Mark J. Pykett, VMD, PhD President and Chief Executive Officer
Dr. Pykett is the President and Chief Executive Officer of Agilis Biotherapeutics, and he has two decades of experience in the pharmaceutical industry. Previously he served as Chief Executive Officer of Navidea Biopharmaceuticals, a precision medicine company focused on oncology and neurology. Prior to Navidea, Dr. Pykett was President and Chief Operating Officer of Alseres Pharmaceuticals, a biotechnology company focused on neurodegenerative and central nervous system disorders. Before Alseres, Dr. Pykett held senior executive roles at several public and private companies, including CEO of Cytomatrix and President of Cygenics, focused on a range of therapeutic areas, indications and products. Dr. Pykett has also served as a Director of several public and private companies, and of the not-for-profit organization HealthBuilders, developing health infrastructure in central Africa. Dr. Pykett received a B.A. degree from Amherst College, a V.M.D. and Ph.D. from the University of Pennsylvania, and an M.B.A. from Northeastern University, and completed post-doctoral fellowships at the University of Pennsylvania and Harvard University.
Jodi A. Cook, PhD Chief Operating Officer
Dr. Cook, Ph.D. is the Chief Operating Officer for Agilis Biotherapeutics. She has more than 20 years of senior executive experience in the life-sciences industry ranging from advanced technology start-ups to a Fortune 500 corporation. Dr. Cook was on faculty at Arizona State University and the Mayo Medical School, and was the Director of the Hearing Aid Program at Mayo Clinic, Rochester, Minnesota. Most recently, as the CEO and founder of Thesia Medical LLC, she was affiliated with University of Pennsylvania’s UpStart program successfully working with life science inventors to develop business plans and go-to-market strategies. Previously, she was Vice President, Clinical Research and Professional Relations for InSound Medical, a venture-backed company sold for over $200 million. Among her experiences, Dr. Cook has been responsible for managing clinical research in the US, Europe, and Asia, and launching new products in the US and UK. She counts among her accomplishments the development and execution of sound clinical and regulatory strategy and leadership for corporate medical and professional affairs. Dr. Cook earned her Ph.D. in Auditory Science at Arizona State University, and completed a fellowship at Johns Hopkins School of Medicine.
Kirsten Gruis, MD, MS Chief Medical Officer
Dr. Kirsten Gruis, MD, MS, is the Chief Medical Officer for Agilis Biotherapeutics. She is a Board Certified Neurologist, with additional certification in Neuromuscular Medicine. She received her MD from the University of Iowa College of Medicine and trained in Neurology at the University of Michigan, where she also did a fellowship in Neuromuscular Diseases and received an MS Degree in Clinical Trial Design and Statistical Analysis from the School of Public Health. She began her academic career at the University of Michigan, where she was the Director of the Motor Neuron Disease Center/ALS Clinic and oversaw the Neuromuscular Medicine Fellowship Program. From there, she moved to State University of New York (SUNY) Upstate Medical University in Syracuse as Associate Professor of Neurology where she was Co-Director of the ALS Clinic and Director of the Muscular Dystrophy Association Clinic. Her previous industry experience includes Pfizer, where she was the Neuromuscular Clinical Lead for projects in DMD, SMA, ALS, and Friedrich’s ataxia, Alnylam where she was the clinical lead for the Phase 3 program of patisiran for familial amyloidotic polyneuropathy (FAP), and Idera where she oversaw implementation of a Phase 2 trial of an oligonucleotide antagonist of toll-like receptors for dermatomyositis. Most recently, she was at WAVE Life Sciences where she oversaw the design of first in human study for a novel nucleic acid therapeutic for exon skipping in DMD.
