Our ability to deliver on our promise to develop novel therapies with high clinical value begins with our experienced, passionate team. Leadiant Biosciences, Inc. is led by a team of experienced pharmaceutical executives who share a common purpose: helping people affected by rare diseases. The team’s collective knowledge and unrivaled expertise in orphan drug development guides our research, development and delivery of crucial therapies to patients who need them most.
Michael Minarich, M.B.A.
Chief Executive Officer
Mr. Minarich is the Chief Executive Officer of Leadiant Biosciences, Inc. and is responsible for leading the company’s continued commitment to rare and ultra-rare disease therapies through registration, commercialization and life-cycle management of its proprietary research and development pipeline.
Prior to joining Leadiant in 2015, Mr. Minarich provided consulting services to start-up, early and mid-stage companies in the biosciences and specialty pharmaceutical industries. He spent the previous 20 years as an expatriate in Asia (Seoul), Canada (Montreal) and Europe (Brussels & Prague) as the Market Company President, Czech Republic, for Pharmacia Corporation and at legacy company, G.D. Searle / Monsanto, with increasing responsibilities in international marketing, business development and general management.
Mr. Minarich received a Master of Business Administration in international management from the Thunderbird School of Global Management in Glendale, Arizona, a unit of Arizona State University.
Gianfranco Fornasini, Ph.D.
Senior Vice President, Scientific Affairs
Dr. Fornasini is Senior Vice President, Scientific Affairs at Leadiant Biosciences, Inc. and is responsible for the overall management of scientific programs to advance the development of Leadiant’s compounds and products. Dr. Fornasini’s expertise includes pharmacokinetics and metabolism, specifically of endogenous substances, analytical methods with emphasis on mass-spectrometry, pharmacokinetic and bioequivalence study design, and regulatory and technical aspects of chemistry manufacturing and control processes.
Dr. Fornasini joined Leadiant in 1996 as Manager of Pharmacokinetics and Drug Metabolism and has since held various regulatory and scientific roles with increasing responsibility until being appointed Senior Vice President of Scientific Affairs in 2003.
During his 30 years of experience in pharmaceuticals in Europe and the U.S., mainly spent in the drug development of small molecules and biologics for rare diseases, he has assumed a wide range of responsibilities, including analytical method development and validation, non-clinical and clinical pharmacokinetics, regulatory sciences and the life cycle management of company commercial products.
Until 2014, Dr. Forasinin also held the position of Head of Manufacturing Operations at Leadiant’s production plant in Indianapolis, a facility that specialized in the production of injectable products of pegylated proteins and liposomal formulations.
Dr. Fornasini earned his doctoral degree in pharmaceutical chemistry and technology from the University of Milan in Italy, and specialized in mass-spectrometry at the Laboratory of Pharmacology and Environmental Toxicology of the “Istituto di Ricerche Farmacologiche M.Negri” in Milan, Italy. He continued his studies at the University of Manchester in the U.K., where he received his post-doctoral training in pharmacokinetics. Dr. Fornasini has co-authored several scientific publications and is co-inventor on a variety of patents.
Vice President, Administration and Chief Financial Officer
Mr. Izzi is the Vice President, Administration and Chief Financial Officer of Leadiant Biosciences, Inc. Mr. Izzi has more than 20 years of financial experience and was previously the Financial Director for Sigma-Tau España based in Madrid, Spain.
Prior to joining Leadiant, he was an executive director with a major accounting firm, providing consulting services in capital market transactions, acquisitions and audit. Mr. Izzi received a bachelor’s degree in economics from the Università degli Studi di Roma ‘La Sapienza’.
Vice President, Commercial Operations, Pharmaceutical Products
Ms. Parsons is the Vice President, Pharmaceutical Products at Leadiant Biosciences, Inc. and is responsible for commercial operations, commercial planning, product management, sales and reimbursement for the company’s portfolio of rare disease therapies.
