Our Company
Amylyx Pharmaceuticals was founded in 2013 with the mission of improving the lives of patients with neurodegenerative diseases. The company’s lead therapeutic, AMX0035, is designed to simultaneously target pathways originating in the mitochondria and endoplasmic reticulum which lead to neuronal death and degradation. AMX0035 is currently in clinical trials in both Alzheimer’s disease and ALS.
The company is focused on evaluating AMX0035 in these indications and, if successful, intends to rapidly provide it to patients in need.
Executive Team
JOSH COHEN
Josh Cohen
CEO and Co-Founder
Joshua Cohen co-founded Amylyx Pharmaceuticals in 2013 and continues to serve as its CEO. Josh has overseen the growth of Amylyx from a dorm-room concept to a clinical stage pharmaceutical company. His research experience includes work both at Brown University and at the National Institute of Standards in Technology. Josh received his BS in biomedical engineering from Brown University.
JUSTIN KLEE
Justin Klee
President and Co-Founder
Justin Klee co-founded Amylyx Pharmaceuticals in 2013 and continues to serve as its President. Along with his co-founder Josh, Justin has overseen the development of Amylyx’s novel platform and therapeutic for neurodegenerative diseases from initial testing through clinical trials. Justin previously did research at Brown University in neural systems and neurophysiology and Alzheimer’s disease at Harvard Medical School. He received his Sc.B in Neuroscience from Brown University.
KENT LESLIE
Kent Leslie
Chief Scientific Officer
Kent Leslie joined Amylyx Pharmaceuticals in 2015 and serves as its Chief Scientific Officer. Kent oversees the design and conduct of all preclinical scientific studies and academic collaborations, as well as seeking new therapies and applications. Kent received his M.Sc in Biotechnology from Brown University while completing research in the lab of Dr. Richard Bennett. Prior to receiving his Master’s degree, Kent received Bachelor’s degrees in Biology and Economics from Brown University.
PATRICK YERAMIAN
Patrick Yeramian, MD MBA
Consulting Chief Medical Officer
Dr. Yeramian joined Amylyx as Chief Medical Officer in 2019 bringing to the company more than 30 years of pharmaceutical industry experience. He was previously the consulting medical director for Amylyx, where he has supported the pre-IND and IND filings of AMX0035 for the treatment of amyotrophic lateral sclerosis and Alzheimer’s disease, and has overseen the design and execution of both clinical trials.
Throughout his career Dr. Yeramian has supervised the clinical development of new drugs, biopharmaceuticals, cellular therapy agents and vaccines. He has held prominent roles in the approval of several drug (metronidazole – Flagyl MR®), biological (interferon alpha – Multiferon®, nafarelin – Synarel®) and device (Inerpan®) applications by the FDA and EMA and granting of more than 20 successful INDs and IMPDs. Previously he served as Chief Medical Officer at Viragen, Inc. where he was responsible for the development of global clinical and regulatory strategies and for the implementation of clinical programs worldwide. Earlier in his career, Dr. Yeramian served as Director of clinical research at GD Searle where he supervised the clinical programs for antibiotics, antivirals, sepsis/thrombosis and cancer vaccines. He also previously served as Medical Director of the Vaccine and Gene Therapy Institute in Florida.
Dr. Yeramian holds a Medical Degree from the University of Paris together with a Master of Clinical Science in experimental oncology and a Graduate Degree in molecular virology. He received his Master of Business Administration from Rutgers University. He completed his medical residency in oncology at the Saint-Louis Hospital in Paris.
TOM HOLMES
Tom Holmes
Global Head, Supply Chain
Tom Holmes joined Amylyx in March 2019 as Global Head, Supply Chain, bringing more than 25 years of leadership experience in supply chain, biopharmaceutical manufacturing and program management. Prior to joining Amylyx, Tom was the Senior Director of External Manufacturing at Biogen Inc., a role he held for 10 years. As Senior Director, Tom managed Biogen’s global external manufacturing network and was responsible for driving supply contracting decisions for 11 commercial assets and more than 42 new molecular entities in various stages of clinical development. Tom held several positions at Biogen beginning in 1994 including planning, logistics program management, Launch Lead, and manufacturing. Tom received a Bachelor of Science in Business Administration with a concentration in Management from Salem State University.
