Agilis Biotherapeutics, a biotechnology company advancing innovative gene therapy products for the treatment of rare genetic diseases that affect the central nervous system (CNS), has expanded its commercial and medical teams, hiring Markus Peters, Ph.D., as chief commercial officer; Kirsten Gruis, M.D., as chief medical officer; and Anne Marie Conway, M.H.A, R.N., as vice president, Clinical Operations.

“We are pleased to welcome these three talented individuals to our leadership team. Each brings a wealth of experience to Agilis that is directly aligned with our mission to help patients with rare CNS diseases, advance our clinical pipeline, and lay the foundation for future approval and commercialization of our promising gene therapy product candidates,” said Dr. Mark Pykett, president and CEO of Agilis.

Dr. Markus Peters will lead Agilis’ commercial, business development and business analytics activities, and will spearhead market efforts for the company’s aromatic L-amino acid decarboxylase (AADC) deficiency gene therapy globally. He brings a significant background to Agilis in the commercialization of rare disease therapeutics and specialty pharmaceuticals. Most recently, he was an associate partner with the consulting group Alacrita.

Dr. Peters was previously vice president, Global Marketing/Commercial with Synageva, where he led the cross-functional global launch team for first-in-class enzyme replacement therapy Kanuma to develop and implement the global strategy and launch plan for the product in ultra-rare LAL deficiency. He was also responsible for the commercial assessment of the Synageva pipeline. Before Synageva, he was head of Global Marketing Nephrology and Transplant Therapeutic Area at Alexion, leading the global launch of the ultra-orphan Soliris aHUS (atypical hemolytic uremic syndrome) franchise.

Dr. Peters previously worked at Merck where he led the global launch of recombinant biologic Elonva, and at Sepracor, Wyeth, Bayer and Boehringer Ingelheim in the US, Japan and Europe in business and commercial roles of increasing responsibility. He holds a Ph.D. in Biochemistry from Heinrich-Heine Universität.

Kirsten Gruis, M.D., is an accomplished physician scientist, board certified neurologist, and rare disease specialist, with a broad background in the development of innovative therapeutics. She has worked in Friedreich’s ataxia, Spinal Muscular Atrophy (SMA), Amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD), among others, across a range of development stages, including preclinical, phase I, phase II and phase III programs.

Dr. Gruis was most recently at WAVE Life Sciences leading their clinical development plans in DMD. Previously, she was at Idera Pharmaceuticals where she lead the team to initiate a global, phase II trial in dermatomyositis and, before that, she was at Alnylam Pharmaceuticals as the clinical lead of a global, phase III program of patisiran in the rare disease familial amyloidotic polyneuropathy and, before that, was with Pfizer managing preclinical and phase I-II assets in the Rare Disease Research Unit focused on Friedreich’s ataxia, SMA, ALS and DMD.

Dr. Gruis held academic appointments as an Associate Professor of Neurology at both the University of Michigan and SUNY Upstate Medical University. She received her M.D. from the University of Iowa and did her residency training at the University of Michigan, where she subsequently joined the faculty. While at SUNY Upstate Medical University, she served as the director of the MDA clinic, co-director of the ALS Clinic, and prior to that was director of the Motor Neuron Disease Center/ALS Clinic at the University of Michigan. Dr. Gruis is a member of the American Academy of Neurology and World Muscle Society, as well as a Fellow American Association of Neuromuscular & Electrodiagnostic Medicine with additional board certification in Neuromuscular Disorders. She has served on multiple NIH Scientific Review Panels for the NINDS and Neurotechnology study groups as well as a principal investigator of several clinical studies for ALS.

Anne Marie Conway, M.H.A., R.N., brings extensive experience in clinical operations to Agilis’ clinical development programs. Most recently, she was principal at AMC Consulting, providing clinical operations services to a range of drug development organizations including Rhythm Pharmaceuticals, bluebird bio and Lantheus Medical Imaging, among others. Before that, she worked at Ziopharm Oncology as head of Clinical Operations and Data Management. While there, she managed the start up of the gene therapy program for high grade gliomas. Prior to that, she was at Shire Human Genetic Therapies (now integrated into Shire) as vice president, Development Operations, providing management oversight for the global filing and approval of VPRIV for Gaucher disease, running a global phase III trial and subsequent approval of Firazyr for hereditary angioedema and, leading global clinical operations, data management and registry group for eight rare disease pipeline products in phases I through IV studies.

Prior to its acquisition by Shire, Conway worked at Transkaryotic Therapies and led the integrated development team for the clinical sections of the BLA/MAA filing and subsequent approval in the U.S., European Union and Japan for elaprase. Before moving into industry, Conway worked at Tufts Medical Center as a Clinical Trials Manager, Outpatient Nurse Coordinator and Staff Nurse. She has an M.H.A. from Suffolk University and a B.S. from Boston University, is a licensed nurse, and holds an adjunct faculty position at Suffolk University.