Leadership
Craig A Metz, PhD, Co-Founder & Chief Executive Officer
Dr. Craig Metz has over 45 years of pharmaceutical industry experience and is a former Vice President of US Regulatory Affairs at GlaxoSmithKline, where he led the regulatory group responsible for GSK’s entire early drug development portfolio. In this capacity, Craig provided oversight and review for 60-80 initial IND submissions each year, many of which were in therapeutic settings involving rare disorders or orphan diseases with significant unmet medical need.
Dr. Patrick Anthony Akkari, PhD, Co-Founder & Chief Scientific Officer
Recruited from the pharmaceutical industry in North Carolina to lead complimentary positions in Perth within Murdoch University and The Perron Institute. In this dual capacity, Anthony has established a genetics drug discovery laboratory and identified a path to more efficiently move potential drug candidates from that laboratory to the clinic. As Head of Motor Neuron Disease Genetics and Therapeutics Research at The Perron Institute and a Professor of Industrial Pharmacogenetics at Murdoch University, Anthony has been instrumental in establishing the foundational science and drug discovery pipeline that comprises the therapeutic development pipeline for Black Swan Pharmaceuticals.
Julian Arbuckle, Co-Founder & Chief Business Officer
Julian Arbuckle has worked in the life sciences sector for over 25 years and has significant knowledge of the research and development process gained by working within both blue-chip pharmaceutical and start-up biotechnology companies.
During his time in the industry he has gained significant experience in leading drug development programs and providing specialist scientific consulting advice to sponsors working on long-term prevention trials in the CNS disease area. He has also initiated, and led, several industry/academic collaborations working primarily in the field of precision medicine. Julian also extensive experience of business development, alliance management and commercial aspects of the drug development business.
Lori K. Parro CPA, MBA CFO
25 years experience, primarily in the life science space (incl. drug development, medical devices and contract research). Currently a CFO Partner with TechCXO LLC, a C-Suite consulting firm. Serves startup or early stage growth. Experience includes M&A, operations, corporate valuation, business planning, cash management and team leadership.
Dr Loren Flynn, BSP Director of Therapeutic Development
Loren is a molecular geneticist with a research focus on the development of antisense oligonucleotides (AOs) and their application in translational medicine. She has 13 years of practical expertise in designing AOs for modulating the splicing and expression of genes in rare genetic and neurodegenerative disorders, including amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA) and Parkinson’s disease (PD). Loren’s experience includes the evaluation of AOs in both in vitro and in vivo models, as well as experience working with industry in drug development and FDA regulatory procedures for a rapid pre-clinical translation of AO therapies. Since 2018, Loren has led the development of BSP’s antisense portfolio.
Scientific Advisory Board
Professor Steve Wilton AO
Professor Steve Wilton is the Director of the Perron Institute, Foundation Chair of Molecular Therapy at Murdoch University and Director of Murdoch University’s Centre for Molecular Medicine and Innovative Therapeutics (CMMIT). In collaboration with Professor Sue Fletcher, Professor Wilton has pioneered the use of antisense oligonucleotides (AOs) to overcome some of the most common dystrophin gene defects causing Duchenne muscular dystrophy (DMD).
Over a research journey spanning more than two decades, the Molecular Therapy Laboratory took the idea of using AOs to treat DMD from the laboratory to clinical application, through a partnership with the US pharmaceutical company, Sarepta Therapeutics (Cambridge, Ma). Three drugs for DMD have now been approved by the US Food and Drug Administration (FDA) and are relevant to nearly 30% of the DMD population. With co-leader Dr May Aung-Htut at Murdoch University, the Molecular Therapy laboratory is exploring therapeutic interventions for more than 50 different inherited and acquired conditions affecting human health. Professor Wilton has received multiple awards for his research on DMD and other diseases, including the Eureka Prize for Medical Research Translation, the Western Australian Innovator of the Year award and Officer of the Order of Australia.
Associate Professor Brad Turner
A/Prof. Bradley Turner is a NHMRC Dementia Research Leadership Fellow and Head of the Motor Neuron Disease Laboratory. He is a molecular neurobiologist who obtained his PhD in biochemistry at the University of Melbourne in 2005 and trained with Prof. Kay Davies and Prof. Kevin Talbot at the University of Oxford in mouse functional genetics as a NHMRC CJ Martin Fellow for 3 years. He was recruited back to the Florey Institute where he established the MND Laboratory supported by a Stafford Fox Senior Research Fellowship.