LINDA PROCTOR
Linda Proctor
Quality
Linda Proctor has over 40 years of experience in the pharmaceutical industry including 20 years of as an independent Quality Assurance-Compliance consultant. Ms. Proctor is currently the Manager of Blue Water Technical Services, LLC which provides a broad range of services to the regulated industries, including validation (CSV, cleaning, process), quality assurance and compliance. Ms. Proctor ensures Amylyx meets regulatory requirements through development and implementation of quality management systems, conducting GxP audits, and manufacturing oversite.
BEVERLY LEWIS
Beverly Lewis
CMC Regulatory Affairs
Beverly Lewis has 35 years of experience in the pharmaceutical industry including nearly 30 years in CMC Regulatory Affairs. Previously she was the Director of Regulatory Affairs at DSM Pharmaceuticals, Inc. and held positions in CMC Regulatory Affairs at Glaxo Wellcome and Burroughs Wellcome. Ms. Lewis oversees all aspects of Amylyx’s CMC Regulatory Affairs, including advising manufacturers on best regulatory practices, development, preparation, and review of CMC dossier sections; overseeing regulatory interactions; and training.
Ms. Lewis is Regulatory Affairs Certified by the Regulatory Affairs Professional Society. She has a B.S. Degree in Chemistry from the University of North Carolina at Chapel Hill.
STACY SUBERG
Stacy Suberg, PhD
FDA Regulatory Affairs
Dr. Stacy Suberg has over 30 years experience in regulatory affairs including in the areas of human drugs, biologics, cellular therapies, medical devices, drug and device combinations, in vitro diagnostics and veterinary drugs. Her expertise and experience includes the preparation, filing, and advising on IND applications and submissions, Supplemental NDAs and BLAs, NDAs, BLAs, de novo 510(k), PMA and supplemental PMAs, Export Authorizations, NDSs, Investigational Brochures, Labeling, Orphan Applications, Fast Track Application, Combination Products and other Subpart E and H strategies and Investigator INDs; acting as a liason with FDA on pre-IND, end of phase I-II, pre-NDA/BLA meetings; resolution of clinical hold and general issues; advising on user fee regulations; advising on manufacturing strategies; advising on generic and anti-generic strategies; interaction with IRBs; and review of labeling and promotion (compliance). Dr. Suberg oversees Amylyx’s regulatory team and strategy and acts as Amylyx’s liason to FDA.
JEFF WILSON
Jeff Wilson
Pharmaceutical Development & Manufacturing
Dr. Jeff Wilson is a pharmaceutical industry veteran with over 30 years of small molecule drug development experience. Dr. Wilson is currently the Managing Director of Twin Leaf Partners, LLC, a consulting firm that provides strategic and technical guidance to the pharmaceutical and biotech industry. Prior to establishing Twin Leaf Partners, Dr. Wilson held a number of technical and managerial positions including President of Pharmaceutical Development and Manufacturing at Aptuit Pharmaceuticals, Vice President of Pharmaceutical Development at Vertex Pharmaceuticals and Director of Global Research Alliances at Glaxo Wellcome.
Dr. Wilson received his B.S. in Chemistry at the University of New Hampshire and Ph.D. from Duke University.
RUDOLPH TANZI
Rudolph Tanzi
Chair of the Scientific Advisory Board
Dr. Rudolph Tanzi serves as the Chairman of our Scientific Advisory Board. He brings immense experience and insight to our team. He is also the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University and Director of the Genetics and Aging Research Unit at Massachusetts General Hospital (MGH). He Chairs the Cure Alzheimer’s Fund Research Consortium.
Dr. Tanzi has been a pioneer in genetic studies of neurological disease since the 1980’s when he participated in the first study using genetic markers to find a disease gene (Huntington’s disease). Dr. Tanzi co-discovered the three familial early-onset Alzheimer’s disease (AD) genes and several other neurological disease genes including that responsible for Wilson’s disease.