CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the appointment of Tammy Sarnelli as Global Head of Regulatory Affairs. Tammy Sarnelli brings more than 30 years of experience in the pharmaceutical industry, with regulatory expertise in early and late stage of neurology and rare disease drug development. In this role, she will oversee regulatory submissions, strategy, and compliance.
“We are confident that Tammy’s experience will provide invaluable guidance in advancing our clinical ALS and Alzheimer’s disease programs as we work toward significant regulatory milestones this year and moving forward,” said Justin Klee, Co-Founder and Co-CEO of Amylyx. “I look forward to having Tammy play an integral role in our pursuit of improving the lives of people affected by neurodegenerative diseases.”
Tammy is a highly accomplished regulatory affairs professional and leader with extensive experience in the serious and rare disease space. She began her career at Biogen, where she worked for 27 years, in senior level Regulatory Affairs positions. Tammy was responsible for regulatory strategy, submissions, and health authority liaison activities, from the initiation of development through commercialization. While at Biogen, she was responsible for BLA construction, review and submission of new products, along with the submission and approval of Amevive® (alefacept) and Tysabri® (natalizumab). Notably, she also served as the regulatory lead for two approved products within the Neurology Therapeutic Area, including Biogen’s multiple sclerosis products, Tecfidera® (dimethyl fumarate) and Zinbryta® (daclizumab) as well as their Alzheimer’s product, aducanumab.
“I am thrilled to join a team that has demonstrated rapid progress in discovering new treatment pathways, and above all, one that’s driven by patients and the urgent need required to find solutions for them,” said Tammy Sarnelli. “I admire Amylyx’s patient-centric vision and I believe my regulatory experience will complement the company’s tenacious attitude and current needs to drive our mission forward and bring new treatments for neurodegenerative diseases to market.”
More recently, Tammy held roles as Executive Director Regulatory Affairs at Bioverativ focusing on hemophilia and sickle cell disease. Prior, as Head of Global Regulatory Affairs, Neurology & Immunology at EMD Serono, her role focused on regulatory strategy and cross functional leadership for the company’s neurology and immunology portfolios. Tammy managed a team responsible for the strategy, submission and health authority liaison activities for their multiple sclerosis oral treatment, Mavenclad® (cladribine), and a late-stage program, evobrutinib.
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals, Inc. is a pharmaceutical company working on developing a novel therapeutic for Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases. For more information, visit www.amylyx.com and follow us on LinkedIn and Twitter.