wayne State University. He has authored/co-authored over 130 publications and delivered over 140 scientific talks internationally. Dr. Kotra is the recipient of several awards, including the Julia Levy Award from the Society of Chemical Industry (SCI) Canada in recognition of his substantial contribution to the successful commercialization of innovation in Canada in the field of biomedical science and engineering. An academic entrepreneur, Dr. Kotra has contributed to a number of important drug discovery and development projects, including anti-HIV drugs, antibacterials, insulin, antimalarials, medical cannabis-based therapeutics, and drugs targeting multiple sclerosis. In addition to Lucid Psycheceuticals, he co-founded WinSanTor Biosciences, a San Diego, CA-based company developing treatments for peripheral neuropathies, and CannScience Innovations (Scientus Pharma), a Toronto, ON-based company focussed on medical cannabis and cannabinoids.

Dr. Andrzej Chruscinski, MD, PhD

Vice-President, Clinical and Scientific Affairs

Dr. Chruscinski will be leading our clinical programs and help lead our clinical trials as Associate Vice-President, Clinical Affairs. Dr. Chruscinski received his MD, PhD from Stanford University, followed by residency in internal medicine at Stanford, fellowship in cardiology at Stanford and Toronto General, and recently led two major clinical trials investigating tolerance in transplantation and new biomarkers discovery.

He is a board certified cardiologist and carries active medical license in Michigan.

Nathan Coyle, CPA

Chief Financial Officer

Nathan Coyle joined FSD Pharma Inc in 2020 as Corporate Controller and was appointed to the Interim Chief Financial Officer role in 2021. Mr. Coyle has 15 years of executive business experience as a finance leader in both public and private roles. With a keen eye for analytical analysis and innovative ideas he has always led his team to success.

Coyle was previously with Illinois Tool Works (NYSE:ITW) where he was a key player in restructuring the organization, shaping the growth and streamlining businesses within his industrial packaging segment. His involvement in multiple mergers and acquisitions and integrating those organizations was key to company growth. After ITW, he worked with a private organization implementing the same corporate strategies to maximize growth. Coyle holds a Bachelor of Business Administration with honours from Brock University and is a Chartered Professional Accountant.

Kevin Cassidy

Vice-President, Quality Systems

Mr. Kevin Cassidy brings over 39 years of biotechnology experience to FSD Pharma. His experience includes biotherapeutic, vaccine development and GMP manufacturing. Mr. Cassidy’s medical device experience also includes development of infectious diseases diagnostics. Mr. Cassidy most recent success was registration of medical devices for COVID-19 testing in the U.S., Europe, UK, Canada, and Australia.

He has established and run operations, validated facilities for GMP manufacturing, biotherapeutic development, and quality testing in Canada, Chile and China. He was lead on process and business development, resulting in the first approved adenovirus-vectored vaccine. The rabies vaccine is the predecessor to several vaccines deployed in the COVID-19 pandemic. Mr. Cassidy was trained in Business Management at George Brown College and received a Bachelor of Science degree from University of Toronto.

Joanne Speed

Senior Director, Drug Development

Ms. Joanne Speed has over fifteen years of experience in the biotech industry with a focus on early-stage drug development and moving development candidates into clinical trials. Ms. Speed also has experience with late-stage candidate development, including being a key contributor to the CMC regulatory package for a new drug submissions to U.S. FDA and Health Canada.

She is familiar with and has working experience on many aspects of drug development—from bench-level chemistry, management of CMC drug substance and drug formulations to regulatory submissions to U.S./Canadian/European drug regulatory agencies. Ms. Speed is also experienced in monitoring clinical studies, implementation of organization-wide quality systems and SOPs. Ms. Speed received her Honours Bachelor of Science in Biological Chemistry (University of Toronto), Certificate in Biotech Project Management from University of Washington and University of California and Clinical Research Associate Certificate from Michener Institute, Toronto, ON.

Dr. Oksana Akhova, PhD, MBA

Director, Licensing, Partnerships and IP

Dr. Oksana Akhova has extensive experience both in industry and academia in business development, IP management and commercialization of innovative technologies. She brings over two decades of experience in commercialization of scientific assets in human and animal health along with academic research and management of start-ups. She worked across in a range of roles in academia and industry and she has strong track record in commercial licensing, management of private-public partnerships, technology marketing and business development.

Oksana has negotiated complex commercial agreements, developed IP and marketing strategies for a variety of technologies, facilitated commercial exploitation of early-stage assets, and concluded multiple deals. She has solid expertise in evaluation of companies and technologies (with the focus in oncology, ophthalmology, inflammation and neurology), building financial models and forecasts as well as IP management. She is a great team player with strong communication skills and superb work ethic. Oksana has made significant contributions to her organizations in her previous roles. She holds a PhD in oncology and an MBA with specialization in biotechnology management.

