SHACKELFORD PHARMA - Key Persons
Bringing nearly two decades of experience in the pharmaceuticals industry, Adam served as Chief Financial Officer (CFO) for five years at GW Pharmaceuticals, the UK-based drug development company focused on using cannabinoid therapeutics for treating a range of diseases. During this time, he oversaw the company's initial public offering on Nasdaq, was involved in subsequent fundraisings totaling over $1.4 billion.
Chris brings 25+ years finance and accounting experience to Shackelford Pharma. He also continues to hold the role of CFO at Neovasc (TSX, NASDAQ: NVCN) since April 2007. Chris received his CA designation from ICAEW, articling with KPMG before moving to Canada in 1998. He has an honors degree in Economics from Swansea University and pursued post graduate studies at Keble College, Oxford.
Job Titles:
- Head of Investor Relations
David Rokoss has a twenty five year career as an entrepreneur and consultant, working with a variety of private and publicly listed companies, focusing on concept development, finance and operational management. For the last decade, he has consulted with numerous early stage companies across the biotechnology, clean tech, retail and tech sectors, focusing on business and corporate development opportunities.
Job Titles:
- Head, Regulatory Strategy
Diane is a pharmaceutical industry veteran who is passionate about changing people's lives by helping groundbreaking drugs reach the global market. Previously, Diane served for more than 30 years in various leadership roles in drug development at Pfizer. She has a proven track record of innovative regulatory strategies, including the first approved "virtual" clinical trial. Diane developed and executed regulatory strategies for a broad portfolio of Pfizer's blockbuster drugs, including Celebrex and Lyrica. Diane holds a B.S. in Chemical Engineering from MIT. She is currently an independent consultant, Greyscaling LLC, with interests in neuroscience, pediatrics, digital health, and working in the grey space of regulatory science.
Dr. Alan Shackelford is a Harvard Medical School trained internist and researcher who is one of the world's foremost authorities on the clinical uses of cannabis. Over the last 12 years, Dr. Shackelford has consulted with thousands of patients for whom medical cannabis has proven to be beneficial and has worked with government agencies in a number of American states and in several other countries on establishing structures and rules governing medical cannabis programs. In addition to his medical practice, he also serves as a physician member of the Board of Medicine of the state of Colorado.
Dr. Alan Shackelford gained national attention for his breakthrough treatment of a young patient with Dravet Syndrome. The child went from having approximately 300 intractable seizures per week to only a few after Dr. Shackelford prescribed a cannabinoid-based treatment. That moment went on to become a national news story in 2013. Since that story broke, Dr. Shackelford has never stopped treating patients and continues to prescribe cannabinoid-based treatments for a wide range of conditions that pose significant unmet medical needs.
By documenting what worked and what didn't over the last 13 years, including both efficacy and safety information, Dr. Shackelford created a database of real-world experience with well over 25,000 patient interactions.
Shackelford Pharma was founded because of Dr. Shackelford's pioneering spirit and determination to help patients who have largely been refractory to or intolerant of available prescription medicines. Those significant unmet medical needs motivated Dr. Shackelford to persevere when he saw improvement, even in the face of potential and actual criticism.
The database is what makes Shackelford Pharma truly unique, and it has attracted a world-class team of entrepreneurs, scientists, physicians, and pharmaceutical executives who are excited to analyze the data to develop new medicines for those with high unmet medical needs.
Job Titles:
- Member of the Scientific Advisory Board
Job Titles:
- Head, Pre - Clinical Neuroscience
Dr. Randall is a renowned neuroscientist, strategic alliance and business development expert with worldwide drug discovery and development experience in the pharmaceutical and biotechnology industry with Merck, GSK, Eisai and Vertex in the USA, UK, China and Japan. Dr. Randall has led multiple preclinical projects in neurology and is currently SVP of External Alliances and Scientific Strategy at Mindset Pharma Inc.
A science-based business leader with a broad healthcare background. Former AstraZeneca Executive Director of Business Development and Licensing, Senior Director Clinical Development, Director of Managed Markets, Director of External Medical Relations, NEXIUM Managed Markets and HCP Brand Marketing Leader, CRESTOR Senior Market Research Manager, Global Strategic Planning Manager and Head of CMC Project Management and Regulatory Documentation.
Geoff Griffiths comes to SPI with 23 years of pharmaceutical experience. He brings a broad spectrum of commercial experience including sales, sales training, sales management, business intelligence, marketing, market access, healthcare policy and commercial development.
Job Titles:
- Member of the Scientific Advisory Board Vice President, Research, Health Policy, and Abuse Liability, Pinney Associates, Inc. Professor, Adjunct, Behavioral Biology at the Johns Hopkins University.
Job Titles:
- Member of the Scientific Advisory Board
Job Titles:
- Head, CMC / Pharm Dev / MFG
John Wahlich is a CMC professional specializing in oral formulations and the analysis of small molecules. He was formerly VP of Product Line Extensions and VP of Early Pharmaceutical Development in GSK where he worked for 25 years. He has been consulting for numerous companies over the past 10 years. He has a PhD in Pharmaceutics from the University of Nottingham (UK).
Job Titles:
- Clinical Development & Psychometrics Consultant
Judith Jaeger is a neuropsychologist with more than 35 years' experience in clinical and experimental neuropsychology and psychopathology. She is owner and president of CognitionMetrics, LLC, a consultancy serving the pharmaceutical industry with expertise on cognitive and behavioural measurement in the context of drug development. She is Clinical Professor of Psychiatry and Behavioral Science at Albert Einstein College of Medicine, New York and the author of over 80 peer reviewed journal articles, several book chapters, co-edited books and hundreds of abstracts and presentations.