A proven executive with more than 30 years of experience in drug development and commercialization, Ms. Parsons has introduced multiple ground-breaking medicines on behalf of Amgen, Bristol-Myers, Elan, Enzon and Genentech.
Most recently, she led the commercial launch of Revcovi™, an enzyme replacement therapy developed by Leadiant for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
Prior to joining Leadiant in 2013, Nancy worked for six years as a medical writer in the oncology and wound care space, and she consulted with pharmaceutical companies around product development, market access, sales, marketing and strategic planning. While at Genentech, she spearheaded marketing and promotion in Canada for Activase®, a revolutionary therapy for people experiencing a heart attack. She also introduced Neupogen®, a leukocyte growth factor, on behalf of Amgen in Canada.
Ms. Parsons has played an integral role in defining access and reimbursement strategies for the products she has commercialized. She draws on her deep experience working with regulators, policymakers and payers in both the U.S. and Canada to define evidence-based approaches to pharmaceutical marketing and reimbursement.
Ms. Parsons brings deep knowledge of rare disease communities and works extensively with patient organizations and physicians to meet the needs of patients beyond their medication. Nancy earned her Master of Science degree in developmental biology and biochemistry technology from Brock University in Ontario, Canada.
Giuseppe D. Testa
Vice President, Product Development
Mr. Testa is Vice President, Product Development at Leadiant Biosciences, Inc. and is responsible for strategic and operational oversight of the development of novel therapeutics in clinical research. He has more than 30 years of experience in research and clinical development including trial planning and implementation, as well as project management, staff recruiting and training. His therapeutic experiences include cardiovascular, oncology and neurology as well as immunology.
Mr. Testa first joined Leadiant Biosciences, Inc. in 1987, serving as the Clinical Research Associate for the International Clinical Trials Division in Research & Development in Italy. In 1997, he transferred to the U.S. and most recently served as the Vice President of Clinical Development. Prior to that, Mr. Testa held a variety of positions with increasing responsibility within the company.
Mr. Testa holds a Bachelor of Arts from the Università degli Studi di Roma ‘La Sapienza’.
Joseph M. Wiley, M.D., F.A.A.P.
Vice President, Medical Affairs, Drug Safety, and Pharmacovigilance
Dr. Wiley is Vice President, Medical Affairs, Drug Safety, and Pharmacovigilance at Leadiant Biosciences, Inc. and is responsible for leading and managing Leadiant’s medical affairs operations and the drug safety and pharmacovigilance activities. Dr. Wiley directs the medical affairs strategic and operational initiatives and the medical science liaison team, as well as providing medical and scientific support of Clinical and Regulatory Affairs. Dr. Wiley supervises the drug safety team to monitor post approval adverse drug effects of the organization’s pharmaceutical portfolio. Dr. Wiley is responsible for managing the safety updates and maintenance of the safety components of the drug label. He has more than 35 years of experience and leadership in the medical field, specifically in pediatric hematology-oncology.
Prior to joining Leadiant, he served as the first Medical Director of Population Health at LifeBridge Health in Baltimore, Maryland after serving as Chairman of Pediatrics for 14 years. Previously, he has also served as the Interim Director, Cancer Institute at the Alvin and Lois Lapidus Cancer Institute, Chairman of the Medical Executive Committee, Chairman of the Institutional Review Board and Chief of the Division of Pediatric Hematology-Oncology at Sinai Hospital of Baltimore.
Dr. Wiley has contributed to more than one hundred publications and was honored as Pediatrician of the Year, Maryland Chapter, of the American Academy of Pediatrics in 2013. He received his Bachelor of Arts in mathematics from Loyola College and his M.D. from the University Of Maryland School Of Medicine. He completed his pediatric residency at The John Hopkins Hospital and a fellowship training in pediatric hematology oncology and bone marrow transplantation at The Johns Hopkins University, School of Medicine and Johns Hopkins Hospital. Dr. Wiley is a member of numerous scientific societies and serves as a board member for the Children’s Cancer Foundation in Maryland.