Ashwini Joshi, MS, PG Diploma (QA&RA)

Director, Pharmaceutical Development

Ms. Ashwini Joshi is a pharmaceutical drug development professional with over 9 years of experience developing formulations on small molecules for global markets in mid to large generic and pharmaceutical industries. She worked in various drug developmental stages starting from product development at R&D to its successful scale-up and subsequent regulatory filings.

Ms. Joshi received her Master’s in Pharmacy (Pharmaceutics) from NMIMS, Mumbai, India and a Post Graduate Diploma in QA & RA from Academy of Applied Pharmaceutical Sciences, Toronto, Canada.

Dr. Sima Salahshor, BSc, MSc, PMP, PhD

Associate Director, Scientific and Clinical Affairs

Dr. Sima Salahshor holds a bachelor’s degree in Clinical Chemistry, a Master’s in Molecular Biology and a Ph.D. in Medical Genetics from Karolinska Institute, Sweden. She is a certified Project Management Professional (PMP) and is an adjunct professor at the University of Toronto’s Faculty of Medicine. She has over 20 years of experience in oncology and cell signalling research working at the Karolinska Institute (Sweden), University Health Network (UHN), and Lunenfeld Research Institute at Mount Sinai Hospital (Canada).

She has published numerous pre-reviewed articles in cancer diagnostic and biomarker discovery and development. For ten years, she led and managed a scientific-business advisory firm focusing on life-sciences and healthcare-related projects and programs. During that time, she worked extensively with early-stage as well as larger corporate companies, and has experience in product evaluation, clinical studies, early stage investment, commercialization, and industry partnership development.

Dr. Patrick Oyanango, PhD

Director, Operations (U.S.)

Dr. Patrick Onyango joined FSD Pharma in early 2022, and in his role is focused on facilitating FSD/Lucid operations in U.S. with the goal of fulfilling the FSD/Lucid-USA mission of developing novel solutions for brain and inflammatory disorders. Dr. Onyango is the founder of Sparks-based American BioInnovations LLC (ABI), a biotech company implementing innovative technologies to help improve human health by manufacturing pharmaceutical ingredients, advanced drug intermediates, and cell culture solutions. Prior to founding ABI, Dr. Onyango was a faculty in the Department of Medicine at Johns Hopkins University School of Medicine for over a decade.

At John Hopkins, Dr. Onyango trained more than 20 trainees, gave talks at several international scientific meetings, authored more than 25 peered reviewed scientific research publications, including pioneering work on functional genomics and discovery of protein deacetylation in mitochondria. Dr. Onyango received the 2003 Eminent Scientist of the year award from International Research Promotion Council in recognition of his Functional Genomics research. He did his postdoctoral studies on Neurobalstoma Tumor Suppressor genes at the International Institute of Molecular Pathology in Vienna and on Epigenetics in the division of Medical Genetics at Johns Hopkins University School of Medicine. Dr. Onyango earned a PhD in Human Molecular Genetics from the University of Vienna. Prior to that, he graduated from University of Nairobi, where he obtained both his BSc (Hons. in Chemistry and Biochemistry) and MSc in Biochemistry.

REGULATORY ADVISORY BOARD

Dr. Joga Gobburu, B.Pharm.(Hons), M.Sc., Ph.D.

Regulatory Advisory Board

Dr. Gobburu is Professor with the School of Pharmacy and the School of Medicine, University of Maryland, Baltimore, MD, USA. He held various positions at the US FDA between 1998 and 2011.

He has experience with overseeing the review of 1000s of Investigational New Drug Applications (INDs), over 250 New Drug and Biological Licensing Applications, numerous FDA Guidance and policies pertaining to drug approval and labeling. At the FDA, he was part of the committee responsible for 21st Review Process and provided input into PDUFA planning. He received numerous FDA awards such as the Outstanding Achievement Award and recognized with the Senior Biomedical Research Scientist appointment. He also received the Outstanding Leadership Award from the American Conference on Pharmacometrics (2008), the Tanabe’s Young Investigator Award from the American College of Clinical Pharmacology (2008) and Sheiner-Beal Pharmacometrics Award from the American Society of Clinical Pharmacology and Therapeutics (2019). He is also a Fellow of AAPS and ACCP. Dr. Gobburu is on the Editorial Boards of several journals. He has published over 100 papers and book chapters.

Dr. Mary Melnyk, M.Sc., Ph.D.