Previously she was Vice President for Clinical Trials at Cogstate, Inc. and Director of Clinical Development at AstraZeneca Pharmaceuticals where she served as company-wide cognition and psychometrics expert. These industry positions followed a distinguished academic career as an NIH funded research clinician and educator.
Since forming CognitionMetrics, she has advised numerous pharmaceutical companies on early phase and experimental medicine projects as well as pivotal and late phase clinical programs in Alzheimer and other dementias, neurodegenerative and neurodevelopmental diseases, ADHD, schizophrenia, bipolar disorder, major depression and oncology.
She has represented pharmaceutical clients in regulatory meetings including the FDA and Japan's PMDA and has been a key presenter at an FDA Advisory Committee meeting.
Job Titles:
- Member of the Scientific Advisory Board / Senior Vice President, Pinney Associates, Inc. Chief Medical Officer, Harm Reduction Therapeutics.
Job Titles:
- Director
- CEO of Drug Development Strategic Consulting
Kathleen's 30+ years of experience spans all phases of pharmaceutical product development, from Phase I-IV, across a variety of therapeutic areas. Previous roles include Director of Investigational Products, Director of Planning and Strategy for Neuroscience Therapeutics, Global Product Director, and Global Product Vice President at AstraZeneca plc.
Currently, Kathleen is the CEO of Drug Development Strategic Consulting, LLC, VP of Alliances at RheoTek Medical, and a Strategic Business Advisor at the University City Science Center in Philadelphia.
Mark Godsy - CEO, Chairman, Founder
Job Titles:
- Chairman
- Chief Executive Officer
- Founder
- Chairman and CEO of Naqi Logix Inc
Mark is a seasoned and successful biotechnology and technology entrepreneur. Mark has started or co-founded many successful companies, including two $1 billion biotech firms - ID Biomedical, which became Canada's largest vaccine company and the fifth-largest vaccine company in the world; and Angiotech Pharmaceuticals, which created the first coated stent, which has gone on to save tens of millions of lives.
Mark Godsy is currently the Chairman and CEO of Naqi Logix Inc., a revolutionary technology platform that transforms our inconspicuous micro-gestures into instant commands to control all the devices where we work. He has also served as Executive Chairman of Exro Technologies, a company whose goal is to improve the efficiency of electric motors and generators. He also serves as Chairman of Code Zero, a technology company focused on developing an IOT platform that allows devices with different architectures to communicate with one another. Mark serves on the advisory board for the Faculty of Law at McGill University. He holds a BA from the University of British Columbia and a law degree from McGill, and is a non practising member of the Law Society of British Columbia.
Job Titles:
- Member of the Scientific Advisory Board / Former Deputy Surgeon General of Canada and Director General for the Laboratory Centre for Disease Control.
Mike Kelly is a preclinical safety, disposition, and translational science consultant, supporting biotech, small and medium pharmaceutical companies, and academic drug discovery enterprises. Mike is also a visiting lecturer in the School of Life and Medical Sciences at the University of Hertfordshire (teaching pharmacology, drug discovery, drug safety and toxicology) and a course tutor for the British Association of Pharmaceutical Physicians and the British Pharmacological Society. He has worked in preclinical development since the mid-80's in academia, CRO, biotech and large pharma. Mike has supported a wide range of treatment modalities (small molecules, vaccines and adjuvants, biopharm, oligos, medical devices and orphan drugs) and in multiple therapeutic areas (immuno-inflammatory, infectious disease, respiratory, metabolic and GI, oncology, psychiatric and neurology).
Job Titles:
- Chairman, Scientific Advisory Board
Job Titles:
- Head, Neurology Clinical Development
Dr. D'Cruz is an experienced epileptologist and clinical investigator who consults with pharmaceutical companies and is on the External Advisory Board for NIH's NeuroNext Program. Dr. D'Cruz is acting as an independent consultant for Shackelford Pharma. He was previously Professor of Neurology and Pediatrics at University of North Carolina-Chapel Hill, USA. Dr. D'Cruz's previous industry appointments include Medical Director, Neurology at UCB Pharma and Chief Medical Officer, Cyberonics. Member of Pediatric Epilepsy Academic Consortium for Extrapolation, Former BOD of American Society of Experimental Neuro-Therapeutics.
Job Titles:
- Head, Clinical Operations
Rebecca brings more than 30 years of clinical drug development experience to Shackelford. Previous roles include SVP of Clinical Operations at Asklepios Biopharmaceuticals and VP Global Development Operations at Theravance BioPharma.
Rebecca has worked across Phases I - IV and multiple therapy areas with expertise in strategic planning, global clinical operations, data management, financial planning and management, business process improvement, post-merger and acquisition integration, CRO and vendor management, personnel management, coaching, and leadership.
Job Titles:
- Member of the Scientific Advisory Board
Job Titles:
- Head, Research and Development
Susan is an extremely accomplished research scientist, medicines developer and pharmaceutical executive with 25 years of pharmaceutical industry experience spanning all phases of drug discovery and development. Susan most recently was the SVP of Global Medicines Development at Indivior. Prior to this, she spent nearly 20 years with GlaxoSmithKline, including the role as VP, Medicines Development Lead and Franchise Head.
Susan brings over 25 years of experience in designing, writing, and reviewing clinical trial protocols, Investigational New Drug applications and annual reports, investigator's brochures, clinical study reports (Phase 1-4), integrated summaries and other New Drug Application components, and packages for sponsor meetings with Food and Drug Administration personnel.