A world-class management team experienced in gene therapy, rare disease drug development and commercialization, and biologics manufacturing.
Natalie Holles has served as President and Chief Executive Officer (CEO) of Audentes since January 2020. She joined the company as Senior Vice President and Chief Operating Officer (COO) in August 2015 and was promoted to President and COO in May 2018. Ms. Holles brings to this role more than twenty years of executive leadership, business development, corporate strategy and commercial experience gained in a range of therapeutic areas with a focus on orphan diseases.
Previously Ms. Holles served as Senior Vice President, Corporate Development at Hyperion Therapeutics, Inc. from 2013 through its acquisition by Horizon Pharma, plc in May 2015. From 2010-2013, Ms. Holles provided executive-level strategy and business development advisory services to a number of privately-held biopharmaceutical companies. Earlier in her career, Ms. Holles served as Vice President, Business Development at KAI Pharmaceuticals, Inc. (acquired by Amgen in 2012) and previously held corporate development and commercial roles at InterMune, Inc. (acquired by Roche in 2014) and Genentech, Inc.
Ms. Holles is a member of the Board of Directors for Rubius Therapeutics, Inc. She holds an M.A. in Molecular, Cellular, and Developmental Biology from the University of Colorado, Boulder, where she was a Howard Hughes Medical Institute Predoctoral Fellow, and an A.B. in Human Biology from Stanford University.
Megan Baierlein is Senior Vice President, Chief Operating Officer at Audentes Therapeutics. Ms. Baierlein joined Audentes in July 2018 and is currently overseeing program management, clinical operations, finance, IT, legal, and corporate compliance. She has more than two decades of drug development and strategic planning experience gained in a range of therapeutic areas, with a focus on orphan diseases for the last 10 years.
Previously Ms. Baierlein served as Executive Director, Program Management at Ultragenyx Pharmaceutical Inc. from 2013 through 2018. From 2009 through 2013, Ms. Baierlein held management positions at BioMarin in both program management and clinical operations. Earlier in her career, Ms. Baierlein held roles of increasing responsibility at Genentech, Inc and Elan Pharmaceuticals.
Ms. Baierlein holds an B.S. in Biology and Kinesiology from the University of Minnesota.
Edward Conner, M.D. is Senior Vice President and Chief Medical Officer at Audentes Therapeutics and is responsible for leading the global clinical development strategy for Audentes. He oversees clinical development, clinical operations, regulatory affairs, medical affairs, and patient advocacy. Dr. Conner brings more than 10 years of industry leadership experience in early and late stage clinical development across a broad range of disease areas, including rare diseases.
Dr. Conner joins Audentes from Sangamo Therapeutics, Inc. where he served as Senior Vice President and Chief Medical Officer and led the clinical development of the company’s pipeline of genomic therapies. Prior to Sangamo, Ed served as Vice President, Global Clinical Development at Ultragenyx Pharmaceutical Inc. where he led the global clinical development efforts for two of the company’s rare disease product candidates. Previously, Ed served as Senior Medical Director at BioMarin Pharmaceutical Inc. where he led clinical development and regulatory interactions for its global Phase 3 program in Pompe disease, and earlier in his career Dr. Conner served as Medical Director at Genentech, Inc. where he was the clinical science team leader of two product candidates, including XOLAIR®.
Dr. Conner completed his Internal Medicine residency training at the University of Michigan and was a fellow in Clinical Immunology and Allergic Diseases at Johns Hopkins School of Medicine. He earned a B.S. in Biology, cum laude, from Duke University and his M.D. from the University of California, San Francisco.
Mathew Pletcher, Ph.D. is Senior Vice President, Research at Audentes Therapeutics. He is responsible for advancing the company’s pipeline from discovery through to IND-enabling preclinical development.
Prior to Audentes in July 2020, Mr. Pletcher worked at Roche Pharma where he was Head of Rare Diseases Research and Early Development, and prior to that, Head of Discovery. Previously, he served as Acting Chief Scientific Officer at Autism Speaks and earlier as Vice President, Head of Genomic Sciences. He also spent eight years working in Pfizer’s Rare Diseases Research Unit in various scientific roles of increasing responsibility including Director, Rare Diseases Research Unit.
Mr. Pletcher also founded and leads a non-profit foundation, Fund for Sight, supporting research and resources for families and children impacted by the genetic disease his daughter inherited called Leber Congenital Amaurosis. He holds a Bachelor of Science in Biology from Duquesne University and a Ph.D. in Human Genetics form Johns Hopkins School of Medicine.