He has broad interest in modelling neurodegenerative diseases affecting the motor system using patient stem cell and animal models, spanning pediatric and adult motor neuron diseases. He is a member of the National Health and Medical Research Council Grant Review Panels, Assigners Academy and MND Australia Research Committee.
Dr. Richard Bedlack
Dr. Richard Bedlack, grew up in a small town in central Connecticut. He went to college at William and Mary in Virginia, then back to Connecticut for an MD and PhD in Neuroscience at UConn. Finally, he came to Duke where he completed his Medicine Internship, Neurology Residency, Neuromuscular Fellowship, and Masters in Clinical Research Science. He is currently a Professor of Neurology at Duke and Director of the Duke ALS Clinic. He has won awards for teaching and patient care, including best Neurology teacher at Duke, Health Care Hero, Strength Hope and Caring Award, America’s Best Doctor, the American Academy of Neurology Patient Advocate of the Year and the Rasmussen ALS Patient Advocate of the Year. He has received ALS research grants, participated in ALS clinical trials, published more than 130 ALS articles. He is leader of the ALS Clinical Research Learning Institute which empowers people living with ALS to be more engaged in research, leader of the international ALSUntangled program which utilizes social networking to investigate alternative and off label treatment options for patients with ALS, and leader of the ALS Reversals program which attempts to understand why some people with ALS recover from it, and to make this happen more often. He lives in Durham, North Carolina with his wife Shelly and two mischievous cats.
Dr. Stephen B. Montgomery
Stephen B. Montgomery, Ph.D. is a founding partner of Regulatory and Toxicology Consultants, LLC with 40+ years of experience in nonclinical drug development focusing on safety pharmacology, toxicology, and safety assessment. These efforts include program design, conduct and evaluation of studies, and CTD/IND/NDA submissions of drug candidates spanning oncology, anti-infective, anti-inflammatory, cardiovascular, anti-diabetic, pain management, inhalation, dermatological, neurological, antiviral, and musculoskeletal therapeutic areas among others. Dr. Montgomery has been consulting for the past 18 years, with previous positions in Toxicology and Safety Assessment at Daiichi Pharmaceutical Company, Boehringer-Ingleheim Pharmaceutical Company, Ives Laboratories (American Home Products/Pfizer), and FDA. Dr. Montgomery is a graduate of Georgetown University Medical Center in Physiology and Biophysics, and was a visiting scientist at NIH. He is an active member of the Society of Toxicology, American College of Toxicology, and Society of Toxicology Pathology, and an editor for the International Journal of Toxicology. Dr. Montgomery is currently a Steering Committee member on the Polio Antiviral Initiative (Task Force for Global Health/WHO/CDC/ FDA/Gates Foundation), and a scientific advisor to Ridgeback Biotherapeutics and Kato Pharmaceuticals, among others.
Dr. James S. Bernstein
James Bernstein leads the Live Oak Pharmaceutical Consulting group, founded in 2007, providing services and consultants across all CMC functions. Project phase ranges from pre-clinical through market application for over 50 clients. Prior to Live Oak, he worked at GSK and heritage companies for 24 years in both drug substance and drug product areas. He also serves as CSO for Marius Pharmaceuticals. His contributions to client projects typically include CMC strategy, regulatory document preparation and review, and analytical science. His formal education includes a B.S. in Chemistry and Physics from Centenary College of Louisiana and a Ph.D. in Physical Chemistry from the University of North Carolina at Chapel Hill.
Om Dhingra, Ph.D.
Dr. Dhingra is currently serving as a Scientific Advisor & Board Member of Marius Pharmaceuticals. Dr. Dhingra founded SOV Therapeutics, a virtual pharmaceutical company in 2009 and developed technology for enhanced Lymphatic delivery of Testosterone Undecanoate, a testosterone pro-drug. After a successful Phase IIb study, SOV Therapeutics formed a partnership in 2017 with Marius Pharmaceuticals for Phase 3 studies and commercialization. Dr. Dhingra served as CEO of Marius Pharmaceuticals from Jan 2017-December 2020. Prior to founding SOV Therapeutics, he worked at GSK and heritage companies for 17 years rising to the rank of Vice President of preclinical drug discovery & development for Metabolic & Viral diseases. Dr. Dhingra was responsible for progressing more than 20 drugs to proof of concept clinical studies at GSK. The oral testosterone undecanoate drug was developed virtually by SOV Therapeutics & Marius Pharmaceutical and approved as KYZATREX by FDA in July 2022. His formal education includes a B.S. & M.S. in Organic Chemistry from Delhi University, India, and a Ph.D. in Organic Chemistry from the University of Virginia, Charlottesville, Virginia.