Innovative science for life-changing medicines

Company Overview

Samus Therapeutics is a Boston-based biopharmaceutical company dedicated to changing the lives of patients with cancer and neurodegenerative diseases by developing novel therapeutics that target epichaperomes.

 

Leadership

John Amedio, PhD

Acting Head of Manufacturing

Dr. John Amedio serves as Acting Head of Manufacturing. Dr. Amedio’s experience spans more than 30 years in the pharmaceutical industry. He most recently served as SVP of Technical Operations at ArQule, a subsidiary of Merck & Co., where he was responsible for global manufacturing operations and drug supply.

Dr. Amedio has delivered profitable and patented drug substance and drug product from pre-clinical through commercial phases and has authored/co-authored CMC sections for numerous regulatory filings. As Principal at Amedio CMC Consulting, he specialized in providing strategy for the technical and regulatory CMC development processes for biotechnology and pharmaceutical companies working to bring drugs through to market. Previously, Dr. Amedio served in several manufacturing guidance leadership roles, including positions at Seaside Therapeutics, ZIOPHARM Oncology, EPIX Pharmaceuticals and Sandoz Research Institute.

He holds a Ph.D. in Organic Chemistry from the University of Delaware and earned his B.S. in Chemistry from Manhattan College. Dr. Amedio completed his post-doctoral research in Natural Product Synthesis and Organic Chemistry at Oregon State University.

Richard Bagley

President and CEO

Richard Bagley joined Samus Therapeutics in November 2016. Most recently, Mr. Bagley served as President, Chief Operating Officer and Chief Financial Officer of ZIOPHARM Oncology. Mr. Bagley began his 45 plus year career in industry at SmithKline in product management. He was later named President of E.R. Squibb U.S. before switching to the biotechnology industry, serving in Chief Executive roles at ImmuLogic, ProSript and AltaRex and as President/COO/CFO of ZIOPHARM. In these roles, Mr. Bagley completed six major biotech-partnering transactions and raised over $500 million from corporate partnering arrangements and equity offerings. Among his product achievements, he launched Tagamet® in the US at SmithKline, positioned Capoten® for heart failure, completed the pre-launch of Pravachol® at Squibb, and led the funding of Velcade® development at ProScript. Mr. Bagley also served on a senior advisory committee at MD Anderson Cancer Center, was a member of the board of the Fox Chase Cancer Center, and a founding director of BIO (the Biotechnology Industry Organization). Mr. Bagley obtained his M.A. in Teaching in Biological Sciences from the Harvard School of Education and his B.S. in Biology from Trinity College.

Stacey Channing, JD

Patent Counsel

Ms. Channing brings over 30 years of experience providing consulting services to various biotechnology, pharmaceutical, drug delivery, device and diagnostic companies in the field of intellectual property law and related legal disciplines including promulgation of an intellectual property strategy with emphasis on patent lifecycle management and negotiation of technology-based agreements. Ms. Channing has served in senior legal roles at Proscript and ImmuLogic Pharmaceutical, where she was Vice President and General Counsel. Ms. Channing received her A.B. in Biology and Political Science from Brown University and her J.D. from Boston University School of Law. She also served as an adjunct Professor at Suffolk University Law School.

Sharlene Cirillo, RPh

Head of Commercial Strategy and Business Development

Sharlene Cirillo has more than 30 years of experience in the pharmaceutical and biotech industries. Most recently she was the VP of Marketing and Commercial Strategy at Verastem Oncology and led the U.S. launch of Copiktra in chronic lymphocytic leukemia and follicular leukemia. Prior, she served as VP of Marketing at Churchill Pharmaceuticals, responsible for all marketing aspects for their portfolio of cancer products. Ms. Cirillo also brings market access experience from her time as Head of Global Market Access for the oncology portfolio at GSK/Novartis. While at GSK, she also led global and US marketing teams through several new product launches. Her broad experience includes pharmaceutical management and a variety of roles in clinical development and medical affairs at Johnson & Johnson. Ms. Cirillo earned her BS in Pharmacy from the University of Rhode Island and is a registered pharmacist.

Gregory Hileman, PhD

Head of Regulatory Affairs

Dr. Hileman has more than 25 years of pharmaceutical regulatory affairs experience, specializing in strategic global regulatory affairs, Food and Drug Administration (FDA) and European Medicines Agency (EMA) meeting management, project team leadership, and pharmaceutical sciences. His areas of therapeutic experience include neurology (sleep disturbances, pain, Alzheimer disease, migraine, epilepsy, seizure disorders, stroke), psychiatry (depression, anxiety, schizophrenia), drug addiction, antibiotics, oncology, reproductive health, osteoarthritis, and osteoporosis. Before joining Cato Research, Dr. Hileman served 19 years at GlaxoSmithKline, most recently as executive director of Global Discovery Regulatory Affairs. At Cato Research, Dr. Hileman is a senior director of regulatory affairs and a principal regulatory scientist in the Regulatory Strategy department, working with project teams guiding biologics, drugs, and medical devices through the regulatory process. He has authored multiple Investigational New Drug applications (INDs), Clinical Trial Applications, New Drug Applications (NDAs), Biologics License Applications, orphan drug designations, fast track designations, and breakthrough therapy applications in traditional and common technical document format, as well as final study reports, clinical protocols, annual reports (Development Safety Update Reports), United States (U.S.) pediatric study plans, European Union pediatric investigational plans, gap analyses, and other sponsor-specific reports, including submissions to European Union regulatory agencies. Dr. Hileman earned a B.S. in pharmacy from the St. Louis College of Pharmacy and a Ph.D. in pharmaceutical sciences and physical chemistry from the University of Missouri-Kansas City.