Markus Peters, PhD Chief Commercial Officer
Dr. Peters, Ph.D. is the Chief Commercial Officer for Agilis Biotherapeutics. He has more than 20 years experience in the global commercialization of treatments that transform the lives of patients with serious medical conditions. Dr. Peters was most recently an Associate Partner at Alacrita LLC based in Cambridge, Massachusetts where he advised Life Science companies on the global commercialization of their therapeutic pipeline assets, with focus on novel rare (orphan) disease and oncology treatments. Dr. Peters was responsible for the global launches of over 10 specialty pharmaceutical franchises, including two ultra-orphan treatments: Soliris (eculizumab) atypical HUS for Alexion, and Kanuma (sebelipase alfa), the first commercial product for Synageva. He also launched the rheumatology and dermatology franchises for the biologic TNF alfa inhibitor Enbrel (etanercept), and oversaw the commercialization of the Wyeth oncology pipeline. Dr. Peters’ therapeutic area experience includes rare genetic diseases, oncology, immunology, hematology, nephrology, hepatology, endocrinology and metabolic/cardiovascular. He has worked on three continents (North America, Europe, and Asia) in global strategic, US in-line and new product planning, market access, business development and corporate development. He holds a Ph.D. in Biochemistry from Heinrich-Heine University in Düsseldorf, Germany.
Anne Marie Conway, MHA, RN Vice President Clinical Operations
Ms. Conway is the Vice President Clinical Operations for Agilis Biotherapeutics. She is a global drug development executive who has been working in clinical drug development for over 25 years and focuses on clinical development operations, observational research, program management and strategic alliance management. She has participated in three successful NDA submissions including elaprase for the treatment of Hunter syndrome. She is the founder and principal of AMC Consulting, LLC, which provides on-demand clinical, data management and quality support to companies ranging from small, virtual starts-ups early in development through growing pharmaceutical companies with late-stage assets. Her prior work includes Senior Director of Clinical Development Operations at ZIOPHARM Oncology and Vice President of Development Operations at Shire Human Genetic Therapies. She is also is an adjunct faculty member at Suffolk University’s Sawyer Business School, teaching a graduate class on Healthcare Innovation.
Kevin O’Brien Vice President of Finance
Mr. O’Brien is the Vice President of Finance for Agilis Biotherapeutics. He has been senior financial executive of five successive venture financed companies he helped grow and lead to successful exit or IPO. Most recently, he was Chief Financial Officer at Ahura Scientific, a manufacturer of handheld spectroscopy instruments, which grew from $1 million to $70 million in revenues and was sold to Thermo Fisher Scientific for $170 million. Prior to Ahura, he was the CFO at Innoveda, a software company created from a leveraged buyout that grew from $50 million to $100 million in revenues went public, and ultimately was sold to Mentor Graphics. He was also the Vice President of Finance at Easel Corporation, a software company that grew rapidly and had a successful IPO. He has a broad operating and financial background as well as extensive experience with mergers and acquisitions.
Patricia Williams, PhD Director of Regulatory Affairs
Dr. Williams is the Director of Regulatory Affairs for Agilis Biotherapeutics. She is a pharmaceutical executive with over 30 years experience in drug discovery and development in the pharmaceutical, biotechnology and contract service industries. She is currently the President & CEO of IND Directions, LLC, a drug development consulting and service company located in Northern Virginia. She has held various management positions in drug development spanning preclinical, manufacturing, clinical and regulatory disciplines at Bristol-Myers Company, Eli Lilly, American Cyanamid, BioChem Therapeutic, Inc., Glycomed, Inc./Ligand Pharmaceuticals, TherImmune Research/Gene Logic Corp and SRA Life Sciences and Summit Drug Development Services.
Richard M. Thorn, PhD Director of Chemistry Manufacturing and Controls
Dr. Thorn is the Director of Chemistry Manufacturing and Controls for Agilis Biotherapeutics. He is a senior pharmaceutical development consultant with more than 30 years experience in the biopharmaceutical industry. He has expertise in licensing and developing therapeutics and was the lead technical team member for four successful NDA submissions. He has successfully supported the CMC activities for 19 other projects, including three in Phase III, four in Phase I/II, two as RDRC phase, two in proof-of-concept, and eight in the exploratory stage. He spent nine years in academic research before entering the biopharmaceutical industry. His most recent previous corporate positions were Program Director of NAV5001 at Navidea Biopharmaceuticals and Senior Vice President of Program Operations at Alseres Pharmaceuticals, Inc. Richard has held various technical and management positions at Boston Biomedica, Verigen, Baxter Diagnostics, and Cambridge BioTech.