Regulatory Advisory Board

Dr. Melnyk is a has over 25 years of pharma/biotech experience in all phases of manufacturing, global regulatory landscape, technology transfer, and business leadership.

Her expertise spans small molecule drugs, biologics and medical devices, especially during development phases and late stage for approvals, in the context of manufacturing and regulatory compliance.

Dr. Kwok Chow, PhD

Regulatory Advisory Board

– President, Covar Pharma – a CDMO with global drug development expertise

– Regulatory strategies and product development

EXPERT RESEARCH AND CLINICAL TEAM

Dr. Albert H.C. Wong, MD, PhD, FRCP(C)

Expert Advisory Committee Member

Dr. Albert Wong, Professor of Psychiatry, University of Toronto, and a Research Scientist in the Neuroscience Department and Staff Psychiatrist in the Schizophrenia Division at the Centre for Addiction and Mental Health, is a world-renowned expert on schizophrenia.

His research focusses on the investigation of genetic, cellular and developmental mechanisms underlying psychiatric symptoms.

Dr. Peter K. Stys, MD, FRCP(C), FRSC

Expert Advisory Committee Member

Dr. Peter Stys, Professor of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, is a neurologist/neuroscientist and a world leader in the detailed study of pathophysiological mechanisms of white matter injury in stroke and trauma.

Dr. Stys and his team have discovered several novel injury mechanisms responsible for axo-glial damage in ischemia/trauma and glutamate excitotoxicity, due to reversal of Na-dependent glutamate transport in damaged spinal axons. Dr. Stys’ insights provide a rational basis for devising drug therapy for the acute phases of stroke, spinal cord injury, brain trauma, and neuroinflammatory conditions (such as multiple sclerosis), in which axons, oligodendrocytes, and myelin are prominent targets of damage. Dr. Stys is the recipient of the Dr. Frank LeBlanc Chair in Spinal Cord Research, Canada Research Chair (Tier 1) in Axo-glial biology, and Alberta Heritage Foundation for Research (AHFMR) scientist award. He is an Adjunct Research Professor at the Department of Systems and Computer Engineering at Carleton University, an Adjunct Professor at the Cumming School of Medicine at the University of Ottawa and a Visiting Assistant Professor at the Department of Neurology at Yale School of Medicine. In addition, Dr. Stys has published 88 peer reviewed articles, 17 book chapters, and two books.

Dr. Shannon Dunn, PhD

Expert Advisory Committee Member

Dr. Shannon Dunn, a scientist at the University Health Network and Women’s College Hospital, and an Associate Professor in the Department of Immunology at the University of Toronto, currently leads a research program focused on various risk factors for the development of T cell-mediated autoimmune diseases, such as multiple sclerosis….

Dr. Dunn holds operating grants from the Canadian Institute of Health Research and MS Society of Canada to conduct her research and has been awarded a Don Paty Salary award from the MS Society of Canada. She was awarded her doctoral degree from the University of Western Ontario in 2002, after which she conducted post-doctoral training in the field of neuroimmunology at Stanford University.

Dr. Hance Clarke, MD, FRCPC

Expert Advisory Committee Member

Dr. Hance Clarke is a staff anesthesiologist and the Director of Pain Services at the Pain Research Unit at the Toronto General Hospital (TGH). He is currently the knowledge Translation Chair for the University of Toronto Centre for the Study of Pain, and in 2016, was awarded an early Career Award from the Canadian Pain Society.

His research interests include identifying novel acute pain treatments following major surgery, identifying the factors involved in the transition of acute post-surgical pain to chronic pain, studying the genetics of acute and chronic pain after surgery, and identifying risk factors associated with continued opioid use and poor health related quality of life after major surgery as well as the efficacy of hyperbaric medicine. To-date, Dr. Clarke has authored over 100 peer reviewed manuscripts. Dr. Clarke has played a leading role in educating the Canadian public about pain control, risk factors for chronic opioid use, alternatives to opioids as a pioneering strategy at TGH, misconceptions about opioid use, and the need for further studies on understanding the beneficial and adverse effects of cannabis. He is a public champion of evidence-based solutions for the opioid crisis and a national pain and addictions strategist.

Dr. Eleanor Fish, PhD

Research and Clinical Advisory Board

– Professor and Associate Chair, Department of Immunology, University of Toronto

– World-renowned immunologist and cytokines researcher
– WHO Consultant
– Member, Expert Scientific Panel to Chief Scientific Advisor, Government of Canada

Dr. Daniele Piomelli, PhD, MD

Research and Clinical Advisory Board

– Professor, University of California at Irvine

– Leading expert in endocannabinoids and associated treatments
– Chief Editor, Cannabis and Cannabinoids Research