Mary Newman is Senior Vice President of Regulatory Affairs at Audentes Therapeutics. She joined the company with more than 20 years of experience in regulatory affairs and research and development within the biotechnology industry, focusing on rare diseases. Ms. Newman oversees global regulatory strategic development, all primary regulatory agency interactions, and regulatory compliance for Audentes’ development candidates.
Prior to joining Audentes, Ms. Newman served as the Senior Vice President, Regulatory Affairs and Quality Assurance at SARcode Bioscience Inc., which was acquired by Shire Ltd. She previously held various management positions, with increasing responsibility in Regulatory Affairs at BioMarin Pharmaceutical, Inc., Berlex Inc. (now Bayer HealthCare Pharmaceuticals Inc.), and Sequus Pharmaceuticals, Inc. (now Johnson & Johnson). While at BioMarin, Ms. Newman oversaw the development and approval of Kuvan® for the treatment of phenylketonuria (PKU), Naglazyme® for mucopolysaccharidosis (MPS) VI, and supported the final approval of Aldurazyme® for MPS I. She has also held various research and development leadership roles in oncology, neurology, and antifungal therapeutic areas.
Ms. Newman holds a B.S. in Physiology from Oregon State University.
Donald Wuchterl has served as Senior Vice President of Technical Operations at Audentes Therapeutics since January 2016. He is responsible for the company’s Quality, Manufacturing, Supply Chain, Facilities & Engineering, and Process & Analytical Development teams.
Mr. Wucheterl has more than 25 years of experience in manufacturing clinical and commercial GMP products including biologics, small molecules, cellular immunotherapies, and AAV gene therapies. Mr. Wuchterl has extensive experience in the design, buildout, validation, licensure, and operation of these facilities.
Mr. Wuchterl joined Audentes from Cytovance Biologics where he was Senior Vice President and Chief Operating Officer. Prior to Cytovance, Mr. Wuchterl held positions of increasing responsibility in manufacturing and operations-related roles at Dendreon, Shire HGT, Amgen, Biogen Idec, and Roche.
Mr. Wuchterl holds a B.S. in Business Administration from Colorado Technical University and a M.B.A. from Fitchburg State University.
Lovena D. Chaput is Senior Vice President, Americas at Audentes Therapeutics. She joined the company in December 2019 as Senior Vice President of Global Market Access. She brings more than 30 years of healthcare leadership experience focused on launching and commercializing treatments for rare and orphan diseases in startup organizations. As Senior VP Market Access, Ms. Chaput is responsible for executing the global market access strategy for the company’s growing portfolio of gene therapy product candidates, and for building the commercial market access organization, including distribution, patient services and market access teams.
Ms. Chaput joined Audentes from AveXis, a Novartis company, where she served as VP, Market Access and Reimbursement. During her tenure with AveXis she led the highly successful launch of ZOLGENSMA®, the first gene therapy for Spinal Muscular Atrophy. Prior to AveXis, Ms. Chaput was with Raptor Pharmaceuticals where she was the Executive Director, Commercial Operations, Americas & Asia Pacific. While at Raptor, she led the U.S. Market Access strategy and launch of Procysbi®, a drug for the treatment of nephropathic cystinosis. Previously, Ms. Chaput designed and built the commercial organization for Amylin Pharmaceuticals. During her tenure at Amylin she held various strategic and leadership roles in sales, marketing, trade and distribution, and market access, launching several first in class products, including Symlin®, Byetta® and BYDUREON®. Ms. Chaput also served in various commercial roles at Raptor, Amylin, Bristol-Myers Squibb and Syntex Laboratories, Inc. Ms. Chaput holds a B.S. in Biology from Willamette University in Salem, Oregon.
Amy Pott is Head of Gene Therapy, Commercial, and is responsible for leading commercialization of our Gene Therapy business. She joined Audentes in January 2021 and brings an impressive amount of experience and expertise developing and launching rare disease therapies.
Ms. Pott joined Audentes us from Swedish Orphan Biovitrum (SOBI), where she was President, North America, and oversaw rare disease/specialty programs such as Synagis for Respiratory Syncytial Virus (RSV); Kineret for Rheumatoid Arthritis; and Gamifant for Hemophagocytic Lymphohistiocytosis (HLH). Prior to joining SOBI, Ms. Pott was Group Vice President, US Franchise Head, Internal Medicine & Oncology at Shire, where she was responsible for four rare disease businesses, including the GI, Endo, LSD and Oncology Businesses. She joined Shire when the company acquired Baxalta, and stayed on to build the US commercial operations group handling seven US franchises.
Ms. Pott earned her B.A. in history from the University of Bristol and her M.S. in European Policy & International Relations from the London School of Economics.