Robert Morgan, JD

Head of Development Operations

Mr. Morgan has been involved in drug development for over 30 years with experience in both large and small pharmaceutical companies covering multiple aspects of pre- and post-approval drug development. During his career Mr. Morgan has submitted and maintained multiple INDs, NDAs and international regulatory filings, including Orphan Drug Designation, Breakthrough Therapy Designation and Emergency Use Authorization, and has been the functional leader for multinational clinical studies in the United States and abroad. He has held positions of increasing responsibility in pharmaceutical research and has worked in the Development Operations setting in multiple therapeutic areas for companies such as Verastem Oncology, MediVector, Ziopharm Oncology, DuPont Pharmaceuticals, Genzyme, Serono and EPIX Pharmaceuticals. Mr. Morgan has a graduate degree in Medical Physics and is an attorney licensed in Massachusetts.

Michael Silverman, MD

Acting Chief Medical Officer

Michael H. Silverman, MD, FACP, is a board-certified internist with over 3 decades of experience in biopharmaceutical industry clinical research, product development, and strategic planning. His pharmaceutical industry career has included positions of increasing responsibility at both global and start-up companies, where he has managed multiple pharmaceutical and biotechnology projects across a broad scope of therapeutic areas. Dr. Silverman is the principal of BioStrategics Consulting Ltd., providing strategic and technical clinical development consulting services to development-stage biotechnology and pharmaceutical companies around the world. Prior to founding his consulting company, Dr. Silverman served as Manager, KPMG Health Care Consulting; Vice President of Clinical Research at Biopure Corporation and Executive Director of Clinical Research at Telor Ophthalmic Pharmaceuticals; Director of Clinical Research at Sandoz Research Institute in East Hanover, NJ; and Clinical Project Director at Sterling-Winthrop Research Institute in Rensselaer, NY. He was in clinical practice of medicine for seven years.

Marc Swikalus, CPA, MBA

Vice President of Finance and Controller

Marc Swikalus joined Samus Therapeutics in April 2018 as the Director of Financial Planning & Analysis and currently serves as Vice President of Finance and Controller. Mr. Swikalus brings over 22 years of finance and accounting experience within the life science, computer software and public accounting industries. Prior to joining Samus, Mr. Swikalus served as the Manager of Accounting and Reporting at Civitas Therapeutics and Manager of Budgeting and Forecasting at Ziopharm Oncology, Inc. Mr. Swikalus obtained his BS in Accounting from Bentley University and his MBA from Western New England University.

Barbara Wallner, PhD

Chief Scientific Officer

Dr. Barbara Wallner joined Samus Therapeutics in January 2017. Dr. Wallner has over 30 years of experience in biotechnology companies with domestic and international operations. Her expertise ranges from establishing corporate strategies to leading company operations in research and development, business development and intellectual property management, establishing and leading corporate partnerships, coordinating multi-company project teams and academic collaborations. Dr. Wallner obtained her B.S. and Ph.D. in Biochemistry from the University of Illinois, and spent her postdoctoral fellowship in Molecular Biology at Harvard University. She started her biotechnology career as one of the first scientists at Biogen, Inc, where she invented Amevive, which obtained market approval for psoriasis. She subsequently served as Vice President of Research and Chair of Scientific Advisory Board at Immulogic, Inc. She co-founded Point Therapeutics, Inc., a biotechnology company where she served as Chief Scientific Officer, Senior Vice President of Research and Development, and Chairman of the Scientific Advisory Board. Point Therapeutics went public and was later acquired by DARA Biosciences. Dr. Wallner then took the position of Chief Scientific Officer and Senior Vice President of Research at BioTransplant, Inc. and subsequently joined ZIOPHARM Oncology as Chief Technology Officer and Senior Vice President of Technology Operations. Dr. Wallner’s areas of scientific expertise include biochemistry, molecular biology, cell biology, immunology, and small molecule and peptide chemistry. During her career Dr. Wallner authored 43 US issued patents and more than 120 patent applications published and issued world-wide.

 

Lead Advisors for CNS Neurodegeneration and Cancer

  • Gabriela Chiosis, PhD (Co-Founder), Memorial Sloan Kettering Cancer Center
  • Howard Colman, MD, PhD, Huntsman Cancer Institute at the University of Utah
  • Jeffrey L. Cummings, MD, ScD, Cleveland Clinic Lou Ruvo Center for Brain Health
  • Howard Fillit, MD, Alzheimer’s Drug Discovery Foundation
  • John de Groot, MD, The University of Texas MD Anderson Cancer Center
  • Terry Heiman-Patterson, MD, Lewis Katz School of Medicine at Temple University
  • David Knopman, MD, Mayo Clinic
  • Larry Norton, MD (Co-Founder), Memorial Sloan Kettering Cancer Center
  • Naveen Pemmaraju, MD, The University of Texas MD Anderson Cancer Center
  • Robert Portney, MD, Massachusetts General Hospital
  • Srdan Verstovsek, MD, PhD, The University of Texas MD Anderson Cancer Center